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Trial record 97 of 150 for:    tetracycline

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

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ClinicalTrials.gov Identifier: NCT02369341
Recruitment Status : Completed
First Posted : February 23, 2015
Results First Posted : August 29, 2016
Last Update Posted : October 9, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Influenza
Intervention Biological: Fluarix Tetra
Enrollment 121
Recruitment Details  
Pre-assignment Details One subject was allocated the subject number but did not receive the study vaccination.
Arm/Group Title Fluarix Tetra (Southern Hemisphere) Adult Group Fluarix Tetra (Southern Hemisphere) Elderly Group
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 63 57
Completed 62 57
Not Completed 1 0
Reason Not Completed
Migrated/moved from study area             1             0
Arm/Group Title Fluarix Tetra (Southern Hemisphere) Adult Group Fluarix Tetra (Southern Hemisphere) Elderly Group Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 63 57 120
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 63 participants 57 participants 120 participants
40.8  (12.2) 67.2  (6.0) 53.3  (16.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants 57 participants 120 participants
Female
52
  82.5%
38
  66.7%
90
  75.0%
Male
11
  17.5%
19
  33.3%
30
  25.0%
1.Primary Outcome
Title Humoral Immune Response for Each Vaccine Strain in Terms of Haemagglutination Inhibition (HI) Antibody Titers.
Hide Description 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).
Time Frame At Days 0 and 21.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Fluarix Tetra (Southern Hemisphere) Adult Group Fluarix Tetra (Southern Hemisphere) Elderly Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 62 57
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
H1N1, Day 0
47.3
(32.2 to 69.4)
31.2
(22.6 to 42.9)
H1N1, Day 21
460.2
(346.7 to 610.8)
166.9
(125.6 to 221.9)
H3N2, Day 0
32.0
(22.6 to 45.3)
41.7
(29.0 to 60.0)
H3N2, Day 21
338.4
(257.3 to 445.0)
306.7
(224.5 to 418.9)
Yamagata, Day 0
84.1
(58.4 to 121.0)
77.6
(62.2 to 96.8)
Yamagata, Day 21
338.4
(266.7 to 429.3)
226.3
(184.6 to 277.3)
Victoria, Day 0
68.8
(51.3 to 92.2)
99.6
(74.2 to 133.6)
Victoria, Day 21
365.9
(291.3 to 459.5)
288.6
(223.7 to 372.3)
2.Primary Outcome
Title Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Vaccine Strains.
Hide Description 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).
Time Frame At Days 0 and 21
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Fluarix Tetra (Southern Hemisphere) Adult Group Fluarix Tetra (Southern Hemisphere) Elderly Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 62 57
Measure Type: Number
Unit of Measure: Subjects
H1N1, Day 0 51 52
H1N1, Day 21 62 57
H3N2, Day 0 52 52
H3N2, Day 21 62 57
Yamagata, Day 0 59 57
Yamagata, Day 21 62 57
Victoria, Day 0 59 57
Victoria, Day 21 62 57
3.Primary Outcome
Title Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains.
Hide Description 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).
Time Frame At Days 0 and 21
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Fluarix Tetra (Southern Hemisphere) Adult Group Fluarix Tetra (Southern Hemisphere) Elderly Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 62 57
Measure Type: Number
Unit of Measure: Subjects
H1N1, Day 0 40 31
H1N1, Day 21 62 54
H3N2, Day 0 29 33
H3N2, Day 21 61 55
Yamagata, Day 0 46 47
Yamagata, Day 21 62 57
Victoria, Day 0 48 48
Victoria, Day 21 62 57
4.Primary Outcome
Title Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains.
Hide Description 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).
Time Frame At Day 21.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Fluarix Tetra (Southern Hemisphere) Adult Group Fluarix Tetra (Southern Hemisphere) Elderly Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 62 57
Measure Type: Number
Unit of Measure: Subjects
H1N1 38 35
H3N2 49 41
Yamagata 31 20
Victoria 38 20
5.Primary Outcome
Title Number of Subjects With Seroprotection Power (SPP) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains Above the Cut-off Value.
Hide Description

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).

Time Frame At Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Fluarix Tetra (Southern Hemisphere) Adult Group Fluarix Tetra (Southern Hemisphere) Elderly Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 62 57
Measure Type: Number
Unit of Measure: Subjects
H1N1 22 23
H3N2 32 22
Yamagata 16 10
Victoria 14 9
6.Primary Outcome
Title Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains.
Hide Description 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).
Time Frame At Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Fluarix Tetra (Southern Hemisphere) Adult Group Fluarix Tetra (Southern Hemisphere) Elderly Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 62 57
Geometric Mean (95% Confidence Interval)
Unit of Measure: Fold increase
H1N1
9.7
(5.9 to 16.1)
5.4
(3.8 to 7.5)
H3N2
10.6
(7.7 to 14.6)
7.4
(5.3 to 10.2)
Yamagata
4.0
(3.0 to 5.4)
2.9
(2.3 to 3.7)
Victoria
5.3
(3.8 to 7.5)
2.9
(2.2 to 3.9)
7.Secondary Outcome
Title Humoral Immune Response for Each Vaccine Strain in Terms of HI Antibodies.
Hide Description 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).
Time Frame At Days 0 and 21
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Fluarix Tetra (Southern Hemisphere) Adult Group_Y Fluarix Tetra (Southern Hemisphere) Adult Group_N Fluarix Tetra (Southern Hemisphere) Elderly Group_Y Fluarix Tetra (Southern Hemisphere) Elderly Group_N
Hide Arm/Group Description:
Subjects aged 18-60 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.
Subjects aged 18-60 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.
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.
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.
Overall Number of Participants Analyzed 31 31 46 11
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
H1N1, Day 0
86.5
(56.7 to 132.0)
25.9
(14.4 to 46.5)
33.9
(23.4 to 48.9)
22.0
(11.0 to 43.9)
H1N1, Day 21
276.7
(206.8 to 370.3)
765.3
(499.0 to 1174.0)
151.8
(111.2 to 207.0)
248.7
(115.6 to 534.9)
H3N2, Day 0
41.3
(26.1 to 65.5)
24.7
(14.5 to 42.2)
44.8
(30.1 to 66.5)
31.0
(11.1 to 87.1)
H3N2, Day 21
342.2
(240.9 to 486.1)
334.6
(215.2 to 520.3)
281.6
(196.3 to 403.9)
438.5
(229.9 to 836.4)
Yamagata, Day 0
133.7
(89.2 to 200.4)
52.9
(29.5 to 94.6)
88.2
(70.2 to 110.8)
45.4
(24.7 to 83.5)
Yamagata, Day 21
306.0
(223.4 to 419.0)
374.2
(257.8 to 543.1)
194.6
(157.6 to 240.3)
425.0
(267.3 to 675.7)
Victoria, Day 0
95.6
(68.7 to 133.0)
49.5
(30.7 to 79.6)
114.9
(82.7 to 159.5)
54.8
(29.3 to 102.8)
Victoria, Day 21
282.9
(207.7 to 385.3)
473.2
(341.5 to 655.7)
259.2
(196.3 to 342.3)
452.5
(236.2 to 867.1)
8.Secondary Outcome
Title Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Vaccine Strains.
Hide Description 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).
Time Frame At Days 0 and 21
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Fluarix Tetra (Southern Hemisphere) Adult Group_Y Fluarix Tetra (Southern Hemisphere) Adult Group_N Fluarix Tetra (Southern Hemisphere) Elderly Group_Y Fluarix Tetra (Southern Hemisphere) Elderly Group_N
Hide Arm/Group Description:
Subjects aged 18-60 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.
Subjects aged 18-60 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.
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.
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.
Overall Number of Participants Analyzed 31 31 46 11
Measure Type: Number
Unit of Measure: Subjects
H1N1, Day 0 30 21 42 10
H1N1, Day 21 31 31 46 11
H3N2, Day 0 30 22 43 9
H3N2, Day 21 31 31 46 11
Yamagata, Day 0 31 28 46 11
Yamagata, Day 21 31 31 46 11
Victoria, Day 0 31 28 46 11
Victoria, Day 21 31 31 46 11
9.Secondary Outcome
Title Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains.
Hide Description 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).
Time Frame At Days 0 and 21
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Fluarix Tetra (Southern Hemisphere) Adult Group_Y Fluarix Tetra (Southern Hemisphere) Adult Group_N Fluarix Tetra (Southern Hemisphere) Elderly Group_Y Fluarix Tetra (Southern Hemisphere) Elderly Group_N
Hide Arm/Group Description:
Subjects aged 18-60 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.
Subjects aged 18-60 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.
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.
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.
Overall Number of Participants Analyzed 31 31 46 11
Measure Type: Number
Unit of Measure: Subjects
H1N1, Day 0 27 13 27 4
H1N1, Day 21 31 31 43 11
H3N2, Day 0 16 13 28 5
H3N2, Day 21 31 30 44 11
Yamagata, Day 0 28 18 41 6
Yamagata, Day 21 31 31 46 11
Victoria, Day 0 27 21 41 7
Victoria, Day 21 31 31 46 11
10.Secondary Outcome
Title MGI for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains.
Hide Description 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).
Time Frame At Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Fluarix Tetra (Southern Hemisphere) Adult Group_Y Fluarix Tetra (Southern Hemisphere) Adult Group_N Fluarix Tetra (Southern Hemisphere) Elderly Group_Y Fluarix Tetra (Southern Hemisphere) Elderly Group_N
Hide Arm/Group Description:
Subjects aged 18-60 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.
Subjects aged 18-60 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.
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.
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.
Overall Number of Participants Analyzed 31 31 46 11
Mean (95% Confidence Interval)
Unit of Measure: Fold increase
H1N1
3.2
(2.3 to 4.5)
29.6
(13.5 to 64.8)
4.5
(3.2 to 6.3)
11.3
(4.1 to 31.1)
H3N2
8.3
(5.4 to 12.7)
13.5
(8.3 to 22.2)
6.3
(4.5 to 8.8)
14.1
(4.9 to 40.8)
Yamagata
2.3
(1.7 to 3.0)
7.1
(4.4 to 11.3)
2.2
(1.8 to 2.6)
9.4
(4.2 to 21.0)
Victoria
3.0
(2.1 to 4.1)
9.6
(5.6 to 16.4)
2.3
(1.8 to 2.9)
8.3
(3.1 to 21.9)
11.Secondary Outcome
Title Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains.
Hide Description 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).
Time Frame At Day 21.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Fluarix Tetra (Southern Hemisphere) Adult Group_Y Fluarix Tetra (Southern Hemisphere) Adult Group_N Fluarix Tetra (Southern Hemisphere) Elderly Group_Y Fluarix Tetra (Southern Hemisphere) Elderly Group_N
Hide Arm/Group Description:
Subjects aged 18-60 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.
Subjects aged 18-60 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.
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.
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.
Overall Number of Participants Analyzed 31 31 46 11
Measure Type: Number
Unit of Measure: Subjects
H1N1 14 24 26 9
H3N2 25 24 33 8
Yamagata 8 23 12 8
Victoria 14 24 13 7
12.Secondary Outcome
Title Number of Subjects With Seroprotection Power (SPP) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains Above the Cut-off Value.
Hide Description 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).
Time Frame At Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Fluarix Tetra (Southern Hemisphere) Adult Group_Y Fluarix Tetra (Southern Hemisphere) Adult Group_N Fluarix Tetra (Southern Hemisphere) Elderly Group_Y Fluarix Tetra (Southern Hemisphere) Elderly Group_N
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Subjects aged 18-60 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.
Subjects aged 18-60 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.
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.
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.
Overall Number of Participants Analyzed 31 31 46 11
Measure Type: Number
Unit of Measure: Subjects
H1N1 4 18 16 7
H3N2 15 17 16 6
Yamagata 3 13 5 5
Victoria 4 10 5 4
13.Secondary Outcome
Title Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
Hide Description 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.
Time Frame During the 4-day (Days 0-3) post-vaccination period
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Hide Analysis Population Description
Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.
Arm/Group Title Fluarix Tetra (Southern Hemisphere) Adult Group Fluarix Tetra (Southern Hemisphere) Elderly Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 62 57
Measure Type: Number
Unit of Measure: Subjects
Any Pain 27 13
Grade 3 Pain 3 0
Any Redness 9 7
Grade 3 Redness 0 0
Any Swelling 7 6
Grade 3 Swelling 0 0
14.Secondary Outcome
Title Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Hide Description 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.
Time Frame During the 4-day (Days 0-3) post-vaccination period
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.
Arm/Group Title Fluarix Tetra (Southern Hemisphere) Adult Group Fluarix Tetra (Southern Hemisphere) Elderly Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 62 57
Measure Type: Number
Unit of Measure: Subjects
Any Arthralgia 6 2
Grade 3 Arthralgia 0 1
Related Arthralgia 5 1
Any Fatigue 6 1
Grade 3 Fatigue 1 0
Related Fatigue 5 0
Any Gastrointestinal symptoms 3 0
Grade 3 Gastrointestinal symptoms 0 0
Related Gastrointestinal symptoms 2 0
Any Headache 8 1
Grade 3 Headache 2 1
Related Headache 6 1
Any Myalgia 9 2
Grade 3 Myalgia 0 1
Related Myalgia 8 1
Any Sweating 2 0
Grade 3 Sweating 1 0
Related Sweating 2 0
Any Shivering 2 0
Grade 3 Shivering 0 0
Related Shivering 1 0
Any Temperature (Oral) 0 0
Grade 3 Temperature (Oral) 0 0
Related Temperature (Oral) 0 0
15.Secondary Outcome
Title Duration of Solicited Local Symptoms
Hide Description Duration was defined as number of days with any grade of local symptoms.
Time Frame During the 4-day (Days 0-3) post-vaccination period
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.
Arm/Group Title Fluarix Tetra (Southern Hemisphere) Adult Group Fluarix Tetra (Southern Hemisphere) Elderly Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 27 13
Median (Full Range)
Unit of Measure: days
Pain (N = 27, 13)
2.0
(1.0 to 4.0)
1.0
(1.0 to 3.0)
Redness (N = 9, 7)
2.0
(1.0 to 4.0)
2.0
(1.0 to 3.0)
Swelling (N = 7, 6)
3.0
(1.0 to 4.0)
1.5
(1.0 to 2.0)
16.Secondary Outcome
Title Number of Subjects Reporting Any, Grade 3 and Related Medically Attended Adverse Events (MAEs).
Hide Description 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.
Time Frame During the entire study period (approximately 21 days for each subject).
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.
Arm/Group Title Fluarix Tetra (Southern Hemisphere) Adult Group Fluarix Tetra (Southern Hemisphere) Elderly Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 63 57
Measure Type: Number
Unit of Measure: subjects
Any MAEs 4 6
Grade 3 MAEs 3 1
Related MAEs 0 0
17.Secondary Outcome
Title Duration of Solicited General Symptoms
Hide Description Duration was defined as number of days with any grade of general symptoms.
Time Frame During the 4-day (Days 0-3) post-vaccination period
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.
Arm/Group Title Fluarix Tetra (Southern Hemisphere) Adult Group Fluarix Tetra (Southern Hemisphere) Elderly Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 9 2
Median (Full Range)
Unit of Measure: days
Arthralgia [N = 6,2]
1.5
(1.0 to 3.0)
2.5
(1.0 to 4.0)
Fatigue [N = 6,1]
3.0
(1.0 to 4.0)
2.0
(2.0 to 2.0)
Gastrointestinal symptoms [N = 3,0]
1.0
(1.0 to 3.0)
0.0
(0.0 to 0.0)
Headache [N = 8,1]
2.5
(1.0 to 3.0)
1.0
(1.0 to 1.0)
Myalgia [N = 9,2]
2.0
(1.0 to 4.0)
3.0
(2.0 to 4.0)
Sweating [N = 2,0]
2.5
(1.0 to 4.0)
0.0
(0.0 to 0.0)
Shivering [N = 2,0]
1.5
(1.0 to 2.0)
0.0
(0.0 to 0.0)
18.Secondary Outcome
Title Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Hide Description 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.
Time Frame During the 21-day (Days 0-20) post-vaccination period.
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.
Arm/Group Title Fluarix Tetra (Southern Hemisphere) Adult Group Fluarix Tetra (Southern Hemisphere) Elderly Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 63 57
Measure Type: Number
Unit of Measure: Subjects
Any Unsolicted AEs 11 10
Grade 3 Unsolicted AEs 4 2
Related Unsolicted AEs 4 0
19.Secondary Outcome
Title Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
Hide Description 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.
Time Frame During the entire study period (approximately 21 days for each subject)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.
Arm/Group Title Fluarix Tetra (Southern Hemisphere) Adult Group Fluarix Tetra (Southern Hemisphere) Elderly Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 63 57
Measure Type: Number
Unit of Measure: Subjects
Any SAEs 0 1
Related SAEs 0 0
Time Frame 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.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Fluarix Tetra (Southern Hemisphere) Adult Group Fluarix Tetra (Southern Hemisphere) Elderly Group
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Fluarix Tetra (Southern Hemisphere) Adult Group Fluarix Tetra (Southern Hemisphere) Elderly Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Fluarix Tetra (Southern Hemisphere) Adult Group Fluarix Tetra (Southern Hemisphere) Elderly Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/63 (0.00%)      1/57 (1.75%)    
Nervous system disorders     
Syncope *  0/63 (0.00%)  0 1/57 (1.75%)  1
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Fluarix Tetra (Southern Hemisphere) Adult Group Fluarix Tetra (Southern Hemisphere) Elderly Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   27/63 (42.86%)      13/57 (22.81%)    
General disorders     
Fatigue   6/63 (9.52%)  6 2/57 (3.51%)  2
Pain   27/63 (42.86%)  27 13/57 (22.81%)  13
Swelling   7/63 (11.11%)  7 6/57 (10.53%)  6
Infections and infestations     
Upper respiratory tract infection *  1/63 (1.59%)  1 3/57 (5.26%)  3
Musculoskeletal and connective tissue disorders     
Arthralgia *  6/63 (9.52%)  6 2/57 (3.51%)  2
Myalgia *  9/63 (14.29%)  9 3/57 (5.26%)  3
Nervous system disorders     
Headache *  8/63 (12.70%)  8 1/57 (1.75%)  1
Skin and subcutaneous tissue disorders     
Erythema (redness)   9/63 (14.29%)  9 7/57 (12.28%)  7
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
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Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02369341     History of Changes
Other Study ID Numbers: 201959
First Submitted: February 16, 2015
First Posted: February 23, 2015
Results First Submitted: June 2, 2016
Results First Posted: August 29, 2016
Last Update Posted: October 9, 2017