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A Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Seasonal Influenza Vaccine in Children

Sponsor
GlaxoSmithKline (Industry)
Overall Status
Completed
CT.gov ID
NCT01198756
Collaborator
(none)
3,109
Enrollment
33
Locations
4
Arms
9
Duration (Months)
94.2
Patients Per Site
10.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is designed to test the immunogenicity and safety of an investigational influenza vaccine, in children compared to two other influenza vaccines.

Condition or Disease Intervention/Treatment Phase
  • Biological: Quadrivalent seasonal influenza vaccine GSK2282512A
  • Biological: Fluarix™ VB
  • Biological: Fluarix™ YB
  • Biological: Quadrivalent seasonal influenza vaccine GSK2282512A
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
3109 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Prevention
Official Title:
Immunogenicity and Safety Study of GSK Biologicals' Quadrivalent Influenza Vaccine (GSK2282512A) When Administered in Children
Study Start Date :
Oct 1, 2010
Actual Primary Completion Date :
Jul 1, 2011
Actual Study Completion Date :
Jul 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: GSK2282512A 1 Group

Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Biological: Quadrivalent seasonal influenza vaccine GSK2282512A
For subject 3 to 8 years of age, single intramuscular dose for primed subjects, two doses for unprimed subjects. For subjects 9 to 17 years of age, single intramuscular dose.
Active Comparator: Victoria strain Fluarix Group

Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Biological: Fluarix™ VB
For subject 3 to 8 years of age, single intramuscular dose for primed subjects, two doses for unprimed subjects. For subjects of 9 to 17 years of age, single intramuscular dose.
Active Comparator: Yamagata strain Fluarix Group

Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Biological: Fluarix™ YB
For subject 3 to 8 years of age, single intramuscular dose for primed subjects, two doses for unprimed subjects. For subjects of 9 to 17 years of age, single intramuscular dose
Experimental: GSK2282512A 2 Group

Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.

Biological: Quadrivalent seasonal influenza vaccine GSK2282512A
Single intramuscular dose for primed subjects, two doses for unprimed subjects.

Outcome Measures

Primary Outcome Measures

  1. Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease [At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)]

    Titers are presented as geometric mean titers (GMTs). The reference cut-off value was the seropositivity cut-off of 1:10. Antibodies assessed were antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains.

  2. Number of Subjects Seroconverted Against 4 Strains of Influenza Disease [At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)]

    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 vaccine strains assessed were the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains.

Secondary Outcome Measures

  1. Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease [At Day 0 and at 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)]

    Titers are presented as geometric mean titers (GMTs). The reference cut-off value was the seropositivity cut-off of 1:10. Antibodies assessed were antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains.

  2. Number of Subjects Seroprotected Against 4 Strains of Influenza Disease [At Day 0 and at 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)]

    A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition titer ≥ 1:40. The 4 assessed influenza strains were the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 flu strains.

  3. Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease [At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)]

    The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination (at Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects (POST)) compared to Day 0 (i.e. the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer). The 4 assessed influenza strains were the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains

  4. Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease - By Age Strata [At Day 0 and at 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)]

    Titers are presented as geometric mean titers (GMTs). The reference cut-off value was the seropositivity cut-off of 1:10. Antibodies assessed were antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains. Subjects were assessed according to 3 age categories, 3-8 years, 9-17 years and 6-35 months.

  5. Number of Subjects Seroconverted Against 4 Strains of Influenza Disease - By Age Strata [At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)]

    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 vaccine strains assessed were A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains. Subjects were assessed according to 3 age categories, 3-8 years, 9-17 years and 6-35 months.

  6. Number of Subjects Seroprotected Against 4 Strains of Influenza Disease - By Age Strata [At Day 0 and at 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)]

    A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition titer ≥ 1:40. The 4 assessed influenza strains were the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 flu strains. Subjects were assessed according to 3 age categories, 3-8 years, 9-17 years and 6-35 months.

  7. Seroconversion Factor for Hemagglutination Inhibition Antibodies Against 4 Strains of Influenza Disease - By Age Strata [At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)]

    The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0 (i.e. the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer). The 4 assessed influenza strains were the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains. Subjects were assessed according to 3 age categories, 3-8 years, 9-17 years and 6-35 months.

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

    Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity grade. Grade 3 pain for subjects < 5 years of age = Cried when limb was moved/spontaneously painful; Grade 3 pain for subjects ≥ 5 years of age = Significant pain at rest, pain that preventeded normal everyday activities. Grade 3 redness and swelling were defined as redness/swelling above 100 millimeters (mm).

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

    Duration was assessed via tabulation of the number of days with local symptoms of any grade after vaccination with Dose 1 and Dose 2 respectively. Solicited local symptoms assessed for duration were pain, redness and swelling.

  10. Number of Subjects Below 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms [During the 7-day follow-up period (Days 0-6) after vaccination]

    Symptoms assessed were drowsiness, irritability, loss of appetite and temperature. Any = Incidence of a particular symptom regardless of intensity grade or relationship to vaccination. Any temperature = Axillary temperature ≥ 38.0 degrees Celsius (°C). Grade 3 temperature = Axillary temperature ≥ 39.0°C. Grade 3 irritability = Crying that could not be comforted/ preventing normal activity. Grade 3 drowsiness = Drowsiness preventing normal activity. Grade 3 loss of appetite = Not eating at all. Related = A general symptom assessed by the investigator as causally related to vaccination.

  11. Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms [During the 7-day follow-up period (Days 0-6) after vaccination]

    Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache, joint pain at other location, muscle aches, shivering and temperature. Any = Incidence of a particular symptom regardless of intensity grade or relationship to vaccination. Any temperature = axillary temperature ≥ 38.0 °C. Grade 3 temperature = axillary temperature ≥ 39.0°C. Grade 3 symptom = Symptom that prevented normal activity. Related = A general symptom assessed by the investigator as causally related to vaccination.

  12. Number of Days With Solicited General Symptoms After Vaccination in Subjects Below 5 Years of Age [During the 7-day follow-up period (Days 0-6) after vaccination]

    Duration was assessed via tabulation of the number of days with local symptoms of any grade after vaccination with Dose 1 and Dose 2, respectively. Solicited general symptoms assessed for duration in subjects below 5 years of age were drowsiness, irritability and loss of appetite.

  13. Number of Days With Solicited General Symptoms After Vaccination in Subjects 5 Years of Age and Above [During the 7-day follow-up period (Days 0-6) after vaccination]

    Duration was assessed via tabulation of the number of days with local symptoms of any grade after vaccination with Dose 1 and Dose 2, respectively. Solicited general symptoms assessed for duration in subjects 5 years of age and above were fatigue, gastrointestinal symptoms, headache, joint pain at other location, muscle aches and shivering.

  14. Number of Days With Fever in All Subjects Regardless of Their Age After Vaccination [During the 7-day follow-up period (Days 0-6) after vaccination]

    Duration for fever was assessed via tabulation of the number of days with local symptoms of fever (axillary temperature ≥ 38°C) after vaccination with Dose 1 and Dose 2, respectively.

  15. Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) [During the 28-day follow-up period (Day 0-27) after 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 unsolicited AE(s) = Occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 unsolicited AE = Occurrence of any unsolicited AE that prevented normal activities. Related unsolicited AE(s) = Occurrence of an unsolicited AE assessed by the investigator to be causally related to vaccination.

  16. Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs) After Vaccination [During the entire study period (from Day 0 to Day 180)]

    Potential immune-mediated diseases (pIMDs) are a subset of adverse events that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Any pIMD(s) = Occurrence of any pIMD(s) regardless of intensity grade or relation to vaccination. Related pIMD(s) = pIMD assessed by the investigator as causally related to the study vaccination.

  17. Number of Subjects With Any and Related Medically-attended Adverse Events (MAEs) After Vaccination [During the entire study period (from Day 0 to Day 180)]

    Medically-attended adverse events (MAEs) were non-serious and serious events leading to an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits. If a medically-attended adverse event was leading to hospitalization (or met any other criterion for serious adverse event (SAE)), it was reported as SAE. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.Relationship to vaccination was not assessed for MAEs.

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

    SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE(s) = Occurrence of any SAE(s) regardless of intensity grade or relation to vaccination. Related SAE(s)= Occurrence of any SAE(s) assessed by the investigator as causally related to vaccination.

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 they and/or their parent(s) or legally acceptable representative(s) can and will comply with the requirements of the protocol.

  • A male or female child aged between 6 months and 17 years inclusive at the time of the first vaccination; children are eligible regardless of history of administration of influenza vaccine in a previous season.

  • Written informed consent obtained from the subject/from the parent(s)/legally acceptable representative(s) of the subject.

  • Written informed assent obtained from the subject if/as required by local regulations.

  • Subjects in stable health as determined by investigator's clinical examination and assessment of subjects' medical history.

  • 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 pregnancy urine 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:

  • Child in care

  • Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.Prior receipt of any seasonal or pandemic influenza vaccine 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 six months prior to the first vaccine dose.

  • Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.

  • History of Guillain-Barré syndrome within 6 weeks of receipt of prior influenza vaccine.

  • Any known or suspected allergy to any constituent of influenza vaccines; a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.

  • Fever at the time of enrolment.

  • Acute disease at the time of enrolment.

  • Any significant disorder of coagulation or treatment with Coumadin derivatives or heparin.

  • Pregnant or lactating female.

  • Female planning to become pregnant or planning to discontinue contraceptive precautions.

  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.

  • Ongoing aspirin therapy.

  • Any other condition which, in the opinion of the Investigator, prevents the subject from participating in the study.

Contacts and Locations

Locations

Site City State Country Postal Code
1 GSK Investigational Site Chandler Arizona United States 85224
2 GSK Investigational Site Scottsdale Arizona United States 85288
3 GSK Investigational Site Harrisburg Arkansas United States 72432
4 GSK Investigational Site Little Rock Arkansas United States 72205
5 GSK Investigational Site Huntington Beach California United States 92647
6 GSK Investigational Site Paramount California United States 90723
7 GSK Investigational Site Centennial Colorado United States 80112
8 GSK Investigational Site Longmont Colorado United States 80501
9 GSK Investigational Site Thornton Colorado United States 80233
10 GSK Investigational Site Niles Michigan United States 49120
11 GSK Investigational Site Saint Louis Missouri United States 63141
12 GSK Investigational Site Omaha Nebraska United States 68131
13 GSK Investigational Site Hermitage Pennsylvania United States 16148
14 GSK Investigational Site Barnwell South Carolina United States 29812
15 GSK Investigational Site Clarksville Tennessee United States 37043
16 GSK Investigational Site Fort Worth Texas United States 76135
17 GSK Investigational Site Edmonton Alberta Canada T6G 2C8
18 GSK Investigational Site Surrey British Columbia Canada V3R 8P8
19 GSK Investigational Site Winnipeg Manitoba Canada R3A 1M3
20 GSK Investigational Site Mount Pearl Newfoundland and Labrador Canada A1N 5B6
21 GSK Investigational Site Halifax Nova Scotia Canada B3K 6R8
22 GSK Investigational Site Brampton Ontario Canada L6T 0G1
23 GSK Investigational Site Hamilton Ontario Canada L8L 5G8
24 GSK Investigational Site Sudbury Ontario Canada P3E 1H5
25 GSK Investigational Site Saskatoon Saskatchewan Canada S7K 3H3
26 GSK Investigational Site Monterrey Nuevo León Mexico 64460
27 GSK Investigational Site Mexico city Mexico 04530
28 GSK Investigational Site Alcala de Guadaira Spain 41500
29 GSK Investigational Site Madrid Spain 28046
30 GSK Investigational Site Pozuelo De Alarcón/Madrid Spain 28223
31 GSK Investigational Site Sevilla Spain 41014
32 GSK Investigational Site Taichung Taiwan 404
33 GSK Investigational Site Taipei Taiwan 100

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:
NCT01198756
Other Study ID Numbers:
  • 113314
First Posted:
Sep 10, 2010
Last Update Posted:
Sep 21, 2018
Last Verified:
Apr 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by GlaxoSmithKline
Influenza
Additional relevant MeSH terms:
Influenza, Human
Vaccines

Study Results

Participant Flow

Recruitment Details A total of 3109 subjects were enrolled, out of which solely 3094 subjects were vaccinated who constituted the analysed population in this study.
Pre-assignment Detail Unprimed Subjects - subjects aged 6 months to 8 years with no H1N1 vaccine or H1N1 infection in the last season, or with no seasonal influenza vaccine in the past or who had received only 1 dose for the first time in the last season - received a 2-dose vaccination course. Primed Subjects - all other subjects - received a 1-dose vaccination course.
Arm/Group Title GSK2282512A 1 Group Victoria Strain Fluarix Group Yamagata Strain Fluarix Group GSK2282512A 2 Group
Arm/Group Description Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
Period Title: Overall Study
STARTED 932 929 932 301
COMPLETED 894 889 902 275
NOT COMPLETED 38 40 30 26

Baseline Characteristics

Arm/Group Title GSK2282512A 1 Group Victoria Strain Fluarix Group Yamagata Strain Fluarix Group GSK2282512A 2 Group Total
Arm/Group Description Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age. Total of all reporting groups
Overall Participants 932 929 932 301 3094
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]
8.9
(4.21)
8.9
(4.23)
8.9
(4.17)
1.2
(0.73)
8.1
(4.60)
Sex: Female, Male (Count of Participants)
Female
434
46.6%
455
49%
464
49.8%
143
47.5%
1496
48.4%
Male
498
53.4%
474
51%
468
50.2%
158
52.5%
1598
51.6%

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 the seropositivity cut-off of 1:10. Antibodies assessed were antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains.
Time Frame At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at 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 evaluable 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 GSK2282512A 1 Group Victoria Strain Fluarix Group Yamagata Strain Fluarix Group GSK2282512A 2 Group
Arm/Group Description Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
Measure Participants 878 871 878 259
H1N1, POST
362.7
429.1
420.2
200.9
H3N2, POST
143.7
139.6
151.0
61.4
Victoria, POST
250.5
245.4
68.1
127.3
Yamagata, POST
512.5
197.0
579.0
192.7
2. Primary Outcome
Title Number of Subjects Seroconverted 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 vaccine strains assessed were the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains.
Time Frame At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)

Outcome Measure Data

Analysis Population Description
The analysis was performed on the According-To-Protocol cohort for immunogenicity, inclusive of all evaluable and eligible subjects with immunogenicity results available for antibodies against at least one study vaccine component after vaccination, solely on subjects with both pre- and post-vaccination immunogenicity results available.
Arm/Group Title GSK2282512A 1 Group Victoria Strain Fluarix Group Yamagata Strain Fluarix Group GSK2282512A 2 Group
Arm/Group Description Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
Measure Participants 876 870 877 259
H1N1, POST
739
79.3%
755
81.3%
750
80.5%
220
73.1%
H3N2, POST
614
65.9%
590
63.5%
610
65.5%
189
62.8%
Victoria, POST
653
70.1%
622
67%
262
28.1%
219
72.8%
Yamagata, POST
659
70.7%
359
38.6%
644
69.1%
243
80.7%
3. Secondary 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 the seropositivity cut-off of 1:10. Antibodies assessed were antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains.
Time Frame At Day 0 and at 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at 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 evaluable 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 GSK2282512A 1 Group Victoria Strain Fluarix Group Yamagata Strain Fluarix Group GSK2282512A 2 Group
Arm/Group Description Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
Measure Participants 878 871 878 259
H1N1, Day 0
29.4
32.2
29.1
16.8
H1N1, POST
362.7
429.1
420.2
200.9
H3N2, Day 0
18.1
19.0
19.4
5.6
H3N2, POST
143.7
139.6
151.0
61.4
Victoria, Day 0
24.8
25.8
25.8
8.7
Victoria, POST
250.5
245.4
68.1
127.3
Yamagata, Day 0
57.9
58.4
65.9
7.7
Yamagata, POST
512.5
197.0
579.0
192.7
4. Secondary Outcome
Title Number of Subjects Seroprotected Against 4 Strains of Influenza Disease
Description A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition titer ≥ 1:40. The 4 assessed influenza strains were the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 flu strains.
Time Frame At Day 0 and at 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at 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 evaluable 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 GSK2282512A 1 Group Victoria Strain Fluarix Group Yamagata Strain Fluarix Group GSK2282512A 2 Group
Arm/Group Description Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
Measure Participants 878 871 878 259
H1N1, Day 0
480
51.5%
496
53.4%
477
51.2%
87
28.9%
H1N1, POST
850
91.2%
848
91.3%
848
91%
232
77.1%
H3N2, Day 0
295
31.7%
301
32.4%
324
34.8%
7
2.3%
H3N2, POST
816
87.6%
808
87%
819
87.9%
193
64.1%
Victoria, Day 0
388
41.6%
404
43.5%
400
42.9%
28
9.3%
Victoria, POST
838
89.9%
839
90.3%
643
69%
228
75.7%
Yamagata, Day 0
578
62%
583
62.8%
622
66.7%
22
7.3%
Yamagata, POST
869
93.2%
805
86.7%
873
93.7%
250
83.1%
5. Secondary Outcome
Title Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease
Description The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination (at Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects (POST)) compared to Day 0 (i.e. the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer). The 4 assessed influenza strains were the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains
Time Frame At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)

Outcome Measure Data

Analysis Population Description
The analysis was performed on the According-To-Protocol cohort for immunogenicity, inclusive of all evaluable and eligible subjects with immunogenicity results available for antibodies against at least one study vaccine component after vaccination, solely on subjects with both pre- and post-vaccination immunogenicity results available.
Arm/Group Title GSK2282512A 1 Group Victoria Strain Fluarix Group Yamagata Strain Fluarix Group GSK2282512A 2 Group
Arm/Group Description Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
Measure Participants 876 870 877 259
H1N1, POST
12.31
13.31
14.42
11.95
H3N2, POST
7.94
7.37
7.78
10.94
Victoria, POST
10.12
9.51
2.63
14.61
Yamagata, POST
8.86
3.37
8.78
24.92
6. 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 the seropositivity cut-off of 1:10. Antibodies assessed were antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains. Subjects were assessed according to 3 age categories, 3-8 years, 9-17 years and 6-35 months.
Time Frame At Day 0 and at 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at 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 evaluable 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 GSK2282512A 1 (3-8 Years) Group GSK2282512A 1 (9-17 Years) Group Victoria Strain Fluarix (3-8 Years) Group Victoria Strain Fluarix (9-17 Years) Group Yamagata Strain Fluarix (3-8 Years) Group Yamagata Strain Fluarix (9-17 Years) Group GSK2282512A 2 Group
Arm/Group Description Subjects, 3 to 8 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects, 9 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects, 3 to 8 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects, 9 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects, 3 to 8 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects, 9 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
Measure Participants 425 453 424 447 424 454 259
H1N1, Day 0
24.7
34.6
26.9
38.2
24.5
34.2
16.8
H1N1, POST
310.5
419.5
382.7
478.2
356.2
490.3
200.9
H3N2, Day 0
19.7
16.7
21.2
17.0
20.2
18.6
5.6
H3N2, POST
138.2
149.1
144.4
135.2
147.9
153.9
61.4
Victoria, Day 0
18.3
32.9
20.2
32.5
18.4
35.4
8.7
Victoria, POST
194.4
317.8
197.4
301.7
52.6
86.6
127.3
Yamagata, Day 0
27.4
116.2
29.5
111.6
29.5
139.6
7.7
Yamagata, POST
363.4
707.5
103.2
363.7
416.7
787.1
192.7
7. Secondary Outcome
Title Number of Subjects Seroconverted 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 vaccine strains assessed were A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains. Subjects were assessed according to 3 age categories, 3-8 years, 9-17 years and 6-35 months.
Time Frame At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)

Outcome Measure Data

Analysis Population Description
The analysis was performed on the According-To-Protocol cohort for immunogenicity, inclusive of all evaluable and eligible subjects with immunogenicity results available for antibodies against at least one study vaccine component after vaccination, solely on subjects with both pre- and post-vaccination immunogenicity results available.
Arm/Group Title GSK2282512A 1 (3-8 Years) Group GSK2282512A 1 (9-17 Years) Group Victoria Strain Fluarix (3-8 Years) Group Victoria Strain Fluarix (9-17 Years) Group Yamagata Strain Fluarix (3-8 Years) Group Yamagata Strain Fluarix (9-17 Years) Group GSK2282512A 2 Group
Arm/Group Description Subjects, 3 to 8 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects, 9 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects, 3 to 8 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects, 9 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects, 3 to 8 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects, 9 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
Measure Participants 423 453 423 447 424 453 259
H1N1, POST
374
40.1%
365
39.3%
390
41.8%
365
121.3%
380
12.3%
370
NaN
220
NaN
H3N2, POST
291
31.2%
323
34.8%
282
30.3%
308
102.3%
296
9.6%
314
NaN
189
NaN
Victoria, POST
329
35.3%
324
34.9%
326
35%
296
98.3%
133
4.3%
129
NaN
219
NaN
Yamagata, POST
366
39.3%
293
31.5%
181
19.4%
178
59.1%
372
12%
272
NaN
243
NaN
8. Secondary Outcome
Title Number of Subjects Seroprotected Against 4 Strains of Influenza Disease - By Age Strata
Description A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition titer ≥ 1:40. The 4 assessed influenza strains were the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 flu strains. Subjects were assessed according to 3 age categories, 3-8 years, 9-17 years and 6-35 months.
Time Frame At Day 0 and at 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at 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 evaluable 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 GSK2282512A 1 (3-8 Years) Group GSK2282512A 1 (9-17 Years) Group Victoria Strain Fluarix (3-8 Years) Group Victoria Strain Fluarix (9-17 Years) Group Yamagata Strain Fluarix (3-8 Years) Group Yamagata Strain Fluarix (9-17 Years) Group GSK2282512A 2 Group
Arm/Group Description Subjects, 3 to 8 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects, 9 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects, 3 to 8 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects, 9 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects, 3 to 8 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects, 9 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
Measure Participants 425 453 424 447 424 454 259
H1N1, Day 0
209
22.4%
271
29.2%
218
23.4%
278
92.4%
207
6.7%
270
NaN
87
NaN
H1N1, POST
405
43.5%
445
47.9%
412
44.2%
436
144.9%
405
13.1%
443
NaN
232
NaN
H3N2, Day 0
161
17.3%
134
14.4%
174
18.7%
127
42.2%
168
5.4%
156
NaN
7
NaN
H3N2, POST
379
40.7%
437
47%
390
41.8%
418
138.9%
389
12.6%
430
NaN
193
NaN
Victoria, Day 0
144
15.5%
244
26.3%
163
17.5%
241
80.1%
150
4.8%
250
NaN
28
NaN
Victoria, POST
398
42.7%
440
47.4%
406
43.6%
433
143.9%
271
8.8%
372
NaN
228
NaN
Yamagata, Day 0
205
22%
373
40.2%
209
22.4%
374
124.3%
220
7.1%
402
NaN
22
NaN
Yamagata, POST
419
45%
450
48.4%
361
38.7%
444
147.5%
420
13.6%
453
NaN
250
NaN
9. Secondary Outcome
Title Seroconversion Factor for Hemagglutination Inhibition Antibodies Against 4 Strains of Influenza Disease - By Age Strata
Description The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0 (i.e. the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer). The 4 assessed influenza strains were the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains. Subjects were assessed according to 3 age categories, 3-8 years, 9-17 years and 6-35 months.
Time Frame At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST)

Outcome Measure Data

Analysis Population Description
The analysis was performed on the According-To-Protocol cohort for immunogenicity, inclusive of all evaluable and eligible subjects with immunogenicity results available for antibodies against at least one study vaccine component after vaccination, solely on subjects with both pre- and post-vaccination immunogenicity results available.
Arm/Group Title GSK2282512A 1 (3-8 Years) Group GSK2282512A 1 (9-17 Years) Group Victoria Strain Fluarix (3-8 Years) Group Victoria Strain Fluarix (9-17 Years) Group Yamagata Strain Fluarix (3-8 Years) Group Yamagata Strain Fluarix (9-17 Years) Group GSK2282512A 2 Group
Arm/Group Description Subjects, 3 to 8 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects, 9 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects, 3 to 8 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects, 9 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects, 3 to 8 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects, 9 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
Measure Participants 423 453 423 447 424 453 259
H1N1, POST
12.50
12.12
14.20
12.52
14.56
14.29
11.95
H3N2, POST
7.02
8.91
6.82
7.94
7.29
8.27
10.94
Victoria, POST
10.64
9.65
9.75
9.28
2.85
2.44
14.61
Yamagata, POST
13.23
6.09
3.49
3.26
14.11
5.63
24.92
10. Secondary Outcome
Title Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination
Description Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity grade. Grade 3 pain for subjects < 5 years of age = Cried when limb was moved/spontaneously painful; Grade 3 pain for subjects ≥ 5 years of age = Significant pain at rest, pain that preventeded normal everyday activities. Grade 3 redness and swelling were defined as redness/swelling above 100 millimeters (mm).
Time Frame During the 7-day follow-up period (Days 0-6) after vaccination

Outcome Measure Data

Analysis Population Description
The analysis was performed on the Total Vaccinated cohort which included all subjects with vaccine administration documented, solely on subjects with symptom sheet completed for the reported specific symptom.
Arm/Group Title GSK2282512A 1 Group Victoria Strain Fluarix Group Yamagata Strain Fluarix Group GSK2282512A 2 Group
Arm/Group Description Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
Measure Participants 913 912 916 294
Any pain
637
68.3%
538
57.9%
542
58.2%
148
49.2%
Grade 3 pain
35
3.8%
21
2.3%
26
2.8%
6
2%
Any redness
57
6.1%
38
4.1%
36
3.9%
24
8%
Grade 3 redness
1
0.1%
0
0%
0
0%
2
0.7%
Any swelling
64
6.9%
40
4.3%
39
4.2%
18
6%
Grade 3 swelling
1
0.1%
0
0%
0
0%
1
0.3%
11. Secondary Outcome
Title Number of Days With Solicited Local Symptoms After Vaccination
Description Duration was assessed via tabulation of the number of days with local symptoms of any grade after vaccination with Dose 1 and Dose 2 respectively. Solicited local symptoms assessed for duration were pain, redness and swelling.
Time Frame During the 7-day follow-up period (Days 0-6) after vaccination

Outcome Measure Data

Analysis Population Description
The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom.
Arm/Group Title GSK2282512A 1 Group Victoria Strain Fluarix Group Yamagata Strain Fluarix Group GSK2282512A 2 Group
Arm/Group Description Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
Measure Participants 597 497 510 131
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
1.0
1.0
1.0
Redness, Dose 2
2.0
1.0
1.5
2.5
Swelling, Dose 1
2.0
2.0
2.0
1.5
Swelling, Dose 2
2.5
2.0
2.0
3.0
12. Secondary Outcome
Title Number of Subjects Below 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms
Description Symptoms assessed were drowsiness, irritability, loss of appetite and temperature. Any = Incidence of a particular symptom regardless of intensity grade or relationship to vaccination. Any temperature = Axillary temperature ≥ 38.0 degrees Celsius (°C). Grade 3 temperature = Axillary temperature ≥ 39.0°C. Grade 3 irritability = Crying that could not be comforted/ preventing normal activity. Grade 3 drowsiness = Drowsiness preventing normal activity. Grade 3 loss of appetite = Not eating at all. Related = A general symptom assessed by the investigator as causally related to vaccination.
Time Frame During the 7-day follow-up period (Days 0-6) after vaccination

Outcome Measure Data

Analysis Population Description
The analysis was performed on the Total Vaccinated cohort which included all subjects with vaccine administration documented, solely on subjects with symptom sheet completed for the reported specific symptom.
Arm/Group Title GSK2282512A 1 Group Victoria Strain Fluarix Group Yamagata Strain Fluarix Group GSK2282512A 2 Group
Arm/Group Description Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
Measure Participants 185 187 189 292
Any drowsiness
46
4.9%
47
5.1%
51
5.5%
102
33.9%
Grade 3 drowsiness
0
0%
3
0.3%
1
0.1%
7
2.3%
Related drowsiness
34
3.6%
40
4.3%
42
4.5%
93
30.9%
Any irritability
59
6.3%
44
4.7%
48
5.2%
141
46.8%
Grade 3 irritability
3
0.3%
0
0%
3
0.3%
14
4.7%
Related irritability
45
4.8%
36
3.9%
45
4.8%
130
43.2%
Any loss of appetite
40
4.3%
41
4.4%
35
3.8%
93
30.9%
Grade 3 loss of appetite
0
0%
6
0.6%
3
0.3%
5
1.7%
Related loss of appetite
21
2.3%
28
3%
24
2.6%
73
24.3%
Any temperature
15
1.6%
16
1.7%
15
1.6%
27
9%
Grade 3 temperature
3
0.3%
5
0.5%
5
0.5%
6
2%
Related temperature
6
0.6%
10
1.1%
6
0.6%
18
6%
13. Secondary Outcome
Title Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms
Description Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache, joint pain at other location, muscle aches, shivering and temperature. Any = Incidence of a particular symptom regardless of intensity grade or relationship to vaccination. Any temperature = axillary temperature ≥ 38.0 °C. Grade 3 temperature = axillary temperature ≥ 39.0°C. Grade 3 symptom = Symptom that prevented normal activity. Related = A general symptom assessed by the investigator as causally related to vaccination.
Time Frame During the 7-day follow-up period (Days 0-6) after vaccination

Outcome Measure Data

Analysis Population Description
The analysis was performed on the Total Vaccinated cohort which included all subjects with vaccine administration documented, solely on subjects with symptom sheet completed for the reported specific symptom.
Arm/Group Title GSK2282512A 1 Group Victoria Strain Fluarix Group Yamagata Strain Fluarix Group
Arm/Group Description Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Measure Participants 727 725 726
Any fatigue
173
18.6%
177
19.1%
177
19%
Grade 3 fatigue
6
0.6%
13
1.4%
8
0.9%
Related fatigue
143
15.3%
149
16%
134
14.4%
Any gastrointestinal symptoms
80
8.6%
82
8.8%
72
7.7%
Grade 3 gastrointestinal symptoms
9
1%
8
0.9%
6
0.6%
Related gastrointestinal symptoms
55
5.9%
51
5.5%
37
4%
Any headache
170
18.2%
171
18.4%
157
16.8%
Grade 3 headache
8
0.9%
9
1%
10
1.1%
Related headache
134
14.4%
134
14.4%
116
12.4%
Any joint pain at other location
103
11.1%
95
10.2%
81
8.7%
Grade 3 joint pain at other location
4
0.4%
5
0.5%
1
0.1%
Related joint pain at other location
82
8.8%
80
8.6%
67
7.2%
Any muscle aches
222
23.8%
194
20.9%
193
20.7%
Grade 3 muscle aches
6
0.6%
5
0.5%
9
1%
Related muscle aches
202
21.7%
178
19.2%
170
18.2%
Any shivering
55
5.9%
51
5.5%
53
5.7%
Grade 3 shivering
4
0.4%
10
1.1%
4
0.4%
Related shivering
45
4.8%
35
3.8%
41
4.4%
Any temperature
26
2.8%
33
3.6%
20
2.1%
Grade 3 temperature
5
0.5%
8
0.9%
2
0.2%
Related temperature
16
1.7%
18
1.9%
13
1.4%
14. Secondary Outcome
Title Number of Days With Solicited General Symptoms After Vaccination in Subjects Below 5 Years of Age
Description Duration was assessed via tabulation of the number of days with local symptoms of any grade after vaccination with Dose 1 and Dose 2, respectively. Solicited general symptoms assessed for duration in subjects below 5 years of age were drowsiness, irritability and loss of appetite.
Time Frame During the 7-day follow-up period (Days 0-6) after vaccination

Outcome Measure Data

Analysis Population Description
The analysis was performed on the Total Vaccinated cohort which included all subjects with vaccine administration documented, solely on subjects with symptom sheet completed for the reported specific symptom.
Arm/Group Title GSK2282512A 1 Group Victoria Strain Fluarix Group Yamagata Strain Fluarix Group GSK2282512A 2 Group
Arm/Group Description Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
Measure Participants 48 37 44 120
Drowsiness, Dose 1
1.0
2.0
1.0
2.0
Drowsiness, Dose 2
1.0
1.0
2.0
2.0
Irritability, Dose 1
1.0
2.0
2.0
2.0
Irritability, Dose 2
1.0
2.0
2.0
2.0
Loss of appetite, Dose 1
1.0
2.0
1.0
2.0
Loss of appetite, Dose 2
2.0
2.0
3.0
2.0
15. Secondary Outcome
Title Number of Days With Solicited General Symptoms After Vaccination in Subjects 5 Years of Age and Above
Description Duration was assessed via tabulation of the number of days with local symptoms of any grade after vaccination with Dose 1 and Dose 2, respectively. Solicited general symptoms assessed for duration in subjects 5 years of age and above were fatigue, gastrointestinal symptoms, headache, joint pain at other location, muscle aches and shivering.
Time Frame During the 7-day follow-up period (Days 0-6) after vaccination

Outcome Measure Data

Analysis Population Description
The analysis was performed on the Total Vaccinated cohort which included all subjects with vaccine administration documented, solely on subjects with symptom sheet completed for the reported specific symptom.
Arm/Group Title GSK2282512A 1 Group Victoria Strain Fluarix Group Yamagata Strain Fluarix Group
Arm/Group Description Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Measure Participants 207 180 179
Fatigue, Dose 1
2.0
1.0
2.0
Fatigue, Dose 2
2.0
2.0
2.0
Gastrointestinal symptoms, Dose 1
1.5
1.0
1.0
Gastrointestinal symptoms, Dose 2
1.0
1.5
2.0
Headache, Dose 1
2.0
1.0
2.0
Headache, Dose 2
1.5
1.0
1.0
Joint pain at other location, Dose 1
2.0
2.0
1.5
Joint pain at other location, Dose 2
2.0
1.0
1.0
Muscle aches, Dose 1
2.0
2.0
2.0
Muscle aches, Dose 2
1.0
1.0
2.0
Shivering, Dose 1
1.0
2.0
1.0
Shivering, Dose 2
1.5
1.0
2.0
16. Secondary Outcome
Title Number of Days With Fever in All Subjects Regardless of Their Age After Vaccination
Description Duration for fever was assessed via tabulation of the number of days with local symptoms of fever (axillary temperature ≥ 38°C) after vaccination with Dose 1 and Dose 2, respectively.
Time Frame During the 7-day follow-up period (Days 0-6) after vaccination

Outcome Measure Data

Analysis Population Description
The analysis was performed on the Total Vaccinated cohort which included all subjects with vaccine administration documented, solely on subjects with symptom sheet completed for the reported specific symptom.
Arm/Group Title GSK2282512A 1 Group Victoria Strain Fluarix Group Yamagata Strain Fluarix Group GSK2282512A 2 Group
Arm/Group Description Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
Measure Participants 25 43 26 16
Fever, Dose 1
1.0
1.0
1.5
1.0
Fever, Dose 2
2.0
1.0
1.0
1.5
17. 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 unsolicited AE(s) = Occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 unsolicited AE = Occurrence of any unsolicited AE that prevented normal activities. Related unsolicited AE(s) = Occurrence of an unsolicited AE assessed by the investigator to be causally related to vaccination.
Time Frame During the 28-day follow-up period (Day 0-27) after vaccination

Outcome Measure Data

Analysis Population Description
The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.
Arm/Group Title GSK2282512A 1 Group Victoria Strain Fluarix Group Yamagata Strain Fluarix Group GSK2282512A 2 Group
Arm/Group Description Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
Measure Participants 932 929 932 301
Any unsolicited AE(s)
283
30.4%
291
31.3%
275
29.5%
160
53.2%
Grade 3 unsolicited AE(s)
40
4.3%
41
4.4%
35
3.8%
24
8%
Related unsolicited AE(s)
44
4.7%
47
5.1%
44
4.7%
43
14.3%
18. Secondary Outcome
Title Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs) After Vaccination
Description Potential immune-mediated diseases (pIMDs) are a subset of adverse events that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Any pIMD(s) = Occurrence of any pIMD(s) regardless of intensity grade or relation to vaccination. Related pIMD(s) = pIMD assessed by the investigator as causally related to the study vaccination.
Time Frame During the entire study period (from Day 0 to Day 180)

Outcome Measure Data

Analysis Population Description
The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.
Arm/Group Title GSK2282512A 1 Group Victoria Strain Fluarix Group Yamagata Strain Fluarix Group GSK2282512A 2 Group
Arm/Group Description Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
Measure Participants 932 929 932 301
Any pIMD(s)
0
0%
1
0.1%
1
0.1%
0
0%
Related pIMD(s)
0
0%
0
0%
0
0%
0
0%
19. Secondary Outcome
Title Number of Subjects With Any and Related Medically-attended Adverse Events (MAEs) After Vaccination
Description Medically-attended adverse events (MAEs) were non-serious and serious events leading to an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits. If a medically-attended adverse event was leading to hospitalization (or met any other criterion for serious adverse event (SAE)), it was reported as SAE. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.Relationship to vaccination was not assessed for MAEs.
Time Frame During the entire study period (from Day 0 to Day 180)

Outcome Measure Data

Analysis Population Description
The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.
Arm/Group Title GSK2282512A 1 Group Victoria Strain Fluarix Group Yamagata Strain Fluarix Group GSK2282512A 2 Group
Arm/Group Description Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
Measure Participants 932 929 932 301
Count of Participants [Participants]
346
37.1%
335
36.1%
350
37.6%
147
48.8%
20. Secondary Outcome
Title Number of Subjects With Any and Related Serious Adverse Events (SAEs)
Description SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE(s) = Occurrence of any SAE(s) regardless of intensity grade or relation to vaccination. Related SAE(s)= Occurrence of any SAE(s) assessed by the investigator as causally related to vaccination.
Time Frame During the entire study period (from Day 0 to Day 180)

Outcome Measure Data

Analysis Population Description
The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.
Arm/Group Title GSK2282512A 1 Group Victoria Strain Fluarix Group Yamagata Strain Fluarix Group GSK2282512A 2 Group
Arm/Group Description Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
Measure Participants 932 929 932 301
Any SAE(s)
3
0.3%
6
0.6%
5
0.5%
7
2.3%
Related SAE(s)
0
0%
0
0%
1
0.1%
2
0.7%

Adverse Events

Time Frame Serious adverse events were assessed from Day 0 to Day 180. Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during a 7-day and 28-day post-vaccination period, respectively.
Adverse Event Reporting Description For the systematically-assessed other non-serious AEs, the number of participants at risk included those from Total Vaccinated cohort whose symptom sheet had been completed.
Arm/Group Title GSK2282512A 1 Group Victoria Strain Fluarix Group Yamagata Strain Fluarix Group GSK2282512A 2 Group
Arm/Group Description Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
All Cause Mortality
GSK2282512A 1 Group Victoria Strain Fluarix Group Yamagata Strain Fluarix Group GSK2282512A 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
GSK2282512A 1 Group Victoria Strain Fluarix Group Yamagata Strain Fluarix Group GSK2282512A 2 Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 3/932 (0.3%) 6/929 (0.6%) 5/932 (0.5%) 7/301 (2.3%)
Blood and lymphatic system disorders
Lymphadenitis 1/932 (0.1%) 0/929 (0%) 0/932 (0%) 0/301 (0%)
Congenital, familial and genetic disorders
Vitello-intestinal duct remnant 0/932 (0%) 1/929 (0.1%) 0/932 (0%) 0/301 (0%)
Eye disorders
Conjunctivitis 0/932 (0%) 0/929 (0%) 1/932 (0.1%) 0/301 (0%)
Hepatobiliary disorders
Biliary dyskinesia 0/932 (0%) 1/929 (0.1%) 0/932 (0%) 0/301 (0%)
Immune system disorders
Anaphylactic reaction 0/932 (0%) 1/929 (0.1%) 0/932 (0%) 0/301 (0%)
Hypersensitivity 0/932 (0%) 1/929 (0.1%) 0/932 (0%) 0/301 (0%)
Infections and infestations
Gastroenteritis 0/932 (0%) 1/929 (0.1%) 0/932 (0%) 1/301 (0.3%)
Bronchopneumonia 0/932 (0%) 0/929 (0%) 1/932 (0.1%) 0/301 (0%)
Gastroenteritis rotavirus 0/932 (0%) 0/929 (0%) 1/932 (0.1%) 0/301 (0%)
Influenza 0/932 (0%) 0/929 (0%) 1/932 (0.1%) 0/301 (0%)
Lobar pneumonia 0/932 (0%) 0/929 (0%) 0/932 (0%) 1/301 (0.3%)
Pneumonia 0/932 (0%) 1/929 (0.1%) 0/932 (0%) 0/301 (0%)
Pneumonia viral 0/932 (0%) 0/929 (0%) 0/932 (0%) 1/301 (0.3%)
Respiratory syncytial virus infection 0/932 (0%) 0/929 (0%) 0/932 (0%) 1/301 (0.3%)
Injury, poisoning and procedural complications
Accidental overdose 1/932 (0.1%) 0/929 (0%) 0/932 (0%) 0/301 (0%)
Facial bones fracture 0/932 (0%) 0/929 (0%) 1/932 (0.1%) 0/301 (0%)
Foreign body 0/932 (0%) 0/929 (0%) 0/932 (0%) 1/301 (0.3%)
Head injury 0/932 (0%) 0/929 (0%) 1/932 (0.1%) 0/301 (0%)
Joint dislocation 0/932 (0%) 0/929 (0%) 1/932 (0.1%) 0/301 (0%)
Traumatic brain injury 0/932 (0%) 1/929 (0.1%) 0/932 (0%) 0/301 (0%)
Metabolism and nutrition disorders
Hypovolaemia 0/932 (0%) 0/929 (0%) 1/932 (0.1%) 0/301 (0%)
Nervous system disorders
Febrile convulsion 0/932 (0%) 0/929 (0%) 0/932 (0%) 1/301 (0.3%)
Grand mal convulsion 0/932 (0%) 0/929 (0%) 0/932 (0%) 1/301 (0.3%)
Psychiatric disorders
Depression 1/932 (0.1%) 1/929 (0.1%) 0/932 (0%) 0/301 (0%)
Anxiety 0/932 (0%) 1/929 (0.1%) 0/932 (0%) 0/301 (0%)
Suicidal ideation 0/932 (0%) 1/929 (0.1%) 0/932 (0%) 0/301 (0%)
Respiratory, thoracic and mediastinal disorders
Asthma 0/932 (0%) 0/929 (0%) 0/932 (0%) 3/301 (1%)
Skin and subcutaneous tissue disorders
Angioedema 0/932 (0%) 0/929 (0%) 1/932 (0.1%) 0/301 (0%)
Urticaria 0/932 (0%) 1/929 (0.1%) 0/932 (0%) 0/301 (0%)
Vascular disorders
Hypertension 1/932 (0.1%) 0/929 (0%) 0/932 (0%) 0/301 (0%)
Other (Not Including Serious) Adverse Events
GSK2282512A 1 Group Victoria Strain Fluarix Group Yamagata Strain Fluarix Group GSK2282512A 2 Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 731/932 (78.4%) 666/929 (71.7%) 659/932 (70.7%) 233/301 (77.4%)
Gastrointestinal disorders
Diarrhoea 11/932 (1.2%) 10/929 (1.1%) 7/932 (0.8%) 20/301 (6.6%)
General disorders
Pain 637/913 (69.8%) 538/912 (59%) 542/916 (59.2%) 148/294 (50.3%)
Redness 57/913 (6.2%) 38/912 (4.2%) 36/916 (3.9%) 24/294 (8.2%)
Swelling 64/913 (7%) 40/912 (4.4%) 39/916 (4.3%) 18/294 (6.1%)
Drowsiness 46/185 (24.9%) 47/187 (25.1%) 51/189 (27%) 102/292 (34.9%)
Irritability 59/185 (31.9%) 44/187 (23.5%) 48/189 (25.4%) 141/292 (48.3%)
Loss of appetite 40/185 (21.6%) 41/187 (21.9%) 35/189 (18.5%) 93/292 (31.8%)
Temperature 15/185 (8.1%) 16/187 (8.6%) 15/189 (7.9%) 27/292 (9.2%)
Fatigue 173/727 (23.8%) 177/725 (24.4%) 177/726 (24.4%) 0/0 (NaN)
Gastrointestinal 80/727 (11%) 82/725 (11.3%) 72/726 (9.9%) 0/0 (NaN)
Headache 170/727 (23.4%) 171/725 (23.6%) 157/726 (21.6%) 0/0 (NaN)
Joint pain at other location 103/727 (14.2%) 95/725 (13.1%) 81/726 (11.2%) 0/0 (NaN)
Muscle aches 222/727 (30.5%) 194/725 (26.8%) 193/726 (26.6%) 0/0 (NaN)
Shivering 55/727 (7.6%) 51/725 (7%) 53/726 (7.3%) 0/0 (NaN)
Pyrexia 19/932 (2%) 16/929 (1.7%) 13/932 (1.4%) 21/301 (7%)
Infections and infestations
Upper respiratory tract infection 36/932 (3.9%) 30/929 (3.2%) 33/932 (3.5%) 24/301 (8%)
Nasopharyngitis 48/932 (5.2%) 47/929 (5.1%) 43/932 (4.6%) 14/301 (4.7%)
Respiratory, thoracic and mediastinal disorders
Cough 53/932 (5.7%) 38/929 (4.1%) 49/932 (5.3%) 34/301 (11.3%)
Rhinorrhoea 17/932 (1.8%) 12/929 (1.3%) 19/932 (2%) 33/301 (11%)

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:
NCT01198756
Other Study ID Numbers:
  • 113314
First Posted:
Sep 10, 2010
Last Update Posted:
Sep 21, 2018
Last Verified:
Apr 1, 2018