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

Sponsor
GlaxoSmithKline (Industry)
Overall Status
Completed
CT.gov ID
NCT01196988
Collaborator
(none)
3,027
Enrollment
59
Locations
4
Arms
8.3
Duration (Months)
51.3
Patients Per Site
6.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Influenza vaccine GSK2321138A
  • Biological: FluarixTM
  • Biological: Influenza vaccine GSK2604409A
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
3027 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Immunogenicity and Safety Study of GSK Biologicals' Influenza Vaccine GSK2321138A When Administered in Children
Study Start Date :
Oct 4, 2010
Actual Primary Completion Date :
Jun 15, 2011
Actual Study Completion Date :
Jun 15, 2011

Arms and Interventions

Arm Intervention/Treatment
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
intramuscular injections
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
intramuscular injections
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
intramuscular injections
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
intramuscular injections

Outcome Measures

Primary Outcome Measures

  1. Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. [At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]]

    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).

  2. Number of Seroconverted Subjects Against 4 Strains of Influenza Disease. [At Day 28 (for primed subjects) and Day 56 (for unprimed subjects)]

    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).

Secondary Outcome Measures

  1. Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. [At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]]

    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.

  2. Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. [At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]]

    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.

  3. Number of Seroconverted Subjects Against 4 Strains of Influenza Disease by Age Strata. [At Day 28 (for primed subjects) and Day 56 (for unprimed subjects)]

    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.

  4. Number of Seroconverted Subjects Against 4 Strains of Influenza Disease by Age Strata. [At Day 28 (for primed subjects) and Day 56 (for unprimed subjects)]

    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.

  5. Number of Seroprotected Subjects Against 4 Strains of Influenza Disease [At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]]

    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).

  6. Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. [At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]]

    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.

  7. Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. [At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]]

    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.

  8. Number of Seroprotected Subjects Against 4 Strains of Influenza. [At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]]

    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).

  9. Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. [At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]]

    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.

  10. Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. [At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]]

    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.

  11. Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. [At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]]

    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).

  12. Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. [At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]]

    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.

  13. Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata. [At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]]

    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.

  14. Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. [At Day 28 (for primed subjects) and Day 56 (for unprimed subjects)]

    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).

  15. Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. [At Day 28 (for primed subjects) and Day 56 (for unprimed subjects)]

    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.

  16. Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata. [At Day 28 (for primed subjects) and Day 56 (for unprimed subjects)]

    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.

  17. Number of Subjects With Any and Grade 3 Solicited Local Symptoms. [During the 7-day (Days 0-6) follow-up period after any vaccination.]

    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.

  18. Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Younger Than 6 Years Old. [During the 7-day (Days 0-6) follow-up period after any vaccination.]

    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.

  19. Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older. [During the 7-day (Days 0-6) follow-up period after any vaccination.]

    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.

  20. Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). [During the 28-day (Days 0-27) follow-up period after any vaccination.]

    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.

  21. Number of Subjects With Any, Grade 3 and Related Medically Attended Adverse Events (MAEs). [During the entire study period (Day 0 - Day 180)]

    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.

  22. Number of Subjects With Any and Related Potential Immune-Mediated Diseases (pIMDs). [During the entire study period (Day 0 - Day 180)]

    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.

  23. Number of Subjects With Any and Related Serious Adverse Events (SAEs). [During the entire study period (Day 0 - Day 180)]

    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.

  24. Number of Days With Solicited Local Symptoms. [During the 7-day (Days 0-6) follow-up period after vaccination.]

    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.

  25. Number of Days With Solicited General Symptoms [During the 7-day (Days 0-6) follow-up period after vaccination.]

    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)].

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Months to 17 Years
Sexes Eligible for Study:
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:

  • 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 GSK Investigational Site Sacramento California United States 95816
2 GSK Investigational Site Boca Raton Florida United States 33432
3 GSK Investigational Site Wichita Kansas United States 67205
4 GSK Investigational Site Wichita Kansas United States 67207
5 GSK Investigational Site Lexington Kentucky United States 40509
6 GSK Investigational Site Metairie Louisiana United States 70006
7 GSK Investigational Site Boston Massachusetts United States 02130
8 GSK Investigational Site Omaha Nebraska United States 68134
9 GSK Investigational Site Binghamton New York United States 13901
10 GSK Investigational Site Elmira New York United States 14901
11 GSK Investigational Site Syracuse New York United States 13210
12 GSK Investigational Site Raleigh North Carolina United States 27609
13 GSK Investigational Site Houston Texas United States 77055
14 GSK Investigational Site San Angelo Texas United States 76904
15 GSK Investigational Site Decin Czechia 405 01
16 GSK Investigational Site Humpolec Czechia 396 01
17 GSK Investigational Site Jindrichuv Hradec Czechia 37701
18 GSK Investigational Site Kolin Czechia 28002
19 GSK Investigational Site Nachod Czechia 547 01
20 GSK Investigational Site Odolena voda Czechia 25070
21 GSK Investigational Site Pardubice Czechia 532 03
22 GSK Investigational Site Plzen Czechia 305 99
23 GSK Investigational Site Praha 6 Czechia 1600
24 GSK Investigational Site Tabor Czechia 390 02
25 GSK Investigational Site Aix en Provence France 13100
26 GSK Investigational Site Draguignan France 83300
27 GSK Investigational Site Essey les Nancy France 54270
28 GSK Investigational Site La Bouexiere France 35340
29 GSK Investigational Site Le Havre France 76600
30 GSK Investigational Site Nantes France 44300
31 GSK Investigational Site Nice France 06300
32 GSK Investigational Site Seysses France 31600
33 GSK Investigational Site Tours France 37100
34 GSK Investigational Site Ettenheim Baden-Wuerttemberg Germany 77955
35 GSK Investigational Site Kehl Baden-Wuerttemberg Germany 77694
36 GSK Investigational Site Schwaebisch-Hall Baden-Wuerttemberg Germany 74523
37 GSK Investigational Site Stuttgart Baden-Wuerttemberg Germany 70469
38 GSK Investigational Site Tauberbischofsheim Baden-Wuerttemberg Germany 97941
39 GSK Investigational Site Tuttlingen Baden-Wuerttemberg Germany 78532
40 GSK Investigational Site Gilching Bayern Germany 82205
41 GSK Investigational Site Kirchheim Bayern Germany 85551
42 GSK Investigational Site Muenchen Bayern Germany 81735
43 GSK Investigational Site Noerdlingen Bayern Germany 86720
44 GSK Investigational Site Eschwege Hessen Germany 37269
45 GSK Investigational Site Wolfenbuettel Niedersachsen Germany 38302
46 GSK Investigational Site Heiligenhaus Nordrhein-Westfalen Germany 42579
47 GSK Investigational Site Kleve-Materborn Nordrhein-Westfalen Germany 47533
48 GSK Investigational Site Solingen Nordrhein-Westfalen Germany 42719
49 GSK Investigational Site Willich Nordrhein-Westfalen Germany 47877
50 GSK Investigational Site Trier Rheinland-Pfalz Germany 54290
51 GSK Investigational Site Leipzig Sachsen Germany 04178
52 GSK Investigational Site Flensburg Schleswig-Holstein Germany 24937
53 GSK Investigational Site Weimar Thueringen Germany 99425
54 GSK Investigational Site Berlin Germany 10315
55 GSK Investigational Site Berlin Germany 10967
56 GSK Investigational Site Berlin Germany 13055
57 GSK Investigational Site Hamburg Germany 22307
58 GSK Investigational Site Dasmariñas, Cavite Philippines 4114
59 GSK Investigational Site Quezon City Philippines 1113

Sponsors and Collaborators

  • GlaxoSmithKline

Investigators

  • Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01196988
Other Study ID Numbers:
  • 113275
First Posted:
Sep 9, 2010
Last Update Posted:
Sep 21, 2018
Last Verified:
Mar 1, 2017
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by GlaxoSmithKline
GSK Biologicals influenza vaccine GSK2321138A
influenza infection
Additional relevant MeSH terms:
Influenza, Human
Vaccines

Study Results

Participant Flow

Recruitment Details 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.
Pre-assignment Detail 3015 subjects out of the 3027 who were enrolled in the study were vaccinated. Remaining subjects were not included in the participant flow as started as they failed to meet protocol criteria. The treatment was stratified by age strata: 3-8 and 9-17 years. Another arm evaluates the GSK2321138A vaccine for children aged 6-17 and 18-35 months.
Arm/Group Title GSK2321138A 1 Group Fluarix Group GSK2604409A Group GSK2321138A 2 Group
Arm/Group Description 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. 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. 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. 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.
Period Title: Overall Study
STARTED 915 912 911 277
COMPLETED 891 880 886 276
NOT COMPLETED 24 32 25 1

Baseline Characteristics

Arm/Group Title GSK2321138A 1 Group Fluarix Group GSK2604409A Group GSK2321138A 2 Group Total
Arm/Group Description 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. 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. 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. 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. Total of all reporting groups
Overall Participants 915 912 911 277 3015
Age (Months) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Months]
98.5
(44.40)
98.2
(45.50)
99.6
(44.20)
22.1
(8.02)
79.6
(35.53)
Sex: Female, Male (Count of Participants)
Female
443
48.4%
439
48.1%
440
48.3%
118
42.6%
1440
47.8%
Male
472
51.6%
473
51.9%
471
51.7%
159
57.4%
1575
52.2%

Outcome Measures

1. Primary Outcome
Title Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.
Description 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]

Outcome Measure Data

Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
Arm/Group Title GSK2321138A 1 Group Fluarix Group GSK2604409A Group GSK2321138A 2 Group
Arm/Group Description 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. 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. 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. 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.
Measure Participants 791 819 801 234
FLU A/Cal/7/09, PRE
21.6
24.9
22.1
12.3
FLU A/Cal/7/09, POST
386.2
433.2
422.3
140.0
FLU A/Vic/210/09, PRE
29.0
31.4
31.2
8.6
FLU A/Vic/210/09, POST
228.8
227.3
234.0
87.5
FLU B/Bri/60/08, PRE
30.9
31.0
33.2
9.0
FLU B/Bri/60/08, POST
244.2
245.6
88.4
86.4
FLU B/Bri/3/07, PRE
77.3
77.2
84.7
13.1
FLU B/Bri/3/07, POST
569.6
224.7
643.3
167.7
2. Primary Outcome
Title Number of Seroconverted Subjects Against 4 Strains of Influenza Disease.
Description 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)

Outcome Measure Data

Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
Arm/Group Title GSK2321138A 1 Group Fluarix Group GSK2604409A Group GSK2321138A 2 Group
Arm/Group Description 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. 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. 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. 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.
Measure Participants 790 818 800 232
FLU A/California/7/09
722
78.9%
735
80.6%
733
80.5%
181
65.3%
FLU A/Victoria/210/09
571
62.4%
578
63.4%
575
63.1%
159
57.4%
FLU B/Brisbane/60/08
553
60.4%
560
61.4%
237
26%
158
57%
FLU B/Brisbane/3/07
573
62.6%
303
33.2%
566
62.1%
191
69%
3. Secondary Outcome
Title Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.
Description 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]

Outcome Measure Data

Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
Arm/Group Title GSK2321138A 1 Group Fluarix Group GSK2604409A Group
Arm/Group Description 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. 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. 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.
Measure Participants 791 819 801
FLU A/Cal/7/09, PRE, 3-8 years
20.7
22.2
22.4
FLU A/Cal/7/09, POST, 3-8 years
353.4
382.1
381.3
FLU A/Cal/7/09, PRE, 9-17 years
23.2
30.2
21.5
FLU A/Cal/7/09, POST, 9-17 years
445.8
533.3
502.0
FLU A/Vic/210/09, PRE, 3-8 years
29.3
32.9
31.5
FLU A/Vic/210/09, POST, 3-8 years
245.5
242.0
244.4
FLU A/Vic/210/09, PRE, 9-17 years
28.5
29.0
30.8
FLU A/Vic/210/09, POST, 9-17 years
204.1
204.9
217.5
FLU B/Bri/60/08, PRE, 3-8 years
27.1
25.1
27.9
FLU B/Bri/60/08, POST, 3-8 years
236.3
222.3
79.2
FLU B/Bri/60/08, PRE, 9-17 years
38.3
43.9
44.7
FLU B/Bri/60/08, POST, 9-17 years
257.5
289.8
106.4
FLU B/Bri/3/07, PRE, 3-8 years
54.9
51.9
57.6
FLU B/Bri/3/07, POST, 3-8 years
481.3
163.5
566.7
FLU B/Bri/3/07, PRE, 9-17 years
134.3
149.3
162.8
FLU B/Bri/3/07, POST, 9-17 years
748.1
380.6
797.9
4. Secondary Outcome
Title Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.
Description 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]

Outcome Measure Data

Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
Arm/Group Title GSK2321138A 2 Group
Arm/Group Description 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.
Measure Participants 234
FLU A/Cal/7/09, PRE, 6-17 months
7.1
FLU A/Cal/7/09, POST, 6-17 months
56.2
FLU A/Cal/7/09, PRE, 18-35 months
15.6
FLU A/Cal/7/09, POST, 18-35 months
208.3
FLU A/Vic/210/09, PRE, 6-17 months
6.2
FLU A/Vic/210/09, POST, 6-17 months
43.8
FLU A/Vic/210/09, PRE, 18-35 months
9.8
FLU A/Vic/210/09, POST, 18-35 months
118.2
FLU B/Bri/60/08, PRE, 6-17 months
5.9
FLU B/Bri/60/08, POST, 6-17 months
40.2
FLU B/Bri/60/08, PRE, 18-35 months
10.8
FLU B/Bri/60/08, POST, 18-35 months
120.7
FLU B/Bri/3/07, PRE, 6-17 months
10.0
FLU B/Bri/3/07, POST, 6-17 months
93.5
FLU B/Bri/3/07, PRE, 18-35 months
14.8
FLU B/Bri/3/07, POST, 18-35 months
216.3
5. Secondary Outcome
Title Number of Seroconverted Subjects Against 4 Strains of Influenza Disease by Age Strata.
Description 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)

Outcome Measure Data

Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
Arm/Group Title GSK2321138A 1 Group Fluarix Group GSK2604409A Group
Arm/Group Description 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. 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. 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.
Measure Participants 790 818 800
FLU A/California/7/09, 3-8 years
447
48.9%
468
51.3%
457
50.2%
FLU A/California/7/09, 9-17 years
275
30.1%
267
29.3%
276
30.3%
FLU A/Victoria/210/09, 3-8 years
367
40.1%
365
40%
376
41.3%
FLU A/Victoria/210/09, 9-17 years
204
22.3%
213
23.4%
199
21.8%
FLU B/Brisbane/60/08, 3-8 years
364
39.8%
367
40.2%
154
16.9%
FLU B/Brisbane/60/08, 9-17 years
189
20.7%
193
21.2%
83
9.1%
FLU B/Brisbane/3/07, 3-8 years
376
41.1%
203
22.3%
403
44.2%
FLU B/Brisbane/3/07, 9-17 years
197
21.5%
100
11%
163
17.9%
6. Secondary Outcome
Title Number of Seroconverted Subjects Against 4 Strains of Influenza Disease by Age Strata.
Description 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)

Outcome Measure Data

Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
Arm/Group Title GSK2321138A 2 Group
Arm/Group Description 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.
Measure Participants 232
FLU A/California/7/09, 6-17 months
43
4.7%
FLU A/California/7/09, 18-35 months
138
15.1%
FLU A/Victoria/210/09, 6-17 months
37
4%
FLU A/Victoria/210/09, 18-35 months
122
13.3%
FLU B/Brisbane/60/08, 6-17 months
36
3.9%
FLU B/Brisbane/60/08, 18-35 months
122
13.3%
FLU B/Brisbane/3/07, 6-17 months
52
5.7%
FLU B/Brisbane/3/07, 18-35 months
139
15.2%
7. Secondary Outcome
Title Number of Seroprotected Subjects Against 4 Strains of Influenza Disease
Description 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]

Outcome Measure Data

Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
Arm/Group Title GSK2321138A 1 Group Fluarix Group GSK2604409A Group GSK2321138A 2 Group
Arm/Group Description 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. 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. 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. 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.
Measure Participants 791 819 801 234
FLU A/California/7/09, PRE
343
37.5%
404
44.3%
353
38.7%
60
21.7%
FLU A/California/7/09, POST
764
83.5%
793
87%
778
85.4%
187
67.5%
FLU A/Victoria/210/09, PRE
381
41.6%
412
45.2%
409
44.9%
34
12.3%
FLU A/Victoria/210/09, POST
775
84.7%
800
87.7%
773
84.9%
169
61%
FLU B/Brisbane/60/08, PRE
381
41.6%
396
43.4%
399
43.8%
28
10.1%
FLU B/Brisbane/60/08, POST
770
84.2%
790
86.6%
639
70.1%
167
60.3%
FLU B/Brisbane/3/07, PRE
565
61.7%
575
63%
593
65.1%
48
17.3%
FLU B/Brisbane/3/07, POST
785
85.8%
772
84.6%
798
87.6%
212
76.5%
8. Secondary Outcome
Title Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
Description 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]

Outcome Measure Data

Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
Arm/Group Title GSK2321138A 1 Group Fluarix Group GSK2604409A Group
Arm/Group Description 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. 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. 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.
Measure Participants 791 819 801
FLU A/Cal/7/09, PRE, 3-8 years
206
22.5%
234
25.7%
230
25.2%
FLU A/Cal/7/09, POST, 3-8 years
469
51.3%
491
53.8%
487
53.5%
FLU A/Cal/7/09, PRE, 9-17 years
137
15%
170
18.6%
123
13.5%
FLU A/Cal/7/09, POST, 9-17 years
295
32.2%
302
33.1%
291
31.9%
FLU A/Vic/210/09, PRE, 3-8 years
253
27.7%
277
30.4%
269
29.5%
FLU A/Vic/210/09, POST, 3-8 years
477
52.1%
496
54.4%
481
52.8%
FLU A/Vic/210/09, PRE, 9-17 years
128
14%
135
14.8%
140
15.4%
FLU A/Vic/210/09, POST, 9-17 years
298
32.6%
304
33.3%
292
32.1%
FLU B/Bri/60/08, PRE, 3-8 years
217
23.7%
218
23.9%
232
25.5%
FLU B/Bri/60/08, POST, 3-8 years
478
52.2%
489
53.6%
378
41.5%
FLU B/Bri/60/08, PRE, 9-17 years
164
17.9%
178
19.5%
167
18.3%
FLU B/Bri/60/08, POST, 9-17 years
292
31.9%
301
33%
261
28.6%
FLU B/Bri/3/07, PRE, 3-8 years
315
34.4%
309
33.9%
329
36.1%
FLU B/Bri/3/07, POST, 3-8 years
485
53%
465
51%
503
55.2%
FLU B/Bri/3/07, PRE, 9-17 years
250
27.3%
266
29.2%
264
29%
FLU B/Bri/3/07, POST, 9-17 years
300
32.8%
307
33.7%
295
32.4%
9. Secondary Outcome
Title Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
Description 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]

Outcome Measure Data

Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
Arm/Group Title GSK2321138A 2 Group
Arm/Group Description 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.
Measure Participants 234
FLU A/Cal/7/09, PRE, 6-17 months
6
0.7%
FLU A/Cal/7/09, POST, 6-17 months
45
4.9%
FLU A/Cal/7/09, PRE, 18-35 months
54
5.9%
FLU A/Cal/7/09, POST, 18-35 months
142
15.5%
FLU A/Vic/210/09, PRE, 6-17 months
4
0.4%
FLU A/Vic/210/09, POST, 6-17 months
39
4.3%
FLU A/Vic/210/09, PRE, 18-35 months
30
3.3%
FLU A/Vic/210/09, POST, 18-35 months
130
14.2%
FLU B/Bri/60/08, PRE, 6-17 months
1
0.1%
FLU B/Bri/60/08, POST, 6-17 months
38
4.2%
FLU B/Bri/60/08, PRE, 18-35 months
27
3%
FLU B/Bri/60/08, POST, 18-35 months
129
14.1%
FLU B/Bri/3/07, PRE, 6-17 months
11
1.2%
FLU B/Bri/3/07, POST, 6-17 months
61
6.7%
FLU B/Bri/3/07, PRE, 18-35 months
37
4%
FLU B/Bri/3/07, POST, 18-35 months
151
16.5%
10. Secondary Outcome
Title Number of Seroprotected Subjects Against 4 Strains of Influenza.
Description 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]

Outcome Measure Data

Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
Arm/Group Title GSK2321138A 1 Group Fluarix Group GSK2604409A Group GSK2321138A 2 Group
Arm/Group Description 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. 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. 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. 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.
Measure Participants 791 819 801 234
FLU A/California/7/09, PRE
201
22%
218
23.9%
202
22.2%
49
17.7%
FLU A/California/7/09, POST
732
80%
763
83.7%
744
81.7%
155
56%
FLU A/Victoria/210/09, PRE
228
24.9%
245
26.9%
267
29.3%
27
9.7%
FLU A/Victoria/210/09, POST
721
78.8%
748
82%
721
79.1%
125
45.1%
FLU B/Brisbane/60/08, PRE
244
26.7%
258
28.3%
269
29.5%
18
6.5%
FLU B/Brisbane/60/08, POST
708
77.4%
733
80.4%
488
53.6%
140
50.5%
FLU B/Brisbane/3/07, PRE
454
49.6%
462
50.7%
476
52.3%
24
8.7%
FLU B/Brisbane/3/07, POST
779
85.1%
692
75.9%
784
86.1%
175
63.2%
11. Secondary Outcome
Title Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
Description 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]

Outcome Measure Data

Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
Arm/Group Title GSK2321138A 1 Group Fluarix Group GSK2604409A Group
Arm/Group Description 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. 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. 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.
Measure Participants 791 819 801
FLU A/Cal/7/09, PRE, 3-8 years
130
14.2%
128
14%
141
15.5%
FLU A/Cal/7/09, POST, 3-8 years
453
49.5%
471
51.6%
464
50.9%
FLU A/Cal/7/09, PRE, 9-17 years
71
7.8%
90
9.9%
61
6.7%
FLU A/Cal/7/09, POST, 9-17 years
279
30.5%
292
32%
280
30.7%
FLU A/Vic/210/09, PRE, 3-8 years
156
17%
177
19.4%
190
20.9%
FLU A/Vic/210/09, POST, 3-8 years
446
48.7%
462
50.7%
446
49%
FLU A/Vic/210/09, PRE, 9-17 years
72
7.9%
68
7.5%
77
8.5%
FLU A/Vic/210/09, POST, 9-17 years
275
30.1%
286
31.4%
275
30.2%
FLU B/Bri/60/08, PRE, 3-8 years
145
15.8%
140
15.4%
150
16.5%
FLU B/Bri/60/08, POST, 3-8 years
430
47%
441
48.4%
286
31.4%
FLU B/Bri/60/08, PRE, 9-17 years
99
10.8%
118
12.9%
119
13.1%
FLU B/Bri/60/08, POST, 9-17 years
278
30.4%
292
32%
202
22.2%
FLU B/Bri/3/07, PRE, 3-8 years
233
25.5%
227
24.9%
248
27.2%
FLU B/Bri/3/07, POST, 3-8 years
480
52.5%
395
43.3%
493
54.1%
FLU B/Bri/3/07, PRE, 9-17 years
221
24.2%
235
25.8%
228
25%
FLU B/Bri/3/07, POST, 9-17 years
299
32.7%
297
32.6%
291
31.9%
12. Secondary Outcome
Title Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
Description 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]

Outcome Measure Data

Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
Arm/Group Title GSK2321138A 2 Group
Arm/Group Description 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.
Measure Participants 234
FLU A/California/7/09, PRE, 6-17 months
6
0.7%
FLU A/California/7/09, POST, 6-17 months
31
3.4%
FLU A/California/7/09, PRE, 18-35 months
43
4.7%
FLU A/California/7/09, POST, 18-35 months
124
13.6%
FLU A/Victoria/210/09, PRE, 6-17 months
4
0.4%
FLU A/Victoria/210/09, POST, 6-17 months
18
2%
FLU A/Victoria/210/09, PRE, 18-35 months
23
2.5%
FLU A/Victoria/210/09, POST, 18-35 months
107
11.7%
FLU B/Brisbane/60/08, PRE, 6-17 months
0
0%
FLU B/Brisbane/60/08, POST, 6-17 months
25
2.7%
FLU B/Brisbane/60/08, PRE, 18-35 months
18
2%
FLU B/Brisbane/60/08, POST, 18-35 months
115
12.6%
FLU B/Brisbane/3/07, PRE, 6-17 months
4
0.4%
FLU B/Brisbane/3/07, POST, 6-17 months
43
4.7%
FLU B/Brisbane/3/07, PRE, 18-35 months
20
2.2%
FLU B/Brisbane/3/07, POST, 18-35 months
132
14.4%
13. Secondary Outcome
Title Number of Seroprotected Subjects Against 4 Strains of Influenza Disease.
Description 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]

Outcome Measure Data

Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
Arm/Group Title GSK2321138A 1 Group Fluarix Group GSK2604409A Group GSK2321138A 2 Group
Arm/Group Description 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. 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. 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. 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.
Measure Participants 791 819 801 234
FLU A/California/7/09, PRE
71
7.8%
92
10.1%
79
8.7%
28
10.1%
FLU A/California/7/09, POST
669
73.1%
720
78.9%
690
75.7%
122
44%
FLU A/Victoria/210/09, PRE
103
11.3%
124
13.6%
121
13.3%
15
5.4%
FLU A/Victoria/210/09, POST
597
65.2%
597
65.5%
599
65.8%
82
29.6%
FLU B/Brisbane/60/08, PRE
123
13.4%
126
13.8%
148
16.2%
9
3.2%
FLU B/Brisbane/60/08, POST
578
63.2%
607
66.6%
300
32.9%
83
30%
FLU B/Brisbane/3/07, PRE
300
32.8%
324
35.5%
327
35.9%
7
2.5%
FLU B/Brisbane/3/07, POST
730
79.8%
564
61.8%
756
83%
129
46.6%
14. Secondary Outcome
Title Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
Description 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]

Outcome Measure Data

Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
Arm/Group Title GSK2321138A 1 Group Fluarix Group GSK2604409A Group
Arm/Group Description 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. 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. 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.
Measure Participants 791 819 801
FLU A/Cal/7/09, PRE, 3-8 years
47
5.1%
56
6.1%
57
6.3%
FLU A/Cal/7/09, POST, 3-8 years
410
44.8%
442
48.5%
428
47%
FLU A/Cal/7/09, PRE, 9-17 years
24
2.6%
36
3.9%
22
2.4%
FLU A/Cal/7/09, POST, 9-17 years
259
28.3%
278
30.5%
262
28.8%
FLU A/Vic/210/09, PRE, 3-8 years
70
7.7%
92
10.1%
87
9.5%
FLU A/Vic/210/09, POST, 3-8 years
380
41.5%
385
42.2%
390
42.8%
FLU A/Vic/210/09, PRE, 9-17 years
33
3.6%
32
3.5%
34
3.7%
FLU A/Vic/210/09, POST, 9-17 years
217
23.7%
212
23.2%
209
22.9%
FLU B/Bri/60/08, PRE, 3-8 years
75
8.2%
66
7.2%
82
9%
FLU B/Bri/60/08, POST, 3-8 years
349
38.1%
357
39.1%
174
19.1%
FLU B/Bri/60/08, PRE, 9-17 years
48
5.2%
60
6.6%
66
7.2%
FLU B/Bri/60/08, POST, 9-17 years
229
25%
250
27.4%
126
13.8%
FLU B/Bri/3/07, PRE, 3-8 years
135
14.8%
155
17%
150
16.5%
FLU B/Bri/3/07, POST, 3-8 years
444
48.5%
301
33%
473
51.9%
FLU B/Bri/3/07, PRE, 9-17 years
165
18%
169
18.5%
177
19.4%
FLU B/Bri/3/07, POST, 9-17 years
286
31.3%
263
28.8%
283
31.1%
15. Secondary Outcome
Title Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.
Description 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]

Outcome Measure Data

Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
Arm/Group Title GSK2321138A 2 Group
Arm/Group Description 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.
Measure Participants 234
FLU A/California/7/09, PRE, 6-17 months
5
0.5%
FLU A/California/7/09, POST, 6-17 months
18
2%
FLU A/California/7/09, PRE, 18-35 months
23
2.5%
FLU A/California/7/09, POST, 18-35 months
104
11.4%
FLU A/Victoria/210/09, PRE, 6-17 months
3
0.3%
FLU A/Victoria/210/09, POST, 6-17 months
11
1.2%
FLU A/Victoria/210/09, PRE, 18-35 months
12
1.3%
FLU A/Victoria/210/09, POST, 18-35 months
71
7.8%
FLU B/Brisbane/60/08, PRE, 6-17 months
0
0%
FLU B/Brisbane/60/08, POST, 6-17 months
7
0.8%
FLU B/Brisbane/60/08, PRE, 18-35 months
9
1%
FLU B/Brisbane/60/08, POST, 18-35 months
76
8.3%
FLU B/Brisbane/3/07, PRE, 6-17 months
1
0.1%
FLU B/Brisbane/3/07, POST, 6-17 months
25
2.7%
FLU B/Brisbane/3/07, PRE, 18-35 months
6
0.7%
FLU B/Brisbane/3/07, POST, 18-35 months
104
11.4%
16. Secondary Outcome
Title Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.
Description 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)

Outcome Measure Data

Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
Arm/Group Title GSK2321138A 1 Group Fluarix Group GSK2604409A Group GSK2321138A 2 Group
Arm/Group Description 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. 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. 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. 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.
Measure Participants 790 818 800 232
FLU A/California/7/09
18.0
17.4
19.2
11.7
FLU A/Victoria/210/09
7.9
7.2
7.5
10.4
FLU B/Brisbane/60/08
7.9
7.9
2.7
9.7
FLU B/Brisbane/3/07
7.4
2.9
7.6
12.9
17. Secondary Outcome
Title Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.
Description 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)

Outcome Measure Data

Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
Arm/Group Title GSK2321138A 1 Group Fluarix Group GSK2604409A Group
Arm/Group Description 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. 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. 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.
Measure Participants 790 818 800
FLU A/California/7/09, 3-8 years
17.2
17.2
17.2
FLU A/California/7/09, 9-17 years
19.2
17.7
23.3
FLU A/Victoria/210/09, 3-8 years
8.4
7.3
7.8
FLU A/Victoria/210/09, 9-17 years
7.2
7.1
7.1
FLU B/Brisbane/60/08, 3-8 years
8.8
8.8
2.8
FLU B/Brisbane/60/08, 9-17 years
6.7
6.6
2.4
FLU B/Brisbane/3/07, 3-8 years
8.8
3.1
9.9
FLU B/Brisbane/3/07, 9-17 years
5.6
2.5
4.9
18. Secondary Outcome
Title Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.
Description 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)

Outcome Measure Data

Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
Arm/Group Title GSK2321138A 2 Group
Arm/Group Description 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.
Measure Participants 232
FLU A/California/7/09, 6-17 months
8.2
FLU A/California/7/09, 18-35 months
13.7
FLU A/Victoria/210/09, 6-17 months
7.3
FLU A/Victoria/210/09, 18-35 months
12.1
FLU B/Brisbane/60/08, 6-17 months
6.9
FLU B/Brisbane/60/08, 18-35 months
11.3
FLU B/Brisbane/3/07, 6-17 months
9.5
FLU B/Brisbane/3/07, 18-35 months
14.8
19. Secondary Outcome
Title Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
Description 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.

Outcome Measure Data

Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, on vaccinated subjects with available results and with the symptom completed.
Arm/Group Title GSK2321138A 1 Group Fluarix Group GSK2604409A Group GSK2321138A 2 Group
Arm/Group Description 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. 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. 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. 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.
Measure Participants 903 902 906 277
Any Pain
444
48.5%
425
46.6%
416
45.7%
116
41.9%
Grade 3 Pain
20
2.2%
21
2.3%
13
1.4%
5
1.8%
Any Redness
225
24.6%
214
23.5%
206
22.6%
100
36.1%
Grade 3 Redness
12
1.3%
3
0.3%
6
0.7%
1
0.4%
Any Swelling
196
21.4%
193
21.2%
160
17.6%
67
24.2%
Grade 3 Swelling
11
1.2%
10
1.1%
3
0.3%
0
0%
20. Secondary Outcome
Title Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Younger Than 6 Years Old.
Description 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.

Outcome Measure Data

Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, on vaccinated subjects with available results and with the symptom sheet completed.
Arm/Group Title GSK2321138A 1 Group Fluarix Group GSK2604409A Group GSK2321138A 2 Group
Arm/Group Description 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. 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. 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. 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.
Measure Participants 291 314 280 277
Any Drowsiness
67
7.3%
55
6%
59
6.5%
84
30.3%
Grade 3 Drowsiness
5
0.5%
3
0.3%
2
0.2%
7
2.5%
Related Drowsiness
44
4.8%
31
3.4%
36
4%
57
20.6%
Any Irritability
65
7.1%
56
6.1%
53
5.8%
119
43%
Grade 3 Irritability
4
0.4%
2
0.2%
3
0.3%
11
4%
Related Irritability
44
4.8%
37
4.1%
31
3.4%
81
29.2%
Any Loss of appetite
59
6.4%
40
4.4%
47
5.2%
83
30%
Grade 3 Loss of appetite
3
0.3%
3
0.3%
3
0.3%
12
4.3%
Related Loss of appetite
37
4%
24
2.6%
25
2.7%
50
18.1%
Temperature ≥37.5°C
50
5.5%
51
5.6%
41
4.5%
81
29.2%
Temperature >39°C
4
0.4%
2
0.2%
3
0.3%
18
6.5%
Related Temperature
24
2.6%
29
3.2%
16
1.8%
37
13.4%
21. Secondary Outcome
Title Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older.
Description 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.

Outcome Measure Data

Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, on vaccinated subjects with available results and with the symptom sheet completed.
Arm/Group Title GSK2321138A 1 Group Fluarix Group GSK2604409A Group
Arm/Group Description 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. 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. 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.
Measure Participants 613 589 626
Any Fatigue
129
14.1%
118
12.9%
114
12.5%
Grade 3 Fatigue
9
1%
8
0.9%
4
0.4%
Related Fatigue
95
10.4%
81
8.9%
76
8.3%
Any Gastro.
66
7.2%
62
6.8%
52
5.7%
Grade 3 Gastro.
7
0.8%
4
0.4%
2
0.2%
Related Gastro.
31
3.4%
29
3.2%
26
2.9%
Any Headache
110
12%
125
13.7%
114
12.5%
Grade 3 Headache
8
0.9%
4
0.4%
5
0.5%
Related Headache
66
7.2%
75
8.2%
71
7.8%
Any Joint Pain
69
7.5%
63
6.9%
51
5.6%
Grade 3 Joint Pain
2
0.2%
4
0.4%
2
0.2%
Related Joint Pain
44
4.8%
43
4.7%
36
4%
Any Muscle aches
116
12.7%
106
11.6%
106
11.6%
Grade 3 Muscle aches
4
0.4%
8
0.9%
3
0.3%
Related Muscle aches
84
9.2%
81
8.9%
87
9.5%
Any Shivering
44
4.8%
31
3.4%
37
4.1%
Grade 3 Shivering
3
0.3%
3
0.3%
1
0.1%
Related Shivering
27
3%
23
2.5%
22
2.4%
Temperature ≥37.5°C
48
5.2%
60
6.6%
47
5.2%
Temperature >39°C
7
0.8%
5
0.5%
3
0.3%
Related Temperature
25
2.7%
30
3.3%
32
3.5%
22. Secondary Outcome
Title Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
Description 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.

Outcome Measure Data

Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, on vaccinated subjects with available results.
Arm/Group Title GSK2321138A 1 Group Fluarix Group GSK2604409A Group GSK2321138A 2 Group
Arm/Group Description 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. 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. 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. 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.
Measure Participants 915 912 911 277
Subjects with any AE(s)
284
31%
305
33.4%
308
33.8%
167
60.3%
Subjects with grade 3 AE(s)
20
2.2%
37
4.1%
26
2.9%
20
7.2%
Subjects with related AE(s)
18
2%
19
2.1%
23
2.5%
5
1.8%
23. Secondary Outcome
Title Number of Subjects With Any, Grade 3 and Related Medically Attended Adverse Events (MAEs).
Description 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)

Outcome Measure Data

Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, on vaccinated subjects with available results.
Arm/Group Title GSK2321138A 1 Group Fluarix Group GSK2604409A Group GSK2321138A 2 Group
Arm/Group Description 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. 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. 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. 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.
Measure Participants 915 912 911 277
Subjects with any MAE(s)
271
29.6%
278
30.5%
303
33.3%
171
61.7%
Subjects with related MAE(s)
2
0.2%
4
0.4%
4
0.4%
2
0.7%
Subjects with Grade 3 MAE(s)
NA
NaN
NA
NaN
NA
NaN
NA
NaN
24. Secondary Outcome
Title Number of Subjects With Any and Related Potential Immune-Mediated Diseases (pIMDs).
Description 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)

Outcome Measure Data

Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, on vaccinated subjects with available results
Arm/Group Title GSK2321138A 1 Group Fluarix Group GSK2604409A Group GSK2321138A 2 Group
Arm/Group Description 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. 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. 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. 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.
Measure Participants 915 912 911 277
Subjects with any pIMD(s)
0
0%
0
0%
2
0.2%
0
0%
Subjects with related pIMD(s)
0
0%
0
0%
0
0%
0
0%
25. Secondary Outcome
Title Number of Subjects With Any and Related Serious Adverse Events (SAEs).
Description 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)

Outcome Measure Data

Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, on vaccinated subjects with available results.
Arm/Group Title GSK2321138A 1 Group Fluarix Group GSK2604409A Group GSK2321138A 2 Group
Arm/Group Description 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. 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. 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. 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.
Measure Participants 915 912 911 277
Subjects with any SAE(s)
8
0.9%
6
0.7%
7
0.8%
9
3.2%
Subjects with related SAE(s)
0
0%
0
0%
0
0%
0
0%
26. Secondary Outcome
Title Number of Days With Solicited Local Symptoms.
Description 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.

Outcome Measure Data

Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, on vaccinated subjects with available results and with the symptom sheet completed.
Arm/Group Title GSK2321138A 1 Group Fluarix Group GSK2604409A Group GSK2321138A 2 Group
Arm/Group Description 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. 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. 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. 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.
Measure Participants 395 382 365 94
Pain, Dose 1
2.0
2.0
2.0
1.0
Pain, Dose 2
2.0
2.0
2.0
2.0
Redness, Dose 1
2.0
2.0
2.0
2.0
Redness, Dose 2
2.0
2.0
2.0
2.0
Swelling, Dose 1
2.0
2.0
2.0
2.0
Swelling, Dose 2
2.0
2.0
2.0
2.0
27. Secondary Outcome
Title Number of Days With Solicited General Symptoms
Description 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.

Outcome Measure Data

Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, on vaccinated subjects with available results and with the symptom sheet completed.
Arm/Group Title GSK2321138A 1 Group Fluarix Group GSK2604409A Group GSK2321138A 2 Group
Arm/Group Description 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. 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. 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. 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.
Measure Participants 121 113 99 79
Drowsiness, Dose 1
1.0
1.0
2.0
1.0
Drowsiness, Dose 2
2.0
1.0
1.0
2.0
Fatigue, Dose 1
2.0
2.0
2.0
NA
Fatigue, Dose 2
1.0
2.0
1.0
NA
Gastro., Dose 1
1.0
2.0
2.0
NA
Gastro., Dose 2
1.0
2.0
1.0
NA
Headache, Dose 1
1.0
1.0
1.0
NA
Headache, Dose 2
1.0
1.0
1.0
NA
Irritability, Dose 1
2.0
2.0
2.0
2.0
Irritability, Dose 2
2.0
1.0
2.0
2.0
Joint pain, Dose 1
2.0
2.0
2.0
NA
Joint pain, Dose 2
1.0
1.0
1.5
NA
Loss of appetite, Dose 1
1.0
2.0
2.0
3.0
Loss of appetite, Dose 2
3.0
1.0
2.0
3.0
Muscle aches, Dose 1
2.0
2.0
2.0
NA
Muscle aches, Dose 2
2.0
2.0
2.0
NA
Shivering, Dose 1
1.0
2.0
1.0
NA
Shivering, Dose 2
1.0
1.5
2.0
NA
Temperature, Dose 1
1.0
1.5
2.0
1.0
Temperature, Dose 2
1.5
1.5
2.0
2.0

Adverse Events

Time Frame 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.
Adverse Event Reporting Description No reported SAE was assessed as related to study vaccination. For systematically assessed other AEs, the number of participants at risk included those from Total Vaccinated cohort with symptom sheet completed.
Arm/Group Title GSK2321138A 1 Group Fluarix Group GSK2604409A Group GSK2321138A 2 Group
Arm/Group Description 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. 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. 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. 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.
All Cause Mortality
GSK2321138A 1 Group Fluarix Group GSK2604409A Group GSK2321138A 2 Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total / (NaN) / (NaN) / (NaN) / (NaN)
Serious Adverse Events
GSK2321138A 1 Group Fluarix Group GSK2604409A Group GSK2321138A 2 Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 8/915 (0.9%) 6/912 (0.7%) 7/911 (0.8%) 9/277 (3.2%)
Blood and lymphatic system disorders
Lymphadenitis 1/915 (0.1%) 0/912 (0%) 0/911 (0%) 0/277 (0%)
Cardiac disorders
Atrioventricular block first degree 1/915 (0.1%) 0/912 (0%) 0/911 (0%) 0/277 (0%)
Myocarditis 1/915 (0.1%) 0/912 (0%) 0/911 (0%) 0/277 (0%)
Infections and infestations
Amoebiasis 0/915 (0%) 0/912 (0%) 0/911 (0%) 1/277 (0.4%)
Appendicitis 0/915 (0%) 0/912 (0%) 1/911 (0.1%) 0/277 (0%)
Bronchiolitis 0/915 (0%) 0/912 (0%) 0/911 (0%) 1/277 (0.4%)
Bronchitis 0/915 (0%) 0/912 (0%) 0/911 (0%) 3/277 (1.1%)
Bronchopneumonia 0/915 (0%) 0/912 (0%) 0/911 (0%) 2/277 (0.7%)
Dengue fever 0/915 (0%) 2/912 (0.2%) 0/911 (0%) 0/277 (0%)
Gastroenteritis 0/915 (0%) 0/912 (0%) 0/911 (0%) 2/277 (0.7%)
Gastroenteritis bacterial 1/915 (0.1%) 0/912 (0%) 0/911 (0%) 0/277 (0%)
Gastroenteritis rotavirus 0/915 (0%) 0/912 (0%) 1/911 (0.1%) 0/277 (0%)
Gastroenteritis viral 0/915 (0%) 0/912 (0%) 0/911 (0%) 1/277 (0.4%)
Infectious mononucleosis 1/915 (0.1%) 0/912 (0%) 0/911 (0%) 0/277 (0%)
Otitis media acute 1/915 (0.1%) 0/912 (0%) 0/911 (0%) 0/277 (0%)
Peritonsillar abscess 1/915 (0.1%) 0/912 (0%) 0/911 (0%) 0/277 (0%)
Pneumococcal sepsis 0/915 (0%) 0/912 (0%) 0/911 (0%) 1/277 (0.4%)
Pneumonia 0/915 (0%) 2/912 (0.2%) 0/911 (0%) 0/277 (0%)
Respiratory syncytial virus infection 0/915 (0%) 0/912 (0%) 0/911 (0%) 1/277 (0.4%)
Tonsillitis 1/915 (0.1%) 0/912 (0%) 0/911 (0%) 1/277 (0.4%)
Injury, poisoning and procedural complications
Abdominal injury 0/915 (0%) 1/912 (0.1%) 0/911 (0%) 0/277 (0%)
Concussion 3/915 (0.3%) 0/912 (0%) 2/911 (0.2%) 0/277 (0%)
Road traffic accident 0/915 (0%) 1/912 (0.1%) 0/911 (0%) 0/277 (0%)
Metabolism and nutrition disorders
Diabetic ketoacidosis 0/915 (0%) 0/912 (0%) 1/911 (0.1%) 0/277 (0%)
Type 1 diabetes mellitus 0/915 (0%) 0/912 (0%) 1/911 (0.1%) 0/277 (0%)
Nervous system disorders
Epilepsy 0/915 (0%) 0/912 (0%) 0/911 (0%) 1/277 (0.4%)
Febrile convulsion 0/915 (0%) 0/912 (0%) 0/911 (0%) 2/277 (0.7%)
Psychiatric disorders
Suicidal ideation 1/915 (0.1%) 0/912 (0%) 1/911 (0.1%) 0/277 (0%)
Skin and subcutaneous tissue disorders
Rash 0/915 (0%) 1/912 (0.1%) 1/911 (0.1%) 0/277 (0%)
Other (Not Including Serious) Adverse Events
GSK2321138A 1 Group Fluarix Group GSK2604409A Group GSK2321138A 2 Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 630/915 (68.9%) 616/912 (67.5%) 620/911 (68.1%) 237/277 (85.6%)
General disorders
Pyrexia 23/915 (2.5%) 23/912 (2.5%) 28/911 (3.1%) 18/277 (6.5%)
Fatigue 129/613 (21%) 118/589 (20%) 114/626 (18.2%) 0/277 (0%)
Gastrointestinal 66/613 (10.8%) 62/589 (10.5%) 52/626 (8.3%) 0/277 (0%)
Headache 110/613 (17.9%) 125/589 (21.2%) 114/626 (18.2%) 0/277 (0%)
Joint Pain 69/613 (11.3%) 63/589 (10.7%) 51/626 (8.1%) 0/277 (0%)
Muscle aches 116/613 (18.9%) 106/589 (18%) 106/626 (16.9%) 0/277 (0%)
Temperature (Axillary) 48/613 (7.8%) 60/589 (10.2%) 47/626 (7.5%) 0/277 (0%)
Irritability 65/291 (22.3%) 56/314 (17.8%) 53/280 (18.9%) 119/277 (43%)
Drowsiness 67/291 (23%) 55/314 (17.5%) 59/280 (21.1%) 84/277 (30.3%)
Loss of appetite 59/291 (20.3%) 40/314 (12.7%) 47/280 (16.8%) 83/277 (30%)
Pain 444/903 (49.2%) 425/902 (47.1%) 416/906 (45.9%) 116/277 (41.9%)
Redness 225/903 (24.9%) 214/902 (23.7%) 206/906 (22.7%) 100/277 (36.1%)
Swelling 196/903 (21.7%) 193/902 (21.4%) 160/906 (17.7%) 67/277 (24.2%)
Temperature (Axillary) 50/291 (17.2%) 51/314 (16.2%) 41/280 (14.6%) 81/277 (29.2%)
Shivering 44/613 (7.2%) 31/589 (5.3%) 37/626 (5.9%) 0/277 (0%)
Infections and infestations
Nasopharyngitis 49/915 (5.4%) 60/912 (6.6%) 64/911 (7%) 37/277 (13.4%)
Upper respiratory tract infection 48/915 (5.2%) 51/912 (5.6%) 46/911 (5%) 26/277 (9.4%)
Bronchitis 13/915 (1.4%) 5/912 (0.5%) 12/911 (1.3%) 29/277 (10.5%)
Respiratory, thoracic and mediastinal disorders
Cough 40/915 (4.4%) 36/912 (3.9%) 45/911 (4.9%) 21/277 (7.6%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

Results Point of Contact

Name/Title GSK Response Center
Organization GlaxoSmithKline
Phone 866-435-7343
Email
Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01196988
Other Study ID Numbers:
  • 113275
First Posted:
Sep 9, 2010
Last Update Posted:
Sep 21, 2018
Last Verified:
Mar 1, 2017