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Trial record 2 of 28 for:    pandemrix

Study to Evaluate the Safety and Immune Response of Two-Doses of Candidate Influenza Vaccine GSK 1557484A in Adults

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ClinicalTrials.gov Identifier: NCT00510874
Recruitment Status : Completed
First Posted : August 2, 2007
Results First Posted : February 7, 2014
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: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition Influenza
Interventions Biological: Pumarix™
Biological: Pandemrix
Enrollment 780

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pumarix Formulation 1 Group Pumarix Formulation 2 Group Pumarix Formulation 3 Group Pandemrix Formulation A Group Pandemrix Formulation B Group Pumarix Formulation 4 Group Pumarix Formulation 5 Group
Hide Arm/Group Description Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one). Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one). Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one). Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one). Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix ™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one). Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one). Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Period Title: Overall Study
Started 78 152 151 151 148 50 50
Completed 75 [1] 148 [1] 150 [1] 148 [1] 141 [1] 50 [1] 49 [1]
Not Completed 3 4 1 3 7 0 1
Reason Not Completed
Withdrawal by Subject             1             1             0             0             3             0             0
Lost to Follow-up             2             3             1             3             4             0             1
[1]
Upto Day 182
Arm/Group Title Pumarix Formulation 1 Group Pumarix Formulation 2 Group Pumarix Formulation 3 Group Pandemrix Formulation A Group Pandemrix Formulation B Group Pumarix Formulation 4 Group Pumarix Formulation 5 Group Total
Hide Arm/Group Description Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one). Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one). Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one). Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one). Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix ™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one). Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one). Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one). Total of all reporting groups
Overall Number of Baseline Participants 78 152 151 151 148 50 50 780
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 78 participants 152 participants 151 participants 151 participants 148 participants 50 participants 50 participants 780 participants
38.5  (12.85) 38.1  (12.10) 39.0  (12.59) 38.7  (11.25) 38.7  (12.20) 39.2  (12.21) 39.9  (13.18) 38.8  (12.22)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 78 participants 152 participants 151 participants 151 participants 148 participants 50 participants 50 participants 780 participants
Female
45
  57.7%
83
  54.6%
87
  57.6%
100
  66.2%
78
  52.7%
32
  64.0%
24
  48.0%
449
  57.6%
Male
33
  42.3%
69
  45.4%
64
  42.4%
51
  33.8%
70
  47.3%
18
  36.0%
26
  52.0%
331
  42.4%
1.Primary Outcome
Title Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.
Hide Description A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer on the specified day.
Time Frame At Day 42
Show Outcome Measure DataHide 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 data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and Day 42 HI titer results for the A/Indonesia/5/05 virus.
Arm/Group Title Pumarix Formulation 1 Group Pumarix Formulation 2 Group Pumarix Formulation 3 Group Pandemrix Formulation A Group Pandemrix Formulation B Group Pumarix Formulation 4 Group Pumarix Formulation 5 Group
Hide Arm/Group Description:
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Overall Number of Participants Analyzed 75 144 146 140 142 49 50
Measure Type: Count of Participants
Unit of Measure: Participants
13
  17.3%
140
  97.2%
131
  89.7%
135
  96.4%
131
  92.3%
47
  95.9%
42
  84.0%
2.Primary Outcome
Title Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.
Hide Description Titers are presented as geometric mean titers (GMTs).
Time Frame At Day 42
Show Outcome Measure DataHide 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 data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and Day 42 HI titer results for the A/Indonesia/5/05 virus.
Arm/Group Title Pumarix Formulation 1 Group Pumarix Formulation 2 Group Pumarix Formulation 3 Group Pandemrix Formulation A Group Pandemrix Formulation B Group Pumarix Formulation 4 Group Pumarix Formulation 5 Group
Hide Arm/Group Description:
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Overall Number of Participants Analyzed 75 144 146 140 142 49 50
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
10.5
(8.2 to 13.5)
464.7
(383.4 to 563.4)
320.7
(246.9 to 416.6)
480.3
(390.5 to 590.7)
347.7
(272 to 444.5)
331.6
(217.4 to 505.6)
173.9
(105.6 to 286.3)
3.Primary Outcome
Title Number of Seroprotected Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.
Hide Description A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40.
Time Frame At Day 42
Show Outcome Measure DataHide 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 data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and Day 42 HI titer results for the A/Indonesia/5/05 virus.
Arm/Group Title Pumarix Formulation 1 Group Pumarix Formulation 2 Group Pumarix Formulation 3 Group Pandemrix Formulation A Group Pandemrix Formulation B Group Pumarix Formulation 4 Group Pumarix Formulation 5 Group
Hide Arm/Group Description:
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Overall Number of Participants Analyzed 75 144 146 140 142 49 50
Measure Type: Count of Participants
Unit of Measure: Participants
13
  17.3%
140
  97.2%
131
  89.7%
135
  96.4%
131
  92.3%
47
  95.9%
42
  84.0%
4.Primary Outcome
Title Number of Subjects With Solicited Local Symptoms.
Hide Description Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any solicited local symptoms regardless of their intensity grade. Any redness and swelling were ≥ 20 millimeters (mm).
Time Frame Within the 7-day follow-up period (Days 0-6) after any vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine for whom any post-vaccination data were available.
Arm/Group Title Pumarix Formulation 1 Group Pumarix Formulation 2 Group Pumarix Formulation 3 Group Pandemrix Formulation A Group Pandemrix Formulation B Group Pumarix Formulation 4 Group Pumarix Formulation 5 Group
Hide Arm/Group Description:
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Overall Number of Participants Analyzed 78 152 151 151 148 50 50
Measure Type: Count of Participants
Unit of Measure: Participants
Any Pain
18
  23.1%
133
  87.5%
130
  86.1%
139
  92.1%
124
  83.8%
48
  96.0%
42
  84.0%
Any Redness
0
   0.0%
7
   4.6%
2
   1.3%
9
   6.0%
6
   4.1%
1
   2.0%
0
   0.0%
Any Swelling
0
   0.0%
12
   7.9%
10
   6.6%
21
  13.9%
9
   6.1%
4
   8.0%
0
   0.0%
5.Primary Outcome
Title Number of Subjects With Solicited General Symptoms.
Hide Description Assessed solicited general symptoms were fatigue, headache, joint pain at other location (joint pain), muscle aches, shivering, sweating and fever. Fever was defined as oral temperature (≥) 38 degrees Celsius (°C). Any = occurrence of any solicited general symptoms regardless of intensity grade or relationship to vaccination.
Time Frame Within the 7-day follow-up period (Days 0-6) after any vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine for whom any post-vaccination data were available.
Arm/Group Title Pumarix Formulation 1 Group Pumarix Formulation 2 Group Pumarix Formulation 3 Group Pandemrix Formulation A Group Pandemrix Formulation B Group Pumarix Formulation 4 Group Pumarix Formulation 5 Group
Hide Arm/Group Description:
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Overall Number of Participants Analyzed 78 152 151 151 148 50 50
Measure Type: Count of Participants
Unit of Measure: Participants
Any Fatigue
16
  20.5%
64
  42.1%
50
  33.1%
67
  44.4%
69
  46.6%
15
  30.0%
15
  30.0%
Any Headache
25
  32.1%
71
  46.7%
61
  40.4%
66
  43.7%
61
  41.2%
11
  22.0%
19
  38.0%
Any Joint Pain
12
  15.4%
49
  32.2%
36
  23.8%
53
  35.1%
39
  26.4%
11
  22.0%
11
  22.0%
Any Muscle Aches
15
  19.2%
74
  48.7%
64
  42.4%
86
  57.0%
63
  42.6%
19
  38.0%
21
  42.0%
Any Shivering
4
   5.1%
18
  11.8%
21
  13.9%
27
  17.9%
17
  11.5%
8
  16.0%
6
  12.0%
Any Sweating
6
   7.7%
23
  15.1%
12
   7.9%
24
  15.9%
21
  14.2%
5
  10.0%
1
   2.0%
Any Fever
0
   0.0%
4
   2.6%
3
   2.0%
12
   7.9%
11
   7.4%
1
   2.0%
0
   0.0%
6.Primary Outcome
Title Number of Subjects With Medically Attended Adverse Events (MAEs) and New Onset Chronic Diseases (NOCDs).
Hide Description A MAE was defined as any unsolicited symptom that received medical attention such as hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. NOCDs included autoimmune diseases, diabetes mellitus.
Time Frame From Day 0 to 182
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine for whom any post-vaccination data were available.
Arm/Group Title Pumarix Formulation 1 Group Pumarix Formulation 2 Group Pumarix Formulation 3 Group Pandemrix Formulation A Group Pandemrix Formulation B Group Pumarix Formulation 4 Group Pumarix Formulation 5 Group
Hide Arm/Group Description:
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Overall Number of Participants Analyzed 78 152 151 151 148 50 50
Measure Type: Count of Participants
Unit of Measure: Participants
Subjects with MAEs
16
  20.5%
29
  19.1%
33
  21.9%
28
  18.5%
34
  23.0%
14
  28.0%
14
  28.0%
Subjects with NOCDs
0
   0.0%
1
   0.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
7.Primary Outcome
Title Number of Subjects With Unsolicited Adverse Events (AEs).
Hide Description An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and 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 During the 21-day follow-up period (Days 0-20) after vaccination.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine for whom any post-vaccination data were available.
Arm/Group Title Pumarix Formulation 1 Group Pumarix Formulation 2 Group Pumarix Formulation 3 Group Pandemrix Formulation A Group Pandemrix Formulation B Group Pumarix Formulation 4 Group Pumarix Formulation 5 Group
Hide Arm/Group Description:
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Overall Number of Participants Analyzed 78 152 151 151 148 50 50
Measure Type: Count of Participants
Unit of Measure: Participants
30
  38.5%
67
  44.1%
60
  39.7%
73
  48.3%
84
  56.8%
26
  52.0%
20
  40.0%
8.Primary Outcome
Title Number of Subjects With Unsolicited Adverse Events (AEs).
Hide Description An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and 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 Between Day 0 and Day 84 after vaccination.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine for whom any post-vaccination data were available.
Arm/Group Title Pumarix Formulation 1 Group Pumarix Formulation 2 Group Pumarix Formulation 3 Group Pandemrix Formulation A Group Pandemrix Formulation B Group Pumarix Formulation 4 Group Pumarix Formulation 5 Group
Hide Arm/Group Description:
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Overall Number of Participants Analyzed 78 152 151 151 148 50 50
Measure Type: Count of Participants
Unit of Measure: Participants
35
  44.9%
77
  50.7%
71
  47.0%
81
  53.6%
89
  60.1%
29
  58.0%
23
  46.0%
9.Primary Outcome
Title Number of Subjects With Any Serious Adverse Events (SAEs).
Hide Description A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or resulted in a congenital anomaly/birth defect in the offspring of a study subject.
Time Frame From Day 0 to 182
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine for whom any post-vaccination data were available.
Arm/Group Title Pumarix Formulation 1 Group Pumarix Formulation 2 Group Pumarix Formulation 3 Group Pandemrix Formulation A Group Pandemrix Formulation B Group Pumarix Formulation 4 Group Pumarix Formulation 5 Group
Hide Arm/Group Description:
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Overall Number of Participants Analyzed 78 152 151 151 148 50 50
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
2
   1.3%
1
   0.7%
2
   1.3%
1
   0.7%
1
   2.0%
0
   0.0%
10.Secondary Outcome
Title Titers for Serum HI Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.
Hide Description Titers are presented as geometric mean titers (GMTs).
Time Frame At Day 21 and Day 182
Show Outcome Measure DataHide 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 data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and Day 42 HI titer results for the A/Indonesia/5/05 virus.
Arm/Group Title Pumarix Formulation 1 Group Pumarix Formulation 2 Group Pumarix Formulation 3 Group Pandemrix Formulation A Group Pandemrix Formulation B Group Pumarix Formulation 4 Group Pumarix Formulation 5 Group
Hide Arm/Group Description:
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Overall Number of Participants Analyzed 75 144 146 140 142 49 50
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
H5N1 at Day 21 Number Analyzed 75 participants 144 participants 146 participants 140 participants 142 participants 49 participants 50 participants
6.1
(5.2 to 7.1)
22.5
(17.8 to 28.6)
19.9
(15.7 to 25.3)
23.5
(18.3 to 30.3)
16.8
(13.5 to 20.9)
23.0
(14.8 to 36.0)
20.8
(13.9 to 31.3)
H5N1 at Day 182 Number Analyzed 74 participants 141 participants 145 participants 138 participants 138 participants 49 participants 49 participants
5.6
(5.1 to 6.2)
27.8
(22.8 to 33.8)
22.6
(18.4 to 27.9)
26.1
(20.7 to 32.8)
22.6
(18.3 to 28.0)
32.5
(20.9 to 50.7)
20.0
(13.6 to 29.3)
11.Secondary Outcome
Title Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.
Hide Description A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer on the specified day.
Time Frame At Days 21 and 182
Show Outcome Measure DataHide 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 data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and Day 42 HI titer results for the A/Indonesia/5/05 virus.
Arm/Group Title Pumarix Formulation 1 Group Pumarix Formulation 2 Group Pumarix Formulation 3 Group Pandemrix Formulation A Group Pandemrix Formulation B Group Pumarix Formulation 4 Group Pumarix Formulation 5 Group
Hide Arm/Group Description:
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Overall Number of Participants Analyzed 75 144 146 140 142 49 50
Measure Type: Count of Participants
Unit of Measure: Participants
H5N1 at Day 21 Number Analyzed 75 participants 144 participants 146 participants 140 participants 142 participants 49 participants 50 participants
5
   6.7%
60
  41.7%
60
  41.1%
64
  45.7%
54
  38.0%
23
  46.9%
21
  42.0%
H5N1 at Day 182 Number Analyzed 74 participants 141 participants 145 participants 138 participants 138 participants 49 participants 49 participants
2
   2.7%
77
  54.6%
66
  45.5%
67
  48.6%
62
  44.9%
24
  49.0%
23
  46.9%
12.Secondary Outcome
Title Geometric Mean Fold-rise (GMFR) Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.
Hide Description GMFR was defined as the geometric mean fold increase in serum HI antibody reciprocal titer on the specified study day compared to Day 0.
Time Frame At Days 21 and 182
Show Outcome Measure DataHide 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 data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and Day 42 HI titer results for the A/Indonesia/5/05 virus.
Arm/Group Title Pumarix Formulation 1 Group Pumarix Formulation 2 Group Pumarix Formulation 3 Group Pandemrix Formulation A Group Pandemrix Formulation B Group Pumarix Formulation 4 Group Pumarix Formulation 5 Group
Hide Arm/Group Description:
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Overall Number of Participants Analyzed 75 144 146 140 142 49 50
Geometric Mean (95% Confidence Interval)
Unit of Measure: Fold increase
H5N1at Day 21 Number Analyzed 75 participants 144 participants 146 participants 140 participants 142 participants 49 participants 50 participants
1.2
(1.0 to 1.4)
4.5
(3.6 to 5.7)
4.0
(3.1 to 5.1)
4.7
(3.6 to 6.0)
3.3
(2.7 to 4.1)
4.1
(2.7 to 6.2)
4.2
(2.8 to 6.3)
H5N1at Day 182 Number Analyzed 74 participants 141 participants 145 participants 138 participants 138 participants 49 participants 49 participants
1.1
(1.0 to 1.2)
5.6
(4.6 to 6.8)
4.5
(3.7 to 5.6)
5.2
(4.1 to 6.5)
4.5
(3.6 to 5.6)
5.8
(3.7 to 9.1)
4.0
(2.7 to 5.9)
13.Secondary Outcome
Title Number of Seroprotected Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.
Hide Description A seroprotected subject was defined as a vaccinated subject who had a serum HI antibody reciprocal titer ≥ 1:40 on the specified study day.
Time Frame At Days 0, 21 and 182
Show Outcome Measure DataHide 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 data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and Day 42 HI titer results for the A/Indonesia/5/05 virus.
Arm/Group Title Pumarix Formulation 1 Group Pumarix Formulation 2 Group Pumarix Formulation 3 Group Pandemrix Formulation A Group Pandemrix Formulation B Group Pumarix Formulation 4 Group Pumarix Formulation 5 Group
Hide Arm/Group Description:
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Overall Number of Participants Analyzed 75 144 146 140 143 49 50
Measure Type: Count of Participants
Unit of Measure: Participants
H5N1 at Day 0 Number Analyzed 75 participants 144 participants 146 participants 140 participants 143 participants 49 participants 50 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.0%
0
   0.0%
H5N1 at Day 21 Number Analyzed 75 participants 144 participants 146 participants 140 participants 142 participants 49 participants 50 participants
5
   6.7%
60
  41.7%
60
  41.1%
64
  45.7%
54
  38.0%
23
  46.9%
21
  42.0%
H5N1 at Day 182 Number Analyzed 74 participants 141 participants 145 participants 138 participants 138 participants 49 participants 49 participants
2
   2.7%
77
  54.6%
66
  45.5%
68
  49.3%
63
  45.7%
26
  53.1%
23
  46.9%
Time Frame Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pumarix Formulation 1 Group Pumarix Formulation 2 Group Pumarix Formulation 3 Group Pandemrix Formulation A Group Pandemrix Formulation B Group Pumarix Formulation 4 Group Pumarix Formulation 5 Group
Hide Arm/Group Description Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one). Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one). Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one). Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one). Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix ™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one). Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one). Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
All-Cause Mortality
Pumarix Formulation 1 Group Pumarix Formulation 2 Group Pumarix Formulation 3 Group Pandemrix Formulation A Group Pandemrix Formulation B Group Pumarix Formulation 4 Group Pumarix Formulation 5 Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Pumarix Formulation 1 Group Pumarix Formulation 2 Group Pumarix Formulation 3 Group Pandemrix Formulation A Group Pandemrix Formulation B Group Pumarix Formulation 4 Group Pumarix Formulation 5 Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/78 (0.00%)   2/152 (1.32%)   1/151 (0.66%)   2/151 (1.32%)   1/148 (0.68%)   1/50 (2.00%)   0/50 (0.00%) 
Gastrointestinal disorders               
Ascites * 1  0/78 (0.00%)  0/152 (0.00%)  0/151 (0.00%)  0/151 (0.00%)  1/148 (0.68%)  0/50 (0.00%)  0/50 (0.00%) 
Pancreatitis * 1  0/78 (0.00%)  1/152 (0.66%)  0/151 (0.00%)  0/151 (0.00%)  0/148 (0.00%)  0/50 (0.00%)  0/50 (0.00%) 
Rectal perforation * 1  0/78 (0.00%)  0/152 (0.00%)  0/151 (0.00%)  0/151 (0.00%)  1/148 (0.68%)  0/50 (0.00%)  0/50 (0.00%) 
General disorders               
Chest pain * 1  0/78 (0.00%)  1/152 (0.66%)  0/151 (0.00%)  0/151 (0.00%)  0/148 (0.00%)  0/50 (0.00%)  0/50 (0.00%) 
Hepatobiliary disorders               
Cholelithiasis * 1  0/78 (0.00%)  1/152 (0.66%)  0/151 (0.00%)  0/151 (0.00%)  0/148 (0.00%)  0/50 (0.00%)  0/50 (0.00%) 
Infections and infestations               
Gastroenteritis clostridial * 1  0/78 (0.00%)  0/152 (0.00%)  0/151 (0.00%)  0/151 (0.00%)  1/148 (0.68%)  0/50 (0.00%)  0/50 (0.00%) 
Pelvic abscess * 1  0/78 (0.00%)  0/152 (0.00%)  0/151 (0.00%)  0/151 (0.00%)  1/148 (0.68%)  0/50 (0.00%)  0/50 (0.00%) 
Injury, poisoning and procedural complications               
Femur fracture * 1  0/78 (0.00%)  0/152 (0.00%)  0/151 (0.00%)  0/151 (0.00%)  0/148 (0.00%)  1/50 (2.00%)  0/50 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)               
Basal cell carcinoma * 1  0/78 (0.00%)  0/152 (0.00%)  1/151 (0.66%)  0/151 (0.00%)  0/148 (0.00%)  0/50 (0.00%)  0/50 (0.00%) 
Cervix carcinoma * 1  0/78 (0.00%)  0/152 (0.00%)  0/151 (0.00%)  0/151 (0.00%)  1/148 (0.68%)  0/50 (0.00%)  0/50 (0.00%) 
Uterine leiomyoma * 1  0/78 (0.00%)  0/152 (0.00%)  0/151 (0.00%)  1/151 (0.66%)  0/148 (0.00%)  0/50 (0.00%)  0/50 (0.00%) 
Renal and urinary disorders               
Hydronephrosis * 1  0/78 (0.00%)  0/152 (0.00%)  0/151 (0.00%)  0/151 (0.00%)  1/148 (0.68%)  0/50 (0.00%)  0/50 (0.00%) 
Reproductive system and breast disorders               
Ovarian cyst * 1  0/78 (0.00%)  0/152 (0.00%)  0/151 (0.00%)  1/151 (0.66%)  0/148 (0.00%)  0/50 (0.00%)  0/50 (0.00%) 
Respiratory, thoracic and mediastinal disorders               
Pleural effusion * 1  0/78 (0.00%)  0/152 (0.00%)  0/151 (0.00%)  0/151 (0.00%)  1/148 (0.68%)  0/50 (0.00%)  0/50 (0.00%) 
Pulmonary embolism * 1  0/78 (0.00%)  0/152 (0.00%)  0/151 (0.00%)  1/151 (0.66%)  0/148 (0.00%)  0/50 (0.00%)  0/50 (0.00%) 
Vascular disorders               
Haematoma * 1  0/78 (0.00%)  0/152 (0.00%)  0/151 (0.00%)  0/151 (0.00%)  1/148 (0.68%)  0/50 (0.00%)  0/50 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pumarix Formulation 1 Group Pumarix Formulation 2 Group Pumarix Formulation 3 Group Pandemrix Formulation A Group Pandemrix Formulation B Group Pumarix Formulation 4 Group Pumarix Formulation 5 Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   45/78 (57.69%)   137/152 (90.13%)   132/151 (87.42%)   146/151 (96.69%)   131/148 (88.51%)   48/50 (96.00%)   42/50 (84.00%) 
Gastrointestinal disorders               
Nausea * 1 [1]  3/78 (3.85%)  10/152 (6.58%)  6/151 (3.97%)  7/151 (4.64%)  5/148 (3.38%)  2/50 (4.00%)  0/50 (0.00%) 
Nausea * 1 [2]  3/78 (3.85%)  11/152 (7.24%)  6/151 (3.97%)  7/151 (4.64%)  5/148 (3.38%)  2/50 (4.00%)  0/50 (0.00%) 
General disorders               
Pain  1  18/78 (23.08%)  133/152 (87.50%)  130/151 (86.09%)  139/151 (92.05%)  124/148 (83.78%)  48/50 (96.00%)  42/50 (84.00%) 
Redness  1  0/78 (0.00%)  7/152 (4.61%)  2/151 (1.32%)  9/151 (5.96%)  6/148 (4.05%)  1/50 (2.00%)  0/50 (0.00%) 
Swelling  1  0/78 (0.00%)  12/152 (7.89%)  10/151 (6.62%)  21/151 (13.91%)  9/148 (6.08%)  4/50 (8.00%)  0/50 (0.00%) 
Fatigue  1  16/78 (20.51%)  64/152 (42.11%)  50/151 (33.11%)  67/151 (44.37%)  69/148 (46.62%)  15/50 (30.00%)  15/50 (30.00%) 
Headache  1  25/78 (32.05%)  71/152 (46.71%)  61/151 (40.40%)  66/151 (43.71%)  61/148 (41.22%)  11/50 (22.00%)  19/50 (38.00%) 
Joint pain  1  12/78 (15.38%)  49/152 (32.24%)  36/151 (23.84%)  53/151 (35.10%)  39/148 (26.35%)  11/50 (22.00%)  11/50 (22.00%) 
Muscle aches  1  15/78 (19.23%)  74/152 (48.68%)  64/151 (42.38%)  86/151 (56.95%)  63/148 (42.57%)  19/50 (38.00%)  21/50 (42.00%) 
Shivering  1  4/78 (5.13%)  18/152 (11.84%)  21/151 (13.91%)  27/151 (17.88%)  17/148 (11.49%)  8/50 (16.00%)  6/50 (12.00%) 
Sweating  1  6/78 (7.69%)  23/152 (15.13%)  12/151 (7.95%)  24/151 (15.89%)  21/148 (14.19%)  5/50 (10.00%)  1/50 (2.00%) 
Fever  1  0/78 (0.00%)  4/152 (2.63%)  4/151 (2.65%)  12/151 (7.95%)  11/148 (7.43%)  1/50 (2.00%)  0/50 (0.00%) 
Infections and infestations               
Upper respiratory tract infection * 1 [1]  0/78 (0.00%)  3/152 (1.97%)  2/151 (1.32%)  5/151 (3.31%)  7/148 (4.73%)  2/50 (4.00%)  4/50 (8.00%) 
Nasopharyngitis * 1 [2]  6/78 (7.69%)  4/152 (2.63%)  14/151 (9.27%)  9/151 (5.96%)  4/148 (2.70%)  2/50 (4.00%)  2/50 (4.00%) 
Upper respiratory tract infection * 1 [2]  3/78 (3.85%)  5/152 (3.29%)  2/151 (1.32%)  7/151 (4.64%)  8/148 (5.41%)  3/50 (6.00%)  4/50 (8.00%) 
Nervous system disorders               
Headache * 1 [1]  3/78 (3.85%)  3/152 (1.97%)  3/151 (1.99%)  13/151 (8.61%)  12/148 (8.11%)  4/50 (8.00%)  4/50 (8.00%) 
Headache * 1 [2]  3/78 (3.85%)  4/152 (2.63%)  3/151 (1.99%)  13/151 (8.61%)  12/148 (8.11%)  4/50 (8.00%)  4/50 (8.00%) 
Respiratory, thoracic and mediastinal disorders               
Pharyngolaryngeal pain * 1 [1]  5/78 (6.41%)  5/152 (3.29%)  4/151 (2.65%)  10/151 (6.62%)  7/148 (4.73%)  0/50 (0.00%)  0/50 (0.00%) 
Oropharyngeal pain * 1 [1]  0/78 (0.00%)  0/152 (0.00%)  0/151 (0.00%)  0/151 (0.00%)  0/148 (0.00%)  1/50 (2.00%)  3/50 (6.00%) 
Rhinorrhoea * 1 [1]  0/78 (0.00%)  0/152 (0.00%)  0/151 (0.00%)  0/151 (0.00%)  0/148 (0.00%)  3/50 (6.00%)  1/50 (2.00%) 
Pharyngolaryngeal pain * 1 [2]  5/78 (6.41%)  5/152 (3.29%)  4/151 (2.65%)  10/151 (6.62%)  7/148 (4.73%)  0/50 (0.00%)  0/50 (0.00%) 
Oropharyngeal pain * 1 [2]  0/78 (0.00%)  0/152 (0.00%)  0/151 (0.00%)  0/151 (0.00%)  0/148 (0.00%)  1/50 (2.00%)  4/50 (8.00%) 
Rhinorrhoea * 1 [2]  0/78 (0.00%)  0/152 (0.00%)  0/151 (0.00%)  0/151 (0.00%)  0/148 (0.00%)  3/50 (6.00%)  1/50 (2.00%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
[1]
Assessed within Days 0-20 following vaccination.
[2]
Assessed within Days 0-84 following vaccination.
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
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00510874     History of Changes
Other Study ID Numbers: 110028
First Submitted: August 1, 2007
First Posted: August 2, 2007
Results First Submitted: December 19, 2013
Results First Posted: February 7, 2014
Last Update Posted: August 17, 2018