Trial Outcomes & Findings for Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Influenza Vaccine, Fluarix®/Influsplit SSW® (2013/2014 Season), in Adults 18 Years of Age and Older (NCT NCT01884519)

NCT ID: NCT01884519

Last Updated: 2018-09-07

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

120 participants

Primary outcome timeframe

At Day 0 and Day 21

Results posted on

2018-09-07

Participant Flow

Participant milestones

Participant milestones
Measure	Fluarix/Influsplit 18-60 Years Group Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	Fluarix/Influsplit > 60 Years Group Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
Overall Study STARTED	60	60
Overall Study COMPLETED	60	60
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Influenza Vaccine, Fluarix®/Influsplit SSW® (2013/2014 Season), in Adults 18 Years of Age and Older

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fluarix/Influsplit 18-60 Years Group n=60 Participants Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	Fluarix/Influsplit > 60 Years Group n=60 Participants Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	Total n=120 Participants Total of all reporting groups
Age, Continuous	42.6 Years STANDARD_DEVIATION 11.5 • n=5 Participants	68.2 Years STANDARD_DEVIATION 5.49 • n=7 Participants	55.4 Years STANDARD_DEVIATION 15.68 • n=5 Participants
Sex: Female, Male Female	38 Participants n=5 Participants	34 Participants n=7 Participants	72 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	26 Participants n=7 Participants	48 Participants n=5 Participants

PRIMARY outcome

Timeframe: At Day 0 and Day 21

Population: Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

Outcome measures

Outcome measures
Measure	Fluarix/Influsplit 18-60 Years Group n=60 Participants Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	Fluarix/Influsplit > 60 Years Group n=60 Participants Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	Fluarix/Influsplit > 60 Years Group With Vaccination Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	Fluarix/Influsplit > 60 Years Group Without Vaccination Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Influenza Strains H3N2, Day 21	73.8 Titer Interval 57.8 to 94.2	80.0 Titer Interval 58.4 to 109.5	—	—
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Influenza Strains H1N1, Day 0	27.3 Titer Interval 20.3 to 36.8	15.7 Titer Interval 12.1 to 20.4	—	—
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Influenza Strains H1N1, Day 21	444.6 Titer Interval 335.6 to 588.9	197.0 Titer Interval 142.6 to 272.1	—	—
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Influenza Strains H3N2, Day 0	15.8 Titer Interval 11.9 to 21.1	14.2 Titer Interval 11.0 to 18.4	—	—
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Influenza Strains Yamagata, Day 0	105.0 Titer Interval 83.6 to 131.8	95.2 Titer Interval 77.5 to 116.9	—	—
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Influenza Strains Yamagata, Day 21	424.6 Titer Interval 347.6 to 518.8	327.5 Titer Interval 266.2 to 402.9	—	—

PRIMARY outcome

Timeframe: At Day 0 and Day 21

Outcome measures

Outcome measures
Measure	Fluarix/Influsplit 18-60 Years Group n=60 Participants Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	Fluarix/Influsplit > 60 Years Group n=60 Participants Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	Fluarix/Influsplit > 60 Years Group With Vaccination Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	Fluarix/Influsplit > 60 Years Group Without Vaccination Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the Three Vaccine Influenza Strains. H1N1, Day 0	25 Subjects	14 Subjects	—	—
Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the Three Vaccine Influenza Strains. H1N1, Day 21	58 Subjects	56 Subjects	—	—
Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the Three Vaccine Influenza Strains. H3N2, Day 0	12 Subjects	12 Subjects	—	—
Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the Three Vaccine Influenza Strains. H3N2, Day 21	50 Subjects	44 Subjects	—	—
Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the Three Vaccine Influenza Strains. Yamagata, Day 0	53 Subjects	55 Subjects	—	—
Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the Three Vaccine Influenza Strains. Yamagata, Day 21	60 Subjects	60 Subjects	—	—

PRIMARY outcome

Timeframe: At Day 21

A seroconverted subjects was defined as a vaccinated subject with either a pre-vaccination titer less than (\<) 1:10 and a post-vaccination titer ≥ 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/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).

Outcome measures

Outcome measures
Measure	Fluarix/Influsplit 18-60 Years Group n=60 Participants Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	Fluarix/Influsplit > 60 Years Group n=60 Participants Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	Fluarix/Influsplit > 60 Years Group With Vaccination Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	Fluarix/Influsplit > 60 Years Group Without Vaccination Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains. H1N1	44 Subjects	46 Subjects	—	—
Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains. H3N2	31 Subjects	29 Subjects	—	—
Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains. Yamagata	30 Subjects	23 Subjects	—	—

PRIMARY outcome

Timeframe: At Day 21

Outcome measures

Outcome measures
Measure	Fluarix/Influsplit 18-60 Years Group n=60 Participants Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	Fluarix/Influsplit > 60 Years Group n=60 Participants Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	Fluarix/Influsplit > 60 Years Group With Vaccination Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	Fluarix/Influsplit > 60 Years Group Without Vaccination Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains. H1N1	16.3 Fold increase Interval 10.8 to 24.5	12.6 Fold increase Interval 8.7 to 18.2	—	—
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains. H3N2	4.7 Fold increase Interval 3.4 to 6.4	5.6 Fold increase Interval 4.0 to 7.9	—	—
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains. Yamagata	4.0 Fold increase Interval 3.1 to 5.3	3.4 Fold increase Interval 2.7 to 4.3	—	—

PRIMARY outcome

Timeframe: At Day 21

SPP was defined as the number of vaccinated subjects with a pre-vaccination titer \< 1:40 and a post-vaccination titer ≥ 1:40. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).

Outcome measures

Outcome measures
Measure	Fluarix/Influsplit 18-60 Years Group n=48 Participants Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	Fluarix/Influsplit > 60 Years Group n=48 Participants Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	Fluarix/Influsplit > 60 Years Group With Vaccination Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	Fluarix/Influsplit > 60 Years Group Without Vaccination Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
Number of Subjects With Seroprotection Power (SPP) for HI Antibody Titer Against Each of the Three Vaccine Influenza Strains Above the Cut-off Value. H1N1 [N=35,46]	33 Subjects	42 Subjects	—	—
Number of Subjects With Seroprotection Power (SPP) for HI Antibody Titer Against Each of the Three Vaccine Influenza Strains Above the Cut-off Value. H3N2 [N=48,48]	38 Subjects	32 Subjects	—	—
Number of Subjects With Seroprotection Power (SPP) for HI Antibody Titer Against Each of the Three Vaccine Influenza Strains Above the Cut-off Value. Yamagata [N=7,5]	7 Subjects	5 Subjects	—	—

SECONDARY outcome

Timeframe: At Days 0 and 21

Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata). This outcome measure was assessed by influenza vaccination status in subjects (18-60 years and \>60 years) who had and who had not received an influenza vaccine during the 2 influenza seasons prior to season 2012/2013.

Outcome measures

Outcome measures
Measure	Fluarix/Influsplit 18-60 Years Group n=20 Participants Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	Fluarix/Influsplit > 60 Years Group n=40 Participants Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	Fluarix/Influsplit > 60 Years Group With Vaccination n=29 Participants Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	Fluarix/Influsplit > 60 Years Group Without Vaccination n=31 Participants Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
Humoral Immune Response in Terms of HI Antibody Titers Against Each of the Three Vaccine Influenza Strains Yamagata, Day 21	355.0 Titers Interval 247.3 to 509.5	464.4 Titers Interval 362.9 to 594.2	237.3 Titers Interval 184.2 to 305.8	442.6 Titers Interval 328.9 to 595.7
Humoral Immune Response in Terms of HI Antibody Titers Against Each of the Three Vaccine Influenza Strains H1N1, Day 0	28.7 Titers Interval 17.2 to 48.1	26.6 Titers Interval 18.2 to 38.9	16.3 Titers Interval 10.5 to 25.2	15.1 Titers Interval 10.9 to 21.0
Humoral Immune Response in Terms of HI Antibody Titers Against Each of the Three Vaccine Influenza Strains H1N1, Day 21	348.8 Titers Interval 200.3 to 607.4	501.9 Titers Interval 361.0 to 698.0	158.2 Titers Interval 99.1 to 252.5	241.9 Titers Interval 152.7 to 383.3
Humoral Immune Response in Terms of HI Antibody Titers Against Each of the Three Vaccine Influenza Strains H3N2, Day 0	18.6 Titers Interval 10.8 to 32.0	14.6 Titers Interval 10.3 to 20.8	17.3 Titers Interval 11.4 to 26.2	11.8 Titers Interval 8.6 to 16.2
Humoral Immune Response in Terms of HI Antibody Titers Against Each of the Three Vaccine Influenza Strains H3N2, Day 21	60.6 Titers Interval 39.3 to 93.5	81.4 Titers Interval 60.0 to 110.4	58.6 Titers Interval 39.9 to 86.2	106.9 Titers Interval 65.6 to 174.3
Humoral Immune Response in Terms of HI Antibody Titers Against Each of the Three Vaccine Influenza Strains Yamagata, Day 0	109.3 Titers Interval 74.3 to 160.9	102.9 Titers Interval 76.7 to 138.0	110.6 Titers Interval 84.6 to 144.5	82.7 Titers Interval 60.3 to 113.4

SECONDARY outcome

Timeframe: At Day 0 and Day 21

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/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata). This outcome measure was assessed by influenza vaccination status in subjects (18-60 years and \>60 years) who had and who had not received an influenza vaccine during the 2 influenza seasons prior to season 2012/2013.

Outcome measures

Outcome measures
Measure	Fluarix/Influsplit 18-60 Years Group n=20 Participants Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	Fluarix/Influsplit > 60 Years Group n=40 Participants Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	Fluarix/Influsplit > 60 Years Group With Vaccination n=29 Participants Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	Fluarix/Influsplit > 60 Years Group Without Vaccination n=31 Participants Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the Three Vaccine Influenza Strains. Yamagata, Day 0	18 Subjects	35 Subjects	29 Subjects	26 Subjects
Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the Three Vaccine Influenza Strains. H1N1, Day 0	9 Subjects	16 Subjects	8 Subjects	6 Subjects
Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the Three Vaccine Influenza Strains. H1N1, Day 21	19 Subjects	39 Subjects	26 Subjects	30 Subjects
Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the Three Vaccine Influenza Strains. H3N2, Day 0	5 Subjects	7 Subjects	6 Subjects	6 Subjects
Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the Three Vaccine Influenza Strains. H3N2, Day 21	16 Subjects	34 Subjects	20 Subjects	24 Subjects
Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the Three Vaccine Influenza Strains. Yamagata, Day 21	20 Subjects	40 Subjects	29 Subjects	31 Subjects

SECONDARY outcome

Timeframe: At Day 21

A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (\<) 1:10 and a post-vaccination titer ≥ 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/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata). This outcome measure was assessed by influenza vaccination status in subjects (18-60 years and \>60 years) who had and who had not received an influenza vaccine during the 2 influenza seasons prior to season 2012/2013.

Outcome measures

Outcome measures
Measure	Fluarix/Influsplit 18-60 Years Group n=20 Participants Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	Fluarix/Influsplit > 60 Years Group n=40 Participants Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	Fluarix/Influsplit > 60 Years Group With Vaccination n=29 Participants Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	Fluarix/Influsplit > 60 Years Group Without Vaccination n=31 Participants Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains. H1N1	13 Subjects	31 Subjects	20 Subjects	26 Subjects
Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains. H3N2	8 Subjects	23 Subjects	10 Subjects	19 Subjects
Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains. Yamagata	6 Subjects	24 Subjects	5 Subjects	18 Subjects

SECONDARY outcome

Timeframe: At Day 21

MGI was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata). This outcome measure was assessed by influenza vaccination status in subjects (18-60 years and \>60 years) who had and who had not received an influenza vaccine during the 2 influenza seasons prior to season 2012/2013.

Outcome measures

Outcome measures
Measure	Fluarix/Influsplit 18-60 Years Group n=20 Participants Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	Fluarix/Influsplit > 60 Years Group n=40 Participants Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	Fluarix/Influsplit > 60 Years Group With Vaccination n=29 Participants Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	Fluarix/Influsplit > 60 Years Group Without Vaccination n=31 Participants Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains. Yamagata	3.2 Fold increase Interval 2.0 to 5.2	4.5 Fold increase Interval 3.2 to 6.3	2.1 Fold increase Interval 1.7 to 2.7	5.4 Fold increase Interval 3.9 to 7.4
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains. H1N1	12.1 Fold increase Interval 5.8 to 25.4	18.9 Fold increase Interval 11.4 to 31.4	9.7 Fold increase Interval 5.5 to 17.0	16.0 Fold increase Interval 9.7 to 26.5
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains. H3N2	3.3 Fold increase Interval 2.0 to 5.2	5.6 Fold increase Interval 3.7 to 8.3	3.4 Fold increase Interval 2.4 to 4.8	9.1 Fold increase Interval 5.3 to 15.5

SECONDARY outcome

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

Population: Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.

Solicited local symptoms assessed were ecchymosis, induration, pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that prevented normal everyday activities. Grade 3 ecchymosis, induration, redness and swelling was greater than 100 millimeters (mm) i.e. \>100mm.

Outcome measures

Outcome measures
Measure	Fluarix/Influsplit 18-60 Years Group n=60 Participants Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	Fluarix/Influsplit > 60 Years Group n=60 Participants Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	Fluarix/Influsplit > 60 Years Group With Vaccination Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	Fluarix/Influsplit > 60 Years Group Without Vaccination Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. Any Pain	38 Subjects	15 Subjects	—	—
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. Grade 3 Pain	0 Subjects	0 Subjects	—	—
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. Any Redness	8 Subjects	3 Subjects	—	—
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. Grade 3 Redness	0 Subjects	0 Subjects	—	—
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. Any Swelling	6 Subjects	2 Subjects	—	—
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. Grade 3 Swelling	0 Subjects	0 Subjects	—	—
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. Any Ecchymosis	0 Subjects	0 Subjects	—	—
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. Grade 3 Ecchymosis	0 Subjects	0 Subjects	—	—
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. Any Induration	0 Subjects	2 Subjects	—	—
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. Grade 3 Induration	0 Subjects	0 Subjects	—	—

SECONDARY outcome

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

Population: Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom.

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

Outcome measures

Outcome measures
Measure	Fluarix/Influsplit 18-60 Years Group n=38 Participants Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	Fluarix/Influsplit > 60 Years Group n=15 Participants Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	Fluarix/Influsplit > 60 Years Group With Vaccination Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	Fluarix/Influsplit > 60 Years Group Without Vaccination Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
Duration of Solicited Local Symptoms. Induration [N=0,2]	0.0 Days Interval 0.0 to 0.0	1.5 Days Interval 1.0 to 2.0	—	—
Duration of Solicited Local Symptoms. Pain [N=38, 15]	2.0 Days Interval 1.0 to 4.0	2.0 Days Interval 1.0 to 4.0	—	—
Duration of Solicited Local Symptoms. Redness [N=8,3]	2.0 Days Interval 1.0 to 4.0	2.0 Days Interval 2.0 to 4.0	—	—
Duration of Solicited Local Symptoms. Swelling [N=6,2]	1.0 Days Interval 1.0 to 4.0	2.0 Days Interval 2.0 to 2.0	—	—

SECONDARY outcome

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

Population: Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.

Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering, increased sweating and fever \[axillary temperature above 37.5 degrees Celsius (°C)\]. Gastrointestinal symptoms included nausea, vomiting, diarrhea and/or abdominal pain. Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = axillary temperature above 39.0°C

Outcome measures

Outcome measures
Measure	Fluarix/Influsplit 18-60 Years Group n=60 Participants Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	Fluarix/Influsplit > 60 Years Group n=60 Participants Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	Fluarix/Influsplit > 60 Years Group With Vaccination Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	Fluarix/Influsplit > 60 Years Group Without Vaccination Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Arthralgia	5 Subjects	5 Subjects	—	—
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Arthralgia	0 Subjects	0 Subjects	—	—
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Arthralgia	4 Subjects	3 Subjects	—	—
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Fatigue	10 Subjects	7 Subjects	—	—
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Fatigue	0 Subjects	0 Subjects	—	—
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Fatigue	6 Subjects	4 Subjects	—	—
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Gastrointestinal symptoms	4 Subjects	1 Subjects	—	—
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Gastrointestinal symptoms	0 Subjects	0 Subjects	—	—
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Gastrointestinal symptoms	3 Subjects	1 Subjects	—	—
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Headache	10 Subjects	5 Subjects	—	—
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Headache	2 Subjects	0 Subjects	—	—
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Headache	9 Subjects	5 Subjects	—	—
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Myalgia	14 Subjects	5 Subjects	—	—
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Myalgia	0 Subjects	0 Subjects	—	—
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Myalgia	12 Subjects	4 Subjects	—	—
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Shivering	4 Subjects	0 Subjects	—	—
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Shivering	0 Subjects	0 Subjects	—	—
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Shivering	4 Subjects	0 Subjects	—	—
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Sweating	3 Subjects	7 Subjects	—	—
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Sweating	0 Subjects	0 Subjects	—	—
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Sweating	1 Subjects	4 Subjects	—	—
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Fever ≥( 37.5°C)	0 Subjects	1 Subjects	—	—
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Fever (>39.0°C)	0 Subjects	0 Subjects	—	—
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Fever	0 Subjects	1 Subjects	—	—

SECONDARY outcome

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

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

Outcome measures

Outcome measures
Measure	Fluarix/Influsplit 18-60 Years Group n=14 Participants Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	Fluarix/Influsplit > 60 Years Group n=7 Participants Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	Fluarix/Influsplit > 60 Years Group With Vaccination Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	Fluarix/Influsplit > 60 Years Group Without Vaccination Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
Duration of Solicited General Symptoms. Fever (Axillary) [N=0,1]	0.0 Days Interval 0.0 to 0.0	1.0 Days Interval 1.0 to 1.0	—	—
Duration of Solicited General Symptoms. Arthralgia [N=5,5]	1.0 Days Interval 1.0 to 4.0	1.0 Days Interval 1.0 to 4.0	—	—
Duration of Solicited General Symptoms. Fatigue [N=10, 7]	1.0 Days Interval 1.0 to 2.0	2.0 Days Interval 1.0 to 4.0	—	—
Duration of Solicited General Symptoms. Gastrointestinal symptoms [N=4,1]	1.0 Days Interval 1.0 to 1.0	3.0 Days Interval 3.0 to 3.0	—	—
Duration of Solicited General Symptoms. Headache [N=10,5]	1.5 Days Interval 1.0 to 3.0	1.0 Days Interval 1.0 to 2.0	—	—
Duration of Solicited General Symptoms. Myalgia [N=14,5]	1.0 Days Interval 1.0 to 4.0	2.0 Days Interval 1.0 to 3.0	—	—
Duration of Solicited General Symptoms. Sweating [N=3,7]	1.0 Days Interval 1.0 to 1.0	1.0 Days Interval 1.0 to 4.0	—	—
Duration of Solicited General Symptoms. Shivering [N=4,0]	1.0 Days Interval 1.0 to 1.0	0.0 Days Interval 0.0 to 0.0	—	—

SECONDARY outcome

Timeframe: During the 21-day (Days 0-20) post-vaccination period

Population: Analysis was performed on the Total Vaccinated cohort, which included all subjects with 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	Fluarix/Influsplit 18-60 Years Group n=60 Participants Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	Fluarix/Influsplit > 60 Years Group n=60 Participants Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	Fluarix/Influsplit > 60 Years Group With Vaccination Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	Fluarix/Influsplit > 60 Years Group Without Vaccination Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Any Unsolicted AEs	5 Subjects	3 Subjects	—	—
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Grade 3 Unsolicted AEs	0 Subjects	0 Subjects	—	—
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Related Unsolicted AEs	0 Subjects	1 Subjects	—	—

SECONDARY outcome

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

Population: Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.

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

Outcome measures

Outcome measures
Measure	Fluarix/Influsplit 18-60 Years Group n=60 Participants Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	Fluarix/Influsplit > 60 Years Group n=60 Participants Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	Fluarix/Influsplit > 60 Years Group With Vaccination Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	Fluarix/Influsplit > 60 Years Group Without Vaccination Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Any SAEs	0 Subjects	0 Subjects	—	—
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Related SAEs	0 Subjects	0 Subjects	—	—

Adverse Events

Fluarix/Influsplit 18-60 Years Group

Serious events: 0 serious events

Other events: 47 other events

Deaths: 0 deaths

Fluarix/Influsplit > 60 Years Group

Serious events: 0 serious events

Other events: 24 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Fluarix/Influsplit 18-60 Years Group n=60 participants at risk Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	Fluarix/Influsplit > 60 Years Group n=60 participants at risk Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
General disorders Shivering	6.7% 4/60 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period; Unsolicited symptoms: During the 21-day (Day 0-20) post-vaccination period For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	0.00% 0/60 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period; Unsolicited symptoms: During the 21-day (Day 0-20) post-vaccination period For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
General disorders Sweating	5.0% 3/60 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period; Unsolicited symptoms: During the 21-day (Day 0-20) post-vaccination period For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	11.7% 7/60 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period; Unsolicited symptoms: During the 21-day (Day 0-20) post-vaccination period For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
General disorders Pain	63.3% 38/60 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period; Unsolicited symptoms: During the 21-day (Day 0-20) post-vaccination period For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	25.0% 15/60 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period; Unsolicited symptoms: During the 21-day (Day 0-20) post-vaccination period For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
General disorders Redness	13.3% 8/60 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period; Unsolicited symptoms: During the 21-day (Day 0-20) post-vaccination period For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	5.0% 3/60 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period; Unsolicited symptoms: During the 21-day (Day 0-20) post-vaccination period For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
General disorders Swelling	10.0% 6/60 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period; Unsolicited symptoms: During the 21-day (Day 0-20) post-vaccination period For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	3.3% 2/60 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period; Unsolicited symptoms: During the 21-day (Day 0-20) post-vaccination period For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
General disorders Arthralgia	8.3% 5/60 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period; Unsolicited symptoms: During the 21-day (Day 0-20) post-vaccination period For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	8.3% 5/60 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period; Unsolicited symptoms: During the 21-day (Day 0-20) post-vaccination period For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
General disorders Fatigue	16.7% 10/60 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period; Unsolicited symptoms: During the 21-day (Day 0-20) post-vaccination period For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	11.7% 7/60 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period; Unsolicited symptoms: During the 21-day (Day 0-20) post-vaccination period For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
General disorders Gastrointestinal symptoms	6.7% 4/60 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period; Unsolicited symptoms: During the 21-day (Day 0-20) post-vaccination period For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	1.7% 1/60 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period; Unsolicited symptoms: During the 21-day (Day 0-20) post-vaccination period For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
General disorders Headache	16.7% 10/60 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period; Unsolicited symptoms: During the 21-day (Day 0-20) post-vaccination period For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	8.3% 5/60 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period; Unsolicited symptoms: During the 21-day (Day 0-20) post-vaccination period For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
General disorders Myalgia	23.3% 14/60 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period; Unsolicited symptoms: During the 21-day (Day 0-20) post-vaccination period For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.	8.3% 5/60 • Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period; Unsolicited symptoms: During the 21-day (Day 0-20) post-vaccination period For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

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

Restriction type: OTHER