Trial Outcomes & Findings for Study to Evaluate Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Vaccine GSK2282512A When Administered to Children 6 to 35 Months of Age (NCT NCT01711736)

Last Updated: 2021-11-01

Results Overview

A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (\<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/CAL/7/09 (H1N1), Flu A/Victoria/361/11 (H3N2), Flu B/Hubei-Wujiagang/158/09 (Yamagata) and Flu B/Bri/60/08 (Victoria). This outcome concerns solely subjects in the GSK2282512A Group.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

606 participants

Primary outcome timeframe

At Day 28 for primed subjects and at Day 56 for unprimed subjects

Results posted on

2021-11-01

Participant Flow

Primed subjects: Received 2 doses of seasonal influenza vaccine separated by at least one month during the last season or had received at least 1 dose prior to last season. Unprimed subjects: Did not receive any seasonal influenza vaccine in the past or received only 1 dose for the first time in the last influenza season.

5 subjects enrolled in the study were allocated subject numbers but the study vaccine dose was not administered.

Participant milestones

Participant milestones
Measure	GSK2282512A Group Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine. Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects \< 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age).	Fluarix Group Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine. Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects \< 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age).
Overall Study STARTED	299	302
Overall Study COMPLETED	287	294
Overall Study NOT COMPLETED	12	8

Reasons for withdrawal

Reasons for withdrawal
Measure	GSK2282512A Group Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine. Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects \< 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age).	Fluarix Group Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine. Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects \< 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age).
Overall Study Lost to Follow-up	4	1
Overall Study Withdrawal by Subject	6	6
Overall Study Migrated/moved from study area	2	1

Baseline Characteristics

Study to Evaluate Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Vaccine GSK2282512A When Administered to Children 6 to 35 Months of Age

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GSK2282512A Group n=299 Participants Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine. Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects \< 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age).	Fluarix Group n=302 Participants Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine. Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects \< 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age).	Total n=601 Participants Total of all reporting groups
Age, Continuous	18.2 Months STANDARD_DEVIATION 8.17 • n=5 Participants	18.1 Months STANDARD_DEVIATION 8.34 • n=7 Participants	18.15 Months STANDARD_DEVIATION 8.25 • n=5 Participants
Sex: Female, Male Female	155 Participants n=5 Participants	146 Participants n=7 Participants	301 Participants n=5 Participants
Sex: Female, Male Male	144 Participants n=5 Participants	156 Participants n=7 Participants	300 Participants n=5 Participants

PRIMARY outcome

Timeframe: At Day 28 for primed subjects and at Day 56 for unprimed subjects

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, in terms of antibody response measured by the Haemagglutination Inhibition assay, included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Outcome measures

Outcome measures
Measure	GSK2282512A Group n=284 Participants Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine. Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects \< 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age).	Fluarix Group Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine. Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects \< 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age).
Number of Seroconverted Subjects for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains of Quadrivalent Influenza GSK2282512A Vaccine. [H1N1, Day 28 = primed and Day 56 = unprimed]	244 subjects	—
Number of Seroconverted Subjects for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains of Quadrivalent Influenza GSK2282512A Vaccine. [H3N2, Day 28 = primed and Day 56 = unprimed]	205 subjects	—
Number of Seroconverted Subjects for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains of Quadrivalent Influenza GSK2282512A Vaccine. [Yamagata, Day 28 = primed and Day 56 = unprimed]	224 subjects	—
Number of Seroconverted Subjects for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains of Quadrivalent Influenza GSK2282512A Vaccine. [Victoria, Day 28 = primed and Day 56 = unprimed]	210 subjects	—

PRIMARY outcome

Timeframe: During the 7-day (Days 0-6) post-vaccination period

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.

Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of the specified solicited local symptom regardless of its intensity. Grade 3 pain was defined as pain that prevented normal everyday activities. Grade 3 swelling was greater than 100 millimeters (mm) i.e. \>100mm.

Outcome measures

Outcome measures
Measure	GSK2282512A Group n=291 Participants Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine. Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects \< 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age).	Fluarix Group n=297 Participants Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine. Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects \< 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age).
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. Any Pain	95 subjects	91 subjects
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. Grade 3 Pain	7 subjects	3 subjects
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. Any Redness	6 subjects	6 subjects
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. Grade 3 Redness	0 subjects	0 subjects
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. Any Swelling	5 subjects	6 subjects
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. Grade 3 Swelling	0 subjects	0 subjects

PRIMARY outcome

Timeframe: During the 7-day (Days 0-6) post-vaccination period

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.

Solicited general symptoms assessed were drowsiness, irritability/fussiness and loss of appetite. Any was defined as any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Grade 3 irritability/fussiness was defined as crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite was defined as not eating at all. Grade 3 drowsiness was defined as drowsiness that prevented normal activity.

Outcome measures

Outcome measures
Measure	GSK2282512A Group n=290 Participants Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine. Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects \< 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age).	Fluarix Group n=296 Participants Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine. Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects \< 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age).
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms (Excluding Fever). Any Drowsiness	93 subjects	88 subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms (Excluding Fever). Grade 3 Drowsiness	9 subjects	9 subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms (Excluding Fever). Related Drowsiness	79 subjects	80 subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms (Excluding Fever). Any Irritability/fussiness	118 subjects	123 subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms (Excluding Fever). Grade 3 Irritability/fussiness	15 subjects	14 subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms (Excluding Fever). Related Irritability/fussiness	104 subjects	106 subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms (Excluding Fever). Any Loss of appetite	99 subjects	100 subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms (Excluding Fever). Grade 3 Loss of appetite	16 subjects	14 subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms (Excluding Fever). Related Loss of appetite	84 subjects	83 subjects

PRIMARY outcome

Timeframe: During the 7-day (Days 0-6) post-vaccination period

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.

Any fever was defined as any fever ≥38.0 degrees Celsius (°C) irrespective of intensity and relationship to vaccination. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Grade 3 fever was defined as fever ≥39.0 °C.

Outcome measures

Outcome measures
Measure	GSK2282512A Group n=290 Participants Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine. Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects \< 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age).	Fluarix Group n=296 Participants Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine. Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects \< 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age).
Number of Subjects Reporting Any, Grade 3 and Related Fever Any Fever	61 subjects	60 subjects
Number of Subjects Reporting Any, Grade 3 and Related Fever Grade 3 Fever	23 subjects	13 subjects
Number of Subjects Reporting Any, Grade 3 and Related Fever Related Fever	49 subjects	48 subjects

SECONDARY outcome

Timeframe: At Day 0 (for all subjects) and 28 days after the last vaccine dose (at Day 28 for primed subjects and at Day 56 for unprimed subjects)

HI antibody titres were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/CAL/7/09 (H1N1), Flu A/Victoria/361/11 (H3N2), Flu B/Hubei-Wujiagang/158/09 (Yamagata) and Flu B/Bri/60/08 (Victoria)

Outcome measures

Outcome measures
Measure	GSK2282512A Group n=284 Participants Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine. Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects \< 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age).	Fluarix Group n=287 Participants Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine. Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects \< 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age).
Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Influenza Strains [Yamagata, Day 28 = primed and Day 56 = unprimed]	114.2 Titers Interval 100.0 to 130.5	107.2 Titers Interval 92.2 to 124.6
Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Influenza Strains [H1N1, Day 0]	9.6 Titers Interval 8.1 to 11.3	9.8 Titers Interval 8.3 to 11.6
Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Influenza Strains [H1N1, Day 28 = primed and Day 56 = unprimed]	157.1 Titers Interval 132.8 to 185.9	61.2 Titers Interval 49.2 to 76.2
Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Influenza Strains [H3N2, Day 0]	17.4 Titers Interval 14.1 to 21.5	13.8 Titers Interval 11.4 to 16.8
Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Influenza Strains [H3N2, Day 28 = primed and Day 56 = unprimed]	159.4 Titers Interval 129.4 to 196.3	103.0 Titers Interval 83.7 to 126.7
Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Influenza Strains [Yamagata, Day 0]	7.7 Titers Interval 6.9 to 8.7	7.2 Titers Interval 6.5 to 8.0
Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Influenza Strains [Victoria, Day 0]	10.6 Titers Interval 9.1 to 12.4	9.3 Titers Interval 8.0 to 10.7
Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Influenza Strains [Victoria, Day 28 = primed and Day 56 = unprimed]	111.4 Titers Interval 91.9 to 135.2	15.6 Titers Interval 13.3 to 18.5

SECONDARY outcome

Timeframe: At Day 28 for primed subjects and at Day 56 for unprimed subjects

Outcome measures

Outcome measures
Measure	GSK2282512A Group n=287 Participants Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine. Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects \< 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age).	Fluarix Group Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine. Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects \< 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age).
Number of Seroconverted Subjects for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains of Fluarix Vaccine [H1N1, Day 28 = primed and Day 56 = unprimed]	154 subjects	—
Number of Seroconverted Subjects for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains of Fluarix Vaccine [H3N2, Day 28 = primed and Day 56 = unprimed]	160 subjects	—
Number of Seroconverted Subjects for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains of Fluarix Vaccine [Yamagata, Day 28 = primed and Day 56 = unprimed]	222 subjects	—
Number of Seroconverted Subjects for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains of Fluarix Vaccine [Victoria, Day 28 = primed and Day 56 = unprimed]	28 subjects	—

SECONDARY outcome

Timeframe: At Day 0 (for all subjects) and Day 28 after last vaccine dose (Day 28 for primed subjects and Day 56 for unprimed subjects)

A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/CAL/7/09 (H1N1), Flu A/Victoria/361/11 (H3N2), Flu B/Hubei-Wujiagang/158/09 (Yamagata) and Flu B/Bri/60/08 (Victoria)

Outcome measures

Outcome measures
Measure	GSK2282512A Group n=284 Participants Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine. Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects \< 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age).	Fluarix Group n=287 Participants Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine. Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects \< 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age).
Number of Subjects Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. [H1N1, Day 0]	46 subjects	47 subjects
Number of Subjects Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. [H1N1, Day 28 = primed and Day 56 = unprimed]	254 subjects	169 subjects
Number of Subjects Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. [H3N2, Day 0]	93 subjects	74 subjects
Number of Subjects Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. [H3N2, Day 28 = primed and Day 56 = unprimed]	231 subjects	191 subjects
Number of Subjects Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. [Yamagata, Day 0]	26 subjects	24 subjects
Number of Subjects Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. [Yamagata, Day 28 = primed and Day 56 = unprimed]	242 subjects	229 subjects
Number of Subjects Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. [Victoria, Day 0]	56 subjects	45 subjects
Number of Subjects Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. [Victoria, Day 28 = primed and Day 56 = unprimed]	216 subjects	74 subjects

SECONDARY outcome

Timeframe: 28 days after the last vaccine dose (at Day 28 for primed subjects and at Day 56 for unprimed subjects)

MGI was defined as the fold increase in serum haemagglutination inhibition (HI) GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/CAL/7/09 (H1N1), Flu A/Victoria/361/11 (H3N2), Flu B/Hubei-Wujiagang/158/09 (Yamagata) and Flu B/Bri/60/08 (Victoria)

Outcome measures

Outcome measures
Measure	GSK2282512A Group n=284 Participants Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine. Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects \< 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age).	Fluarix Group n=287 Participants Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine. Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects \< 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age).
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains. [H1N1, Day 28 = primed and Day 56 = unprimed]	16.4 Fold increase Interval 14.3 to 18.7	6.2 Fold increase Interval 5.3 to 7.3
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains. [H3N2, Day 28 = primed and Day 56 = unprimed]	9.1 Fold increase Interval 8.0 to 10.5	7.5 Fold increase Interval 6.4 to 8.7
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains. [Yamagata, Day 28 = primed and Day 56 = unprimed]	14.8 Fold increase Interval 12.8 to 17.1	14.8 Fold increase Interval 12.8 to 17.2
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains. [Victoria, Day 28 = primed and Day 56 = unprimed]	10.5 Fold increase Interval 9.2 to 11.9	1.7 Fold increase Interval 1.5 to 1.9

SECONDARY outcome

Timeframe: During the 4-day (Days 0-3) post-vaccination period

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.

Any fever was defined as any fever ≥38.0 °C irrespective of intensity and relationship to vaccination. Related was defined as symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 fever was defined as fever ≥39.0 °C.

Outcome measures

Outcome measures
Measure	GSK2282512A Group n=290 Participants Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine. Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects \< 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age).	Fluarix Group n=296 Participants Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine. Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects \< 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age).
Number of Subjects Reporting Any, Grade 3 and Related Fever Any Fever	46 subjects	42 subjects
Number of Subjects Reporting Any, Grade 3 and Related Fever Grade 3 Fever	16 subjects	8 subjects
Number of Subjects Reporting Any, Grade 3 and Related Fever Related Fever	39 subjects	38 subjects

SECONDARY outcome

Timeframe: During the entire study period (Day 0 to Day 180)

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.

MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s).

Outcome measures

Outcome measures
Measure	GSK2282512A Group n=299 Participants Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine. Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects \< 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age).	Fluarix Group n=302 Participants Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine. Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects \< 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age).
Number of Subjects Reporting Any Medically Attended Adverse Events (MAEs)	156 subjects	156 subjects

SECONDARY outcome

Timeframe: During the entire study period (Day 0 to Day 180)

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.

Potential immune-mediated diseases (pIMDs) were defined as a subset of adverse events that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which might or might not have an autoimmune aetiology. Any pIMD was defined as at least one pIMD experienced by the study subject.

Outcome measures

Outcome measures
Measure	GSK2282512A Group n=299 Participants Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine. Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects \< 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age).	Fluarix Group n=302 Participants Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine. Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects \< 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age).
Number of Subjects Reporting Any Potential Immune-Mediated Diseases (pIMDs) Any pIMD(s)	0 subjects	2 subjects
Number of Subjects Reporting Any Potential Immune-Mediated Diseases (pIMDs) Related pIMD(s)	0 subjects	0 subjects

SECONDARY outcome

Timeframe: During the 28-day (Days 0-27) post-vaccination period.

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.

An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.

Outcome measures

Outcome measures
Measure	GSK2282512A Group n=299 Participants Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine. Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects \< 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age).	Fluarix Group n=302 Participants Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine. Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects \< 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age).
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs). Any Unsolicited AEs	142 subjects	165 subjects
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs). Grade 3 Unsolicited AEs	9 subjects	5 subjects
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs). Related Unsolicited AEs	17 subjects	13 subjects

SECONDARY outcome

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

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.

A serious adverse event was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.

Outcome measures

Outcome measures
Measure	GSK2282512A Group n=299 Participants Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine. Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects \< 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age).	Fluarix Group n=302 Participants Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine. Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects \< 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age).
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Any SAEs	9 subjects	8 subjects
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Related SAEs	1 subjects	0 subjects

Adverse Events

GSK2282512A Group

Serious events: 9 serious events

Other events: 200 other events

Deaths: 0 deaths

Fluarix Group

Serious events: 8 serious events

Other events: 211 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	GSK2282512A Group n=299 participants at risk Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine. Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects \< 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age).	Fluarix Group n=302 participants at risk Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine. Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects \< 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age).
General disorders Pain	31.8% 95/299 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	30.1% 91/302 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
General disorders Drowsiness	32.1% 93/290 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	29.7% 88/296 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
General disorders Irritability/fussiness	40.7% 118/290 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	41.6% 123/296 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
General disorders Loss of appetite	34.1% 99/290 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	33.8% 100/296 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
General disorders Fever	15.9% 46/290 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	14.2% 42/296 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
Infections and infestations Nasopharyngitis	26.1% 78/299 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	29.8% 90/302 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
Gastrointestinal disorders Diarrhoea	12.7% 38/299 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	12.6% 38/302 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER

Measure	GSK2282512A Group n=299 participants at risk Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine. Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects \< 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age).	Fluarix Group n=302 participants at risk Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine. Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects \< 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age).
Infections and infestations Bronchiolitis	0.00% 0/299 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.66% 2/302 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
Metabolism and nutrition disorders Dehydration	0.33% 1/299 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.33% 1/302 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
Infections and infestations Gastroenteritis rotavirus	0.00% 0/299 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.66% 2/302 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
Infections and infestations Amoebic dysentery	0.33% 1/299 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.00% 0/302 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/299 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.33% 1/302 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
Infections and infestations Bacterial pyelonephritis	0.33% 1/299 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.00% 0/302 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
Infections and infestations Blastocystis infection	0.00% 0/299 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.33% 1/302 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
Respiratory, thoracic and mediastinal disorders Bronchial hyperreactivity	0.00% 0/299 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.33% 1/302 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
Gastrointestinal disorders Colitis ulcerative	0.00% 0/299 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.33% 1/302 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
Infections and infestations Dengue fever	0.33% 1/299 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.00% 0/302 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
Gastrointestinal disorders Diarrhoea	0.33% 1/299 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.00% 0/302 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
Nervous system disorders Febrile convulsion	0.33% 1/299 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.00% 0/302 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/299 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.33% 1/302 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
Infections and infestations Otitis media acute	0.00% 0/299 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.33% 1/302 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
Infections and infestations Peritonitis	0.00% 0/299 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.33% 1/302 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
Infections and infestations Pharyngitis streptococcal	0.33% 1/299 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.00% 0/302 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.33% 1/299 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.00% 0/302 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
Infections and infestations Respiratory syncytial virus bronchiolitis	0.00% 0/299 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.33% 1/302 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
Infections and infestations Rotavirus infection	0.33% 1/299 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.00% 0/302 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
Infections and infestations Septic shock	0.00% 0/299 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.33% 1/302 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
Infections and infestations Tonsillitis	0.00% 0/299 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.33% 1/302 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.