Trial Outcomes & Findings for Immunogenicity and Reactogenicity of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Split Virion Influenza Vaccine Fluarix Tetra (2015 Season Southern Hemisphere) in Adults 18 Years of Age and Above (NCT NCT02369341)
NCT ID: NCT02369341
Last Updated: 2017-10-09
Results Overview
Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
121 participants
Primary outcome timeframe
At Days 0 and 21.
Results posted on
2017-10-09
Participant Flow
One subject was allocated the subject number but did not receive the study vaccination.
Participant milestones
| Measure |
Fluarix Tetra (Southern Hemisphere) Adult Group
Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
|
Fluarix Tetra (Southern Hemisphere) Elderly Group
Subjects aged \>60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
|
|---|---|---|
|
Overall Study
STARTED
|
63
|
57
|
|
Overall Study
COMPLETED
|
62
|
57
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Fluarix Tetra (Southern Hemisphere) Adult Group
Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
|
Fluarix Tetra (Southern Hemisphere) Elderly Group
Subjects aged \>60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
|
|---|---|---|
|
Overall Study
Migrated/moved from study area
|
1
|
0
|
Baseline Characteristics
Immunogenicity and Reactogenicity of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Split Virion Influenza Vaccine Fluarix Tetra (2015 Season Southern Hemisphere) in Adults 18 Years of Age and Above
Baseline characteristics by cohort
| Measure |
Fluarix Tetra (Southern Hemisphere) Adult Group
n=63 Participants
Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
|
Fluarix Tetra (Southern Hemisphere) Elderly Group
n=57 Participants
Subjects aged \>60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) 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
|
40.8 Years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
67.2 Years
STANDARD_DEVIATION 6.0 • n=7 Participants
|
53.3 Years
STANDARD_DEVIATION 16.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
30 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/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).
Outcome measures
| Measure |
Fluarix Tetra (Southern Hemisphere) Adult Group
n=62 Participants
Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
|
Fluarix Tetra (Southern Hemisphere) Elderly Group
n=57 Participants
Subjects aged \>60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
|
Fluarix Tetra (Southern Hemisphere) Elderly Group_Y
Subjects aged \>60 years administered with the study vaccine \[1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm\] and who had received vaccination in 2014.
|
Fluarix Tetra (Southern Hemisphere) Elderly Group_N
Subjects aged \>60 years administered with the study vaccine \[1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm\] and who had not received vaccination in 2014.
|
|---|---|---|---|---|
|
Humoral Immune Response for Each Vaccine Strain in Terms of Haemagglutination Inhibition (HI) Antibody Titers.
H1N1, Day 0
|
47.3 Titers
Interval 32.2 to 69.4
|
31.2 Titers
Interval 22.6 to 42.9
|
—
|
—
|
|
Humoral Immune Response for Each Vaccine Strain in Terms of Haemagglutination Inhibition (HI) Antibody Titers.
H1N1, Day 21
|
460.2 Titers
Interval 346.7 to 610.8
|
166.9 Titers
Interval 125.6 to 221.9
|
—
|
—
|
|
Humoral Immune Response for Each Vaccine Strain in Terms of Haemagglutination Inhibition (HI) Antibody Titers.
H3N2, Day 0
|
32.0 Titers
Interval 22.6 to 45.3
|
41.7 Titers
Interval 29.0 to 60.0
|
—
|
—
|
|
Humoral Immune Response for Each Vaccine Strain in Terms of Haemagglutination Inhibition (HI) Antibody Titers.
H3N2, Day 21
|
338.4 Titers
Interval 257.3 to 445.0
|
306.7 Titers
Interval 224.5 to 418.9
|
—
|
—
|
|
Humoral Immune Response for Each Vaccine Strain in Terms of Haemagglutination Inhibition (HI) Antibody Titers.
Yamagata, Day 0
|
84.1 Titers
Interval 58.4 to 121.0
|
77.6 Titers
Interval 62.2 to 96.8
|
—
|
—
|
|
Humoral Immune Response for Each Vaccine Strain in Terms of Haemagglutination Inhibition (HI) Antibody Titers.
Yamagata, Day 21
|
338.4 Titers
Interval 266.7 to 429.3
|
226.3 Titers
Interval 184.6 to 277.3
|
—
|
—
|
|
Humoral Immune Response for Each Vaccine Strain in Terms of Haemagglutination Inhibition (HI) Antibody Titers.
Victoria, Day 0
|
68.8 Titers
Interval 51.3 to 92.2
|
99.6 Titers
Interval 74.2 to 133.6
|
—
|
—
|
|
Humoral Immune Response for Each Vaccine Strain in Terms of Haemagglutination Inhibition (HI) Antibody Titers.
Victoria, Day 21
|
365.9 Titers
Interval 291.3 to 459.5
|
288.6 Titers
Interval 223.7 to 372.3
|
—
|
—
|
PRIMARY outcome
Timeframe: At Days 0 and 21Population: 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.
A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cutoff value of 1:10. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).
Outcome measures
| Measure |
Fluarix Tetra (Southern Hemisphere) Adult Group
n=62 Participants
Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
|
Fluarix Tetra (Southern Hemisphere) Elderly Group
n=57 Participants
Subjects aged \>60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
|
Fluarix Tetra (Southern Hemisphere) Elderly Group_Y
Subjects aged \>60 years administered with the study vaccine \[1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm\] and who had received vaccination in 2014.
|
Fluarix Tetra (Southern Hemisphere) Elderly Group_N
Subjects aged \>60 years administered with the study vaccine \[1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm\] and who had not received vaccination in 2014.
|
|---|---|---|---|---|
|
Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Vaccine Strains.
H1N1, Day 0
|
51 Subjects
|
52 Subjects
|
—
|
—
|
|
Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Vaccine Strains.
H1N1, Day 21
|
62 Subjects
|
57 Subjects
|
—
|
—
|
|
Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Vaccine Strains.
H3N2, Day 0
|
52 Subjects
|
52 Subjects
|
—
|
—
|
|
Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Vaccine Strains.
H3N2, Day 21
|
62 Subjects
|
57 Subjects
|
—
|
—
|
|
Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Vaccine Strains.
Yamagata, Day 0
|
59 Subjects
|
57 Subjects
|
—
|
—
|
|
Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Vaccine Strains.
Yamagata, Day 21
|
62 Subjects
|
57 Subjects
|
—
|
—
|
|
Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Vaccine Strains.
Victoria, Day 0
|
59 Subjects
|
57 Subjects
|
—
|
—
|
|
Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Vaccine Strains.
Victoria, Day 21
|
62 Subjects
|
57 Subjects
|
—
|
—
|
PRIMARY outcome
Timeframe: At Days 0 and 21Population: 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.
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/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).
Outcome measures
| Measure |
Fluarix Tetra (Southern Hemisphere) Adult Group
n=62 Participants
Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
|
Fluarix Tetra (Southern Hemisphere) Elderly Group
n=57 Participants
Subjects aged \>60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
|
Fluarix Tetra (Southern Hemisphere) Elderly Group_Y
Subjects aged \>60 years administered with the study vaccine \[1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm\] and who had received vaccination in 2014.
|
Fluarix Tetra (Southern Hemisphere) Elderly Group_N
Subjects aged \>60 years administered with the study vaccine \[1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm\] and who had not received vaccination in 2014.
|
|---|---|---|---|---|
|
Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains.
H1N1, Day 0
|
40 Subjects
|
31 Subjects
|
—
|
—
|
|
Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains.
H1N1, Day 21
|
62 Subjects
|
54 Subjects
|
—
|
—
|
|
Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains.
H3N2, Day 0
|
29 Subjects
|
33 Subjects
|
—
|
—
|
|
Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains.
H3N2, Day 21
|
61 Subjects
|
55 Subjects
|
—
|
—
|
|
Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains.
Yamagata, Day 0
|
46 Subjects
|
47 Subjects
|
—
|
—
|
|
Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains.
Yamagata, Day 21
|
62 Subjects
|
57 Subjects
|
—
|
—
|
|
Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains.
Victoria, Day 0
|
48 Subjects
|
48 Subjects
|
—
|
—
|
|
Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains.
Victoria, Day 21
|
62 Subjects
|
57 Subjects
|
—
|
—
|
PRIMARY outcome
Timeframe: At 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.
A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination HI titer less than (\<) 1:10 and a post-vaccination HI titer ≥1:40 or pre-vaccination HI titer ≥ 1:10 and at least a 4-fold increase in post-vaccination HI titer. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).
Outcome measures
| Measure |
Fluarix Tetra (Southern Hemisphere) Adult Group
n=62 Participants
Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
|
Fluarix Tetra (Southern Hemisphere) Elderly Group
n=57 Participants
Subjects aged \>60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
|
Fluarix Tetra (Southern Hemisphere) Elderly Group_Y
Subjects aged \>60 years administered with the study vaccine \[1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm\] and who had received vaccination in 2014.
|
Fluarix Tetra (Southern Hemisphere) Elderly Group_N
Subjects aged \>60 years administered with the study vaccine \[1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm\] and who had not received vaccination in 2014.
|
|---|---|---|---|---|
|
Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains.
H1N1
|
38 Subjects
|
35 Subjects
|
—
|
—
|
|
Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains.
H3N2
|
49 Subjects
|
41 Subjects
|
—
|
—
|
|
Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains.
Yamagata
|
31 Subjects
|
20 Subjects
|
—
|
—
|
|
Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains.
Victoria
|
38 Subjects
|
20 Subjects
|
—
|
—
|
PRIMARY outcome
Timeframe: At Day 21Population: 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.
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/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).
Outcome measures
| Measure |
Fluarix Tetra (Southern Hemisphere) Adult Group
n=62 Participants
Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
|
Fluarix Tetra (Southern Hemisphere) Elderly Group
n=57 Participants
Subjects aged \>60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
|
Fluarix Tetra (Southern Hemisphere) Elderly Group_Y
Subjects aged \>60 years administered with the study vaccine \[1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm\] and who had received vaccination in 2014.
|
Fluarix Tetra (Southern Hemisphere) Elderly Group_N
Subjects aged \>60 years administered with the study vaccine \[1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm\] and who had not received vaccination in 2014.
|
|---|---|---|---|---|
|
Number of Subjects With Seroprotection Power (SPP) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains Above the Cut-off Value.
H1N1
|
22 Subjects
|
23 Subjects
|
—
|
—
|
|
Number of Subjects With Seroprotection Power (SPP) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains Above the Cut-off Value.
H3N2
|
32 Subjects
|
22 Subjects
|
—
|
—
|
|
Number of Subjects With Seroprotection Power (SPP) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains Above the Cut-off Value.
Yamagata
|
16 Subjects
|
10 Subjects
|
—
|
—
|
|
Number of Subjects With Seroprotection Power (SPP) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains Above the Cut-off Value.
Victoria
|
14 Subjects
|
9 Subjects
|
—
|
—
|
PRIMARY outcome
Timeframe: At Day 21Population: 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.
MGI also known as the seroconversion factor \[SCF\] was defined as the fold increase in serum HI GMTs post vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).
Outcome measures
| Measure |
Fluarix Tetra (Southern Hemisphere) Adult Group
n=62 Participants
Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
|
Fluarix Tetra (Southern Hemisphere) Elderly Group
n=57 Participants
Subjects aged \>60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
|
Fluarix Tetra (Southern Hemisphere) Elderly Group_Y
Subjects aged \>60 years administered with the study vaccine \[1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm\] and who had received vaccination in 2014.
|
Fluarix Tetra (Southern Hemisphere) Elderly Group_N
Subjects aged \>60 years administered with the study vaccine \[1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm\] and who had not received vaccination in 2014.
|
|---|---|---|---|---|
|
Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains.
H1N1
|
9.7 Fold increase
Interval 5.9 to 16.1
|
5.4 Fold increase
Interval 3.8 to 7.5
|
—
|
—
|
|
Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains.
H3N2
|
10.6 Fold increase
Interval 7.7 to 14.6
|
7.4 Fold increase
Interval 5.3 to 10.2
|
—
|
—
|
|
Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains.
Yamagata
|
4.0 Fold increase
Interval 3.0 to 5.4
|
2.9 Fold increase
Interval 2.3 to 3.7
|
—
|
—
|
|
Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains.
Victoria
|
5.3 Fold increase
Interval 3.8 to 7.5
|
2.9 Fold increase
Interval 2.2 to 3.9
|
—
|
—
|
SECONDARY outcome
Timeframe: At Days 0 and 21Population: 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 GMTs. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).
Outcome measures
| Measure |
Fluarix Tetra (Southern Hemisphere) Adult Group
n=31 Participants
Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
|
Fluarix Tetra (Southern Hemisphere) Elderly Group
n=31 Participants
Subjects aged \>60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
|
Fluarix Tetra (Southern Hemisphere) Elderly Group_Y
n=46 Participants
Subjects aged \>60 years administered with the study vaccine \[1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm\] and who had received vaccination in 2014.
|
Fluarix Tetra (Southern Hemisphere) Elderly Group_N
n=11 Participants
Subjects aged \>60 years administered with the study vaccine \[1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm\] and who had not received vaccination in 2014.
|
|---|---|---|---|---|
|
Humoral Immune Response for Each Vaccine Strain in Terms of HI Antibodies.
H1N1, Day 0
|
86.5 Titers
Interval 56.7 to 132.0
|
25.9 Titers
Interval 14.4 to 46.5
|
33.9 Titers
Interval 23.4 to 48.9
|
22.0 Titers
Interval 11.0 to 43.9
|
|
Humoral Immune Response for Each Vaccine Strain in Terms of HI Antibodies.
H1N1, Day 21
|
276.7 Titers
Interval 206.8 to 370.3
|
765.3 Titers
Interval 499.0 to 1174.0
|
151.8 Titers
Interval 111.2 to 207.0
|
248.7 Titers
Interval 115.6 to 534.9
|
|
Humoral Immune Response for Each Vaccine Strain in Terms of HI Antibodies.
H3N2, Day 0
|
41.3 Titers
Interval 26.1 to 65.5
|
24.7 Titers
Interval 14.5 to 42.2
|
44.8 Titers
Interval 30.1 to 66.5
|
31.0 Titers
Interval 11.1 to 87.1
|
|
Humoral Immune Response for Each Vaccine Strain in Terms of HI Antibodies.
H3N2, Day 21
|
342.2 Titers
Interval 240.9 to 486.1
|
334.6 Titers
Interval 215.2 to 520.3
|
281.6 Titers
Interval 196.3 to 403.9
|
438.5 Titers
Interval 229.9 to 836.4
|
|
Humoral Immune Response for Each Vaccine Strain in Terms of HI Antibodies.
Yamagata, Day 0
|
133.7 Titers
Interval 89.2 to 200.4
|
52.9 Titers
Interval 29.5 to 94.6
|
88.2 Titers
Interval 70.2 to 110.8
|
45.4 Titers
Interval 24.7 to 83.5
|
|
Humoral Immune Response for Each Vaccine Strain in Terms of HI Antibodies.
Yamagata, Day 21
|
306.0 Titers
Interval 223.4 to 419.0
|
374.2 Titers
Interval 257.8 to 543.1
|
194.6 Titers
Interval 157.6 to 240.3
|
425.0 Titers
Interval 267.3 to 675.7
|
|
Humoral Immune Response for Each Vaccine Strain in Terms of HI Antibodies.
Victoria, Day 0
|
95.6 Titers
Interval 68.7 to 133.0
|
49.5 Titers
Interval 30.7 to 79.6
|
114.9 Titers
Interval 82.7 to 159.5
|
54.8 Titers
Interval 29.3 to 102.8
|
|
Humoral Immune Response for Each Vaccine Strain in Terms of HI Antibodies.
Victoria, Day 21
|
282.9 Titers
Interval 207.7 to 385.3
|
473.2 Titers
Interval 341.5 to 655.7
|
259.2 Titers
Interval 196.3 to 342.3
|
452.5 Titers
Interval 236.2 to 867.1
|
SECONDARY outcome
Timeframe: At Days 0 and 21Population: 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.
A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cutoff value of 1:10. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).
Outcome measures
| Measure |
Fluarix Tetra (Southern Hemisphere) Adult Group
n=31 Participants
Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
|
Fluarix Tetra (Southern Hemisphere) Elderly Group
n=31 Participants
Subjects aged \>60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
|
Fluarix Tetra (Southern Hemisphere) Elderly Group_Y
n=46 Participants
Subjects aged \>60 years administered with the study vaccine \[1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm\] and who had received vaccination in 2014.
|
Fluarix Tetra (Southern Hemisphere) Elderly Group_N
n=11 Participants
Subjects aged \>60 years administered with the study vaccine \[1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm\] and who had not received vaccination in 2014.
|
|---|---|---|---|---|
|
Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Vaccine Strains.
H1N1, Day 0
|
30 Subjects
|
21 Subjects
|
42 Subjects
|
10 Subjects
|
|
Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Vaccine Strains.
H1N1, Day 21
|
31 Subjects
|
31 Subjects
|
46 Subjects
|
11 Subjects
|
|
Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Vaccine Strains.
H3N2, Day 0
|
30 Subjects
|
22 Subjects
|
43 Subjects
|
9 Subjects
|
|
Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Vaccine Strains.
H3N2, Day 21
|
31 Subjects
|
31 Subjects
|
46 Subjects
|
11 Subjects
|
|
Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Vaccine Strains.
Yamagata, Day 0
|
31 Subjects
|
28 Subjects
|
46 Subjects
|
11 Subjects
|
|
Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Vaccine Strains.
Yamagata, Day 21
|
31 Subjects
|
31 Subjects
|
46 Subjects
|
11 Subjects
|
|
Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Vaccine Strains.
Victoria, Day 0
|
31 Subjects
|
28 Subjects
|
46 Subjects
|
11 Subjects
|
|
Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Vaccine Strains.
Victoria, Day 21
|
31 Subjects
|
31 Subjects
|
46 Subjects
|
11 Subjects
|
SECONDARY outcome
Timeframe: At Days 0 and 21Population: 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.
A seroprotected subject was defined as a vaccinated subject with a serum HI titer ≥ 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).
Outcome measures
| Measure |
Fluarix Tetra (Southern Hemisphere) Adult Group
n=31 Participants
Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
|
Fluarix Tetra (Southern Hemisphere) Elderly Group
n=31 Participants
Subjects aged \>60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
|
Fluarix Tetra (Southern Hemisphere) Elderly Group_Y
n=46 Participants
Subjects aged \>60 years administered with the study vaccine \[1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm\] and who had received vaccination in 2014.
|
Fluarix Tetra (Southern Hemisphere) Elderly Group_N
n=11 Participants
Subjects aged \>60 years administered with the study vaccine \[1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm\] and who had not received vaccination in 2014.
|
|---|---|---|---|---|
|
Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains.
H3N2, Day 0
|
16 Subjects
|
13 Subjects
|
28 Subjects
|
5 Subjects
|
|
Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains.
H3N2, Day 21
|
31 Subjects
|
30 Subjects
|
44 Subjects
|
11 Subjects
|
|
Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains.
Yamagata, Day 0
|
28 Subjects
|
18 Subjects
|
41 Subjects
|
6 Subjects
|
|
Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains.
Yamagata, Day 21
|
31 Subjects
|
31 Subjects
|
46 Subjects
|
11 Subjects
|
|
Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains.
Victoria, Day 0
|
27 Subjects
|
21 Subjects
|
41 Subjects
|
7 Subjects
|
|
Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains.
Victoria, Day 21
|
31 Subjects
|
31 Subjects
|
46 Subjects
|
11 Subjects
|
|
Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains.
H1N1, Day 0
|
27 Subjects
|
13 Subjects
|
27 Subjects
|
4 Subjects
|
|
Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains.
H1N1, Day 21
|
31 Subjects
|
31 Subjects
|
43 Subjects
|
11 Subjects
|
SECONDARY outcome
Timeframe: At Day 21Population: 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.
MGI also known as the seroconversion factor \[SCF\] was defined as the fold increase in serum HI GMTs post vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).
Outcome measures
| Measure |
Fluarix Tetra (Southern Hemisphere) Adult Group
n=31 Participants
Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
|
Fluarix Tetra (Southern Hemisphere) Elderly Group
n=31 Participants
Subjects aged \>60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
|
Fluarix Tetra (Southern Hemisphere) Elderly Group_Y
n=46 Participants
Subjects aged \>60 years administered with the study vaccine \[1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm\] and who had received vaccination in 2014.
|
Fluarix Tetra (Southern Hemisphere) Elderly Group_N
n=11 Participants
Subjects aged \>60 years administered with the study vaccine \[1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm\] and who had not received vaccination in 2014.
|
|---|---|---|---|---|
|
MGI for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains.
H1N1
|
3.2 Fold increase
Interval 2.3 to 4.5
|
29.6 Fold increase
Interval 13.5 to 64.8
|
4.5 Fold increase
Interval 3.2 to 6.3
|
11.3 Fold increase
Interval 4.1 to 31.1
|
|
MGI for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains.
H3N2
|
8.3 Fold increase
Interval 5.4 to 12.7
|
13.5 Fold increase
Interval 8.3 to 22.2
|
6.3 Fold increase
Interval 4.5 to 8.8
|
14.1 Fold increase
Interval 4.9 to 40.8
|
|
MGI for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains.
Yamagata
|
2.3 Fold increase
Interval 1.7 to 3.0
|
7.1 Fold increase
Interval 4.4 to 11.3
|
2.2 Fold increase
Interval 1.8 to 2.6
|
9.4 Fold increase
Interval 4.2 to 21.0
|
|
MGI for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains.
Victoria
|
3.0 Fold increase
Interval 2.1 to 4.1
|
9.6 Fold increase
Interval 5.6 to 16.4
|
2.3 Fold increase
Interval 1.8 to 2.9
|
8.3 Fold increase
Interval 3.1 to 21.9
|
SECONDARY outcome
Timeframe: At 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.
A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination HI titer less than (\<) 1:10 and a post-vaccination HI titer ≥1:40 or pre-vaccination HI titer ≥1:10 and at least a 4-fold increase in post-vaccination HI titer. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).
Outcome measures
| Measure |
Fluarix Tetra (Southern Hemisphere) Adult Group
n=31 Participants
Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
|
Fluarix Tetra (Southern Hemisphere) Elderly Group
n=31 Participants
Subjects aged \>60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
|
Fluarix Tetra (Southern Hemisphere) Elderly Group_Y
n=46 Participants
Subjects aged \>60 years administered with the study vaccine \[1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm\] and who had received vaccination in 2014.
|
Fluarix Tetra (Southern Hemisphere) Elderly Group_N
n=11 Participants
Subjects aged \>60 years administered with the study vaccine \[1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm\] and who had not received vaccination in 2014.
|
|---|---|---|---|---|
|
Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains.
H1N1
|
14 Subjects
|
24 Subjects
|
26 Subjects
|
9 Subjects
|
|
Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains.
H3N2
|
25 Subjects
|
24 Subjects
|
33 Subjects
|
8 Subjects
|
|
Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains.
Yamagata
|
8 Subjects
|
23 Subjects
|
12 Subjects
|
8 Subjects
|
|
Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains.
Victoria
|
14 Subjects
|
24 Subjects
|
13 Subjects
|
7 Subjects
|
SECONDARY outcome
Timeframe: At Day 21Population: 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.
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/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).
Outcome measures
| Measure |
Fluarix Tetra (Southern Hemisphere) Adult Group
n=31 Participants
Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
|
Fluarix Tetra (Southern Hemisphere) Elderly Group
n=31 Participants
Subjects aged \>60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
|
Fluarix Tetra (Southern Hemisphere) Elderly Group_Y
n=46 Participants
Subjects aged \>60 years administered with the study vaccine \[1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm\] and who had received vaccination in 2014.
|
Fluarix Tetra (Southern Hemisphere) Elderly Group_N
n=11 Participants
Subjects aged \>60 years administered with the study vaccine \[1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm\] and who had not received vaccination in 2014.
|
|---|---|---|---|---|
|
Number of Subjects With Seroprotection Power (SPP) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains Above the Cut-off Value.
H1N1
|
4 Subjects
|
18 Subjects
|
16 Subjects
|
7 Subjects
|
|
Number of Subjects With Seroprotection Power (SPP) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains Above the Cut-off Value.
H3N2
|
15 Subjects
|
17 Subjects
|
16 Subjects
|
6 Subjects
|
|
Number of Subjects With Seroprotection Power (SPP) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains Above the Cut-off Value.
Yamagata
|
3 Subjects
|
13 Subjects
|
5 Subjects
|
5 Subjects
|
|
Number of Subjects With Seroprotection Power (SPP) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains Above the Cut-off Value.
Victoria
|
4 Subjects
|
10 Subjects
|
5 Subjects
|
4 Subjects
|
SECONDARY outcome
Timeframe: During the 4-day (Days 0-3) post-vaccination periodPopulation: Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.
Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that prevented normal everyday activities. Grade 3 redness and swelling was greater than 100 millimeters (mm) i.e. \>100mm.
Outcome measures
| Measure |
Fluarix Tetra (Southern Hemisphere) Adult Group
n=62 Participants
Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
|
Fluarix Tetra (Southern Hemisphere) Elderly Group
n=57 Participants
Subjects aged \>60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
|
Fluarix Tetra (Southern Hemisphere) Elderly Group_Y
Subjects aged \>60 years administered with the study vaccine \[1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm\] and who had received vaccination in 2014.
|
Fluarix Tetra (Southern Hemisphere) Elderly Group_N
Subjects aged \>60 years administered with the study vaccine \[1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm\] and who had not received vaccination in 2014.
|
|---|---|---|---|---|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
Any Pain
|
27 Subjects
|
13 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
Grade 3 Pain
|
3 Subjects
|
0 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
Any Redness
|
9 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
|
7 Subjects
|
6 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 periodPopulation: 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, Sweating and Temperature (Oral). Any was defined as any general symptom reported irrespective of intensity or relationship to vaccination. Grade 3 was defined as symptoms that prevented normal activity. Related was defined as general symptom assessed by the investigator to have a causal relationship to vaccination.
Outcome measures
| Measure |
Fluarix Tetra (Southern Hemisphere) Adult Group
n=62 Participants
Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
|
Fluarix Tetra (Southern Hemisphere) Elderly Group
n=57 Participants
Subjects aged \>60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
|
Fluarix Tetra (Southern Hemisphere) Elderly Group_Y
Subjects aged \>60 years administered with the study vaccine \[1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm\] and who had received vaccination in 2014.
|
Fluarix Tetra (Southern Hemisphere) Elderly Group_N
Subjects aged \>60 years administered with the study vaccine \[1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm\] and who had not received vaccination in 2014.
|
|---|---|---|---|---|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Any Shivering
|
2 Subjects
|
0 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Headache
|
2 Subjects
|
1 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Related Headache
|
6 Subjects
|
1 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Temperature (Oral)
|
0 Subjects
|
0 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Any Myalgia
|
9 Subjects
|
2 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
|
8 Subjects
|
1 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Any Sweating
|
2 Subjects
|
0 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Sweating
|
1 Subjects
|
0 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Any Arthralgia
|
6 Subjects
|
2 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
|
5 Subjects
|
1 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Any Fatigue
|
6 Subjects
|
1 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
|
5 Subjects
|
0 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Any Gastrointestinal symptoms
|
3 Subjects
|
0 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Related Temperature (Oral)
|
0 Subjects
|
0 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Related Sweating
|
2 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
|
1 Subjects
|
0 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Any Temperature (Oral)
|
0 Subjects
|
0 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
|
0 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Any Headache
|
8 Subjects
|
1 Subjects
|
—
|
—
|
SECONDARY outcome
Timeframe: During the 4-day (Days 0-3) post-vaccination periodPopulation: 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
| Measure |
Fluarix Tetra (Southern Hemisphere) Adult Group
n=27 Participants
Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
|
Fluarix Tetra (Southern Hemisphere) Elderly Group
n=13 Participants
Subjects aged \>60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
|
Fluarix Tetra (Southern Hemisphere) Elderly Group_Y
Subjects aged \>60 years administered with the study vaccine \[1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm\] and who had received vaccination in 2014.
|
Fluarix Tetra (Southern Hemisphere) Elderly Group_N
Subjects aged \>60 years administered with the study vaccine \[1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm\] and who had not received vaccination in 2014.
|
|---|---|---|---|---|
|
Duration of Solicited Local Symptoms
Redness (N = 9, 7)
|
2.0 days
Interval 1.0 to 4.0
|
2.0 days
Interval 1.0 to 3.0
|
—
|
—
|
|
Duration of Solicited Local Symptoms
Pain (N = 27, 13)
|
2.0 days
Interval 1.0 to 4.0
|
1.0 days
Interval 1.0 to 3.0
|
—
|
—
|
|
Duration of Solicited Local Symptoms
Swelling (N = 7, 6)
|
3.0 days
Interval 1.0 to 4.0
|
1.5 days
Interval 1.0 to 2.0
|
—
|
—
|
SECONDARY outcome
Timeframe: During the entire study period (approximately 21 days for each subject).Population: Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.
MAEs were defined as AEs with a medically-attended visit i.e. prompting emergency room (ER) visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination. Any MAE was defined as at least one MAE experienced. Grade 3 was defined as MAEs that prevented normal activities and related was defined as MAEs assessed by the investigator to be causally related to the study vaccination.
Outcome measures
| Measure |
Fluarix Tetra (Southern Hemisphere) Adult Group
n=63 Participants
Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
|
Fluarix Tetra (Southern Hemisphere) Elderly Group
n=57 Participants
Subjects aged \>60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
|
Fluarix Tetra (Southern Hemisphere) Elderly Group_Y
Subjects aged \>60 years administered with the study vaccine \[1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm\] and who had received vaccination in 2014.
|
Fluarix Tetra (Southern Hemisphere) Elderly Group_N
Subjects aged \>60 years administered with the study vaccine \[1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm\] and who had not received vaccination in 2014.
|
|---|---|---|---|---|
|
Number of Subjects Reporting Any, Grade 3 and Related Medically Attended Adverse Events (MAEs).
Any MAEs
|
4 subjects
|
6 subjects
|
—
|
—
|
|
Number of Subjects Reporting Any, Grade 3 and Related Medically Attended Adverse Events (MAEs).
Grade 3 MAEs
|
3 subjects
|
1 subjects
|
—
|
—
|
|
Number of Subjects Reporting Any, Grade 3 and Related Medically Attended Adverse Events (MAEs).
Related MAEs
|
0 subjects
|
0 subjects
|
—
|
—
|
SECONDARY outcome
Timeframe: During the 4-day (Days 0-3) post-vaccination periodPopulation: 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
| Measure |
Fluarix Tetra (Southern Hemisphere) Adult Group
n=9 Participants
Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
|
Fluarix Tetra (Southern Hemisphere) Elderly Group
n=2 Participants
Subjects aged \>60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
|
Fluarix Tetra (Southern Hemisphere) Elderly Group_Y
Subjects aged \>60 years administered with the study vaccine \[1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm\] and who had received vaccination in 2014.
|
Fluarix Tetra (Southern Hemisphere) Elderly Group_N
Subjects aged \>60 years administered with the study vaccine \[1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm\] and who had not received vaccination in 2014.
|
|---|---|---|---|---|
|
Duration of Solicited General Symptoms
Arthralgia [N = 6,2]
|
1.5 days
Interval 1.0 to 3.0
|
2.5 days
Interval 1.0 to 4.0
|
—
|
—
|
|
Duration of Solicited General Symptoms
Fatigue [N = 6,1]
|
3.0 days
Interval 1.0 to 4.0
|
2.0 days
Interval 2.0 to 2.0
|
—
|
—
|
|
Duration of Solicited General Symptoms
Gastrointestinal symptoms [N = 3,0]
|
1.0 days
Interval 1.0 to 3.0
|
0.0 days
Interval 0.0 to 0.0
|
—
|
—
|
|
Duration of Solicited General Symptoms
Headache [N = 8,1]
|
2.5 days
Interval 1.0 to 3.0
|
1.0 days
Interval 1.0 to 1.0
|
—
|
—
|
|
Duration of Solicited General Symptoms
Myalgia [N = 9,2]
|
2.0 days
Interval 1.0 to 4.0
|
3.0 days
Interval 2.0 to 4.0
|
—
|
—
|
|
Duration of Solicited General Symptoms
Sweating [N = 2,0]
|
2.5 days
Interval 1.0 to 4.0
|
0.0 days
Interval 0.0 to 0.0
|
—
|
—
|
|
Duration of Solicited General Symptoms
Shivering [N = 2,0]
|
1.5 days
Interval 1.0 to 2.0
|
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
| Measure |
Fluarix Tetra (Southern Hemisphere) Adult Group
n=63 Participants
Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
|
Fluarix Tetra (Southern Hemisphere) Elderly Group
n=57 Participants
Subjects aged \>60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
|
Fluarix Tetra (Southern Hemisphere) Elderly Group_Y
Subjects aged \>60 years administered with the study vaccine \[1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm\] and who had received vaccination in 2014.
|
Fluarix Tetra (Southern Hemisphere) Elderly Group_N
Subjects aged \>60 years administered with the study vaccine \[1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm\] and who had not received vaccination in 2014.
|
|---|---|---|---|---|
|
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Any Unsolicted AEs
|
11 Subjects
|
10 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Grade 3 Unsolicted AEs
|
4 Subjects
|
2 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Related Unsolicted AEs
|
4 Subjects
|
0 Subjects
|
—
|
—
|
SECONDARY outcome
Timeframe: During the entire study period (approximately 21 days for each subject)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
| Measure |
Fluarix Tetra (Southern Hemisphere) Adult Group
n=63 Participants
Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
|
Fluarix Tetra (Southern Hemisphere) Elderly Group
n=57 Participants
Subjects aged \>60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
|
Fluarix Tetra (Southern Hemisphere) Elderly Group_Y
Subjects aged \>60 years administered with the study vaccine \[1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm\] and who had received vaccination in 2014.
|
Fluarix Tetra (Southern Hemisphere) Elderly Group_N
Subjects aged \>60 years administered with the study vaccine \[1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm\] and who had not received vaccination in 2014.
|
|---|---|---|---|---|
|
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
Any SAEs
|
0 Subjects
|
1 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
Related SAEs
|
0 Subjects
|
0 Subjects
|
—
|
—
|
Adverse Events
Fluarix Tetra (Southern Hemisphere) Adult Group
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
Fluarix Tetra (Southern Hemisphere) Elderly Group
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fluarix Tetra (Southern Hemisphere) Adult Group
n=63 participants at risk
Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
|
Fluarix Tetra (Southern Hemisphere) Elderly Group
n=57 participants at risk
Subjects aged ˃60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
|
|---|---|---|
|
Nervous system disorders
Syncope
|
0.00%
0/63 • Serious Adverse events (SAE) =Entire study period. Solicited local and general symptoms = During the 4-day follow up period post vaccination. Unsolicited AEs = during the 21-day follow-up period after vaccination.
|
1.8%
1/57 • Number of events 1 • Serious Adverse events (SAE) =Entire study period. Solicited local and general symptoms = During the 4-day follow up period post vaccination. Unsolicited AEs = during the 21-day follow-up period after vaccination.
|
Other adverse events
| Measure |
Fluarix Tetra (Southern Hemisphere) Adult Group
n=63 participants at risk
Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
|
Fluarix Tetra (Southern Hemisphere) Elderly Group
n=57 participants at risk
Subjects aged ˃60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
|
|---|---|---|
|
General disorders
Fatigue
|
9.5%
6/63 • Number of events 6 • Serious Adverse events (SAE) =Entire study period. Solicited local and general symptoms = During the 4-day follow up period post vaccination. Unsolicited AEs = during the 21-day follow-up period after vaccination.
|
3.5%
2/57 • Number of events 2 • Serious Adverse events (SAE) =Entire study period. Solicited local and general symptoms = During the 4-day follow up period post vaccination. Unsolicited AEs = during the 21-day follow-up period after vaccination.
|
|
General disorders
Pain
|
42.9%
27/63 • Number of events 27 • Serious Adverse events (SAE) =Entire study period. Solicited local and general symptoms = During the 4-day follow up period post vaccination. Unsolicited AEs = during the 21-day follow-up period after vaccination.
|
22.8%
13/57 • Number of events 13 • Serious Adverse events (SAE) =Entire study period. Solicited local and general symptoms = During the 4-day follow up period post vaccination. Unsolicited AEs = during the 21-day follow-up period after vaccination.
|
|
General disorders
Swelling
|
11.1%
7/63 • Number of events 7 • Serious Adverse events (SAE) =Entire study period. Solicited local and general symptoms = During the 4-day follow up period post vaccination. Unsolicited AEs = during the 21-day follow-up period after vaccination.
|
10.5%
6/57 • Number of events 6 • Serious Adverse events (SAE) =Entire study period. Solicited local and general symptoms = During the 4-day follow up period post vaccination. Unsolicited AEs = during the 21-day follow-up period after vaccination.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.6%
1/63 • Number of events 1 • Serious Adverse events (SAE) =Entire study period. Solicited local and general symptoms = During the 4-day follow up period post vaccination. Unsolicited AEs = during the 21-day follow-up period after vaccination.
|
5.3%
3/57 • Number of events 3 • Serious Adverse events (SAE) =Entire study period. Solicited local and general symptoms = During the 4-day follow up period post vaccination. Unsolicited AEs = during the 21-day follow-up period after vaccination.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.5%
6/63 • Number of events 6 • Serious Adverse events (SAE) =Entire study period. Solicited local and general symptoms = During the 4-day follow up period post vaccination. Unsolicited AEs = during the 21-day follow-up period after vaccination.
|
3.5%
2/57 • Number of events 2 • Serious Adverse events (SAE) =Entire study period. Solicited local and general symptoms = During the 4-day follow up period post vaccination. Unsolicited AEs = during the 21-day follow-up period after vaccination.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
14.3%
9/63 • Number of events 9 • Serious Adverse events (SAE) =Entire study period. Solicited local and general symptoms = During the 4-day follow up period post vaccination. Unsolicited AEs = during the 21-day follow-up period after vaccination.
|
5.3%
3/57 • Number of events 3 • Serious Adverse events (SAE) =Entire study period. Solicited local and general symptoms = During the 4-day follow up period post vaccination. Unsolicited AEs = during the 21-day follow-up period after vaccination.
|
|
Nervous system disorders
Headache
|
12.7%
8/63 • Number of events 8 • Serious Adverse events (SAE) =Entire study period. Solicited local and general symptoms = During the 4-day follow up period post vaccination. Unsolicited AEs = during the 21-day follow-up period after vaccination.
|
1.8%
1/57 • Number of events 1 • Serious Adverse events (SAE) =Entire study period. Solicited local and general symptoms = During the 4-day follow up period post vaccination. Unsolicited AEs = during the 21-day follow-up period after vaccination.
|
|
Skin and subcutaneous tissue disorders
Erythema (redness)
|
14.3%
9/63 • Number of events 9 • Serious Adverse events (SAE) =Entire study period. Solicited local and general symptoms = During the 4-day follow up period post vaccination. Unsolicited AEs = during the 21-day follow-up period after vaccination.
|
12.3%
7/57 • Number of events 7 • Serious Adverse events (SAE) =Entire study period. Solicited local and general symptoms = During the 4-day follow up period post vaccination. Unsolicited AEs = during the 21-day follow-up period after vaccination.
|
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