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Trial record 9 of 28 for:    pandemrix

Immunogenicity and Safety of Vaccine GSK2340272A (H1N1) and GSK Biologicals Fluarix™ Vaccine When Co-administered in Elderly

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ClinicalTrials.gov Identifier: NCT00968890
Recruitment Status : Completed
First Posted : August 31, 2009
Results First Posted : March 16, 2011
Last Update Posted : August 20, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Influenza
Interventions Biological: Pandemrix (Influenza vaccine GSK2340272A)
Biological: Fluarix™
Biological: Placebo
Enrollment 168
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pandemrix+Fluarix and Pandemrix+Placebo Pandemrix+Placebo and Pandemrix+Fluarix
Hide Arm/Group Description Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm. Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
Period Title: Overall Study
Started 84 84
Completed 84 84
Not Completed 0 0
Arm/Group Title Pandemrix+Fluarix and Pandemrix+Placebo Pandemrix+Placebo and Pandemrix+Fluarix Total
Hide Arm/Group Description Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm. Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm. Total of all reporting groups
Overall Number of Baseline Participants 84 84 168
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 84 participants 84 participants 168 participants
68.9  (4.63) 69.1  (4.70) 69.0  (4.65)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 84 participants 84 participants 168 participants
Female
42
  50.0%
47
  56.0%
89
  53.0%
Male
42
  50.0%
37
  44.0%
79
  47.0%
1.Primary Outcome
Title Number of Seroconverted Subjects After the Second Dose of Pandemrix and After Vaccination With Fluarix
Hide Description

A seroconverted subject is a subject who had either a pre-vaccination reciprocal hemagglutination inhibition (HI) titer < 10 and a postvaccination reciprocal titer >= 40, or a pre-vaccination reciprocal HI titer >= 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.

The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08.

Time Frame 21 days after the second dose of Pandemrix (=Day 42) and after vaccination with Fluarix (=Day 21 for Pandemrix+Fluarix and Pandemrix+Placebo Group or Day 42 for Pandemrix+ Placebo and Pandemrix+Fluarix Group)
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 blood samples were taken and immunogenicity data were available.
Arm/Group Title Pandemrix+Fluarix and Pandemrix+Placebo Pandemrix+Placebo and Pandemrix+Fluarix
Hide Arm/Group Description:
Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
Overall Number of Participants Analyzed 83 84
Measure Type: Number
Unit of Measure: subjects
A/Cal/09 79 82
B/Bri/08 40 22
A/Uru/07 36 23
A/Bri/07 31 23
2.Primary Outcome
Title Number of Seroprotected Subjects After the Second Dose of Pandemrix and After Vaccination With Fluarix
Hide Description

A seroprotected subject was a subject with reciprocal HI titers >= 40 against the vaccine homologous virus.

The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08.

Time Frame 21 days after the second dose of Pandemrix (=Day 42) and after vaccination with Fluarix (=Day 21 for Pandemrix+Fluarix and Pandemrix+Placebo Group or Day 42 for Pandemrix+ Placebo and Pandemrix+Fluarix Group)
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 blood samples were taken and immunogenicity data were available.
Arm/Group Title Pandemrix+Fluarix and Pandemrix+Placebo Pandemrix+Placebo and Pandemrix+Fluarix
Hide Arm/Group Description:
Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
Overall Number of Participants Analyzed 83 84
Measure Type: Number
Unit of Measure: subjects
A/Cal/09 82 84
A/Bri/07 57 52
A/Uru/07 65 54
B/Bri/08 83 84
3.Primary Outcome
Title Geometric Mean Fold Rise (GMFR) After the Second Dose of Pandemrix and After Vaccination With Fluarix
Hide Description

The GMFR is defined as the Geometric Mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.

The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08.

Time Frame 21 days after the second dose of Pandemrix (=Day 42) and after vaccination with Fluarix (=Day 21 for Pandemrix+Fluarix and Pandemrix+Placebo Group or Day 42 for Pandemrix+ Placebo and Pandemrix+Fluarix Group)
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 blood samples were taken and immunogenicity data were available.
Arm/Group Title Pandemrix+Fluarix and Pandemrix+Placebo Pandemrix+Placebo and Pandemrix+Fluarix
Hide Arm/Group Description:
Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
Overall Number of Participants Analyzed 83 84
Geometric Mean (95% Confidence Interval)
Unit of Measure: ratio
A/Cal/09
33.1
(26.0 to 42.1)
32.2
(25.6 to 40.4)
B/Bri/08
4.7
(3.6 to 6.1)
2.1
(1.8 to 2.5)
A/Uru/07
4.2
(3.3 to 5.4)
3.0
(2.4 to 3.9)
A/Bri/07
3.5
(2.9 to 4.3)
2.7
(2.2 to 3.3)
4.Secondary Outcome
Title Geometric Mean Titers for Antibodies Against Pandemrix and Fluarix Vaccine Strains
Hide Description

Titers are expressed as GMTs.

The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08.

Time Frame Days 0, 21, 42, 182, 364
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 blood samples were taken and immunogenicity data were available.
Arm/Group Title Pandemrix+Fluarix and Pandemrix+Placebo Pandemrix+Placebo and Pandemrix+Fluarix
Hide Arm/Group Description:
Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
Overall Number of Participants Analyzed 84 84
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
A/Cal/09 Day 0 (N=83;84)
7.4
(6.1 to 9.0)
8.5
(7.1 to 10.2)
A/Cal/09 Day 21 (N=83;84)
138.8
(107.7 to 178.9)
168.2
(137.5 to 205.7)
A/Cal/09 Day 42 (N=83;84)
246.1
(201.3 to 300.8)
273.6
(231.4 to 323.4)
A/Cal/09 Day 182 (N=84;84)
71.2
(57.4 to 88.4)
84.0
(69.8 to 101.2)
A/Cal/09 Day 364 (N=84;84)
29.1
(22.8 to 37.0)
34.4
(28.0 to 42.4)
A/Bri/07 Day 0 (N=83;84)
15.2
(12.4 to 18.7)
16.0
(13.3 to 19.2)
A/Bri/07 Day 21/Day 42 (N=83;84)
53.6
(43.1 to 66.5)
42.5
(34.5 to 52.4)
A/Bri/07 Day 182 (N=84;84)
37.9
(31.6 to 45.4)
36.8
(30.5 to 44.4)
A/Bri/07 Day 364 (N=84;84)
29.4
(24.9 to 34.7)
28.8
(24.4 to 34.0)
A/Uru/07 Day 0 (N=83;84)
17.9
(14.0 to 22.8)
19.7
(15.0 to 25.8)
A/Uru/07 Day 21/Day 42 (N=83;84)
74.8
(57.6 to 97.1)
59.7
(44.5 to 80.0)
A/Uru/07 Day 182 (N=84;84)
35.9
(28.0 to 46.0)
35.0
(26.2 to 46.9)
A/Uru/07 Day 364 (N=84;84)
28.7
(22.8 to 36.3)
27.7
(20.6 to 37.2)
B/Bri/08 Day 0 (N=83;84)
49.9
(38.8 to 64.1)
115.5
(96.3 to 138.5)
B/Bri/08 Day 21/Day 42 (N=83;84)
235.0
(199.5 to 276.8)
246.7
(208.5 to 292.0)
B/Bri/08 Day 182 (N=84;84)
220.7
(187.9 to 259.3)
222.5
(188.6 to 262.6)
B/Bri/08 Day 364 (N=84;84)
104.6
(88.5 to 123.7)
112.7
(92.4 to 137.4)
5.Secondary Outcome
Title Number of Seroconverted Subjects
Hide Description

A seroconverted subject is a subject who had either a pre-vaccination reciprocal hemagglutination inhibition (HI) titer < 10 and a postvaccination reciprocal titer >= 40, or a pre-vaccination reciprocal HI titer >= 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.

The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08.

Time Frame at Day 21 (for Pandemrix vaccine strain only), Day 182 and Day 364
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 blood samples were taken and immunogenicity data were available.
Arm/Group Title Pandemrix+Fluarix and Pandemrix+Placebo Pandemrix+Placebo and Pandemrix+Fluarix
Hide Arm/Group Description:
Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
Overall Number of Participants Analyzed 84 84
Measure Type: Number
Unit of Measure: subjects
A/Cal/09 Day 21 (N=83;84) 73 78
A/Cal/09 Day 182 (N=84;84) 64 69
A/Cal/09 Day 364 (N=84;84) 25 30
A/Bri/07 Day 182 (N=84;84) 18 13
A/Bri/07 Day 364 (N=84;84) 5 8
A/Uru/07 Day 182 (N=84;84) 13 9
A/Uru/07 Day 364 (N=84;84) 7 6
B/Bri/08 Day 182 (N=84;84) 40 13
B/Bri/08 Day 364 (N=84;84) 19 3
6.Secondary Outcome
Title Number of Seroprotected Subjects
Hide Description A seroprotected subject is a subject with reciprocal HI titers >= 40 against the vaccine homologous virus. The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08.
Time Frame at Day 21 (for Pandemrix vaccine strain only), Day 182 and Day 364
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 blood samples were taken and immunogenicity data were available.
Arm/Group Title Pandemrix+Fluarix and Pandemrix+Placebo Pandemrix+Placebo and Pandemrix+Fluarix
Hide Arm/Group Description:
Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
Overall Number of Participants Analyzed 84 84
Measure Type: Number
Unit of Measure: subjects
A/Cal/09 Day 0 (N=83;84) 6 7
A/Cal/09 Day 21 (N=83;84) 74 81
A/Cal/09 Day 182 (N=84;84) 67 75
A/Cal/09 Day 364 (N=84;84) 32 40
A/Bri/07 Day 0 (N=83;84) 22 17
A/Bri/07 Day 182 (N=84;84) 48 44
A/Bri/07 Day 364 (N=84;84) 36 34
A/Uru/07 Day 0 (N=83;84) 29 31
A/Uru/07 Day 182 (N=84;84) 44 43
A/Uru/07 Day 364 (N=84;84) 36 40
B/Bri/08 Day 0 (N=83;84) 56 78
B/Bri/08 Day 182 (N=84;84) 84 84
B/Bri/08 Day 364 (N=84;84) 78 77
7.Secondary Outcome
Title Geometric Mean Fold Rise (GMFR)
Hide Description The GMFR is defined as the Geometric Mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus. The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08.
Time Frame at Day 21 (for Pandemrix vaccine strain only), Day 182 and Day 364
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 blood samples were taken and immunogenicity data were available.
Arm/Group Title Pandemrix+Fluarix and Pandemrix+Placebo Pandemrix+Placebo and Pandemrix+Fluarix
Hide Arm/Group Description:
Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
Overall Number of Participants Analyzed 84 84
Geometric Mean (95% Confidence Interval)
Unit of Measure: ratio
A/Cal/09 Day 21 (N=83;84)
18.7
(14.6 to 23.8)
19.8
(15.7 to 25.0)
A/Cal/09 Day 182 (N=84;84)
9.6
(7.8 to 11.9)
9.9
(8.1 to 12.0)
A/Cal/09 Day 364 (N=84;84)
3.9
(3.2 to 4.8)
4.0
(3.3 to 4.9)
A/Bri/07 Day 182 (N=84;84)
2.5
(2.1 to 2.9)
2.3
(2.0 to 2.7)
A/Bri/07 Day 364 (N=84;84)
1.9
(1.7 to 2.2)
1.8
(1.6 to 2.1)
A/Uru/07 Day 182 (N=84;84)
2.0
(1.6 to 2.4)
1.8
(1.5 to 2.1)
A/Uru/07 Day 364 (N=84;84)
1.6
(1.4 to 1.9)
1.4
(1.2 to 1.7)
B/Bri/08 Day 182 (N=84;84)
4.4
(3.6 to 5.5)
1.9
(1.7 to 2.2)
B/Bri/08 Day 364 (N=84;84)
2.1
(1.7 to 2.6)
1.0
(0.9 to 1.0)
8.Secondary Outcome
Title Number of Subjects With Titers Equal to or Above Titer 1:10
Hide Description

The cut-off 1:10 was considered as seropositivity.

The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08.

Time Frame Days 0, 21, 42, 182, 364
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 blood samples were taken and immunogenicity data were available.
Arm/Group Title Pandemrix+Fluarix and Pandemrix+Placebo Pandemrix+Placebo and Pandemrix+Fluarix
Hide Arm/Group Description:
Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
Overall Number of Participants Analyzed 84 84
Measure Type: Number
Unit of Measure: subjects
A/Cal/09 Day 0 (N=83;84) 20 32
A/Cal/09 Day 21 (N=83;84) 82 84
A/Cal/09 Day 42 (N=83;84) 83 84
A/Cal/09 Day 182 (N=84;84) 84 84
A/Cal/09 Day 364 (N=84;84) 78 81
A/Bri/07 Day 0 (N=83;84) 59 68
A/Bri/07 Day 21/Day 42 (N=83;84) 82 82
A/Bri/07 Day 182 (N=84;84) 83 83
A/Bri/07 Day 364 (N=84;84) 82 83
A/Uru/07 Day 0 (N=83;84) 58 57
A/Uru/07 Day 21/Day 42 (N=83;84) 79 80
A/Uru/07 Day 182 (N=84;84) 77 73
A/Uru/07 Day 364 (N=84;84) 76 65
B/Bri/08 Day 0 (N=83;84) 76 84
B/Bri/08 Day 21/Day 42 (N=83;84) 83 84
B/Bri/08 Day 182 (N=84;84) 84 84
B/Bri/08 Day 364 (N=84;84) 84 84
9.Secondary Outcome
Title Number of Subjects With Solicited Local and General Symptoms
Hide Description Solicited local symptoms are pain, redness and swelling at the injection site. They are divided between solicited local symptoms occurring after administration of Pandemrix, Fluarix or Placebo. Solicited general symptoms are fatigue, headache, joint pain at other location, muscle aches, shivering, sweating and temperature (defined as axillary temperature >= 38.0 degrees Celsius).
Time Frame Within 7 days (Day 0-Day 6) after each vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total Vaccinated cohort.
Arm/Group Title Pandemrix+Fluarix and Pandemrix+Placebo Pandemrix+Placebo and Pandemrix+Fluarix
Hide Arm/Group Description:
Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
Overall Number of Participants Analyzed 84 84
Measure Type: Number
Unit of Measure: subjects
Pain after Pandemrix 64 74
Pain after Fluarix 18 26
Pain after Placebo 0 8
Redness after Pandemrix 15 19
Redness after Fluarix 0 1
Redness after Placebo 0 0
Swelling after Pandemrix 22 27
Swelling after Fluarix 3 4
Swelling after Placebo 0 2
Fatigue 25 27
Headache 23 23
Joint pain at other location 13 17
Muscle aches 18 26
Shivering 12 16
Sweating 2 8
Temperature 3 0
10.Secondary Outcome
Title Number of Subjects With 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
Time Frame From Day 0 to Day 83
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort.
Arm/Group Title Pandemrix+Fluarix and Pandemrix+Placebo Pandemrix+Placebo and Pandemrix+Fluarix
Hide Arm/Group Description:
Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
Overall Number of Participants Analyzed 84 84
Measure Type: Number
Unit of Measure: subjects
41 41
11.Secondary Outcome
Title Number of Subjects With Adverse Events of Specific Interest
Hide Description Adverse events of specific interest include autoimmune diseases and other immune mediated inflammatory disorders.
Time Frame From Day 0 to Day 364
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort.
Arm/Group Title Pandemrix+Fluarix and Pandemrix+Placebo Pandemrix+Placebo and Pandemrix+Fluarix
Hide Arm/Group Description:
Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
Overall Number of Participants Analyzed 84 84
Measure Type: Number
Unit of Measure: subjects
0 0
12.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 From Day 0 to Day 364
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort.
Arm/Group Title Pandemrix+Fluarix and Pandemrix+Placebo Pandemrix+Placebo and Pandemrix+Fluarix
Hide Arm/Group Description:
Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
Overall Number of Participants Analyzed 84 84
Measure Type: Number
Unit of Measure: subjects
2 3
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pandemrix+Fluarix and Pandemrix+Placebo Pandemrix+Placebo and Pandemrix+Fluarix
Hide Arm/Group Description Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm. Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
All-Cause Mortality
Pandemrix+Fluarix and Pandemrix+Placebo Pandemrix+Placebo and Pandemrix+Fluarix
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Pandemrix+Fluarix and Pandemrix+Placebo Pandemrix+Placebo and Pandemrix+Fluarix
Affected / at Risk (%) Affected / at Risk (%)
Total   2/84 (2.38%)   3/84 (3.57%) 
Cardiac disorders     
Cardiac failure *  0/84 (0.00%)  1/84 (1.19%) 
Eye disorders     
Retinal detachment *  0/84 (0.00%)  1/84 (1.19%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Lymphoma *  1/84 (1.19%)  0/84 (0.00%) 
Prostate cancer *  0/84 (0.00%)  1/84 (1.19%) 
Vascular disorders     
Hypertension *  1/84 (1.19%)  0/84 (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%
Pandemrix+Fluarix and Pandemrix+Placebo Pandemrix+Placebo and Pandemrix+Fluarix
Affected / at Risk (%) Affected / at Risk (%)
Total   71/84 (84.52%)   78/84 (92.86%) 
Gastrointestinal disorders     
Nausea *  2/84 (2.38%)  5/84 (5.95%) 
General disorders     
Pain after Pandemrix   64/84 (76.19%)  74/84 (88.10%) 
Pain after Fluarix   18/84 (21.43%)  26/84 (30.95%) 
Pain after Placebo   0/84 (0.00%)  8/84 (9.52%) 
Redness after Pandemrix   15/84 (17.86%)  19/84 (22.62%) 
Swelling after Pandemrix   22/84 (26.19%)  27/84 (32.14%) 
Fatigue   25/84 (29.76%)  27/84 (32.14%) 
Headache   23/84 (27.38%)  23/84 (27.38%) 
Joint pain at other location   13/84 (15.48%)  17/84 (20.24%) 
Muscle aches   18/84 (21.43%)  26/84 (30.95%) 
Shivering   12/84 (14.29%)  16/84 (19.05%) 
Sweating   2/84 (2.38%)  8/84 (9.52%) 
Infections and infestations     
Nasopharyngitis *  15/84 (17.86%)  14/84 (16.67%) 
Musculoskeletal and connective tissue disorders     
Arthralgia *  5/84 (5.95%)  2/84 (2.38%) 
Nervous system disorders     
Dizziness *  5/84 (5.95%)  0/84 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Oropharyngeal pain *  2/84 (2.38%)  6/84 (7.14%) 
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
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00968890     History of Changes
Other Study ID Numbers: 113525
First Submitted: August 27, 2009
First Posted: August 31, 2009
Results First Submitted: February 17, 2011
Results First Posted: March 16, 2011
Last Update Posted: August 20, 2018