Trial Outcomes & Findings for Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Trivalent Split Virion Influenza Vaccine Fluviral™ (2013-2014 Season) in Adults Aged 18 Years and Older (NCT NCT01878825)

Last Updated: 2018-09-07

Results Overview

Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

121 participants

Primary outcome timeframe

At Days 0 and 21

Results posted on

2018-09-07

Participant Flow

1 volunteer was assigned a subject number but was subsequently determined to be ineligible for study participation and was never vaccinated.

Participant milestones

Participant milestones
Measure	Fluviral 18-60 Years Group Subjects aged between 18 and 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Fluviral >60 Years Group Subjects aged \> 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region 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' Trivalent Split Virion Influenza Vaccine Fluviral™ (2013-2014 Season) in Adults Aged 18 Years and Older

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fluviral 18-60 Years Group n=60 Participants Subjects aged between 18 and 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Fluviral >60 Years Group n=60 Participants Subjects aged \> 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm	Total n=120 Participants Total of all reporting groups
Age, Continuous	41.1 Years STANDARD_DEVIATION 11.63 • n=5 Participants	68.6 Years STANDARD_DEVIATION 4.92 • n=7 Participants	54.9 Years STANDARD_DEVIATION 16.42 • n=5 Participants
Sex: Female, Male Female	40 Participants n=5 Participants	32 Participants n=7 Participants	72 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	28 Participants n=7 Participants	48 Participants n=5 Participants

PRIMARY outcome

Timeframe: At Days 0 and 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.

Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).

Outcome measures

Outcome measures
Measure	Fluviral 18-60 Years Group n=59 Participants Subjects aged between 18 and 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Fluviral >60 Years Group n=60 Participants Subjects aged \> 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm	Fluviral >60 Years Group With Vaccination Subjects above 60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2012-2013 influenza season. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	Fluviral > 60 Years Group Without Vaccination Subjects above 60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2012-2013 influenza season. 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 H1N1, Day 0	61.0 Titer Interval 41.2 to 90.5	65.7 Titer Interval 48.6 to 88.9	—	—
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Influenza Strains H1N1, Day 21	337.4 Titer Interval 260.9 to 436.3	207.5 Titer Interval 163.3 to 263.5	—	—
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Influenza Strains H3N2, Day 0	37.3 Titer Interval 26.9 to 51.6	31.5 Titer Interval 23.3 to 42.7	—	—
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Influenza Strains H3N2, Day 21	159.0 Titer Interval 124.1 to 203.8	133.7 Titer Interval 101.5 to 176.2	—	—
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Influenza Strains Yamagata, Day 0	200.0 Titer Interval 150.3 to 266.1	159.0 Titer Interval 118.0 to 214.3	—	—
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Influenza Strains Yamagata, Day 21	521.1 Titer Interval 417.9 to 649.8	407.8 Titer Interval 328.9 to 505.7	—	—

PRIMARY outcome

Timeframe: At Day 21

Outcome measures

Outcome measures
Measure	Fluviral 18-60 Years Group n=59 Participants Subjects aged between 18 and 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Fluviral >60 Years Group n=60 Participants Subjects aged \> 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm	Fluviral >60 Years Group With Vaccination Subjects above 60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2012-2013 influenza season. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	Fluviral > 60 Years Group Without Vaccination Subjects above 60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2012-2013 influenza season. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
Number of Seroconverted Subjects for HI Antibodies Against Each of the Three Vaccine Influenza Strains. H1N1	32 Subjects	22 Subjects	—	—
Number of Seroconverted Subjects for HI Antibodies Against Each of the Three Vaccine Influenza Strains. H3N2	24 Subjects	25 Subjects	—	—
Number of Seroconverted Subjects for HI Antibodies Against Each of the Three Vaccine Influenza Strains. Yamagata	21 Subjects	17 Subjects	—	—

PRIMARY outcome

Timeframe: At Day 21

Outcome measures

Outcome measures
Measure	Fluviral 18-60 Years Group n=59 Participants Subjects aged between 18 and 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Fluviral >60 Years Group n=60 Participants Subjects aged \> 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm	Fluviral >60 Years Group With Vaccination Subjects above 60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2012-2013 influenza season. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	Fluviral > 60 Years Group Without Vaccination Subjects above 60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2012-2013 influenza season. 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	5.5 Fold increase Interval 3.5 to 8.6	3.2 Fold increase Interval 2.2 to 4.4	—	—
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains. H3N2	4.3 Fold increase Interval 3.0 to 6.1	4.2 Fold increase Interval 3.0 to 6.0	—	—
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains. Yamagata	2.6 Fold increase Interval 1.9 to 3.5	2.6 Fold increase Interval 1.9 to 3.5	—	—

PRIMARY outcome

Timeframe: At Days 0 and Day 21

Outcome measures

Outcome measures
Measure	Fluviral 18-60 Years Group n=59 Participants Subjects aged between 18 and 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Fluviral >60 Years Group n=60 Participants Subjects aged \> 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm	Fluviral >60 Years Group With Vaccination Subjects above 60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2012-2013 influenza season. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	Fluviral > 60 Years Group Without Vaccination Subjects above 60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2012-2013 influenza season. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Three Vaccine Influenza Strains. H1N1, Day 0	41 Subjects	44 Subjects	—	—
Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Three Vaccine Influenza Strains. H1N1, Day 21	59 Subjects	59 Subjects	—	—
Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Three Vaccine Influenza Strains. H3N2, Day 0	37 Subjects	33 Subjects	—	—
Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Three Vaccine Influenza Strains. H3N2, Day 21	56 Subjects	54 Subjects	—	—
Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Three Vaccine Influenza Strains. Yamagata, Day 0	55 Subjects	56 Subjects	—	—
Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Three Vaccine Influenza Strains. Yamagata, Day 21	59 Subjects	60 Subjects	—	—

SECONDARY outcome

Timeframe: At Days 0 and Day 21

Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/California/7/2009 (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 2012/2013 influenza season.

Outcome measures

Outcome measures
Measure	Fluviral 18-60 Years Group n=29 Participants Subjects aged between 18 and 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Fluviral >60 Years Group n=30 Participants Subjects aged \> 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm	Fluviral >60 Years Group With Vaccination n=30 Participants Subjects above 60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2012-2013 influenza season. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	Fluviral > 60 Years Group Without Vaccination n=30 Participants Subjects above 60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2012-2013 influenza season. 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 H1N1, Day 0	132.2 Titers Interval 91.6 to 190.8	28.9 Titers Interval 16.0 to 52.2	70.5 Titers Interval 49.2 to 100.9	61.3 Titers Interval 36.9 to 101.8
Humoral Immune Response in Terms of HI Antibody Titers Against Each of the Three Vaccine Influenza Strains H1N1, Day 21	249.0 Titers Interval 177.6 to 349.0	452.6 Titers Interval 311.4 to 657.7	136.1 Titers Interval 105.1 to 176.2	316.3 Titers Interval 222.0 to 450.7
Humoral Immune Response in Terms of HI Antibody Titers Against Each of the Three Vaccine Influenza Strains H3N2, Day 0	58.6 Titers Interval 38.1 to 90.2	24.1 Titers Interval 15.3 to 38.0	47.5 Titers Interval 32.5 to 69.6	20.9 Titers Interval 13.4 to 32.7
Humoral Immune Response in Terms of HI Antibody Titers Against Each of the Three Vaccine Influenza Strains H3N2, Day 21	107.9 Titers Interval 78.1 to 148.9	231.5 Titers Interval 165.1 to 324.6	109.3 Titers Interval 75.8 to 157.4	163.6 Titers Interval 107.3 to 249.5
Humoral Immune Response in Terms of HI Antibody Titers Against Each of the Three Vaccine Influenza Strains Yamagata, Day 0	352.1 Titers Interval 250.2 to 495.4	115.8 Titers Interval 79.8 to 168.0	218.6 Titers Interval 160.0 to 298.6	115.7 Titers Interval 70.1 to 191.1
Humoral Immune Response in Terms of HI Antibody Titers Against Each of the Three Vaccine Influenza Strains Yamagata, Day 21	436.7 Titers Interval 319.0 to 597.6	618.2 Titers Interval 450.8 to 847.8	342.9 Titers Interval 259.9 to 452.3	485.0 Titers Interval 347.4 to 677.1

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 greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/California/7/2009 (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 2012/2013 influenza season.

Outcome measures

Outcome measures
Measure	Fluviral 18-60 Years Group n=29 Participants Subjects aged between 18 and 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Fluviral >60 Years Group n=30 Participants Subjects aged \> 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm	Fluviral >60 Years Group With Vaccination n=30 Participants Subjects above 60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2012-2013 influenza season. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	Fluviral > 60 Years Group Without Vaccination n=30 Participants Subjects above 60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2012-2013 influenza season. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
Number of Seroconverted Subjects for HI Antibodies Against Each of the Three Vaccine Influenza Strains. H1N1	7 Subjects	25 Subjects	6 Subjects	16 Subjects
Number of Seroconverted Subjects for HI Antibodies Against Each of the Three Vaccine Influenza Strains. H3N2	4 Subjects	20 Subjects	7 Subjects	18 Subjects
Number of Seroconverted Subjects for HI Antibodies Against Each of the Three Vaccine Influenza Strains. Yamagata	2 Subjects	19 Subjects	3 Subjects	14 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/California/7/2009 (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 2012/2013 influenza season.

Outcome measures

Outcome measures
Measure	Fluviral 18-60 Years Group n=29 Participants Subjects aged between 18 and 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Fluviral >60 Years Group n=30 Participants Subjects aged \> 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm	Fluviral >60 Years Group With Vaccination n=30 Participants Subjects above 60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2012-2013 influenza season. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	Fluviral > 60 Years Group Without Vaccination n=30 Participants Subjects above 60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2012-2013 influenza season. 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	1.9 Fold increase Interval 1.4 to 2.5	15.6 Fold increase Interval 8.2 to 29.9	1.9 Fold increase Interval 1.5 to 2.5	5.2 Fold increase Interval 2.9 to 9.3
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains. H3N2	1.8 Fold increase Interval 1.4 to 2.4	9.6 Fold increase Interval 5.7 to 16.1	2.3 Fold increase Interval 1.6 to 3.2	7.8 Fold increase Interval 4.5 to 13.6
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains. Yamagata	1.2 Fold increase Interval 1.0 to 1.5	5.3 Fold increase Interval 3.5 to 8.1	1.6 Fold increase Interval 1.3 to 1.9	4.2 Fold increase Interval 2.5 to 7.1

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/California/7/2009 (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 2012/2013 influenza season.

Outcome measures

Outcome measures
Measure	Fluviral 18-60 Years Group n=29 Participants Subjects aged between 18 and 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Fluviral >60 Years Group n=30 Participants Subjects aged \> 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm	Fluviral >60 Years Group With Vaccination n=30 Participants Subjects above 60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2012-2013 influenza season. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	Fluviral > 60 Years Group Without Vaccination n=30 Participants Subjects above 60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2012-2013 influenza season. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Three Vaccine Influenza Strains. H1N1, Day 0	27 Subjects	14 Subjects	23 Subjects	21 Subjects
Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Three Vaccine Influenza Strains. H1N1, Day 21	29 Subjects	30 Subjects	29 Subjects	30 Subjects
Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Three Vaccine Influenza Strains. H3N2, Day 0	22 Subjects	15 Subjects	20 Subjects	13 Subjects
Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Three Vaccine Influenza Strains. H3N2, Day 21	27 Subjects	29 Subjects	26 Subjects	28 Subjects
Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Three Vaccine Influenza Strains. Yamagata, Day 0	29 Subjects	26 Subjects	30 Subjects	26 Subjects
Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Three Vaccine Influenza Strains. Yamagata, Day 21	29 Subjects	30 Subjects	30 Subjects	30 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.

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	Fluviral 18-60 Years Group n=60 Participants Subjects aged between 18 and 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Fluviral >60 Years Group n=60 Participants Subjects aged \> 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm	Fluviral >60 Years Group With Vaccination Subjects above 60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2012-2013 influenza season. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	Fluviral > 60 Years Group Without Vaccination Subjects above 60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2012-2013 influenza season. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
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 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	2 Subjects	1 Subjects	—	—
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. Grade 3 Induration	0 Subjects	0 Subjects	—	—
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. Any Pain	42 Subjects	15 Subjects	—	—
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. Any Redness	0 Subjects	0 Subjects	—	—
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. Grade 3 Redness	0 Subjects	0 Subjects	—	—
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. Any Swelling	5 Subjects	2 Subjects	—	—
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. Grade 3 Swelling	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.

Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering, increased sweating and fever \[oral temperature above 37.5 degrees Celsius (°C)\]. 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 = oral temperature above 39.0°C

Outcome measures

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

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.

Outcome measures

Outcome measures
Measure	Fluviral 18-60 Years Group n=60 Participants Subjects aged between 18 and 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Fluviral >60 Years Group n=60 Participants Subjects aged \> 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm	Fluviral >60 Years Group With Vaccination Subjects above 60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2012-2013 influenza season. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	Fluviral > 60 Years Group Without Vaccination Subjects above 60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2012-2013 influenza season. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)	9 Subjects	7 Subjects	—	—

SECONDARY outcome

Timeframe: During the entire study period (Days 0-20 post vaccination)

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.

Outcome measures

Outcome measures
Measure	Fluviral 18-60 Years Group n=60 Participants Subjects aged between 18 and 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Fluviral >60 Years Group n=60 Participants Subjects aged \> 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm	Fluviral >60 Years Group With Vaccination Subjects above 60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2012-2013 influenza season. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	Fluviral > 60 Years Group Without Vaccination Subjects above 60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2012-2013 influenza season. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
Number of Subjects Reporting Any Serious Adverse Events (SAEs)	0 Subjects	0 Subjects	—	—

Adverse Events

Fluarix/Influsplit 18-60 Years Group

Serious events: 0 serious events

Other events: 45 other events

Deaths: 0 deaths

Fluarix/Influsplit > 60 Years Group

Serious events: 0 serious events

Other events: 23 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 aged between 18 and 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.	Fluarix/Influsplit > 60 Years Group n=60 participants at risk Subjects aged \> 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
General disorders Pain	70.0% 42/60 • Serious Adverse Events: From Day 0 to Day 20 post vaccination; 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 20 post vaccination; 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	8.3% 5/60 • Serious Adverse Events: From Day 0 to Day 20 post vaccination; 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 20 post vaccination; 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	6.7% 4/60 • Serious Adverse Events: From Day 0 to Day 20 post vaccination; 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 20 post vaccination; 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 20 post vaccination; 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 20 post vaccination; 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	10.0% 6/60 • Serious Adverse Events: From Day 0 to Day 20 post vaccination; 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.	10.0% 6/60 • Serious Adverse Events: From Day 0 to Day 20 post vaccination; 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	30.0% 18/60 • Serious Adverse Events: From Day 0 to Day 20 post vaccination; 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.	10.0% 6/60 • Serious Adverse Events: From Day 0 to Day 20 post vaccination; 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	0.00% 0/60 • Serious Adverse Events: From Day 0 to Day 20 post vaccination; 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 20 post vaccination; 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.
Infections and infestations Upper respiratory tract infection	5.0% 3/60 • Serious Adverse Events: From Day 0 to Day 20 post vaccination; 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 20 post vaccination; 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	15.0% 9/60 • Serious Adverse Events: From Day 0 to Day 20 post vaccination; 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.	10.0% 6/60 • Serious Adverse Events: From Day 0 to Day 20 post vaccination; 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