CClinicalTrials.gg
Sign In
CompletedNCT01196988Updated Sep 21, 2018Results posted

Immunogenicity and Safety Study of GSK Biologicals' Influenza Vaccine When Administered in Children

A Phase 3 interventional study of Influenza vaccine GSK2321138A and FluarixTM in Influenza, sponsored by GlaxoSmithKline. Completed at 59 sites in 5 countries. Open to participants aged 6 Months to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-09-21.

Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
3,027
Allocation
Randomized
Ages
6 Months to 17 Years
Sex
All
01

Study summary

This study is designed to assess the safety and immunogenicity of GlaxoSmithKline (GSK) Biologicals' investigational vaccine GSK2321138A in children aged 3 to 17 years, and to describe safety and immunogenicity of the GSK Biologicals' investigational vaccine GSK2321138A in children aged 6 to 35 months.

02

Conditions studied

  • Influenza

Browse trials for

Keywords

  • GSK Biologicals influenza vaccine GSK2321138A
  • influenza infection
03

In context

Influenza, Human

2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.

This study's enrollment of 3,027 is above the median of 238 across 1,853 interventional studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months to 17 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol.
  • For non US countries:
    • Children, male or female, aged between 6 months and 17 years at the time of the first study vaccination.

For US :

  • Children, male or female, aged between 3 and 17 years at the time of the first study vaccination
  • Written informed consent obtained from the subject parent(s) or LAR(s) of the subject. Assent obtained from the subject when applicable.
  • Subjects in stable health as determined by investigator's clinical examination and assessment of subjects' medical history.
  • Written informed assent obtained from the subject if/as required by local regulations.
  • Female subjects of non-childbearing potential may be enrolled in the study.
  • Female subjects of childbearing potential may be enrolled in the study, if the subject:
    • has practiced adequate contraception for 30 days prior to vaccination,
    • and has a negative urine pregnancy test on the day of vaccination,
    • and has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series

Exclusion criteria

Exclusion Criteria:

  • Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period. Routine registered childhood vaccinations are permitted.
  • Planned administration of any vaccine 30 days prior and 30 days after any study vaccine administration.
  • Acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination.
  • Prior receipt of any seasonal or pandemic influenza vaccine (registered or investigational) within 6 months preceding the first dose of study vaccine, or planned use during the study period.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within three months prior to enrolment in this study or planned administration during the study period.
  • Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned during the study.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
  • History of seizures or progressive neurological disease.
  • History of Guillain-Barré syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine.
  • Concurrently participating in another clinical study, at any time during the study period in which the subject has been or will be exposed to an investigational or a non-investigational product .
  • History of hypersensitivity to a previous dose of influenza vaccine, history of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines
  • Acute disease and/or fever at the time of enrolment
  • Ongoing aspirin therapy
  • Pregnant or lactating female
  • Female planning to become pregnant or planning to discontinue contraceptive precautions.
  • Any other condition which, in the opinion of the investigator, prevents the subject from participating in the study
  • Child in Care.
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
3,027 participants (actual)

Study arms

  • Experimental
    GSK2321138A 1 Group

    Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.

    Biological: Influenza vaccine GSK2321138A

  • Active comparator
    Fluarix Group

    Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.

    Biological: FluarixTM

  • Active comparator
    GSK2604409A Group

    Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.

    Biological: Influenza vaccine GSK2604409A

  • Experimental
    GSK2321138A 2 Group

    Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.

    Biological: Influenza vaccine GSK2321138A

Interventions

  • BiologicalInfluenza vaccine GSK2321138A

    intramuscular injections

  • BiologicalFluarixTM

    intramuscular injections

  • BiologicalInfluenza vaccine GSK2604409A

    intramuscular injections

06

What researchers measure

Primary outcomes

  1. Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.

    Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata).

    Time frame: At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]

  2. Number of Seroconverted Subjects Against 4 Strains of Influenza Disease.

    A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer \< 1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata).

    Time frame: At Day 28 (for primed subjects) and Day 56 (for unprimed subjects)

Secondary outcomes

  1. Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.

    Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 3-8 years and 9-17 years.

    Time frame: At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]

  2. Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.

    Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 6-17 months and 18-35 months.

    Time frame: At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]

  3. Number of Seroconverted Subjects Against 4 Strains of Influenza Disease by Age Strata.

    A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer \< 1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 3-8 years and 9-17 years.

    Time frame: At Day 28 (for primed subjects) and Day 56 (for unprimed subjects)

  4. Number of Seroconverted Subjects Against 4 Strains of Influenza Disease by Age Strata.

    A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer \< 1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 6-17 months and 18-35 months.

    Time frame: At Day 28 (for primed subjects) and Day 56 (for unprimed subjects)

  5. Number of Seroprotected Subjects Against 4 Strains of Influenza Disease

    A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata).

    Time frame: At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]

  6. Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.

    A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 3-8 years and 9-17 years.

    Time frame: At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]

  7. Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.

    A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 6-17 months and 18-35 months.

    Time frame: At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]

  8. Number of Seroprotected Subjects Against 4 Strains of Influenza.

    A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:80. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata).

    Time frame: At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]

  9. Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.

    A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:80. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 3-8 years and 9-17 years.

    Time frame: At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]

  10. Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.

    A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:80. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 6-17 months and 18-35 months.

    Time frame: At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]

  11. Number of Seroprotected Subjects Against 4 Strains of Influenza Disease.

    A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:120. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata).

    Time frame: At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]

  12. Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.

    A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:120. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 3-8 years and 9-17 years.

    Time frame: At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]

  13. Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.

    A seroprotected subject was defined as as a vaccinated subject who had a serum HI titer ≥ 1:120. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 6 -17 months and 18-35 months.

    Time frame: At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]

  14. Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.

    MGI is defined as the geometric mean of the within subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata).

    Time frame: At Day 28 (for primed subjects) and Day 56 (for unprimed subjects)

  15. Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.

    MGI is defined as the geometric mean of the within subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 3-8 years and 9-17 years.

    Time frame: At Day 28 (for primed subjects) and Day 56 (for unprimed subjects)

  16. Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.

    MGI is defined as the geometric mean of the within subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 6 -17 months and 18-35 months.

    Time frame: At Day 28 (for primed subjects) and Day 56 (for unprimed subjects)

  17. Number of Subjects With Any and Grade 3 Solicited Local Symptoms.

    Assessed solicited local symptoms were pain, redness and swelling at the injection site. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = Cried when limb was moved/spontaneously painful (Child \<6 years) or pain that prevented normal activity (Child \>6 years). Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of the injection site.

    Time frame: During the 7-day (Days 0-6) follow-up period after any vaccination.

  18. Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Younger Than 6 Years Old.

    Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature \[axillary temperature equal to or above 37.5 degrees Celsius (°C)\]. Any = occurrence of any solicited general symptom regardless of intensity grade or relation to vaccination. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 irritability = crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite = not eating at all. Related = general symptom assessed by the investigator as causally related to the study vaccination. Grade 3 temperature = temperature \>39.0°C.

    Time frame: During the 7-day (Days 0-6) follow-up period after any vaccination.

  19. Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older.

    Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature \[axillary temperature equal to or above 37.5 degrees Celsius (°C)\]. Any = occurrence of any solicited general symptom regardless of intensity grade or relation to vaccination. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 irritability = crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite = not eating at all. Related = general symptom assessed by the investigator as causally related to the study vaccination. Grade 3 temperature = temperature \>39.0°C.

    Time frame: During the 7-day (Days 0-6) follow-up period after any vaccination.

  20. Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).

    Unsolicited AE covers any AE 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 = any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = unsolicited AE that prevented normal activity Related = unsolicited AE assessed by the investigator as related to the vaccination.

    Time frame: During the 28-day (Days 0-27) follow-up period after any vaccination.

  21. Number of Subjects With Any, Grade 3 and Related Medically Attended Adverse Events (MAEs).

    MAEs were defined as AEs that resulted in medical attention (defined as hospitalization, an emergency room visit or a visit to or from medical personnel for any reason). Any = any MAE regardless of intensity or relationship to vaccination. Grade 3 MAE = MAE which prevented normal, everyday activities. Related = MAE assessed by the investigator as related to the vaccination. Assessment of intensity for MAEs was not performed.

    Time frame: During the entire study period (Day 0 - Day 180)

  22. Number of Subjects With Any and Related Potential Immune-Mediated Diseases (pIMDs).

    pIMDs were defined as a subset of AEs that included both clearly autoimmune diseases (AID) and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.

    Time frame: During the entire study period (Day 0 - Day 180)

  23. Number of Subjects With Any and Related 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.

    Time frame: During the entire study period (Day 0 - Day 180)

  24. Number of Days With Solicited Local Symptoms.

    The number of days with any grade of local symptoms after Dose 1 and Dose 2 vaccination respectively was tabulated. Assessed solicited local symptoms for duration were pain, redness and swelling at the injection site.

    Time frame: During the 7-day (Days 0-6) follow-up period after vaccination.

  25. Number of Days With Solicited General Symptoms

    The number of days with any grade of local symptoms after Dose 1 and Dose 2 vaccination respectively was tabulated. Assessed solicited general symptoms for duration were drowsiness, fatigue, gastrointestinal symptoms (Gastro.), headache, irritability, loss of appetite, muscle aches, shivering and temperature \[axillary temperature equal to or above 37.5 degrees Celsius (°C)\].

    Time frame: During the 7-day (Days 0-6) follow-up period after vaccination.

07

Results

Posted Mar 19, 2013

Participant flow

Subjects were differentiated according to their priming status. Primed subjects had received at least 1 dose of an influenza A (H1N1) 2009 monovalent vaccine and had received 2 doses of seasonal influenza in the last season or had received at least 1 dose prior to last season. Unprimed subjects had not.

Participant flow — Overall Study
MilestoneGSK2321138A 1 GroupFluarix GroupGSK2604409A GroupGSK2321138A 2 Group
Started915912911277
Completed891880886276
Not completed2432251
Withdrew: Adverse event1200
Withdrew: Withdrawal by subject5140
Withdrew: Lost to follow-up1629211
Withdrew: Other2000

Outcome measures

PrimaryTiters for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.

Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata).

Time frame:
At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]
Reported as:
Geometric mean · titers
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.
titersGSK2321138A 1 GroupFluarix GroupGSK2604409A GroupGSK2321138A 2 Group
FLU A/Cal/7/09, PRE21.6 (19.7 to 23.7)24.9 (22.8 to 27.3)22.1 (20.1 to 24.2)12.3 (10.2 to 14.8)
FLU A/Cal/7/09, POST386.2 (357.3 to 417.4)433.2 (401.0 to 468.0)422.3 (390.5 to 456.5)140.0 (113.7 to 172.3)
FLU A/Vic/210/09, PRE29.0 (26.6 to 31.6)31.4 (28.8 to 34.2)31.2 (28.6 to 34.2)8.6 (7.4 to 9.9)
FLU A/Vic/210/09, POST228.8 (215.0 to 243.4)227.3 (213.3 to 242.3)234.0 (219.1 to 249.9)87.5 (73.8 to 103.7)
FLU B/Bri/60/08, PRE30.9 (28.2 to 33.9)31.0 (28.2 to 34.0)33.2 (30.2 to 36.6)9.0 (7.9 to 10.4)
FLU B/Bri/60/08, POST244.2 (227.5 to 262.1)245.6 (229.2 to 263.2)88.4 (81.5 to 95.8)86.4 (72.6 to 102.9)
FLU B/Bri/3/07, PRE77.3 (70.0 to 85.3)77.2 (70.0 to 85.2)84.7 (76.6 to 93.6)13.1 (11.4 to 15.2)
FLU B/Bri/3/07, POST569.6 (533.6 to 608.1)224.7 (207.9 to 242.9)643.3 (603.2 to 686.1)167.7 (144.1 to 195.3)
PrimaryNumber of Seroconverted Subjects Against 4 Strains of Influenza Disease.

A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer \< 1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata).

Time frame:
At Day 28 (for primed subjects) and Day 56 (for unprimed subjects)
Reported as:
Count of participants · Participants
Number of Seroconverted Subjects Against 4 Strains of Influenza Disease.
ParticipantsGSK2321138A 1 GroupFluarix GroupGSK2604409A GroupGSK2321138A 2 Group
FLU A/California/7/09722735733181
FLU A/Victoria/210/09571578575159
FLU B/Brisbane/60/08553560237158
FLU B/Brisbane/3/07573303566191
SecondaryTiters for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.

Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 3-8 years and 9-17 years.

Time frame:
At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]
Reported as:
Geometric mean · titers
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.
titersGSK2321138A 1 GroupFluarix GroupGSK2604409A Group
FLU A/Cal/7/09, PRE, 3-8 years20.7 (18.3 to 23.3)22.2 (19.8 to 24.9)22.4 (19.8 to 25.3)
FLU A/Cal/7/09, POST, 3-8 years353.4 (319.9 to 390.3)382.1 (345.4 to 422.7)381.3 (345.0 to 421.5)
FLU A/Cal/7/09, PRE, 9-17 years23.2 (20.2 to 26.6)30.2 (26.1 to 34.9)21.5 (18.6 to 24.8)
FLU A/Cal/7/09, POST, 9-17 years445.8 (393.9 to 504.7)533.3 (474.9 to 599.0)502.0 (444.1 to 567.5)
FLU A/Vic/210/09, PRE, 3-8 years29.3 (26.1 to 32.9)32.9 (29.2 to 37.0)31.5 (28.0 to 35.5)
FLU A/Vic/210/09, POST, 3-8 years245.5 (226.4 to 266.2)242.0 (222.9 to 262.8)244.4 (224.1 to 266.5)
FLU A/Vic/210/09, PRE, 9-17 years28.5 (25.1 to 32.3)29.0 (25.8 to 32.7)30.8 (27.0 to 35.1)
FLU A/Vic/210/09, POST, 9-17 years204.1 (185.5 to 224.5)204.9 (185.4 to 226.6)217.5 (196.9 to 240.2)
FLU B/Bri/60/08, PRE, 3-8 years27.1 (24.0 to 30.6)25.1 (22.3 to 28.3)27.9 (24.6 to 31.6)
FLU B/Bri/60/08, POST, 3-8 years236.3 (215.4 to 259.2)222.3 (202.8 to 243.7)79.2 (71.2 to 88.2)
FLU B/Bri/60/08, PRE, 9-17 years38.3 (33.4 to 43.9)43.9 (38.2 to 50.6)44.7 (38.6 to 51.7)
FLU B/Bri/60/08, POST, 9-17 years257.5 (230.7 to 287.5)289.8 (262.1 to 320.4)106.4 (94.6 to 119.8)
FLU B/Bri/3/07, PRE, 3-8 years54.9 (48.7 to 61.9)51.9 (45.9 to 58.7)57.6 (50.9 to 65.1)
FLU B/Bri/3/07, POST, 3-8 years481.3 (443.2 to 522.8)163.5 (148.4 to 180.1)566.7 (522.9 to 614.1)
FLU B/Bri/3/07, PRE, 9-17 years134.3 (115.2 to 156.5)149.3 (130.3 to 171.1)162.8 (140.4 to 188.6)
FLU B/Bri/3/07, POST, 9-17 years748.1 (676.9 to 826.8)380.6 (342.1 to 423.4)797.9 (719.5 to 885.0)
SecondaryTiters for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.

Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 6-17 months and 18-35 months.

Time frame:
At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]
Reported as:
Geometric mean · titers
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.
titersGSK2321138A 2 Group
FLU A/Cal/7/09, PRE, 6-17 months7.1 (5.5 to 9.1)
FLU A/Cal/7/09, POST, 6-17 months56.2 (39.9 to 79.2)
FLU A/Cal/7/09, PRE, 18-35 months15.6 (12.3 to 19.8)
FLU A/Cal/7/09, POST, 18-35 months208.3 (164.6 to 263.4)
FLU A/Vic/210/09, PRE, 6-17 months6.2 (5.1 to 7.6)
FLU A/Vic/210/09, POST, 6-17 months43.8 (33.7 to 57.0)
FLU A/Vic/210/09, PRE, 18-35 months9.8 (8.1 to 11.9)
FLU A/Vic/210/09, POST, 18-35 months118.2 (96.8 to 144.4)
FLU B/Bri/60/08, PRE, 6-17 months5.9 (5.3 to 6.6)
FLU B/Bri/60/08, POST, 6-17 months40.2 (31.2 to 51.6)
FLU B/Bri/60/08, PRE, 18-35 months10.8 (9.0 to 13.1)
FLU B/Bri/60/08, POST, 18-35 months120.7 (98.2 to 148.4)
FLU B/Bri/3/07, PRE, 6-17 months10.0 (7.9 to 12.7)
FLU B/Bri/3/07, POST, 6-17 months93.5 (73.5 to 119.0)
FLU B/Bri/3/07, PRE, 18-35 months14.8 (12.4 to 17.7)
FLU B/Bri/3/07, POST, 18-35 months216.3 (180.9 to 258.7)
SecondaryNumber of Seroconverted Subjects Against 4 Strains of Influenza Disease by Age Strata.

A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer \< 1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 3-8 years and 9-17 years.

Time frame:
At Day 28 (for primed subjects) and Day 56 (for unprimed subjects)
Reported as:
Count of participants · Participants
Number of Seroconverted Subjects Against 4 Strains of Influenza Disease by Age Strata.
ParticipantsGSK2321138A 1 GroupFluarix GroupGSK2604409A Group
FLU A/California/7/09, 3-8 years447468457
FLU A/California/7/09, 9-17 years275267276
FLU A/Victoria/210/09, 3-8 years367365376
FLU A/Victoria/210/09, 9-17 years204213199
FLU B/Brisbane/60/08, 3-8 years364367154
FLU B/Brisbane/60/08, 9-17 years18919383
FLU B/Brisbane/3/07, 3-8 years376203403
FLU B/Brisbane/3/07, 9-17 years197100163
SecondaryNumber of Seroconverted Subjects Against 4 Strains of Influenza Disease by Age Strata.

A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer \< 1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 6-17 months and 18-35 months.

Time frame:
At Day 28 (for primed subjects) and Day 56 (for unprimed subjects)
Reported as:
Count of participants · Participants
Number of Seroconverted Subjects Against 4 Strains of Influenza Disease by Age Strata.
ParticipantsGSK2321138A 2 Group
FLU A/California/7/09, 6-17 months43
FLU A/California/7/09, 18-35 months138
FLU A/Victoria/210/09, 6-17 months37
FLU A/Victoria/210/09, 18-35 months122
FLU B/Brisbane/60/08, 6-17 months36
FLU B/Brisbane/60/08, 18-35 months122
FLU B/Brisbane/3/07, 6-17 months52
FLU B/Brisbane/3/07, 18-35 months139
SecondaryNumber of Seroprotected Subjects Against 4 Strains of Influenza Disease

A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata).

Time frame:
At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]
Reported as:
Count of participants · Participants
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease
ParticipantsGSK2321138A 1 GroupFluarix GroupGSK2604409A GroupGSK2321138A 2 Group
FLU A/California/7/09, PRE34340435360
FLU A/California/7/09, POST764793778187
FLU A/Victoria/210/09, PRE38141240934
FLU A/Victoria/210/09, POST775800773169
FLU B/Brisbane/60/08, PRE38139639928
FLU B/Brisbane/60/08, POST770790639167
FLU B/Brisbane/3/07, PRE56557559348
FLU B/Brisbane/3/07, POST785772798212
SecondaryNumber of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.

A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 3-8 years and 9-17 years.

Time frame:
At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]
Reported as:
Count of participants · Participants
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
ParticipantsGSK2321138A 1 GroupFluarix GroupGSK2604409A Group
FLU A/Cal/7/09, PRE, 3-8 years206234230
FLU A/Cal/7/09, POST, 3-8 years469491487
FLU A/Cal/7/09, PRE, 9-17 years137170123
FLU A/Cal/7/09, POST, 9-17 years295302291
FLU A/Vic/210/09, PRE, 3-8 years253277269
FLU A/Vic/210/09, POST, 3-8 years477496481
FLU A/Vic/210/09, PRE, 9-17 years128135140
FLU A/Vic/210/09, POST, 9-17 years298304292
FLU B/Bri/60/08, PRE, 3-8 years217218232
FLU B/Bri/60/08, POST, 3-8 years478489378
FLU B/Bri/60/08, PRE, 9-17 years164178167
FLU B/Bri/60/08, POST, 9-17 years292301261
FLU B/Bri/3/07, PRE, 3-8 years315309329
FLU B/Bri/3/07, POST, 3-8 years485465503
FLU B/Bri/3/07, PRE, 9-17 years250266264
FLU B/Bri/3/07, POST, 9-17 years300307295
SecondaryNumber of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.

A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 6-17 months and 18-35 months.

Time frame:
At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]
Reported as:
Count of participants · Participants
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
ParticipantsGSK2321138A 2 Group
FLU A/Cal/7/09, PRE, 6-17 months6
FLU A/Cal/7/09, POST, 6-17 months45
FLU A/Cal/7/09, PRE, 18-35 months54
FLU A/Cal/7/09, POST, 18-35 months142
FLU A/Vic/210/09, PRE, 6-17 months4
FLU A/Vic/210/09, POST, 6-17 months39
FLU A/Vic/210/09, PRE, 18-35 months30
FLU A/Vic/210/09, POST, 18-35 months130
FLU B/Bri/60/08, PRE, 6-17 months1
FLU B/Bri/60/08, POST, 6-17 months38
FLU B/Bri/60/08, PRE, 18-35 months27
FLU B/Bri/60/08, POST, 18-35 months129
FLU B/Bri/3/07, PRE, 6-17 months11
FLU B/Bri/3/07, POST, 6-17 months61
FLU B/Bri/3/07, PRE, 18-35 months37
FLU B/Bri/3/07, POST, 18-35 months151
SecondaryNumber of Seroprotected Subjects Against 4 Strains of Influenza.

A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:80. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata).

Time frame:
At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]
Reported as:
Count of participants · Participants
Number of Seroprotected Subjects Against 4 Strains of Influenza.
ParticipantsGSK2321138A 1 GroupFluarix GroupGSK2604409A GroupGSK2321138A 2 Group
FLU A/California/7/09, PRE20121820249
FLU A/California/7/09, POST732763744155
FLU A/Victoria/210/09, PRE22824526727
FLU A/Victoria/210/09, POST721748721125
FLU B/Brisbane/60/08, PRE24425826918
FLU B/Brisbane/60/08, POST708733488140
FLU B/Brisbane/3/07, PRE45446247624
FLU B/Brisbane/3/07, POST779692784175
SecondaryNumber of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.

A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:80. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 3-8 years and 9-17 years.

Time frame:
At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]
Reported as:
Count of participants · Participants
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
ParticipantsGSK2321138A 1 GroupFluarix GroupGSK2604409A Group
FLU A/Cal/7/09, PRE, 3-8 years130128141
FLU A/Cal/7/09, POST, 3-8 years453471464
FLU A/Cal/7/09, PRE, 9-17 years719061
FLU A/Cal/7/09, POST, 9-17 years279292280
FLU A/Vic/210/09, PRE, 3-8 years156177190
FLU A/Vic/210/09, POST, 3-8 years446462446
FLU A/Vic/210/09, PRE, 9-17 years726877
FLU A/Vic/210/09, POST, 9-17 years275286275
FLU B/Bri/60/08, PRE, 3-8 years145140150
FLU B/Bri/60/08, POST, 3-8 years430441286
FLU B/Bri/60/08, PRE, 9-17 years99118119
FLU B/Bri/60/08, POST, 9-17 years278292202
FLU B/Bri/3/07, PRE, 3-8 years233227248
FLU B/Bri/3/07, POST, 3-8 years480395493
FLU B/Bri/3/07, PRE, 9-17 years221235228
FLU B/Bri/3/07, POST, 9-17 years299297291
SecondaryNumber of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.

A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:80. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 6-17 months and 18-35 months.

Time frame:
At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]
Reported as:
Count of participants · Participants
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
ParticipantsGSK2321138A 2 Group
FLU A/California/7/09, PRE, 6-17 months6
FLU A/California/7/09, POST, 6-17 months31
FLU A/California/7/09, PRE, 18-35 months43
FLU A/California/7/09, POST, 18-35 months124
FLU A/Victoria/210/09, PRE, 6-17 months4
FLU A/Victoria/210/09, POST, 6-17 months18
FLU A/Victoria/210/09, PRE, 18-35 months23
FLU A/Victoria/210/09, POST, 18-35 months107
FLU B/Brisbane/60/08, PRE, 6-17 months0
FLU B/Brisbane/60/08, POST, 6-17 months25
FLU B/Brisbane/60/08, PRE, 18-35 months18
FLU B/Brisbane/60/08, POST, 18-35 months115
FLU B/Brisbane/3/07, PRE, 6-17 months4
FLU B/Brisbane/3/07, POST, 6-17 months43
FLU B/Brisbane/3/07, PRE, 18-35 months20
FLU B/Brisbane/3/07, POST, 18-35 months132
SecondaryNumber of Seroprotected Subjects Against 4 Strains of Influenza Disease.

A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:120. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata).

Time frame:
At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]
Reported as:
Count of participants · Participants
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease.
ParticipantsGSK2321138A 1 GroupFluarix GroupGSK2604409A GroupGSK2321138A 2 Group
FLU A/California/7/09, PRE71927928
FLU A/California/7/09, POST669720690122
FLU A/Victoria/210/09, PRE10312412115
FLU A/Victoria/210/09, POST59759759982
FLU B/Brisbane/60/08, PRE1231261489
FLU B/Brisbane/60/08, POST57860730083
FLU B/Brisbane/3/07, PRE3003243277
FLU B/Brisbane/3/07, POST730564756129
SecondaryNumber of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.

A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:120. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 3-8 years and 9-17 years.

Time frame:
At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]
Reported as:
Count of participants · Participants
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
ParticipantsGSK2321138A 1 GroupFluarix GroupGSK2604409A Group
FLU A/Cal/7/09, PRE, 3-8 years475657
FLU A/Cal/7/09, POST, 3-8 years410442428
FLU A/Cal/7/09, PRE, 9-17 years243622
FLU A/Cal/7/09, POST, 9-17 years259278262
FLU A/Vic/210/09, PRE, 3-8 years709287
FLU A/Vic/210/09, POST, 3-8 years380385390
FLU A/Vic/210/09, PRE, 9-17 years333234
FLU A/Vic/210/09, POST, 9-17 years217212209
FLU B/Bri/60/08, PRE, 3-8 years756682
FLU B/Bri/60/08, POST, 3-8 years349357174
FLU B/Bri/60/08, PRE, 9-17 years486066
FLU B/Bri/60/08, POST, 9-17 years229250126
FLU B/Bri/3/07, PRE, 3-8 years135155150
FLU B/Bri/3/07, POST, 3-8 years444301473
FLU B/Bri/3/07, PRE, 9-17 years165169177
FLU B/Bri/3/07, POST, 9-17 years286263283
SecondaryNumber of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.

A seroprotected subject was defined as as a vaccinated subject who had a serum HI titer ≥ 1:120. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 6 -17 months and 18-35 months.

Time frame:
At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]
Reported as:
Count of participants · Participants
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
ParticipantsGSK2321138A 2 Group
FLU A/California/7/09, PRE, 6-17 months5
FLU A/California/7/09, POST, 6-17 months18
FLU A/California/7/09, PRE, 18-35 months23
FLU A/California/7/09, POST, 18-35 months104
FLU A/Victoria/210/09, PRE, 6-17 months3
FLU A/Victoria/210/09, POST, 6-17 months11
FLU A/Victoria/210/09, PRE, 18-35 months12
FLU A/Victoria/210/09, POST, 18-35 months71
FLU B/Brisbane/60/08, PRE, 6-17 months0
FLU B/Brisbane/60/08, POST, 6-17 months7
FLU B/Brisbane/60/08, PRE, 18-35 months9
FLU B/Brisbane/60/08, POST, 18-35 months76
FLU B/Brisbane/3/07, PRE, 6-17 months1
FLU B/Brisbane/3/07, POST, 6-17 months25
FLU B/Brisbane/3/07, PRE, 18-35 months6
FLU B/Brisbane/3/07, POST, 18-35 months104
SecondaryMean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.

MGI is defined as the geometric mean of the within subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata).

Time frame:
At Day 28 (for primed subjects) and Day 56 (for unprimed subjects)
Reported as:
Geometric mean · fold change
Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.
fold changeGSK2321138A 1 GroupFluarix GroupGSK2604409A GroupGSK2321138A 2 Group
FLU A/California/7/0918.0 (16.6 to 19.5)17.4 (16.0 to 18.8)19.2 (17.7 to 20.9)11.7 (10.2 to 13.4)
FLU A/Victoria/210/097.9 (7.3 to 8.6)7.2 (6.7 to 7.8)7.5 (6.9 to 8.1)10.4 (9.0 to 11.9)
FLU B/Brisbane/60/087.9 (7.3 to 8.6)7.9 (7.2 to 8.6)2.7 (2.5 to 2.9)9.7 (8.5 to 11.2)
FLU B/Brisbane/3/077.4 (6.8 to 8.0)2.9 (2.7 to 3.1)7.6 (7.0 to 8.3)12.9 (11.0 to 15.3)
SecondaryMean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.

MGI is defined as the geometric mean of the within subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 3-8 years and 9-17 years.

Time frame:
At Day 28 (for primed subjects) and Day 56 (for unprimed subjects)
Reported as:
Geometric mean · fold change
Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.
fold changeGSK2321138A 1 GroupFluarix GroupGSK2604409A Group
FLU A/California/7/09, 3-8 years17.2 (15.6 to 19.0)17.2 (15.6 to 18.9)17.2 (15.6 to 18.9)
FLU A/California/7/09, 9-17 years19.2 (16.7 to 22.2)17.7 (15.2 to 20.5)23.3 (20.3 to 26.9)
FLU A/Victoria/210/09, 3-8 years8.4 (7.6 to 9.3)7.3 (6.6 to 8.1)7.8 (7.1 to 8.5)
FLU A/Victoria/210/09, 9-17 years7.2 (6.2 to 8.2)7.1 (6.2 to 8.1)7.1 (6.2 to 8.1)
FLU B/Brisbane/60/08, 3-8 years8.8 (7.9 to 9.8)8.8 (7.9 to 9.8)2.8 (2.6 to 3.1)
FLU B/Brisbane/60/08, 9-17 years6.7 (5.8 to 7.8)6.6 (5.7 to 7.6)2.4 (2.1 to 2.7)
FLU B/Brisbane/3/07, 3-8 years8.8 (7.9 to 9.8)3.1 (2.9 to 3.4)9.9 (8.9 to 11.0)
FLU B/Brisbane/3/07, 9-17 years5.6 (4.9 to 6.3)2.5 (2.3 to 2.8)4.9 (4.3 to 5.6)
SecondaryMean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.

MGI is defined as the geometric mean of the within subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 6 -17 months and 18-35 months.

Time frame:
At Day 28 (for primed subjects) and Day 56 (for unprimed subjects)
Reported as:
Geometric mean · fold change
Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.
fold changeGSK2321138A 2 Group
FLU A/California/7/09, 6-17 months8.2 (6.4 to 10.6)
FLU A/California/7/09, 18-35 months13.7 (11.7 to 16.0)
FLU A/Victoria/210/09, 6-17 months7.3 (5.9 to 9.0)
FLU A/Victoria/210/09, 18-35 months12.1 (10.2 to 14.3)
FLU B/Brisbane/60/08, 6-17 months6.9 (5.4 to 8.9)
FLU B/Brisbane/60/08, 18-35 months11.3 (9.6 to 13.2)
FLU B/Brisbane/3/07, 6-17 months9.5 (7.0 to 12.8)
FLU B/Brisbane/3/07, 18-35 months14.8 (12.2 to 18.0)
SecondaryNumber of Subjects With Any and Grade 3 Solicited Local Symptoms.

Assessed solicited local symptoms were pain, redness and swelling at the injection site. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = Cried when limb was moved/spontaneously painful (Child \<6 years) or pain that prevented normal activity (Child \>6 years). Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of the injection site.

Time frame:
During the 7-day (Days 0-6) follow-up period after any vaccination.
Reported as:
Count of participants · Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
ParticipantsGSK2321138A 1 GroupFluarix GroupGSK2604409A GroupGSK2321138A 2 Group
Any Pain444425416116
Grade 3 Pain2021135
Any Redness225214206100
Grade 3 Redness12361
Any Swelling19619316067
Grade 3 Swelling111030
SecondaryNumber of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Younger Than 6 Years Old.

Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature \[axillary temperature equal to or above 37.5 degrees Celsius (°C)\]. Any = occurrence of any solicited general symptom regardless of intensity grade or relation to vaccination. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 irritability = crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite = not eating at all. Related = general symptom assessed by the investigator as causally related to the study vaccination. Grade 3 temperature = temperature \>39.0°C.

Time frame:
During the 7-day (Days 0-6) follow-up period after any vaccination.
Reported as:
Count of participants · Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Younger Than 6 Years Old.
ParticipantsGSK2321138A 1 GroupFluarix GroupGSK2604409A GroupGSK2321138A 2 Group
Any Drowsiness67555984
Grade 3 Drowsiness5327
Related Drowsiness44313657
Any Irritability655653119
Grade 3 Irritability42311
Related Irritability44373181
Any Loss of appetite59404783
Grade 3 Loss of appetite33312
Related Loss of appetite37242550
Temperature ≥37.5°C50514181
Temperature >39°C42318
Related Temperature24291637
SecondaryNumber of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older.

Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature \[axillary temperature equal to or above 37.5 degrees Celsius (°C)\]. Any = occurrence of any solicited general symptom regardless of intensity grade or relation to vaccination. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 irritability = crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite = not eating at all. Related = general symptom assessed by the investigator as causally related to the study vaccination. Grade 3 temperature = temperature \>39.0°C.

Time frame:
During the 7-day (Days 0-6) follow-up period after any vaccination.
Reported as:
Count of participants · Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older.
ParticipantsGSK2321138A 1 GroupFluarix GroupGSK2604409A Group
Any Fatigue129118114
Grade 3 Fatigue984
Related Fatigue958176
Any Gastro.666252
Grade 3 Gastro.742
Related Gastro.312926
Any Headache110125114
Grade 3 Headache845
Related Headache667571
Any Joint Pain696351
Grade 3 Joint Pain242
Related Joint Pain444336
Any Muscle aches116106106
Grade 3 Muscle aches483
Related Muscle aches848187
Any Shivering443137
Grade 3 Shivering331
Related Shivering272322
Temperature ≥37.5°C486047
Temperature >39°C753
Related Temperature253032
SecondaryNumber of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).

Unsolicited AE covers any AE 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 = any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = unsolicited AE that prevented normal activity Related = unsolicited AE assessed by the investigator as related to the vaccination.

Time frame:
During the 28-day (Days 0-27) follow-up period after any vaccination.
Reported as:
Count of participants · Participants
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
ParticipantsGSK2321138A 1 GroupFluarix GroupGSK2604409A GroupGSK2321138A 2 Group
Subjects with any AE(s)284305308167
Subjects with grade 3 AE(s)20372620
Subjects with related AE(s)1819235
SecondaryNumber of Subjects With Any, Grade 3 and Related Medically Attended Adverse Events (MAEs).

MAEs were defined as AEs that resulted in medical attention (defined as hospitalization, an emergency room visit or a visit to or from medical personnel for any reason). Any = any MAE regardless of intensity or relationship to vaccination. Grade 3 MAE = MAE which prevented normal, everyday activities. Related = MAE assessed by the investigator as related to the vaccination. Assessment of intensity for MAEs was not performed.

Time frame:
During the entire study period (Day 0 - Day 180)
Reported as:
Count of participants · Participants
Number of Subjects With Any, Grade 3 and Related Medically Attended Adverse Events (MAEs).
ParticipantsGSK2321138A 1 GroupFluarix GroupGSK2604409A GroupGSK2321138A 2 Group
Subjects with any MAE(s)271278303171
Subjects with related MAE(s)2442
Subjects with Grade 3 MAE(s)NANANANA
SecondaryNumber of Subjects With Any and Related Potential Immune-Mediated Diseases (pIMDs).

pIMDs were defined as a subset of AEs that included both clearly autoimmune diseases (AID) and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.

Time frame:
During the entire study period (Day 0 - Day 180)
Reported as:
Count of participants · Participants
Number of Subjects With Any and Related Potential Immune-Mediated Diseases (pIMDs).
ParticipantsGSK2321138A 1 GroupFluarix GroupGSK2604409A GroupGSK2321138A 2 Group
Subjects with any pIMD(s)0020
Subjects with related pIMD(s)0000
SecondaryNumber of Subjects With Any and Related 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.

Time frame:
During the entire study period (Day 0 - Day 180)
Reported as:
Count of participants · Participants
Number of Subjects With Any and Related Serious Adverse Events (SAEs).
ParticipantsGSK2321138A 1 GroupFluarix GroupGSK2604409A GroupGSK2321138A 2 Group
Subjects with any SAE(s)8679
Subjects with related SAE(s)0000
SecondaryNumber of Days With Solicited Local Symptoms.

The number of days with any grade of local symptoms after Dose 1 and Dose 2 vaccination respectively was tabulated. Assessed solicited local symptoms for duration were pain, redness and swelling at the injection site.

Time frame:
During the 7-day (Days 0-6) follow-up period after vaccination.
Reported as:
Median · days
Number of Days With Solicited Local Symptoms.
daysGSK2321138A 1 GroupFluarix GroupGSK2604409A GroupGSK2321138A 2 Group
Pain, Dose 12.0 (1.0 to 2.0)2.0 (1.0 to 3.0)2.0 (1.0 to 3.0)1.0 (1.0 to 2.0)
Pain, Dose 22.0 (1.0 to 2.0)2.0 (1.0 to 2.0)2.0 (1.0 to 2.0)2.0 (1.0 to 2.0)
Redness, Dose 12.0 (1.0 to 3.0)2.0 (1.0 to 3.0)2.0 (1.0 to 3.0)2.0 (1.5 to 4.0)
Redness, Dose 22.0 (1.0 to 3.0)2.0 (1.0 to 3.0)2.0 (1.0 to 3.0)2.0 (1.0 to 3.0)
Swelling, Dose 12.0 (1.0 to 3.0)2.0 (1.0 to 3.0)2.0 (1.0 to 3.0)2.0 (1.0 to 3.0)
Swelling, Dose 22.0 (1.0 to 2.0)2.0 (1.0 to 3.0)2.0 (1.0 to 3.0)2.0 (1.0 to 4.0)
SecondaryNumber of Days With Solicited General Symptoms

The number of days with any grade of local symptoms after Dose 1 and Dose 2 vaccination respectively was tabulated. Assessed solicited general symptoms for duration were drowsiness, fatigue, gastrointestinal symptoms (Gastro.), headache, irritability, loss of appetite, muscle aches, shivering and temperature \[axillary temperature equal to or above 37.5 degrees Celsius (°C)\].

Time frame:
During the 7-day (Days 0-6) follow-up period after vaccination.
Reported as:
Median · days
Number of Days With Solicited General Symptoms
daysGSK2321138A 1 GroupFluarix GroupGSK2604409A GroupGSK2321138A 2 Group
Drowsiness, Dose 11.0 (1.0 to 2.0)1.0 (1.0 to 2.0)2.0 (1.0 to 3.0)1.0 (1.0 to 3.0)
Drowsiness, Dose 22.0 (1.0 to 3.0)1.0 (1.0 to 2.0)1.0 (1.0 to 2.0)2.0 (1.0 to 3.0)
Fatigue, Dose 12.0 (1.0 to 3.0)2.0 (1.0 to 3.0)2.0 (1.0 to 3.0)NA (NA to NA)
Fatigue, Dose 21.0 (1.0 to 2.0)2.0 (1.0 to 2.0)1.0 (1.0 to 2.0)NA (NA to NA)
Gastro., Dose 11.0 (1.0 to 2.0)2.0 (1.0 to 2.0)2.0 (1.0 to 2.0)NA (NA to NA)
Gastro., Dose 21.0 (1.0 to 2.0)2.0 (1.0 to 2.0)1.0 (1.0 to 2.0)NA (NA to NA)
Headache, Dose 11.0 (1.0 to 2.5)1.0 (1.0 to 2.0)1.0 (1.0 to 2.0)NA (NA to NA)
Headache, Dose 21.0 (1.0 to 2.0)1.0 (1.0 to 2.0)1.0 (1.0 to 2.0)NA (NA to NA)
Irritability, Dose 12.0 (1.0 to 3.0)2.0 (1.0 to 3.0)2.0 (1.0 to 3.0)2.0 (1.0 to 3.0)
Irritability, Dose 22.0 (1.0 to 3.0)1.0 (1.0 to 3.0)2.0 (1.0 to 3.0)2.0 (1.0 to 3.0)
Joint pain, Dose 12.0 (1.0 to 3.0)2.0 (1.0 to 3.0)2.0 (1.0 to 2.0)NA (NA to NA)
Joint pain, Dose 21.0 (1.0 to 2.0)1.0 (1.0 to 2.0)1.5 (1.0 to 2.0)NA (NA to NA)
Loss of appetite, Dose 11.0 (1.0 to 2.0)2.0 (1.0 to 3.0)2.0 (1.0 to 4.0)3.0 (1.0 to 4.5)
Loss of appetite, Dose 23.0 (1.0 to 4.0)1.0 (1.0 to 3.0)2.0 (1.0 to 2.0)3.0 (2.0 to 4.0)
Muscle aches, Dose 12.0 (1.0 to 3.0)2.0 (1.0 to 2.0)2.0 (1.0 to 2.0)NA (NA to NA)
Muscle aches, Dose 22.0 (1.0 to 3.0)2.0 (1.0 to 2.0)2.0 (1.0 to 2.0)NA (NA to NA)
Shivering, Dose 11.0 (1.0 to 2.0)2.0 (1.0 to 5.0)1.0 (1.0 to 2.0)NA (NA to NA)
Shivering, Dose 21.0 (1.0 to 3.0)1.5 (1.0 to 3.0)2.0 (1.0 to 2.0)NA (NA to NA)
Temperature, Dose 11.0 (1.0 to 2.0)1.5 (1.0 to 3.0)2.0 (1.0 to 3.0)1.0 (1.0 to 2.0)
Temperature, Dose 21.5 (1.0 to 2.0)1.5 (1.0 to 2.0)2.0 (1.0 to 3.0)2.0 (1.0 to 3.0)

Adverse events

Collected over SAE(s): during the entire study period (Day 0 - Day 180); Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination, Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
GSK2321138A 1 Group—8/915 (0.9%)630/915 (68.9%)
Fluarix Group—6/912 (0.7%)616/912 (67.5%)
GSK2604409A Group—7/911 (0.8%)620/911 (68.1%)
GSK2321138A 2 Group—9/277 (3.2%)237/277 (85.6%)
Most frequent serious events
Showing 10 of 29
Most frequent serious events
EventGSK2321138A 1 GroupFluarix GroupGSK2604409A GroupGSK2321138A 2 Group
BronchitisInfections and infestations0/9150/9120/9113/277
BronchopneumoniaInfections and infestations0/9150/9120/9112/277
GastroenteritisInfections and infestations0/9150/9120/9112/277
Febrile convulsionNervous system disorders0/9150/9120/9112/277
AmoebiasisInfections and infestations0/9150/9120/9111/277
BronchiolitisInfections and infestations0/9150/9120/9111/277
Gastroenteritis viralInfections and infestations0/9150/9120/9111/277
Pneumococcal sepsisInfections and infestations0/9150/9120/9111/277
Respiratory syncytial virus infectionInfections and infestations0/9150/9120/9111/277
TonsillitisInfections and infestations1/9150/9120/9111/277
Most frequent other events
Showing 10 of 19
Most frequent other events
EventGSK2321138A 1 GroupFluarix GroupGSK2604409A GroupGSK2321138A 2 Group
PainGeneral disorders444/903425/902416/906116/277
IrritabilityGeneral disorders65/29156/31453/280119/277
RednessGeneral disorders225/903214/902206/906100/277
DrowsinessGeneral disorders67/29155/31459/28084/277
Loss of appetiteGeneral disorders59/29140/31447/28083/277
Temperature (Axillary)General disorders50/29151/31441/28081/277
SwellingGeneral disorders196/903193/902160/90667/277
HeadacheGeneral disorders110/613125/589114/6260/277
FatigueGeneral disorders129/613118/589114/6260/277
Muscle achesGeneral disorders116/613106/589106/6260/277

Baseline characteristics

Age, Continuous
Age, Continuous(Months)GSK2321138A 1 GroupFluarix GroupGSK2604409A GroupGSK2321138A 2 GroupTotal
Mean98.5 ± 44.4098.2 ± 45.5099.6 ± 44.2022.1 ± 8.0279.6 ± 35.53
Sex: Female, Male
Sex: Female, Male(Participants)GSK2321138A 1 GroupFluarix GroupGSK2604409A GroupGSK2321138A 2 GroupTotal
Female4434394401181440
Male4724734711591575
08

Study locations

59 sites
  • GSK Investigational Site
    Sacramento, California 95816, United States
  • GSK Investigational Site
    Boca Raton, Florida 33432, United States
  • GSK Investigational Site
    Wichita, Kansas 67205, United States
  • GSK Investigational Site
    Wichita, Kansas 67207, United States
  • GSK Investigational Site
    Lexington, Kentucky 40509, United States
  • GSK Investigational Site
    Metairie, Louisiana 70006, United States
  • GSK Investigational Site
    Boston, Massachusetts 02130, United States
  • GSK Investigational Site
    Omaha, Nebraska 68134, United States
  • GSK Investigational Site
    Binghamton, New York 13901, United States
  • GSK Investigational Site
    Elmira, New York 14901, United States
  • GSK Investigational Site
    Syracuse, New York 13210, United States
  • GSK Investigational Site
    Raleigh, North Carolina 27609, United States
  • GSK Investigational Site
    Houston, Texas 77055, United States
  • GSK Investigational Site
    San Angelo, Texas 76904, United States
  • GSK Investigational Site
    Decin, 405 01, Czechia
  • GSK Investigational Site
    Humpolec, 396 01, Czechia
  • GSK Investigational Site
    Jindrichuv Hradec, 37701, Czechia
  • GSK Investigational Site
    Kolin, 28002, Czechia
  • GSK Investigational Site
    Nachod, 547 01, Czechia
  • GSK Investigational Site
    Odolena voda, 25070, Czechia
  • GSK Investigational Site
    Pardubice, 532 03, Czechia
  • GSK Investigational Site
    Plzen, 305 99, Czechia
  • GSK Investigational Site
    Praha 6, 1600, Czechia
  • GSK Investigational Site
    Tabor, 390 02, Czechia
  • GSK Investigational Site
    Aix en Provence, 13100, France
  • GSK Investigational Site
    Draguignan, 83300, France
  • GSK Investigational Site
    Essey les Nancy, 54270, France
  • GSK Investigational Site
    La Bouexiere, 35340, France
  • GSK Investigational Site
    Le Havre, 76600, France
  • GSK Investigational Site
    Nantes, 44300, France
  • GSK Investigational Site
    Nice, 06300, France
  • GSK Investigational Site
    Seysses, 31600, France
  • GSK Investigational Site
    Tours, 37100, France
  • GSK Investigational Site
    Ettenheim, Baden-Wuerttemberg 77955, Germany
  • GSK Investigational Site
    Kehl, Baden-Wuerttemberg 77694, Germany
  • GSK Investigational Site
    Schwaebisch-Hall, Baden-Wuerttemberg 74523, Germany
  • GSK Investigational Site
    Stuttgart, Baden-Wuerttemberg 70469, Germany
  • GSK Investigational Site
    Tauberbischofsheim, Baden-Wuerttemberg 97941, Germany
  • GSK Investigational Site
    Tuttlingen, Baden-Wuerttemberg 78532, Germany
  • GSK Investigational Site
    Gilching, Bayern 82205, Germany
  • GSK Investigational Site
    Kirchheim, Bayern 85551, Germany
  • GSK Investigational Site
    Muenchen, Bayern 81735, Germany
  • GSK Investigational Site
    Noerdlingen, Bayern 86720, Germany
  • GSK Investigational Site
    Eschwege, Hessen 37269, Germany
  • GSK Investigational Site
    Wolfenbuettel, Niedersachsen 38302, Germany
  • GSK Investigational Site
    Heiligenhaus, Nordrhein-Westfalen 42579, Germany
  • GSK Investigational Site
    Kleve-Materborn, Nordrhein-Westfalen 47533, Germany
  • GSK Investigational Site
    Solingen, Nordrhein-Westfalen 42719, Germany
  • GSK Investigational Site
    Willich, Nordrhein-Westfalen 47877, Germany
  • GSK Investigational Site
    Trier, Rheinland-Pfalz 54290, Germany
  • GSK Investigational Site
    Leipzig, Sachsen 04178, Germany
  • GSK Investigational Site
    Flensburg, Schleswig-Holstein 24937, Germany
  • GSK Investigational Site
    Weimar, Thueringen 99425, Germany
  • GSK Investigational Site
    Berlin, 10315, Germany
  • GSK Investigational Site
    Berlin, 10967, Germany
  • GSK Investigational Site
    Berlin, 13055, Germany
  • GSK Investigational Site
    Hamburg, 22307, Germany
  • GSK Investigational Site
    Dasmariñas, Cavite, 4114, Philippines
  • GSK Investigational Site
    Quezon City, 1113, Philippines
09

References and documents

Publications

  • Domachowske JB, Pankow-Culot H, Bautista M, Feng Y, Claeys C, Peeters M, Innis BL, Jain V. A randomized trial of candidate inactivated quadrivalent influenza vaccine versus trivalent influenza vaccines in children aged 3-17 years. J Infect Dis. 2013 Jun 15;207(12):1878-87. doi: 10.1093/infdis/jit091. Epub 2013 Mar 7. PubMed 23470848 ↗

Individual participant data

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.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 21, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01196988
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Sep 9, 2010
Start date
Oct 4, 2010
Primary completion
Jun 15, 2011
Completion
Jun 15, 2011
Results posted
Mar 19, 2013
Last update
Sep 21, 2018

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Influenza, Human→

Other studies from this sponsor

GlaxoSmithKline

Start the discussion