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Trial record 26 of 28 for:    pandemrix

A Trial to Test the Response to Different Vaccination Regimens With an H5N1 Vaccine With AS03 in Adults Aged 18-64

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ClinicalTrials.gov Identifier: NCT00695669
Recruitment Status : Completed
First Posted : June 12, 2008
Results First Posted : February 7, 2014
Last Update Posted : July 31, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Influenza
Intervention Biological: Influenza A (H5N1) Virus Monovalent Vaccine
Enrollment 312
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Influenza A (H5N1) 1 Group Influenza A (H5N1) 2 Group Influenza A (H5N1) 3 Group Influenza A (H5N1) 4 Group
Hide Arm/Group Description Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm. Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm. Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm. Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
Period Title: Overall Study
Started 78 78 78 78
Completed 74 74 75 74
Not Completed 4 4 3 4
Reason Not Completed
Adverse Event             0             0             2             0
Lost to Follow-up             4             4             1             4
Arm/Group Title Influenza A (H5N1) 1 Group Influenza A (H5N1) 2 Group Influenza A (H5N1) 3 Group Influenza A (H5N1) 4 Group Total
Hide Arm/Group Description Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm. Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm. Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm. Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm. Total of all reporting groups
Overall Number of Baseline Participants 78 78 78 78 312
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 78 participants 78 participants 78 participants 78 participants 312 participants
40.2  (13.88) 39.7  (13.81) 40.8  (13.87) 40.7  (13.22) 40.3  (13.64)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 78 participants 78 participants 78 participants 78 participants 312 participants
Female
39
  50.0%
36
  46.2%
43
  55.1%
48
  61.5%
166
  53.2%
Male
39
  50.0%
42
  53.8%
35
  44.9%
30
  38.5%
146
  46.8%
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 (Day 0) reciprocal hemagglutination inhibition (HI) titer less than (<) 1:10 and a post-vaccination (at Day 14 post Dose 2) reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal HI titer ≥ 1:10 and at least a four-fold increase in post-vaccination (at Day 14 post Dose 2) titer.
Time Frame At Day 14 post Dose 2
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 data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.
Arm/Group Title Influenza A (H5N1) 1 Group Influenza A (H5N1) 2 Group Influenza A (H5N1) 3 Group Influenza A (H5N1) 4 Group
Hide Arm/Group Description:
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
Overall Number of Participants Analyzed 65 69 74 75
Measure Type: Number
Unit of Measure: Subjects
63 64 53 54
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). The Confidence Interval for this outcome was 98.75%.
Time Frame At Day 0 and at Day 14 post Dose 2
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 data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.
Arm/Group Title Influenza A (H5N1) 1 Group Influenza A (H5N1) 2 Group Influenza A (H5N1) 3 Group Influenza A (H5N1) 4 Group
Hide Arm/Group Description:
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
Overall Number of Participants Analyzed 65 69 74 75
Geometric Mean (95% Confidence Interval)
Unit of Measure: titers
H5N1 at Day 0
5.4
(4.7 to 6.1)
5.3
(4.7 to 6.0)
5.5
(4.8 to 6.3)
5.8
(4.8 to 7.0)
H5N1 at Day 14 post Dose 2
640.0
(413.7 to 990.0)
345.0
(221.2 to 538.1)
77.7
(49.9 to 121.0)
67.4
(42.5 to 107.0)
3.Primary Outcome
Title Number of Seroprotected Subjects Against 3 Strains 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 0 and at Day 14 post Dose 2
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 data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.
Arm/Group Title Influenza A (H5N1) 1 Group Influenza A (H5N1) 2 Group Influenza A (H5N1) 3 Group Influenza A (H5N1) 4 Group
Hide Arm/Group Description:
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
Overall Number of Participants Analyzed 65 69 74 75
Measure Type: Number
Unit of Measure: Subjects
H5N1 at Day 0 2 1 2 3
H5N1 at Day 14 post Dose 2 63 64 55 56
4.Secondary 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). This outcome only covers results for the Pumarix 1 Group.
Time Frame At Days 0, 21, 28, 35, 42 and 182.
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 data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.
Arm/Group Title Influenza A (H5N1) 1 Group
Hide Arm/Group Description:
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
Overall Number of Participants Analyzed 65
Geometric Mean (95% Confidence Interval)
Unit of Measure: titers
H5N1 at Day 0 [N=65]
5.4
(4.9 to 5.9)
H5N1 at Day 21 [N=64]
40.2
(27.9 to 58.1)
H5N1 at Day 28 [N=65]
150.9
(101.1 to 225.1)
H5N1 at Day 35 [N=65]
640.0
(455.9 to 898.4)
H5N1 at Day 42 [N=62]
523.3
(366.0 to 748.3)
H5N1 at Day 182 [N=65]
51.1
(37.0 to 70.6)
5.Secondary 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). This outcome only covers results for the Pumarix 2 Group.
Time Frame At Days 0, 14, 21, 28, 35, 42 and 182.
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 data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.
Arm/Group Title Influenza A (H5N1) 2 Group
Hide Arm/Group Description:
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
Overall Number of Participants Analyzed 69
Geometric Mean (95% Confidence Interval)
Unit of Measure: titers
H5N1 at Day 0 [N=69]
5.3
(4.9 to 27.5)
H5N1 at Day 14 [N=68]
26.8
(18.8 to 38.0)
H5N1 at Day 21 [N=69]
99.8
(67.0 to 148.8)
H5N1 at Day 28 [N=69]
345.0
(244.2 to 487.5)
H5N1 at Day 35 [N=69]
305.9
(220.8 to 423.7)
H5N1 at Day 42 [N=68]
262.3
(192.9 to 356.8)
H5N1 at Day 182 [N=68]
36.5
(27.5 to 48.4)
6.Secondary 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). This outcome only covers results for the Pumarix 3 Group.
Time Frame At Days 0, 7, 14, 21, 28, 42 and 182.
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 data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.
Arm/Group Title Influenza A (H5N1) 3 Group
Hide Arm/Group Description:
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
Overall Number of Participants Analyzed 74
Geometric Mean (95% Confidence Interval)
Unit of Measure: titers
H5N1 at Day 0 [N=74]
5.5
(4.9 to 6.1)
H5N1 at Day 7 [N=74]
7.6
(6.1 to 9.4)
H5N1 at Day 14 [N=73]
45.1
(32.0 to 63.5)
H5N1 at Day 21 [N=74]
77.7
(55.1 to 109.7)
H5N1 at Day 28 [N=72]
99.8
(70.9 to 140.6)
H5N1 at Day 42 [N=73]
81.1
(58.7 to 112.0)
H5N1 at Day 182 [N=71]
21.3
(16.2 to 28.1)
7.Secondary 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). This outcome only covers results for the Pumarix 4 Group.
Time Frame At Days 0, 7, 14, 21, 42 and 182.
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 data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.
Arm/Group Title Influenza A (H5N1) 4 Group
Hide Arm/Group Description:
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
Overall Number of Participants Analyzed 75
Geometric Mean (95% Confidence Interval)
Unit of Measure: titers
H5N1 at Day 0 [N=75]
5.8
(5.0 to 6.7)
H5N1 at Day 7 [N=74]
10.8
(8.0 to 14.6)
H5N1 at Day 14 [N=75]
67.4
(47.1 to 96.6)
H5N1 at Day 21 [N=74]
76.3
(52.6 to 110.8)
H5N1 at Day 42 [N=74]
78.9
(55.8 to 111.5)
H5N1 at Day 182 [N=73]
28.2
(21.0 to 37.8)
8.Secondary Outcome
Title Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.
Hide Description Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 1 Group.
Time Frame At Days 0, 21, 28, 35, 42 and 182.
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 data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.
Arm/Group Title Influenza A (H5N1) 1 Group
Hide Arm/Group Description:
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
Overall Number of Participants Analyzed 65
Geometric Mean (95% Confidence Interval)
Unit of Measure: titers
VIET at Day 0 [N=65]
5.3
(4.9 to 5.8)
VIET at Day 21 [N=64]
9.7
(7.3 to 12.9)
VIET at Day 28 [N=65]
20.7
(15.0 to 28.6)
VIET at Day 35 [N=65]
61.6
(44.4 to 85.6)
VIET at Day 42 [N=62]
48.6
(34.7 to 68.1)
TURK at Day 0 [N=65]
7.6
(6.0 to 9.7)
TURK at Day 21 [N=64]
22.5
(16.5 to 30.8)
TURK at Day 28 [N=65]
46.4
(32.0 to 67.4)
TURK at Day 35 [N=65]
181.8
(131.9 to 250.7)
TURK at Day 42 [N=62]
162.7
(120.9 to 218.9)
TURK at 182 [N=65]
25.8
(19.1 to 35.0)
9.Secondary Outcome
Title Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.
Hide Description Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 2 Group.
Time Frame At Days 0, 14, 21, 28, 35, 42 and 182.
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 data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.
Arm/Group Title Influenza A (H5N1) 2 Group
Hide Arm/Group Description:
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
Overall Number of Participants Analyzed 69
Geometric Mean (95% Confidence Interval)
Unit of Measure: titers
VIET at Day 0 [N=69]
5.4
(5.0 to 5.9)
VIET at Day 14 [N=68]
9.2
(7.2 to 11.7)
VIET at Day 21 [N=69]
15.1
(11.2 to 20.3)
VIET at Day 28 [N=69]
29.9
(21.8 to 40.9)
VIET at Day 35 [N=69]
26.5
(19.9 to 35.2)
VIET at Day 42 [N=68]
23.2
(17.4 to 30.9)
TURK at Day 0 [N=69]
7.1
(5.7 to 8.9)
TURK at Day 14 [N=68]
17.0
(12.0 to 24.0)
TURK at Day 21 [N=69]
36.4
(25.4 to 52.1)
TURK at Day 28 [N=69]
83.7
(59.2 to 118.4)
TURK at Day 35 [N=69]
74.9
(54.7 to 102.5)
TURK at Day 42 [N=68]
68.3
(50.5 to 92.4)
TURK at Day 182 [N=68]
18.5
(14.1 to 24.4)
10.Secondary Outcome
Title Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.
Hide Description Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 3 Group.
Time Frame At Days 0, 7, 14, 21, 28, 42 and 182.
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 data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.
Arm/Group Title Influenza A (H5N1) 3 Group
Hide Arm/Group Description:
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
Overall Number of Participants Analyzed 74
Geometric Mean (95% Confidence Interval)
Unit of Measure: titers
VIET at Day 0 [N=74]
5.3
(4.9 to 5.8)
VIET at Day 7 [N=74]
6.4
(5.6 to 7.4)
VIET at Day 14 [N=73]
13.7
(10.4 to 17.9)
VIET at Day 21 [N=74]
16.1
(12.2 to 21.2)
VIET at Day 28 [N=72]
15.3
(11.6 to 20.1)
VIET at Day 42 [N=73]
13.4
(10.5 to 17.1)
TURK at Day 0 [N=74]
7.2
(5.9 to 8.9)
TURK at Day 7 [N=74]
8.7
(6.8 to 11.2)
TURK at Day 14 [N=73]
27.2
(19.9 to 37.3)
TURK at Day 21 [N=74]
33.5
(23.9 to 46.7)
TURK at Day 28 [N=72]
34.9
(25.2 to 48.4)
TURK at Day 42 [N=73]
34.7
(24.9 to 48.4)
TURK at Day 182 [N=71]
13.7
(10.6 to 17.7)
11.Secondary Outcome
Title Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.
Hide Description Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 4 Group.
Time Frame At Days 0, 7, 14, 21, 42 and 182.
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 data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.
Arm/Group Title Influenza A (H5N1) 4 Group
Hide Arm/Group Description:
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
Overall Number of Participants Analyzed 75
Geometric Mean (95% Confidence Interval)
Unit of Measure: titers
VIET at Day 0 [N=75]
5.8
(5.1 to 6.6)
VIET at Day 7 [N=74]
7.9
(6.4 to 9.8)
VIET at Day 14 [N=75]
16.3
(12.1 to 21.9)
VIET at Day 21 [N=74]
16.2
(12.1 to 21.6)
VIET at Day 42 [N=74]
16.0
(12.3 to 20.6)
TURK at Day 0 [N=75]
7.7
(6.2 to 9.4)
TURK at Day 7 [N=74]
11.8
(8.7 to 16.0)
TURK at Day 14 [N=75]
28.9
(20.5 to 40.8)
TURK at Day 21 [N=74]
31.2
(22.4 to 43.5)
TURK at Day 42 [N=74]
35.6
(25.9 to 48.9)
TURK at Day 182 [N=73]
16.4
(12.4 to 21.7)
12.Secondary Outcome
Title Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1), Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.
Hide Description A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination (Day 0) reciprocal HI titer < 1:10 and a post-vaccination (at Day 14 post Dose 2) reciprocal titer ≥ 1:40 or a pre-vaccination reciprocal HI titer ≥ 1:10 and at least a four-fold increase in post-vaccination (at Day 14 post Dose 2) 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 data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.
Arm/Group Title Influenza A (H5N1) 1 Group Influenza A (H5N1) 2 Group Influenza A (H5N1) 3 Group Influenza A (H5N1) 4 Group
Hide Arm/Group Description:
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
Overall Number of Participants Analyzed 62 78 73 74
Measure Type: Number
Unit of Measure: Subjects
H5N1 59 63 57 55
VIET 41 35 16 19
TURK 52 51 41 39
13.Secondary Outcome
Title Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.
Hide Description A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination (Day 0) reciprocal hemagglutination inhibition (HI) titer < 1:10 and a post-vaccination (at Day 14 post Dose 2) reciprocal titer ≥ 1:40 or a pre-vaccination reciprocal HI titer ≥ 1:10 and at least a four-fold increase in post-vaccination (at Day 14 post Dose 2) titer.
Time Frame At Day 182
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 data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.
Arm/Group Title Influenza A (H5N1) 1 Group Influenza A (H5N1) 2 Group Influenza A (H5N1) 3 Group Influenza A (H5N1) 4 Group
Hide Arm/Group Description:
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
Overall Number of Participants Analyzed 65 68 71 73
Measure Type: Number
Unit of Measure: Subjects
H5N1 45 42 29 38
TURK 30 22 14 18
14.Secondary Outcome
Title Geometric Mean Fold-rise (GMFR) for the A/Indonesia/5/2005 (H5N1), Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.
Hide Description The GMFR is presented as the GMT ratio between GMTs at Day 42/182 and at Day 0.
Time Frame At Days 0, 42 and 182.
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 data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.
Arm/Group Title Influenza A (H5N1) 1 Group Influenza A (H5N1) 2 Group Influenza A (H5N1) 3 Group Influenza A (H5N1) 4 Group
Hide Arm/Group Description:
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
Overall Number of Participants Analyzed 65 68 73 74
Geometric Mean (95% Confidence Interval)
Unit of Measure: Fold increase
H5N1 at Day 42 [N=62,68,73,74]
97.3
(67.1 to 141.2)
49.4
(36.0 to 67.7)
14.8
(10.6 to 20.5)
13.5
(9.4 to 19.4)
H5N1 at Day 182 [N=65,68,71,73]
9.5
(6.9 to 13.2)
6.9
(5.2 to 9.1)
3.9
(2.9 to 5.1)
4.8
(3.6 to 6.5)
VIET at Day 42 [N=62,68,73,74]
9.1
(6.5 to 12.8)
4.3
(3.2 to 5.7)
2.5
(2.0 to 3.2)
2.7
(2.2 to 3.5)
TURK at Day 42 [N=62,68,73,74]
21.7
(15.1 to 31.3)
9.6
(6.8 to 13.4)
4.8
(3.4 to 6.6)
4.6
(3.4 to 6.3)
TURK at Day 182 [N=65,68,71,73]
3.4
(2.5 to 4.6)
2.7
(2.0 to 3.7)
1.9
(1.5 to 2.6)
2.1
(1.6 to 2.8)
15.Secondary Outcome
Title Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.
Hide Description Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 1 Group.
Time Frame At Days 0, 21, 28, 35, 42 and 182.
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 data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.
Arm/Group Title Influenza A (H5N1) 1 Group
Hide Arm/Group Description:
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
Overall Number of Participants Analyzed 65
Geometric Mean (95% Confidence Interval)
Unit of Measure: titers
VIET at Day 0 [N=65]
31.8
(24.3 to 41.4)
VIET at Day 21 [N=64]
85.0
(65.0 to 111.1)
VIET at Day 28 [N=65]
99.8
(78.2 to 127.3)
VIET at Day 35 [N=65]
142.6
(113.7 to 178.8)
VIET at Day 42 [N=62]
151.3
(120.3 to 190.3)
TURK at Day 0 [N=65]
26.5
(20.1 to 35.1)
TURK at Day 21 [N=64]
57.5
(43.7 to 75.6)
TURK at Day 28 [N=65]
139.9
(102.5 to 191.1)
TURK at Day 35 [N=65]
442.6
(343.6 to 570.3)
TURK at Day 42 [N=62]
377.0
(296.1 to 480.0)
TURK at Day 182 [N=65]
245.5
(186.2 to 323.5)
16.Secondary Outcome
Title Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.
Hide Description Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 2 Group.
Time Frame At Days 0, 14, 21, 28, 35, 42 and 182.
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 data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.
Arm/Group Title Influenza A (H5N1) 2 Group
Hide Arm/Group Description:
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
Overall Number of Participants Analyzed 69
Geometric Mean (95% Confidence Interval)
Unit of Measure: titers
VIET at Day 0 [N=69]
34.5
(27.7 to 42.8)
VIET at Day 14 [N=69]
99.4
(80.6 to 122.5)
VIET at Day 21 [N=69]
104.3
(85.4 to 127.4)
VIET at Day 28 [N=69]
146.9
(119.6 to 180.4)
VIET at Day 35 [N=69]
142.0
(119.1 to 169.4)
VIET at Day 42 [N=68]
134.5
(109.0 to 166.0)
TURK at Day 0 [N=69]
24.1
(20.0 to 29.1)
TURK at Day 14 [N=68]
64.9
(49.6 to 84.9)
TURK at Day 21 [N=69]
107.0
(82.0 to 139.7)
TURK at Day 28 [N=69]
224.0
(183.4 to 273.4)
TURK at Day 35 [N=69]
221.7
(181.9 to 270.3)
TURK at Day 42 [N=68]
227.8
(187.0 to 277.6)
TURK at Day 182 [N=68]
230.2
(184.2 to 287.6)
17.Secondary Outcome
Title Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.
Hide Description Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 3 Group.
Time Frame At Days 0, 7, 14, 21, 28, 42 and 182.
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 data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.
Arm/Group Title Influenza A (H5N1) 3 Group
Hide Arm/Group Description:
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
Overall Number of Participants Analyzed 74
Geometric Mean (95% Confidence Interval)
Unit of Measure: titers
VIET at Day 0 [N=74]
32.9
(26.0 to 41.6)
VIET at Day 7 [N=74]
42.2
(33.5 to 53.1)
VIET at Day 14 [N=73]
125.5
(96.4 to 163.3)
VIET at Day 21 [N=74]
133.8
(103.1 to 173.8)
VIET at Day 28 [N=72]
119.4
(93.6 to 152.3)
VIET at Day 42 [N=73]
114.5
(91.2 to 143.7)
TURK at Day 0 [N=74]
23.4
(18.7 to 29.4)
TURK at Day 7 [N=74]
25.1
(20.3 to 31.1)
TURK at Day 14 [N=73]
83.6
(61.6 to 113.5)
TURK at Day 21 [N=74]
105.8
(80.0 to 140.0)
TURK at Day 28 [N=72]
115.5
(87.0 to 153.4)
TURK at Day 42 [N=73]
146.7
(118.3 to 182.0)
TURK at Day 182 [N=71]
138.7
(105.9 to 181.8)
18.Secondary Outcome
Title Micro-neutralization (MN) Titers for Antibodies Against the Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.
Hide Description Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 4 Group.
Time Frame At Days 0, 7, 14, 21, 42 and 182.
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 data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.
Arm/Group Title Influenza A (H5N1) 4 Group
Hide Arm/Group Description:
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
Overall Number of Participants Analyzed 75
Geometric Mean (95% Confidence Interval)
Unit of Measure: titers
VIET at Day 0 [N=75]
36.1
(28.4 to 45.8)
VIET at Day 7 [N=74]
62.8
(48.3 to 81.5)
VIET at Day 14 [N=75]
135.6
(106.9 to 171.9)
VIET at Day 21 [N=74]
109.3
(85.3 to 140.0)
VIET at Day 42 [N=74]
93.7
(72.3 to 121.4)
TURK at Day 0 [N=75]
24.3
(19.6 to 30.1)
TURK at Day 7 [N=74]
36.5
(27.8 to 47.8)
TURK at Day 14 [N=75]
97.2
(74.2 to 127.3)
TURK at Day 21 [N=74]
97.5
(75.3 to 126.4)
TURK at Day 42 [N=74]
132.1
(103.1 to 169.3)
TURK at Day 182 [N=73]
147.3
(112.9 to 192.3)
19.Secondary Outcome
Title Number of Subjects With a Vaccine Response of MN Assessed Antibodies for Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.
Hide Description Subjects with a vaccine response were defined as vaccinated subjects who had either a pre-vaccination titer < 1:28 and a post vaccination titer ≥ 1:56 or a pre-vaccination titer ≥ 1:28 and at least a four-fold increase in post-vaccination titer.
Time Frame At 7, 14 and 21 days after the second dose
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 data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.
Arm/Group Title Influenza A (H5N1) 1 Group Influenza A (H5N1) 2 Group Influenza A (H5N1) 3 Group Influenza A (H5N1) 4 Group
Hide Arm/Group Description:
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
Overall Number of Participants Analyzed 65 69 74 75
Measure Type: Number
Unit of Measure: Subjects
VIET at 7 days post dose 2 [N=65,69,72,74] 28 26 34 16
VIET at 14 days post dose 2 [N=65,69,73,75] 35 36 33 32
VIET at 21 days post dose 2 [N=62,69,71,74] 33 32 33 33
TURK at 7 days post dose 2 [N=65,69,73,74] 37 37 33 11
TURK at 14 days post dose 2 [N=65,69,74,75] 54 54 43 35
TURK at 21 days post dose 2 [N=62,69,72,74] 50 53 40 37
20.Secondary Outcome
Title Number of Subjects With a Vaccine Response of MN Assessed Antibodies for Flu A/Vietnam/1194/2004 (VIET) and Flu A/Turkey/Turkey/1/2005 (TURK) Strains of Influenza Disease.
Hide Description Subjects with a vaccine response were defined as vaccinated subjects who had either a pre-vaccination titer < 1:28 and a post vaccination titer ≥ 1:56 or a pre-vaccination titer ≥ 1:28 and at least a four-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 data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.
Arm/Group Title Influenza A (H5N1) 1 Group Influenza A (H5N1) 2 Group Influenza A (H5N1) 3 Group Influenza A (H5N1) 4 Group
Hide Arm/Group Description:
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
Overall Number of Participants Analyzed 62 68 73 74
Measure Type: Number
Unit of Measure: Subjects
VIET [N=62,68,72,74] 33 34 30 24
TURK [N=62,68,73,74] 50 55 49 44
21.Secondary Outcome
Title Number of Subjects With a Vaccine Response of MN Assessed Antibodies for the Flu A/Turkey/Turkey/1/2005 (TURK) Strain of Influenza Disease.
Hide Description Subjects with vaccine response were defined as vaccinated subjects who had either a pre-vaccination titer < 1:28 and a post vaccination titer ≥ 1:56 or a pre-vaccination titer ≥ 1:28 and at least a four-fold increase in post-vaccination titer.
Time Frame At Day 182
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 data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.
Arm/Group Title Influenza A (H5N1) 1 Group Influenza A (H5N1) 2 Group Influenza A (H5N1) 3 Group Influenza A (H5N1) 4 Group
Hide Arm/Group Description:
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
Overall Number of Participants Analyzed 65 68 71 73
Measure Type: Number
Unit of Measure: Subjects
47 51 45 43
22.Secondary 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.
Time Frame Within the 7-day follow-up period (Days 0-6) after any vaccination
Hide 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 and for whom any post-vaccination data were available and had the symptom sheet completed.
Arm/Group Title Influenza A (H5N1) 1 Group Influenza A (H5N1) 2 Group Influenza A (H5N1) 3 Group Influenza A (H5N1) 4 Group
Hide Arm/Group Description:
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
Overall Number of Participants Analyzed 76 77 78 77
Measure Type: Number
Unit of Measure: Subjects
Any Pain 60 64 65 65
Any Redness 2 5 5 4
Any Swelling 4 5 5 3
23.Secondary 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
Hide 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 and for whom any post-vaccination data were available and had the symptom sheet completed.
Arm/Group Title Influenza A (H5N1) 1 Group Influenza A (H5N1) 2 Group Influenza A (H5N1) 3 Group Influenza A (H5N1) 4 Group
Hide Arm/Group Description:
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
Overall Number of Participants Analyzed 76 77 78 77
Measure Type: Number
Unit of Measure: Subjects
Any Fatigue 23 30 22 27
Any Headache 30 28 24 20
Any Joint Pain 20 23 22 11
Any Muscle Aches 49 43 40 40
Any Shivering 10 13 13 10
Any Sweating 15 11 8 5
Any Fever 2 4 1 1
24.Secondary Outcome
Title Number of Subjects With Medically Attended Adverse Events (MAEs).
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.
Time Frame From Day 0 to 182
Hide 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 and for whom any post-vaccination data were available.
Arm/Group Title Influenza A (H5N1) 1 Group Influenza A (H5N1) 2 Group Influenza A (H5N1) 3 Group Influenza A (H5N1) 4 Group
Hide Arm/Group Description:
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
Overall Number of Participants Analyzed 78 78 78 78
Measure Type: Number
Unit of Measure: Subjects
18 19 15 21
25.Secondary 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 Within the 51-day follow-up period (Days 0-50) after first vaccination.
Hide 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 and for whom any post-vaccination data were available.
Arm/Group Title Influenza A (H5N1) 1 Group Influenza A (H5N1) 2 Group Influenza A (H5N1) 3 Group Influenza A (H5N1) 4 Group
Hide Arm/Group Description:
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
Overall Number of Participants Analyzed 78 78 78 78
Measure Type: Number
Unit of Measure: Subjects
34 37 41 27
26.Secondary 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
Hide 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 and for whom any post-vaccination data were available.
Arm/Group Title Influenza A (H5N1) 1 Group Influenza A (H5N1) 2 Group Influenza A (H5N1) 3 Group Influenza A (H5N1) 4 Group
Hide Arm/Group Description:
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
Overall Number of Participants Analyzed 78 78 78 78
Measure Type: Number
Unit of Measure: Subjects
1 0 3 1
Time Frame Solicited local and general symptoms: Within the 7-day period after primary vaccination. Unsolicited AEs: Within the 51-day period after primary vaccination. SAEs: from Day 0 to Day 182.
Adverse Event Reporting Description For solicited and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
 
Arm/Group Title Influenza A (H5N1) 1 Group Influenza A (H5N1) 2 Group Influenza A (H5N1) 3 Group Influenza A (H5N1) 4 Group
Hide Arm/Group Description Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm. Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 14. The vaccine was administered intramuscularly in the deltoid region of the arm. Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted,at Day 0 and Day 7. The vaccine was administered intramuscularly in the deltoid region of the arm. Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0. The vaccine was administered intramuscularly in the deltoid region of the arm.
All-Cause Mortality
Influenza A (H5N1) 1 Group Influenza A (H5N1) 2 Group Influenza A (H5N1) 3 Group Influenza A (H5N1) 4 Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Influenza A (H5N1) 1 Group Influenza A (H5N1) 2 Group Influenza A (H5N1) 3 Group Influenza A (H5N1) 4 Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/78 (1.28%)   0/78 (0.00%)   3/78 (3.85%)   1/78 (1.28%) 
Cardiac disorders         
Cardiac failure congestive * 1  0/78 (0.00%)  0/78 (0.00%)  1/78 (1.28%)  0/78 (0.00%) 
Myocardial infarction * 1  0/78 (0.00%)  0/78 (0.00%)  1/78 (1.28%)  0/78 (0.00%) 
Gastrointestinal disorders         
Irritable bowel syndrome * 1  1/78 (1.28%)  0/78 (0.00%)  0/78 (0.00%)  0/78 (0.00%) 
Infections and infestations         
Cellulitis * 1  0/78 (0.00%)  0/78 (0.00%)  1/78 (1.28%)  0/78 (0.00%) 
Injury, poisoning and procedural complications         
Injury * 1  0/78 (0.00%)  0/78 (0.00%)  1/78 (1.28%)  0/78 (0.00%) 
Metabolism and nutrition disorders         
Diabetes mellitus * 1  0/78 (0.00%)  0/78 (0.00%)  1/78 (1.28%)  0/78 (0.00%) 
Nervous system disorders         
Syncope * 1  0/78 (0.00%)  0/78 (0.00%)  1/78 (1.28%)  0/78 (0.00%) 
Vascular disorders         
Phlebitis * 1  0/78 (0.00%)  0/78 (0.00%)  0/78 (0.00%)  1/78 (1.28%) 
*
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%
Influenza A (H5N1) 1 Group Influenza A (H5N1) 2 Group Influenza A (H5N1) 3 Group Influenza A (H5N1) 4 Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   66/78 (84.62%)   67/78 (85.90%)   68/78 (87.18%)   67/78 (85.90%) 
Blood and lymphatic system disorders         
Lymphadenopathy * 1  3/78 (3.85%)  5/78 (6.41%)  4/78 (5.13%)  2/78 (2.56%) 
Gastrointestinal disorders         
Nausea * 1  1/78 (1.28%)  5/78 (6.41%)  5/78 (6.41%)  0/78 (0.00%) 
Diarrhoea * 1  4/78 (5.13%)  1/78 (1.28%)  4/78 (5.13%)  0/78 (0.00%) 
General disorders         
Pain  1  60/76 (78.95%)  64/77 (83.12%)  65/78 (83.33%)  65/77 (84.42%) 
Redness  1  2/76 (2.63%)  5/77 (6.49%)  5/78 (6.41%)  4/77 (5.19%) 
Swelling  1  4/76 (5.26%)  5/77 (6.49%)  6/78 (7.69%)  3/77 (3.90%) 
Fatigue  1  23/76 (30.26%)  30/77 (38.96%)  22/78 (28.21%)  27/77 (35.06%) 
Headache  1  30/76 (39.47%)  28/77 (36.36%)  24/78 (30.77%)  20/77 (25.97%) 
Joint pain  1  20/76 (26.32%)  23/77 (29.87%)  22/78 (28.21%)  11/77 (14.29%) 
Muscle aches  1  49/76 (64.47%)  43/77 (55.84%)  40/78 (51.28%)  40/77 (51.95%) 
Shivering  1  10/76 (13.16%)  13/77 (16.88%)  13/78 (16.67%)  10/77 (12.99%) 
Sweating  1  15/76 (19.74%)  11/77 (14.29%)  8/78 (10.26%)  5/77 (6.49%) 
Fever  1  2/76 (2.63%)  4/77 (5.19%)  1/78 (1.28%)  1/77 (1.30%) 
Injection site warmth * 1  2/78 (2.56%)  0/78 (0.00%)  1/78 (1.28%)  4/78 (5.13%) 
Oedema peripheral * 1  0/78 (0.00%)  1/78 (1.28%)  4/78 (5.13%)  0/78 (0.00%) 
Infections and infestations         
Nasopharyngitis * 1  2/78 (2.56%)  2/78 (2.56%)  5/78 (6.41%)  4/78 (5.13%) 
Respiratory, thoracic and mediastinal disorders         
Oropharyngeal pain * 1  5/78 (6.41%)  3/78 (3.85%)  2/78 (2.56%)  2/78 (2.56%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
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
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00695669     History of Changes
Other Study ID Numbers: 111626
First Submitted: June 10, 2008
First Posted: June 12, 2008
Results First Submitted: December 19, 2013
Results First Posted: February 7, 2014
Last Update Posted: July 31, 2018