Trial Outcomes & Findings for An Efficacy Study of GlaxoSmithKline (GSK) Biologicals' Candidate Influenza Vaccine GSK2321138A in Children (NCT NCT01439360)

NCT ID: NCT01439360

Last Updated: 2018-09-26

Results Overview

Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

12046 participants

Primary outcome timeframe

During the surveillance period (approximately 6 to 8 months)

Results posted on

2018-09-26

Participant Flow

Out of the 12046 enrolled subjects, 21 subjects were excluded from all statistical analyses due to an invalid informed consent form (ICF) and 7 subjects did not receive any study vaccine despite being allocated a subject number, hence only 12018 subjects started this study.

Participant milestones

Participant milestones
Measure	D-QIV Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).	Control In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
Overall Study STARTED	6006	6012
Overall Study COMPLETED	5808	5804
Overall Study NOT COMPLETED	198	208

Reasons for withdrawal

Reasons for withdrawal
Measure	D-QIV Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).	Control In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
Overall Study Adverse Event	4	16
Overall Study Lost to Follow-up	43	58
Overall Study Others	10	5
Overall Study Protocol Violation	1	0
Overall Study Withdrawal by Subject	140	129

Baseline Characteristics

An Efficacy Study of GlaxoSmithKline (GSK) Biologicals' Candidate Influenza Vaccine GSK2321138A in Children

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	D-QIV n=6006 Participants Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).	Control n=6012 Participants In function of their age and D-QIV-vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).	Total n=12018 Participants Total of all reporting groups
Age, Continuous	21.9 Months STANDARD_DEVIATION 8.0 • n=93 Participants	21.8 Months STANDARD_DEVIATION 8.0 • n=4 Participants	21.9 Months STANDARD_DEVIATION 8.0 • n=27 Participants
Sex: Female, Male Female	2933 Participants n=93 Participants	2925 Participants n=4 Participants	5858 Participants n=27 Participants
Sex: Female, Male Male	3073 Participants n=93 Participants	3087 Participants n=4 Participants	6160 Participants n=27 Participants
Race/Ethnicity, Customized African Heritage / African American	24 Participants n=93 Participants	20 Participants n=4 Participants	44 Participants n=27 Participants
Race/Ethnicity, Customized Asian - Central/South Asian Heritage	1062 Participants n=93 Participants	1053 Participants n=4 Participants	2115 Participants n=27 Participants
Race/Ethnicity, Customized Asian - East Asian Heritage	2 Participants n=93 Participants	0 Participants n=4 Participants	2 Participants n=27 Participants
Race/Ethnicity, Customized Asian - Japanese Heritage	2 Participants n=93 Participants	0 Participants n=4 Participants	2 Participants n=27 Participants
Race/Ethnicity, Customized Asian - South East Asian Heritage	1661 Participants n=93 Participants	1666 Participants n=4 Participants	3327 Participants n=27 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	3 Participants n=93 Participants	0 Participants n=4 Participants	3 Participants n=27 Participants
Race/Ethnicity, Customized Other	1639 Participants n=93 Participants	1642 Participants n=4 Participants	3281 Participants n=27 Participants
Race/Ethnicity, Customized White - Arabic / North African Heritage	142 Participants n=93 Participants	149 Participants n=4 Participants	291 Participants n=27 Participants
Race/Ethnicity, Customized White - Caucasian / European Heritage	1471 Participants n=93 Participants	1482 Participants n=4 Participants	2953 Participants n=27 Participants

PRIMARY outcome

Timeframe: During the surveillance period (approximately 6 to 8 months)

Population: The ATP cohort for efficacy - Time to event included all eligible subjects who received study vaccine(s) according to their random assignment, for whom vaccine administration site was known, who had a swab collected during the window (0-7 days) of episode onset and who would be censored but not eliminated based on protocol criteria.

Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.

Outcome measures

Outcome measures
Measure	D-QIV n=5707 Participants Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).	Control n=5697 Participants In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
Number of Subjects With Moderate to Severe RT-PCR Confirmed Influenza.	90 Participants	242 Participants

PRIMARY outcome

Timeframe: During the surveillance period (approximately 6 to 8 months)

Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.

Outcome measures

Outcome measures
Measure	D-QIV n=5707 Participants Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).	Control n=5697 Participants In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
Number of Subjects With RT-PCR Confirmed Influenza of Any Severity.	344 Participants	662 Participants

SECONDARY outcome

Timeframe: At any time starting 7 days before the onset of LRI and ending 7 days after end of LRI during the surveillance period (approximately 6 to 8 months)

Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.

Outcome measures

Outcome measures
Measure	D-QIV n=5707 Participants Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).	Control n=5697 Participants In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
Number of Subjects With First Occurrence of Lower Respiratory Illness (LRI) With RT-PCR Confirmed Influenza.	28 Participants	61 Participants

SECONDARY outcome

Timeframe: During the surveillance period (approximately 6 to 8 months)

Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.

Outcome measures

Outcome measures
Measure	D-QIV n=5707 Participants Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).	Control n=5697 Participants In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
Number of Subjects With First Occurrence of Culture-confirmed Moderate to Severe Influenza A and/or B Disease Due to Antigenically-matching Influenza Strains.	20 Participants	88 Participants

SECONDARY outcome

Timeframe: During the surveillance period (approximately 6 to 8 months)

Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.

Outcome measures

Outcome measures
Measure	D-QIV n=5707 Participants Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).	Control n=5697 Participants In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
Number of Subjects With First Occurrence of Culture-confirmed Influenza A and/or B Disease of Any Severity Due to Antigenically-matching Influenza Strains	88 Participants	216 Participants

SECONDARY outcome

Timeframe: During the surveillance period (approximately 6 to 8 months)

Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.

Outcome measures

Outcome measures
Measure	D-QIV n=5707 Participants Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).	Control n=5697 Participants In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
Number of Subjects With First Occurrence of Culture-confirmed Moderate to Severe Influenza A and/or B Disease Due to Any Seasonal Influenza Strain.	79 Participants	216 Participants

SECONDARY outcome

Timeframe: During the surveillance period (approximately 6 to 8 months)

Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.

Outcome measures

Outcome measures
Measure	D-QIV n=5707 Participants Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).	Control n=5697 Participants In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
Number of Subjects With First Occurrence of Culture-confirmed Influenza A and/or B Disease of Any Severity Due to Any Seasonal Influenza Strain.	303 Participants	602 Participants

SECONDARY outcome

Timeframe: At any time starting 7 days before the onset of LRI and ending 7 days after end of LRI during the surveillance period (approximately 6 to 8 months)

Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.

Outcome measures

Outcome measures
Measure	D-QIV n=5707 Participants Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).	Control n=5697 Participants In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
Number of Subjects With First Occurrence of Acute Otitis Media (AOM) With RT-PCR Confirmed Influenza A and/or B Infection Due to Any Seasonal Influenza Strain.	12 Participants	28 Participants

SECONDARY outcome

Timeframe: During the surveillance period (approximately 6 to 8 months)

Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.

Outcome measures

Outcome measures
Measure	D-QIV n=5707 Participants Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).	Control n=5697 Participants In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
Number of Subjects With First Occurrence of RT-PCR Confirmed Severe Influenza A and/or B Due to Any Seasonal Influenza Strain.	2 Participants	3 Participants

SECONDARY outcome

Timeframe: At Days 0 and 28/56

Population: The ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. These included subjects for whom assay results were available for antibodies against at least one study vaccine strain after vaccination.

Titers were expressed as geometric mean antibody titers (GMTs). The vaccine strains assessed were A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Brisbane/3/2007 (Yamagata). PRE= Pre-vaccination at Day 0; POST = Post-vaccination 1 at Day 28 for primed subjects or post-vaccination 2 at Day 56 for unprimed subjects

Outcome measures

Outcome measures
Measure	D-QIV n=753 Participants Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).	Control n=579 Participants In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
Humoral Immune Response in Terms of Haemagglutination-inhibition (HI) Antibody Titres Against Each of Four Vaccine Strains Contained in the D-QIV (in Immuno Subcohort of Subjects Only) H1N1, PRE	11.9 Titers Interval 10.6 to 13.2	11.9 Titers Interval 10.5 to 13.5
Humoral Immune Response in Terms of Haemagglutination-inhibition (HI) Antibody Titres Against Each of Four Vaccine Strains Contained in the D-QIV (in Immuno Subcohort of Subjects Only) H1N1, POST	165.3 Titers Interval 148.6 to 183.8	12.6 Titers Interval 11.1 to 14.3
Humoral Immune Response in Terms of Haemagglutination-inhibition (HI) Antibody Titres Against Each of Four Vaccine Strains Contained in the D-QIV (in Immuno Subcohort of Subjects Only) H3N2, PRE	14.8 Titers Interval 13.2 to 16.5	13.4 Titers Interval 11.8 to 15.2
Humoral Immune Response in Terms of Haemagglutination-inhibition (HI) Antibody Titres Against Each of Four Vaccine Strains Contained in the D-QIV (in Immuno Subcohort of Subjects Only) H3N2, POST	132.1 Titers Interval 119.1 to 146.5	14.7 Titers Interval 12.9 to 16.7
Humoral Immune Response in Terms of Haemagglutination-inhibition (HI) Antibody Titres Against Each of Four Vaccine Strains Contained in the D-QIV (in Immuno Subcohort of Subjects Only) Victoria, PRE	10.0 Titers Interval 9.1 to 11.0	9.2 Titers Interval 8.3 to 10.1
Humoral Immune Response in Terms of Haemagglutination-inhibition (HI) Antibody Titres Against Each of Four Vaccine Strains Contained in the D-QIV (in Immuno Subcohort of Subjects Only) Victoria, POST	92.6 Titers Interval 82.3 to 104.1	9.2 Titers Interval 8.4 to 10.1
Humoral Immune Response in Terms of Haemagglutination-inhibition (HI) Antibody Titres Against Each of Four Vaccine Strains Contained in the D-QIV (in Immuno Subcohort of Subjects Only) Yamagata, PRE	7.3 Titers Interval 6.8 to 7.8	7.3 Titers Interval 6.8 to 7.9
Humoral Immune Response in Terms of Haemagglutination-inhibition (HI) Antibody Titres Against Each of Four Vaccine Strains Contained in the D-QIV (in Immuno Subcohort of Subjects Only) Yamagata, POST	121.4 Titers Interval 110.1 to 133.8	7.6 Titers Interval 7.0 to 8.3

SECONDARY outcome

Timeframe: At Day 0 and Day 28/56

A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cut-off value of 1:10. The vaccine strains assessed were A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Brisbane/3/2007 (Yamagata). PRE= Pre-vaccination at Day 0; POST = Post-vaccination 1 at Day 28 for primed subjects or post-vaccination 2 at Day 56 for unprimed subjects.

Outcome measures

Outcome measures
Measure	D-QIV n=753 Participants Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).	Control n=579 Participants In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only) H1N1, PRE	200 Participants	152 Participants
Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only) H1N1, POST	728 Participants	170 Participants
Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only) H3N2, PRE	266 Participants	187 Participants
Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only) H3N2, POST	740 Participants	210 Participants
Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only) Victoria, PRE	205 Participants	138 Participants
Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only) Victoria, POST	701 Participants	147 Participants
Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only) Yamagata, PRE	134 Participants	93 Participants
Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only) Yamagata, POST	719 Participants	108 Participants

SECONDARY outcome

Timeframe: At Day 28/56 (POST)

Seroconversion rate (SCR) was defined as the number of subjects who have either a pre-vaccination reciprocal HI titer \< 1:10 and a post-vaccination reciprocal titer ≥ 1:40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4 fold increase in post vaccination reciprocal titer against the vaccine virus. PRE= Pre-vaccination at Day 0; POST = Post-vaccination 1 at Day 28 for primed subjects or post-vaccination 2 at Day 56 for unprimed subjects

Outcome measures

Outcome measures
Measure	D-QIV n=746 Participants Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).	Control n=568 Participants In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only) H1N1	596 Participants	20 Participants
Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only) H3N2	513 Participants	24 Participants
Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only) Victoria	514 Participants	5 Participants
Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only) Yamagata	605 Participants	13 Participants

SECONDARY outcome

Timeframe: At Day 28/56 (POST)

MGI also known as the seroconversion factor \[SCF\] was defined as the fold increase in serum HI GMTs post vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Brisbane/3/2007 (Yamagata). POST = Post-vaccination 1 at Day 28 for primed subjects or post-vaccination 2 at Day 56 for unprimed subjects.

Outcome measures

Outcome measures
Measure	D-QIV n=746 Participants Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).	Control n=568 Participants In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only). H3N2	9.0 Fold change Interval 8.2 to 9.8	1.1 Fold change Interval 1.0 to 1.2
Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only). H1N1	14 Fold change Interval 12.8 to 15.3	1.1 Fold change Interval 1.0 to 1.1
Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only). Victoria	9.3 Fold change Interval 8.6 to 10.2	1.0 Fold change Interval 1.0 to 1.1
Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only). Yamagata	16.7 Fold change Interval 15.2 to 18.3	1.1 Fold change Interval 1.0 to 1.1

SECONDARY outcome

Timeframe: At Day 0 and Day 28/56

Seroprotection rate (SPR) was defined as the number of subjects with H1N1 reciprocal HI titers ≥ 1:40 against the tested vaccine virus.The vaccine strains assessed were A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Brisbane/3/2007 (Yamagata). PRE= Pre-vaccination at Day 0; POST = Post-vaccination 1 at Day 28 for primed subjects or post-vaccination 2 at Day 56 for unprimed subjects

Outcome measures

Outcome measures
Measure	D-QIV n=753 Participants Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).	Control n=579 Participants In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
Number of Seroprotected Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only) H1N1, POST	640 Participants	146 Participants
Number of Seroprotected Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only) H1N1, PRE	182 Participants	134 Participants
Number of Seroprotected Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only) H3N2, PRE	238 Participants	159 Participants
Number of Seroprotected Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only) H3N2, POST	612 Participants	175 Participants
Number of Seroprotected Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only) Victoria, PRE	143 Participants	103 Participants
Number of Seroprotected Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only) Victoria, POST	539 Participants	101 Participants
Number of Seroprotected Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only) Yamagata, PRE	73 Participants	59 Participants
Number of Seroprotected Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only) Yamagata, POST	638 Participants	64 Participants

SECONDARY outcome

Timeframe: During the 7-day post-vaccination period (Days 0-6 for Dose 1, Days 28-34 for Dose 2)

Population: The Total Vaccinated cohort included all subjects with at least one vaccine administration documented. The analysis of solicited symptoms based on the Total Vaccinated cohort included only subjects/doses with documented safety data (i.e. symptom screen/sheet completed).

Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that resulted crying when limb was moved/ spontaneously painful. Grade 3 redness and swelling was greater than 50 millimeters (mm) i.e. \>50mm.

Outcome measures

Outcome measures
Measure	D-QIV n=5907 Participants Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).	Control n=5901 Participants In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. Any Pain, Dose 1	1015 Participants	1047 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. Any Swelling, Dose 2	375 Participants	409 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. Grade 3 Swelling, Dose 2	2 Participants	3 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. Grade 3 Pain, Across doses	42 Participants	48 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. Grade 3 Redness, Across doses	3 Participants	0 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. Grade 3 Pain, Dose 1	23 Participants	30 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. Any Redness, Dose 1	775 Participants	831 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. Grade 3 Redness, Pain, Dose 1	1 Participants	0 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. Any Swelling, Dose 1	467 Participants	518 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. Grade 3 Swelling, Dose 1	0 Participants	0 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. Any Pain, Dose 2	808 Participants	820 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. Grade 3 Pain, Dose 2	21 Participants	21 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. Any Redness, Dose 2	587 Participants	631 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. Grade 3 Redness, Dose 2	2 Participants	0 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. Any Pain, Across doses	1350 Participants	1375 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. Any Redness, Across doses	980 Participants	1091 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. Any Swelling, Across doses	665 Participants	742 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. Grade 3 Swelling, Across doses	2 Participants	3 Participants

SECONDARY outcome

Timeframe: During the 7-day post-vaccination period (Days 0-6 for Dose 1, Days 28-34 for Dose 2)

Solicited general symptoms assessed were Drowsiness, Irritability/fussiness, Loss of appetite and Temperature (Axillary). Any was defined as any general symptom reported irrespective of intensity or relationship to vaccination. Grade 3 was defined as symptoms that prevented normal activity. Related was defined as general symptom assessed by the investigator to have a causal relationship to vaccination.

Outcome measures

Outcome measures
Measure	D-QIV n=5908 Participants Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).	Control n=5901 Participants In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Drowsiness, Across Doses	673 Participants	738 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Irritability, Across Doses	1383 Participants	1427 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Irritability, Across Doses	77 Participants	107 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Loss of appetite, Across Doses	1227 Participants	1288 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Loss of appetite,AcrossDoses	774 Participants	809 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Fever, Across Doses	659 Participants	732 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Fever, Dose 1	78 Participants	76 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Fever, Dose 1	243 Participants	287 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Irritability, Across Doses	905 Participants	940 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade3 Loss of appetite,Across Doses	111 Participants	97 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Drowsiness, Dose 1	739 Participants	829 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Drowsiness, Dose 1	39 Participants	52 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Drowsiness, Dose 1	490 Participants	535 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Irritability, Dose 1	955 Participants	1029 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Irritability, Dose 1	42 Participants	62 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Irritability, Dose 1	617 Participants	669 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Loss of appetite, Dose 1	847 Participants	872 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Loss of appetite, Dose 1	68 Participants	60 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Loss of appetite, Dose 1	541 Participants	523 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Fever, Dose 1	372 Participants	425 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Drowsiness, Dose 2	519 Participants	558 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Drowsiness, Dose 2	25 Participants	24 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Drowsiness, Dose 2	324 Participants	361 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Irritability, Dose 2	777 Participants	777 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Irritability, Dose 2	36 Participants	52 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Irritability, Dose 2	488 Participants	495 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Loss of appetite, Dose 2	652 Participants	681 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Loss of appetite, Dose 2	47 Participants	44 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Loss of appetite, Dose 2	378 Participants	413 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Fever, Dose 2	336 Participants	363 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Fever, Dose 2	65 Participants	70 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Fever, Dose 2	195 Participants	215 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Drowsiness, Across Doses	1024 Participants	1129 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Drowsiness, Across Doses	61 Participants	73 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Fever, Across Doses	137 Participants	141 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Fever, Across Doses	413 Participants	476 Participants

SECONDARY outcome

Timeframe: During the 7-day post-vaccination period (Days 0-6 for Dose 1, Days 28-34 for Dose 2)

Duration was defined as number of days with any grade of local symptoms.

Outcome measures

Outcome measures
Measure	D-QIV n=1015 Participants Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).	Control n=1047 Participants In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
Duration of Solicited Local Symptoms Swelling, Dose 1	2.0 Days Interval 1.0 to 3.0	2.0 Days Interval 1.0 to 3.0
Duration of Solicited Local Symptoms Pain, Dose 1	1.0 Days Interval 1.0 to 2.0	1.0 Days Interval 1.0 to 2.0
Duration of Solicited Local Symptoms Pain, Dose 2	1.0 Days Interval 1.0 to 2.0	1.0 Days Interval 1.0 to 2.0
Duration of Solicited Local Symptoms Redness, Dose 1	2.0 Days Interval 1.0 to 3.0	2.0 Days Interval 1.0 to 3.0
Duration of Solicited Local Symptoms Redness, Dose 2	2.0 Days Interval 1.0 to 3.0	2.0 Days Interval 1.0 to 3.0
Duration of Solicited Local Symptoms Swelling, Dose 2	1.0 Days Interval 1.0 to 2.0	2.0 Days Interval 1.0 to 2.0

SECONDARY outcome

Timeframe: During the 7-day post-vaccination period (Days 0-6 for Dose 1, Days 28-34 for Dose 2)

Duration was defined as number of days with any grade of general symptoms.

Outcome measures

Outcome measures
Measure	D-QIV n=955 Participants Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).	Control n=1029 Participants In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
Duration of Solicited General Symptoms Drowsiness, Dose 1	2.0 Days Interval 1.0 to 3.0	2.0 Days Interval 1.0 to 3.0
Duration of Solicited General Symptoms Drowsiness, Dose 2	2.0 Days Interval 1.0 to 3.0	2.0 Days Interval 1.0 to 3.0
Duration of Solicited General Symptoms Irritability, Dose 1	2.0 Days Interval 1.0 to 3.0	2.0 Days Interval 1.0 to 3.0
Duration of Solicited General Symptoms Irritability, Dose 2	2.0 Days Interval 1.0 to 3.0	2.0 Days Interval 1.0 to 3.0
Duration of Solicited General Symptoms Loss of appetite, Dose 1	2.0 Days Interval 1.0 to 4.0	2.0 Days Interval 1.0 to 4.0
Duration of Solicited General Symptoms Loss of appetite, Dose 2	3.0 Days Interval 2.0 to 4.0	2.0 Days Interval 1.0 to 4.0
Duration of Solicited General Symptoms Fever, Dose 1	1.0 Days Interval 1.0 to 2.0	1.0 Days Interval 1.0 to 2.0
Duration of Solicited General Symptoms Fever, Dose 2	2.0 Days Interval 1.0 to 3.0	1.0 Days Interval 1.0 to 3.0

SECONDARY outcome

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

Population: The Total Vaccinated cohort 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 was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.

Outcome measures

Outcome measures
Measure	D-QIV n=6006 Participants Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).	Control n=6012 Participants In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Any unsolicited AEs	2640 Participants	2679 Participants
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Grade 3 unsolicited AEs	160 Participants	149 Participants
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Related unsolicited AEs	106 Participants	116 Participants

SECONDARY outcome

Timeframe: During the entire study period (approximately 6- 8 months per subject)

Population: The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.

MAVs were defined as AEs with a medically-attended visit i.e. prompting emergency room (ER) visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination. Any MAV was defined as at least one MAV experienced. Grade 3 was defined as MAVs that prevented normal activities and related was defined as MAVs assessed by the investigator to be causally related to the study vaccination.

Outcome measures

Outcome measures
Measure	D-QIV n=6006 Participants Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).	Control n=6012 Participants In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
Number of Subjects Reporting Any, Grade 3 and Related AEs With Medically Attended Visits (MAVs) Any MAVs	3885 Participants	3988 Participants
Number of Subjects Reporting Any, Grade 3 and Related AEs With Medically Attended Visits (MAVs) Grade 3 MAVs	200 Participants	211 Participants
Number of Subjects Reporting Any, Grade 3 and Related AEs With Medically Attended Visits (MAVs) Related MAVs	57 Participants	58 Participants

SECONDARY outcome

Timeframe: During the entire study period (approximately 6- 8 months per subject)

Population: The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.

pIMDs are a subset of adverse events (AEs) that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Grade 3 = pIMDs that prevented normal activities. Related = symptom assed by the investigator as causally related to the study vaccination.

Outcome measures

Outcome measures
Measure	D-QIV n=6006 Participants Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).	Control n=6012 Participants In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
Number of Subjects Reporting Any, Grade 3 and Related Potential Immune-mediated Diseases (pIMDs). Any pIMDs	5 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Potential Immune-mediated Diseases (pIMDs). Grade 3 pIMDs	3 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Potential Immune-mediated Diseases (pIMDs). Related pIMDs	3 Participants	0 Participants

SECONDARY outcome

Timeframe: During the entire study period (approximately 6- 8 months per subject)

Population: The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.

SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. Related = symptom assessed by the investigator as causally related to the study vaccination.

Outcome measures

Outcome measures
Measure	D-QIV n=6006 Participants Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).	Control n=6012 Participants In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs). Related fatal SAEs	0 Participants	0 Participants
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs). Any SAEs	217 Participants	201 Participants
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs). Related SAEs	6 Participants	2 Participants
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs). Fatal SAEs	1 Participants	3 Participants

Adverse Events

D-QIV

Serious events: 217 serious events

Other events: 3427 other events

Deaths: 0 deaths

Control

Serious events: 201 serious events

Other events: 3501 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	D-QIV n=6006 participants at risk Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).	Control n=6012 participants at risk In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
Metabolism and nutrition disorders Decreased appetite	20.5% 1230/6006 • Number of events 1504 • Solicited local and general symptoms were assessed during the 7-day post-vaccination period (Days 0-6 for Dose 1, Days 28-34 for Dose 2); unsolicited AEs were assessed during the 28-day (Days 0-27) post-vaccination period; SAEs were reported during the entire study period (approximately 6- 8 months per subject)	21.5% 1293/6012 • Number of events 1561 • Solicited local and general symptoms were assessed during the 7-day post-vaccination period (Days 0-6 for Dose 1, Days 28-34 for Dose 2); unsolicited AEs were assessed during the 28-day (Days 0-27) post-vaccination period; SAEs were reported during the entire study period (approximately 6- 8 months per subject)
Skin and subcutaneous tissue disorders Erythema	16.4% 983/6006 • Number of events 1365 • Solicited local and general symptoms were assessed during the 7-day post-vaccination period (Days 0-6 for Dose 1, Days 28-34 for Dose 2); unsolicited AEs were assessed during the 28-day (Days 0-27) post-vaccination period; SAEs were reported during the entire study period (approximately 6- 8 months per subject)	18.2% 1094/6012 • Number of events 1467 • Solicited local and general symptoms were assessed during the 7-day post-vaccination period (Days 0-6 for Dose 1, Days 28-34 for Dose 2); unsolicited AEs were assessed during the 28-day (Days 0-27) post-vaccination period; SAEs were reported during the entire study period (approximately 6- 8 months per subject)
Psychiatric disorders Irritability	23.1% 1385/6006 • Number of events 1734 • Solicited local and general symptoms were assessed during the 7-day post-vaccination period (Days 0-6 for Dose 1, Days 28-34 for Dose 2); unsolicited AEs were assessed during the 28-day (Days 0-27) post-vaccination period; SAEs were reported during the entire study period (approximately 6- 8 months per subject)	23.8% 1428/6012 • Number of events 1808 • Solicited local and general symptoms were assessed during the 7-day post-vaccination period (Days 0-6 for Dose 1, Days 28-34 for Dose 2); unsolicited AEs were assessed during the 28-day (Days 0-27) post-vaccination period; SAEs were reported during the entire study period (approximately 6- 8 months per subject)
Infections and infestations Nasopharyngitis	14.5% 871/6006 • Number of events 1050 • Solicited local and general symptoms were assessed during the 7-day post-vaccination period (Days 0-6 for Dose 1, Days 28-34 for Dose 2); unsolicited AEs were assessed during the 28-day (Days 0-27) post-vaccination period; SAEs were reported during the entire study period (approximately 6- 8 months per subject)	15.7% 943/6012 • Number of events 1111 • Solicited local and general symptoms were assessed during the 7-day post-vaccination period (Days 0-6 for Dose 1, Days 28-34 for Dose 2); unsolicited AEs were assessed during the 28-day (Days 0-27) post-vaccination period; SAEs were reported during the entire study period (approximately 6- 8 months per subject)
General disorders Pain	22.5% 1351/6006 • Number of events 1824 • Solicited local and general symptoms were assessed during the 7-day post-vaccination period (Days 0-6 for Dose 1, Days 28-34 for Dose 2); unsolicited AEs were assessed during the 28-day (Days 0-27) post-vaccination period; SAEs were reported during the entire study period (approximately 6- 8 months per subject)	22.9% 1376/6012 • Number of events 1868 • Solicited local and general symptoms were assessed during the 7-day post-vaccination period (Days 0-6 for Dose 1, Days 28-34 for Dose 2); unsolicited AEs were assessed during the 28-day (Days 0-27) post-vaccination period; SAEs were reported during the entire study period (approximately 6- 8 months per subject)
General disorders Pyrexia	14.4% 866/6006 • Number of events 954 • Solicited local and general symptoms were assessed during the 7-day post-vaccination period (Days 0-6 for Dose 1, Days 28-34 for Dose 2); unsolicited AEs were assessed during the 28-day (Days 0-27) post-vaccination period; SAEs were reported during the entire study period (approximately 6- 8 months per subject)	15.8% 949/6012 • Number of events 1042 • Solicited local and general symptoms were assessed during the 7-day post-vaccination period (Days 0-6 for Dose 1, Days 28-34 for Dose 2); unsolicited AEs were assessed during the 28-day (Days 0-27) post-vaccination period; SAEs were reported during the entire study period (approximately 6- 8 months per subject)
Nervous system disorders Somnolence	17.1% 1025/6006 • Number of events 1259 • Solicited local and general symptoms were assessed during the 7-day post-vaccination period (Days 0-6 for Dose 1, Days 28-34 for Dose 2); unsolicited AEs were assessed during the 28-day (Days 0-27) post-vaccination period; SAEs were reported during the entire study period (approximately 6- 8 months per subject)	18.8% 1129/6012 • Number of events 1388 • Solicited local and general symptoms were assessed during the 7-day post-vaccination period (Days 0-6 for Dose 1, Days 28-34 for Dose 2); unsolicited AEs were assessed during the 28-day (Days 0-27) post-vaccination period; SAEs were reported during the entire study period (approximately 6- 8 months per subject)
General disorders Swelling	11.1% 665/6006 • Number of events 842 • Solicited local and general symptoms were assessed during the 7-day post-vaccination period (Days 0-6 for Dose 1, Days 28-34 for Dose 2); unsolicited AEs were assessed during the 28-day (Days 0-27) post-vaccination period; SAEs were reported during the entire study period (approximately 6- 8 months per subject)	12.4% 743/6012 • Number of events 928 • Solicited local and general symptoms were assessed during the 7-day post-vaccination period (Days 0-6 for Dose 1, Days 28-34 for Dose 2); unsolicited AEs were assessed during the 28-day (Days 0-27) post-vaccination period; SAEs were reported during the entire study period (approximately 6- 8 months per subject)
Infections and infestations Upper respiratory tract infection	8.7% 522/6006 • Number of events 629 • Solicited local and general symptoms were assessed during the 7-day post-vaccination period (Days 0-6 for Dose 1, Days 28-34 for Dose 2); unsolicited AEs were assessed during the 28-day (Days 0-27) post-vaccination period; SAEs were reported during the entire study period (approximately 6- 8 months per subject)	8.6% 516/6012 • Number of events 609 • Solicited local and general symptoms were assessed during the 7-day post-vaccination period (Days 0-6 for Dose 1, Days 28-34 for Dose 2); unsolicited AEs were assessed during the 28-day (Days 0-27) post-vaccination period; SAEs were reported during the entire study period (approximately 6- 8 months per subject)

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