A Phase 2 interventional study of Pandemic Influenza Vaccine (GSK1562902A) and Fluarix™ in Influenza, sponsored by GlaxoSmithKline. Completed at 7 sites in Spain. Open to participants aged 3 Years to 9 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-10-25.
Sponsored by GlaxoSmithKline · Phase 2, Interventional, and Prevention
The present study is designed to evaluate in children (aged between 3 and 9 years) the immunogenicity and safety of different antigen doses of the candidate vaccine (GSK1562902A) administered following a two-administration schedule (21 days apart). Subjects in the control group will receive Fluarix. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
This 107066 study is a participating study to the broader NCT00502593 study, which included 2 other studies, the 108498 and 108500 studies. The NCT00502593 study had a staggered design (subjects from each group being enrolled sequentially into 2 age strata, '6-9 years' 1st, and '3-5 years' next) and was run in 3 phases, phases A (Study 107066), B (Study 108498) and C (Study 108500). In each phase, the decision to vaccinate subjects aged 3-5 years and to administer a 2nd injection to subjects aged 6-9 years was made based on safety data collected on Days 0-6 after the 1st injection for the subjects aged 6-9 years. Decision to start Phase B was made on complete safety data including those collected on Day 28 of Phase A (7 days after the 2nd injection) for each age group. A similar approach was to be used to start Phase C. As safety data in Phase A did not raise any safety concerns, Phases B and C were run in parallel.
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Exclusion criteria:
Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Biological: Pandemic Influenza Vaccine (GSK1562902A)
Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Biological: Fluarix™
Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Biological: Pandemic Influenza Vaccine (GSK1562902A)
Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Biological: Fluarix™
Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Biological: Pandemic Influenza Vaccine (GSK1562902A)
Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Biological: Fluarix™
Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Biological: Pandemic Influenza Vaccine (GSK1562902A)
Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Biological: Fluarix™
Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Biological: Pandemic Influenza Vaccine (GSK1562902A)
Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Biological: Fluarix™
Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Biological: Pandemic Influenza Vaccine (GSK1562902A)
Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
Biological: Fluarix™
2 doses, intramuscular injection on Days 0 and 21, 3 different formulations are tested.
2 doses, intramuscular injection on Days 0 and 21.
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
Titers of serum HI antibodies are presented as geometric mean titers (GMTs). The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO). The cut-off of the assay was the seropositivity cut-off value of 1:10.
Time frame: At Day 0
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
Titers of serum HI antibodies are presented as geometric mean titers (GMTs). The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO). The cut-off of the assay was the seropositivity cut-off value of 1:10
Time frame: At Day 21
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (A/VIET) and A/Indonesia/5/2005 (A/INDO). The cut-off of the assay was the seropositivity cut-off value of 1:10
Time frame: At Day 42
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
Titers of serum HI antibodies are presented as geometric mean titers (GMTs). The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO). The cut-off of the assay was the seropositivity cut-off value of 1:10.
Time frame: At Month 6
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (A/VIET) and A/Indonesia/5/2005 (A/INDO). The cut-off of the assay was the seropositivity cut-off value of 1:10
Time frame: At Month 12
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
Titers of serum HI antibodies are presented as geometric mean titers (GMTs). The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO). The cut-off of the assay was the seropositivity cut-off value of 1:10
Time frame: At Month 24
Number of Seroconverted Subjects Against 2 Strains of Influenza Disease
A seroconverted subject was a subject with a pre-vaccination serum haemagglutination-inhibition (HI) antibody titer below (\<) 1:10 and a post-vaccination HI antibody titer above than or equal to (≥)1:40 or a pre-vaccination HI antibody titer ≥ 1:10 and at least four-fold increase in post-vaccination HI antibody titer. The 2 strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO).
Time frame: At Day 21
Number of Seroconverted Subjects Against 2 Strains of Influenza Disease
A seroconverted subject was a subject with a pre-vaccination serum haemagglutination-inhibition (HI) antibody titer \< 1:10 and a post-vaccination HI antibody titer ≥1:40 or a pre-vaccination HI antibody titer ≥ 1:10 and at least four-fold increase in post-vaccination HI antibody titer. The 2 strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO).
Time frame: At Day 42
Number of Seroconverted Subjects Against 2 Strains of Influenza Disease
A seroconverted subject was a subject with a pre-vaccination serum haemagglutination-inhibition (HI) antibody titer \< 1:10 and a post-vaccination HI antibody titer ≥1:40 or a pre-vaccination HI antibody titer ≥ 1:10 and at least four-fold increase in post-vaccination HI antibody titer. The 2 strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO).
Time frame: At Month 6
Number of Seroconverted Subjects Against 2 Strains of Influenza Disease
A seroconverted subject was a subject with a pre-vaccination serum haemagglutination-inhibition (HI) antibody titer \< 1:10 and a post-vaccination HI antibody titer ≥1:40 or a pre-vaccination HI antibody titer ≥ 1:10 and at least four-fold increase in post-vaccination HI antibody titer. The 2 strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO).
Time frame: At Month 12
Number of Seroconverted Subjects Against 2 Strains of Influenza Disease
A seroconverted subject was a subject with a pre-vaccination serum haemagglutination-inhibition (HI) antibody titer \< 1:10 and a post-vaccination HI antibody titer ≥1:40 or a pre-vaccination HI antibody titer ≥ 1:10 and at least four-fold increase in post-vaccination HI antibody titer. The 2 strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO).
Time frame: At Month 24
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO).
Time frame: At Day 21
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO).
Time frame: At Day 42
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO).
Time frame: At Month 6
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 (A/VIET) and A/Indonesia/5/2005 (A/INDO).
Time frame: At Month 12
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 (A/VIET) and A/Indonesia/5/2005 (A/INDO).
Time frame: At Month 24
Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease
A seroprotected subject was defined as a vaccinated subject with a haemagglutination-inhibition (HI) antibody titer above or equal to the seroprotection threshold of 1:40. The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/5/2005 (A/INDO).
Time frame: At Day 0
Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease
A seroprotected subject was defined as a vaccinated subject with a haemagglutination-inhibition (HI) antibody titer above or equal to the seroprotection threshold of 1:40. The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/5/2005 (A/INDO).
Time frame: At Day 21
Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease
A seroprotected subject was defined as a vaccinated subject with a haemagglutination-inhibition (HI) antibody titer above or equal to the seroprotection threshold of 1:40. The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/5/2005 (A/INDO).
Time frame: At Day 42
Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease
A seroprotected subject was defined as a vaccinated subject with a haemagglutination-inhibition (HI) antibody titer above or equal to the seroprotection threshold of 1:40. The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/5/2005 (A/INDO)
Time frame: At Month 6
Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease
A seroprotected subject was defined as a vaccinated subject with a haemagglutination-inhibition (HI) antibody titer above or equal to the seroprotection threshold of 1:40. The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/5/2005 (A/INDO)
Time frame: At Month 12
Number of Seroprotected Subjects Against the 2 Strains of Influenza Disease
A seroprotected subject was defined as a vaccinated subject with a serum HI antibody titer ≥ 1:40, a level of HI antibody that has been viewed as correlating with protection against influenza. The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/5/2005 (A/INDO).
Time frame: At Month 24
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms
Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling at the injection site. Any = occurrence of a symptom regardless of intensity. Grade 3 pain = significant pain at rest/ that prevented normal activities. Grade 3 ecchymosis/induration/redness/swelling = ecchymosis/induration/redness/swelling larger than (\>) 100 millimeters (mm). All solicited local symptoms were considered to be related to study vaccination. This outcome presents results from subjects participating in Phase A of the study.
Time frame: During the 7 day follow-up period after each vaccination
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms
Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling at the injection site. Any = occurrence of a symptom regardless of intensity. Grade 3 pain = significant pain at rest/ that prevented normal activities. Grade 3 ecchymosis/induration/redness/swelling = ecchymosis/induration/redness/swelling larger than (\>) 100 millimeters (mm). All solicited local symptoms were considered to be related to study vaccination. This outcome presents results from subjects participating in Phase C of the study.
Time frame: During the 7-day follow-up period after each vaccination
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were drowsiness, fever (axillary temperature above or equal (≥) 37.5°C), irritability, loss of appetite, shivering, sweating and vomiting. Any = occurrence of a symptom regardless of intensity or relationship to vaccination. Grade 3 = general symptom that prevented normal activity. Grade 3 temperature = axillary temperature \> 39.0°C. Related = symptom assessed as causally related to study vaccination. This outcome presents results for subjects aged between 3 and 5 years participating in Phases A, B and C of the study.
Time frame: During the 7-day (Days 0-6) follow-up period after any vaccination
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Solicited general symptoms were arthralgia, fatigue, headache, muscle aches, shivering and fever, assessed as oral temperature above or equal (≥) 37.0 degrees Celsius (°C). Any = occurrence of a symptom regardless of intensity or relationship to vaccination. Grade 3 = general symptom that prevented normal activity, everyday activities, or required intervention of a physician/healthcare provider. Grade 3 fever= oral temperature ≥ 39.0°C. Related = symptom assessed as causally related to study vaccination. This outcome presents results related to subjects aged 6 to 9 years participating in the study phases A, B and C.
Time frame: During the 7-day (Days 0-6) follow-up period after any vaccination
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms
Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling at the injection site. Any = occurrence of a symptom regardless of intensity. Grade 3 pain = significant pain at rest/ that prevented normal activities. Grade 3 ecchymosis/induration/redness/swelling = ecchymosis/induration/redness/swelling larger than (\>) 100 millimeters (mm). All solicited local symptoms were considered to be related to study vaccination. This outcome presents results from subjects participating to Phase B of the study.
Time frame: During the 7-day follow-up period after each vaccination
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE = any SAE regardless of intensity or relationship to vaccination.
Time frame: During the entire study (Day 0 to Month 24)
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events
An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study. Also any "solicited" symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event. Grade 3 AE = AE that prevented normal activity, everyday activities, or required intervention of a physician/healthcare provider. Related = symptom assessed as causally related to study vaccination.
Time frame: During a 21 day follow-up period after the first vaccination, during a 30-day follow-up period after the second vaccination
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase A
Changes from baseline are categorised as below, within(normal), or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for ALT for subjects participating in Phase A of the study.
Time frame: At Days 21 and 42 and Months 6, 12 and 24
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase A
Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for AST for subjects participating in Phase A of the study.
Time frame: At Days 21 and 42 and Months 6, 12 and 24
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase A
Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for BUN for subjects participating in Phase A of the study.
Time frame: At Days 21 and 42 and Months 6, 12 and 24
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase A
Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for CPK for subjects participating in Phase A of the study.
Time frame: At Days 21 and 42 and Months 6, 12 and 24
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase A
Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for CREA for subjects participating in Phase A of the study.
Time frame: At Days 21 and 42 and Months 6, 12 and 24
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase A
Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for LDH for subjects participating in Phase A of the study
Time frame: At Days 21 and 42 and Months 6, 12 and 24
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase B
Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for ALT for subjects participating in Phase B of the study.
Time frame: At Days 21 and 42 and Months 6, 12 and 24
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase B
Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for AST for subjects participating in Phase B of the study.
Time frame: At Days 21, and 42, and at Months 6, 12 and 24
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase B
Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for BUN for subjects participating in Phase B of the study.
Time frame: At Days 21, and 42, and at Months 6, 12 and 24
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Creatine Phosphokinase (CPK) in Study Phase B
Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for CPK for subjects participating in Phase B of the study.
Time frame: At Days 21, and 42, and at Months 6, 12 and 24
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase B
Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for CREA for subjects participating in Phase B of the study.
Time frame: At Days 21, and 42, and at Months 6, 12 and 24
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Lactate Dehydrogenase (LDH) in Study Phase B
Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for LDH for subjects participating in Phase B of the study.
Time frame: At Days 21, and 42, and at Months 6, 12 and 24
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Alanine Aminotransferase (ALT) for Subjects in Study Phase C
Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for ALT for subjects participating in Phase C of the study.
Time frame: At Days 21, and 42, and at Months 6, 12 and 24
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Aspartate Aminotransferase (AST) in Study Phase C
Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for AST for subjects participating in Phase C of the study.
Time frame: At Days 21, and 42, and at Months 6, 12 and 24
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Urea Nitrogen (BUN) in Study Phase C
Changes from baseline are categorised as below, within(normal), or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for BUN for subjects participating in Phase C of the study.
Time frame: At Days 21, and 42, and at Months 6, 12 and 24
Number of Subjects With Changed Status as Regards to the Biochemical Parameter Blood Creatinine (CREA) in Study Phase C
Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for CREA for subjects participating in Phase C of the study.
Time frame: At Days 21, and 42, and at Months 6, 12 and 24
Number of Subjects With Changed Status With Regards to Creatine Phosphokinase (CPK) in Study Phase C
Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for CPK for subjects participating in Phase C of the study.
Time frame: At Days 21, and 42, and at Months 6, 12 and 24
Number of Subjects With Changed Status With Regards to Lactate Dehydrogenase (LDH) in Study Phase C
Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for LDH for subjects participating in Phase C of the study.
Time frame: At Days 21, and 42, and at Months 6, 12 and 24
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT) in Study Phase A
Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents ALT results for subjects participating in Phase A of the study.
Time frame: At Days 0, 21, and 42, and at Months 6, 12 and 24
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Aspartate Aminotransferase (AST) in Study Phase A
Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents AST results for subjects participating in Phase A of the study.
Time frame: At Days 0, 21, and 42, and at Months 6, 12 and 24
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Blood Urea Nitrogen (BUN) in Study Phase A
Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents BUN results for subjects participating in Phase A of the study.
Time frame: At Days 0, 21, and 42, and at Months 6, 12 and 24
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatinine (CREA) in Study Phase A
Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents CREA results, for subjects participating in Phase A of the study.
Time frame: At Days 0, 21, and 42, and at Months 6, 12 and 24
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatine Phosphokinase (CPK) in Study Phase A
Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents CPK results for subjects participating in Phase A of the study.
Time frame: At Days 0, 21, and 42, and at Months 6, 12 and 24
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Lactate Dehydrogenase (LDH) in Study Phase A
Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents LDH results for subjects participating in Phase A of the study.
Time frame: At Days 0, 21, and 42, and at Months 6, 12 and 24
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT) in Study Phase B
Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents AST results, for subjects participating to Phase B of the study.
Time frame: At Days 0, 21, and 42, and at Months 6, 12 and 24
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Aspartate Aminotransferase (AST) in Study Phase B
Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents AST results, for subjects participating to Phase B of the study.
Time frame: At Days 0, 21, and 42, and at Months 6, 12 and 24
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatinine (CREA) in Study Phase B
Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents CREA results, for subjects participating in Phase B of the study.
Time frame: At Days 0, 21 and 42 and at Month 6, 12 and 24
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Lactate Dehydrogenase (LDH) in Study Phase B
Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents LDH results, for subjects participating to Phase B of the study.
Time frame: At Days 0, 21, and 42, and at Months 6, 12 and 24
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Blood Urea Nitrogen (BUN) in Study Phase B
Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents BUN results, for subjects participating to Phase B of the study.
Time frame: At Days 0, 21, and 42, and at Months 6, 12 and 24
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Blood Urea Nitrogen (BUN) in Study Phase C
Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents BUN results, for subjects participating to Phase C of the study.
Time frame: At Days 0, 21 and 42 and at Months 6, 12 and 24
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALT) in Study Phase C
Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents ALT results, for subjects participating to Phase C of the study.
Time frame: At Days 0, 21, and 42, and at Months 6, 12 and 24
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatine Phosphokinase (CPK) in Study Phase B
Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents CPK results, for subjects participating to Phase B of the study.
Time frame: At Days 0, 21, and 42, and at Months 6, 12 and 24
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Aspartate Aminotransferase (AST) in Study Phase C
Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents AST results, for subjects participating to Phase C of the study.
Time frame: At Days 0, 21, and 42, and at Months 6, 12 and 24
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatine Phosphokinase (CPK) in Study Phase C
Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents CPK results, for subjects participating to Phase C of the study.
Time frame: At Days 0, 21, and 42, and at Months 6, 12 and 24
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Creatinine (CREA) in Study Phase C
Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents CREA results, for subjects participating to Phase C of the study.
Time frame: At Days 0, 21 and 42 and at Months 6, 12 and 24
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Regards to Lactate Dehydrogenase (LDH) in Study Phase C
Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents LDH results, for subjects participating to Phase C of the study.
Time frame: At Days 0, 21 and 42 and at Months 6, 12 and 24
Titers for Serum Neutralizing Antibodies Against 1 Strain of Influenza Disease
Titers of serum neutralizing antibodies are presented as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off value of 1:28. The influenza strain assessed was A/Vietnam/1194/04 (A/VIET).Results presented are for subjects participating in Phase A of the study
Time frame: At Days 0, 21 and 42
Titers for Serum Neutralizing Antibodies Against 1 Strain of Influenza Disease
Titers of serum neutralizing antibodies are presented as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off value of 1:28. The influenza strain assessed was A/Vietnam/1194/04 (A/VIET). Results presented are for subjects participating in Phase B of the study.
Time frame: At Days 0, 21 and 42
Titers for Serum Neutralizing Antibodies Against 1 Strain of Influenza Disease
Titers of serum neutralizing antibodies are presented as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off value of 1:28. The influenza strain assessed was A/Vietnam/1194/04 (A/VIET). Results presented are for subjects participating in Phase C of the study.
Time frame: At Days 0, 21 and 42
Number of Seroconverted Subjects Against One Strain of Influenza Disease With Respect to Serum Neutralizing Antibodies
A seroconverted subject as regards to serum neutralizing antibodies against influenza disease was a subject with a minimum 4-fold increase in serum neutralizing antibody titer at post-vaccination. The flu strain assessed was A/Vietnam/1194/2004 (A/VIET). This outcome presents results for subjects participating to Phase A of the study.
Time frame: At Days 21 and 42
Number of Seroconverted Subjects Against One Strain of Influenza Disease With Respect to Serum Neutralizing Antibodies
A seroconverted subject as regards to serum neutralizing antibodies against influenza disease was a subject with a minimum 4-fold increase in serum neutralizing antibody titer at post-vaccination. The flu strain assessed was A/Vietnam/1194/2004 (A/VIET). This outcome presents results for subjects participating to Phase B of the study.
Time frame: At Days 21 and 42
Number of Seroconverted Subjects Against One Strain of Influenza Disease With Respect to Serum Neutralizing Antibodies
A seroconverted subject as regards to serum neutralizing antibodies against influenza disease was a subject with a minimum 4-fold increase in serum neutralizing antibody titer at post-vaccination. The flu strain assessed was A/Vietnam/1194/2004 (A/VIET). This outcome presents results for subjects participating to Phase C of the study.
Time frame: At Days 21 and 42
Titers for Serum Neutralizing Antibodies Against 2 Strains of Influenza Disease
Titers of serum neutralizing antibodies are presented as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off value of 1:28. The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO) strains. Results presented are for subjects participating in Phase A of the study. Subjects participating to Phases B and C of the study were not analysed at these persistence time points for this outcome.
Time frame: At Months 6, 12 and 24
Number of Seroconverted Subjects Against 2 Strains of Influenza Disease as Regards to Neutralizing Antibody Response
A seroconverted subject as regards to neutralizing antibody response was a subject with a minimum 4-fold increase in neutralizing antibody titer at post-vaccination. The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO) strains. Results presented are for subjects participating in Phase A of the study. Subjects participating to Phases B and C of the study were not analysed at these persistence time points for this outcome.
Time frame: At Months 6, 12 and 24.
Number of Subjects With Adverse Events of Specific Interest (AESIs)
AESIs are adverse events such as clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. AESIs assessed included neuroinflammatory disorders such as cranial nerve disorders, multiple sclerosis,transverse myelitis, Guillain-Barré syndromeor neuritis), musculoskeletal disorders (such as systemic lupus erythematosus, cutaneous lupus, polymyositis, rheumatoid arthritis, reactive arthritis, psoriatic arthropathy, or undifferentiated spondyloarthropathy), gastrointestinal disorders (such as Crohn's disease, ulcerative colitis, ulcerative proctitis, celiac disease), metabolic diseases (such as autoimmune thyroiditis, Addison's disease). skin disorders (such as psoriasis, vitiligo, Raynaud's phenomenon, or autoimmune bullous skin diseases), and other conditions as autoimmune hemolytic anemia, thrombocytopenias, antiphospholipid syndrome, vasculitis, autoimmune hepatitis, or sarcoidosis.
Time frame: Throughout the entire study period, from Day 0 to Month 24
138 subjects were enrolled as part of the first 107066/Phase A part of this NCT00502593 study. This first part was then followed by a second and third part (Phases B \[study 108498\] and C \[study 108500\] during which 134 and 133 subjects were enrolled, respectively. Duration of the study was of 24 months for all subjects.
| Milestone | GSK1562902A-A Lot 1 3-5Y Group | Fluarix-A 3-5Y Group | GSK1562902A-A Lot 1 6-9Y Group | Fluarix-A 6-9Y Group | GSK1562902A-B Lot 2 3-5Y Group | Fluarix-B 3-5Y Group | GSK1562902A-B Lot 2 6-9Y Group | Fluarix-B 6-9Y Group | GSK1562902A-C Lot 3 3-5Y Group | Fluarix-C 3-5Y Group | GSK1562902A-C Lot 3 6-9Y Group | Fluarix-C 6-9Y Group |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Started | 51 | 18 | 51 | 18 | 51 | 17 | 49 | 17 | 49 | 17 | 49 | 18 |
| Completed | 48 | 16 | 41 | 14 | 47 | 17 | 44 | 17 | 43 | 17 | 47 | 18 |
| Not completed | 3 | 2 | 10 | 4 | 4 | 0 | 5 | 0 | 6 | 0 | 2 | 0 |
| Withdrew: Withdrawn unspecified reason | 1 | 1 | 3 | 1 | 2 | 0 | 2 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 0 | 0 | 6 | 2 | 2 | 0 | 3 | 0 | 3 | 0 | 1 | 0 |
| Withdrew: Lost to follow-up | 2 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 3 | 0 | 1 | 0 |
Titers of serum HI antibodies are presented as geometric mean titers (GMTs). The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO). The cut-off of the assay was the seropositivity cut-off value of 1:10.
| Titer | GSK1562902A-A Lot 1 3-5Y Group | Fluarix-A 3-5Y Group | GSK1562902A-A Lot 1 6-9Y Group | Fluarix-A 6-9Y Group | GSK1562902A-B Lot 2 3-5Y Group | Fluarix-B 3-5Y Group | GSK1562902A-B Lot 2 6-9Y Group | Fluarix-B 6-9Y Group | GSK1562902A-C Lot 3 3-5Y Group | Fluarix-C 3-5Y Group | GSK1562902A-C Lot 3 6-9Y Group | Fluarix-C 6-9Y Group |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| A/VIET | NA (NA to NA) | NA (NA to NA) | NA (NA to NA) | NA (NA to NA) | 5.1 (4.9 to 5.4) | NA (NA to NA) | NA (NA to NA) | NA (NA to NA) | NA (NA to NA) | NA (NA to NA) | NA (NA to NA) | NA (NA to NA) |
| A/INDO | NA (NA to NA) | NA (NA to NA) | NA (NA to NA) | NA (NA to NA) | NA (NA to NA) | NA (NA to NA) | NA (NA to NA) | NA (NA to NA) | NA (NA to NA) | NA (NA to NA) | NA (NA to NA) | NA (NA to NA) |
Titers of serum HI antibodies are presented as geometric mean titers (GMTs). The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO). The cut-off of the assay was the seropositivity cut-off value of 1:10
| Titer | GSK1562902A-A Lot 1 3-5Y Group | Fluarix-A 3-5Y Group | GSK1562902A-A Lot 1 6-9Y Group | Fluarix-A 6-9Y Group | GSK1562902A-B Lot 2 3-5Y Group | Fluarix-B 3-5Y Group | GSK1562902A-B Lot 2 6-9Y Group | Fluarix-B 6-9Y Group | GSK1562902A-C Lot 3 3-5Y Group | Fluarix-C 3-5Y Group | GSK1562902A-C Lot 3 6-9Y Group | Fluarix-C 6-9Y Group |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| A/VIET | 8.7 (6.2 to 12.3) | NA (NA to NA) | 12.1 (8.4 to 17.5) | NA (NA to NA) | 22.7 (14.6 to 35.3) | NA (NA to NA) | 23.7 (14.3 to 39.1) | NA (NA to NA) | 25.0 (16.0 to 39.3) | 5.7 (4.3 to 7.7) | 27.3 (16.2 to 46.0) | NA (NA to NA) |
| A/INDO | 5.2 (4.9 to 5.6) | NA (NA to NA) | 5.2 (4.8 to 5.8) | NA (NA to NA) | 5.5 (4.9 to 6.2) | NA (NA to NA) | 5.3 (4.9 to 5.8) | NA (NA to NA) | 7.7 (6.0 to 9.8) | NA (NA to NA) | 6.0 (5.0 to 7.2) | NA (NA to NA) |
Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (A/VIET) and A/Indonesia/5/2005 (A/INDO). The cut-off of the assay was the seropositivity cut-off value of 1:10
| Titer | GSK1562902A-A Lot 1 3-5Y Group | Fluarix-A 3-5Y Group | GSK1562902A-A Lot 1 6-9Y Group | Fluarix-A 6-9Y Group | GSK1562902A-B Lot 2 3-5Y Group | Fluarix-B 3-5Y Group | GSK1562902A-B Lot 2 6-9Y Group | Fluarix-B 6-9Y Group | GSK1562902A-C Lot 3 3-5Y Group | Fluarix-C 3-5Y Group | GSK1562902A-C Lot 3 6-9Y Group | Fluarix-C 6-9Y Group |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| A/VIET | 392.7 (280.4 to 550.2) | NA (NA to NA) | 540.3 (424.5 to 687.7) | NA (NA to NA) | 678.1 (475.7 to 966.6) | NA (NA to NA) | 615.8 (429 to 884) | NA (NA to NA) | 956.4 (769.2 to 1189.3) | NA (NA to NA) | 883.5 (737.3 to 1058.6) | NA (NA to NA) |
| A/INDO | 53.5 (35 to 81.7) | NA (NA to NA) | 60.8 (38.7 to 95.5) | NA (NA to NA) | 73.7 (45.2 to 120.3) | NA (NA to NA) | 64.9 (38.7 to 108.9) | NA (NA to NA) | 167.9 (121.7 to 231.5) | NA (NA to NA) | 92.5 (59.3 to 144.2) | NA (NA to NA) |
Titers of serum HI antibodies are presented as geometric mean titers (GMTs). The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO). The cut-off of the assay was the seropositivity cut-off value of 1:10.
| Titer | GSK1562902A-A Lot 1 3-5Y Group | Fluarix-A 3-5Y Group | GSK1562902A-A Lot 1 6-9Y Group | Fluarix-A 6-9Y Group | GSK1562902A-B Lot 2 3-5Y Group | Fluarix-B 3-5Y Group | GSK1562902A-B Lot 2 6-9Y Group | Fluarix-B 6-9Y Group | GSK1562902A-C Lot 3 3-5Y Group | Fluarix-C 3-5Y Group | GSK1562902A-C Lot 3 6-9Y Group | Fluarix-C 6-9Y Group |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| A/VIET | 29.3 (19.2 to 44.6) | 5.9 (4.2 to 8.3) | 33.4 (21.2 to 52.7) | NA (NA to NA) | 46.3 (29.8 to 72.0) | NA (NA to NA) | 43.2 (27.9 to 66.8) | NA (NA to NA) | 80.0 (47.0 to 136.4) | NA (NA to NA) | 61.5 (38.9 to 97.3) | NA (NA to NA) |
| A/INDO | 6.9 (5.6 to 8.4) | NA (NA to NA) | 6.6 (5.2 to 8.4) | NA (NA to NA) | 21.7 (14.3 to 33.0) | NA (NA to NA) | 11.9 (8.4 to 16.9) | NA (NA to NA) | 42.5 (23.7 to 76.3) | NA (NA to NA) | 36.8 (22.3 to 60.6) | NA (NA to NA) |
Titers are presented as geometric mean titers (GMTs). The 2 flu strains assessed were A/Vietnam/1194/2004 (A/VIET) and A/Indonesia/5/2005 (A/INDO). The cut-off of the assay was the seropositivity cut-off value of 1:10
| Titer | GSK1562902A-A Lot 1 3-5Y Group | Fluarix-A 3-5Y Group | GSK1562902A-A Lot 1 6-9Y Group | Fluarix-A 6-9Y Group | GSK1562902A-B Lot 2 3-5Y Group | Fluarix-B 3-5Y Group | GSK1562902A-B Lot 2 6-9Y Group | Fluarix-B 6-9Y Group | GSK1562902A-C Lot 3 3-5Y Group | Fluarix-C 3-5Y Group | GSK1562902A-C Lot 3 6-9Y Group | Fluarix-C 6-9Y Group |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| A/VIET | 13.9 (9.7 to 20.0) | NA (NA to NA) | 12.0 (8.0 to 18.1) | 5.8 (4.2 to 8.0) | 19.8 (13.6 to 28.8) | 5.2 (4.8 to 5.7) | 22.4 (15.4 to 32.5) | 5.2 (4.8 to 5.7) | 23.9 (15.1 to 37.8) | NA (NA to NA) | 27.7 (19.1 to 40.4) | 5.4 (4.6 to 6.4) |
| A/INDO | 13.0 (9.1 to 18.7) | NA (NA to NA) | 10.5 (7.0 to 15.8) | 5.5 (4.5 to 6.8) | 16.4 (11.4 to 23.5) | 5.9 (4.5 to 7.9) | 15.0 (11.1 to 20.1) | 6.5 (5.2 to 8.2) | 18.5 (11.5 to 29.9) | NA (NA to NA) | 20.4 (13.4 to 31.1) | NA (NA to NA) |
Titers of serum HI antibodies are presented as geometric mean titers (GMTs). The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO). The cut-off of the assay was the seropositivity cut-off value of 1:10
| Titer | GSK1562902A-A Lot 1 3-5Y Group | Fluarix-A 3-5Y Group | GSK1562902A-A Lot 1 6-9Y Group | Fluarix-A 6-9Y Group | GSK1562902A-B Lot 2 3-5Y Group | Fluarix-B 3-5Y Group | GSK1562902A-B Lot 2 6-9Y Group | Fluarix-B 6-9Y Group | GSK1562902A-C Lot 3 3-5Y Group | Fluarix-C 3-5Y Group | GSK1562902A-C Lot 3 6-9Y Group | Fluarix-C 6-9Y Group |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| A/VIET | 14.9 (10.3 to 21.5) | NA (NA to NA) | 13.2 (9.1 to 19.2) | NA (NA to NA) | 52.2 (33.6 to 81.1) | 6.8 (4.7 to 9.7) | 20.1 (13.9 to 29.3) | NA (NA to NA) | 55.8 (33.2 to 93.8) | 6.6 (3.5 to 12.4) | 36.5 (24.8 to 53.8) | 6.2 (3.9 to 9.8) |
| A/INDO | 10.1 (7.7 to 13.4) | NA (NA to NA) | 7.7 (5.9 to 10.0) | NA (NA to NA) | 22.7 (15.2 to 33.7) | 5.3 (4.6 to 6.1) | 8.7 (7.0 to 10.8) | NA (NA to NA) | 27.5 (16.1 to 47) | NA (NA to NA) | 18.2 (12.1 to 27.6) | NA (NA to NA) |
A seroconverted subject was a subject with a pre-vaccination serum haemagglutination-inhibition (HI) antibody titer below (\<) 1:10 and a post-vaccination HI antibody titer above than or equal to (≥)1:40 or a pre-vaccination HI antibody titer ≥ 1:10 and at least four-fold increase in post-vaccination HI antibody titer. The 2 strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO).
| Participants | GSK1562902A-A Lot 1 3-5Y Group | Fluarix-A 3-5Y Group | GSK1562902A-A Lot 1 6-9Y Group | Fluarix-A 6-9Y Group | GSK1562902A-B Lot 2 3-5Y Group | Fluarix-B 3-5Y Group | GSK1562902A-B Lot 2 6-9Y Group | Fluarix-B 6-9Y Group | GSK1562902A-C Lot 3 3-5Y Group | Fluarix-C 3-5Y Group | GSK1562902A-C Lot 3 6-9Y Group | Fluarix-C 6-9Y Group |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| A/VIET | 6 | 0 | 13 | 0 | 20 | 0 | 19 | 0 | 20 | 1 | 17 | 0 |
| A/INDO | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 3 | 0 | 1 | 0 |
A seroconverted subject was a subject with a pre-vaccination serum haemagglutination-inhibition (HI) antibody titer \< 1:10 and a post-vaccination HI antibody titer ≥1:40 or a pre-vaccination HI antibody titer ≥ 1:10 and at least four-fold increase in post-vaccination HI antibody titer. The 2 strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO).
| Participants | GSK1562902A-A Lot 1 3-5Y Group | Fluarix-A 3-5Y Group | GSK1562902A-A Lot 1 6-9Y Group | Fluarix-A 6-9Y Group | GSK1562902A-B Lot 2 3-5Y Group | Fluarix-B 3-5Y Group | GSK1562902A-B Lot 2 6-9Y Group | Fluarix-B 6-9Y Group | GSK1562902A-C Lot 3 3-5Y Group | Fluarix-C 3-5Y Group | GSK1562902A-C Lot 3 6-9Y Group | Fluarix-C 6-9Y Group |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| A/VIET | 47 | 0 | 43 | 0 | 41 | 0 | 44 | 0 | 44 | 0 | 43 | 0 |
| A/INDO | 35 | 0 | 32 | 0 | 32 | 0 | 31 | 0 | 42 | 0 | 34 | 0 |
A seroconverted subject was a subject with a pre-vaccination serum haemagglutination-inhibition (HI) antibody titer \< 1:10 and a post-vaccination HI antibody titer ≥1:40 or a pre-vaccination HI antibody titer ≥ 1:10 and at least four-fold increase in post-vaccination HI antibody titer. The 2 strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO).
| Participants | GSK1562902A -A Lot 1 3-5Y Group | Fluarix-A 3-5Y Group | GSK1562902A-A Lot 1 6-9Y Group | Fluarix-A 6-9Y Group | GSK1562902A-B Lot 2 3-5Y Group | Fluarix-B 3-5Y Group | GSK1562902A-B Lot 2 6-9Y Group | Fluarix-B 6-9Y Group | GSK1562902A-C Lot 3 3-5Y Group | Fluarix-C 3-5Y Group | GSK1562902A-C Lot 3 6-9Y Group | Fluarix-C 6-9Y Group |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| A/VIET | 28 | 1 | 25 | 0 | 32 | 0 | 31 | 0 | 24 | 0 | 32 | 0 |
| A/INDO | 3 | 0 | 1 | 0 | 23 | 0 | 12 | 0 | 20 | 0 | 25 | 0 |
A seroconverted subject was a subject with a pre-vaccination serum haemagglutination-inhibition (HI) antibody titer \< 1:10 and a post-vaccination HI antibody titer ≥1:40 or a pre-vaccination HI antibody titer ≥ 1:10 and at least four-fold increase in post-vaccination HI antibody titer. The 2 strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO).
| Participants | GSK1562902A-A Lot 1 3-5Y Group | Fluarix-A 3-5Y Group | GSK1562902A-A Lot 1 6-9Y Group | Fluarix-A 6-9Y Group | GSK1562902A-B Lot 2 3-5Y Group | Fluarix-B 3-5Y Group | GSK1562902A-B Lot 2 6-9Y Group | Fluarix-B 6-9Y Group | GSK1562902A-C Lot 3 3-5Y Group | Fluarix-C 3-5Y Group | GSK1562902A-C Lot 3 6-9Y Group | Fluarix-C 6-9Y Group |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| A/VIET | 18 | 0 | 8 | 1 | 17 | 0 | 20 | 0 | 13 | 0 | 22 | 0 |
| A/INDO | 17 | 0 | 6 | 0 | 16 | 1 | 7 | 0 | 12 | 0 | 15 | 0 |
A seroconverted subject was a subject with a pre-vaccination serum haemagglutination-inhibition (HI) antibody titer \< 1:10 and a post-vaccination HI antibody titer ≥1:40 or a pre-vaccination HI antibody titer ≥ 1:10 and at least four-fold increase in post-vaccination HI antibody titer. The 2 strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO).
| Participants | GSK1562902A-A Lot 1 3-5Y Group | Fluarix-A 3-5Y Group | GSK1562902A-A Lot 1 6-9Y Group | Fluarix-A 6-9Y Group | GSK1562902A-B Lot 2 3-5Y Group | Fluarix-B 3-5Y Group | GSK1562902A-B Lot 2 6-9Y Group | Fluarix-B 6-9Y Group | GSK1562902A-C Lot 3 3-5Y Group | Fluarix-C 3-5Y Group | GSK1562902A-C Lot 3 6-9Y Group | Fluarix-C 6-9Y Group |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| A/VIET | 18 | 0 | 8 | 0 | 30 | 1 | 18 | 0 | 19 | 1 | 23 | 1 |
| A/INDO | 5 | 0 | 3 | 0 | 19 | 0 | 2 | 0 | 14 | 0 | 10 | 0 |
The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO).
| Fold | GSK1562902A -A Lot 1 3-5Y Group | Fluarix-A 3-5Y Group | GSK1562902A-A Lot 1 6-9Y Group | Fluarix-A 6-9Y Group | GSK1562902A-B Lot 2 3-5Y Group | Fluarix-B 3-5Y Group | GSK1562902A-B Lot 2 6-9Y Group | Fluarix-B 6-9Y Group | GSK1562902A-C Lot 3 3-5Y Group | Fluarix-C 3-5Y Group | GSK1562902A-C Lot 3 6-9Y Group | Fluarix-C 6-9Y Group |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| A/VIET | 1.7 (1.2 to 2.5) | NA (NA to NA) | 2.4 (1.7 to 3.5) | NA (NA to NA) | 4.4 (2.9 to 6.8) | NA (NA to NA) | 4.7 (2.9 to 7.8) | NA (NA to NA) | 5.0 (3.2 to 7.9) | 1.1 (0.9 to 1.5) | 5.5 (3.2 to 9.2) | NA (NA to NA) |
| A/INDO | NA (NA to NA) | NA (NA to NA) | NA (NA to NA) | NA (NA to NA) | 1.1 (1.0 to 1.2) | NA (NA to NA) | 1.1 (1.0 to 1.2) | NA (NA to NA) | 1.5 (1.2 to 2.0) | NA (NA to NA) | 1.2 (1.0 to 1.4) | NA (NA to NA) |
The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO).
| Fold | GSK1562902A-A Lot 1 3-5Y Group | Fluarix-A 3-5Y Group | GSK1562902A-A Lot 1 6-9Y Group | Fluarix-A 6-9Y Group | GSK1562902A-B Lot 2 3-5Y Group | Fluarix-B 3-5Y Group | GSK1562902A-B Lot 2 6-9Y Group | Fluarix-B 6-9Y Group | GSK1562902A-C Lot 3 3-5Y Group | Fluarix-C 3-5Y Group | GSK1562902A-C Lot 3 6-9Y Group | Fluarix-C 6-9Y Group |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| A/VIET | 78.5 (56.1 to 110.0) | NA (NA to NA) | 108.1 (84.9 to 137.5) | NA (NA to NA) | 132.3 (91.8 to 190.7) | NA (NA to NA) | 123.2 (85.8 to 176.8) | NA (NA to NA) | 191.3 (153.8 to 237.9) | NA (NA to NA) | 176.7 (147.5 to 211.7) | NA (NA to NA) |
| A/INDO | 10.7 (7.0 to 16.3) | NA (NA to NA) | 12.2 (7.7 to 19.1) | NA (NA to NA) | 14.7 (9.0 to 24.1) | NA (NA to NA) | 13.0 (7.7 to 21.8) | NA (NA to NA) | 33.6 (24.3 to 46.3) | NA (NA to NA) | 18.5 (11.9 to 28.8) | NA (NA to NA) |
The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO).
| Fold | GSK1562902A-A Lot 1 3-5Y Group | Fluarix-A 3-5Y Group | GSK1562902A-A Lot 1 6-9Y Group | Fluarix-A 6-9Y Group | GSK1562902A-B Lot 2 3-5Y Group | Fluarix-B 3-5Y Group | GSK1562902A-B Lot 2 6-9Y Group | Fluarix-B 6-9Y Group | GSK1562902A-C Lot 3 3-5Y Group | Fluarix-C 3-5Y Group | GSK1562902A-C Lot 3 6-9Y Group | Fluarix-C 6-9Y Group |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| A/VIET | 5.9 (3.8 to 8.9) | 1.2 (0.8 to 1.7) | 6.1 (3.8 to 9.7) | NA (NA to NA) | 9.1 (5.8 to 14.1) | NA (NA to NA) | 8.6 (5.6 to 13.4) | NA (NA to NA) | 16.0 (9.4 to 27.3) | NA (NA to NA) | 12.3 (7.8 to 19.5) | NA (NA to NA) |
| A/INDO | 1.4 (1.1 to 1.7) | NA (NA to NA) | 1.2 (1.0 to 1.5) | 1.2 (1.0 to 1.5) | 4.3 (2.9 to 6.6) | 1.1 (0.9 to 1.4) | 2.4 (1.7 to 3.4) | NA (NA to NA) | 8.5 (4.7 to 15.3) | NA (NA to NA) | 7.4 (4.5 to 12.1) | NA (NA to NA) |
The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 (A/VIET) and A/Indonesia/5/2005 (A/INDO).
| Fold | GSK1562902A-A Lot 1 3-5Y Group | Fluarix-A 3-5Y Group | GSK1562902A-A Lot 1 6-9Y Group | Fluarix-A 6-9Y Group | GSK1562902A-B Lot 2 3-5Y Group | Fluarix-B 3-5Y Group | GSK1562902A-B Lot 2 6-9Y Group | Fluarix-B 6-9Y Group | GSK1562902A-C Lot 3 3-5Y Group | Fluarix-C 3-5Y Group | GSK1562902A-C Lot 3 6-9Y Group | Fluarix-C 6-9Y Group |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| A/VIET | 2.8 (1.9 to 4.0) | NA (NA to NA) | 2.2 (1.5 to 3.3) | 1.2 (0.8 to 1.6) | 4.0 (2.7 to 5.8) | 1.0 (1.0 to 1.1) | 4.5 (3.1 to 6.5) | 1.0 (1.0 to 1.1) | 4.8 (3.0 to 7.6) | NA (NA to NA) | 5.5 (3.8 to 8.1) | 1.1 (0.9 to 1.3) |
| A/INDO | 2.6 (1.8 to 3.7) | NA (NA to NA) | 1.9 (1.3 to 2.8) | 1.1 (0.9 to 1.4) | 3.3 (2.3 to 4.7) | 1.2 (0.9 to 1.6) | 3.0 (2.2 to 4.0) | 1.3 (1.0 to 1.6) | 3.7 (2.3 to 6.0) | NA (NA to NA) | 4.1 (2.7 to 6.2) | NA (NA to NA) |
The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 2 flu strains assessed were A/Vietnam/1194/2004 (A/VIET) and A/Indonesia/5/2005 (A/INDO).
| Fold | GSK1562902A-A Lot 1 3-5Y Group | Fluarix-A 3-5Y Group | GSK1562902A-A Lot 1 6-9Y Group | Fluarix-A 6-9Y Group | GSK1562902A-B Lot 2 3-5Y Group | Fluarix-B 3-5Y Group | GSK1562902A-B Lot 2 6-9Y Group | Fluarix-B 6-9Y Group | GSK1562902A-C Lot 3 3-5Y Group | Fluarix-C 3-5Y Group | GSK1562902A-C Lot 3 6-9Y Group | Fluarix-C 6-9Y Group |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| A/VIET | 3.0 (2.1 to 4.3) | NA (NA to NA) | 2.5 (1.7 to 3.6) | NA (NA to NA) | 10.4 (6.7 to 16.2) | 1.4 (0.9 to 1.9) | 4.0 (2.8 to 5.9) | NA (NA to NA) | 11.2 (6.6 to 18.8) | 1.3 (0.7 to 2.5) | 7.3 (5.0 to 10.8) | 1.2 (0.8 to 2.0) |
| A/INDO | 2.0 (1.5 to 2.7) | NA (NA to NA) | 1.5 (1.1 to 1.9) | NA (NA to NA) | 4.5 (3.0 to 6.7) | 1.1 (0.9 to 1.2) | 1.7 (1.4 to 2.2) | NA (NA to NA) | 5.5 (3.2 to 9.4) | NA (NA to NA) | 3.6 (2.4 to 5.5) | NA (NA to NA) |
A seroprotected subject was defined as a vaccinated subject with a haemagglutination-inhibition (HI) antibody titer above or equal to the seroprotection threshold of 1:40. The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/5/2005 (A/INDO).
| Participants | GSK1562902A-A Lot 1 3-5Y Group | Fluarix-A 3-5Y Group | GSK1562902A-A Lot 1 6-9Y Group | Fluarix-A 6-9Y Group | GSK1562902A-B Lot 2 3-5Y Group | Fluarix-B 3-5Y Group | GSK1562902A-B Lot 2 6-9Y Group | Fluarix-B 6-9Y Group | GSK1562902A-C Lot 3 3-5Y Group | Fluarix-C 3-5Y Group | GSK1562902A-C Lot 3 6-9Y Group | Fluarix-C 6-9Y Group |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| A/VIET | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| A/INDO | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
A seroprotected subject was defined as a vaccinated subject with a haemagglutination-inhibition (HI) antibody titer above or equal to the seroprotection threshold of 1:40. The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/5/2005 (A/INDO).
| Participants | GSK1562902A-A Lot 1 3-5Y Group | Fluarix-A 3-5Y Group | GSK1562902A-A Lot 1 6-9Y Group | Fluarix-A 6-9Y Group | GSK1562902A-B Lot 2 3-5Y Group | Fluarix-B 3-5Y Group | GSK1562902A-B Lot 2 6-9Y Group | Fluarix-B 6-9Y Group | GSK1562902A-C Lot 3 3-5Y Group | Fluarix-C 3-5Y Group | GSK1562902A-C Lot 3 6-9Y Group | Fluarix-C 6-9Y Group |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| A/VIET | 6 | 0 | 13 | 0 | 20 | 0 | 19 | 0 | 20 | 1 | 17 | 0 |
| A/INDO | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 3 | 0 | 1 | 0 |
A seroprotected subject was defined as a vaccinated subject with a haemagglutination-inhibition (HI) antibody titer above or equal to the seroprotection threshold of 1:40. The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/5/2005 (A/INDO).
| Participants | GSK1562902A-A Lot 1 3-5Y Group | Fluarix-A 3-5Y Group | GSK1562902A-A Lot 1 6-9Y Group | Fluarix-A 6-9Y Group | GSK1562902A-B Lot 2 3-5Y Group | Fluarix-B 3-5Y Group | GSK1562902A-B Lot 2 6-9Y Group | Fluarix-B 6-9Y Group | GSK1562902A-C Lot 3 3-5Y Group | Fluarix-C 3-5Y Group | GSK1562902A-C Lot 3 6-9Y Group | Fluarix-C 6-9Y Group |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| A/VIET | 47 | 0 | 43 | 0 | 41 | 0 | 44 | 0 | 44 | 0 | 43 | 0 |
| A/INDO | 35 | 0 | 32 | 0 | 32 | 0 | 31 | 0 | 42 | 0 | 34 | 0 |
A seroprotected subject was defined as a vaccinated subject with a haemagglutination-inhibition (HI) antibody titer above or equal to the seroprotection threshold of 1:40. The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/5/2005 (A/INDO)
| Participants | GSK1562902A -A Lot 1 3-5Y Group | Fluarix-A 3-5Y Group | GSK1562902A-A Lot 1 6-9Y Group | Fluarix-A 6-9Y Group | GSK1562902A-B Lot 2 3-5Y Group | Fluarix-B 3-5Y Group | GSK1562902A-B Lot 2 6-9Y Group | Fluarix-B 6-9Y Group | GSK1562902A-C Lot 3 3-5Y Group | Fluarix-C 3-5Y Group | GSK1562902A-C Lot 3 6-9Y Group | Fluarix-C 6-9Y Group |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| A/VIET | 28 | 1 | 28 | 0 | 33 | 0 | 31 | 0 | 24 | 0 | 32 | 0 |
| A/INDO | 3 | 0 | 2 | 0 | 23 | 0 | 12 | 0 | 20 | 0 | 25 | 0 |
A seroprotected subject was defined as a vaccinated subject with a haemagglutination-inhibition (HI) antibody titer above or equal to the seroprotection threshold of 1:40. The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/5/2005 (A/INDO)
| Participants | GSK1562902A -A Lot 1 3-5Y Group | Fluarix-A 3-5Y Group | GSK1562902A-A Lot 1 6-9Y Group | Fluarix-A 6-9Y Group | GSK1562902A-B Lot 2 3-5Y Group | Fluarix-B 3-5Y Group | GSK1562902A-B Lot 2 6-9Y Group | Fluarix-B 6-9Y Group | GSK1562902A-C Lot 3 3-5Y Group | Fluarix-C 3-5Y Group | GSK1562902A-C Lot 3 6-9Y Group | Fluarix-C 6-9Y Group |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| A/VIET | 18 | 0 | 9 | 1 | 17 | 0 | 20 | 0 | 13 | 0 | 22 | 0 |
| A/INDO | 17 | 0 | 7 | 0 | 16 | 1 | 7 | 0 | 12 | 0 | 15 | 0 |
A seroprotected subject was defined as a vaccinated subject with a serum HI antibody titer ≥ 1:40, a level of HI antibody that has been viewed as correlating with protection against influenza. The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/5/2005 (A/INDO).
| Participants | GSK1562902A-A Lot 1 3-5Y Group | Fluarix-A 3-5Y Group | GSK1562902A-A Lot 1 6-9Y Group | Fluarix-A 6-9Y Group | GSK1562902A-B Lot 2 3-5Y Group | Fluarix-B 3-5Y Group | GSK1562902A-B Lot 2 6-9Y Group | Fluarix-B 6-9Y Group | GSK1562902A-C Lot 3 3-5Y Group | Fluarix-C 3-5Y Group | GSK1562902A-C Lot 3 6-9Y Group | Fluarix-C 6-9Y Group |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| A/VIET | 18 | 0 | 9 | 0 | 30 | 1 | 18 | 0 | 19 | 1 | 23 | 1 |
| A/INDO | 5 | 0 | 4 | 0 | 19 | 0 | 2 | 0 | 14 | 0 | 10 | 0 |
Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling at the injection site. Any = occurrence of a symptom regardless of intensity. Grade 3 pain = significant pain at rest/ that prevented normal activities. Grade 3 ecchymosis/induration/redness/swelling = ecchymosis/induration/redness/swelling larger than (\>) 100 millimeters (mm). All solicited local symptoms were considered to be related to study vaccination. This outcome presents results from subjects participating in Phase A of the study.
| Participants | GSK1562902A-A Lot 1 3-5Y Group | Fluarix-A 3-5Y Group | GSK1562902A-A Lot 1 6-9Y Group | Fluarix-A 6-9Y Group |
|---|---|---|---|---|
| Any ecchymosis | 9 | 3 | 3 | 2 |
| Ecchymosis >50mm | 0 | 0 | 0 | 0 |
| Any induration | 7 | 1 | 12 | 6 |
| Induration >50mm | 1 | 0 | 0 | 1 |
| Any pain | 31 | 7 | 44 | 12 |
| Grade 3 pain | 2 | 0 | 5 | 0 |
| Any redness | 10 | 2 | 12 | 5 |
| Redness >50mm | 0 | 0 | 0 | 0 |
| Any swelling | 10 | 1 | 14 | 7 |
| Swelling >50mm | 1 | 0 | 1 | 0 |
Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling at the injection site. Any = occurrence of a symptom regardless of intensity. Grade 3 pain = significant pain at rest/ that prevented normal activities. Grade 3 ecchymosis/induration/redness/swelling = ecchymosis/induration/redness/swelling larger than (\>) 100 millimeters (mm). All solicited local symptoms were considered to be related to study vaccination. This outcome presents results from subjects participating in Phase C of the study.
| Participants | GSK1562902A-C Lot 3 3-5Y Group | Fluarix-C 3-5Y Group | GSK1562902A-C Lot 3 6-9Y Group | Fluarix-C 6-9Y Group |
|---|---|---|---|---|
| Any ecchymosis | 4 | 0 | 0 | 2 |
| Ecchymosys >50mm | 0 | 0 | 0 | 0 |
| Any induration | 14 | 0 | 10 | 1 |
| Induration >50mm | 1 | 0 | 1 | 0 |
| Any pain | 37 | 7 | 44 | 15 |
| Grade 3 pain | 5 | 0 | 3 | 0 |
| Any redness | 16 | 2 | 6 | 1 |
| Redness >50mm | 1 | 0 | 2 | 0 |
| Any swelling | 18 | 2 | 14 | 3 |
| Swelling >50mm | 2 | 0 | 2 | 0 |
Assessed solicited general symptoms were drowsiness, fever (axillary temperature above or equal (≥) 37.5°C), irritability, loss of appetite, shivering, sweating and vomiting. Any = occurrence of a symptom regardless of intensity or relationship to vaccination. Grade 3 = general symptom that prevented normal activity. Grade 3 temperature = axillary temperature \> 39.0°C. Related = symptom assessed as causally related to study vaccination. This outcome presents results for subjects aged between 3 and 5 years participating in Phases A, B and C of the study.
| Participants | GSK1562902A-A Lot 1 3-5Y Group | Fluarix-A 3-5Y Group | GSK1562902A-B Lot 2 3-5Y Group | Fluarix-B 3-5Y Group | GSK1562902A-C Lot 3 3-5Y Group | Fluarix-C 3-5Y Group |
|---|---|---|---|---|---|---|
| Any drowsiness | 7 | 1 | 9 | 1 | 12 | 1 |
| Grade 3 drowsiness | 1 | 0 | 1 | 0 | 2 | 0 |
| Related drowsiness | 6 | 1 | 6 | 0 | 12 | 1 |
| Fever (Axillary) >=37.5 deg C | 8 | 0 | 10 | 2 | 18 | 0 |
| Fever >39degC (Axillary) | 2 | 0 | 0 | 1 | 5 | 0 |
| Related fever (Axillary) | 6 | 0 | 5 | 1 | 17 | 0 |
| Any irritability | 9 | 1 | 13 | 2 | 18 | 0 |
| Grade 3 irritability | 0 | 0 | 0 | 0 | 1 | 0 |
| Related irritability | 7 | 1 | 9 | 1 | 15 | 0 |
| Any loss of appetite | 12 | 1 | 8 | 1 | 15 | 1 |
| Grade 3 loss of appetite | 3 | 0 | 1 | 0 | 5 | 0 |
| Related loss of appetite | 4 | 1 | 5 | 1 | 13 | 1 |
| Any shivering | 1 | 0 | 4 | 1 | 10 | 1 |
| Grade 3 shivering | 0 | 0 | 0 | 0 | 0 | 0 |
| Related shivering | 1 | 0 | 2 | 0 | 9 | 1 |
| Any sweating | 4 | 0 | 1 | 0 | 4 | 0 |
| Grade 3 sweating | 0 | 0 | 0 | 0 | 1 | 0 |
| Related sweating | 2 | 0 | 1 | 0 | 3 | 0 |
| Any vomiting | 7 | 0 | 6 | 0 | 6 | 1 |
| Grade 3 vomiting | 0 | 0 | 1 | 0 | 0 | 0 |
| Related vomiting | 3 | 0 | 2 | 0 | 3 | 1 |
Solicited general symptoms were arthralgia, fatigue, headache, muscle aches, shivering and fever, assessed as oral temperature above or equal (≥) 37.0 degrees Celsius (°C). Any = occurrence of a symptom regardless of intensity or relationship to vaccination. Grade 3 = general symptom that prevented normal activity, everyday activities, or required intervention of a physician/healthcare provider. Grade 3 fever= oral temperature ≥ 39.0°C. Related = symptom assessed as causally related to study vaccination. This outcome presents results related to subjects aged 6 to 9 years participating in the study phases A, B and C.
| Participants | GSK1562902A-A Lot 1 6-9Y Group | Fluarix-A 6-9Y Group | GSK1562902A-B Lot 2 6-9Y Group | Fluarix-B 6-9Y Group | GSK1562902A-C Lot 3 6-9Y Group | Fluarix-C 6-9Y Group |
|---|---|---|---|---|---|---|
| Any arthralgia | 6 | 3 | 7 | 0 | 9 | 2 |
| Grade 3 arthralgia | 0 | 0 | 1 | 0 | 0 | 0 |
| Related arthralgia | 6 | 3 | 7 | 0 | 7 | 2 |
| Any fatigue | 7 | 1 | 6 | 1 | 11 | 2 |
| Grade 3 fatigue | 0 | 0 | 0 | 0 | 1 | 0 |
| Related fatigue | 7 | 1 | 6 | 1 | 11 | 2 |
| Fever >=37.5 deg C | 7 | 3 | 3 | 0 | 18 | 0 |
| Fever >39.0 deg C | 0 | 1 | 1 | 0 | 7 | 0 |
| Related fever | 6 | 2 | 1 | 0 | 17 | 0 |
| Any gastrointestinal symptoms | 9 | 5 | 4 | 5 | 16 | 5 |
| Grade 3 gastrointestinal symptoms | 1 | 0 | 1 | 0 | 0 | 1 |
| Related gastrointestinal symptoms | 8 | 4 | 2 | 2 | 13 | 3 |
| Any headache | 20 | 5 | 11 | 2 | 25 | 3 |
| Grade 3 headache | 2 | 0 | 2 | 0 | 3 | 0 |
| Related headache | 16 | 3 | 8 | 2 | 22 | 3 |
| Any myalgia | 10 | 3 | 11 | 2 | 13 | 2 |
| Grade 3 myalgia | 1 | 0 | 1 | 0 | 1 | 0 |
| Related myalgia | 9 | 3 | 11 | 1 | 11 | 2 |
| Any shivering | 3 | 1 | 7 | 0 | 13 | 3 |
| Grade 3 Shivering | 0 | 0 | 0 | 0 | 2 | 0 |
| Related Shivering | 3 | 1 | 5 | 0 | 13 | 2 |
| Any sweating | 3 | 2 | 3 | 2 | 6 | 1 |
| Grade 3 sweating | 0 | 0 | 0 | 0 | 0 | 0 |
| Related sweating | 3 | 2 | 1 | 1 | 6 | 1 |
Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling at the injection site. Any = occurrence of a symptom regardless of intensity. Grade 3 pain = significant pain at rest/ that prevented normal activities. Grade 3 ecchymosis/induration/redness/swelling = ecchymosis/induration/redness/swelling larger than (\>) 100 millimeters (mm). All solicited local symptoms were considered to be related to study vaccination. This outcome presents results from subjects participating to Phase B of the study.
| Participants | GSK1562902A-B Lot 2 3-5Y Group | Fluarix-B 3-5Y Group | GSK1562902A-B Lot 2 6-9Y Group | Fluarix-B 6-9Y Group |
|---|---|---|---|---|
| Any ecchymosis | 4 | 0 | 4 | 1 |
| Ecchymosis >50mm | 0 | 0 | 0 | 0 |
| Any induration | 4 | 1 | 6 | 1 |
| Induration >50mm | 0 | 0 | 1 | 0 |
| Any pain | 27 | 3 | 36 | 9 |
| Grade 3 pain | 5 | 0 | 3 | 0 |
| Any redness | 6 | 4 | 6 | 3 |
| Redness >50mm | 1 | 0 | 0 | 0 |
| Any swelling | 9 | 2 | 10 | 2 |
| Swelling >50mm | 0 | 0 | 1 | 0 |
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE = any SAE regardless of intensity or relationship to vaccination.
| Participants | GSK1562902A-A Lot 1 3-5Y Group | Fluarix-A 3-5Y Group | GSK1562902A-A Lot 1 6-9Y Group | Fluarix-A 6-9Y Group | GSK1562902A-B Lot 2 3-5Y Group | Fluarix-B 3-5Y Group | GSK1562902A-B Lot 2 6-9Y Group | Fluarix-B 6-9Y Group | GSK1562902A-C Lot 3 3-5Y Group | Fluarix-C 3-5Y Group | GSK1562902A-C Lot 3 6-9Y Group | Fluarix-C 6-9Y Group |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Number of Subjects With Serious Adverse Events (SAEs) | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 2 | 0 | 1 | 0 |
An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study. Also any "solicited" symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event. Grade 3 AE = AE that prevented normal activity, everyday activities, or required intervention of a physician/healthcare provider. Related = symptom assessed as causally related to study vaccination.
| Participants | GSK1562902A-A Lot 1 3-5Y Group | Fluarix-A 3-5Y Group | GSK1562902A-A Lot 1 6-9Y Group | Fluarix-A 6-9Y Group | GSK1562902A-B Lot 2 3-5Y Group | Fluarix-B 3-5Y Group | GSK1562902A-B Lot 2 6-9Y Group | Fluarix-B 6-9Y Group | GSK1562902A-C Lot 3 3-5Y Group | Fluarix-C 3-5Y Group | GSK1562902A-C Lot 3 6-9Y Group | Fluarix-C 6-9Y Group |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Subjects with any AE(s) | 29 | 12 | 10 | 5 | 28 | 9 | 19 | 6 | 26 | 8 | 27 | 6 |
| Subjects with any Grade 3 AE(s) | 4 | 1 | 1 | 0 | 3 | 0 | 0 | 1 | 3 | 0 | 1 | 1 |
| Subjects with any related AE(s) | 6 | 2 | 2 | 1 | 3 | 1 | 4 | 1 | 9 | 0 | 3 | 1 |
Changes from baseline are categorised as below, within(normal), or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for ALT for subjects participating in Phase A of the study.
| Participants | GSK1562902A-A Lot 1 3-5Y Group | Fluarix-A 3-5Y Group | GSK1562902A-A Lot 1 6-9Y Group | Fluarix-A 6-9Y Group |
|---|---|---|---|---|
| ALT,Unknown,Day 21,Below | 0 | 0 | 0 | 0 |
| ALT,Unknown,Day 21,Normal | 1 | 0 | 0 | 1 |
| ALT,Unknown,Day 21,Above | 0 | 0 | 0 | 0 |
| ALT,Unknown,Day 21,Unknown | 0 | 0 | 0 | 0 |
| ALT,Normal,Day 21,Below | 0 | 0 | 0 | 0 |
| ALT,Normal,Day 21,Normal | 47 | 16 | 44 | 17 |
| ALT,Normal,Day 21,Above | 0 | 0 | 0 | 0 |
| ALT,Normal,Day 21,Unknown | 1 | 1 | 4 | 0 |
| ALT,Unknown,Day 42,Below | 0 | 0 | 0 | 0 |
| ALT,Unknown,Day 42,Normal | 1 | 0 | 0 | 1 |
| ALT,Unknown,Day 42,Above | 0 | 0 | 0 | 0 |
| ALT,Unknown,Day 42,Unknown | 0 | 0 | 0 | 0 |
| ALT,Normal,Day 42,Below | 0 | 0 | 0 | 0 |
| ALT,Normal,Day 42,Normal | 48 | 15 | 45 | 15 |
| ALT,Normal,Day 42,Above | 0 | 1 | 0 | 0 |
| ALT,Normal,Day 42,Unknown | 1 | 1 | 4 | 2 |
| ALT,Unknown, Month 6,Below | 0 | 0 | 0 | 0 |
| ALT,Unknown, Month 6,Normal | 1 | 0 | 0 | 1 |
| ALT,Unknown, Month 6,Above | 0 | 0 | 0 | 0 |
| ALT,Unknown, Month 6,Unknown | 0 | 0 | 0 | 0 |
| ALT,Normal, Month 6,Below | 0 | 0 | 0 | 0 |
| ALT,Normal, Month 6,Normal | 47 | 15 | 42 | 16 |
| ALT,Normal, Month 6,Above | 1 | 0 | 1 | 0 |
| ALT,Normal, Month 6,Unknown | 1 | 2 | 4 | 0 |
| ALT,Unknown, Month 12,Below | 0 | 0 | 0 | 0 |
| ALT,Unknown, Month 12,Normal | 1 | 0 | 0 | 1 |
| ALT,Unknown, Month 12,Unknown | 0 | 0 | 0 | 0 |
| ALT,Unknown, Month 12,Above | 0 | 0 | 0 | 0 |
| ALT,Normal, Month 12,Below | 0 | 0 | 0 | 0 |
| ALT,Normal, Month 12,Normal | 45 | 17 | 41 | 16 |
| ALT,Normal, Month 12,Above | 1 | 0 | 1 | 0 |
| ALT,Normal, Month 12,Unknown | 3 | 0 | 2 | 0 |
| ALT,Unknown, Month 24,Below | 0 | 0 | 0 | 0 |
| ALT,Unknown, Month 24,Normal | 1 | 0 | 0 | 1 |
| ALT,Unknown, Month 24,Above | 0 | 0 | 0 | 0 |
| ALT,Unknown, Month 24,Unknown | 0 | 0 | 0 | 0 |
| ALT,Normal, Month 24,Below | 0 | 0 | 0 | 0 |
| ALT,Normal, Month 24,Normal | 46 | 16 | 40 | 13 |
| ALT,Normal, Month 24,Above | 0 | 0 | 0 | 0 |
| ALT,Normal, Month 24,Unknown | 0 | 0 | 2 | 0 |
Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for AST for subjects participating in Phase A of the study.
| Participants | GSK1562902A-A Lot 1 3-5Y Group | Fluarix-A 3-5Y Group | GSK1562902A-A Lot 1 6-9Y Group | Fluarix-A 6-9Y Group |
|---|---|---|---|---|
| AST,Unknown,Day 21,Below | 0 | 0 | 0 | 0 |
| AST,Unknown,Day 21,Normal | 1 | 0 | 0 | 1 |
| AST,Unknown,Day 21,Above | 0 | 0 | 0 | 0 |
| AST,Unknown,Day 21,Unknown | 0 | 0 | 0 | 0 |
| AST,Normal,Day 21,Below | 0 | 0 | 0 | 0 |
| AST,Normal,Day 21,Normal | 39 | 16 | 44 | 16 |
| AST,Normal,Day 21,Above | 4 | 0 | 0 | 0 |
| AST,Normal,Day 21,Unknown | 1 | 1 | 4 | 1 |
| AST,Above,Day 21,Below | 0 | 0 | 0 | 0 |
| AST,Above,Day 21,Normal | 2 | 0 | 0 | 0 |
| AST,Above,Day 21,Above | 2 | 0 | 0 | 0 |
| AST,Above,Day 21,Unknown | 0 | 0 | 0 | 0 |
| AST,Unknown,Day 42,Below | 0 | 0 | 0 | 0 |
| AST,Unknown,Day 42,Normal | 1 | 0 | 0 | 1 |
| AST,Unknown,Day 42,Above | 0 | 0 | 0 | 0 |
| AST,Unknown,Day 42,Unknown | 0 | 0 | 0 | 0 |
| AST,Normal,Day 42,Below | 0 | 0 | 0 | 0 |
| AST,Normal,Day 42,Normal | 42 | 13 | 45 | 15 |
| AST,Normal,Day 42,Above | 2 | 2 | 0 | 0 |
| AST,Normal,Day 42,Unknown | 1 | 2 | 4 | 2 |
| AST,Above,Day 42,Below | 0 | 0 | 0 | 0 |
| AST,Above,Day 42,Normal | 3 | 0 | 0 | 0 |
| AST,Above,Day 42,Above | 1 | 0 | 0 | 0 |
| AST,Above,Day 42,Unknown | 0 | 0 | 0 | 0 |
| AST,Unknown, Month 6,Below | 0 | 0 | 0 | 0 |
| AST,Unknown, Month 6,Normal | 1 | 0 | 0 | 1 |
| AST,Unknown, Month 6,Above | 0 | 0 | 0 | 0 |
| AST,Unknown, Month 6,Unknown | 0 | 0 | 0 | 0 |
| AST,Normal, Month 6,Below | 0 | 0 | 0 | 0 |
| AST,Normal, Month 6,Normal | 42 | 14 | 42 | 16 |
| AST,Normal, Month 6,Above | 2 | 1 | 1 | 0 |
| AST,Normal, Month 6,Unknown | 1 | 2 | 4 | 0 |
| AST,Above, Month 6,Below | 0 | 0 | 0 | 0 |
| AST,Above,Month 6,Normal | 3 | 0 | 0 | 0 |
| AST,Above, Month 6,Above | 1 | 0 | 0 | 0 |
| AST,Above, Month 6,Unknown | 0 | 0 | 0 | 0 |
| AST,Unknown, Month 12,Below | 0 | 0 | 0 | 0 |
| AST,Unknown, Month 12,Normal | 1 | 0 | 0 | 1 |
| AST,Unknown, Month 12,Above | 0 | 0 | 0 | 0 |
| AST,Unknown, Month 12,Unknown | 0 | 0 | 0 | 0 |
| AST,Normal, Month 12,Below | 0 | 0 | 0 | 0 |
| AST,Normal, Month 12,Normal | 41 | 16 | 42 | 16 |
| AST,Normal, Month 12,Above | 2 | 1 | 0 | 0 |
| AST,Normal, Month 12,Unknown | 2 | 0 | 2 | 0 |
| AST,Above, Month 12,Below | 0 | 0 | 0 | 0 |
| AST,Above, Month 12,Normal | 1 | 0 | 0 | 0 |
| AST,Above, Month 12,Above | 2 | 0 | 0 | 0 |
| AST,Above, Month 12,Unknown | 1 | 0 | 0 | 0 |
| AST,Unknown, Month 24,Below | 0 | 0 | 0 | 0 |
| AST,Unknown, Month 24,Normal | 1 | 0 | 0 | 1 |
| AST,Unknown, Month 24,Above | 0 | 0 | 0 | 0 |
| AST,Unknown, Month 24,Unknown | 0 | 0 | 0 | 0 |
| AST,Normal,Month 24,Below | 0 | 0 | 0 | 0 |
| AST,Normal,Month 24,Normal | 41 | 16 | 40 | 13 |
| AST,Normal,Month 24,Above | 2 | 0 | 0 | 0 |
| AST,Normal,Month 24,Unknown | 0 | 0 | 2 | 0 |
| AST,Above,Month 24,Below | 0 | 0 | 0 | 0 |
| AST,Above,Month 24,Normal | 2 | 0 | 0 | 0 |
| AST,Above,Month 24,Above | 1 | 0 | 0 | 0 |
| AST,Above,Month 24,Unknown | 0 | 0 | 0 | 0 |
Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for BUN for subjects participating in Phase A of the study.
| Participants | GSK1562902A -A Lot 1 3-5Y Group | Fluarix-A 3-5Y Group | GSK1562902A-A Lot 1 6-9Y Group | Fluarix-A 6-9Y Group |
|---|---|---|---|---|
| BUN,Unknown, Day 21, Below | 0 | 0 | 0 | 0 |
| BUN,Unknown, Day 21, Normal | 1 | 0 | 0 | 0 |
| BUN,Unknown, Day 21, Above | 0 | 0 | 0 | 1 |
| BUN,Unknown, Day 21, Unknown | 0 | 0 | 0 | 0 |
| BUN,Normal, Day 21, Below | 0 | 1 | 0 | 0 |
| BUN,Normal, Day 21, Normal | 43 | 14 | 38 | 16 |
| BUN,Normal, Day 21, Above | 2 | 1 | 5 | 0 |
| BUN,Normal, Day 21, Unknown | 1 | 1 | 4 | 0 |
| BUN,Above, Day 21, Below | 0 | 0 | 0 | 0 |
| BUN,Above, Day 21, Normal | 1 | 0 | 1 | 0 |
| BUN,Above, Day 21, Above | 1 | 0 | 0 | 1 |
| BUN,Above, Day 21, Unknown | 0 | 0 | 0 | 0 |
| BUN,Unknown, Day 42, Below | 0 | 0 | 0 | 0 |
| BUN,Unknown, Day 42, Normal | 1 | 0 | 0 | 1 |
| BUN,Unknown, Day 42, Above | 0 | 0 | 0 | 0 |
| BUN,Unknown, Day 42, Unknown | 0 | 0 | 0 | 0 |
| BUN,Normal, Day 42, Below | 0 | 0 | 0 | 0 |
| BUN,Normal, Day 42, Normal | 40 | 16 | 38 | 12 |
| BUN,Normal, Day 42,Above | 6 | 0 | 6 | 2 |
| BUN,Normal, Day 42, Unknown | 1 | 1 | 4 | 2 |
| BUN,Above, Day 42, Below | 0 | 0 | 0 | 0 |
| BUN,Above, Day 42, Normal | 1 | 0 | 1 | 1 |
| BUN,Above, Day 42, Above | 1 | 0 | 0 | 0 |
| BUN,Above, Day 42, Unknkwn | 0 | 0 | 0 | 0 |
| BUN,Unknown, Month 6,Below | 0 | 0 | 0 | 0 |
| BUN,Unknown, Month 6,Normal | 1 | 0 | 0 | 1 |
| BUN,Unknown, Month 6,Above | 0 | 0 | 0 | 0 |
| BUN,Unknown, Month 6,Unknown | 0 | 0 | 0 | 0 |
| BUN,Normal, Month 6,Below | 0 | 1 | 0 | 0 |
| BUN,Normal, Month 6,Normal | 43 | 13 | 38 | 14 |
| BUN,Normal, Month 6,Above | 3 | 1 | 4 | 1 |
| BUN,Normal, Month 6,Unknown | 1 | 2 | 4 | 0 |
| BUN,Above, Month 6,Below | 0 | 0 | 0 | 0 |
| BUN,Above,Month 6,Normal | 2 | 0 | 1 | 0 |
| BUN,Above, Month 6,Above | 0 | 0 | 0 | 1 |
| BUN,Above, Month 6,Unknown | 0 | 0 | 0 | 0 |
| BUN,Unknown, Month 12,Below | 0 | 0 | 0 | 0 |
| BUN,Unknown, Month 12,Normal | 1 | 0 | 0 | 1 |
| BUN,Unknown, Month 12,Above | 0 | 0 | 0 | 0 |
| BUN,Unknown, Month 12,Unknown | 0 | 0 | 0 | 0 |
| BUN,Normal, Month 12,Below | 0 | 0 | 1 | 0 |
| BUN,Normal, Month 12,Normal | 41 | 16 | 40 | 13 |
| BUN,Normal, Month 12,Above | 3 | 1 | 0 | 2 |
| BUN,Normal, Month 12,Unknown | 3 | 0 | 2 | 0 |
| BUN,Above, Month 12,Below | 0 | 0 | 0 | 0 |
| BUN,Above, Month 12,Normal | 0 | 0 | 1 | 1 |
| BUN,Above, Month 12,Above | 2 | 0 | 0 | 0 |
| BUN,Above, Month 12,Unknown | 0 | 0 | 0 | 0 |
| BUN,Unknown, Month 24,Below | 0 | 0 | 0 | 0 |
| BUN,Unknown, Month 24,Normal | 1 | 0 | 0 | 1 |
| BUN,Unknown, Month 24,Above | 0 | 0 | 0 | 0 |
| BUN,Unknown, Month 24,Unknown | 0 | 0 | 0 | 0 |
| BUN,Normal, Month 24,Below | 0 | 0 | 1 | 0 |
| BUN,Normal, Month 24,Normal | 42 | 16 | 37 | 11 |
| BUN,Normal, Month 24,Above | 2 | 0 | 1 | 1 |
| BUN,Normal, Month 24,Unknown | 0 | 0 | 2 | 0 |
| BUN,Above, Month 24,Below | 0 | 0 | 0 | 0 |
| BUN,Above, Month 24,Normal | 2 | 0 | 1 | 0 |
| BUN,Above, Month 24,Above | 0 | 0 | 0 | 1 |
| BUN,Above, Month 24,Unknown | 0 | 0 | 0 | 0 |
Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for CPK for subjects participating in Phase A of the study.
| Participants | GSK1562902A-A Lot 1 3-5Y Group | Fluarix-A 3-5Y Group | GSK1562902A-A Lot 1 6-9Y Group | Fluarix-A 6-9Y Group |
|---|---|---|---|---|
| CPK,Unknown, Day 21,Below | 0 | 0 | 0 | 0 |
| CPK,Unknown, Day 21,Normal | 1 | 0 | 0 | 1 |
| CPK,Unknown, Day 21,Above | 0 | 0 | 0 | 0 |
| CPK,Unknown, Day 21,Unknown | 0 | 0 | 0 | 0 |
| CPK,Normal, Day 21, Below | 0 | 0 | 0 | 0 |
| CPK,Normal, Day 21, Normal | 44 | 15 | 42 | 16 |
| CPK,Normal, Day 21, Above | 2 | 0 | 2 | 1 |
| CPK,Normal, Day 21, Unknown | 1 | 1 | 4 | 0 |
| CPK, Above, Day 21, Below | 0 | 0 | 0 | 0 |
| CPK, Above, Day 21, Normal | 1 | 1 | 0 | 0 |
| CPK, Above, Day 21, Above | 0 | 0 | 0 | 0 |
| CPK, Above, Day 21, Unknown | 0 | 0 | 0 | 0 |
| CPK,Unknown, Day 42,Below | 0 | 0 | 0 | 0 |
| CPK,Unknown, Day 42,Normal | 1 | 0 | 0 | 1 |
| CPK,Unknown, Day 42,Above | 0 | 0 | 0 | 0 |
| CPK,Unknown, Day 42,Unknown | 0 | 0 | 0 | 0 |
| CPK,Normal, Day 42, Below | 0 | 0 | 0 | 0 |
| CPK,Normal, Day 42, Normal | 46 | 14 | 42 | 14 |
| CPK,Normal, Day 42, Above | 2 | 1 | 3 | 1 |
| CPK,Normal, Day 42, Unknown | 1 | 1 | 4 | 2 |
| CPK, Above, Day 42, Below | 0 | 0 | 0 | 0 |
| CPK, Above, Day 42, Normal | 0 | 1 | 0 | 0 |
| CPK, Above, Day 42, Above | 0 | 0 | 1 | 0 |
| CPK, Above, Day 42, Unknown | 0 | 0 | 0 | 0 |
| CPK,Unknown, Month 6,Below | 0 | 0 | 0 | 0 |
| CPK,Unknown, Month 6,Normal | 1 | 0 | 0 | 1 |
| CPK,Unknown, Month 6,Above | 0 | 0 | 0 | 0 |
| CPK,Unknown, Month 6,Unknown | 0 | 0 | 0 | 0 |
| CPK,Normal, Month 6,Below | 0 | 0 | 0 | 0 |
| CPK,Normal, Month 6,Normal | 45 | 13 | 38 | 15 |
| CPK,Normal, Month 6,Above | 2 | 1 | 5 | 1 |
| CPK,Normal, Month 6,Unknown | 1 | 2 | 4 | 0 |
| CPK,Above, Month 6,Below | 0 | 0 | 0 | 0 |
| CPK,Above,Month 6,Normal | 1 | 1 | 0 | 0 |
| CPK,Above, Month 6,Above | 0 | 0 | 0 | 0 |
| CPK,Above, Month 6,Unknown | 0 | 0 | 0 | 0 |
| CPK,Unknown, Month 12,Below | 0 | 0 | 0 | 0 |
| CPK,Unknown, Month 12,Normal | 1 | 0 | 0 | 1 |
| CPK,Unknown, Month 12,Above | 0 | 0 | 0 | 0 |
| CPK,Unknown, Month 12,Unknown | 0 | 0 | 0 | 0 |
| CPK,Normal, Month 12,Below | 0 | 0 | 0 | 0 |
| CPK,Normal, Month 12,Normal | 43 | 14 | 40 | 15 |
| CPK,Normal, Month 12,Above | 2 | 2 | 2 | 1 |
| CPK,Normal, Month 12,Unknown | 3 | 0 | 2 | 0 |
| CPK,Above, Month 12,Below | 0 | 0 | 0 | 0 |
| CPK,Above, Month 12,Normal | 1 | 1 | 0 | 0 |
| CPK,Above, Month 12,Above | 0 | 0 | 0 | 0 |
| CPK,Above, Month 12,Unknown | 0 | 0 | 0 | 0 |
| CPK,Unknown, Month 24,Below | 0 | 0 | 0 | 0 |
| CPK,Unknown, Month 24,Normal | 1 | 0 | 0 | 1 |
| CPK,Unknown, Month 24,Above | 0 | 0 | 0 | 0 |
| CPK,Unknown, Month 24,Unknown | 0 | 0 | 0 | 0 |
| CPK,Normal, Month 24,Below | 0 | 0 | 0 | 0 |
| CPK,Normal, Month 24,Normal | 45 | 14 | 36 | 12 |
| CPK,Normal, Month 24,Above | 0 | 1 | 2 | 1 |
| CPK,Normal, Month 24,Unknown | 0 | 0 | 3 | 0 |
| CPK,Above, Month 24,Below | 0 | 0 | 0 | 0 |
| CPK,Above, Month 24,Normal | 1 | 1 | 0 | 0 |
| CPK,Above, Month 24,Above | 0 | 0 | 1 | 0 |
| CPK,Above, Month 24,Unknown | 0 | 0 | 0 | 0 |
Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for CREA for subjects participating in Phase A of the study.
| Participants | GSK1562902A-A Lot 1 3-5Y Group | Fluarix-A 3-5Y Group | GSK1562902A-A Lot 1 6-9Y Group | Fluarix-A 6-9Y Group |
|---|---|---|---|---|
| CREA, Unknown, Day 21, Below | 0 | 0 | 0 | 0 |
| CREA, Unknown, Day 21, Normal | 1 | 0 | 0 | 1 |
| CREA, Unknown, Day 21, Above | 0 | 0 | 0 | 0 |
| CREA, Unknown, Day 21, Unknown | 0 | 0 | 0 | 0 |
| CREA, Normal, Day 21, Below | 0 | 0 | 0 | 0 |
| CREA, Normal, Day 21, Normal | 47 | 16 | 42 | 17 |
| CREA, Normal, Day 21, Above | 0 | 0 | 2 | 0 |
| CREA, Normal, Day 21, Unknown | 1 | 1 | 4 | 0 |
| CREA, Unknown, Day 42, Below | 0 | 0 | 0 | 0 |
| CREA, Unknown, Day 42, Normal | 1 | 0 | 0 | 1 |
| CREA, Unknown, Day 42, Above | 0 | 0 | 0 | 0 |
| CREA, Unknown, Day 42, Unknown | 0 | 0 | 0 | 0 |
| CREA, Normal, Day 42, Below | 0 | 0 | 0 | 0 |
| CREA, Normal, Day 42, Normal | 48 | 16 | 43 | 15 |
| CREA, Normal, Day 42, Above | 0 | 0 | 2 | 0 |
| CREA, Normal, Day 42, Unknown | 1 | 1 | 4 | 2 |
| CREA,Unknown, Month 6,Below | 0 | 0 | 0 | 0 |
| CREA,Unknown, Month 6,Normal | 1 | 0 | 0 | 1 |
| CREA,Unknown, Month 6,Above | 0 | 0 | 0 | 0 |
| CREA,Unknown, Month 6,Unknown | 0 | 0 | 0 | 0 |
| CREA,Normal, Month 6,Below | 0 | 0 | 0 | 0 |
| CREA,Normal, Month 6,Normal | 48 | 15 | 43 | 16 |
| CREA,Normal, Month 6,Above | 0 | 0 | 0 | 0 |
| CREA,Normal, Month 6,Unknown | 1 | 2 | 4 | 0 |
| CREA,Unknown, Month 12,Below | 0 | 0 | 0 | 0 |
| CREA,Unknown, Month 12,Normal | 1 | 0 | 0 | 1 |
| CREA,Unknown, Month 12,Above | 0 | 0 | 0 | 0 |
| CREA,Unknown, Month 12,Unknown | 0 | 0 | 0 | 0 |
| CREA,Normal, Month 12,Below | 0 | 0 | 0 | 0 |
| CREA,Normal, Month 12,Normal | 46 | 17 | 42 | 16 |
| CREA,Normal, Month 12,Above | 0 | 0 | 0 | 0 |
| CREA,Normal, Month 12,Unknown | 3 | 0 | 2 | 0 |
| CREA,Unknown, Month 24,Below | 0 | 0 | 0 | 0 |
| CREA,Unknown, Month 24,Normal | 1 | 0 | 0 | 1 |
| CREA,Unknown, Month 24,Above | 0 | 0 | 0 | 0 |
| CREA,Unknown, Month 24,Unknown | 0 | 0 | 0 | 0 |
| CREA,Normal, Month 24,Below | 0 | 0 | 0 | 0 |
| CREA,Normal, Month 24,Normal | 46 | 16 | 39 | 13 |
| CREA,Normal, Month 24,Above | 0 | 0 | 1 | 0 |
| CREA,Normal, Month 24,Unknown | 0 | 0 | 2 | 0 |
Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for LDH for subjects participating in Phase A of the study
| Participants | GSK1562902A -A Lot 1 3-5Y Group | Fluarix-A 3-5Y Group | GSK1562902A-A Lot 1 6-9Y Group | Fluarix-A 6-9Y Group |
|---|---|---|---|---|
| LDH, Unknown, Day 21, Below | 0 | 0 | 0 | 0 |
| LDH, Unknown, Day 21, Normal | 1 | 0 | 0 | 1 |
| LDH, Unknown, Day 21, Above | 0 | 0 | 0 | 0 |
| LDH, Unknown, Day 21, Unknown | 0 | 0 | 0 | 0 |
| LDH, Normal, Day 21, Below | 0 | 0 | 0 | 0 |
| LDH, Normal, Day 21, Normal | 36 | 8 | 40 | 14 |
| LDH, Normal, Day 21, Above | 2 | 3 | 3 | 2 |
| LDH, Normal, Day 21, Unknown | 1 | 1 | 4 | 1 |
| LDH, Above, Day 21, Below | 0 | 0 | 0 | 0 |
| LDH, Above, Day 21, Normal | 5 | 2 | 1 | 0 |
| LDH, Above, Day 21, Above | 4 | 3 | 0 | 0 |
| LDH, Above, Day 21, Unknown | 0 | 0 | 0 | 0 |
| LDH, Unknown, Day 42, Below | 0 | 0 | 0 | 0 |
| LDH, Unknown, Day 42, Normal | 1 | 0 | 0 | 1 |
| LDH, Unknown, Day 42, Above | 0 | 0 | 0 | 0 |
| LDH, Unknown, Day 42, Unknown | 0 | 0 | 0 | 0 |
| LDH, Normal, Day 42, Above | 7 | 4 | 4 | 1 |
| LDH, Normal, Day 42, Below | 0 | 0 | 0 | 0 |
| LDH, Normal, Day 42, Normal | 32 | 6 | 41 | 14 |
| LDH, Normal, Day 42, Unknown | 1 | 2 | 3 | 2 |
| LDH, Above, Day 42, Above | 4 | 2 | 0 | 0 |
| LDH, Above, Day 42, Below | 0 | 0 | 1 | 0 |
| LDH, Above, Day 42, Normal | 5 | 3 | 0 | 0 |
| LDH, Above, Day 42, Unknow | 0 | 0 | 0 | 0 |
| LDH,Unknown, Month 6,Below | 0 | 0 | 0 | 0 |
| LDH,Unknown, Month 6,Normal | 1 | 0 | 0 | 1 |
| LDH,Unknown, Month 6,Above | 0 | 0 | 0 | 0 |
| LDH,Unknown, Month 6,Unknown | 0 | 0 | 0 | 0 |
| LDH,Normal, Month 6,Below | 0 | 0 | 0 | 0 |
| LDH,Normal, Month 6,Normal | 31 | 7 | 38 | 13 |
| LDH,Normal, Month 6,Above | 8 | 3 | 4 | 3 |
| LDH,Normal, Month 6,Unknown | 1 | 2 | 4 | 0 |
| LDH,Above, Month 6,Below | 0 | 0 | 0 | 0 |
| LDH,Above,Month 6,Normal | 5 | 4 | 1 | 0 |
| LDH,Above, Month 6,Above | 4 | 1 | 0 | 0 |
| LDH,Above, Month 6,Unknown | 0 | 0 | 0 | 0 |
| LDH,Unknown, Month 12,Below | 0 | 0 | 0 | 0 |
| LDH,Unknown, Month 12,Normal | 1 | 0 | 0 | 1 |
| LDH,Unknown, Month 12,Above | 0 | 0 | 0 | 0 |
| LDH,Unknown, Month 12,Unknown | 0 | 0 | 0 | 0 |
| LDH,Normal, Month 12,Below | 0 | 0 | 0 | 0 |
| LDH,Normal, Month 12,Normal | 33 | 8 | 40 | 14 |
| LDH,Normal, Month 12,Above | 4 | 4 | 1 | 2 |
| LDH,Normal, Month 12,Unknown | 3 | 0 | 2 | 0 |
| LDH,Above, Month 12,Below | 0 | 0 | 0 | 0 |
| LDH,Above, Month 12,Normal | 6 | 4 | 1 | 0 |
| LDH,Above, Month 12,Above | 3 | 1 | 0 | 0 |
| LDH,Above, Month 12,Unknown | 0 | 0 | 0 | 0 |
| LDH,Unknown, Month 24,Below | 0 | 0 | 0 | 0 |
| LDH,Unknown, Month 24,Normal | 1 | 0 | 0 | 1 |
| LDH,Unknown, Month 24,Above | 0 | 0 | 0 | 0 |
| LDH,Unknown, Month 24,Unknown | 0 | 0 | 0 | 0 |
| LDH,Normal, Month 24,Below | 0 | 0 | 0 | 0 |
| LDH,Normal, Month 24,Normal | 35 | 8 | 36 | 11 |
| LDH,Normal, Month 24,Above | 3 | 3 | 3 | 2 |
| LDH,Normal, Month 24,Unknown | 0 | 0 | 3 | 0 |
| LDH,Above, Month 24,Below | 0 | 0 | 0 | 0 |
| LDH,Above, Month 24,Normal | 6 | 5 | 0 | 0 |
| LDH,Above, Month 24,Above | 2 | 0 | 0 | 0 |
| LDH,Above, Month 24,Unknown | 0 | 0 | 0 | 0 |
Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for ALT for subjects participating in Phase B of the study.
| Participants | GSK1562902A-B Lot 2 3-5Y Group | Fluarix-B 3-5Y Group | GSK1562902A-B Lot 2 6-9Y Group | Fluarix-B 6-9Y Group |
|---|---|---|---|---|
| ALT,Unknown,Day 21,Below | 0 | 0 | 0 | 0 |
| ALT,Unknown,Day 21,Normal | 0 | 0 | 1 | 0 |
| ALT,Unknown,Day 21,Above | 0 | 1 | 0 | 0 |
| ALT,Unknown,Day 21,Unknown | 0 | 0 | 0 | 0 |
| ALT,Normal,Day 21,Below | 0 | 0 | 0 | 0 |
| ALT,Normal,Day 21,Normal | 44 | 16 | 44 | 16 |
| ALT,Normal,Day 21,Above | 1 | 0 | 1 | 0 |
| ALT,Normal,Day 21,Unknown | 3 | 0 | 0 | 0 |
| ALT,Above,Day 21,Below | 0 | 0 | 0 | 0 |
| ALT,Above,Day 21,Normal | 0 | 0 | 0 | 1 |
| ALT,Above,Day 21,Above | 0 | 0 | 0 | 0 |
| ALT,Above,Day 21,Unknown | 0 | 0 | 0 | 0 |
| ALT,Unknown,Day 42,Below | 0 | 0 | 0 | 0 |
| ALT,Unknown,Day 42,Normal | 0 | 1 | 1 | 0 |
| ALT,Unknown,Day 42,Above | 0 | 0 | 0 | 0 |
| ALT,Unknown,Day 42,Unknown | 0 | 0 | 0 | 0 |
| ALT,Normal,Day 42,Below | 0 | 0 | 0 | 0 |
| ALT,Normal,Day 42,Normal | 46 | 16 | 44 | 16 |
| ALT,Normal,Day 42,Above | 1 | 0 | 2 | 0 |
| ALT,Normal,Day 42,Unknown | 2 | 0 | 0 | 0 |
| ALT,Above,Day 42,Below | 0 | 0 | 0 | 0 |
| ALT,Above,Day 42,Normal | 0 | 0 | 0 | 0 |
| ALT,Above,Day 42,Above | 0 | 0 | 0 | 1 |
| ALT,Above,Day 42,Unknown | 0 | 0 | 0 | 0 |
| ALT,Unknown,Month 6,Below | 0 | 0 | 0 | 0 |
| ALT,Unknown,Month 6,Normal | 0 | 1 | 1 | 0 |
| ALT,Unknown,Month 6,Above | 0 | 0 | 0 | 0 |
| ALT,Unknown,Month 6,Unknown | 0 | 0 | 0 | 0 |
| ALT,Normal,Month 6,Below | 0 | 0 | 0 | 0 |
| ALT,Normal,Month 6,Normal | 48 | 16 | 44 | 16 |
| ALT,Normal,Month 6,Above | 0 | 0 | 0 | 0 |
| ALT,Normal,Month 6,Unknown | 1 | 0 | 0 | 0 |
| ALT,Above,Month 6,Below | 0 | 0 | 0 | 0 |
| ALT,Above,Month 6,Normal | 0 | 0 | 0 | 1 |
| ALT,Above, Month 6,Above | 0 | 0 | 0 | 0 |
| ALT,Above, Month 6,Unknown | 0 | 0 | 0 | 0 |
| ALT,Unknown, Month 12,Below | 0 | 0 | 0 | 0 |
| ALT,Unknown, Month 12,Normal | 0 | 1 | 1 | 0 |
| ALT,Unknown, Month 12,Above | 0 | 0 | 0 | 0 |
| ALT,Unknown, Month 12,Unknown | 0 | 0 | 0 | 0 |
| ALT,Normal, Month 12,Below | 0 | 0 | 0 | 0 |
| ALT,Normal, Month 12,Normal | 44 | 16 | 44 | 16 |
| ALT,Normal, Month 12,Above | 0 | 0 | 0 | 0 |
| ALT,Normal, Month 12,Unknown | 2 | 0 | 0 | 0 |
| ALT,Above, Month 12,Below | 0 | 0 | 0 | 0 |
| ALT,Above,Month 12,Normal | 0 | 0 | 0 | 1 |
| ALT,Above, Month 12,Above | 0 | 0 | 0 | 0 |
| ALT,Above, Month 12,Unknown | 0 | 0 | 0 | 0 |
| ALT,Unknown, Month 24,Below | 0 | 0 | 0 | 0 |
| ALT,Unknown, Month 24,Normal | 0 | 1 | 0 | 0 |
| ALT,Unknown, Month 24,Above | 0 | 0 | 0 | 0 |
| ALT,Unknown, Month 24,Unknown | 0 | 0 | 0 | 0 |
| ALT,Normal, Month 24,Below | 0 | 0 | 0 | 0 |
| ALT,Normal, Month 24,Normal | 44 | 16 | 43 | 16 |
| ALT,Normal, Month 24,Above | 1 | 0 | 1 | 0 |
| ALT,Normal, Month 24,Unknown | 0 | 0 | 0 | 0 |
| ALT,Above, Month 24,Below | 0 | 0 | 0 | 0 |
| ALT,Above, Month 24,Normal | 0 | 0 | 0 | 1 |
| ALT,Above, Month 24,Above | 0 | 0 | 0 | 0 |
| ALT,Above, Month 24,Unknown | 0 | 0 | 0 | 0 |
Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for AST for subjects participating in Phase B of the study.
| Participants | GSK1562902A-B Lot 2 3-5Y Group | Fluarix-B 3-5Y Group | GSK1562902A-B Lot 2 6-9Y Group | Fluarix-B 6-9Y Group |
|---|---|---|---|---|
| AST,Unknown,Day 21,Below | 0 | 0 | 0 | 0 |
| AST,Unknown,Day 21,Normal | 0 | 0 | 1 | 0 |
| AST,Unknown,Day 21,Above | 0 | 1 | 0 | 0 |
| AST,Unknown,Day 21,Unknown | 0 | 0 | 0 | 0 |
| AST,Normal,Day 21,Below | 0 | 0 | 0 | 0 |
| AST,Normal,Day 21,Normal | 40 | 15 | 41 | 16 |
| AST,Normal,Day 21,Above | 3 | 0 | 1 | 0 |
| AST,Normal,Day 21,Unknown | 3 | 0 | 0 | 0 |
| AST,Above,Day 21,Below | 0 | 0 | 0 | 0 |
| AST,Above,Day 21,Normal | 1 | 1 | 3 | 1 |
| AST,Above,Day 21,Above | 0 | 0 | 0 | 0 |
| AST,Above,Day 21,Unknown | 1 | 0 | 0 | 0 |
| AST,Unknown,Day 42,Below | 0 | 0 | 0 | 0 |
| AST,Unknown,Day 42,Normal | 0 | 1 | 1 | 0 |
| AST,Unknown,Day 42,Above | 0 | 0 | 0 | 0 |
| AST,Unknown,Day 42,Unknown | 0 | 0 | 0 | 0 |
| AST,Normal,Day 42,Below | 0 | 0 | 0 | 0 |
| AST,Normal,Day 42,Normal | 40 | 13 | 40 | 16 |
| AST,Normal,Day 42,Above | 5 | 2 | 3 | 0 |
| AST,Normal,Day 42,Unknown | 2 | 0 | 0 | 0 |
| AST,Above,Day 42,Below | 0 | 0 | 0 | 0 |
| AST,Above,Day 42,Normal | 2 | 1 | 3 | 0 |
| AST,Above,Day 42,Above | 0 | 0 | 0 | 1 |
| AST,Above,Day 42,Unknown | 0 | 0 | 0 | 0 |
| AST,Unknown, Month 6,Below | 0 | 0 | 0 | 0 |
| AST,Unknown, Month 6,Normal | 0 | 1 | 1 | 0 |
| AST,Unknown, Month 6,Above | 0 | 0 | 0 | 0 |
| AST,Unknown, Month 6,Unknown | 0 | 0 | 0 | 0 |
| AST,Normal, Month 6,Below | 0 | 0 | 0 | 0 |
| AST,Normal, Month 6,Normal | 45 | 14 | 40 | 16 |
| AST,Normal, Month 6,Above | 2 | 1 | 0 | 0 |
| AST,Normal, Month 6,Unknown | 0 | 0 | 1 | 0 |
| AST,Above, Month 6,Below | 0 | 0 | 0 | 0 |
| AST,Above,Month 6,Normal | 2 | 1 | 3 | 1 |
| AST,Above, Month 6,Above | 0 | 0 | 0 | 0 |
| AST,Above, Month 6,Unknown | 0 | 0 | 0 | 0 |
| AST,Unknown, Month 12,Below | 0 | 0 | 0 | 0 |
| AST,Unknown, Month 12,Normal | 0 | 1 | 1 | 0 |
| AST,Unknown, Month 12,Above | 0 | 0 | 0 | 0 |
| AST,Unknown, Month 12,Unknown | 0 | 0 | 0 | 0 |
| AST,Normal, Month 12,Below | 0 | 0 | 0 | 0 |
| AST,Normal, Month 12,Normal | 44 | 15 | 41 | 16 |
| AST,Normal, Month 12,Above | 0 | 0 | 0 | 0 |
| AST,Normal, Month 12,Unknown | 1 | 0 | 0 | 0 |
| AST,Above, Month 12,Below | 0 | 0 | 0 | 0 |
| AST,Above,Month 12,Normal | 0 | 1 | 3 | 1 |
| AST,Above, Month 12,Above | 0 | 0 | 0 | 0 |
| AST,Above, Month 12,Unknown | 1 | 0 | 0 | 0 |
| AST,Unknown, Month 24,Below | 0 | 0 | 0 | 0 |
| AST,Unknown, Month 24,Normal | 0 | 1 | 0 | 0 |
| AST,Unknown, Month 24,Above | 0 | 0 | 0 | 0 |
| AST,Unknown, Month 24,Unknown | 0 | 0 | 0 | 0 |
| AST,Normal, Month 24,Below | 0 | 0 | 0 | 0 |
| AST,Normal, Month 24,Normal | 44 | 15 | 41 | 16 |
| AST,Normal, Month 24,Above | 1 | 0 | 0 | 0 |
| AST,Normal, Month 24,Unknown | 0 | 0 | 0 | 0 |
| AST,Above, Month 24,Below | 0 | 0 | 0 | 0 |
| AST,Above, Month 24,Normal | 0 | 1 | 2 | 1 |
| AST,Above, Month 24,Above | 0 | 0 | 1 | 0 |
| AST,Above, Month 24,Unknown | 0 | 0 | 0 | 0 |
Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for BUN for subjects participating in Phase B of the study.
| Participants | GSK1562902A-B Lot 2 3-5Y Group | Fluarix-B 3-5Y Group | GSK1562902A-B Lot 2 6-9Y Group | Fluarix-B 6-9Y Group |
|---|---|---|---|---|
| BUN,Unknown,Day 21,Below | 0 | 0 | 0 | 0 |
| BUN,Unknown,Day 21,Normal | 0 | 0 | 1 | 1 |
| BUN,Unknown,Day 21,Above | 0 | 1 | 0 | 0 |
| BUN,Unknown,Day 21,Unknown | 0 | 0 | 0 | 0 |
| BUN,Normal,Day 21,Below | 0 | 0 | 0 | 0 |
| BUN,Normal,Day 21,Normal | 35 | 13 | 37 | 12 |
| BUN,Normal,Day 21,Above | 6 | 1 | 3 | 1 |
| BUN,Normal,Day 21,Unknown | 3 | 0 | 0 | 0 |
| BUN,Above,Day 21,Below | 0 | 0 | 0 | 0 |
| BUN,Above,Day 21,Normal | 3 | 1 | 5 | 2 |
| BUN,Above,Day 21,Above | 1 | 1 | 0 | 1 |
| BUN,Above,Day 21,Unknown | 0 | 0 | 0 | 0 |
| BUN,Unknown,Day 42,Below | 0 | 0 | 0 | 0 |
| BUN,Unknown,Day 42,Normal | 0 | 1 | 1 | 1 |
| BUN,Unknown,Day 42,Above | 0 | 0 | 0 | 0 |
| BUN,Unknown,Day 42,Unknown | 0 | 0 | 0 | 0 |
| BUN,Normal,Day 42,Below | 0 | 0 | 0 | 0 |
| BUN,Normal,Day 42,Normal | 38 | 12 | 39 | 11 |
| BUN,Normal,Day 42,Above | 6 | 2 | 2 | 2 |
| BUN,Normal,Day 42,Unknown | 1 | 0 | 0 | 0 |
| BUN,Above,Day 42,Below | 0 | 0 | 0 | 0 |
| BUN,Above,Day 42,Normal | 2 | 1 | 3 | 2 |
| BUN,Above,Day 42,Above | 1 | 1 | 2 | 1 |
| BUN,Above,Day 42,Unknown | 1 | 0 | 0 | 0 |
| BUN,Unknown, Month 6,Below | 0 | 0 | 0 | 0 |
| BUN,Unknown, Month 6,Normal | 0 | 1 | 1 | 1 |
| BUN,Unknown, Month 6,Above | 0 | 0 | 0 | 0 |
| BUN,Unknown, Month 6,Unknown | 0 | 0 | 0 | 0 |
| BUN,Normal, Month 6,Below | 0 | 0 | 0 | 0 |
| BUN,Normal, Month 6,Normal | 42 | 12 | 39 | 13 |
| BUN,Normal, Month 6,Above | 3 | 2 | 0 | 0 |
| BUN,Normal, Month 6,Unknown | 0 | 0 | 0 | 0 |
| BUN,Above, Month 6,Below | 0 | 0 | 0 | 0 |
| BUN,Above,Month 6,Normal | 4 | 1 | 5 | 3 |
| BUN,Above, Month 6,Above | 0 | 1 | 0 | 0 |
| BUN,Above, Month 6,Unknown | 0 | 0 | 0 | 0 |
| BUN,Unknown, Month 12,Below | 0 | 0 | 0 | 0 |
| BUN,Unknown, Month 12,Normal | 0 | 1 | 1 | 1 |
| BUN,Unknown, Month 12,Above | 0 | 0 | 0 | 0 |
| BUN,Unknown, Month 12,Unknown | 0 | 0 | 0 | 0 |
| BUN,Normal, Month 12,Below | 0 | 0 | 0 | 0 |
| BUN,Normal, Month 12,Normal | 36 | 12 | 38 | 11 |
| BUN,Normal, Month 12,Above | 4 | 2 | 1 | 2 |
| BUN,Normal, Month 12,Unknown | 2 | 0 | 0 | 0 |
| BUN,Above, Month 12,Below | 0 | 0 | 0 | 0 |
| BUN,Above,Month 12,Normal | 3 | 2 | 5 | 2 |
| BUN,Above, Month 12,Above | 1 | 0 | 0 | 1 |
| BUN,Above, Month 12,Unknown | 0 | 0 | 0 | 0 |
| BUN,Unknown, Month 24,Below | 0 | 0 | 0 | 0 |
| BUN,Unknown, Month 24,Normal | 0 | 1 | 0 | 1 |
| BUN,Unknown, Month 24,Above | 0 | 0 | 0 | 0 |
| BUN,Unknown, Month 24,Unknown | 0 | 0 | 0 | 0 |
| BUN,Normal, Month 24,Below | 0 | 0 | 0 | 0 |
| BUN,Normal, Month 24,Normal | 36 | 11 | 39 | 13 |
| BUN,Normal, Month 24,Above | 5 | 3 | 0 | 0 |
| BUN,Normal, Month 24,Unknown | 0 | 0 | 0 | 0 |
| BUN,Above, Month 24,Below | 0 | 0 | 0 | 0 |
| BUN,Above, Month 24,Normal | 4 | 1 | 2 | 2 |
| BUN,Above, Month 24,Above | 0 | 1 | 3 | 1 |
| BUN,Above, Month 24,Unknown | 0 | 0 | 0 | 0 |
Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for CPK for subjects participating in Phase B of the study.
| Participants | GSK1562902A-B Lot 2 3-5Y Group | Fluarix-B 3-5Y Group | GSK1562902A-B Lot 2 6-9Y Group | Fluarix-B 6-9Y Group |
|---|---|---|---|---|
| CPK,Unknown,Day 21,Below | 0 | 0 | 0 | 0 |
| CPK,Unknown,Day 21,Normal | 0 | 1 | 1 | 0 |
| CPK,Unknown,Day 21,Above | 0 | 0 | 0 | 0 |
| CPK,Unknown,Day 21,Unknown | 0 | 0 | 0 | 0 |
| CPK,Normal,Day 21,Below | 0 | 0 | 0 | 0 |
| CPK,Normal,Day 21,Normal | 46 | 16 | 43 | 16 |
| CPK,Normal,Day 21,Above | 2 | 1 | 0 | 0 |
| CPK,Normal,Day 21,Unknown | 2 | 0 | 0 | 0 |
| CPK,Above,Day 21,Below | 0 | 0 | 0 | 0 |
| CPK,Above,Day 21,Normal | 0 | 0 | 1 | 0 |
| CPK,Above,Day 21,Above | 1 | 0 | 1 | 1 |
| CPK,Above,Day 21,Unknown | 1 | 0 | 0 | 1 |
| CPK,Unknown,Day 42,Below | 0 | 0 | 0 | 0 |
| CPK,Unknown,Day 42,Normal | 0 | 1 | 1 | 0 |
| CPK,Unknown,Day 42,Above | 0 | 0 | 0 | 0 |
| CPK,Unknown,Day 42,Unknown | 0 | 0 | 0 | 0 |
| CPK,Normal,Day 42,Below | 0 | 0 | 0 | 0 |
| CPK,Normal,Day 42,Normal | 43 | 16 | 42 | 14 |
| CPK,Normal,Day 42,Above | 2 | 2 | 2 | 0 |
| CPK,Normal,Day 42,Unknown | 2 | 0 | 0 | 0 |
| CPK,Above,Day 42,Below | 0 | 0 | 0 | 0 |
| CPK,Above,Day 42,Normal | 0 | 0 | 1 | 0 |
| CPK,Above,Day 42,Above | 2 | 0 | 1 | 1 |
| CPK,Above,Day 42,Unknown | 0 | 0 | 0 | 0 |
| CPK,Unknown, Month 6,Below | 0 | 0 | 0 | 0 |
| CPK,Unknown, Month 6,Normal | 0 | 1 | 0 | 0 |
| CPK,Unknown, Month 6,Above | 0 | 0 | 1 | 0 |
| CPK,Unknown, Month 6,Unknown | 0 | 0 | 0 | 0 |
| CPK,Normal, Month 6,Below | 0 | 0 | 0 | 0 |
| CPK,Normal, Month 6,Normal | 46 | 13 | 42 | 15 |
| CPK,Normal, Month 6,Above | 1 | 3 | 1 | 1 |
| CPK,Normal, Month 6,Unknown | 0 | 0 | 0 | 0 |
| CPK,Above, Month 6,Below | 0 | 0 | 0 | 0 |
| CPK,Above,Month 6,Normal | 1 | 0 | 1 | 0 |
| CPK,Above, Month 6,Above | 1 | 0 | 0 | 1 |
| CPK,Above, Month 6,Unknown | 0 | 0 | 0 | 0 |
| CPK,Unknown, Month 12,Below | 0 | 0 | 0 | 0 |
| CPK,Unknown, Month 12,Normal | 0 | 1 | 1 | 0 |
| CPK,Unknown, Month 12,Above | 0 | 0 | 0 | 0 |
| CPK,Unknown, Month 12,Unknown | 0 | 0 | 0 | 0 |
| CPK,Normal, Month 12,Below | 0 | 0 | 0 | 0 |
| CPK,Normal, Month 12,Normal | 39 | 13 | 42 | 16 |
| CPK,Normal, Month 12,Above | 4 | 3 | 1 | 0 |
| CPK,Normal, Month 12,Unknown | 1 | 0 | 0 | 0 |
| CPK,Above, Month 12,Below | 0 | 0 | 0 | 0 |
| CPK,Above,Month 12,Normal | 0 | 0 | 1 | 1 |
| CPK,Above, Month 12,Above | 1 | 0 | 0 | 0 |
| CPK,Above, Month 12,Unknown | 1 | 0 | 0 | 0 |
| CPK,Unknown, Month 24,Below | 0 | 0 | 0 | 0 |
| CPK,Unknown, Month 24,Normal | 0 | 1 | 0 | 0 |
| CPK,Unknown, Month 24,Above | 0 | 0 | 0 | 0 |
| CPK,Unknown, Month 24,Unknown | 0 | 0 | 0 | 0 |
| CPK,Normal, Month 24,Below | 0 | 0 | 0 | 0 |
| CPK,Normal, Month 24,Normal | 43 | 14 | 41 | 16 |
| CPK,Normal, Month 24,Above | 1 | 2 | 2 | 0 |
| CPK,Normal, Month 24,Unknown | 0 | 0 | 0 | 0 |
| CPK,Above, Month 24,Below | 0 | 0 | 0 | 0 |
| CPK,Above, Month 24,Normal | 1 | 0 | 1 | 0 |
| CPK,Above, Month 24,Above | 0 | 0 | 0 | 1 |
| CPK,Above, Month 24,Unknown | 0 | 0 | 0 | 0 |
Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for CREA for subjects participating in Phase B of the study.
| Participants | GSK1562902A-B Lot 2 3-5Y Group | Fluarix-B 3-5Y Group | GSK1562902A-B Lot 2 6-9Y Group | Fluarix-B 6-9Y Group |
|---|---|---|---|---|
| CREA,Unknown,Day 21,Below | 0 | 0 | 0 | 0 |
| CREA,Unknown,Day 21,Normal | 0 | 1 | 1 | 0 |
| CREA,Unknown,Day 21,Above | 0 | 0 | 0 | 0 |
| CREA,Unknown,Day 21,Unknown | 0 | 0 | 0 | 0 |
| CREA,Normal,Day 21,Below | 0 | 0 | 0 | 0 |
| CREA,Normal,Day 21,Normal | 44 | 16 | 43 | 17 |
| CREA,Normal,Day 21,Above | 1 | 0 | 1 | 0 |
| CREA,Normal,Day 21,Unknown | 3 | 0 | 0 | 0 |
| CREA,Above,Day 21,Below | 0 | 0 | 0 | 0 |
| CREA,Above,Day 21,Normal | 0 | 0 | 1 | 0 |
| CREA,Above,Day 21,Above | 0 | 0 | 0 | 0 |
| CREA,Above,Day 21,Unknow | 0 | 0 | 0 | 0 |
| CREA,Unknown,Day 42,Below | 0 | 0 | 0 | 0 |
| CREA,Unknown,Day 42,Normal | 0 | 1 | 1 | 0 |
| CREA,Unknown,Day 42,Above | 0 | 0 | 0 | 0 |
| CREA,Unknown,Day 42,Unknown | 0 | 0 | 0 | 0 |
| CREA,Normal,Day 42,Below | 0 | 0 | 0 | 0 |
| CREA,Normal,Day 42,Normal | 46 | 16 | 45 | 17 |
| CREA,Normal,Day 42,Above | 1 | 0 | 0 | 0 |
| CREA,Normal,Day 42,Unknown | 2 | 0 | 0 | 0 |
| CREA,Above,Day 42,Below | 0 | 0 | 0 | 0 |
| CREA,Above,Day 42,Normal | 0 | 0 | 1 | 0 |
| CREA,Above,Day 42,Above | 0 | 0 | 0 | 0 |
| CREA,Above,Day 42,Unknown | 0 | 0 | 0 | 0 |
| CREA,Unknown, Month 6,Below | 0 | 0 | 0 | 0 |
| CREA,Unknown, Month 6,Normal | 0 | 1 | 1 | 0 |
| CREA,Unknown, Month 6,Above | 0 | 0 | 0 | 0 |
| CREA,Unknown, Month 6,Unknown | 0 | 0 | 0 | 0 |
| CREA,Normal, Month 6,Below | 0 | 0 | 0 | 0 |
| CREA,Normal, Month 6,Normal | 49 | 16 | 42 | 17 |
| CREA,Normal, Month 6,Above | 0 | 0 | 1 | 0 |
| CREA,Normal, Month 6,Unknown | 0 | 0 | 0 | 0 |
| CREA,Above, Month 6,Below | 0 | 0 | 0 | 0 |
| CREA,Above, Month 6,Normal | 0 | 0 | 0 | 0 |
| CREA,Above, Month 6,Above | 0 | 0 | 1 | 0 |
| CREA,Above, Month 6,Unknown | 0 | 0 | 0 | 0 |
| CREA,Unknown, Month 12,Below | 0 | 0 | 0 | 0 |
| CREA,Unknown, Month 12,Normal | 0 | 1 | 1 | 0 |
| CREA,Unknown, Month 12,Above | 0 | 0 | 0 | 0 |
| CREA,Unknown, Month 12,Unknown | 0 | 0 | 0 | 0 |
| CREA,Normal, Month 12,Below | 0 | 0 | 0 | 0 |
| CREA,Normal, Month 12,Normal | 44 | 16 | 42 | 17 |
| CREA,Normal, Month 12,Above | 0 | 0 | 1 | 0 |
| CREA,Normal, Month 12,Unknown | 2 | 0 | 0 | 0 |
| CREA,Above, Month 12,Below | 0 | 0 | 0 | 0 |
| CREA,Above,Month 12,Normal | 0 | 0 | 1 | 0 |
| CREA,Above, Month 12,Above | 0 | 0 | 0 | 0 |
| CREA,Above, Month 12,Unknown | 0 | 0 | 0 | 0 |
| CREA,Unknown, Month 24,Below | 0 | 0 | 0 | 0 |
| CREA,Unknown, Month 24,Normal | 0 | 1 | 0 | 0 |
| CREA,Unknown, Month 24,Above | 0 | 0 | 0 | 0 |
| CREA,Unknown, Month 24,Unknown | 0 | 0 | 0 | 0 |
| CREA,Normal, Month 24,Below | 0 | 0 | 0 | 0 |
| CREA,Normal, Month 24,Normal | 45 | 16 | 43 | 17 |
| CREA,Normal, Month 24,Above | 0 | 0 | 0 | 0 |
| CREA,Normal, Month 24,Unknown | 0 | 0 | 0 | 0 |
| CREA,Above, Month 24,Below | 0 | 0 | 0 | 0 |
| CREA,Above, Month 24,Normal | 0 | 0 | 1 | 0 |
| CREA,Above, Month 24,Above | 0 | 0 | 0 | 0 |
| CREA,Above, Month 24,Unknown | 0 | 0 | 0 | 0 |
Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for LDH for subjects participating in Phase B of the study.
| Participants | GSK1562902A-B Lot 2 3-5Y Group | Fluarix-B 3-5Y Group | GSK1562902A-B Lot 2 6-9Y Group | Fluarix-B 6-9Y Group |
|---|---|---|---|---|
| LDH,Unknown,Day 21,Below | 0 | 0 | 0 | 0 |
| LDH,Unknown,Day 21,Normal | 0 | 0 | 1 | 0 |
| LDH,Unknown,Day 21,Above | 0 | 1 | 0 | 0 |
| LDH,Unknown,Day 21,Unknown | 0 | 0 | 0 | 0 |
| LDH,Normal,Day 21,Below | 0 | 0 | 0 | 0 |
| LDH,Normal,Day 21,Normal | 33 | 13 | 38 | 15 |
| LDH,Normal,Day 21,Above | 7 | 1 | 0 | 0 |
| LDH,Normal,Day 21,Unknown | 3 | 0 | 0 | 0 |
| LDH,Above,Day 21,Below | 0 | 0 | 0 | 0 |
| LDH,Above,Day 21,Normal | 2 | 1 | 3 | 1 |
| LDH,Above,Day 21,Above | 2 | 1 | 4 | 1 |
| LDH,Above,Day 21,Unknown | 1 | 0 | 0 | 0 |
| LDH,Unknown,Day 42,Below | 0 | 0 | 0 | 0 |
| LDH,Unknown,Day 42,Normal | 0 | 0 | 1 | 0 |
| LDH,Unknown,Day 42,Above | 0 | 1 | 0 | 0 |
| LDH,Unknown,Day 42,Unknown | 0 | 0 | 0 | 0 |
| LDH,Normal,Day 42,Below | 0 | 0 | 0 | 0 |
| LDH,Normal,Day 42,Normal | 33 | 9 | 37 | 14 |
| LDH,Normal,Day 42,Above | 9 | 5 | 2 | 1 |
| LDH,Normal,Day 42,Unknown | 2 | 0 | 0 | 0 |
| LDH,Above,Day 42,Below | 0 | 0 | 0 | 0 |
| LDH,Above,Day 42,Normal | 2 | 1 | 3 | 0 |
| LDH,Above,Day 42,Above | 3 | 1 | 4 | 2 |
| LDH,Above,Day 42,Unknown | 0 | 0 | 0 | 0 |
| LDH,Unknown, Month 6,Below | 0 | 0 | 0 | 0 |
| LDH,Unknown, Month 6,Normal | 0 | 1 | 1 | 0 |
| LDH,Unknown, Month 6,Above | 0 | 0 | 0 | 0 |
| LDH,Unknown, Month 6,Unknown | 0 | 0 | 0 | 0 |
| LDH,Normal, Month 6,Below | 0 | 0 | 0 | 0 |
| LDH,Normal, Month 6,Normal | 37 | 9 | 34 | 14 |
| LDH,Normal, Month 6,Above | 6 | 5 | 3 | 1 |
| LDH,Normal, Month 6,Unknown | 1 | 0 | 1 | 0 |
| LDH,Above, Month 6,Below | 0 | 0 | 0 | 0 |
| LDH,Above,Month 6,Normal | 3 | 2 | 2 | 1 |
| LDH,Above, Month 6,Above | 2 | 0 | 4 | 1 |
| LDH,Above, Month 6,Unknown | 0 | 0 | 0 | 0 |
| LDH,Unknown, Month 12,Below | 0 | 0 | 0 | 0 |
| LDH,Unknown, Month 12,Normal | 0 | 0 | 1 | 0 |
| LDH,Unknown, Month 12,Above | 0 | 1 | 0 | 0 |
| LDH,Unknown, Month 12,Unknown | 0 | 0 | 0 | 0 |
| LDH,Normal, Month 12,Below | 0 | 0 | 0 | 0 |
| LDH,Normal, Month 12,Normal | 32 | 10 | 36 | 15 |
| LDH,Normal, Month 12,Above | 9 | 4 | 2 | 0 |
| LDH,Normal, Month 12,Unknown | 1 | 0 | 0 | 0 |
| LDH,Above, Month 12,Below | 0 | 0 | 0 | 0 |
| LDH,Above,Month 12,Normal | 3 | 2 | 5 | 1 |
| LDH,Above, Month 12,Above | 0 | 0 | 1 | 1 |
| LDH,Above, Month 12,Unknown | 1 | 0 | 0 | 0 |
| LDH,Unknown, Month 24,Below | 0 | 0 | 0 | 0 |
| LDH,Unknown, Month 24,Normal | 0 | 1 | 0 | 0 |
| LDH,Unknown, Month 24,Above | 0 | 0 | 0 | 0 |
| LDH,Unknown, Month 24,Unknown | 0 | 0 | 0 | 0 |
| LDH,Normal, Month 24,Below | 0 | 0 | 0 | 0 |
| LDH,Normal, Month 24,Normal | 40 | 13 | 37 | 15 |
| LDH,Normal, Month 24,Above | 2 | 1 | 1 | 0 |
| LDH,Normal, Month 24,Unknown | 0 | 0 | 0 | 0 |
| LDH,Above, Month 24,Below | 0 | 0 | 0 | 0 |
| LDH,Above, Month 24,Normal | 3 | 2 | 4 | 0 |
| LDH,Above, Month 24,Above | 0 | 0 | 2 | 2 |
| LDH,Above, Month 24,Unknown | 0 | 0 | 0 | 0 |
Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for ALT for subjects participating in Phase C of the study.
| Participants | GSK1562902A-C Lot 3 3-5Y Group | Fluarix-C 3-5Y Group | GSK1562902A-C Lot 3 6-9Y Group | Fluarix-C 6-9Y Group |
|---|---|---|---|---|
| ALT, Unknown, Day 21, Below | 0 | 0 | 0 | 0 |
| ALT, Unknown, Day 21, Normal | 3 | 0 | 1 | 1 |
| ALT, Unknown, Day 21, Above | 0 | 0 | 0 | 0 |
| ALT, Unknown, Day 21, Unknown | 2 | 1 | 1 | 0 |
| ALT, Normal, Day 21, Below | 0 | 0 | 0 | 0 |
| ALT, Normal, Day 21, Normal | 41 | 12 | 40 | 17 |
| ALT, Normal, Day 21, Above | 0 | 0 | 0 | 0 |
| ALT, Normal, Day 21, Unknown | 1 | 3 | 4 | 0 |
| ALT, Above, Day 21, Below | 0 | 0 | 0 | 0 |
| ALT, Above, Day 21, Normal | 0 | 0 | 1 | 0 |
| ALT, Above, Day 21, Above | 1 | 0 | 0 | 0 |
| ALT, Above, Day 21, Unknown | 0 | 0 | 0 | 0 |
| ALT, Unknown, Day 42, Below | 0 | 0 | 0 | 0 |
| ALT, Unknown, Day 42, Normal | 5 | 2 | 2 | 1 |
| ALT, Unknown, Day 42, Above | 0 | 0 | 0 | 0 |
| ALT, Unknown, Day 42, Unknown | 0 | 0 | 0 | 0 |
| ALT, Normal, Day 42, Below | 0 | 0 | 0 | 0 |
| ALT, Normal, Day 42, Normal | 40 | 14 | 43 | 17 |
| ALT, Normal, Day 42, Above | 0 | 0 | 0 | 0 |
| ALT, Normal, Day 42, Unknown | 2 | 1 | 2 | 0 |
| ALT, Above, Day 42, Below | 0 | 0 | 0 | 0 |
| ALT, Above, Day 42, Normal | 1 | 0 | 1 | 0 |
| ALT, Above, Day 42, Above | 0 | 0 | 0 | 0 |
| ALT, Above, Day 42, Unknown | 0 | 0 | 0 | 0 |
| ALT, Unknown, Month 6, Below | 0 | 0 | 0 | 0 |
| ALT, Unknown, Month 6, Normal | 4 | 2 | 2 | 1 |
| ALT, Unknown, Month 6, Above | 0 | 0 | 0 | 0 |
| ALT, Unknown, Month 6, Unknown | 0 | 0 | 0 | 0 |
| ALT, Normal , Month 6, Below | 0 | 0 | 0 | 0 |
| ALT, Normal , Month 6, Normal | 36 | 13 | 41 | 17 |
| ALT, Normal , Month 6, Above | 0 | 1 | 0 | 0 |
| ALT, Normal , Month 6, Unknown | 4 | 1 | 2 | 0 |
| ALT, Above, Month 6, Below | 0 | 0 | 0 | 0 |
| ALT, Above, Month 6, Normal | 1 | 0 | 1 | 0 |
| ALT, Above, Month 6, Above | 0 | 0 | 0 | 0 |
| ALT, Above, Month 6, Unknown | 0 | 0 | 0 | 0 |
| ALT, Unknown, Month 12, Below | 0 | 0 | 0 | 0 |
| ALT, Unknown, Month 12, Normal | 3 | 2 | 2 | 1 |
| ALT, Unknown, Month 12, Above | 0 | 0 | 1 | 0 |
| ALT, Unknown, Month 12, Unknown | 0 | 0 | 0 | 0 |
| ALT, Normal , Month 12, Below | 0 | 0 | 0 | 0 |
| ALT, Normal , Month 12, Normal | 38 | 15 | 41 | 16 |
| ALT, Normal , Month 12, Above | 0 | 0 | 1 | 0 |
| ALT, Normal , Month 12, Unknown | 2 | 0 | 2 | 1 |
| ALT, Above, Month 12, Below | 0 | 0 | 0 | 0 |
| ALT, Above, Month 12, Normal | 1 | 0 | 1 | 0 |
| ALT, Above, Month 12, Above | 0 | 0 | 0 | 0 |
| ALT, Above, Month 12, Unknown | 0 | 0 | 0 | 0 |
| ALT, Unknown, Month 24, Below | 0 | 0 | 0 | 0 |
| ALT, Unknown, Month 24, Normal | 2 | 2 | 2 | 1 |
| ALT, Unknown, Month 24, Above | 0 | 0 | 0 | 0 |
| ALT, Unknown, Month 24, Unknown | 1 | 0 | 0 | 0 |
| ALT, Normal , Month 24, Below | 0 | 0 | 0 | 0 |
| ALT, Normal , Month 24, Normal | 36 | 15 | 41 | 17 |
| ALT, Normal , Month 24, Above | 2 | 0 | 2 | 0 |
| ALT, Normal , Month 24, Unknown | 0 | 0 | 0 | 0 |
| ALT, Above, Month 24, Below | 0 | 0 | 0 | 0 |
| ALT, Above, Month 24, Normal | 1 | 0 | 1 | 0 |
| ALT, Above, Month 24, Above | 0 | 0 | 0 | 0 |
| ALT, Above, Month 24, Unknown | 0 | 0 | 0 | 0 |
Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for AST for subjects participating in Phase C of the study.
| Participants | GSK1562902A-C Lot 3 3-5Y Group | Fluarix-C 3-5Y Group | GSK1562902A-C Lot 3 6-9Y Group | Fluarix-C 6-9Y Group |
|---|---|---|---|---|
| AST, Unknown, Day 21, Below | 0 | 0 | 0 | 0 |
| AST, Unknown, Day 21, Normal | 3 | 0 | 1 | 1 |
| AST, Unknown, Day 21, Above | 0 | 0 | 0 | 0 |
| AST, Unknown, Day 21, Unknown | 2 | 1 | 1 | 0 |
| AST, Normal, Day 21, Below | 0 | 0 | 0 | 0 |
| AST, Normal, Day 21, Normal | 39 | 10 | 40 | 17 |
| AST, Normal, Day 21, Above | 0 | 0 | 0 | 0 |
| AST, Normal, Day 21, Unknown | 1 | 2 | 4 | 0 |
| AST, Above, Day 21, Below | 0 | 0 | 0 | 0 |
| AST, Above, Day 21, Normal | 2 | 2 | 1 | 0 |
| AST, Above, Day 21, Above | 1 | 0 | 0 | 0 |
| AST, Above, Day 21, Unknown | 0 | 1 | 0 | 0 |
| AST, Unknown, Day 42, Below | 0 | 0 | 0 | 0 |
| AST, Unknown, Day 42, Normal | 5 | 2 | 1 | 1 |
| AST, Unknown, Day 42, Above | 0 | 0 | 1 | 0 |
| AST, Unknown, Day 42, Unknown | 0 | 0 | 0 | 0 |
| AST, Normal, Day 42, Below | 0 | 0 | 0 | 0 |
| AST, Normal, Day 42, Normal | 36 | 11 | 41 | 17 |
| AST, Normal, Day 42, Above | 2 | 0 | 2 | 0 |
| AST, Normal, Day 42, Unknown | 2 | 1 | 2 | 0 |
| AST, Above, Day 42, Below | 0 | 0 | 0 | 0 |
| AST, Above, Day 42, Normal | 3 | 1 | 1 | 0 |
| AST, Above, Day 42, Above | 0 | 2 | 0 | 0 |
| AST, Above, Day 42, Unknown | 0 | 0 | 0 | 0 |
| AST, Unknown, Month 6, Below | 0 | 0 | 0 | 0 |
| AST, Unknown, Month 6, Normal | 3 | 2 | 2 | 1 |
| AST, Unknown, Month 6, Above | 0 | 0 | 0 | 0 |
| AST, Unknown, Month 6, Unknown | 1 | 0 | 0 | 0 |
| AST, Normal, Month 6, Below | 0 | 0 | 0 | 0 |
| AST, Normal, Month 6, Normal | 34 | 9 | 40 | 17 |
| AST, Normal, Month 6, Above | 1 | 2 | 1 | 0 |
| AST, Normal, Month 6, Unknown | 4 | 1 | 2 | 0 |
| AST, Above, Month 6, Below | 0 | 0 | 0 | 0 |
| AST, Above, Month 6, Normal | 2 | 3 | 1 | 0 |
| AST, Above, Month 6, Above | 0 | 0 | 0 | 0 |
| AST, Above, Month 6, Unknown | 0 | 0 | 0 | 0 |
| AST, Unknown, Month 12, Below | 0 | 0 | 0 | 0 |
| AST, Unknown, Month 12, Normal | 3 | 2 | 2 | 1 |
| AST, Unknown, Month 12, Above | 0 | 0 | 1 | 0 |
| AST, Unknown, Month 12, Unknown | 0 | 0 | 0 | 0 |
| AST, Normal, Month 12, Below | 0 | 0 | 0 | 0 |
| AST, Normal, Month 12, Normal | 36 | 12 | 37 | 16 |
| AST, Normal, Month 12, Above | 0 | 0 | 4 | 0 |
| AST, Normal, Month 12, Unknown | 3 | 0 | 3 | 1 |
| AST, Above, Month 12, Below | 0 | 0 | 0 | 0 |
| AST, Above, Month 12, Normal | 2 | 3 | 1 | 0 |
| AST, Above, Month 12, Above | 0 | 0 | 0 | 0 |
| AST, Above, Month 12, Unknown | 0 | 0 | 0 | 0 |
| AST, Unknown, Month 24, Below | 0 | 0 | 0 | 0 |
| AST, Unknown, Month 24, Normal | 2 | 2 | 2 | 1 |
| AST, Unknown, Month 24, Above | 0 | 0 | 0 | 0 |
| AST, Unknown, Month 24, Unknown | 1 | 0 | 0 | 0 |
| AST, Normal, Month 24, Below | 0 | 0 | 0 | 0 |
| AST, Normal, Month 24, Normal | 34 | 12 | 42 | 17 |
| AST, Normal, Month 24, Above | 3 | 0 | 1 | 0 |
| AST, Normal, Month 24, Unknown | 0 | 0 | 0 | 0 |
| AST, Above, Month 24, Below | 0 | 0 | 0 | 0 |
| AST, Above, Month 24, Normal | 2 | 3 | 1 | 0 |
| AST, Above, Month 24, Above | 0 | 0 | 0 | 0 |
| AST, Above, Month 24, Unknown | 0 | 0 | 0 | 0 |
Changes from baseline are categorised as below, within(normal), or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for BUN for subjects participating in Phase C of the study.
| Participants | GSK1562902A-C Lot 3 3-5Y Group | Fluarix-C 3-5Y Group | GSK1562902A-C Lot 3 6-9Y Group | Fluarix-C 6-9Y Group |
|---|---|---|---|---|
| BUN,Unknown,Day 21,Below | 0 | 0 | 0 | 0 |
| BUN,Unknown,Day 21,Normal | 3 | 0 | 0 | 1 |
| BUN,Unknown,Day 21,Above | 0 | 0 | 0 | 0 |
| BUN,Unknown,Day 21,Unknown | 2 | 1 | 1 | 0 |
| BUN,Below,Day 21,Below | 0 | 0 | 0 | 0 |
| BUN,Below,Day 21,Normal | 0 | 0 | 0 | 0 |
| BUN,Below,Day 21,Above | 0 | 0 | 0 | 0 |
| BUN,Below,Day 21,Unknown | 0 | 1 | 0 | 0 |
| BUN,Normal,Day 21,Below | 1 | 0 | 0 | 0 |
| BUN,Normal,Day 21,Normal | 37 | 9 | 41 | 16 |
| BUN,Normal,Day 21,Above | 2 | 0 | 0 | 1 |
| BUN,Normal,Day 21,Unknown | 1 | 2 | 4 | 0 |
| BUN,Above,Day 21,Below | 0 | 0 | 0 | 0 |
| BUN,Above,Day 21,Normal | 2 | 3 | 1 | 0 |
| BUN,Above,Day 21,Above | 0 | 0 | 0 | 0 |
| BUN,Above,Day 21,Unknown | 0 | 0 | 0 | 0 |
| BUN,Unknown,Day 42,Below | 0 | 0 | 0 | 0 |
| BUN,Unknown,Day 42,Normal | 5 | 2 | 1 | 1 |
| BUN,Unknown,Day 42,Above | 0 | 0 | 0 | 0 |
| BUN,Unknown,Day 42,Unknown | 0 | 0 | 0 | 0 |
| BUN,Below,Day 42,Below | 0 | 0 | 0 | 0 |
| BUN,Below,Day 42,Normal | 0 | 1 | 0 | 0 |
| BUN,Below,Day 42,Above | 0 | 0 | 0 | 0 |
| BUN,Below,Day 42,Unknown | 0 | 0 | 0 | 0 |
| BUN,Normal,Day 42,Below | 0 | 0 | 3 | 0 |
| BUN,Normal,Day 42,Normal | 37 | 11 | 38 | 16 |
| BUN,Normal,Day 42, Above | 2 | 0 | 3 | 1 |
| BUN,Normal,Day 42,Unknown | 2 | 0 | 2 | 0 |
| BUN,Above,Day 42,Below | 0 | 0 | 0 | 0 |
| BUN,Above,Day 42,Normal | 1 | 2 | 1 | 0 |
| BUN,Above,Day 42,Above | 1 | 0 | 0 | 0 |
| BUN,Above,Day 42,Unknown | 0 | 1 | 0 | 0 |
| BUN,Unknown,Month 6,Below | 0 | 0 | 0 | 0 |
| BUN,Unknown,Month 6,Normal | 4 | 2 | 1 | 1 |
| BUN,Unknown,Month 6,Above | 0 | 0 | 0 | 0 |
| BUN,Unknown,Month 6,Unknown | 0 | 0 | 0 | 0 |
| BUN,Below,Month 6,Below | 0 | 0 | 0 | 0 |
| BUN,Below,Month 6,Normal | 0 | 1 | 0 | 0 |
| BUN,Below,Month 6,Above | 0 | 0 | 0 | 0 |
| BUN,Below,Month 6,Unknown | 0 | 0 | 0 | 0 |
| BUN,Normal,Month 6,Below | 0 | 0 | 2 | 0 |
| BUN,Normal,Month 6,Normal | 34 | 10 | 35 | 17 |
| BUN,Normal,Month 6,Above | 1 | 0 | 5 | 0 |
| BUN,Normal,Month 6,Unknown | 4 | 1 | 2 | 0 |
| BUN,Above,Month 6,Below | 0 | 0 | 0 | 0 |
| BUN,Above,Month 6,Normal | 2 | 2 | 0 | 0 |
| BUN,Above,Month 6,Above | 0 | 1 | 1 | 0 |
| BUN,Above,Month 6,Unknown | 0 | 0 | 0 | 0 |
| BUN,Unknown,Month 12,Below | 0 | 0 | 0 | 0 |
| BUN,Unknown,Month 12,Normal | 3 | 2 | 1 | 1 |
| BUN,Unknown,Month 12,Above | 0 | 0 | 1 | 0 |
| BUN,Unknown,Month 12,Unknown | 0 | 0 | 0 | 0 |
| BUN,Below,Month 12,Below | 0 | 0 | 0 | 0 |
| BUN,Below,Month 12,Normal | 0 | 1 | 0 | 0 |
| BUN,Below,Month 12,Above | 0 | 0 | 0 | 0 |
| BUN,Below,Month 12,Unknown | 0 | 0 | 0 | 0 |
| BUN,Normal,Month12,Below | 0 | 0 | 0 | 0 |
| BUN,Normal,Month12,Normal | 36 | 10 | 41 | 16 |
| BUN,Normal,Month12,Above | 1 | 1 | 2 | 0 |
| BUN,Normal,Month12,Unknown | 2 | 0 | 2 | 1 |
| BUN,Above,Month 12,Below | 0 | 0 | 0 | 0 |
| BUN,Above,Month 12,Normal | 2 | 2 | 1 | 0 |
| BUN,Above,Month 12,Above | 0 | 1 | 0 | 0 |
| BUN,Above,Month 12,Unknown | 0 | 0 | 0 | 0 |
| BUN,Unknown,Month 24,Below | 0 | 0 | 0 | 0 |
| BUN,Unknown,Month 24,Normal | 2 | 2 | 1 | 1 |
| BUN,Unknown,Month 24,Above | 0 | 0 | 0 | 0 |
| BUN,Unknown,Month 24,Unknown | 1 | 0 | 0 | 0 |
| BUN,Below,Month 24,Below | 0 | 0 | 0 | 0 |
| BUN,Below,Month 24,Normal | 0 | 1 | 0 | 0 |
| BUN,Below,Month 24,Above | 0 | 0 | 0 | 0 |
| BUN,Below,Month 24,Unknown | 0 | 0 | 0 | 0 |
| BUN,Normal,Month 24,Below | 0 | 0 | 1 | 0 |
| BUN,Normal,Month 24,Normal | 35 | 9 | 39 | 16 |
| BUN,Normal,Month 24,Above | 2 | 2 | 4 | 1 |
| BUN,Normal,Month 24,Unknown | 0 | 0 | 0 | 0 |
| BUN,Above,Month 24,Below | 0 | 0 | 0 | 0 |
| BUN,Above,Month 24,Normal | 2 | 3 | 0 | 0 |
| BUN,Above,Month 24,Above | 0 | 0 | 1 | 0 |
| BUN,Above,Month 24,Unknown | 0 | 0 | 0 | 0 |
Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for CREA for subjects participating in Phase C of the study.
| Participants | GSK1562902A-C Lot 3 3-5Y Group | Fluarix-C 3-5Y Group | GSK1562902A-C Lot 3 6-9Y Group | Fluarix-C 6-9Y Group |
|---|---|---|---|---|
| CREA,Unknown,Day 21,Below | 0 | 0 | 0 | 0 |
| CREA,Unknown,Day 21,Normal | 3 | 0 | 1 | 1 |
| CREA,Unknown,Day 21,Above | 0 | 0 | 0 | 0 |
| CREA,Unknown,Day 21,Unknown | 2 | 1 | 1 | 0 |
| CREA,Normal,Day 21,Below | 0 | 0 | 0 | 0 |
| CREA,Normal,Day 21,Normal | 42 | 12 | 41 | 17 |
| CREA,Normal,Day 21,Above | 0 | 0 | 0 | 0 |
| CREA,Normal,Day 21,Unknown | 1 | 3 | 4 | 0 |
| CREA,Unknown,Day 42,Below | 0 | 0 | 0 | 0 |
| CREA,Unknown,Day 42,Normal | 5 | 2 | 2 | 1 |
| CREA,Unknown,Day 42,Above | 0 | 0 | 0 | 0 |
| CREA,Unknown,Day 42,Unknown | 0 | 0 | 0 | 0 |
| CREA,Normal,Day 42,Below | 0 | 0 | 0 | 0 |
| CREA,Normal,Day 42,Normal | 41 | 14 | 44 | 17 |
| CREA,Normal,Day 42,Above | 0 | 0 | 0 | 0 |
| CREA,Normal,Day 42,Unknown | 2 | 1 | 2 | 0 |
| CREA,Unknown,Month 6,Below | 0 | 0 | 0 | 0 |
| CREA,Unknown,Month 6,Normal | 4 | 2 | 2 | 1 |
| CREA,Unknown,Month 6,Above | 0 | 0 | 0 | 0 |
| CREA,Unknown,Month 6,Unknown | 0 | 0 | 0 | 0 |
| CREA,Normal,Month 6,Below | 0 | 0 | 0 | 0 |
| CREA,Normal,Month 6,Normal | 37 | 14 | 42 | 17 |
| CREA,Normal,Month 6,Above | 0 | 0 | 0 | 0 |
| CREA,Normal,Month 6,Unknown | 4 | 1 | 2 | 0 |
| CREA,Unknown,Month 12,Below | 0 | 0 | 0 | 0 |
| CREA,Unknown,Month 12,Normal | 3 | 2 | 3 | 1 |
| CREA,Unknown,Month 12,Above | 0 | 0 | 0 | 0 |
| CREA,Unknown,Month 12,Unknown | 0 | 0 | 0 | 0 |
| CREA,Normal,Month 12,Below | 0 | 0 | 0 | 0 |
| CREA,Normal,Month 12,Normal | 39 | 15 | 43 | 16 |
| CREA,Normal,Month 12,Above | 0 | 0 | 0 | 0 |
| CREA,Normal,Month 12,Unknown | 2 | 0 | 2 | 1 |
| CREA,Unknown,Month 24,Below | 0 | 0 | 0 | 0 |
| CREA,Unknown,Month 24,Normal | 2 | 2 | 2 | 1 |
| CREA,Unknown,Month 24,Above | 0 | 0 | 0 | 0 |
| CREA,Unknown,Month 24,Unknown | 1 | 0 | 0 | 0 |
| CREA,Normal,Month 24,Below | 0 | 0 | 0 | 0 |
| CREA,Normal,Month 24,Normal | 39 | 15 | 44 | 17 |
| CREA,Normal,Month 24,Above | 0 | 0 | 0 | 0 |
| CREA,Normal,Month 24,Unknown | 0 | 0 | 0 | 0 |
Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for CPK for subjects participating in Phase C of the study.
| Participants | GSK1562902A-C Lot 3 3-5Y Group | Fluarix-C 3-5Y Group | GSK1562902A-C Lot 3 6-9Y Group | Fluarix-C 6-9Y Group |
|---|---|---|---|---|
| CPK,Unknown,Day 21,Below | 0 | 0 | 0 | 0 |
| CPK,Unknown,Day 21,Normal | 3 | 0 | 0 | 1 |
| CPK,Unknown,Day 21,Above | 0 | 0 | 1 | 0 |
| CPK,Unknown,Day 21,Unknown | 2 | 1 | 1 | 0 |
| CPK,Normal,Day 21,Below | 0 | 0 | 0 | 0 |
| CPK,Normal,Day 21,Normal | 39 | 10 | 37 | 14 |
| CPK,Normal,Day 21,Above | 2 | 0 | 0 | 2 |
| CPK,Normal,Day 21,Unknown | 1 | 3 | 4 | 0 |
| CPK,Above,Day 21,Below | 0 | 0 | 0 | 0 |
| CPK,Above,Day 21,Normal | 1 | 1 | 4 | 1 |
| CPK,Above,Day 21,Above | 0 | 1 | 0 | 0 |
| CPK,Above,Day 21,Unknown | 0 | 0 | 0 | 0 |
| CPK,Unknown,Day 42,Below | 0 | 0 | 0 | 0 |
| CPK,Unknown,Day 42,Normal | 5 | 1 | 2 | 1 |
| CPK,Unknown,Day 42,Above | 0 | 1 | 0 | 0 |
| CPK,Unknown,Day 42,Unknown | 0 | 0 | 0 | 0 |
| CPK,Normal,Day 42,Below | 0 | 0 | 0 | 0 |
| CPK,Normal,Day 42,Normal | 39 | 11 | 40 | 15 |
| CPK,Normal,Day 42,Above | 1 | 1 | 0 | 1 |
| CPK,Normal,Day 42,Unknown | 2 | 1 | 2 | 0 |
| CPK,Above,Day 42,Below | 0 | 0 | 0 | 0 |
| CPK,Above,Day 42,Normal | 0 | 1 | 4 | 1 |
| CPK,Above,Day 42,Above | 1 | 1 | 0 | 0 |
| CPK,Above,Day 42,Unknown | 0 | 0 | 0 | 0 |
| CPK,Unknown,Month 6,Below | 0 | 0 | 0 | 0 |
| CPK,Unknown,Month 6,Normal | 3 | 2 | 2 | 1 |
| CPK,Unknown,Month 6,Above | 1 | 0 | 0 | 0 |
| CPK,Unknown,Month 6,Unknown | 0 | 0 | 0 | 0 |
| CPK,Normal,Month 6,Below | 0 | 0 | 0 | 0 |
| CPK,Normal,Month 6,Normal | 34 | 12 | 36 | 16 |
| CPK,Normal,Month 6,Above | 2 | 0 | 3 | 0 |
| CPK,Normal,Month 6,Unknown | 4 | 1 | 1 | 0 |
| CPK,Above,Month 6,Below | 0 | 0 | 0 | 0 |
| CPK,Above,Month 6,Normal | 0 | 1 | 3 | 1 |
| CPK,Above,Month 6,Above | 1 | 1 | 0 | 0 |
| CPK,Above,Month 6,Unknown | 0 | 0 | 1 | 0 |
| CPK,Unknown,Month 12,Below | 0 | 0 | 0 | 0 |
| CPK,Unknown,Month 12,Normal | 2 | 2 | 2 | 1 |
| CPK,Unknown,Month 12,Above | 1 | 0 | 1 | 0 |
| CPK,Unknown,Month 12,Unknown | 0 | 0 | 0 | 0 |
| CPK,Normal,Month 12,Below | 0 | 0 | 0 | 0 |
| CPK,Normal,Month 12,Normal | 35 | 12 | 36 | 14 |
| CPK,Normal,Month 12,Above | 3 | 1 | 3 | 1 |
| CPK,Normal,Month 12,Unknown | 2 | 0 | 2 | 1 |
| CPK,Above,Month 12,Below | 0 | 0 | 0 | 0 |
| CPK,Above,Month 12,Normal | 1 | 1 | 4 | 1 |
| CPK,Above,Month 12,Above | 0 | 1 | 0 | 0 |
| CPK,Above,Month 12,Unknown | 0 | 0 | 0 | 0 |
| CPK,Unknown,Month 24,Below | 0 | 0 | 0 | 0 |
| CPK,Unknown,Month 24,Normal | 2 | 2 | 2 | 1 |
| CPK,Unknown,Month 24,Above | 0 | 0 | 0 | 0 |
| CPK,Unknown,Month 24,Unknown | 1 | 0 | 0 | 0 |
| CPK,Normal,Month 24,Below | 0 | 0 | 0 | 0 |
| CPK,Normal,Month 24,Normal | 36 | 12 | 38 | 14 |
| CPK,Normal,Month 24,Above | 2 | 1 | 2 | 2 |
| CPK,Normal,Month 24,Unknown | 0 | 0 | 0 | 0 |
| CPK,Above,Month 24,Below | 0 | 0 | 0 | 0 |
| CPK,Above,Month 24,Normal | 1 | 1 | 3 | 1 |
| CPK,Above,Month 24,Above | 0 | 1 | 1 | 0 |
| CPK,Above,Month 24,Unknown | 0 | 0 | 0 | 0 |
Changes from baseline are categorised as below, within, or above the normal ranges at each scheduled post-vaccination time point versus the category of the laboratory values at baseline. Assessed parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) Per parameter and range, it was assessed according to baseline values whether laboratory values of the subjects were below normal, normal or above the normal range. This outcome presents results for LDH for subjects participating in Phase C of the study.
| Participants | GSK1562902A-C Lot 3 3-5Y Group | Fluarix-C 3-5Y Group | GSK1562902A-C Lot 3 6-9Y Group | Fluarix-C 6-9Y Group |
|---|---|---|---|---|
| LDH,Unknown,Day 21,Below | 0 | 0 | 0 | 0 |
| LDH,Unknown,Day 21,Normal | 2 | 0 | 0 | 1 |
| LDH,Unknown,Day 21,Above | 1 | 0 | 0 | 0 |
| LDH,Unknown,Day 21,Unknown | 2 | 1 | 1 | 0 |
| LDH,Normal,Day 21,Below | 0 | 0 | 0 | 0 |
| LDH,Normal,Day 21,Normal | 31 | 9 | 37 | 16 |
| LDH,Normal,Day 21,Above | 4 | 1 | 2 | 1 |
| LDH,Normal,Day 21,Unknown | 0 | 2 | 4 | 0 |
| LDH,Above,Day 21,Below | 0 | 0 | 0 | 0 |
| LDH,Above,Day 21,Normal | 5 | 2 | 2 | 0 |
| LDH,Above,Day 21,Above | 2 | 0 | 1 | 0 |
| LDH,Above,Day 21,Unknown | 1 | 1 | 0 | 0 |
| LDH,Unknown,Day 42,Below | 0 | 0 | 0 | 0 |
| LDH,Unknown,Day 42,Normal | 4 | 0 | 1 | 1 |
| LDH,Unknown,Day 42,Above | 1 | 2 | 0 | 0 |
| LDH,Unknown,Day 42,Unknown | 0 | 0 | 0 | 0 |
| LDH,Normal,Day 42,Below | 0 | 0 | 0 | 0 |
| LDH,Normal,Day 42,Normal | 29 | 7 | 39 | 16 |
| LDH,Normal,Day 42,Above | 4 | 4 | 3 | 1 |
| LDH,Normal,Day 42,Unknown | 2 | 1 | 2 | 0 |
| LDH,Above,Day 42,Below | 0 | 0 | 0 | 0 |
| LDH,Above,Day 42,Normal | 2 | 1 | 2 | 0 |
| LDH,Above,Day 42,Above | 6 | 2 | 1 | 0 |
| LDH,Above,Day 42,Unknown | 0 | 0 | 0 | 0 |
| LDH, Unknown, Month 6, Below | 0 | 0 | 0 | 0 |
| LDH, Unknown, Month 6, Normal | 2 | 0 | 1 | 1 |
| LDH,Unknown, Month 6, Above | 1 | 2 | 0 | 0 |
| LDH, Unknown, Month 6, Unknown | 1 | 0 | 0 | 0 |
| LDH, Normal, Month 6, Below | 0 | 0 | 0 | 0 |
| LDH, Normal, Month 6, Normal | 28 | 8 | 37 | 17 |
| LDH, Normal, Month 6, Above | 2 | 3 | 3 | 0 |
| LDH, Normal, Month 6, Unknown | 4 | 1 | 2 | 0 |
| LDH, Above, Month 6, Below | 0 | 0 | 0 | 0 |
| LDH, Above, Month 6, Normal | 2 | 2 | 2 | 0 |
| LDH, Above, Month 6, Above | 5 | 1 | 1 | 0 |
| LDH, Above, Month 6, Unknown | 0 | 0 | 0 | 0 |
| LDH, Unknown, Month 12, Below | 0 | 0 | 0 | 0 |
| LDH, Unknown, Month 12, Normal | 3 | 2 | 0 | 1 |
| LDH, Unknown, Month 12, Above | 0 | 0 | 2 | 0 |
| LDH, Unknown, Month 12, Unknown | 0 | 0 | 0 | 0 |
| LDH, Normal, Month 12, Below | 0 | 0 | 0 | 0 |
| LDH, Normal, Month 12, Normal | 26 | 9 | 34 | 14 |
| LDH, Normal, Month 12, Above | 6 | 3 | 6 | 2 |
| LDH, Normal, Month 12, Unknwon | 2 | 0 | 3 | 1 |
| LDH, Above, Month 12, Below | 0 | 0 | 0 | 0 |
| LDH, Above, Month 12, Normal | 1 | 1 | 2 | 0 |
| LDH, Above, Month 12, Above | 5 | 2 | 1 | 0 |
| LDH, Above, Month 12, Unknown | 1 | 0 | 0 | 0 |
| LDH, Unknown, Month 24, Below | 0 | 0 | 0 | 0 |
| LDH, Unknown, Month 24, Normal | 2 | 2 | 1 | 1 |
| LDH, Unknown, Month 24, Above | 0 | 0 | 0 | 0 |
| LDH, Unknown, Month 24, Unknown | 1 | 0 | 0 | 0 |
| LDH, Normal, Month 24, Below | 0 | 0 | 0 | 0 |
| LDH, Normal, Month 24, Normal | 24 | 10 | 40 | 16 |
| LDH, Normal, Month 24, Above | 8 | 2 | 2 | 1 |
| LDH, Normal, Month 24, Unknown | 0 | 0 | 0 | 0 |
| LDH, Above, Month 24, Below | 0 | 0 | 0 | 0 |
| LDH, Above, Month 24, Normal | 2 | 2 | 2 | 0 |
| LDH, Above, Month 24, Above | 5 | 1 | 1 | 0 |
| LDH, Above, Month 24, Unknown | 0 | 0 | 0 | 0 |
Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents ALT results for subjects participating in Phase A of the study.
| Participants | GSK1562902A-A Lot 1 3-5Y Group | Fluarix-A 3-5Y Group | GSK1562902A-A Lot 1 6-9Y Group | Fluarix-A 6-9Y Group |
|---|---|---|---|---|
| ALT, Day 0, Below | 0 | 0 | 0 | 0 |
| ALT, Day 0, Normal | 50 | 18 | 51 | 17 |
| ALT, Day 0, Above | 2 | 0 | 2 | 0 |
| ALT, Day 21, Below | 0 | 0 | 0 | 0 |
| ALT, Day 21, Normal | 48 | 16 | 44 | 18 |
| ALT, Day 21, Above | 0 | 0 | 0 | 0 |
| ALT, Day 42, Below | 0 | 0 | 0 | 0 |
| ALT, Day 42, Normal | 49 | 15 | 45 | 16 |
| ALT, Day 42, Above | 0 | 1 | 0 | 0 |
| ALT, Month 6, Below | 0 | 0 | 0 | 0 |
| ALT, Month 6, Normal | 48 | 15 | 42 | 17 |
| ALT, Month 6, Above | 1 | 0 | 1 | 0 |
| ALT, Month 12, Below | 0 | 0 | 0 | 0 |
| ALT, Month 12, Normal | 46 | 17 | 41 | 17 |
| ALT, Month 12, Above | 1 | 0 | 1 | 0 |
| ALT, Month 24, Below | 0 | 0 | 0 | 0 |
| ALT, Month 24, Normal | 47 | 16 | 40 | 14 |
| ALT, Month 24, Above | 0 | 0 | 0 | 0 |
Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents AST results for subjects participating in Phase A of the study.
| Participants | GSK1562902A-B Lot 2 3-5Y Group | Fluarix-B 3-5Y Group | GSK1562902A-B Lot 2 6-9Y Group | Fluarix-B 6-9Y Group |
|---|---|---|---|---|
| AST, Day 0, Below | 0 | 0 | 0 | 0 |
| AST, Day 0, Normal | 46 | 18 | 51 | 17 |
| AST, Day 0, Above | 6 | 0 | 2 | 0 |
| AST, Day 21, Below | 0 | 0 | 0 | 0 |
| AST, Day 21, Normal | 42 | 16 | 44 | 17 |
| AST, Day 21, Above | 6 | 0 | 0 | 0 |
| AST, Day 42, Below | 0 | 0 | 0 | 0 |
| AST, Day 42, Normal | 46 | 13 | 45 | 16 |
| AST, Day 42, Above | 3 | 2 | 0 | 0 |
| AST, Month 6, Below | 0 | 0 | 0 | 0 |
| AST, Month 6, Normal | 46 | 14 | 42 | 17 |
| AST, Month 6, Above | 3 | 1 | 1 | 0 |
| AST, Month 12, Below | 0 | 0 | 0 | 0 |
| AST, Month 12, Normal | 43 | 16 | 42 | 17 |
| AST, Month 12, Above | 4 | 1 | 0 | 0 |
| AST, Month 24, Below | 0 | 0 | 0 | 0 |
| AST, Month 24, Normal | 44 | 16 | 40 | 14 |
| AST, Month 24, Above | 3 | 0 | 0 | 0 |
Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents BUN results for subjects participating in Phase A of the study.
| Participants | GSK1562902A -A Lot 1 3-5Y Group | Fluarix-A 3-5Y Group | GSK1562902A-A Lot 1 6-9Y Group | Fluarix-A 6-9Y Group |
|---|---|---|---|---|
| BUN, Day 0, Below | 0 | 0 | 0 | 0 |
| BUN, Day 0, Normal | 50 | 18 | 52 | 16 |
| BUN, Day 0, Above | 2 | 0 | 1 | 1 |
| BUN, Day 21, Below | 0 | 1 | 0 | 0 |
| BUN, Day 21, Normal | 45 | 14 | 39 | 16 |
| BUN, Day 21, Above | 3 | 1 | 5 | 2 |
| BUN, Day 42, Below | 0 | 0 | 0 | 0 |
| BUN, Day 42, Normal | 42 | 16 | 39 | 14 |
| BUN, Day 42, Above | 7 | 0 | 6 | 2 |
| BUN, Month 6, Below | 0 | 1 | 0 | 0 |
| BUN, Month 6, Normal | 46 | 13 | 39 | 15 |
| BUN, Month 6, Above | 3 | 1 | 4 | 2 |
| BUN, Month 12, Below | 0 | 0 | 1 | 0 |
| BUN, Month 12, Normal | 42 | 16 | 41 | 15 |
| BUN, Month 12, Above | 5 | 1 | 0 | 2 |
| BUN, Month 24, Below | 0 | 0 | 1 | 0 |
| BUN, Month 24, Normal | 45 | 16 | 38 | 12 |
| BUN, Month 24, Above | 2 | 0 | 1 | 2 |
Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents CREA results, for subjects participating in Phase A of the study.
| Participants | GSK1562902A-A Lot 1 3-5Y Group | Fluarix-A 3-5Y Group | GSK1562902A-A Lot 1 6-9Y Group | Fluarix-A 6-9Y Group |
|---|---|---|---|---|
| CREA, Day 0, Below | 0 | 0 | 0 | 0 |
| CREA, Day 0, Normal | 52 | 18 | 53 | 17 |
| CREA, Day 0, Above | 0 | 0 | 0 | 0 |
| CREA, Day 21, Below | 0 | 0 | 0 | 0 |
| CREA, Day 21, Normal | 48 | 16 | 42 | 18 |
| CREA, Day 21, Above | 0 | 0 | 2 | 0 |
| CREA, Day 42, Below | 0 | 0 | 0 | 0 |
| CREA, Day 42, Normal | 49 | 16 | 43 | 16 |
| CREA, Day 42, Above | 0 | 0 | 2 | 0 |
| CREA, Month 6, Below | 0 | 0 | 0 | 0 |
| CREA, Month 6, Normal | 49 | 15 | 43 | 17 |
| CREA, Month 6, Above | 0 | 0 | 0 | 0 |
| CREA, Month 12, Below | 0 | 0 | 0 | 0 |
| CREA, Month 12, Normal | 47 | 17 | 42 | 17 |
| CREA, Month 12, Above | 0 | 0 | 0 | 0 |
| CREA, Month 24, Below | 0 | 0 | 0 | 0 |
| CREA, Month 24, Normal | 47 | 16 | 39 | 14 |
| CREA, Month 24, Above | 0 | 0 | 1 | 0 |
Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents CPK results for subjects participating in Phase A of the study.
| Participants | GSK1562902A -A Lot 1 3-5Y Group | Fluarix-A 3-5Y Group | GSK1562902A-A Lot 1 6-9Y Group | Fluarix-A 6-9Y Group |
|---|---|---|---|---|
| CPK, Day 0, Below | 0 | 0 | 0 | 0 |
| CPK, Day 0, Normal | 51 | 17 | 51 | 17 |
| CPK, Day 0, Above | 1 | 1 | 2 | 0 |
| CPK, Day 21, Below | 0 | 0 | 0 | 0 |
| CPK, Day 21, Normal | 46 | 16 | 42 | 17 |
| CPK, Day 21, Above | 2 | 0 | 2 | 1 |
| CPK, Day 42, Below | 0 | 0 | 0 | 0 |
| CPK, Day 42, Normal | 47 | 14 | 42 | 15 |
| CPK, Day 42, Above | 2 | 2 | 3 | 1 |
| CPK, Month 6, Below | 0 | 0 | 0 | 0 |
| CPK, Month 6, Normal | 47 | 14 | 38 | 16 |
| CPK, Month 6, Above | 2 | 1 | 5 | 1 |
| CPK, Month 12, Below | 0 | 0 | 0 | 0 |
| CPK, Month 12, Normal | 45 | 15 | 40 | 16 |
| CPK, Month 12, Above | 2 | 2 | 2 | 1 |
| CPK, Month 24, Below | 0 | 0 | 0 | 0 |
| CPK, Month 24, Normal | 47 | 15 | 36 | 13 |
| CPK, Month 24, Above | 0 | 1 | 3 | 1 |
Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents LDH results for subjects participating in Phase A of the study.
| Participants | GSK1562902A -A Lot 1 3-5Y Group | Fluarix-A 3-5Y Group | GSK1562902A-A Lot 1 6-9Y Group | Fluarix-A 6-9Y Group |
|---|---|---|---|---|
| LDH, Day 0, Below | 0 | 0 | 0 | 0 |
| LDH, Day 0, Normal | 41 | 12 | 52 | 17 |
| LDH, Day 0, Above | 11 | 6 | 1 | 0 |
| LDH, Day 21, Below | 0 | 0 | 0 | 0 |
| LDH, Day 21, Normal | 42 | 10 | 41 | 15 |
| LDH, Day 21, Above | 6 | 6 | 3 | 2 |
| LDH, Day 42, Below | 0 | 0 | 0 | 0 |
| LDH, Day 42, Normal | 38 | 9 | 42 | 15 |
| LDH, Day 42, Above | 11 | 6 | 4 | 1 |
| LDH, Month 6, Below | 0 | 0 | 0 | 0 |
| LDH, Month 6, Normal | 37 | 11 | 39 | 14 |
| LDH, Month 6, Above | 12 | 4 | 4 | 3 |
| LDH, Month 12, Below | 0 | 0 | 0 | 0 |
| LDH, Month 12, Normal | 40 | 12 | 41 | 15 |
| LDH, Month 12, Above | 7 | 5 | 1 | 2 |
| LDH, Month 24, Below | 0 | 0 | 0 | 0 |
| LDH, Month 24, Normal | 42 | 13 | 36 | 12 |
| LDH, Month 24, Above | 5 | 3 | 3 | 2 |
Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents AST results, for subjects participating to Phase B of the study.
| Participants | GSK1562902A-B Lot 2 3-5Y Group | Fluarix-B 3-5Y Group | GSK1562902A-B Lot 2 6-9Y Group | Fluarix-B 6-9Y Group |
|---|---|---|---|---|
| ALT, Day 0, Below | 0 | 0 | 0 | 0 |
| ALT, Day 0, Normal | 50 | 16 | 48 | 16 |
| ALT, Day 0, Above | 1 | 0 | 0 | 1 |
| ALT, Day 21, Below | 0 | 0 | 0 | 0 |
| ALT, Day 21, Normal | 44 | 16 | 45 | 17 |
| ALT, Day 21, Above | 1 | 1 | 1 | 0 |
| ALT, Day 42, Below | 0 | 0 | 0 | 0 |
| ALT, Day 42, Normal | 46 | 17 | 45 | 16 |
| ALT, Day 42, Above | 1 | 0 | 2 | 1 |
| ALT, Month 6, Below | 0 | 0 | 0 | 0 |
| ALT, Month 6, Normal | 41 | 16 | 43 | 17 |
| ALT, Month 6, Above | 0 | 0 | 0 | 0 |
| ALT, Month 12, Below | 0 | 0 | 0 | 0 |
| ALT, Month 12, Normal | 44 | 17 | 45 | 17 |
| ALT, Month 12, Above | 0 | 0 | 0 | 0 |
| ALT, Month 24, Below | 0 | 0 | 0 | 0 |
| ALT, Month 24, Normal | 44 | 17 | 43 | 17 |
| ALT, Month 24, Above | 1 | 0 | 1 | 0 |
Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents AST results, for subjects participating to Phase B of the study.
| Participants | GSK1562902A -B Lot 1 3-5Y Group | Fluarix-B 3-5Y Group | GSK1562902A-B Lot 1 6-9Y Group | Fluarix-B 6-9Y Group |
|---|---|---|---|---|
| AST, Day 0, Below | 0 | 0 | 0 | 0 |
| AST, Day 0, Normal | 48 | 15 | 45 | 16 |
| AST, Day 0, Above | 3 | 1 | 3 | 1 |
| AST, Day 21, Below | 0 | 0 | 0 | 0 |
| AST, Day 21, Normal | 41 | 16 | 45 | 17 |
| AST, Day 21, Above | 3 | 1 | 1 | 0 |
| AST, Day 42, Below | 0 | 0 | 0 | 0 |
| AST, Day 42, Normal | 42 | 15 | 44 | 16 |
| AST, Day 42, Above | 5 | 2 | 3 | 1 |
| AST, Month 6, Below | 0 | 0 | 0 | 0 |
| AST, Month 6, Normal | 40 | 15 | 42 | 17 |
| AST, Month 6, Above | 2 | 1 | 0 | 0 |
| AST, Month 12, Below | 0 | 0 | 0 | 0 |
| AST, Month 12, Normal | 44 | 17 | 45 | 17 |
| AST, Month 12, Above | 0 | 0 | 0 | 0 |
| AST, Month 24, Below | 0 | 0 | 0 | 0 |
| AST, Month 24, Normal | 44 | 17 | 43 | 17 |
| AST, Month 24, Above | 1 | 0 | 1 | 0 |
Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents CREA results, for subjects participating in Phase B of the study.
| Participants | GSK1562902A-B Lot 2 3-5Y Group | Fluarix-B 3-5Y Group | GSK1562902A-B Lot 2 6-9Y Group | Fluarix-B 6-9Y Group |
|---|---|---|---|---|
| CREA, Day 0, Below | 0 | 0 | 0 | 0 |
| CREA, Day 0, Normal | 51 | 16 | 47 | 17 |
| CREA, Day 0, Above | 0 | 0 | 1 | 0 |
| CREA, Day 21, Below | 0 | 0 | 0 | 0 |
| CREA, Day 21, Normal | 44 | 17 | 45 | 17 |
| CREA, Day 21, Above | 1 | 0 | 1 | 0 |
| CREA, Day 42, Below | 0 | 0 | 0 | 0 |
| CREA, Day 42, Normal | 46 | 17 | 47 | 17 |
| CREA, Day 42, Above | 1 | 0 | 0 | 0 |
| CREA, Month 6, Below | 0 | 0 | 0 | 0 |
| CREA, Month 6, Normal | 42 | 16 | 41 | 17 |
| CREA, Month 6, Above | 0 | 0 | 2 | 0 |
| CREA, Month 12, Below | 0 | 0 | 0 | 0 |
| CREA, Month 12, Normal | 44 | 17 | 44 | 17 |
| CREA, Month 12, Above | 0 | 0 | 1 | 0 |
| CREA, Month 24, Below | 0 | 0 | 0 | 0 |
| CREA, Month 24, Normal | 45 | 17 | 44 | 17 |
| CREA, Month 24, Above | 0 | 0 | 0 | 0 |
Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents LDH results, for subjects participating to Phase B of the study.
| Participants | GSK1562902A-B Lot 2 3-5Y Group | Fluarix-B 3-5Y Group | GSK1562902A-B Lot 2 6-9Y Group | Fluarix-B 6-9Y Group |
|---|---|---|---|---|
| LDH, Day 0, Below | 0 | 0 | 0 | 0 |
| LDH, Day 0, Normal | 46 | 14 | 41 | 15 |
| LDH, Day 0, Above | 5 | 2 | 7 | 2 |
| LDH, Day 21, Below | 0 | 0 | 0 | 0 |
| LDH, Day 21, Normal | 35 | 14 | 42 | 16 |
| LDH, Day 21, Above | 9 | 3 | 4 | 1 |
| LDH, Day 42, Below | 0 | 0 | 0 | 0 |
| LDH, Day 42, Normal | 35 | 10 | 41 | 14 |
| LDH, Day 42, Above | 12 | 7 | 6 | 3 |
| LDH, Month 6, Below | 0 | 0 | 0 | 0 |
| LDH, Month 6, Normal | 35 | 11 | 36 | 15 |
| LDH, Month 6, Above | 6 | 5 | 6 | 2 |
| LDH, Month 12, Below | 0 | 0 | 0 | 0 |
| LDH, Month 12, Normal | 35 | 12 | 42 | 16 |
| LDH, Month 12, Above | 9 | 5 | 3 | 1 |
| LDH, Month 24, Below | 0 | 0 | 0 | 0 |
| LDH, Month 24, Normal | 43 | 16 | 41 | 15 |
| LDH, Month 24, Above | 2 | 1 | 3 | 2 |
Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents BUN results, for subjects participating to Phase B of the study.
| Participants | GSK1562902A-B Lot 2 3-5Y Group | Fluarix-B 3-5Y Group | GSK1562902A-B Lot 2 6-9Y Group | Fluarix-B 6-9Y Group |
|---|---|---|---|---|
| BUN, Day 0, Below | 0 | 0 | 0 | 0 |
| BUN, Day 0, Normal | 47 | 14 | 43 | 13 |
| BUN, Day 0, Above | 4 | 2 | 5 | 3 |
| BUN, Day 21, Below | 0 | 0 | 0 | 0 |
| BUN, Day 21, Normal | 38 | 14 | 43 | 15 |
| BUN, Day 21, Above | 7 | 3 | 3 | 2 |
| BUN, Day 42, Below | 0 | 0 | 0 | 0 |
| BUN, Day 42, Normal | 40 | 14 | 43 | 14 |
| BUN, Day 42, Above | 7 | 3 | 4 | 3 |
| BUN, Month 6, Below | 0 | 0 | 0 | 0 |
| BUN, Month 6, Normal | 42 | 13 | 43 | 17 |
| BUN, Month 6, Above | 0 | 3 | 0 | 0 |
| BUN, Month 12, Below | 0 | 0 | 0 | 0 |
| BUN, Month 12, Normal | 39 | 15 | 44 | 14 |
| BUN, Month 12, Above | 5 | 2 | 1 | 3 |
| BUN, Month 24, Below | 0 | 0 | 0 | 0 |
| BUN, Month 24, Normal | 40 | 13 | 41 | 16 |
| BUN, Month 24, Above | 5 | 4 | 3 | 1 |
Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents BUN results, for subjects participating to Phase C of the study.
| Participants | GSK1562902A-C Lot 3 3-5Y Group | Fluarix-C 3-5Y Group | GSK1562902A-C Lot 3 6-9Y Group | Fluarix-C 6-9Y Group |
|---|---|---|---|---|
| BUN, Day 0, Below | 0 | 1 | 0 | 0 |
| BUN, Day 0, Normal | 42 | 11 | 46 | 17 |
| BUN, Day 0, Above | 2 | 3 | 1 | 0 |
| BUN, Day 21, Below | 1 | 0 | 0 | 0 |
| BUN, Day 21, Normal | 42 | 12 | 42 | 17 |
| BUN, Day 21, Above | 2 | 0 | 0 | 1 |
| BUN, Day 42, Below | 0 | 0 | 3 | 0 |
| BUN, Day 42, Normal | 43 | 16 | 40 | 17 |
| BUN, Day 42, Above | 3 | 0 | 3 | 1 |
| BUN, Month 6, Below | 0 | 0 | 2 | 0 |
| BUN, Month 6, Normal | 40 | 15 | 36 | 18 |
| BUN, Month 6, Above | 1 | 1 | 6 | 0 |
| BUN, Month 12, Below | 0 | 0 | 0 | 0 |
| BUN, Month 12, Normal | 41 | 15 | 43 | 17 |
| BUN, Month 12, Above | 1 | 2 | 3 | 0 |
| BUN, Month 24, Below | 0 | 0 | 1 | 0 |
| BUN, Month 24, Normal | 39 | 15 | 40 | 17 |
| BUN, Month 24, Above | 2 | 2 | 5 | 1 |
Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents ALT results, for subjects participating to Phase C of the study.
| Participants | GSK1562902A-C Lot 3 3-5Y Group | Fluarix-C 3-5Y Group | GSK1562902A-C Lot 3 6-9Y Group | Fluarix-C 6-9Y Group |
|---|---|---|---|---|
| ALT,Day 0,Below | 0 | 0 | 0 | 0 |
| ALT, Day 0,Normal | 43 | 15 | 45 | 17 |
| ALT,Day 0,Above | 1 | 0 | 1 | 0 |
| ALT,Day 21,Below | 0 | 0 | 0 | 0 |
| ALT,Day 21,Normal | 44 | 12 | 42 | 18 |
| ALT,Day 21,Above | 1 | 0 | 0 | 0 |
| ALT,Day 42,Below | 0 | 0 | 0 | 0 |
| ALT,Day 42,Normal | 46 | 16 | 46 | 18 |
| ALT,Day 42,Above | 0 | 0 | 0 | 0 |
| ALT, Month 6, Below | 0 | 0 | 0 | 0 |
| ALT, Month 6, Normal | 41 | 15 | 44 | 18 |
| ALT, Month 6, Above | 0 | 1 | 0 | 0 |
| ALT,Month12,Below | 0 | 0 | 0 | 0 |
| ALT,Month 12,Normal | 42 | 17 | 44 | 17 |
| ALT,Month 12,Above | 0 | 0 | 2 | 0 |
| ALT,Month 24,Below | 0 | 0 | 0 | 0 |
| ALT,Month 24,Normal | 39 | 17 | 44 | 18 |
| ALT,Month 24,Above | 2 | 0 | 2 | 0 |
Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents CPK results, for subjects participating to Phase B of the study.
| Participants | GSK1562902A-B Lot 2 3-5Y Group | Fluarix-B 3-5Y Group | GSK1562902A-B Lot 2 6-9Y Group | Fluarix-B 6-9Y Group |
|---|---|---|---|---|
| CPK, Day 0, Below | 0 | 0 | 0 | 0 |
| CPK, Day 0, Normal | 49 | 16 | 46 | 16 |
| CPK, Day 0, Above | 2 | 0 | 2 | 1 |
| CPK, Day 21, Below | 0 | 0 | 0 | 0 |
| CPK, Day 21, Normal | 42 | 16 | 45 | 16 |
| CPK, Day 21, Above | 3 | 1 | 1 | 1 |
| CPK, Day 42, Below | 0 | 0 | 0 | 0 |
| CPK, Day 42, Normal | 43 | 15 | 44 | 16 |
| CPK, Day 42, Above | 4 | 2 | 3 | 1 |
| CPK, Month 6, Below | 0 | 0 | 0 | 0 |
| CPK, Month 6, Normal | 40 | 13 | 41 | 15 |
| CPK, Month 6, Above | 2 | 3 | 2 | 2 |
| CPK, Month 12, Below | 0 | 0 | 0 | 0 |
| CPK, Month 12, Normal | 39 | 14 | 44 | 17 |
| CPK, Month 12, Above | 5 | 3 | 1 | 0 |
| CPK, Month 24, Below | 0 | 0 | 0 | 0 |
| CPK, Month 24, Normal | 44 | 15 | 42 | 16 |
| CPK, Month 24, Above | 1 | 2 | 2 | 1 |
Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents AST results, for subjects participating to Phase C of the study.
| Participants | GSK1562902A-C Lot 3 3-5Y Group | Fluarix-C 3-5Y Group | GSK1562902A-C Lot 3 6-9Y Group | Fluarix-C 6-9Y Group |
|---|---|---|---|---|
| AST,Day 0,Below | 0 | 0 | 0 | 0 |
| AST,Day 0,Normal | 41 | 12 | 45 | 17 |
| AST,Day 0,Above | 3 | 3 | 1 | 0 |
| AST, Day 21,Below | 0 | 0 | 0 | 0 |
| AST,Day 21,Normal | 44 | 12 | 42 | 18 |
| AST,Day 21,Above | 1 | 0 | 0 | 0 |
| AST,Day 42,Below | 0 | 0 | 0 | 0 |
| AST,Day 42,Normal | 44 | 14 | 43 | 18 |
| AST,Day 42,Above | 2 | 2 | 3 | 0 |
| AST,Month 6,Below | 0 | 0 | 0 | 0 |
| AST, Month 6, Normal | 39 | 14 | 43 | 18 |
| AST, Month 6, Above | 1 | 2 | 1 | 0 |
| AST,Month 12,Below | 0 | 0 | 0 | 0 |
| AST,Month 12,Normal | 41 | 17 | 40 | 17 |
| AST,Month 12,Above | 0 | 0 | 5 | 0 |
| AST,Month 24,Below | 0 | 0 | 0 | 0 |
| AST,Month 24,Normal | 38 | 17 | 45 | 18 |
| AST,Month 24,Above | 3 | 0 | 1 | 0 |
Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents CPK results, for subjects participating to Phase C of the study.
| Participants | GSK1562902A-C Lot 3 3-5Y Group | Fluarix-C 3-5Y Group | GSK1562902A-C Lot 3 6-9Y Group | Fluarix-C 6-9Y Group |
|---|---|---|---|---|
| CPK, Day 0, Below | 0 | 0 | 0 | 0 |
| CPK, Day 0, Normal | 43 | 13 | 42 | 16 |
| CPK, Day 0, Above | 1 | 2 | 4 | 1 |
| CPK, Day 21, Below | 0 | 0 | 0 | 0 |
| CPK, Day 21, Normal | 43 | 11 | 41 | 16 |
| CPK, Day 21, Above | 2 | 1 | 1 | 2 |
| CPK, Day 42, Below | 0 | 0 | 0 | 0 |
| CPK, Day 42, Normal | 44 | 13 | 46 | 17 |
| CPK, Day 42, Above | 2 | 3 | 0 | 1 |
| CPK, Month 6, Below | 0 | 0 | 0 | 0 |
| CPK, Month 6, Normal | 37 | 15 | 41 | 18 |
| CPK, Month 6, Above | 4 | 1 | 3 | 0 |
| CPK, Month 12, Below | 0 | 0 | 0 | 0 |
| CPK, Month 12, Normal | 38 | 15 | 42 | 16 |
| CPK, Month 12, Above | 4 | 2 | 4 | 1 |
| CPK, Month 24, Below | 0 | 0 | 0 | 0 |
| CPK, Month 24, Normal | 39 | 15 | 43 | 16 |
| CPK, Month 24, Above | 2 | 2 | 3 | 2 |
Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents CREA results, for subjects participating to Phase C of the study.
| Participants | GSK1562902A-C Lot 3 3-5Y Group | Fluarix-C 3-5Y Group | GSK1562902A-C Lot 3 6-9Y Group | Fluarix-C 6-9Y Group |
|---|---|---|---|---|
| CREA, Day 0, Below | 0 | 0 | 0 | 0 |
| CREA, Day 0, Normal | 44 | 15 | 46 | 17 |
| CREA, Day 0, Above | 0 | 0 | 0 | 0 |
| CREA, Day 21, Below | 0 | 0 | 0 | 0 |
| CREA, Day 21, Normal | 45 | 12 | 42 | 18 |
| CREA, Day 21, Above | 0 | 0 | 0 | 0 |
| CREA, Day 42, Below | 0 | 0 | 0 | 0 |
| CREA, Day 42, Normal | 46 | 16 | 46 | 18 |
| CREA, Day 42, Above | 0 | 0 | 0 | 0 |
| CREA, Month 6, Below | 0 | 0 | 0 | 0 |
| CREA, Month 6, Normal | 41 | 16 | 44 | 18 |
| CREA, Month 6, Above | 0 | 0 | 0 | 0 |
| CREA, Month 12, Below | 0 | 0 | 0 | 0 |
| CREA, Month 12, Normal | 42 | 17 | 46 | 17 |
| CREA, Month 12, Above | 0 | 0 | 0 | 0 |
| CREA, Month 24, Below | 0 | 0 | 0 | 0 |
| CREA, Month 24, Normal | 41 | 17 | 46 | 18 |
| CREA, Month 24, Above | 0 | 0 | 0 | 0 |
Assessed biochemical parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (CREA), blood urea nitrogen (BUN), lactate dehydrogenase (LDH), and creatine phosphokinase (CPK). Per parameter , it was assessed whether subjects had laboratory values below normal, normal, or above normal range. This outcome presents LDH results, for subjects participating to Phase C of the study.
| Participants | GSK1562902A-C Lot 3 3-5Y Group | Fluarix-C 3-5Y Group | GSK1562902A-C Lot 3 6-9Y Group Subjects Aged 6-9 Years Receive | Fluarix-C 6-9Y Group |
|---|---|---|---|---|
| LDH, Day 0, Below | 0 | 0 | 0 | 0 |
| LDH, Day 0, Normal | 36 | 12 | 44 | 17 |
| LDH, Day 0, Above | 8 | 3 | 3 | 0 |
| LDH, Day 21, Below | 0 | 0 | 0 | 0 |
| LDH, Day 21, Normal | 38 | 11 | 39 | 17 |
| LDH, Day 21, Above | 7 | 1 | 3 | 1 |
| LDH, Day 42, Below | 0 | 0 | 0 | 0 |
| LDH, Day 42, Normal | 35 | 8 | 42 | 17 |
| LDH, Day 42, Above | 11 | 8 | 4 | 1 |
| LDH, Month 6, Below | 0 | 0 | 0 | 0 |
| LDH, Month 6, Normal | 32 | 10 | 40 | 18 |
| LDH, Month 6, Above | 8 | 6 | 4 | 0 |
| LDH, Month 12, Below | 0 | 0 | 0 | 0 |
| LDH, Month 12, Normal | 30 | 12 | 36 | 15 |
| LDH, Month 12, Above | 11 | 5 | 9 | 2 |
| LDH, Month 24, Below | 0 | 0 | 0 | 0 |
| LDH, Month 24, Normal | 28 | 14 | 43 | 17 |
| LDH, Month 24, Above | 13 | 3 | 3 | 1 |
Titers of serum neutralizing antibodies are presented as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off value of 1:28. The influenza strain assessed was A/Vietnam/1194/04 (A/VIET).Results presented are for subjects participating in Phase A of the study
| Titer | GSK1562902A -A Lot 1 3-5Y Group | Fluarix-A 3-5Y Group | GSK1562902A-A Lot 1 6-9Y Group | Fluarix-A 6-9Y Group |
|---|---|---|---|---|
| A/VIET, Day 0 | 31.0 (21.8 to 44.0) | 29.0 (15.2 to 55.2) | 32.2 (23.1 to 44.9) | 18.2 (12.2 to 27.3) |
| A/VIET, Day 21 | 173.5 (123.3 to 244.0) | 98.2 (52.4 to 184.1) | 177.5 (127.0 to 248.0) | 97.2 (46.3 to 204.0) |
| A/VIET, Day 42 | 1044.4 (845.4 to 1290.3) | 158.4 (76.5 to 327.8) | 1155.1 (920.9 to 1448.7) | 104.5 (51.2 to 213.3) |
Titers of serum neutralizing antibodies are presented as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off value of 1:28. The influenza strain assessed was A/Vietnam/1194/04 (A/VIET). Results presented are for subjects participating in Phase B of the study.
| Titer | GSK1562902A-B Lot 2 3-5Y Group | Fluarix-B 3-5Y Group | GSK1562902A-B Lot 2 6-9Y Group | Fluarix-B 6-9Y Group |
|---|---|---|---|---|
| A/VIET, Day 0 | 65.5 (47.3 to 90.7) | 48.8 (29.7 to 80.2) | 46.2 (33.2 to 64.2) | 25.6 (17.3 to 37.8) |
| A/VIET, Day 21 | 344.7 (260.9 to 455.3) | 124.9 (60.7 to 257.2) | 461.7 (376.2 to 566.5) | 148.3 (81.2 to 271.1) |
| A/VIET, Day 42 | 1553.2 (1105.9 to 2181.5) | 86.9 (42.5 to 177.6) | 1519.4 (1229.9 to 1877.0) | 154.6 (97.9 to 244.0) |
Titers of serum neutralizing antibodies are presented as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off value of 1:28. The influenza strain assessed was A/Vietnam/1194/04 (A/VIET). Results presented are for subjects participating in Phase C of the study.
| Titer | GSK1562902A-C Lot 3 3-5Y Group | Fluarix-C 3-5Y Group | GSK1562902A-C Lot 3 6-9Y Group | Fluarix-C 6-9Y Group |
|---|---|---|---|---|
| A/VIET, Day 0 | 37.3 (23.9 to 58.1) | 35.5 (17.3 to 72.8) | 25.6 (18.6 to 35.3) | 27.1 (13.3 to 55.4) |
| A/VIET, Day 21 | 473.8 (351.2 to 639.3) | 111.3 (52.7 to 234.9) | 313.5 (193.3 to 508.4) | 190.1 (57.6 to 628.2) |
| A/VIET, Day 42 | 4578.3 (3786.6 to 5535.6) | 102.3 (45.9 to 228.2) | 3032.5 (2431.8 to 3781.6) | 77.6 (31.3 to 192.7) |
A seroconverted subject as regards to serum neutralizing antibodies against influenza disease was a subject with a minimum 4-fold increase in serum neutralizing antibody titer at post-vaccination. The flu strain assessed was A/Vietnam/1194/2004 (A/VIET). This outcome presents results for subjects participating to Phase A of the study.
| Participants | GSK1562902A -A Lot 1 3-5Y Group | Fluarix-A 3-5Y Group | GSK1562902A-A Lot 1 6-9Y Group | Fluarix-A 6-9Y Group |
|---|---|---|---|---|
| A/VIET, Day 21 | 31 | 6 | 28 | 10 |
| A/VIET, Day 42 | 43 | 8 | 42 | 10 |
A seroconverted subject as regards to serum neutralizing antibodies against influenza disease was a subject with a minimum 4-fold increase in serum neutralizing antibody titer at post-vaccination. The flu strain assessed was A/Vietnam/1194/2004 (A/VIET). This outcome presents results for subjects participating to Phase B of the study.
| Participants | GSK1562902A-B Lot 2 3-5Y Group | Fluarix-B 3-5Y Group | GSK1562902A-B Lot 2 6-9Y Group | Fluarix-B 6-9Y Group |
|---|---|---|---|---|
| A/VIET, Day 21 | 25 | 6 | 35 | 11 |
| A/VIET, Day 42 | 40 | 2 | 42 | 11 |
A seroconverted subject as regards to serum neutralizing antibodies against influenza disease was a subject with a minimum 4-fold increase in serum neutralizing antibody titer at post-vaccination. The flu strain assessed was A/Vietnam/1194/2004 (A/VIET). This outcome presents results for subjects participating to Phase C of the study.
| Participants | GSK1562902A-C Lot 3 3-5Y Group | Fluarix-C 3-5Y Group | GSK1562902A-C Lot 3 6-9Y Group | Fluarix-C 6-9Y Group |
|---|---|---|---|---|
| A/VIET, Day 21 | 29 | 7 | 23 | 3 |
| A/VIET, Day 42 | 37 | 6 | 42 | 5 |
Titers of serum neutralizing antibodies are presented as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off value of 1:28. The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO) strains. Results presented are for subjects participating in Phase A of the study. Subjects participating to Phases B and C of the study were not analysed at these persistence time points for this outcome.
| Titer | GSK1562902A-A Lot 1 3-5Y Group | Fluarix-A 3-5Y Group | GSK1562902A-A Lot 1 6-9Y Group | Fluarix-A 6-9Y Group |
|---|---|---|---|---|
| A/VIET, Month 6 | 781.2 (641.5 to 951.5) | 208.5 (108.6 to 400.3) | 756.1 (624.5 to 915.5) | 482.3 (313.4 to 742.3) |
| A/VIET, Month 12 | 238.9 (186.1 to 306.6) | 35.4 (16.7 to 74.9) | 179.4 (126.1 to 255.3) | 27.6 (13.4 to 56.9) |
| A/VIET, Month 24 | 302.5 (231.0 to 396.0) | 39.4 (16.3 to 95.5) | 234.5 (177.1 to 310.6) | 46.6 (18.4 to 118.3) |
| A/INDO, Month 6 | 113.8 (87.2 to 148.6) | 17.0 (11.1 to 26.1) | 106.8 (82.6 to 138.0) | 16.9 (11.1 to 25.8) |
| A/INDO, Month 12 | 170.8 (132.7 to 220.0) | 18.2 (11.4 to 29.1) | 139.7 (105.8 to 184.6) | 21.9 (12.2 to 39.2) |
| A/INDO, Month 24 | 188.5 (144.6 to 245.7) | 31.8 (14.6 to 69.3) | 146.0 (111.7 to 190.8) | 20.5 (11.6 to 36.3) |
A seroconverted subject as regards to neutralizing antibody response was a subject with a minimum 4-fold increase in neutralizing antibody titer at post-vaccination. The 2 influenza strains assessed were A/Vietnam/1194/04 (A/VIET) and A/Indonesia/05/2005 (A/INDO) strains. Results presented are for subjects participating in Phase A of the study. Subjects participating to Phases B and C of the study were not analysed at these persistence time points for this outcome.
| Participants | GSK1562902A-A Lot 1 3-5Y Group | Fluarix-A 3-5Y Group | GSK1562902A-A Lot 1 6-9Y Group | Fluarix-A 6-9Y Group |
|---|---|---|---|---|
| A/VIET, Month 6 | 41 | 9 | 38 | 13 |
| A/VIET, Month 12 | 37 | 3 | 23 | 3 |
| A/VIET, Month 24 | 36 | 3 | 23 | 4 |
| A/INDO, Month 6 | 34 | 0 | 31 | 1 |
| A/INDO, Month 12 | 37 | 1 | 31 | 2 |
| A/INDO, Month 24 | 40 | 3 | 33 | 2 |
AESIs are adverse events such as clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. AESIs assessed included neuroinflammatory disorders such as cranial nerve disorders, multiple sclerosis,transverse myelitis, Guillain-Barré syndromeor neuritis), musculoskeletal disorders (such as systemic lupus erythematosus, cutaneous lupus, polymyositis, rheumatoid arthritis, reactive arthritis, psoriatic arthropathy, or undifferentiated spondyloarthropathy), gastrointestinal disorders (such as Crohn's disease, ulcerative colitis, ulcerative proctitis, celiac disease), metabolic diseases (such as autoimmune thyroiditis, Addison's disease). skin disorders (such as psoriasis, vitiligo, Raynaud's phenomenon, or autoimmune bullous skin diseases), and other conditions as autoimmune hemolytic anemia, thrombocytopenias, antiphospholipid syndrome, vasculitis, autoimmune hepatitis, or sarcoidosis.
| Participants | GSK1562902A-A Lot 1 3-5Y Group | Fluarix-A 3-5Y Group | GSK1562902A-A Lot 1 6-9Y Group | Fluarix-A 6-9Y Group | GSK1562902A-B Lot 2 3-5Y Group | Fluarix-B 3-5Y Group | GSK1562902A-B Lot 2 6-9Y Group | Fluarix-B 6-9Y Group | GSK1562902A-C Lot 3 3-5Y Group | Fluarix-C 3-5Y Group | GSK1562902A-C Lot 3 6-9Y Group | Fluarix-C 6-9Y Group |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Number of Subjects With Adverse Events of Specific Interest (AESIs) | 1 | 0 | 0 | 1 | 1 | 1 | 0 | 0 | 1 | 0 | 0 | 0 |
Collected over Serious adverse events (SAEs): from Day 0 to Month 24. Unsolicited adverse events (AEs): during the 21-days period post Dose 1 on Day 0 or the 30-days period post Dose 2 on Day 42. Solicited local and general symptoms: within 7 days post any vaccination.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| GSK1562902A -A Lot 1 3-5Y Group | — | 0/51 (0%) | 42/51 (82.4%) |
| Fluarix-A 3-5Y Group | — | 0/18 (0%) | 17/18 (94.4%) |
| GSK1562902A-A Lot 1 6-9Y Group | — | 0/51 (0%) | 48/51 (94.1%) |
| Fluarix-A 6-9Y Group | — | 0/18 (0%) | 14/18 (77.8%) |
| GSK1562902A-B Lot 2 3-5Y Group | — | 1/51 (2%) | 42/51 (82.4%) |
| Fluarix-B 3-5Y Group | — | 1/17 (5.9%) | 11/17 (64.7%) |
| GSK1562902A-B Lot 2 6-9Y Group | — | 0/49 (0%) | 41/49 (83.7%) |
| Fluarix-B 6-9Y Group | — | 0/17 (0%) | 13/17 (76.5%) |
| GSK1562902A-C Lot 3 3-5Y Group | — | 2/49 (4.1%) | 43/49 (87.8%) |
| Fluarix-C 3-5Y Group | — | 0/17 (0%) | 13/17 (76.5%) |
| GSK1562902A-C Lot 3 6-9Y Group | — | 1/49 (2%) | 46/49 (93.9%) |
| Fluarix-C 6-9Y Group | — | 0/18 (0%) | 17/18 (94.4%) |
| Event | GSK1562902A -A Lot 1 3-5Y Group | Fluarix-A 3-5Y Group | GSK1562902A-A Lot 1 6-9Y Group | Fluarix-A 6-9Y Group | GSK1562902A-B Lot 2 3-5Y Group | Fluarix-B 3-5Y Group | GSK1562902A-B Lot 2 6-9Y Group | Fluarix-B 6-9Y Group | GSK1562902A-C Lot 3 3-5Y Group | Fluarix-C 3-5Y Group | GSK1562902A-C Lot 3 6-9Y Group | Fluarix-C 6-9Y Group |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Type 1 diabetes mellitusMetabolism and nutrition disorders | 0/51 | 0/18 | 0/51 | 0/18 | 0/51 | 1/17 | 0/49 | 0/17 | 0/49 | 0/17 | 0/49 | 0/18 |
| WoundInjury, poisoning and procedural complications | 0/51 | 0/18 | 0/51 | 0/18 | 0/51 | 0/17 | 0/49 | 0/17 | 0/49 | 0/17 | 1/49 | 0/18 |
| GastroenteritisInfections and infestations | 0/51 | 0/18 | 0/51 | 0/18 | 0/51 | 0/17 | 0/49 | 0/17 | 1/49 | 0/17 | 0/49 | 0/18 |
| Traumatic brain injuryInjury, poisoning and procedural complications | 0/51 | 0/18 | 0/51 | 0/18 | 0/51 | 0/17 | 0/49 | 0/17 | 1/49 | 0/17 | 0/49 | 0/18 |
| Autoimmune hepatitisHepatobiliary disorders | 0/51 | 0/18 | 0/51 | 0/18 | 1/51 | 0/17 | 0/49 | 0/17 | 0/49 | 0/17 | 0/49 | 0/18 |
| Transaminases increasedInvestigations | 0/51 | 0/18 | 0/51 | 0/18 | 1/51 | 0/17 | 0/49 | 0/17 | 0/49 | 0/17 | 0/49 | 0/18 |
| Event | GSK1562902A -A Lot 1 3-5Y Group | Fluarix-A 3-5Y Group | GSK1562902A-A Lot 1 6-9Y Group | Fluarix-A 6-9Y Group | GSK1562902A-B Lot 2 3-5Y Group | Fluarix-B 3-5Y Group | GSK1562902A-B Lot 2 6-9Y Group | Fluarix-B 6-9Y Group | GSK1562902A-C Lot 3 3-5Y Group | Fluarix-C 3-5Y Group | GSK1562902A-C Lot 3 6-9Y Group | Fluarix-C 6-9Y Group |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| PainGeneral disorders | 31/51 | 7/18 | 44/51 | 12/18 | 27/51 | 3/17 | 36/49 | 9/17 | 37/49 | 7/17 | 44/49 | 15/18 |
| HeadacheGeneral disorders | 0/51 | 0/18 | 20/51 | 5/18 | 0/51 | 0/17 | 11/49 | 2/17 | 0/49 | 0/17 | 25/49 | 3/18 |
| SwellingGeneral disorders | 10/51 | 1/18 | 14/51 | 7/18 | 9/51 | 2/17 | 10/49 | 2/17 | 18/49 | 2/17 | 14/49 | 3/18 |
| Fever (axillary temperature >=37.5°C)General disorders | 8/51 | 0/18 | 0/51 | 0/18 | 10/51 | 2/17 | 0/49 | 0/17 | 18/49 | 0/17 | 0/49 | 0/18 |
| IrritabilityGeneral disorders | 9/51 | 1/18 | 0/51 | 0/18 | 13/51 | 2/17 | 0/49 | 0/17 | 18/49 | 0/17 | 0/49 | 0/18 |
| Fever (axillary temperature >= 37.5°C)General disorders | 0/51 | 0/18 | 7/51 | 3/18 | 0/51 | 0/17 | 3/49 | 0/17 | 0/49 | 0/17 | 18/49 | 0/18 |
| IndurationGeneral disorders | 7/51 | 1/18 | 12/51 | 6/18 | 4/51 | 1/17 | 6/49 | 1/17 | 14/49 | 0/17 | 10/49 | 1/18 |
| RednessGeneral disorders | 10/51 | 2/18 | 12/51 | 5/18 | 6/51 | 4/17 | 6/49 | 3/17 | 16/49 | 2/17 | 6/49 | 1/18 |
| Gastrointestinal symptomsGeneral disorders | 0/51 | 0/18 | 9/51 | 5/18 | 0/51 | 0/17 | 4/49 | 5/17 | 0/49 | 0/17 | 16/49 | 5/18 |
| Loss of appetiteGeneral disorders | 12/51 | 1/18 | 0/51 | 0/18 | 8/51 | 1/17 | 0/49 | 0/17 | 15/49 | 1/17 | 0/49 | 0/18 |
| Age, Continuous(Years) | GSK1562902A -A Lot 1 3-5Y Group | Fluarix-A 3-5Y Group | GSK1562902A-A Lot 1 6-9Y Group | Fluarix-A 6-9Y Group | GSK1562902A-B Lot 2 3-5Y Group | Fluarix-B 3-5Y Group | GSK1562902A-B Lot 2 6-9Y Group | Fluarix-B 6-9Y Group | GSK1562902A-C Lot 3 3-5Y Group | Fluarix-C 3-5Y Group | GSK1562902A-C Lot 3 6-9Y Group | Fluarix-C 6-9Y Group | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mean | 3.9 ± 0.84 | 3.6 ± 0.70 | 7.6 ± 1.06 | 7.6 ± 1.38 | 4.2 ± 0.85 | 4.4 ± 0.79 | 7.3 ± 1.28 | 7.2 ± 1.20 | 4.2 ± 0.85 | 3.9 ± 0.93 | 7.0 ± 1.06 | 7.4 ± 0.98 | 6.1 ± 0.92 |
| Sex: Female, Male(Participants) | GSK1562902A -A Lot 1 3-5Y Group | Fluarix-A 3-5Y Group | GSK1562902A-A Lot 1 6-9Y Group | Fluarix-A 6-9Y Group | GSK1562902A-B Lot 2 3-5Y Group | Fluarix-B 3-5Y Group | GSK1562902A-B Lot 2 6-9Y Group | Fluarix-B 6-9Y Group | GSK1562902A-C Lot 3 3-5Y Group | Fluarix-C 3-5Y Group | GSK1562902A-C Lot 3 6-9Y Group | Fluarix-C 6-9Y Group | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Female | 25 | 9 | 24 | 7 | 25 | 10 | 19 | 3 | 22 | 11 | 18 | 9 | 182 |
| Male | 26 | 9 | 27 | 11 | 26 | 7 | 30 | 14 | 27 | 6 | 31 | 9 | 223 |
Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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