Trial Outcomes & Findings for A Study to Evaluate the Efficacy of GSK Biologicals' Influenza Vaccine in Children (NCT NCT01218308)

Last Updated: 2018-08-01

Results Overview

To confirm influenza A and/or B disease, a positive reverse transcriptase polymerase chain reaction (RT-PCR) result for influenza A or B virus from a nose and throat swab obtained concurrently with an influenza like illness (ILI) was required. ILI was defined as the presence of an oral or axillary temperature ≥ 37.8 degrees Celsius (°C) in the presence of at least one of the following symptoms on the same day: cough, sore throat, runny nose or nasal congestion.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

5220 participants

Primary outcome timeframe

From Day 14 to Day 180

Results posted on

2018-08-01

Participant Flow

A total of 5168 subjects have been enrolled in this study. Primed subjects had received at least 1 dose of an influenza A (H1N1) 2009 monovalent vaccine and had received 2 doses of seasonal influenza vaccine. Unprimed subjects had not received any influenza A (H1N1) 2009 monovalent vaccine or seasonal influenza vaccine.

The duration of the study was approximately 4-8 weeks to complete enrolment, with at least six months extended safety follow-up (ESFU) after first vaccination, and lasted until the end of the influenza like illness (ILI) surveillance period.

Participant milestones

Participant milestones
Measure	FluLaval® Quadrivalent Group Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.	Havrix Group Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
Overall Study STARTED	2584	2584
Overall Study COMPLETED	2481	2464
Overall Study NOT COMPLETED	103	120

Reasons for withdrawal

Reasons for withdrawal
Measure	FluLaval® Quadrivalent Group Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.	Havrix Group Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
Overall Study Adverse Event	1	2
Overall Study Protocol Violation	0	2
Overall Study Withdrawal by Subject	61	64
Overall Study Lost to Follow-up	27	31
Overall Study Other	14	21

Baseline Characteristics

A Study to Evaluate the Efficacy of GSK Biologicals' Influenza Vaccine in Children

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FluLaval® Quadrivalent Group n=2584 Participants Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.	Havrix Group n=2584 Participants Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.	Total n=5168 Participants Total of all reporting groups
Age, Continuous	5.4 Years STANDARD_DEVIATION 1.66 • n=99 Participants	5.4 Years STANDARD_DEVIATION 1.65 • n=107 Participants	5.4 Years STANDARD_DEVIATION 1.65 • n=206 Participants
Sex: Female, Male Female	1251 Participants n=99 Participants	1245 Participants n=107 Participants	2496 Participants n=206 Participants
Sex: Female, Male Male	1333 Participants n=99 Participants	1339 Participants n=107 Participants	2672 Participants n=206 Participants

PRIMARY outcome

Timeframe: From Day 14 to Day 180

Population: The analysis was performed on the According-To-Protocol cohort for efficacy - Time to event, which included all eligible subjects who met all inclusion criteria and no exclusion criteria, followed their study treatment assignment and were successfully contacted at least once after the first vaccination.

Outcome measures

Outcome measures
Measure	FluLaval® Quadrivalent Group n=2379 Participants Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.	Havrix Group n=2398 Participants Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
Number of Subjects Reporting at Least One Confirmed Occurrence of Influenza A or B.	58 subjects	128 subjects

SECONDARY outcome

Timeframe: From Day 14 to Day 180

To confirm influenza A and/or B disease moderate to severe cases, a positive RT-PCR result for influenza A or B virus from a nose and throat swab obtained concurrently with an ILI was required. Moderate to severe influenza was defined as RT-PCR-confirmed ILI with: * Fever \>39°C, and/or at least one of the following manifestations, * Physician-verified shortness of breath, pulmonary congestion, pneumonia, bronchiolitis, bronchitis, wheezing, croup, or acute otitis media, and/or one of the following, * Physician-diagnosed serious extra-pulmonary complication of influenza, including myositis, encephalitis, seizure, or myocarditis

Outcome measures

Outcome measures
Measure	FluLaval® Quadrivalent Group n=2379 Participants Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.	Havrix Group n=2398 Participants Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
Number of Subjects Reporting at Least One Moderate to Severe Occurrence of Influenza A or B.	14 subjects	52 subjects

SECONDARY outcome

Timeframe: From Day 14 to Day 180

To confirm influenza A and/or B disease due to antigenically matched strain, a positive reverse transcriptase polymerase chain reaction (RT-PCR) result for influenza A or B virus from a nose and throat swab obtained concurrently with an influenza like illness (ILI) was required. ILI was defined as the presence of an oral or axillary temperature ≥ 37.8 degrees Celsius (°C) in the presence of at least one of the following symptoms on the same day: cough, sore throat, runny nose or nasal congestion.

Outcome measures

Outcome measures
Measure	FluLaval® Quadrivalent Group n=2379 Participants Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.	Havrix Group n=2398 Participants Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
Number of Subjects Reporting at Least One Culture Confirmed Occurrence of Influenza A or B Due to Antigenically Matched Strain.	31 subjects	56 subjects

SECONDARY outcome

Timeframe: From Day 14 to Day 180

To confirm influenza A and/or B disease due to any strain, a positive reverse transcriptase polymerase chain reaction (RT-PCR) result for influenza A or B virus from a nose and throat swab obtained concurrently with an influenza like illness (ILI) was required. ILI was defined as the presence of an oral or axillary temperature ≥ 37.8 degrees Celsius (°C) in the presence of at least one of the following symptoms on the same day: cough, sore throat, runny nose or nasal congestion.

Outcome measures

Outcome measures
Measure	FluLaval® Quadrivalent Group n=2379 Participants Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.	Havrix Group n=2398 Participants Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
Number of Subjects Reporting at Least One Culture Confirmed Occurrence of Influenza A or B Due to Any Strain.	50 subjects	112 subjects

SECONDARY outcome

Timeframe: At Day 0 [PRE] and 28 days post vaccination (Day 28 for primed subjects and day 56 for unprimed subjects) [POST]

Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects (those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measure were available.

Titers are presented as geometric mean titers (GMTs). The reference cut-off value was the seropositivity cut-off of 1:10. The 4 influenza strains assessed were the Flu A/California/7/09 (H1N1), Flu A/Victoria/210/09 (H3N2), FluB/Brisbane/60/08 (Victoria) and Flu B/Florida/4/06 (Yamagata).

Outcome measures

Outcome measures
Measure	FluLaval® Quadrivalent Group n=457 Participants Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.	Havrix Group n=122 Participants Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. H1N1, PRE [N=457;117]	15.3 titers Interval 13.6 to 17.3	16.1 titers Interval 12.6 to 20.5
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. H1N1, POST [N=457;121]	318.8 titers Interval 291.0 to 349.2	16.1 titers Interval 12.8 to 20.2
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. H3N2, PRE [N=457;117]	24.3 titers Interval 21.9 to 27.0	28.6 titers Interval 23.5 to 34.8
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. H3N2, POST [N=457;122]	264.7 titers Interval 244.3 to 286.8	30.3 titers Interval 24.8 to 36.9
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. Victoria, PRE [N=457;117]	13.7 titers Interval 12.2 to 15.4	15.6 titers Interval 12.2 to 20.1
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. Victoria, POST [N=457;120]	239.9 titers Interval 214.6 to 268.2	17.8 titers Interval 13.7 to 23.1
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. Yamagata, PRE [N=457;117]	16.2 titers Interval 14.3 to 18.4	18.8 titers Interval 14.4 to 24.5
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. Yamagata, POST [N=457;117]	361.5 titers Interval 330.7 to 395.3	19.2 titers Interval 14.9 to 24.7

SECONDARY outcome

Timeframe: At 28 days post vaccination (Day 28 for primed subjects and 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 4 influenza strains assessed were the Flu A/California/7/09 (H1N1), Flu A/Victoria/210/09 (H3N2), FluB/Brisbane/60/08 (Victoria) and Flu B/Florida/4/06 (Yamagata).

Outcome measures

Outcome measures
Measure	FluLaval® Quadrivalent Group n=457 Participants Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.	Havrix Group n=117 Participants Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
Number of Seroconverted Subjects Against 4 Strains of Influenza Disease. H1N1, POST	438 subjects	1 subjects
Number of Seroconverted Subjects Against 4 Strains of Influenza Disease. H3N2, POST	385 subjects	2 subjects
Number of Seroconverted Subjects Against 4 Strains of Influenza Disease. Victoria, POST	425 subjects	3 subjects
Number of Seroconverted Subjects Against 4 Strains of Influenza Disease. Yamagata, POST	435 subjects	1 subjects

SECONDARY outcome

Timeframe: At Day 0 [PRE] and 28 days post vaccination (Day 28 for primed subjects and day 56 for unprimed subjects) [POST]

A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 4 influenza strains assessed were the Flu A/California/7/09 (H1N1), Flu A/Victoria/210/09 (H3N2), FluB/Brisbane/60/08 (Victoria) and Flu B/Florida/4/06 (Yamagata).

Outcome measures

Outcome measures
Measure	FluLaval® Quadrivalent Group n=457 Participants Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.	Havrix Group n=122 Participants Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. H1N1, PRE [N=457;117]	151 subjects	37 subjects
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. H1N1, POST [N=457;121]	451 subjects	39 subjects
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. H3N2, PRE [N=457;117]	205 subjects	63 subjects
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. H3N2, POST [N=457;122]	445 subjects	63 subjects
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. Victoria, PRE [N=457;117]	127 subjects	35 subjects
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. Victoria, POST [N=457;120]	443 subjects	38 subjects
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. Yamagata, PRE [N=457;117]	159 subjects	45 subjects
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. Yamagata, POST [N=457;117]	452 subjects	45 subjects

SECONDARY outcome

Timeframe: At 28 days post vaccination (Day 28 for primed subjects and 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. The 4 influenza strains assessed were the Flu A/California/7/09 (H1N1), Flu A/Victoria/210/09 (H3N2), FluB/Brisbane/60/08 (Victoria) and Flu B/Florida/4/06 (Yamagata).

Outcome measures

Outcome measures
Measure	FluLaval® Quadrivalent Group n=457 Participants Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.	Havrix Group n=117 Participants Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. H1N1, POST	20.8 fold increase Interval 19.0 to 22.8	1.0 fold increase Interval 0.9 to 1.1
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. H3N2, POST	10.9 fold increase Interval 9.8 to 12.1	1.0 fold increase Interval 0.9 to 1.2
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. Victoria, POST	17.5 fold increase Interval 16.0 to 19.1	1.1 fold increase Interval 1.0 to 1.3
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. Yamagata, POST	22.3 fold increase Interval 20.1 to 24.8	1.0 fold increase Interval 1.0 to 1.1

SECONDARY outcome

Timeframe: On Day 0 and at least 6 months after first vaccination (Month 6)

Population: The ATP Cohort for persistence included, in terms of antibody response measured by the HI assay, all evaluable subjects for whom data concerning immunogenicity outcome measure were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

HI antibody titres were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Victoria/210/09 (H3N2), Flu B/Brisbane/60/08 (Victoria) and Flu B/Florida/4/06 (Yamagata).

Outcome measures

Outcome measures
Measure	FluLaval® Quadrivalent Group n=444 Participants Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.	Havrix Group n=112 Participants Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Strains H1N1, PRE [N=444;112]	15.5 Titer Interval 13.8 to 17.6	16.5 Titer Interval 12.9 to 21.2
Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Strains H1N1, POST [N=444;112]	138.6 Titer Interval 122.6 to 156.6	23.2 Titer Interval 17.9 to 30.1
Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Strains H3N2, PRE [N=444;112]	24.6 Titer Interval 22.1 to 27.4	29.1 Titer Interval 23.8 to 35.5
Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Strains H3N2, POST [N=443;112]	136.5 Titer Interval 124.3 to 149.9	43.6 Titer Interval 34.9 to 54.5
Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Strains Victoria, PRE [N=444;112]	13.7 Titer Interval 12.2 to 15.4	15.1 Titer Interval 11.8 to 19.5
Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Strains Victoria, POST [N=443;112]	110.2 Titer Interval 97.1 to 125.0	19.7 Titer Interval 15.0 to 25.8
Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Strains Yamagata, PRE [N=444;112]	16.1 Titer Interval 14.2 to 18.4	18.7 Titer Interval 14.3 to 24.6
Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Strains Yamagata, POST [N=444;112]	157.0 Titer Interval 143.1 to 172.3	21.8 Titer Interval 16.5 to 28.9

SECONDARY outcome

Timeframe: At least 6 months after first vaccination (Month 6)

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/California/7/09 (H1N1), Flu A/Victoria/210/09 (H3N2), FluB/Brisbane/60/08 (Victoria) and Flu B/Florida/4/06 (Yamagata).

Outcome measures

Outcome measures
Measure	FluLaval® Quadrivalent Group n=444 Participants Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.	Havrix Group n=112 Participants Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
Number of Seroconverted Subjects for HI Antibody Titers Against Each of the 4 Vaccine Influenza Strains. H1N1, POST [N=444;112]	349 Subjects	9 Subjects
Number of Seroconverted Subjects for HI Antibody Titers Against Each of the 4 Vaccine Influenza Strains. H3N2, POST [N=443;112]	290 Subjects	10 Subjects
Number of Seroconverted Subjects for HI Antibody Titers Against Each of the 4 Vaccine Influenza Strains. Victoria, POST [N=443;112]	323 Subjects	12 Subjects
Number of Seroconverted Subjects for HI Antibody Titers Against Each of the 4 Vaccine Influenza Strains. Yamagata, POST [N=444;112]	354 Subjects	8 Subjects

SECONDARY outcome

Timeframe: At Day 0 and at least 6 months after first vaccination (Month 6)

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/California/7/09 (H1N1), Flu A/Victoria/210/09 (H3N2), FluB/Brisbane/60/08 (Victoria) and Flu B/Florida/4/06 (Yamagata).

Outcome measures

Outcome measures
Measure	FluLaval® Quadrivalent Group n=444 Participants Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.	Havrix Group n=112 Participants Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
Number of Seroprotected Subjects for HI Antibody Titers Against Each of the 4 Vaccine Influenza Strains. H1N1, PRE [N=444;112]	148 Subjects	36 Subjects
Number of Seroprotected Subjects for HI Antibody Titers Against Each of the 4 Vaccine Influenza Strains. H1N1, POST [N=444;112]	383 Subjects	49 Subjects
Number of Seroprotected Subjects for HI Antibody Titers Against Each of the 4 Vaccine Influenza Strains. H3N2, PRE [N=444;112]	204 Subjects	60 Subjects
Number of Seroprotected Subjects for HI Antibody Titers Against Each of the 4 Vaccine Influenza Strains. H3N2, POST [N=443;112]	412 Subjects	71 Subjects
Number of Seroprotected Subjects for HI Antibody Titers Against Each of the 4 Vaccine Influenza Strains. Victoria, PRE [N=444;112]	123 Subjects	32 Subjects
Number of Seroprotected Subjects for HI Antibody Titers Against Each of the 4 Vaccine Influenza Strains. Victoria, POST [N=443;112]	374 Subjects	39 Subjects
Number of Seroprotected Subjects for HI Antibody Titers Against Each of the 4 Vaccine Influenza Strains. Yamagata, PRE [N=444;112]	153 Subjects	43 Subjects
Number of Seroprotected Subjects for HI Antibody Titers Against Each of the 4 Vaccine Influenza Strains. Yamagata, POST [N=444;112]	427 Subjects	49 Subjects

SECONDARY outcome

Timeframe: At least 6 months after first vaccination (Month 6)

Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The 4 influenza strains assessed were the Flu A/California/7/09 (H1N1), Flu A/Victoria/210/09 (H3N2), FluB/Brisbane/60/08 (Victoria) and Flu B/Florida/4/06 (Yamagata).

Outcome measures

Outcome measures
Measure	FluLaval® Quadrivalent Group n=444 Participants Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.	Havrix Group n=112 Participants Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
Seroconversion Factors for HI Antibodies Against 4 Strains of Influenza Disease. H1N1, POST [N=444;112]	8.9 Fold increase Interval 8.1 to 9.8	1.4 Fold increase Interval 1.2 to 1.6
Seroconversion Factors for HI Antibodies Against 4 Strains of Influenza Disease. H3N2, POST [N=443;112]	5.5 Fold increase Interval 5.0 to 6.1	1.5 Fold increase Interval 1.2 to 1.8
Seroconversion Factors for HI Antibodies Against 4 Strains of Influenza Disease. Victoria, POST [N=443;112	8.0 Fold increase Interval 7.3 to 8.9	1.3 Fold increase Interval 1.1 to 1.6
Seroconversion Factors for HI Antibodies Against 4 Strains of Influenza Disease. Yamagata, POST [N=444;112]	9.7 Fold increase Interval 8.7 to 10.8	1.2 Fold increase Interval 1.0 to 1.4

SECONDARY outcome

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

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

Assessed solicited local symptoms were pain, redness and swelling at the injection site. Any = Incidence of a particular symptom regardless of intensity grade. Grade 3 pain = Cried when limb was moved/spontaneously painful for subjects \< 5 years of age or significant pain at rest that prevented normal, everyday activities for subjects ≥ 5 years of age. Grade 3 redness/swelling = Redness/swelling above 100 millimeters (mm) of the injection site. All solicited local symptoms were considered related to vaccination.

Outcome measures

Outcome measures
Measure	FluLaval® Quadrivalent Group n=2546 Participants Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.	Havrix Group n=2551 Participants Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms. Grade 3 Pain	36 subjects	20 subjects
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms. Any Pain	1215 subjects	888 subjects
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms. Any Redness	17 subjects	5 subjects
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms. Grade 3 Redness	0 subjects	0 subjects
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms. Any Swelling	46 subjects	10 subjects
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms. Grade 3 Swelling	0 subjects	0 subjects

SECONDARY outcome

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

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

Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature. Any = Occurrence of any solicited general symptom regardless of intensity grade and relation to vaccination. Any temperature = Axillary temperature ≥ 38.0 °C. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irritability = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = not eating at all. Related = General symptom assessed by the investigator as causally related to the study vaccination. Grade 3 temperature = Axillary temperature ≥ 39.0°C.

Outcome measures

Outcome measures
Measure	FluLaval® Quadrivalent Group n=899 Participants Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.	Havrix Group n=896 Participants Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Below 5 Years of Age. Any Drowsiness	100 subjects	93 subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Below 5 Years of Age. Grade 3 Drowsiness	5 subjects	4 subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Below 5 Years of Age. Related Drowsiness	57 subjects	61 subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Below 5 Years of Age. Any Irritability	102 subjects	91 subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Below 5 Years of Age. Grade 3 Irritability	5 subjects	4 subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Below 5 Years of Age. Related Irritability	60 subjects	59 subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Below 5 Years of Age. Any Loss of appetite	119 subjects	120 subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Below 5 Years of Age. Grade 3 Loss of appetite	6 subjects	7 subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Below 5 Years of Age. Related Loss of appetite	55 subjects	61 subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Below 5 Years of Age. Any Temperature	74 subjects	74 subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Below 5 Years of Age. Grade 3 Temperature	21 subjects	18 subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Below 5 Years of Age. Related Temperature	35 subjects	35 subjects

SECONDARY outcome

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

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

Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (Gastro.), headache, joint pain at other location (Joint pain), muscle aches, shivering and temperature. Any = Occurrence of any solicited general symptom regardless of intensity grade or relation to vaccination. Any temperature = Axillary temperature ≥ 38.0 °C. Grade 3 symptom = Symptom that prevented normal activity. Related = Symptom assessed by the investigator as causally related to the vaccination. Grade 3 temperature = Axillary temperature ≥ 39.0°C.

Outcome measures

Outcome measures
Measure	FluLaval® Quadrivalent Group n=1648 Participants Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.	Havrix Group n=1654 Participants Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects of 5 Years of Age and Above. Any Fatigue	188 subjects	145 subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects of 5 Years of Age and Above. Grade 3 Fatigue	1 subjects	6 subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects of 5 Years of Age and Above. Related Fatigue	101 subjects	78 subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects of 5 Years of Age and Above. Any Gastro.	133 subjects	146 subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects of 5 Years of Age and Above. Grade 3 Gastro.	9 subjects	9 subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects of 5 Years of Age and Above. Related Gastro.	68 subjects	54 subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects of 5 Years of Age and Above. Any Headache	243 subjects	217 subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects of 5 Years of Age and Above. Grade 3 Headache	9 subjects	14 subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects of 5 Years of Age and Above. Related Headache	154 subjects	125 subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects of 5 Years of Age and Above. Any Joint pain	143 subjects	93 subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects of 5 Years of Age and Above. Grade 3 Joint pain	3 subjects	2 subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects of 5 Years of Age and Above. Related Joint pain	98 subjects	54 subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects of 5 Years of Age and Above. Any Muscle aches	257 subjects	194 subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects of 5 Years of Age and Above. Grade 3 Muscle aches	3 subjects	5 subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects of 5 Years of Age and Above. Related Muscle aches	162 subjects	109 subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects of 5 Years of Age and Above. Any Shivering	63 subjects	59 subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects of 5 Years of Age and Above. Grade 3 Shivering	2 subjects	2 subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects of 5 Years of Age and Above. Related Shivering	32 subjects	26 subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects of 5 Years of Age and Above. Any Temperature	72 subjects	82 subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects of 5 Years of Age and Above. Grade 3 Temperature	21 subjects	17 subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects of 5 Years of Age and Above. Related Temperature	46 subjects	37 subjects

SECONDARY outcome

Timeframe: During the 28-day (Days 0-27) follow-up period after vaccination

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

Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = Any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = Unsolicited AE that prevented normal activity. Related = Unsolicited AE assessed by the investigator as causally related to the vaccination.

Outcome measures

Outcome measures
Measure	FluLaval® Quadrivalent Group n=2584 Participants Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.	Havrix Group n=2584 Participants Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). Any unsolicited AE(s)	843 subjects	855 subjects
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). Grade 3 unsolicited AE(s)	25 subjects	20 subjects
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs). Related unsolicited AE(s)	30 subjects	37 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 subjects with at least one vaccine administration documented.

MAEs were defined as AEs that resulted in medical attention (defined as hospitalization, an emergency room visit or a visit to or from medical personnel for any reason). Any = Any MAE regardless of intensity or relationship to vaccination. Related = MAE assessed by the investigator as causally related to the vaccination.

Outcome measures

Outcome measures
Measure	FluLaval® Quadrivalent Group n=2584 Participants Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.	Havrix Group n=2584 Participants Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
Number of Subjects With Any and Related Medically Attended Adverse Events (MAEs). Any MAE(s)	792 subjects	749 subjects
Number of Subjects With Any and Related Medically Attended Adverse Events (MAEs). Related MAE(s)	6 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 subjects with at least one vaccine administration documented.

pIMDs were defined as a subset of AEs that included both clearly autoimmune diseases (AID) and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Any = Any pIMD(s) regardless of intensity or relationship to vaccination. Related = pIMDs assessed by the investigator as causally related to the vaccination.

Outcome measures

Outcome measures
Measure	FluLaval® Quadrivalent Group n=2584 Participants Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.	Havrix Group n=2584 Participants Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs). Any pIMD(s)	0 subjects	1 subjects
Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs). Related pIMD(s)	0 subjects	0 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 subjects with at least one vaccine administration documented.

Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Any = Any SAE(s) regardless of intensity or relationship to vaccination. Related = SAEs assessed by the investigator as causally related to the vaccination.

Outcome measures

Outcome measures
Measure	FluLaval® Quadrivalent Group n=2584 Participants Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.	Havrix Group n=2584 Participants Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
Number of Subjects With Any and Related Serious Adverse Events (SAEs). Any SAE(s)	36 subjects	24 subjects
Number of Subjects With Any and Related Serious Adverse Events (SAEs). Related SAE(s)	1 subjects	0 subjects

Adverse Events

FluLaval® Quadrivalent Group

Serious events: 36 serious events

Other events: 1215 other events

Deaths: 0 deaths

Havrix Group

Serious events: 24 serious events

Other events: 1297 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	FluLaval® Quadrivalent Group n=2584 participants at risk Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.	Havrix Group n=2584 participants at risk Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
Infections and infestations Nasopharyngitis	8.2% 213/2584 • SAEs: during the entire study period (Day 0-Day 180); Unsolicited AEs: during the 28-day (Day 0-Day 27) follow-up period after vaccination; Solicited local/general symptoms: during the 7-day (Day 0-Day 6) follow-up period after any vaccination. 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.	8.9% 231/2584 • SAEs: during the entire study period (Day 0-Day 180); Unsolicited AEs: during the 28-day (Day 0-Day 27) follow-up period after vaccination; Solicited local/general symptoms: during the 7-day (Day 0-Day 6) follow-up period after any vaccination. 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.
Respiratory, thoracic and mediastinal disorders Cough	5.6% 145/2584 • SAEs: during the entire study period (Day 0-Day 180); Unsolicited AEs: during the 28-day (Day 0-Day 27) follow-up period after vaccination; Solicited local/general symptoms: during the 7-day (Day 0-Day 6) follow-up period after any vaccination. 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.	5.3% 137/2584 • SAEs: during the entire study period (Day 0-Day 180); Unsolicited AEs: during the 28-day (Day 0-Day 27) follow-up period after vaccination; Solicited local/general symptoms: during the 7-day (Day 0-Day 6) follow-up period after any vaccination. 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.
General disorders Pain	47.7% 1215/2546 • SAEs: during the entire study period (Day 0-Day 180); Unsolicited AEs: during the 28-day (Day 0-Day 27) follow-up period after vaccination; Solicited local/general symptoms: during the 7-day (Day 0-Day 6) follow-up period after any vaccination. 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.	34.8% 888/2551 • SAEs: during the entire study period (Day 0-Day 180); Unsolicited AEs: during the 28-day (Day 0-Day 27) follow-up period after vaccination; Solicited local/general symptoms: during the 7-day (Day 0-Day 6) follow-up period after any vaccination. 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.
General disorders Drowsiness	11.1% 100/899 • SAEs: during the entire study period (Day 0-Day 180); Unsolicited AEs: during the 28-day (Day 0-Day 27) follow-up period after vaccination; Solicited local/general symptoms: during the 7-day (Day 0-Day 6) follow-up period after any vaccination. 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.	10.4% 93/896 • SAEs: during the entire study period (Day 0-Day 180); Unsolicited AEs: during the 28-day (Day 0-Day 27) follow-up period after vaccination; Solicited local/general symptoms: during the 7-day (Day 0-Day 6) follow-up period after any vaccination. 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.
General disorders Irritability	11.3% 102/899 • SAEs: during the entire study period (Day 0-Day 180); Unsolicited AEs: during the 28-day (Day 0-Day 27) follow-up period after vaccination; Solicited local/general symptoms: during the 7-day (Day 0-Day 6) follow-up period after any vaccination. 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.	10.2% 91/896 • SAEs: during the entire study period (Day 0-Day 180); Unsolicited AEs: during the 28-day (Day 0-Day 27) follow-up period after vaccination; Solicited local/general symptoms: during the 7-day (Day 0-Day 6) follow-up period after any vaccination. 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.
General disorders Loss of appetite	13.2% 119/899 • SAEs: during the entire study period (Day 0-Day 180); Unsolicited AEs: during the 28-day (Day 0-Day 27) follow-up period after vaccination; Solicited local/general symptoms: during the 7-day (Day 0-Day 6) follow-up period after any vaccination. 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.	13.4% 120/896 • SAEs: during the entire study period (Day 0-Day 180); Unsolicited AEs: during the 28-day (Day 0-Day 27) follow-up period after vaccination; Solicited local/general symptoms: during the 7-day (Day 0-Day 6) follow-up period after any vaccination. 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.
General disorders Temperature	8.2% 74/899 • SAEs: during the entire study period (Day 0-Day 180); Unsolicited AEs: during the 28-day (Day 0-Day 27) follow-up period after vaccination; Solicited local/general symptoms: during the 7-day (Day 0-Day 6) follow-up period after any vaccination. 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.	8.3% 74/896 • SAEs: during the entire study period (Day 0-Day 180); Unsolicited AEs: during the 28-day (Day 0-Day 27) follow-up period after vaccination; Solicited local/general symptoms: during the 7-day (Day 0-Day 6) follow-up period after any vaccination. 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.
General disorders Fatigue	11.4% 188/1648 • SAEs: during the entire study period (Day 0-Day 180); Unsolicited AEs: during the 28-day (Day 0-Day 27) follow-up period after vaccination; Solicited local/general symptoms: during the 7-day (Day 0-Day 6) follow-up period after any vaccination. 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.	8.8% 145/1654 • SAEs: during the entire study period (Day 0-Day 180); Unsolicited AEs: during the 28-day (Day 0-Day 27) follow-up period after vaccination; Solicited local/general symptoms: during the 7-day (Day 0-Day 6) follow-up period after any vaccination. 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.
General disorders Gastro.	8.1% 133/1648 • SAEs: during the entire study period (Day 0-Day 180); Unsolicited AEs: during the 28-day (Day 0-Day 27) follow-up period after vaccination; Solicited local/general symptoms: during the 7-day (Day 0-Day 6) follow-up period after any vaccination. 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.	8.8% 146/1654 • SAEs: during the entire study period (Day 0-Day 180); Unsolicited AEs: during the 28-day (Day 0-Day 27) follow-up period after vaccination; Solicited local/general symptoms: during the 7-day (Day 0-Day 6) follow-up period after any vaccination. 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.
General disorders Headache	14.7% 243/1648 • SAEs: during the entire study period (Day 0-Day 180); Unsolicited AEs: during the 28-day (Day 0-Day 27) follow-up period after vaccination; Solicited local/general symptoms: during the 7-day (Day 0-Day 6) follow-up period after any vaccination. 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.	13.1% 217/1654 • SAEs: during the entire study period (Day 0-Day 180); Unsolicited AEs: during the 28-day (Day 0-Day 27) follow-up period after vaccination; Solicited local/general symptoms: during the 7-day (Day 0-Day 6) follow-up period after any vaccination. 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.
General disorders Joint pain	8.7% 143/1648 • SAEs: during the entire study period (Day 0-Day 180); Unsolicited AEs: during the 28-day (Day 0-Day 27) follow-up period after vaccination; Solicited local/general symptoms: during the 7-day (Day 0-Day 6) follow-up period after any vaccination. 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.	5.6% 93/1654 • SAEs: during the entire study period (Day 0-Day 180); Unsolicited AEs: during the 28-day (Day 0-Day 27) follow-up period after vaccination; Solicited local/general symptoms: during the 7-day (Day 0-Day 6) follow-up period after any vaccination. 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.
General disorders Muscle aches	15.6% 257/1648 • SAEs: during the entire study period (Day 0-Day 180); Unsolicited AEs: during the 28-day (Day 0-Day 27) follow-up period after vaccination; Solicited local/general symptoms: during the 7-day (Day 0-Day 6) follow-up period after any vaccination. 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.	11.7% 194/1654 • SAEs: during the entire study period (Day 0-Day 180); Unsolicited AEs: during the 28-day (Day 0-Day 27) follow-up period after vaccination; Solicited local/general symptoms: during the 7-day (Day 0-Day 6) follow-up period after any vaccination. 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.

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