Trial Outcomes & Findings for A Study for Evaluation of Immunogenicity and Reactogenicity of Fluarix/Influsplit SSW 2012/2013 in People Aged 18 Years and Above (NCT NCT01607112)

Last Updated: 2018-09-07

Results Overview

Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/Christchurch/16/10 (H1N1), Flu A/Victoria/361/11 (H3N2) and Flu B/Hubei-Wujiagang/158/09 (Yamagata).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

119 participants

Primary outcome timeframe

At Day 0 and Day 21

Results posted on

2018-09-07

Participant Flow

Approximately 50% of subjects in the Fluarix/Influsplit \> 60 Years Group and a maximum of 25% of subjects in the Fluarix/Influsplit 18-60 Years Group were allowed to have had a seasonal influenza vaccination the year before.

Participant milestones

Participant milestones
Measure	Fluarix/Influsplit 18-60 Years Group Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 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 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
Overall Study STARTED	60	59
Overall Study COMPLETED	60	59
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study for Evaluation of Immunogenicity and Reactogenicity of Fluarix/Influsplit SSW 2012/2013 in People Aged 18 Years and Above

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 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	Fluarix/Influsplit > 60 Years Group n=59 Participants Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	Total n=119 Participants Total of all reporting groups
Age, Continuous	35.7 Years STANDARD_DEVIATION 11.98 • n=93 Participants	70.3 Years STANDARD_DEVIATION 5.87 • n=4 Participants	52.8 Years STANDARD_DEVIATION 19.7 • n=27 Participants
Sex: Female, Male Female	30 Participants n=93 Participants	34 Participants n=4 Participants	64 Participants n=27 Participants
Sex: Female, Male Male	30 Participants n=93 Participants	25 Participants n=4 Participants	55 Participants n=27 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.

Outcome measures

Outcome measures
Measure	Fluarix/Influsplit 18-60 Years Group n=59 Participants Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	Fluarix/Influsplit > 60 Years Group n=58 Participants Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
Humoral Immune Response in Terms of Haemagglutination (HA) Antibody Titers Against Each of the Three Vaccine Influenza Strains H1N1, Day 0	20.57 Titer Interval 13.98 to 30.27	19.02 Titer Interval 14.35 to 25.22
Humoral Immune Response in Terms of Haemagglutination (HA) Antibody Titers Against Each of the Three Vaccine Influenza Strains H1N1, Day 21	366.04 Titer Interval 264.22 to 507.09	110.44 Titer Interval 79.5 to 153.43
Humoral Immune Response in Terms of Haemagglutination (HA) Antibody Titers Against Each of the Three Vaccine Influenza Strains H3N2, Day 0	16.17 Titer Interval 12.07 to 21.65	23.90 Titer Interval 17.07 to 33.45
Humoral Immune Response in Terms of Haemagglutination (HA) Antibody Titers Against Each of the Three Vaccine Influenza Strains H3N2, Day 21	93.19 Titer Interval 73.75 to 117.76	65.63 Titer Interval 48.37 to 89.05
Humoral Immune Response in Terms of Haemagglutination (HA) Antibody Titers Against Each of the Three Vaccine Influenza Strains Yamagata, Day 0	68.60 Titer Interval 50.26 to 93.63	70.19 Titer Interval 58.98 to 83.53
Humoral Immune Response in Terms of Haemagglutination (HA) Antibody Titers Against Each of the Three Vaccine Influenza Strains Yamagata, Day 21	431.85 Titer Interval 332.61 to 560.7	223.56 Titer Interval 183.62 to 272.19

PRIMARY outcome

Timeframe: At Day 0 and Day 21

Seroprotection rate (SPR) was defined as the number of vaccinees with serum haemagglutination inhibition (HI) titer greater than or equal to (≥) 1:40.

Outcome measures

Outcome measures
Measure	Fluarix/Influsplit 18-60 Years Group n=59 Participants Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	Fluarix/Influsplit > 60 Years Group n=58 Participants Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
Number of Subjects Who Were Seroprotected for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains. H1N1, Day 0	20 Subjects	14 Subjects
Number of Subjects Who Were Seroprotected for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains. H1N1, Day 21	55 Subjects	47 Subjects
Number of Subjects Who Were Seroprotected for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains. H3N2, Day 0	15 Subjects	23 Subjects
Number of Subjects Who Were Seroprotected for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains. H3N2, Day 21	51 Subjects	41 Subjects
Number of Subjects Who Were Seroprotected for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains. Yamagata, Day 0	42 Subjects	51 Subjects
Number of Subjects Who Were Seroprotected for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains. Yamagata, Day 21	59 Subjects	58 Subjects

PRIMARY outcome

Timeframe: At Day 21

A seroconverted subjects was defined as a vaccinee 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.

Outcome measures

Outcome measures
Measure	Fluarix/Influsplit 18-60 Years Group n=59 Participants Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	Fluarix/Influsplit > 60 Years Group n=58 Participants Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. 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	45 Subjects	34 Subjects
Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains. H3N2	34 Subjects	14 Subjects
Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains. Yamagata	38 Subjects	24 Subjects

PRIMARY outcome

Timeframe: At Day 21

MGI was defined as the fold increase in serum HI GMT post-vaccination compared to Day 0.

Outcome measures

Outcome measures
Measure	Fluarix/Influsplit 18-60 Years Group n=59 Participants Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	Fluarix/Influsplit > 60 Years Group n=58 Participants Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. 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	17.8 Fold increase Interval 11.5 to 27.6	5.8 Fold increase Interval 4.2 to 8.0
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains. H3N2	5.8 Fold increase Interval 4.2 to 7.8	2.7 Fold increase Interval 2.2 to 3.4
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains. Yamagata	6.3 Fold increase Interval 4.6 to 8.7	3.2 Fold increase Interval 2.6 to 3.9

PRIMARY outcome

Timeframe: At Day 21

SPP was defined as the number of vaccinees with a pre-vaccination titer \< 1:40 and a post-vaccination titer ≥ 1:40.

Outcome measures

Outcome measures
Measure	Fluarix/Influsplit 18-60 Years Group n=44 Participants Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	Fluarix/Influsplit > 60 Years Group n=44 Participants Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. 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=39,44]	35 Subjects	33 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=44,35]	36 Subjects	18 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=17,7]	17 Subjects	7 Subjects

SECONDARY outcome

Timeframe: At Day 0 and Day 21

Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains included H1N1, H3N2 and Yamagata antigens. The outcome measure was assessed by influenza vaccination status in the 2011-2012 season, in subjects aged greater than (\>) 60 years.

Outcome measures

Outcome measures
Measure	Fluarix/Influsplit 18-60 Years Group n=30 Participants Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	Fluarix/Influsplit > 60 Years Group n=28 Participants Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
Humoral Immune Response in Terms of Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains. H3N2, Day 0	24.02 Titer Interval 15.11 to 38.17	23.76 Titer Interval 14.12 to 40.0
Humoral Immune Response in Terms of Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains. H3N2, Day 21	57.22 Titer Interval 35.97 to 91.03	76.01 Titer Interval 50.24 to 114.99
Humoral Immune Response in Terms of Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains. Yamagata, Day 0	77.34 Titer Interval 62.16 to 96.23	63.26 Titer Interval 47.63 to 84.01
Humoral Immune Response in Terms of Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains. Yamagata, Day 21	208.70 Titer Interval 159.83 to 272.52	240.65 Titer Interval 177.18 to 326.87
Humoral Immune Response in Terms of Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains. H1N1, Day 0	22.13 Titer Interval 14.86 to 32.95	16.18 Titer Interval 10.67 to 24.53
Humoral Immune Response in Terms of Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains. H1N1, Day 21	92.92 Titer Interval 59.75 to 144.52	132.89 Titer Interval 79.8 to 221.3

SECONDARY outcome

Timeframe: At Day 0 and Day 21

Seroprotection rate SPR was defined as the number of vaccinees with serum haemagglutination inhibition (HI) titer greater than or equal to (≥) 1:40. The outcome measure was assessed by the influenza vaccination status in the 2011-2012 season, in subjects aged \> 60 years.

Outcome measures

Outcome measures
Measure	Fluarix/Influsplit 18-60 Years Group n=30 Participants Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	Fluarix/Influsplit > 60 Years Group n=28 Participants Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
Number of Subjects Who Were Seroprotected for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains. H1N1, Day 0	9 Subjects	5 Subjects
Number of Subjects Who Were Seroprotected for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains. H3N2, Day 0	12 Subjects	11 Subjects
Number of Subjects Who Were Seroprotected for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains. H3N2, Day 21	21 Subjects	20 Subjects
Number of Subjects Who Were Seroprotected for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains. H1N1, Day 21	24 Subjects	23 Subjects
Number of Subjects Who Were Seroprotected for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains. Yamagata, Day 0	28 Subjects	23 Subjects
Number of Subjects Who Were Seroprotected for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains. Yamagata, Day 21	30 Subjects	28 Subjects

SECONDARY outcome

Timeframe: At Day 21

SCR was defined as the number of vaccinees 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 4-fold increase in post-vaccination titer. The outcome measure was assessed by influenza vaccination status in the 2011-2012 season, in subjects aged \> 60 years.

Outcome measures

Outcome measures
Measure	Fluarix/Influsplit 18-60 Years Group n=30 Participants Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	Fluarix/Influsplit > 60 Years Group n=28 Participants Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
Number of Subjects Who Seroconverted for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains. H1N1	15 Subjects	19 Subjects
Number of Subjects Who Seroconverted for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains. H3N2	6 Subjects	8 Subjects
Number of Subjects Who Seroconverted for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains. Yamagata	11 Subjects	13 Subjects

SECONDARY outcome

Timeframe: At Day 21

MGI was defined as the fold increase in serum HI GMT post-vaccination compared to Day 0. This outcome measure was assessed by influenza vaccination status in the 2011-2012 season, in subjects aged \> 60 years.

Outcome measures

Outcome measures
Measure	Fluarix/Influsplit 18-60 Years Group n=30 Participants Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	Fluarix/Influsplit > 60 Years Group n=28 Participants Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. 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	4.2 Fold increase Interval 2.8 to 6.4	8.2 Fold increase Interval 5.1 to 13.3
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains. H3N2	2.4 Fold increase Interval 1.9 to 3.0	3.2 Fold increase Interval 2.1 to 4.8
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains. Yamagata	2.7 Fold increase Interval 2.2 to 3.4	3.8 Fold increase Interval 2.8 to 5.3

SECONDARY outcome

Timeframe: During the 4-day follow-up period (Days 0-3) after vaccination

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

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=33 Participants Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	Fluarix/Influsplit > 60 Years Group n=23 Participants Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
Duration of Solicited Local Symptoms. Redness [N=6,7]	2.5 Days Interval 1.0 to 4.0	2.0 Days Interval 1.0 to 3.0
Duration of Solicited Local Symptoms. Induration [N=2,4]	2.5 Days Interval 2.0 to 3.0	2.0 Days Interval 1.0 to 2.0
Duration of Solicited Local Symptoms. Pain [N=33,23]	2.0 Days Interval 1.0 to 4.0	2.0 Days Interval 1.0 to 3.0
Duration of Solicited Local Symptoms. Swelling [N=6,5]	2.0 Days Interval 1.0 to 4.0	2.0 Days Interval 1.0 to 3.0

SECONDARY outcome

Timeframe: During the 4-day (Day 0-Day 3) follow-up period after vaccination

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 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	Fluarix/Influsplit > 60 Years Group n=59 Participants Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. 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 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	4 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	33 Subjects	23 Subjects
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. Grade 3 Pain	1 Subjects	0 Subjects
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. Any Redness	6 Subjects	7 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	5 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 follow-up period (Days 0-3) after vaccination

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

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=15 Participants Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	Fluarix/Influsplit > 60 Years Group n=14 Participants Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
Duration of Solicited General Symptoms. Myalgia [N=11,7]	1.0 Days Interval 1.0 to 3.0	1.0 Days Interval 1.0 to 4.0
Duration of Solicited General Symptoms. Arthralgia [N=2,4]	2.5 Days Interval 2.0 to 3.0	3.0 Days Interval 1.0 to 4.0
Duration of Solicited General Symptoms. Fatigue [N=11,14]	1.0 Days Interval 1.0 to 3.0	2.0 Days Interval 1.0 to 4.0
Duration of Solicited General Symptoms. Gastrointestinal symptoms [N=4,3]	1.0 Days Interval 1.0 to 2.0	1.0 Days Interval 1.0 to 2.0
Duration of Solicited General Symptoms. Headache [N=15,7]	1.0 Days Interval 1.0 to 4.0	1.0 Days Interval 1.0 to 1.0
Duration of Solicited General Symptoms. Sweating increase [N=8,9]	1.0 Days Interval 1.0 to 4.0	2.0 Days Interval 1.0 to 4.0
Duration of Solicited General Symptoms. Shivering [N=1,2]	1.0 Days Interval 1.0 to 1.0	1.5 Days Interval 1.0 to 2.0
Duration of Solicited General Symptoms. Fever (Axillary) [N=2,1]	1.0 Days Interval 1.0 to 1.0	4.0 Days Interval 4.0 to 4.0

SECONDARY outcome

Timeframe: During the 4-day follow-up period (Day 0-3) after vaccination

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 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	Fluarix/Influsplit > 60 Years Group n=59 Participants Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. 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. Related Arthralgia	2 Subjects	1 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Arthralgia	2 Subjects	4 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. Any Fatigue	11 Subjects	14 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Fatigue	1 Subjects	0 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Fatigue	7 Subjects	10 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	0 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Gastrointestinal symptoms	2 Subjects	3 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Headache	15 Subjects	7 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Headache	1 Subjects	1 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Headache	11 Subjects	6 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Myalgia	11 Subjects	7 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	11 Subjects	5 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Shivering	1 Subjects	2 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	1 Subjects	1 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Sweating increase	8 Subjects	9 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Sweating increase	0 Subjects	0 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Sweating increase	6 Subjects	6 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 follow-up period (Days 0-20) after vaccination

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 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	Fluarix/Influsplit > 60 Years Group n=59 Participants Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. 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). Related Unsolicted AEs	4 Subjects	3 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs). Any Unsolicted AEs	8 Subjects	11 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs). Grade 3 Unsolicted AEs	0 Subjects	1 Subjects

SECONDARY outcome

Timeframe: During the entire study period (Days 0-21)

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 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	Fluarix/Influsplit > 60 Years Group n=59 Participants Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. 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

Adult Group

Serious events: 0 serious events

Other events: 39 other events

Deaths: 0 deaths

Elderly Group

Serious events: 0 serious events

Other events: 35 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Adult Group n=60 participants at risk Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	Elderly Group n=59 participants at risk Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
General disorders Induration	3.3% 2/60 • Serious Adverse Events: From Day 0 to Day 21; 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	6.8% 4/59 • Serious Adverse Events: From Day 0 to Day 21; 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
General disorders Pain	55.0% 33/60 • Serious Adverse Events: From Day 0 to Day 21; 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	39.0% 23/59 • Serious Adverse Events: From Day 0 to Day 21; 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
General disorders Redness	10.0% 6/60 • Serious Adverse Events: From Day 0 to Day 21; 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	11.9% 7/59 • Serious Adverse Events: From Day 0 to Day 21; 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
General disorders Swelling	10.0% 6/60 • Serious Adverse Events: From Day 0 to Day 21; 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	8.5% 5/59 • Serious Adverse Events: From Day 0 to Day 21; 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
General disorders Arthralgia	3.3% 2/60 • Serious Adverse Events: From Day 0 to Day 21; 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	6.8% 4/59 • Serious Adverse Events: From Day 0 to Day 21; 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
General disorders Fatigue	18.3% 11/60 • Serious Adverse Events: From Day 0 to Day 21; 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	23.7% 14/59 • Serious Adverse Events: From Day 0 to Day 21; 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
General disorders Gastrointestinal symptoms	6.7% 4/60 • Serious Adverse Events: From Day 0 to Day 21; 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	5.1% 3/59 • Serious Adverse Events: From Day 0 to Day 21; 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
General disorders Headache	25.0% 15/60 • Serious Adverse Events: From Day 0 to Day 21; 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	11.9% 7/59 • Serious Adverse Events: From Day 0 to Day 21; 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
General disorders Myalgia	18.3% 11/60 • Serious Adverse Events: From Day 0 to Day 21; 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	11.9% 7/59 • Serious Adverse Events: From Day 0 to Day 21; 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
General disorders Sweating increase	13.3% 8/60 • Serious Adverse Events: From Day 0 to Day 21; 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	15.3% 9/59 • Serious Adverse Events: From Day 0 to Day 21; 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
General disorders Injection site pruritus	5.0% 3/60 • Serious Adverse Events: From Day 0 to Day 21; 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	3.4% 2/59 • Serious Adverse Events: From Day 0 to Day 21; 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

Additional Information

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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