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Evaluation of the Immune Response and the Safety of a Pandemic Influenza Candidate Vaccine (H1N1)

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ClinicalTrials.gov Identifier: NCT00971425
Recruitment Status : Completed
First Posted : September 3, 2009
Results First Posted : March 4, 2011
Last Update Posted : August 17, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Prevention
Condition Influenza
Interventions Biological: Pandemrix (GSK investigational influenza GSK2340272A vaccine)
Biological: Fluarix™
Biological: Placebo
Enrollment 145
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo-Pandemrix-Fluarix Group Fluarix-Pandemrix-Placebo Group
Hide Arm/Group Description Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42. Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
Period Title: Overall Study
Started 72 73
Completed 71 71
Not Completed 1 2
Reason Not Completed
Adverse Event             1             1
Withdrawal by Subject             0             1
Arm/Group Title Placebo-Pandemrix-Fluarix Group Fluarix-Pandemrix-Placebo Group Total
Hide Arm/Group Description Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42. Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42. Total of all reporting groups
Overall Number of Baseline Participants 72 73 145
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 72 participants 73 participants 145 participants
69.1  (5.16) 69.7  (5.59) 69.4  (5.37)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 72 participants 73 participants 145 participants
Female
39
  54.2%
34
  46.6%
73
  50.3%
Male
33
  45.8%
39
  53.4%
72
  49.7%
1.Primary Outcome
Title Geometric Mean Titers (GMTs) of Antibodies Against Pandemrix Vaccine Strain
Hide Description

Titers were expressed as GMTs.

The Pandemrix vaccine strain was A/Cal/7/09.

Time Frame At Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity , which included all evaluable subjects for whom immunogenicity results were available.
Arm/Group Title Placebo-Pandemrix-Fluarix Group Fluarix-Pandemrix-Placebo Group
Hide Arm/Group Description:
Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
Overall Number of Participants Analyzed 64 67
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
309.8
(246.4 to 389.6)
227.5
(181.5 to 285.3)
2.Primary Outcome
Title Number of Subjects With a Titer Greater Than or Equal to 1:10 for Antibodies Against Pandemrix Vaccine Strain
Hide Description

The Pandemrix vaccine strain was A/Cal/7/09.

The cut-off was a titer of 1:10 and this titer was considered as seropositivity.

Time Frame At Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity , which included all evaluable subjects for whom immunogenicity results were available.
Arm/Group Title Placebo-Pandemrix-Fluarix Group Fluarix-Pandemrix-Placebo Group
Hide Arm/Group Description:
Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
Overall Number of Participants Analyzed 64 67
Measure Type: Number
Unit of Measure: subjects
64 67
3.Primary Outcome
Title Number of Seroconverted Subjects for Antibodies Against Pandemrix Vaccine Strain
Hide Description

The Pandemrix vaccine strain was A/Cal/7/09.

A subject seroconverted for haemagglutination inhibition (HI) antibodies was defined as a subject with either a prevaccination (Day 0) HI antibody titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a prevaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer.

Time Frame At Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity , which included all evaluable subjects for whom immunogenicity results were available.
Arm/Group Title Placebo-Pandemrix-Fluarix Group Fluarix-Pandemrix-Placebo Group
Hide Arm/Group Description:
Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
Overall Number of Participants Analyzed 64 67
Measure Type: Number
Unit of Measure: subjects
61 59
4.Primary Outcome
Title Seroconversion Factor for Antibodies Against Pandemrix Vaccine Strain
Hide Description

Seroconversion Factor (SCF) is defined as the fold increase in serum HI antibody GMTs post-vaccination compared to prevaccination (Day 0).

The Pandemrix vaccine strain was A/Cal/7/09.

Time Frame At Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity , which included all evaluable subjects for whom immunogenicity results were available.
Arm/Group Title Placebo-Pandemrix-Fluarix Group Fluarix-Pandemrix-Placebo Group
Hide Arm/Group Description:
Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
Overall Number of Participants Analyzed 64 67
Mean (95% Confidence Interval)
Unit of Measure: fold increase
33.6
(25.5 to 44.3)
16.5
(12.4 to 21.9)
5.Primary Outcome
Title Number of Seroprotected Subjects for Antibodies Against Pandemrix Vaccine Strain
Hide Description

The Pandemrix vaccine strain was A/Cal/7/09.

A seroprotected subject was defined as a subject with a serum HI antibody titer greater than or equal to 1:40.

Time Frame At Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity , which included all evaluable subjects for whom immunogenicity results were available.
Arm/Group Title Placebo-Pandemrix-Fluarix Group Fluarix-Pandemrix-Placebo Group
Hide Arm/Group Description:
Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
Overall Number of Participants Analyzed 64 67
Measure Type: Number
Unit of Measure: subjects
64 67
6.Secondary Outcome
Title Geometric Mean Titers (GMTs) of Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains
Hide Description

Pandemrix vaccine strain (A/Cal/7/09) data were assessed up to Month 12. Note that Day 42 data for Pandemrix vaccine strain were already addressed as a primary outcome measure.

Fluarix vaccine strains (A/Bri/59/07, B/Bri/60/08, and A/Uru/716/07) data were only assessed up to Day 63.

Time Frame Day -21, Day 0, Day 21, Day 42, Day 63, Month 6 and Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity , which included all evaluable subjects for whom immunogenicity results were available.
Arm/Group Title Placebo-Pandemrix-Fluarix Group Fluarix-Pandemrix-Placebo Group
Hide Arm/Group Description:
Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
Overall Number of Participants Analyzed 64 67
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
Day -21 A/Cal/7/09 (N=64;67)
8.7
(6.9 to 11.1)
7.4
(6.3 to 8.7)
Day 0 A/Cal/7/09 (N=64;67)
9.2
(7.3 to 11.7)
13.8
(11.3 to 16.9)
Day 21 A/Cal/7/09 (N=64;67)
147.5
(111.9 to 194.4)
109.6
(82.4 to 145.8)
Day 63 A/Cal/7/09 (N=63;66)
223.8
(181.2 to 276.5)
174.0
(138.7 to 218.4)
Month 6 A/Cal/7/09 (N=60;63)
102.0
(78.6 to 132.3)
74.1
(59.0 to 92.9)
Month 12 A/Cal/7/09 (N=60;64)
35.6
(27.0 to 47.0)
25.7
(20.8 to 31.9)
Day -21 A/Bri/59/07 (N=64;67)
23.1
(18.9 to 28.4)
20.8
(16.7 to 25.9)
Day 0 A/Bri/59/07 (N=64;67)
22.4
(18.2 to 27.5)
64.0
(50.8 to 80.5)
Day 42 A/Bri/59/07 (N=64;67)
32.3
(26.4 to 39.7)
56.5
(45.3 to 70.5)
Day 63 A/Bri/59/07 (N=63;66)
55.7
(45.1 to 68.7)
49.8
(40.1 to 61.9)
Day -21 B/Bri/60/08 (N=64;67)
120.7
(98.7 to 147.7)
135.6
(107.2 to 171.6)
Day 0 B/Bri/60/08 (N=64;67)
118.8
(97.7 to 144.5)
351.2
(285.6 to 431.9)
Day 42 B/Bri/60/08 (N=64;67)
182.2
(154.7 to 214.6)
291.5
(238.8 to 355.8)
Day 63 B/Bri/60/08 (N=63;66)
291.3
(246.2 to 344.7)
273.3
(225.3 to 331.6)
Day -21 A/Uru/716/07 (N=64;67)
26.2
(19.2 to 35.7)
22.5
(16.2 to 31.2)
Day 0 A/Uru/716/07 (N=64;67)
25.5
(18.8 to 34.6)
100.9
(75.9 to 134.1)
Day 42 A/Uru/716/07 (N=64;67)
27.1
(20.7 to 35.4)
69.2
(51.0 to 93.7)
Day 63 A/Uru/716/07 (N=63;66)
85.9
(65.2 to 113.2)
62.4
(46.9 to 83.2)
7.Secondary Outcome
Title Number of Subjects With a Titer Greater Than or Equal to 1:10 for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains
Hide Description

The cut-off was a titer of 1:10 and this titer was considered as seropositivity.

Pandemrix vaccine strain (A/Cal/7/09) data were assessed up to Month 12. Note that Day 42 data for Pandemrix vaccine strain were already addressed as a primary outcome measure.

Fluarix vaccine strains (A/Bri/59/07, B/Bri/60/08, and A/Uru/716/07) data were only assessed up to Day 63.

Time Frame At Day -21, Day 0, Day 21, Day 42, Day 63, Month 6 and Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity , which included all evaluable subjects for whom immunogenicity results were available.
Arm/Group Title Placebo-Pandemrix-Fluarix Group Fluarix-Pandemrix-Placebo Group
Hide Arm/Group Description:
Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
Overall Number of Participants Analyzed 64 67
Measure Type: Number
Unit of Measure: subjects
Day -21 A/Cal/7/09 (N=64;67) 22 21
Day 0 A/Cal/7/09 (N=64;67) 26 50
Day 21 A/Cal/7/09 (N=64;67) 64 67
Day 63 A/Cal/7/09 (N=63;66) 63 66
Month 6 A/Cal/7/09 (N=60;63) 60 63
Month 12 A/Cal/7/09 (N=60;64) 57 60
Day -21 A/Bri/59/07 (N=64;67) 57 58
Day 0 A/Bri/59/07 (N=64;67) 56 67
Day 42 A/Bri/59/07 (N=64;67) 62 67
Day 63 A/Bri/59/07 (N=63;66) 62 66
Day -21 B/Bri/60/08 (N=64;67) 64 67
Day 0 B/Bri/60/08 (N=64;67) 64 67
Day 42 B/Bri/60/08 (N=64;67) 64 67
Day 63 B/Bri/60/08 (N=63;66) 63 66
Day -21 A/Uru/716/07 (N=64;67) 51 52
Day 0 A/Uru/716/07 (N=64;67) 51 66
Day 42 A/Uru/716/07 (N=64;67) 57 66
Day 63 A/Uru/716/07 (N=63;66) 63 65
8.Secondary Outcome
Title Number of Seroconverted Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains
Hide Description

A seroconverted subject was defined as a subject with either a prevaccination (Day 0) HI antibody titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a prevaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer.

Pandemrix vaccine strain (A/Cal/7/09) data were generated for Day 21, Month 6 and Month 12.

Fluarix vaccine strains (A/Bri/59/07, B/Bri/60/08, and A/Uru/716/07) data were generated at 21 days after Fluarix administration, i.e. depending on the group at Day 0 or Day 63 (Day 0/Day 63).

Time Frame At Day 21, Month 6 and Month 12 for Pandemrix vaccine strain, and at Day 0/Day 63 for Fluarix vaccine strains.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity , which included all evaluable subjects for whom immunogenicity results were available.
Arm/Group Title Placebo-Pandemrix-Fluarix Group Fluarix-Pandemrix-Placebo Group
Hide Arm/Group Description:
Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
Overall Number of Participants Analyzed 64 67
Measure Type: Number
Unit of Measure: subjects
Day 21 A/Cal/7/09 (N=64;67) 57 43
Month 6 A/Cal/7/09 (N=60;63) 48 39
Month 12 A/Cal/7/09 (N=60;64) 19 11
Day 63/Day 0 A/Bri/56/07 (N=63;67) 9 21
Day 63/Day 0 B/Bri/60/08 (N=63;67) 4 18
Day 63/Day 0 A/Uru/716/07 (N=63;67) 25 34
9.Secondary Outcome
Title Seroconversion Factor for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains
Hide Description

For the definition of seroconversion factor, please refer to the primary outcome measure.

Pandemrix vaccine strain (A/Cal/7/09) data were generated for Day 21, Month 6 and Month 12.

Fluarix vaccine strains (A/Bri/59/07, B/Bri/60/08, and A/Uru/716/07) data were generated at 21 days after Fluarix administration, i.e. depending on the group at Day 0 or Day 63 (Day 0/Day 63).

Time Frame At Day 21, Month 6 and Month 12 for Pandemrix vaccine strain, and at Day 0/Day 63 for Fluarix vaccine strains.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity , which included all evaluable subjects for whom immunogenicity results were available.
Arm/Group Title Placebo-Pandemrix-Fluarix Group Fluarix-Pandemrix-Placebo Group
Hide Arm/Group Description:
Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
Overall Number of Participants Analyzed 64 67
Mean (95% Confidence Interval)
Unit of Measure: fold increase
Day 21 A/Cal/7/09 (N=64;67)
16.0
(12.2 to 21.0)
7.9
(5.8 to 10.8)
Month 6 A/Cal/7/09 (N=60;63)
10.9
(8.5 to 14.1)
5.2
(3.8 to 6.9)
Month 12 A/Cal/7/09 (N=60;64)
3.8
(2.9 to 5.0)
1.8
(1.4 to 2.4)
Day 63/Day 0 A/Bri/56/07 (N=63;67)
1.7
(1.4 to 2.1)
3.1
(2.3 to 4.1)
Day 63/Day 0 B/Bri/60/08 (N=63;67)
1.6
(1.4 to 1.8)
2.6
(2.1 to 3.2)
Day 63/Day 0 A/Uru/716/07 (N=63;67)
3.1
(2.5 to 4.0)
4.5
(3.3 to 6.0)
10.Secondary Outcome
Title Number of Seroprotected Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains
Hide Description

A seroprotected subject was defined as a subject with a serum HI antibody titer greater than or equal to 1:40.

Pandemrix vaccine strain (A/Cal/7/09) data were assessed up to Month 12. Note that Day 42 data for Pandemrix vaccine strain were already addressed as a primary outcome measure.

Fluarix vaccine strains (A/Bri/59/07, B/Bri/60/08, and A/Uru/716/07) data were only assessed up to Day 63.

Time Frame Day -21, Day 0, Day 21, Day 42, Day 63, Month 6 and Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity , which included all evaluable subjects for whom immunogenicity results were available.
Arm/Group Title Placebo-Pandemrix-Fluarix Group Fluarix-Pandemrix-Placebo Group
Hide Arm/Group Description:
Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
Overall Number of Participants Analyzed 64 67
Measure Type: Number
Unit of Measure: subjects
Day -21 A/Cal/7/09 (N=64;67) 9 4
Day 0 A/Cal/7/09 (N=64;67) 9 12
Day 21 A/Cal/7/09 (N=64;67) 60 58
Day 63 A/Cal/7/09 (N=63;66) 63 65
Month 6 A/Cal/7/09 (N=60;63) 52 53
Month 12 A/Cal/7/09 (N=60;64) 28 19
Day -21 A/Bri/59/07 (N=64;67) 25 21
Day 0 A/Bri/59/07 (N=64;67) 26 50
Day 42 A/Bri/59/07 (N=64;67) 30 47
Day 63 A/Bri/59/07 (N=63;66) 50 42
Day -21 B/Bri/60/08 (N=64;67) 61 63
Day 0 B/Bri/60/08 (N=64;67) 61 67
Day 42 B/Bri/60/08 (N=64;67) 64 67
Day 63 B/Bri/60/08 (N=63;66) 63 66
Day -21 A/Uru/716/07 (N=64;67) 30 22
Day 0 A/Uru/716/07 (N=64;67) 29 57
Day 42 A/Uru/716/07 (N=64;67) 30 47
Day 63 A/Uru/716/07 (N=63;66) 54 46
11.Secondary Outcome
Title Number of Subjects With Solicited Local and General Symptoms After Administration of Pandemrix
Hide Description Solicited local symptoms were pain, redness and swelling at the injection site. Solicited general symptoms were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating, temperature (defined as axillary temperature equal to or above 37.5 degrees Celsius).
Time Frame During a 7-Day (Day 0-6) follow-up period after each administration of Pandemrix
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort on subjects with available results
Arm/Group Title Placebo-Pandemrix-Fluarix Group Fluarix-Pandemrix-Placebo Group
Hide Arm/Group Description:
Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
Overall Number of Participants Analyzed 72 71
Measure Type: Number
Unit of Measure: subjects
Pain 49 43
Redness 11 10
Swelling 8 11
Fatigue 22 18
Headache 23 19
Joint pain at other location 20 13
Muscle aches 23 22
Shivering 14 15
Sweating 12 13
Temperature 2 3
12.Secondary Outcome
Title Number of Subjects With Solicited Local and General Symptoms After Administration of Placebo or Fluarix
Hide Description Solicited local symptoms were pain, redness and swelling at the injection site. General symptoms were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating, temperature (defined as axillary temperature equal to or above 37.5 degrees Celsius)
Time Frame During a 7-Day (Day 0-6) follow-up period after each administration of (at Day -21 and at Day 42) placebo or Fluarix
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort on subjects with available results.
Arm/Group Title Placebo-Pandemrix-Fluarix Group Fluarix-Pandemrix-Placebo Group
Hide Arm/Group Description:
Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
Overall Number of Participants Analyzed 72 72
Measure Type: Number
Unit of Measure: subjects
pain Day -21 (N=72;72) 5 12
redness Day -21 (N=72;72) 2 1
swelling Day -21 (N=72;72) 0 1
pain Day 42 (N=69;71) 17 4
redness Day 42 (N=69;71) 1 0
swelling Day 42 (N=69;71) 2 0
fatigue Day -21 (N=72;72) 9 7
headache Day -21 (N=72;72) 5 10
joint pain at other location Day -21 (N=72;72) 7 2
muscle aches Day -21 (N=72;72) 4 6
shivering Day -21 (N=72;72) 2 4
sweating Day -21 (N=72;72) 5 6
temperature Day -21 (N=72;72) 0 1
fatigue Day 42 (N=69;71) 10 4
headache Day 42 (N=69;71) 10 8
joint pain at other location Day 42 (N=69;71) 8 6
muscle aches Day 42 (N=69;71) 7 5
shivering Day 42 (N=69;71) 3 3
sweating Day -21 (N=69;71) 3 4
temperature Day 42 (N=69;71) 0 0
13.Secondary Outcome
Title Number of Subjects With 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: any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3: unsolicited AE that prevented normal everyday activity Related: unsolicited AE assessed by the investigator as related to the vaccination

Time Frame During 21 days (Day 0-20) after each vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort.
Arm/Group Title Placebo-Pandemrix-Fluarix Group Fluarix-Pandemrix-Placebo Group
Hide Arm/Group Description:
Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
Overall Number of Participants Analyzed 72 73
Measure Type: Number
Unit of Measure: subjects
Any 33 37
Grade 3 4 10
Related 14 9
14.Secondary Outcome
Title Number of Subjects With Serious Adverse Events (SAEs)
Hide Description SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Time Frame During the entire study period (Day 0-364)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort.
Arm/Group Title Placebo-Pandemrix-Fluarix Group Fluarix-Pandemrix-Placebo Group
Hide Arm/Group Description:
Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
Overall Number of Participants Analyzed 72 73
Measure Type: Number
Unit of Measure: subjects
11 14
15.Secondary Outcome
Title Number of Subjects With AEs of Specific Interest
Hide Description Adverse events of specific interest included auto-immune diseases and other immune mediated disorders.
Time Frame During the entire study period (Day 0-364)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort.
Arm/Group Title Placebo-Pandemrix-Fluarix Group Fluarix-Pandemrix-Placebo Group
Hide Arm/Group Description:
Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
Overall Number of Participants Analyzed 72 73
Measure Type: Number
Unit of Measure: subjects
0 1
Time Frame [Not Specified]
Adverse Event Reporting Description Number of subjects at risk differs for other adverse events, as it depends on the number of subjects with available results. After the different vaccinations there were different numbers of subjects for whom results were available.
 
Arm/Group Title Placebo-Pandemrix-Fluarix Group Fluarix-Pandemrix-Placebo Group
Hide Arm/Group Description Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42. Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
All-Cause Mortality
Placebo-Pandemrix-Fluarix Group Fluarix-Pandemrix-Placebo Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo-Pandemrix-Fluarix Group Fluarix-Pandemrix-Placebo Group
Affected / at Risk (%) Affected / at Risk (%)
Total   11/72 (15.28%)   14/73 (19.18%) 
Cardiac disorders     
Atrial fibrillation *  1/72 (1.39%)  0/73 (0.00%) 
Cardiac failure *  0/72 (0.00%)  1/73 (1.37%) 
myocardial infarction *  1/72 (1.39%)  0/73 (0.00%) 
Tachycardia paroxysmal *  1/72 (1.39%)  0/73 (0.00%) 
Ear and labyrinth disorders     
Vertigo *  1/72 (1.39%)  0/73 (0.00%) 
Eye disorders     
Eyelid ptosis *  1/72 (1.39%)  0/73 (0.00%) 
Gastrointestinal disorders     
Enterocolitis *  0/72 (0.00%)  1/73 (1.37%) 
Faecaloma *  0/72 (0.00%)  1/73 (1.37%) 
Inguinal hernia *  0/72 (0.00%)  1/73 (1.37%) 
General disorders     
Death *  0/72 (0.00%)  1/73 (1.37%) 
Infections and infestations     
Gastroenteritis *  0/72 (0.00%)  1/73 (1.37%) 
Gastroenteritis norovirus *  1/72 (1.39%)  0/73 (0.00%) 
Urinary tract infection *  0/72 (0.00%)  1/73 (1.37%) 
Injury, poisoning and procedural complications     
Ligament rupture *  0/72 (0.00%)  1/73 (1.37%) 
Lumbar vertebral fracture *  1/72 (1.39%)  0/73 (0.00%) 
Meniscus lesion *  0/72 (0.00%)  1/73 (1.37%) 
Radius fracture *  1/72 (1.39%)  0/73 (0.00%) 
Spinal compression fracture *  0/72 (0.00%)  1/73 (1.37%) 
Musculoskeletal and connective tissue disorders     
Osteoarthritis *  0/72 (0.00%)  2/73 (2.74%) 
Intervertebral disc protrusion *  1/72 (1.39%)  0/73 (0.00%) 
Lumbar spinal stenosis *  0/72 (0.00%)  1/73 (1.37%) 
Myalgia *  0/72 (0.00%)  1/73 (1.37%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Colon cancer *  0/72 (0.00%)  1/73 (1.37%) 
Nervous system disorders     
Sciatica *  0/72 (0.00%)  2/73 (2.74%) 
Cerebrovascular accident *  1/72 (1.39%)  0/73 (0.00%) 
Syncope *  1/72 (1.39%)  0/73 (0.00%) 
VIth nerve paralysis *  0/72 (0.00%)  1/73 (1.37%) 
Reproductive system and breast disorders     
Breast mass *  1/72 (1.39%)  0/73 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease *  0/72 (0.00%)  1/73 (1.37%) 
Vascular disorders     
Femoral arterial stenosis *  0/72 (0.00%)  1/73 (1.37%) 
Hypertensive crisis *  1/72 (1.39%)  0/73 (0.00%) 
*
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%
Placebo-Pandemrix-Fluarix Group Fluarix-Pandemrix-Placebo Group
Affected / at Risk (%) Affected / at Risk (%)
Total   59/72 (81.94%)   57/73 (78.08%) 
General disorders     
Pain  [1]  49/72 (68.06%)  43/71 (60.56%) 
Redness  [1]  11/72 (15.28%)  10/71 (14.08%) 
Swelling  [1]  8/72 (11.11%)  11/71 (15.49%) 
Pain  [2]  17/69 (24.64%)  12/72 (16.67%) 
Fatigue  [1]  22/72 (30.56%)  18/71 (25.35%) 
Headache  [1]  23/72 (31.94%)  19/71 (26.76%) 
Joint pain at other location  [1]  20/72 (27.78%)  13/71 (18.31%) 
Muscle aches  [1]  23/72 (31.94%)  22/71 (30.99%) 
Shivering  [1]  14/72 (19.44%)  15/71 (21.13%) 
Sweating  [1]  12/72 (16.67%)  13/71 (18.31%) 
Fatigue  [2]  10/69 (14.49%)  7/72 (9.72%) 
Headache  [2]  10/69 (14.49%)  10/72 (13.89%) 
Joint pain at other location  [2]  8/69 (11.59%)  2/72 (2.78%) 
Muscle aches  [2]  7/69 (10.14%)  6/72 (8.33%) 
Shivering  [2]  3/69 (4.35%)  4/72 (5.56%) 
Sweating  [2]  3/69 (4.35%)  6/72 (8.33%) 
Infections and infestations     
Nasopharyngitis *  11/72 (15.28%)  8/73 (10.96%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
[1]
after Pandemrix administration
[2]
after Fluarix administration
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: NCT00971425     History of Changes
Other Study ID Numbers: 113572
First Submitted: August 27, 2009
First Posted: September 3, 2009
Results First Submitted: February 10, 2011
Results First Posted: March 4, 2011
Last Update Posted: August 17, 2018