A Phase 3 interventional study of Influenza A (H5N1) Virus monovalent vaccine and Saline placebo in Influenza and Influenza Vaccines, sponsored by GlaxoSmithKline. Completed at 17 sites in 3 countries. Open to participants aged 6 Months to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-11-01.
Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Prevention
This study will assess safety and immunogenicity of GSK Biologicals' H5N1 flu candidate vaccine GSK1557484A in children 6 months to \< 18 years of age.
2,214 studies on the registry are indexed under Influenza, Human; 164 are open to participants now.
This study's enrollment of 842 is above the median of 238 across 1,853 interventional studies indexed under Influenza, Human.
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Female subjects of childbearing potential must
Exclusion Criteria:
Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (\< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (\>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Biological: Influenza A (H5N1) Virus monovalent vaccine
Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Biological: Influenza A (H5N1) Virus monovalent vaccine
Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals' monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Biological: Influenza A (H5N1) Virus monovalent vaccine
Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (\< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (\>=) 12 months, Dose 1 was administered in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Biological: Saline placebo
Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Biological: Saline placebo
Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
Biological: Saline placebo
Subjects in this group were those who were administered the saline placebo solution in the Blinded Phase of the study (either in the Placebo 6-\<36M, Placebo 3-\<9Y or Placebo 9-\<18Y Group). These were subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who had received 2 doses of saline placebo at Days 0 and 21 in the Blinded Phase of the study, as per described in the descriptions of the Placebo 6-\<36M, Placebo 3-\<9Y and Placebo 9-\<18Y groups. After consenting to participating to the Unblinded Phase of the study, these subjects received in addition 2 doses of Influenza A (H5N1) Virus monovalent vaccine at Days 385 (Day U0) and Day 385 + 21 days (Day U21). Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. Dose 1 of was administered in the deltoid region of the non-dominant arm and Dose 2 in the deltoid region of the dominant arm.
Biological: Influenza A (H5N1) Virus monovalent vaccine
All subjects will receive 2 doses administered as an intramuscular (IM) injection.
All subjects will receive 2 doses administered as an intramuscular (IM) injection.
Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain.
A seroprotected subject against the a/Indonesia/5/2005 (A/INDO) virus strain was defined as a subject with H5N1 reciprocal haemagglutination inhibition (HI) antibody titers greater than or equal to (\>=) the seroprotection cut-off of 1:40.
Time frame: At Day 42.
Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain.
HI antibody titers against the H5N1 A/Indonesia virus strain (A/INDO) were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of higher than or equal to (\>=) 1:10.
Time frame: At Days 0 and 21
Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain.
A seroprotected subject against the a/Indonesia/5/2005 (A/INDO) virus strain was defined as a subject with H5N1 reciprocal haemagglutination inhibition (HI) antibody titers greater than or equal to (\>=) the seroprotection cut-off of 1:40.
Time frame: At Days 0 and 21
Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the H5N1 A/Indonesia Virus Strain.
A subject seroconverted for HI antibodies against the H5N1 A/Indonesia virus strain (A/INDO) was defined as a vaccinee with either a pre-vaccination titer less than (\<) 1:10 and a post-vaccination titer higher than or equal to (\>=) 1:40, or with a pre-vaccination titer \>= 1:10 and at least a 4-fold increase in post-vaccination titer. As the analyses were performed and disclosed stepwise - i.e. as soon as a study phase was completed - several releases of the CTRS (result summaries) were published. To generate an integrated Clinical Study Report, one set of domain datasets covering all analyses was used and the Adapted ATP cohort for immunogenicity has been defined. As a consequence, some of the data previously disclosed and based on ATP cohort for immunogenicity at Day 42, Day 182 and Day 385 have been replaced in this summary with data generated with the Adapted ATP cohort for immunogenicity.
Time frame: At Days 21 and 42
Geometric Mean Increase (GMI) for Haemagglutination Inhibition (HI) Antibodies Against the H5N1 A/Indonesia Virus Strain.
GMI also known as the seroconversion factor (SCF) or geometric mean fold rise (GMFR) was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titre to the pre-vaccination reciprocal HI titre for the vaccine virus.
Time frame: At Days 21 and 42
Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain.
HI antibody titers against the H5N1 A/Indonesia virus strain (A/INDO) were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of higher than or equal to (\>=) 1:10. Adapted ATP cohort for immunogenicity included all evaluable subjects for which Day 21 and Day 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Day 182 data were obtained from the ATP cohort for immunogenicity at Day 182, and Day 385 data were obtained from the ATP cohort for immunogenicity at Day 385.
Time frame: At Day 0 and Day 182.
Number of Subjects Seroprotected as Regards Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain.
A seroprotected subject against the a/Indonesia/5/2005 (A/INDO) virus strain was defined as a subject with H5N1 reciprocal haemagglutination inhibition (HI) antibody titers greater than or equal to (\>=) the seroprotection cut-off of 1:40. As the analyses were performed and disclosed stepwise - i.e. as soon as a study phase was completed - several releases of the CTRS (result summaries) were published. To generate an integrated Clinical Study Report, one set of domain datasets covering all analyses was used and the Adapted ATP cohort for immunogenicity has been defined. As a consequence, some of the data previously disclosed and based on ATP cohort for immunogenicity at Day 42, Day 182 and Day 385 have been replaced in this summary with data generated with the Adapted ATP cohort for immunogenicity.
Time frame: At Day 0 and Day 182
Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain
HI antibody titers against the H5N1 A/Indonesia virus strain (A/INDO) were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of higher than or equal to (\>=) 1:10. As the analyses were performed and disclosed stepwise - i.e. as soon as a study phase was completed - several releases of the CTRS (result summaries) were published. To generate an integrated Clinical Study Report, one set of domain datasets covering all analyses was used and the Adapted ATP cohort for immunogenicity has been defined. As a consequence, some of the data previously disclosed and based on ATP cohort for immunogenicity at Day 42, Day 182 and Day 385 have been replaced in this summary with data generated with the Adapted ATP cohort for immunogenicity.
Time frame: At Day 42.
Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the H5N1 A/Indonesia Virus Strain.
A subject seroconverted for HI antibodies against the H5N1 A/Indonesia virus strain (A/INDO) was defined as a vaccinee with either a pre-vaccination titer less than (\<) 1:10 and a post-vaccination titer higher than or equal to (\>=) 1:40, or with a pre-vaccination titer \>= 1:10 and at least a 4-fold increase in post-vaccination titer.
Time frame: At Day 182
Geometric Mean Increase (GMI) for Haemagglutination Inhibition (HI) Antibodies Against the H5N1 A/Indonesia Virus Strain.
GMI also known as the seroconversion factor (SCF) or geometric mean fold rise (GMFR) was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titre to the pre-vaccination reciprocal HI titre for the vaccine virus.
Time frame: At Day 182
Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain.
HI antibody titers against the H5N1 A/Indonesia virus strain (A/INDO) were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of higher than or equal to (\>=) 1:10. As the analyses were performed and disclosed stepwise - i.e. as soon as a study phase was completed - several releases of the CTRS (result summaries) were published. To generate an integrated Clinical Study Report, one set of domain datasets covering all analyses was used and the Adapted ATP cohort for immunogenicity has been defined. As a consequence, some of the data previously disclosed and based on ATP cohort for immunogenicity at Day 42, Day 182 and Day 385 have been replaced in this summary with data generated with the Adapted ATP cohort for immunogenicity.
Time frame: At Day 0 and Day 385
Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain.
A seroprotected subject against the a/Indonesia/5/2005 (A/INDO) virus strain was defined as a subject with H5N1 reciprocal haemagglutination inhibition (HI) antibody titers greater than or equal to (\>=) the seroprotection cut-off of 1:40. As the analyses were performed and disclosed stepwise - i.e. as soon as a study phase was completed - several releases of the CTRS (result summaries) were published. To generate an integrated Clinical Study Report, one set of domain datasets covering all analyses was used and the Adapted ATP cohort for immunogenicity has been defined. As a consequence, some of the data previously disclosed and based on ATP cohort for immunogenicity at Day 42, Day 182 and Day 385 have been replaced in this summary with data generated with the Adapted ATP cohort for immunogenicity.
Time frame: At Day 0 and Day 385
Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the H5N1 A/Indonesia Virus Strain.
A subject seroconverted for HI antibodies against the H5N1 A/Indonesia virus strain (A/INDO) was defined as a vaccinee with either a pre-vaccination titer less than (\<) 1:10 and a post-vaccination titer higher than or equal to (\>=) 1:40, or with a pre-vaccination titer \>= 1:10 and at least a 4-fold increase in post-vaccination titer.
Time frame: At Day 385
Geometric Mean Increase (GMI) for Haemagglutination Inhibition (HI) Antibodies Against the H5N1 A/Indonesia Virus Strain.
GMI also known as the seroconversion factor (SCF) or geometric mean fold rise (GMFR) was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.
Time frame: At Day 385.
Microneutralization (MN) Antibody Titers Against the H5N1 A/Indonesia and H5N1 A/Vietnam Virus Strains.
MN HI antibody titers against the H5N1 A/Indonesia (A/INDO) and H5N1 A/Vietnam (A/VIET) virus strains were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of higher than or equal to (\>=) 1:28.
Time frame: At Days 0, 42, 182 and 385
Number of Subjects Seropositive for Microneutralization (MN) Antibodies Against the H5N1 A/Indonesia Virus Strain.
Time frame: At Days 0 and 42
Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the H5N1 A/Indonesia and H5N1 A/Vietnam Virus Strains.
VRR for MN was defined as as the incidence rate of vaccinees with a 4-fold increase in post vaccination reciprocal titer relative to Day 0.
Time frame: At Day 42
Number of Subjects Reporting Solicited Local Symptoms.
Solicited local symptoms assessed were pain, redness and swelling. "Any" was defined as any occurrence of the specified solicited local symptom reported, regardless of intensity. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling were defined as redness/swelling above 100 millimeter (mm).
Time frame: During the 7-day (Days 0-6) post-vaccination periods post Doses 1 and 2 of vaccine/placebo, across doses (Year 1)
Number of Subjects Reporting Solicited Local Symptoms.
Solicited local symptoms assessed were pain and swelling. "Any" was defined as any occurrence of the specified solicited local symptom reported, regardless of intensity. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling were defined as redness/swelling above 100 millimeter (mm).
Time frame: During the 7-day (Days U0-U6) post-vaccination periods post Doses 1 and 2 of vaccine/placebo, across doses (Year 2)
Number of Subjects of Less Than 6 Years of Age Reporting Solicited General Symptoms.
Solicited general symptoms assessed in subjects of less than 6 years of age were drowsiness, irritability/fussiness, loss of appetite and fever \[axillary temperature (T) higher than or equal to (\>=) 38.0 degrees Celsius (°C)\]. "Any" was defined as any occurrence of the specified solicited general symptom reported, regardless of intensity or relationship to vaccination. Grade 3 was defined as a general symptom that prevented normal activity. Related was defined as a general symptom assessed by the investigator as causally related to the study vaccination. Any fever was defined as axillary temperature above 38.0 degrees Celsius (°C). Grade 3 fever was axillary temperature \>= 39.0°C.
Time frame: During the 7-day (Days 0-6) post-vaccination periods post Doses 1 and 2 of vaccine/placebo, across doses (Year 1)
Number of Subjects of Less Than 6 Years of Age Reporting Solicited General Symptoms.
Solicited general symptoms assessed in subjects of less than 6 years of age were drowsiness, irritability/fussiness, loss of appetite and fever \[axillary temperature (T) higher than or equal to (\>=) 38.0 degrees Celsius (°C)\]. "Any" was defined as any occurrence of the specified solicited general symptom reported, regardless of intensity or relationship to vaccination. Grade 3 was defined as a general symptom that prevented normal activity. Related was defined as a general symptom assessed by the investigator as causally related to the study vaccination. Any fever was defined as axillary temperature above 38.0 degrees Celsius (°C). Grade 3 fever was axillary temperature \>=39.0°C.
Time frame: During the 7-day (Days U0-U6) post-vaccination periods post Doses 1 and 2 of vaccine/placebo, across doses (Year 2)
Number of Subjects at Least 6 Years of Age Reporting Solicited General Symptoms.
Solicited general symptoms assessed in subjects of at least 6 years of age were fatigue, gastrointestinal symptoms, headache, joint pain at other location, muscle aches, shivering, sweating and fever \[axillary temperature (T) \>= 38.0 degrees Celsius (°C)\]. Gastrointestinal symptoms included nausea, vomiting, diaorrhea and/or abdominal pain. "Any" was defined as any occurrence of the specified solicited general symptom reported, regardless of intensity or relationship to vaccination. Grade 3 was defined as a general symptom that prevented normal activity. Related was defined as a general symptom assessed by the investigator as causally related to the study vaccination. Grade 3 fever was axillary temperature \>= 39.0°C.
Time frame: During the 7-day (Days 0-6) post-vaccination periods post Doses 1 and 2 of vaccine/placebo, across doses (Year 1)
Number of Subjects at Least 6 Years of Age Reporting Solicited General Symptoms.
Solicited general symptoms assessed in subjects of at least 6 years of age were fatigue, gastrointestinal symptoms, headache, joint pain at other location, muscle aches, shivering, sweating and fever \[axillary temperature (T) \>= 38.0 degrees Celsius (°C)\]. Gastrointestinal symptoms included nausea, vomiting, diaorrhea and/or abdominal pain. "Any" was defined as any occurrence of the specified solicited general symptom reported, regardless of intensity or relationship to vaccination. Grade 3 was defined as a general symptom that prevented normal activity. Related was defined as a general symptom assessed by the investigator as causally related to the study vaccination. Grade 3 fever was axillary temperature \>= 39.0°C.
Time frame: During the 7-day (Days U0-U6) post-vaccination periods post Doses 1 and 2 of vaccine/placebo, across doses (Year 2)
Number of Subjects With Medically-attended Adverse Events (MAEs)
MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination. Any MAE was defined as atleast 1 MAE experienced.
Time frame: From Day 0 up to Day 385
Number of Subjects With Medically-attended Adverse Events (MAEs)
MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination. Any MAE was defined as atleast 1 MAE experienced.
Time frame: From Day U0 up to Day U385
Number of Subjects With Any Potential Immune-Mediated Diseases (pIMDs)
Potential immune-mediated diseases (pIMDs) were defined as a subset of adverse events that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which might or might not have an autoimmune aetiology. "Any pIMD" was defined as at least one pIMD experienced by the study subject.
Time frame: From Day 0 up to Day 385
Number of Subjects With Any Potential Immune-Mediated Diseases (pIMDs)
Potential immune-mediated diseases (pIMDs) were defined as a subset of adverse events that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which might or might not have an autoimmune aetiology. "Any pIMD" was defined as at least one pIMD experienced by the study subject.
Time frame: From Day U0 to Day U385
Number of Subjects Reporting Pregnancies, and Outcomes of These Reported Pregnancies
Time frame: From Day 0 up to Day 385
Number of Subjects Reporting Pregnancies, and Outcomes of These Reported Pregnancies
Time frame: From Day U0 to Day U385
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Alanine Aminotransferase (ALAT) and Aspartate Aminotransferase (ASAT)
Subjects were categorized according to their results at pre-vaccination (PRE), Day 42, Day 182 and Day 385 which were normal, above normal, below the normal ranges or unknown.
Time frame: From Day 0 up to Day 385
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Total Bilirubin (T-BIL) and Bilirubin Conjugated/Direct (BIL-C/D)
Subjects were categorized according to their results at pre-vaccination (PRE), Day 42, Day 182 and Day 385 which were normal, above normal, below the normal ranges or unknown.
Time frame: From Day 0 up to Day 385
Number of Subjects With Normal and Abnormal Biochemical Parameters Assessed With Respect to Creatinine (CREA) and Blood Urea Nitrogen (BUN)
Subjects were categorized according to their results at pre-vaccination (PRE), Day 42, Day 182 and Day 385 which were normal, above normal, below the normal ranges or unknown.
Time frame: From Day 0 up to Day 385
Number of Subjects With Normal and Abnormal Haematological Parameters Assessed With Respect to Basophils (BAS) and Eosinophils (EOS)
Subjects were categorized according to their results at pre-vaccination (PRE), Day 42, Day 182 and Day 385 which were normal, above normal, below the normal ranges or unknown.
Time frame: From Day 0 up to Day 385
Number of Subjects With Normal and Abnormal Haematological Parameters Assessed With Respect to Haematocrit (Hcr) and Haemoglobin (Hgb)
Subjects were categorized according to their results at pre-vaccination (PRE), Day 42, Day 182 and Day 385 which were normal, above normal, below the normal ranges or unknown.
Time frame: From Day 0 up to Day 385
Number of Subjects With Normal and Abnormal Haematological Parameters Assessed With Respect to Neutrophils (NEU) and Platelets (PLA)
Subjects were categorized according to their results at pre-vaccination (PRE), Day 42, Day 182 and Day 385 which were normal, above normal, below the normal ranges or unknown.
Time frame: From Day 0 up to Day 385
Number of Subjects With Normal and Abnormal Haematological Parameters Assessed With Respect to Lymphocytes (LYM) and Monocytes (MON)
Subjects were categorized according to their results at pre-vaccination (PRE), Day 42, Day 182 and Day 385 which were normal, above normal, below the normal ranges or unknown.
Time frame: From Day 0 up to Day 385
Number of Subjects With Normal and Abnormal Haematological Parameters Assessed With Respect to Red and White Blood Cells (RBC and WBC)
Subjects were categorized according to their results at pre-vaccination (PRE), Day 42, Day 182 and Day 385 which were normal, above normal, below the normal ranges or unknown.
Time frame: From Day 0 up to Day 385
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).
An unsolicited AE was defined as any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. "Any" was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.
Time frame: During the 21-day (Days 0-20) post-vaccination period following Dose 1 of vaccine/placebo
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).
An unsolicited AE was defined as any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. "Any" was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.
Time frame: During the 21-day (Days 21-41) post-vaccination period following Dose 2 of vaccine/placebo
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).
An unsolicited AE was defined as any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. "Any" was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.
Time frame: During the 42-day (Days 0-41) post-vaccination period following Dose 1 of vaccine/placebo
Number of Subjects Reporting Serious Adverse Events (SAEs)
A SAE was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
Time frame: From Day 0 up to Day 385
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).
An unsolicited AE was defined as any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. "Any" was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.
Time frame: During the 21-day (Days U0-U20) post-vaccination period following Dose 1 of Influenza A (H5N1) Virus monovalent vaccine
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).
An unsolicited AE was defined as any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. "Any" was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.
Time frame: During the 21-day (Days U21-U41) post-vaccination period following Dose 2 of Influenza A (H5N1) Virus monovalent vaccine
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).
An unsolicited AE was defined as any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. "Any" was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. As the study is still ongoing and data per age group are not available, results are presented for the groups pooled by vaccine/placebo administered. This outcome measure will be amended when data by age group become available.
Time frame: During the 42-day (Days U0-U41) post-vaccination period following Dose 1 of Influenza A (H5N1) Virus monovalent vaccine
Number of Subjects Reporting Serious Adverse Events (SAEs)
A SAE was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
Time frame: From Day U0 up to Day U385
The study included a first 385-days Blinded Phase (all subjects), followed by a 385-days Unblinded Phase. In this phase, subjects who received the placebo in the Blinded Phase were offered, after completing the Blinded Phase, 2 doses of Influenza A (H5N1) Virus monovalent vaccine administered for Dose 1 within a short delay of Day 385 (Day U0).
| Milestone | Influenza A (H5N1) Adjuvanted 6-<36M Group | Influenza A (H5N1) Adjuvanted 3-<9Y Group | Influenza A (H5N1) Adjuvanted 9-<18Y Group | Placebo 6-<36M Group | Placebo 3-<9Y Group | Placebo 9-<18Y Group | Placebo/Influenza A (H5N1) Adjuvanted Group |
|---|---|---|---|---|---|---|---|
| Started | 199 | 198 | 210 | 75 | 76 | 80 | 0 |
| Completed | 172 | 190 | 203 | 67 | 73 | 77 | 0 |
| Not completed | 27 | 8 | 7 | 8 | 3 | 3 | 0 |
| Withdrew: Withdrawal by subject | 5 | 2 | 0 | 2 | 1 | 1 | 0 |
| Withdrew: Lost to follow-up | 18 | 3 | 3 | 5 | 1 | 2 | 0 |
| Withdrew: Migrated/moved from study area | 3 | 3 | 1 | 1 | 1 | 0 | 0 |
| Withdrew: Other | 1 | 0 | 3 | 0 | 0 | 0 | 0 |
| Milestone | Influenza A (H5N1) Adjuvanted 6-<36M Group | Influenza A (H5N1) Adjuvanted 3-<9Y Group | Influenza A (H5N1) Adjuvanted 9-<18Y Group | Placebo 6-<36M Group | Placebo 3-<9Y Group | Placebo 9-<18Y Group | Placebo/Influenza A (H5N1) Adjuvanted Group |
|---|---|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 0 | 0 | 0 | 155 |
| Completed | 0 | 0 | 0 | 0 | 0 | 0 | 152 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 3 |
| Withdrew: Withdrawal by subject | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Withdrew: Lost to follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 2 |
A seroprotected subject against the a/Indonesia/5/2005 (A/INDO) virus strain was defined as a subject with H5N1 reciprocal haemagglutination inhibition (HI) antibody titers greater than or equal to (\>=) the seroprotection cut-off of 1:40.
| Subject | Influenza A (H5N1) Adjuvanted 6-<36M Group | Influenza A (H5N1) Adjuvanted 3-<9Y Group | Influenza A (H5N1) Adjuvanted 9-<18Y Group | Placebo 6-<36M Group | Placebo 3-<9Y Group | Placebo 9-<18Y Group |
|---|---|---|---|---|---|---|
| Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain. | 175 | 184 | 201 | 0 | 0 | 1 |
HI antibody titers against the H5N1 A/Indonesia virus strain (A/INDO) were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of higher than or equal to (\>=) 1:10.
| Titer | Influenza A (H5N1) Adjuvanted 6-<36M Group | Influenza A (H5N1) Adjuvanted 3-<9Y Group | Influenza A (H5N1) Adjuvanted 9-<18Y Group | Placebo 6-<36M Group | Placebo 3-<9Y Group | Placebo 9-<18Y Group |
|---|---|---|---|---|---|---|
| A/INDO, Day 0 [N=182;184;204;67;71;76] | 5.3 (5.1 to 5.5) | 5.6 (5.3 to 5.9) | 5.7 (5.4 to 6.1) | 5.3 (5.0 to 5.7) | 5.6 (5.1 to 6.0) | 5.4 (5.1 to 5.8) |
| A/INDO, Day 21 [N=179;184;204;67;70;76] | 38.7 (33.9 to 44.2) | 44.6 (39.2 to 50.9) | 35.3 (31.7 to 39.5) | 5.2 (5.0 to 5.4) | 5.4 (5.0 to 5.7) | 5.4 (5.1 to 5.7) |
A seroprotected subject against the a/Indonesia/5/2005 (A/INDO) virus strain was defined as a subject with H5N1 reciprocal haemagglutination inhibition (HI) antibody titers greater than or equal to (\>=) the seroprotection cut-off of 1:40.
| Subject | Influenza A (H5N1) Adjuvanted 6-<36M Group | Influenza A (H5N1) Adjuvanted 3-<9Y Group | Influenza A (H5N1) Adjuvanted 9-<18Y Group | Placebo 6-<36M Group | Placebo 3-<9Y Group | Placebo 9-<18Y Group |
|---|---|---|---|---|---|---|
| A/INDO, Day 0 [N=182;184;204;67;71;76] | 1 | 2 | 1 | 0 | 0 | 0 |
| A/INDO, Day 21 [N=179;184;204;67;70;76] | 105 | 110 | 108 | 0 | 1 | 0 |
A subject seroconverted for HI antibodies against the H5N1 A/Indonesia virus strain (A/INDO) was defined as a vaccinee with either a pre-vaccination titer less than (\<) 1:10 and a post-vaccination titer higher than or equal to (\>=) 1:40, or with a pre-vaccination titer \>= 1:10 and at least a 4-fold increase in post-vaccination titer. As the analyses were performed and disclosed stepwise - i.e. as soon as a study phase was completed - several releases of the CTRS (result summaries) were published. To generate an integrated Clinical Study Report, one set of domain datasets covering all analyses was used and the Adapted ATP cohort for immunogenicity has been defined. As a consequence, some of the data previously disclosed and based on ATP cohort for immunogenicity at Day 42, Day 182 and Day 385 have been replaced in this summary with data generated with the Adapted ATP cohort for immunogenicity.
| Subject | Influenza A (H5N1) Adjuvanted 6-<36M Group | Influenza A (H5N1) Adjuvanted 3-<9Y Group | Influenza A (H5N1) Adjuvanted 9-<18Y Group | Placebo 6-<36M Group | Placebo 3-<9Y Group | Placebo 9-<18Y Group |
|---|---|---|---|---|---|---|
| A/INDO, Day 21 [N=179;183;204;67;70;76] | 103 | 107 | 105 | 0 | 0 | 0 |
| A/INDO, Day 42 [N=175;184;203;64;71;76] | 175 | 183 | 201 | 0 | 0 | 1 |
GMI also known as the seroconversion factor (SCF) or geometric mean fold rise (GMFR) was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titre to the pre-vaccination reciprocal HI titre for the vaccine virus.
| Ratio | Influenza A (H5N1) Adjuvanted 6-<36M Group | Influenza A (H5N1) Adjuvanted 3-<9Y Group | Influenza A (H5N1) Adjuvanted 9-<18Y Group | Placebo 6-<36M Group | Placebo 3-<9Y Group | Placebo 9-<18Y Group |
|---|---|---|---|---|---|---|
| A/INDO, Day 21 [N=179;183;204;67;70;76] | 7.3 (6.4 to 8.4) | 8.0 (7.0 to 9.1) | 6.2 (5.5 to 6.9) | 1.0 (0.9 to 1.0) | 1.0 (0.9 to 1.0) | 1.0 (0.9 to 1.1) |
| A/INDO, Day 42 [N=175;184;203;64;71;76] | 148.5 (134.5 to 164.1) | 96.9 (85.3 to 110.1) | 72.4 (63.9 to 82.0) | 1.0 (0.9 to 1.0) | 1.0 (0.9 to 1.0) | 1.1 (1.0 to 1.2) |
HI antibody titers against the H5N1 A/Indonesia virus strain (A/INDO) were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of higher than or equal to (\>=) 1:10. Adapted ATP cohort for immunogenicity included all evaluable subjects for which Day 21 and Day 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Day 182 data were obtained from the ATP cohort for immunogenicity at Day 182, and Day 385 data were obtained from the ATP cohort for immunogenicity at Day 385.
| Titre | Influenza A (H5N1) Adjuvanted 6-<36M Group | Influenza A (H5N1) Adjuvanted 3-<9Y Group | Influenza A (H5N1) Adjuvanted 9-<18Y Group | Placebo 6-<36M Group | Placebo 3-<9Y Group | Placebo 9-<18Y Group |
|---|---|---|---|---|---|---|
| A/INDO, Day 0 [N=107;101;100;36;37;35] | 5.1 (5.0 to 5.2) | 5.2 (5.0 to 5.4) | 5.6 (5.2 to 6.0) | 5.3 (4.9 to 5.7) | 5.2 (4.8 to 5.8) | 5.4 (4.8 to 6.0) |
| A/INDO, Day 182 [N=84;89;87;29;34;31] | 90.6 (78.1 to 105.0) | 57.4 (50.8 to 64.9) | 50.2 (43.3 to 58.2) | 5.0 (5.0 to 5.0) | 5.4 (4.9 to 6.0) | 5.4 (4.9 to 5.9) |
A seroprotected subject against the a/Indonesia/5/2005 (A/INDO) virus strain was defined as a subject with H5N1 reciprocal haemagglutination inhibition (HI) antibody titers greater than or equal to (\>=) the seroprotection cut-off of 1:40. As the analyses were performed and disclosed stepwise - i.e. as soon as a study phase was completed - several releases of the CTRS (result summaries) were published. To generate an integrated Clinical Study Report, one set of domain datasets covering all analyses was used and the Adapted ATP cohort for immunogenicity has been defined. As a consequence, some of the data previously disclosed and based on ATP cohort for immunogenicity at Day 42, Day 182 and Day 385 have been replaced in this summary with data generated with the Adapted ATP cohort for immunogenicity.
| Subject | Influenza A (H5N1) Adjuvanted 6-<36M Group | Influenza A (H5N1) Adjuvanted 3-<9Y Group | Influenza A (H5N1) Adjuvanted 9-<18Y Group | Placebo 6-<36M Group | Placebo 3-<9Y Group | Placebo 9-<18Y Group |
|---|---|---|---|---|---|---|
| A/INDO, Day 0 [N=182;184;204;67;71;76] | 1 | 2 | 1 | 0 | 0 | 0 |
| A/INDO, Day 182 [N=84;89;87;29;34;31] | 80 | 75 | 63 | 0 | 0 | 0 |
HI antibody titers against the H5N1 A/Indonesia virus strain (A/INDO) were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of higher than or equal to (\>=) 1:10. As the analyses were performed and disclosed stepwise - i.e. as soon as a study phase was completed - several releases of the CTRS (result summaries) were published. To generate an integrated Clinical Study Report, one set of domain datasets covering all analyses was used and the Adapted ATP cohort for immunogenicity has been defined. As a consequence, some of the data previously disclosed and based on ATP cohort for immunogenicity at Day 42, Day 182 and Day 385 have been replaced in this summary with data generated with the Adapted ATP cohort for immunogenicity.
| Titer | Influenza A (H5N1) Adjuvanted 6-<36M Group | Influenza A (H5N1) Adjuvanted 3-<9Y Group | Influenza A (H5N1) Adjuvanted 9-<18Y Group | Placebo 6-<36M Group | Placebo 3-<9Y Group | Placebo 9-<18Y Group |
|---|---|---|---|---|---|---|
| Haemagglutination Inhibition (HI) Antibody Titers Against the H5N1 A/Indonesia Virus Strain | 777.1 (705.6 to 855.9) | 543.8 (484.9 to 609.8) | 416.2 (371.5 to 466.2) | 5.1 (4.9 to 5.3) | 5.4 (5.0 to 5.7) | 5.8 (5.3 to 6.3) |
A subject seroconverted for HI antibodies against the H5N1 A/Indonesia virus strain (A/INDO) was defined as a vaccinee with either a pre-vaccination titer less than (\<) 1:10 and a post-vaccination titer higher than or equal to (\>=) 1:40, or with a pre-vaccination titer \>= 1:10 and at least a 4-fold increase in post-vaccination titer.
| Subject | Influenza A (H5N1) Adjuvanted 6-<36M Group | Influenza A (H5N1) Adjuvanted 3-<9Y Group | Influenza A (H5N1) Adjuvanted 9-<18Y Group | Placebo 6-<36M Group | Placebo 3-<9Y Group | Placebo 9-<18Y Group |
|---|---|---|---|---|---|---|
| Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the H5N1 A/Indonesia Virus Strain. | 80 | 75 | 61 | 0 | 0 | 0 |
GMI also known as the seroconversion factor (SCF) or geometric mean fold rise (GMFR) was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titre to the pre-vaccination reciprocal HI titre for the vaccine virus.
| Ratio | Influenza A (H5N1) Adjuvanted 6-<36M Group | Influenza A (H5N1) Adjuvanted 3-<9Y Group | Influenza A (H5N1) Adjuvanted 9-<18Y Group | Placebo 6-<36M Group | Placebo 3-<9Y Group | Placebo 9-<18Y Group |
|---|---|---|---|---|---|---|
| Geometric Mean Increase (GMI) for Haemagglutination Inhibition (HI) Antibodies Against the H5N1 A/Indonesia Virus Strain. | 17.8 (15.3 to 20.8) | 11.0 (9.7 to 12.4) | 8.8 (7.5 to 10.4) | 1.0 (0.9 to 1.0) | 1.1 (1.0 to 1.2) | 1.0 (0.9 to 1.2) |
HI antibody titers against the H5N1 A/Indonesia virus strain (A/INDO) were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of higher than or equal to (\>=) 1:10. As the analyses were performed and disclosed stepwise - i.e. as soon as a study phase was completed - several releases of the CTRS (result summaries) were published. To generate an integrated Clinical Study Report, one set of domain datasets covering all analyses was used and the Adapted ATP cohort for immunogenicity has been defined. As a consequence, some of the data previously disclosed and based on ATP cohort for immunogenicity at Day 42, Day 182 and Day 385 have been replaced in this summary with data generated with the Adapted ATP cohort for immunogenicity.
| Titer | Influenza A (H5N1) Adjuvanted 6-<36M Group | Influenza A (H5N1) Adjuvanted 3-<9Y Group | Influenza A (H5N1) Adjuvanted 9-<18Y Group | Placebo 6-<36M Group | Placebo 3-<9Y Group | Placebo 9-<18Y Group |
|---|---|---|---|---|---|---|
| A/INDO, Day 0 [N=182;184;204;67;71;76] | 5.3 (5.1 to 5.5) | 5.6 (5.3 to 5.9) | 5.7 (5.4 to 6.1) | 5.3 (5.0 to 5.7) | 5.6 (5.1 to 6.0) | 5.4 (5.1 to 5.8) |
| A/INDO, Day 385 [N=63;85;95;26;34;36] | 65.6 (55.9 to 76.9) | 32.8 (28.1 to 38.4) | 21.6 (18.6 to 25.1) | 5.1 (4.9 to 5.4) | 5.4 (4.9 to 5.8) | 5.3 (4.8 to 5.9) |
A seroprotected subject against the a/Indonesia/5/2005 (A/INDO) virus strain was defined as a subject with H5N1 reciprocal haemagglutination inhibition (HI) antibody titers greater than or equal to (\>=) the seroprotection cut-off of 1:40. As the analyses were performed and disclosed stepwise - i.e. as soon as a study phase was completed - several releases of the CTRS (result summaries) were published. To generate an integrated Clinical Study Report, one set of domain datasets covering all analyses was used and the Adapted ATP cohort for immunogenicity has been defined. As a consequence, some of the data previously disclosed and based on ATP cohort for immunogenicity at Day 42, Day 182 and Day 385 have been replaced in this summary with data generated with the Adapted ATP cohort for immunogenicity.
| Subjects | Influenza A (H5N1) Adjuvanted 6-<36M Group | Influenza A (H5N1) Adjuvanted 3-<9Y Group | Influenza A (H5N1) Adjuvanted 9-<18Y Group | Placebo 6-<36M Group | Placebo 3-<9Y Group | Placebo 9-<18Y Group |
|---|---|---|---|---|---|---|
| A/INDO, Day 0 [N=182, 184,204,67,71,76] | 1 | 2 | 1 | 0 | 0 | 0 |
| A/INDO, Day 385 [N=63;85;95;26;34;36] | 54 | 47 | 27 | 0 | 0 | 0 |
A subject seroconverted for HI antibodies against the H5N1 A/Indonesia virus strain (A/INDO) was defined as a vaccinee with either a pre-vaccination titer less than (\<) 1:10 and a post-vaccination titer higher than or equal to (\>=) 1:40, or with a pre-vaccination titer \>= 1:10 and at least a 4-fold increase in post-vaccination titer.
| Subjects | Influenza A (H5N1) Adjuvanted 6-<36M Group | Influenza A (H5N1) Adjuvanted 3-<9Y Group | Influenza A (H5N1) Adjuvanted 9-<18Y Group | Placebo 6-<36M Group | Placebo 3-<9Y Group | Placebo 9-<18Y Group |
|---|---|---|---|---|---|---|
| Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the H5N1 A/Indonesia Virus Strain. | 53 | 45 | 23 | 0 | 0 | 0 |
GMI also known as the seroconversion factor (SCF) or geometric mean fold rise (GMFR) was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.
| Fold increase | Influenza A (H5N1) Adjuvanted 6-<36M Group | Influenza A (H5N1) Adjuvanted 3-<9Y Group | Influenza A (H5N1) Adjuvanted 9-<18Y Group | Placebo 6-<36M Group | Placebo 3-<9Y Group | Placebo 9-<18Y Group |
|---|---|---|---|---|---|---|
| Geometric Mean Increase (GMI) for Haemagglutination Inhibition (HI) Antibodies Against the H5N1 A/Indonesia Virus Strain. | 12.1 (10.3 to 14.2) | 5.5 (4.7 to 6.6) | 3.6 (3.1 to 4.3) | 1.0 (0.9 to 1.1) | 0.9 (0.8 to 1.0) | 1.0 (0.8 to 1.1) |
MN HI antibody titers against the H5N1 A/Indonesia (A/INDO) and H5N1 A/Vietnam (A/VIET) virus strains were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of higher than or equal to (\>=) 1:28.
| Titer | Influenza A (H5N1) Adjuvanted 6-<36M Group | Influenza A (H5N1) Adjuvanted 3-<9Y Group | Influenza A (H5N1) Adjuvanted 9-<18Y Group | Placebo 6-<36M Group | Placebo 3-<9Y Group | Placebo 9-<18Y Group |
|---|---|---|---|---|---|---|
| A/INDO, Day 0 [N=36;37;40;7;10;11] | 14.00 (14.00 to 14.00) | 15.67 (14.37 to 17.08) | 15.54 (14.13 to 17.09) | 15.46 (12.13 to 19.70) | 14.00 (14.00 to 14.00) | 14.91 (12.96 to 17.16) |
| A/INDO, Day 42 [N=34;37;40;6;10;11] | 855.62 (597.88 to 1224.47) | 657.60 (453.13 to 954.33) | 380.62 (277.43 to 522.20) | 14.00 (14.00 to 14.00) | 14.00 (14.00 to 14.00) | 14.91 (12.96 to 17.16) |
| A/INDO, Day 182 [N=33;39;33;10;10;9] | 216.82 (162.03 to 290.14) | 130.32 (107.30 to 158.26) | 104.18 (86.95 to 124.82) | 16.11 (11.73 to 22.13) | 14.00 (14.00 to 14.00) | 17.67 (12.08 to 25.86) |
| A/INDO, Day 385 [N=25;33;37;8;11;9] | 166.64 (135.90 to 204.32) | 108.59 (87.88 to 134.19) | 82.26 (67.27 to 100.59) | 15.27 (12.44 to 18.74) | 14.91 (12.96 to 17.16) | 16.33 (12.91 to 20.66) |
| A/VIET, Day 0 [N=36;36;40;7;10;11] | 14.83 (13.89 to 15.84) | 19.84 (16.82 to 23.40) | 24.88 (20.75 to 29.85) | 17.11 (10.47 to 27.95) | 16.08 (13.05 to 19.82) | 20.47 (14.82 to 28.26) |
| A/VIET, Day 42 [N=34;37;40;6;10;11] | 68.18 (58.05 to 80.07) | 71.15 (61.62 to 82.15) | 65.25 (57.03 to 74.64) | 17.69 (9.69 to 32.28) | 19.87 (12.97 to 30.43) | 28.14 (19.53 to 40.54) |
| A/VIET, Day 182 [N=33;39;33;10;10;9] | 48.77 (36.56 to 65.06) | 44.11 (36.19 to 53.77) | 61.67 (51.38 to 74.01) | 19.82 (12.22 to 32.14) | 17.24 (13.56 to 21.90) | 24.14 (14.29 to 40.78) |
| A/VIET, Day 385 [N=25;33;37;8;11;9] | 59.83 (48.09 to 74.43) | 38.62 (30.60 to 48.73) | 47.73 (38.76 to 58.79) | 14.00 (14.00 to 14.00) | 18.07 (12.34 to 26.47) | 35.42 (19.45 to 64.49) |
| Subject | Influenza A (H5N1) Adjuvanted 6-<36M Group | Influenza A (H5N1) Virus Monovalent Vaccine 3-<9Y Group | Influenza A (H5N1) Virus Monovalent Vaccine 9-<18Y Group | Placebo 6-<36M Group | Placebo 3-<9Y Group | Placebo 9-<18Y Group |
|---|---|---|---|---|---|---|
| At Day 0 | 0 | 6 | 5 | 1 | 0 | 1 |
| At Day 42 | 34 | 37 | 40 | 0 | 0 | 1 |
VRR for MN was defined as as the incidence rate of vaccinees with a 4-fold increase in post vaccination reciprocal titer relative to Day 0.
| Subject | Influenza A (H5N1) Adjuvanted 6-<36M Group | Influenza A (H5N1) Adjuvanted 3-<9Y Group | Influenza A (H5N1) Adjuvanted 9-<18Y Group | Placebo 6-<36M Group | Placebo 3-<9Y Group | Placebo 9-<18Y Group |
|---|---|---|---|---|---|---|
| A/INDO [N=34;37;40;6;10;11] | 34 | 37 | 39 | 0 | 0 | 0 |
| A/VIET [N=34;36;40;6;10;11] | 30 | 26 | 16 | 0 | 1 | 0 |
Solicited local symptoms assessed were pain, redness and swelling. "Any" was defined as any occurrence of the specified solicited local symptom reported, regardless of intensity. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling were defined as redness/swelling above 100 millimeter (mm).
| Subject | Influenza A (H5N1) Adjuvanted Group | Placebo Group |
|---|---|---|
| Any pain | 405 | 69 |
| Grade 3 pain | 25 | 4 |
| Any redness | 29 | 0 |
| Grade 3 redness | 1 | 0 |
| Any swelling | 41 | 1 |
| Grade 3 swelling | 1 | 0 |
Solicited local symptoms assessed were pain and swelling. "Any" was defined as any occurrence of the specified solicited local symptom reported, regardless of intensity. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling were defined as redness/swelling above 100 millimeter (mm).
| Subject | Placebo/Placebo/ Influenza A (H5N1) Adjuvanted Group |
|---|---|
| Any Pain | 111 |
| Grade 3 Pain | 8 |
| Any Redness | 6 |
| Grade 3 Redness | 0 |
| Any Swelling | 5 |
| Grade 3 Swelling | 0 |
Solicited general symptoms assessed in subjects of less than 6 years of age were drowsiness, irritability/fussiness, loss of appetite and fever \[axillary temperature (T) higher than or equal to (\>=) 38.0 degrees Celsius (°C)\]. "Any" was defined as any occurrence of the specified solicited general symptom reported, regardless of intensity or relationship to vaccination. Grade 3 was defined as a general symptom that prevented normal activity. Related was defined as a general symptom assessed by the investigator as causally related to the study vaccination. Any fever was defined as axillary temperature above 38.0 degrees Celsius (°C). Grade 3 fever was axillary temperature \>= 39.0°C.
| Subject | Influenza A (H5N1) Adjuvanted Group | Placebo Group |
|---|---|---|
| Any Drowsiness | 101 | 29 |
| Grade 3 Drowsiness | 9 | 2 |
| Related Drowsiness | 81 | 21 |
| Any Irritability/fussiness | 128 | 40 |
| Grade 3 Irritability/fussiness | 10 | 2 |
| Related Irritability/fussiness | 111 | 33 |
| Any Loss of appetite | 79 | 29 |
| Grade 3 Loss of appetite | 8 | 4 |
| Related Loss of appetite | 63 | 20 |
| Any Fever | 59 | 21 |
| Grade 3 Fever | 14 | 5 |
| Related Fever | 41 | 14 |
Solicited general symptoms assessed in subjects of less than 6 years of age were drowsiness, irritability/fussiness, loss of appetite and fever \[axillary temperature (T) higher than or equal to (\>=) 38.0 degrees Celsius (°C)\]. "Any" was defined as any occurrence of the specified solicited general symptom reported, regardless of intensity or relationship to vaccination. Grade 3 was defined as a general symptom that prevented normal activity. Related was defined as a general symptom assessed by the investigator as causally related to the study vaccination. Any fever was defined as axillary temperature above 38.0 degrees Celsius (°C). Grade 3 fever was axillary temperature \>=39.0°C.
| Subject | Placebo/ Influenza A (H5N1) Adjuvanted Group |
|---|---|
| Any Drowsiness | 23 |
| Grade 3 Drowsiness | 1 |
| Related Drowsiness | 17 |
| Any Irritability/Fussiness | 28 |
| Grade 3 Irritability/Fussiness | 1 |
| Related Irritability/Fussiness | 23 |
| Any Loss of appetite | 18 |
| Grade 3 Loss of appetite | 0 |
| Related Loss of appetite | 13 |
| Any Fever | 4 |
| Grade 3 Fever | 2 |
| Related Fever | 3 |
Solicited general symptoms assessed in subjects of at least 6 years of age were fatigue, gastrointestinal symptoms, headache, joint pain at other location, muscle aches, shivering, sweating and fever \[axillary temperature (T) \>= 38.0 degrees Celsius (°C)\]. Gastrointestinal symptoms included nausea, vomiting, diaorrhea and/or abdominal pain. "Any" was defined as any occurrence of the specified solicited general symptom reported, regardless of intensity or relationship to vaccination. Grade 3 was defined as a general symptom that prevented normal activity. Related was defined as a general symptom assessed by the investigator as causally related to the study vaccination. Grade 3 fever was axillary temperature \>= 39.0°C.
| Subject | Influenza A (H5N1) Adjuvanted Group | Placebo Group |
|---|---|---|
| Any fatigue | 89 | 19 |
| Grade 3 fatigue | 4 | 2 |
| Related fatigue | 77 | 16 |
| Any gastrointestinal symptoms | 43 | 18 |
| Grade 3 gastrointestinal symptoms | 4 | 2 |
| Related gastrointestinal symptoms | 27 | 11 |
| Any headache | 100 | 18 |
| Grade 3 headache | 8 | 3 |
| Related headache | 87 | 15 |
| Any joint pain | 50 | 9 |
| Grade 3 joint pain | 2 | 0 |
| Related joint pain | 43 | 8 |
| Any muscle aches | 123 | 17 |
| Grade 3 muscle aches | 7 | 1 |
| Related muscle aches | 114 | 14 |
| Any shivering | 25 | 7 |
| Grade 3 shivering | 2 | 1 |
| Related shivering | 19 | 5 |
| Any sweating | 25 | 4 |
| Grade 3 sweating | 2 | 0 |
| Related sweating | 22 | 1 |
| Any fever | 19 | 3 |
| Grade 3 fever | 5 | 1 |
| Related fever | 13 | 2 |
Solicited general symptoms assessed in subjects of at least 6 years of age were fatigue, gastrointestinal symptoms, headache, joint pain at other location, muscle aches, shivering, sweating and fever \[axillary temperature (T) \>= 38.0 degrees Celsius (°C)\]. Gastrointestinal symptoms included nausea, vomiting, diaorrhea and/or abdominal pain. "Any" was defined as any occurrence of the specified solicited general symptom reported, regardless of intensity or relationship to vaccination. Grade 3 was defined as a general symptom that prevented normal activity. Related was defined as a general symptom assessed by the investigator as causally related to the study vaccination. Grade 3 fever was axillary temperature \>= 39.0°C.
| Subject | Placebo/Influenza A (H5N1) Adjuvanted Group |
|---|---|
| Any Fatigue | 18 |
| Grade 3 Fatigue | 1 |
| Related Fatigue | 13 |
| Any Gastrointestinal | 7 |
| Grade 3 Gastrointestinal | 0 |
| Related Gastrointestinal | 5 |
| Any Headache | 24 |
| Grade 3 Headache | 1 |
| Related Headache | 20 |
| Any Increased Sweating | 5 |
| Grade 3 Increased Sweating | 0 |
| Related Increased Sweating | 3 |
| Any Joint Pain | 14 |
| Grade 3 Joint Pain | 0 |
| Related Joint Pain | 12 |
| Any Muscle Aches | 34 |
| Grade 3 Muscle Aches | 0 |
| Related Muscle Aches | 28 |
| Any Shivering (Chills) | 7 |
| Grade 3 Shivering (Chills) | 2 |
| Related Shivering (Chills) | 4 |
| Any Fever | 1 |
| Grade 3 Fever | 0 |
| Related Fever | 0 |
MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination. Any MAE was defined as atleast 1 MAE experienced.
| Subject | Influenza A (H5N1) Adjuvanted Group | Placebo Group |
|---|---|---|
| Number of Subjects With Medically-attended Adverse Events (MAEs) | 189 | 77 |
MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination. Any MAE was defined as atleast 1 MAE experienced.
| Subject | Placebo/ Influenza A (H5N1) Adjuvanted Group |
|---|---|
| Number of Subjects With Medically-attended Adverse Events (MAEs) | 36 |
Potential immune-mediated diseases (pIMDs) were defined as a subset of adverse events that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which might or might not have an autoimmune aetiology. "Any pIMD" was defined as at least one pIMD experienced by the study subject.
| Subject | Influenza A (H5N1) Adjuvanted Group | Placebo Group |
|---|---|---|
| Number of Subjects With Any Potential Immune-Mediated Diseases (pIMDs) | 1 | 1 |
Potential immune-mediated diseases (pIMDs) were defined as a subset of adverse events that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which might or might not have an autoimmune aetiology. "Any pIMD" was defined as at least one pIMD experienced by the study subject.
| Subject | Placebo/ Influenza A (H5N1) Adjuvanted Group |
|---|---|
| Number of Subjects With Any Potential Immune-Mediated Diseases (pIMDs) | 0 |
| Subject | Influenza A (H5N1) Adjuvanted Group | Placebo Group |
|---|---|---|
| Subject(s) with any pregnancy | 2 | 0 |
| Subject(s) with related pregnancy | 0 | 0 |
| Spontaneous abortion | 1 | 0 |
| Healthy live birth | 1 | 0 |
| Subject | Placebo/ Influenza A (H5N1) Adjuvanted Group |
|---|---|
| Number of Subjects Reporting Pregnancies, and Outcomes of These Reported Pregnancies | 0 |
Subjects were categorized according to their results at pre-vaccination (PRE), Day 42, Day 182 and Day 385 which were normal, above normal, below the normal ranges or unknown.
| Subject | Influenza A (H5N1) Adjuvanted Group | Placebo Group |
|---|---|---|
| ALAT, PRE Unknown [N=606,231] | 15 | 4 |
| ALAT, PRE Below [N=606,231] | 0 | 0 |
| ALAT, PRE Normal [N=606,231] | 586 | 221 |
| ALAT, PRE Above [N=606,231] | 5 | 6 |
| ALAT, Day 42 Unknown [N=583,220] | 17 | 4 |
| ALAT, Day 42 Below [N=583,220] | 0 | 0 |
| ALAT, Day 42 Normal [N=583,220] | 562 | 212 |
| ALAT, Day 42 Above [N=583,220] | 4 | 4 |
| ALAT, Day 182 Unknown [N=304,110] | 6 | 0 |
| ALAT, Day 182 Below [N=304,110] | 0 | 0 |
| ALAT, Day 182 Normal [N=304,110] | 289 | 110 |
| ALAT, Day 182 Above [N=304,110] | 9 | 0 |
| ALAT, Day 385 Unknown [N=251,104] | 5 | 0 |
| ALAT, Day 385 Below [N=251,104] | 0 | 0 |
| ALAT, Day 385 Normal [N=251,104] | 245 | 100 |
| ALAT, Day 385 Above [N=251,104] | 1 | 4 |
| ASAT, PRE Unknown [N=606,231] | 15 | 4 |
| ASAT, PRE Below [N=606,231] | 0 | 0 |
| ASAT, PRE Normal [N=606,231] | 577 | 219 |
| ASAT, PRE Above [N=606,231] | 14 | 8 |
| ASAT, Day 42 Unknown [N=583,220] | 19 | 4 |
| ASAT, Day 42 Below [N=583,220] | 0 | 0 |
| ASAT, Day 42 Normal [N=583,220] | 552 | 208 |
| ASAT, Day 42 Above [N=583,220] | 12 | 8 |
| ASAT, Day 182 Unknown [N=304,110] | 8 | 0 |
| ASAT, Day 182 Below [N=304,110] | 0 | 0 |
| ASAT, Day 182 Normal [N=304,110] | 284 | 108 |
| ASAT, Day 182 Above [N=304,110] | 12 | 2 |
| ASAT, Day 385 Unknown [N=251,104] | 7 | 0 |
| ASAT, Day 385 Below [N=251,104] | 0 | 0 |
| ASAT, Day 385 Normal [N=251,104] | 240 | 100 |
| ASAT, Day 385 Above [N=251,104] | 4 | 4 |
Subjects were categorized according to their results at pre-vaccination (PRE), Day 42, Day 182 and Day 385 which were normal, above normal, below the normal ranges or unknown.
| Subject | Influenza A (H5N1) Adjuvanted Group | Placebo Group |
|---|---|---|
| T-BIL, PRE Unknown [N=606,231] | 15 | 4 |
| T-BIL, PRE Below [N=606,231] | 0 | 0 |
| T-BIL, PRE Normal [N=606,231] | 587 | 224 |
| T-BIL, PRE Above [N=606,231] | 4 | 3 |
| T-BIL, Day 42 Unknown [N=583,220] | 16 | 4 |
| T-BIL, Day 42 Below [N=583,220] | 0 | 0 |
| T-BIL, Day 42 Normal [N=583,220] | 558 | 214 |
| T-BIL, Day 42 Above [N=583,220] | 9 | 2 |
| T-BIL, Day 182 Unknown [N=304,110] | 6 | 0 |
| T-BIL, Day 182 Below [N=304,110] | 0 | 0 |
| T-BIL, Day 182 Normal [N=304,110] | 296 | 110 |
| T-BIL, Day 182 Above [N=304,110] | 2 | 0 |
| T-BIL, Day 385 Unknown [N=251,104] | 7 | 1 |
| T-BIL, Day 385 Below [N=251,104] | 0 | 0 |
| T-BIL, Day 385 Normal [N=251,104] | 240 | 102 |
| T-BIL, Day 385 Above [N=251,104] | 4 | 1 |
| BIL-C/D, PRE Unknown [N=606,231] | 15 | 4 |
| BIL-C/D, PRE Below [N=606,231] | 0 | 0 |
| BIL-C/D, PRE Normal [N=606,231] | 591 | 226 |
| BIL-C/D, PRE Above [N=606,231] | 0 | 1 |
| BIL-C/D, Day 42 Unknown [N=583,220] | 16 | 4 |
| BIL-C/D, Day 42 Below [N=583,220] | 0 | 0 |
| BIL-C/D, Day 42 Normal [N=583,220] | 558 | 214 |
| BIL-C/D, Day 42 Above [N=583,220] | 9 | 2 |
| BIL-C/D, Day 182 Unknown [N=304,110] | 7 | 0 |
| BIL-C/D, Day 182 Below [N=304,110] | 0 | 0 |
| BIL-C/D, Day 182 Normal [N=304,110] | 297 | 110 |
| BIL-C/D, Day 182 Above [N=304,110] | 0 | 0 |
| BIL-C/D, Day 385 Unknown [N=251,104] | 8 | 1 |
| BIL-C/D, Day 385 Below [N=251,104] | 0 | 0 |
| BIL-C/D, Day 385 Normal [N=251,104] | 240 | 103 |
| BIL-C/D, Day 385 Above [N=251,104] | 3 | 0 |
Subjects were categorized according to their results at pre-vaccination (PRE), Day 42, Day 182 and Day 385 which were normal, above normal, below the normal ranges or unknown.
| Subject | Influenza A (H5N1) Adjuvanted Group | Placebo Group |
|---|---|---|
| CREA, PRE Unknown [N=606,231] | 15 | 4 |
| CREA, PRE Below [N=606, 231] | 142 | 61 |
| CREA, PRE Within [N=606, 231] | 447 | 165 |
| CREA, PRE Above [N=606, 231] | 2 | 1 |
| CREA, Day 42 Unknown [N=583,220] | 17 | 4 |
| CREA, Day 42 Below [N=583,220] | 130 | 48 |
| CREA, Day 42 Within [N=583,220] | 432 | 166 |
| CREA, Day 42 Above [N=583,220] | 4 | 2 |
| CREA, Day 182 Unknown [N=304,110] | 6 | 1 |
| CREA, Day 182 Below [N=304,110] | 66 | 26 |
| CREA, Day 182 Within [N=304,110] | 231 | 83 |
| CREA, Day 182 Above [N=304,110] | 1 | 0 |
| CREA, Day 385 Unknown [N=251,104] | 6 | 0 |
| CREA, Day 385 Below [N=251,104] | 51 | 24 |
| CREA, Day 385 Within [N=251,104] | 191 | 80 |
| CREA, Day 385 Above [N=251,104] | 3 | 0 |
| BUN, PRE Unknown [N=606,231] | 15 | 4 |
| BUN, PRE Below [N=606,231] | 13 | 4 |
| BUN, PRE Within [N=606,231] | 553 | 218 |
| BUN, PRE Above [N=606,231] | 25 | 5 |
| BUN, Day 42 Unknown [N=583,220] | 17 | 4 |
| BUN, Day 42 Below [N=583,220] | 11 | 3 |
| BUN, Day 42 Within [N=583,220] | 531 | 209 |
| BUN, Day 42 Above [N=583,220] | 24 | 4 |
| BUN, Day 182 Unknown [N=304,110] | 6 | 0 |
| BUN, Day 182 Below [N=304,110] | 8 | 2 |
| BUN, Day 182 Within [N=304,110] | 281 | 105 |
| BUN, Day 182 Above [N=304,110] | 9 | 3 |
| BUN, Day 385 Unknown [N=251,104] | 7 | 0 |
| BUN, Day 385 Below [N=251,104] | 3 | 2 |
| BUN, Day 385 Within [N=251,104] | 237 | 100 |
| BUN, Day 385 Above [N=251,104] | 4 | 2 |
Subjects were categorized according to their results at pre-vaccination (PRE), Day 42, Day 182 and Day 385 which were normal, above normal, below the normal ranges or unknown.
| Subject | Influenza A (H5N1) Adjuvanted Group | Placebo Group |
|---|---|---|
| BAS, PRE Unknown [N=606,231] | 29 | 12 |
| BAS, PRE Below [N=606,231] | 0 | 0 |
| BAS, PRE Within [N=606,231] | 576 | 219 |
| BAS, PRE Above [N=606,231] | 1 | 0 |
| BAS, Day 42 Unknown [N=583,220] | 34 | 13 |
| BAS, Day 42 Below [N=583,220] | 0 | 0 |
| BAS, Day 42 Within [N=583,220] | 549 | 207 |
| BAS, Day 42 Above [N=583,220] | 0 | 0 |
| BAS, Day 182 Unknown [N=304,110] | 17 | 2 |
| BAS, Day 182 Below [N=304,110] | 0 | 0 |
| BAS, Day 182 Within [N=304,110] | 287 | 108 |
| BAS, Day 182 Above [N=304,110] | 0 | 0 |
| BAS, Day 385 Unknown [N=251,104] | 6 | 3 |
| BAS, Day 385 Below [N=251,104] | 0 | 0 |
| BAS, Day 385 Within [N=251,104] | 245 | 101 |
| BAS, Day 385 Above [N=251,104] | 0 | 0 |
| EOS, PRE Unknown [N=606,231] | 29 | 12 |
| EOS, PRE Below [N=606,231] | 68 | 19 |
| EOS, PRE Within [N=606,231] | 473 | 187 |
| EOS, PRE Above [N=606,231] | 36 | 13 |
| EOS, Day 42 Unknown [N=583,220] | 34 | 13 |
| EOS, Day 42 Below [N=583,220] | 49 | 15 |
| EOS, Day 42 Within [N=583,220] | 452 | 175 |
| EOS, Day 42 Above [N=583,220] | 48 | 17 |
| EOS, Day 182 Unknown [N=304,110] | 17 | 2 |
| EOS, Day 182 Below [N=304,110] | 33 | 11 |
| EOS, Day 182 Within [N=304,110] | 237 | 85 |
| EOS, Day 182 Above [N=304,110] | 17 | 12 |
| EOS, Day 385 Unknown [N=251,104] | 6 | 3 |
| EOS, Day 385 Below [N=251,104] | 32 | 17 |
| EOS, Day 385 Within [N=251,104] | 198 | 77 |
| EOS, Day 385 Above [N=251,104] | 15 | 7 |
Subjects were categorized according to their results at pre-vaccination (PRE), Day 42, Day 182 and Day 385 which were normal, above normal, below the normal ranges or unknown.
| Subject | Influenza A (H5N1) Adjuvanted Group | Placebo Group |
|---|---|---|
| Hcr, PRE Unknown [N=606,231] | 26 | 10 |
| Hcr, PRE Below [N=606,231] | 53 | 21 |
| Hcr, PRE Within [N=606,231] | 480 | 181 |
| Hcr, PRE Above [N=606,231] | 47 | 19 |
| Hcr, Day 42 Unknown [N=583,220] | 19 | 7 |
| Hcr, Day 42 Below [N=583,220] | 45 | 13 |
| Hcr, Day 42 Within [N=583,220] | 477 | 178 |
| Hcr, Day 42 Above [N=583,220] | 42 | 22 |
| Hcr, Day 182 Unknown [N=304,110] | 12 | 2 |
| Hcr, Day 182 Below [N=304,110] | 38 | 7 |
| Hcr, Day 182 Within [N=304,110] | 238 | 91 |
| Hcr, Day 182 Above [N=304,110] | 16 | 10 |
| Hcr, Day 385 Unknown [N=251,104] | 5 | 3 |
| Hcr, Day 385 Below [N=251,104] | 18 | 12 |
| Hcr, Day 385 Within [N=251,104] | 215 | 85 |
| Hcr, Day 385 Above [N=251,104] | 13 | 4 |
| Hgb, PRE Unknown [N=606,231] | 26 | 10 |
| Hgb, PRE Below [N=606,231] | 61 | 26 |
| Hgb, PRE Within [N=606,231] | 497 | 182 |
| Hgb, PRE Above [N=606,231] | 22 | 13 |
| Hgb, Day 42 Unknown [N=583,220] | 19 | 8 |
| Hgb, Day 42 Below [N=583,220] | 69 | 19 |
| Hgb, Day 42 Within [N=583,220] | 476 | 185 |
| Hgb, Day 42 Above [N=583,220] | 19 | 8 |
| Hgb, Day 182 Unknown [N=304,110] | 11 | 2 |
| Hgb, Day 182 Below [N=304,110] | 42 | 16 |
| Hgb, Day 182 Within [N=304,110] | 241 | 89 |
| Hgb, Day 182 Above [N=304,110] | 10 | 3 |
| Hgb, Day 385 Unknown [N=251,104] | 5 | 3 |
| Hbg, Day 385 Below [N=251,104] | 27 | 15 |
| Hbg, Day 385 Within [N=251,104] | 210 | 84 |
| Hbg, Day 385 Above [N=251,104] | 9 | 2 |
Subjects were categorized according to their results at pre-vaccination (PRE), Day 42, Day 182 and Day 385 which were normal, above normal, below the normal ranges or unknown.
| Subject | Influenza A (H5N1) Adjuvanted Group | Placebo Group |
|---|---|---|
| NEU, PRE Unknown [N=606,231] | 29 | 12 |
| NEU, PRE Below [N=606,231] | 26 | 10 |
| NEU, PRE Within [N=606,231] | 534 | 202 |
| NEU, PRE Above [N=606,231] | 17 | 7 |
| NEU, Day 42 Unknown [N=583,220] | 34 | 13 |
| NEU, Day 42 Below [N=583,220] | 29 | 8 |
| NEU, Day 42 Within [N=583,220] | 505 | 189 |
| NEU, Day 42 Above [N=583,220] | 15 | 10 |
| NEU, Day 182 Unknown [N=304,110] | 17 | 2 |
| NEU, Day 182 Below [N=304,110] | 14 | 3 |
| NEU, Day 182 Within [N=304,110] | 266 | 105 |
| NEU, Day 182 Above [N=304,110] | 7 | 0 |
| NEU, Day 385 Unknown [N=251,104] | 6 | 3 |
| NEU, Day 385 Below [N=251,104] | 12 | 3 |
| NEU, Day 385 Within [N=251,104] | 227 | 96 |
| NEU, Day 385 Above [N=251,104] | 6 | 2 |
| PLA, PRE Unknown [N=606,231] | 35 | 17 |
| PLA, PRE Below [N=606,231] | 3 | 0 |
| PLA, PRE Within [N=606,231] | 518 | 187 |
| PLA, PRE Above [N=606,231] | 50 | 27 |
| PLA, Day 42 Unknown [N=583,220] | 32 | 12 |
| PLA, Day 42 Below [N=583,220] | 1 | 0 |
| PLA, Day 42 Within [N=583,220] | 500 | 184 |
| PLA, Day 42 Above [N=583,220] | 50 | 24 |
| PLA, Day 182 Unknown [N=304,110] | 20 | 5 |
| PLA, Day 182 Below [N=304,110] | 0 | 0 |
| PLA, Day 182 Within [N=304,110] | 260 | 96 |
| PLA, Day 182 Above [N=304,110] | 24 | 9 |
| PLA, Day 385 Unknown [N=251,104] | 8 | 8 |
| PLA, Day 385 Below [N=251,104] | 1 | 0 |
| PLA, Day 385 Within [N=251,104] | 234 | 94 |
| PLA, Day 385 Above [N=251,104] | 8 | 2 |
Subjects were categorized according to their results at pre-vaccination (PRE), Day 42, Day 182 and Day 385 which were normal, above normal, below the normal ranges or unknown.
| Subject | Influenza A (H5N1) Adjuvanted Group | Placebo Group |
|---|---|---|
| LYM, PRE Unknown [N=606,231] | 29 | 12 |
| LYM, PRE Below [N=606,231] | 7 | 1 |
| LYM, PRE Within [N=606,231] | 441 | 161 |
| LYM, PRE Above [N=606,231] | 129 | 57 |
| LYM, Day 42 Unknown [N=583,220] | 34 | 13 |
| LYM, Day 42 Below [N=583,220] | 6 | 2 |
| LYM, Day 42 Within [N=583,220] | 446 | 162 |
| LYM, Day 42 Above [N=583,220] | 97 | 43 |
| LYM, Day 182 Unknown [N=304,110] | 17 | 2 |
| LYM, Day 182 Below [N=304,110] | 0 | 1 |
| LYM, Day 182 Within [N=304,110] | 235 | 93 |
| LYM, Day 182 Above [N=304,110] | 52 | 14 |
| LYM, Day 385 Unknown [N=251,104] | 6 | 3 |
| LYM, Day 385 Below [N=251,104] | 0 | 0 |
| LYM, Day 385 Within [N=251,104] | 223 | 86 |
| LYM, Day 385 Above [N=251,104] | 22 | 15 |
| MON, PRE Unknown [N=606,231] | 29 | 12 |
| MON, PRE Below [N=606,231] | 94 | 46 |
| MON, PRE Within [N=606,231] | 480 | 170 |
| MON, PRE Above [N=606,231] | 3 | 3 |
| MON, Day 42 Unknown [N=583,220] | 34 | 13 |
| MON, Day 42 Below [N=583,220] | 110 | 37 |
| MON, Day 42 Within [N=583,220] | 434 | 167 |
| MON, Day 42 Above [N=583,220] | 5 | 3 |
| MON, Day 182 Unknown [N=304,110] | 17 | 2 |
| MON, Day 182 Below [N=304,110] | 61 | 20 |
| MON, Day 182 Within [N=304,110] | 221 | 88 |
| MON, Day 182 Above [N=304,110] | 5 | 0 |
| MON, Day 385 Unknown [N=251,104] | 6 | 3 |
| MON, Day 385 Below [N=251,104] | 31 | 18 |
| MON, Day 385 Within [N=251,104] | 211 | 83 |
| MON, Day 385 Above [N=251,104] | 3 | 0 |
Subjects were categorized according to their results at pre-vaccination (PRE), Day 42, Day 182 and Day 385 which were normal, above normal, below the normal ranges or unknown.
| Subject | Influenza A (H5N1) Adjuvanted Group | Placebo Group |
|---|---|---|
| RBC, PRE Unknown [N=606,231] | 26 | 10 |
| RBC, PRE Below [N=606,231] | 25 | 4 |
| RBC, PRE Within [N=606,231] | 504 | 198 |
| RBC, PRE Above [N=606,231] | 51 | 19 |
| RBC, Day 42 Unknown [N=583,220] | 19 | 8 |
| RBC, Day 42 Below [N=583,220] | 21 | 6 |
| RBC, Day 42 Within [N=583,220] | 496 | 189 |
| RBC, Day 42 Above [N=583,220] | 47 | 17 |
| RBC, Day 182 Unknown [N=304,110] | 11 | 2 |
| RBC, Day 182 Below [N=304,110] | 13 | 5 |
| RBC, Day 182 Within [N=304,110] | 266 | 93 |
| RBC, Day 182 Above [N=304,110] | 14 | 10 |
| RBC, Day 385 Unknown [N=251,104] | 5 | 3 |
| RBC, Day 385 Below [N=251,104] | 8 | 2 |
| RBC, Day 385 Within [N=251,104] | 214 | 90 |
| RBC, Day 385 Above [N=251,104] | 24 | 9 |
| WBC, PRE Unknown [N=606,231] | 29 | 12 |
| WBC, PRE Below [N=606,231] | 27 | 9 |
| WBC, PRE Within [N=606,231] | 543 | 207 |
| WBC, PRE Above [N=606,231] | 7 | 3 |
| WBC, Day 42 Unknown [N=583,220] | 34 | 13 |
| WBC, Day 42 Below [N=583,220] | 38 | 8 |
| WBC, Day 42 Within [N=583,220] | 508 | 198 |
| WBC, Day 42 Above [N=583,220] | 3 | 1 |
| WBC, Day 182 Unknown [N=304,110] | 17 | 2 |
| WBC, Day 182 Below [N=304,110] | 21 | 7 |
| WBC, Day 182 Within [N=304,110] | 264 | 101 |
| WBC, Day 182 Above [N=304,110] | 2 | 0 |
| WBC, Day 385 Unknown [N=251,104] | 6 | 3 |
| WBC, Day 385 Below [N=251,104] | 15 | 6 |
| WBC, Day 385 Within [N=251,104] | 230 | 94 |
| WBC, Day 385 Above [N=251,104] | 0 | 1 |
An unsolicited AE was defined as any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. "Any" was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.
| Subject | Influenza A (H5N1) Adjuvanted Group | Placebo Group |
|---|---|---|
| Number of Subjects Reporting Any Unsolicited Adverse Events (AEs). | 153 | 63 |
An unsolicited AE was defined as any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. "Any" was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.
| Subject | Influenza A (H5N1) Adjuvanted Group | Placebo Group |
|---|---|---|
| Number of Subjects Reporting Any Unsolicited Adverse Events (AEs). | 135 | 54 |
An unsolicited AE was defined as any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. "Any" was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.
| Subject | Influenza A (H5N1) Adjuvanted Group | Placebo Group |
|---|---|---|
| Number of Subjects Reporting Any Unsolicited Adverse Events (AEs). | 243 | 97 |
A SAE was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
| Subject | Influenza A (H5N1) Adjuvanted Group | Placebo Group |
|---|---|---|
| Number of Subjects Reporting Serious Adverse Events (SAEs) | 8 | 4 |
An unsolicited AE was defined as any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. "Any" was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.
| Subject | Placebo/Influenza A (H5N1) Virus Monovalent Vaccine Group |
|---|---|
| Number of Subjects Reporting Any Unsolicited Adverse Events (AEs). | 21 |
An unsolicited AE was defined as any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. "Any" was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.
| Subject | Placebo/Influenza A (H5N1) Adjuvanted Group |
|---|---|
| Number of Subjects Reporting Any Unsolicited Adverse Events (AEs). | 27 |
An unsolicited AE was defined as any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. "Any" was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. As the study is still ongoing and data per age group are not available, results are presented for the groups pooled by vaccine/placebo administered. This outcome measure will be amended when data by age group become available.
| Subject | Placebo/Influenza A (H5N1) Virus Monovalent Vaccine Group |
|---|---|
| Number of Subjects Reporting Any Unsolicited Adverse Events (AEs). | 41 |
A SAE was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
| Subject | Placebo/Influenza A (H5N1) Adjuvanted Group |
|---|---|
| Number of Subjects Reporting Serious Adverse Events (SAEs) | 2 |
Collected over Serious Adverse events (SAE) = Day 0 to Day 385 and Day U0 to U385. Solicited local and general symptoms = During the 7-day period post vaccine/placebo administration. Unsolicited AEs = During the 42-day post vaccine/placebo administration.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Influenza A (H5N1) Adjuvanted Group | — | 8/607 (1.3%) | 502/607 (82.7%) |
| Placebo Group | — | 4/231 (1.7%) | 189/231 (81.8%) |
| Placebo/Influenza A (H5N1) Adjuvanted Group | — | 2/155 (1.3%) | 124/155 (80%) |
| Event | Influenza A (H5N1) Adjuvanted Group | Placebo Group | Placebo/Influenza A (H5N1) Adjuvanted Group |
|---|---|---|---|
| Scarlet feverInfections and infestations | 0/607 | 0/231 | 1/155 |
| WoundInjury, poisoning and procedural complications | 0/607 | 0/231 | 1/155 |
| AsthmaRespiratory, thoracic and mediastinal disorders | 0/607 | 1/231 | 0/155 |
| LymphadenitisBlood and lymphatic system disorders | 0/607 | 1/231 | 0/155 |
| Suicidal ideationPsychiatric disorders | 0/607 | 1/231 | 0/155 |
| Type 1 diabetes mellitusMetabolism and nutrition disorders | 0/607 | 1/231 | 0/155 |
| Infectious mononucleosisInfections and infestations | 2/607 | 0/231 | 0/155 |
| Abortion spontaneousPregnancy, puerperium and perinatal conditions | 1/607 | 0/231 | 0/155 |
| Bronchial hyperreactivityRespiratory, thoracic and mediastinal disorders | 1/607 | 0/231 | 0/155 |
| DehydrationMetabolism and nutrition disorders | 1/607 | 0/231 | 0/155 |
| Event | Influenza A (H5N1) Adjuvanted Group | Placebo Group | Placebo/Influenza A (H5N1) Adjuvanted Group |
|---|---|---|---|
| PainGeneral disorders | 405/603 | 69/229 | 111/154 |
| Muscle achesGeneral disorders | 123/309 | 17/107 | 34/75 |
| Irritability/fussinessGeneral disorders | 128/294 | 40/122 | 28/79 |
| DrowsinessGeneral disorders | 101/294 | 29/122 | 23/79 |
| HeadacheGeneral disorders | 100/309 | 18/107 | 24/75 |
| FatigueGeneral disorders | 89/309 | 19/107 | 18/75 |
| Loss of appetiteGeneral disorders | 79/294 | 29/122 | 18/79 |
| Fever (axillary temperature >= 38.0°C)General disorders | 59/294 | 21/122 | 4/79 |
| Joint pain at other locationGeneral disorders | 50/309 | 9/107 | 14/75 |
| Gastrointestinal disordersGeneral disorders | 43/309 | 18/107 | 7/75 |
| Age, Continuous(Months) | Influenza A (H5N1) Adjuvanted 6-<36M Group | Influenza A (H5N1) Adjuvanted 3-<9Y Group | Influenza A (H5N1) Adjuvanted 9-<18Y Group | Placebo 6-<36M Group | Placebo 3-<9Y Group | Placebo 9-<18Y Group | Total |
|---|---|---|---|---|---|---|---|
| Mean | 21.7 ± 8.17 | 70.5 ± 21.71 | 160.8 ± 28.21 | 22.6 ± 8.17 | 65.2 ± 20.2 | 156.0 ± 31.29 | 84.9 ± 61.40 |
| Sex: Female, Male(Participants) | Influenza A (H5N1) Adjuvanted 6-<36M Group | Influenza A (H5N1) Adjuvanted 3-<9Y Group | Influenza A (H5N1) Adjuvanted 9-<18Y Group | Placebo 6-<36M Group | Placebo 3-<9Y Group | Placebo 9-<18Y Group | Total |
|---|---|---|---|---|---|---|---|
| Female | 92 | 90 | 103 | 39 | 35 | 42 | 401 |
| Male | 107 | 108 | 107 | 36 | 41 | 38 | 437 |
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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