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Trial record 23 of 28 for:    pandemrix

Immunogenicity and Safety of GSK Biologicals' (Pre-) Pandemic Influenza Candidate Vaccine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00742885
Recruitment Status : Completed
First Posted : August 28, 2008
Results First Posted : February 24, 2014
Last Update Posted : August 20, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Influenza
Intervention Biological: Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted
Enrollment 100
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Influenza A (H5N1) 20-40 Years Group Influenza A (H5N1) 41-64 Years Group
Hide Arm/Group Description Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm. Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
Period Title: Overall Study
Started 50 50
Completed 49 [1] 50 [1]
Not Completed 1 0
Reason Not Completed
Lost to Follow-up             1             0
[1]
to Day 182
Arm/Group Title Influenza A (H5N1) 20-40 Years Group Influenza A (H5N1) 41-64 Years Group Total
Hide Arm/Group Description Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm. Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm. Total of all reporting groups
Overall Number of Baseline Participants 50 50 100
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants 50 participants 100 participants
31.1  (5.69) 49.6  (6.04) 40.3  (10.98)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
Female
25
  50.0%
32
  64.0%
57
  57.0%
Male
25
  50.0%
18
  36.0%
43
  43.0%
1.Primary Outcome
Title Haemagglutination Inhibition (HI) Antibody Titers for the H5N1 Vaccine Strain
Hide Description Antibody titers were expressed as Geometric mean titers (GMTs). The H5N1 vaccine strain included A/Indonesia/05/2005 antigen (A/Indonesia).
Time Frame At Day 0 and Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and assay results were available for antibodies against the study vaccine antigen component after vaccination.
Arm/Group Title Influenza A (H5N1) 20-40 Years Group Influenza A (H5N1) 41-64 Years Group
Hide Arm/Group Description:
Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 50 50
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer
A/Indonesia at Day 0
5.0
(5.0 to 5.0)
5.4
(5.0 to 5.8)
A/Indonesia at Day 42
156.8
(105.8 to 232.3)
142.1
(104.0 to 194.3)
2.Primary Outcome
Title Number of Subjects Seroconverted for H5N1 HI Antibodies
Hide Description A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer. The H5N1 vaccine strain included A/Indonesia antigen.
Time Frame At Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and assay results were available for antibodies against the study vaccine antigen component after vaccination.
Arm/Group Title Influenza A (H5N1) 20-40 Years Group Influenza A (H5N1) 41-64 Years Group
Hide Arm/Group Description:
Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 50 50
Measure Type: Count of Participants
Unit of Measure: Participants
45
  90.0%
46
  92.0%
3.Primary Outcome
Title HI Antibody Seroconversion Factors for H5N1 HI Antibodies
Hide Description Seroconversion factors (SCF) were defined as the fold increase in serum H5N1 HI antibody GMTs post-vaccination compared to Day 0, at Day 42. The H5N1 vaccine strain included A/Indonesia antigen.
Time Frame At Day 0 and Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and assay results were available for antibodies against the study vaccine antigen component after vaccination.
Arm/Group Title Influenza A (H5N1) 20-40 Years Group Influenza A (H5N1) 41-64 Years Group
Hide Arm/Group Description:
Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 50 50
Geometric Mean (95% Confidence Interval)
Unit of Measure: Fold Increase
31.4
(21.2 to 46.5)
26.2
(19.2 to 35.8)
4.Primary Outcome
Title Number of Subjects Seroprotected for H5N1 HI Antibodies
Hide Description A seroprotected subject was defined as a subject with a serum H5N1 HI antibody titer greater than or equal to 1:40, at Day 42. The H5N1 vaccine strain included A/Indonesia antigen.
Time Frame At Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and assay results were available for antibodies against the study vaccine antigen component after vaccination.
Arm/Group Title Influenza A (H5N1) 20-40 Years Group Influenza A (H5N1) 41-64 Years Group
Hide Arm/Group Description:
Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 50 50
Measure Type: Count of Participants
Unit of Measure: Participants
45
  90.0%
46
  92.0%
5.Primary Outcome
Title Haemagglutination Inhibition (HI) Antibody Titers for the H5N1 Vaccine Strain
Hide Description Antibody titers were expressed as Geometric mean titers (GMTs). The H5N1 vaccine strain included A/Indonesia antigen.
Time Frame At Day 0, Day 21 and Day 182
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on According-To-Protocol (ATP) cohort for persistence which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and assay results were available for antibodies against the study vaccine antigen component on Day 182.
Arm/Group Title Influenza A (H5N1) 20-40 Years Group Influenza A (H5N1) 41-64 Years Group
Hide Arm/Group Description:
Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 50 50
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer
A/Indonesia at Day 0 Number Analyzed 50 participants 50 participants
5.0
(5.0 to 5.0)
5.4
(5.0 to 5.8)
A/Indonesia at Day 21 Number Analyzed 50 participants 50 participants
15.8
(11.0 to 22.8)
15.4
(10.7 to 22.0)
A/Indonesia at Day 182 Number Analyzed 49 participants 50 participants
25.6
(17.3 to 38.1)
37.4
(27.5 to 50.8)
6.Secondary Outcome
Title Number of Subjects Seroconverted for H5N1 HI Antibodies
Hide Description A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer, at Days 21 and 182. The H5N1 vaccine strain included A/Indonesia antigen.
Time Frame At Day 21 and Day 182
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on According-To-Protocol (ATP) cohort for persistence which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and assay results were available for antibodies against the study vaccine antigen component on Day 182.
Arm/Group Title Influenza A (H5N1) 20-40 Years Group Influenza A (H5N1) 41-64 Years Group
Hide Arm/Group Description:
Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 50 50
Measure Type: Count of Participants
Unit of Measure: Participants
A/Indonesia at Day 21 Number Analyzed 50 participants 50 participants
19
  38.0%
16
  32.0%
A/Indonesia at Day 182 Number Analyzed 49 participants 50 participants
29
  59.2%
38
  76.0%
7.Secondary Outcome
Title Seroconversion Factors for H5N1 HI Antibodies
Hide Description Seroconversion factors (SCF) were defined as the fold increase in serum H5N1 HI antibody GMTs post-vaccination compared to Day 0, at Days 21 and 182. The H5N1 vaccine strain included A/Indonesia antigen.
Time Frame At Day 21 and Day 182
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on According-To-Protocol (ATP) cohort for persistence which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and assay results were available for antibodies against the study vaccine antigen component on Day 182.
Arm/Group Title Influenza A (H5N1) 20-40 Years Group Influenza A (H5N1) 41-64 Years Group
Hide Arm/Group Description:
Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 50 50
Geometric Mean (95% Confidence Interval)
Unit of Measure: Fold Increase
A/Indonesia at Day 21 Number Analyzed 50 participants 50 participants
3.2
(2.2 to 4.6)
2.8
(2.0 to 4.0)
A/Indonesia at Day 182 Number Analyzed 49 participants 50 participants
5.1
(3.5 to 7.6)
6.9
(5.1 to 9.2)
8.Secondary Outcome
Title Number of Subjects Seroprotected for H5N1 HI Antibodies
Hide Description A seroprotected subject was defined as a subject with a serum H5N1 HI antibody titer greater than or equal to 1:40, at Days 21 and 182. The H5N1 vaccine strain included A/Indonesia antigen.
Time Frame At Day 0, Day 21 and Day 182
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on According-To-Protocol (ATP) cohort for persistence which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and assay results were available for antibodies against the study vaccine antigen component on Day 182.
Arm/Group Title Influenza A (H5N1) 20-40 Years Group Influenza A (H5N1) 41-64 Years Group
Hide Arm/Group Description:
Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 50 50
Measure Type: Count of Participants
Unit of Measure: Participants
A/Indonesia at Day 0 Number Analyzed 50 participants 50 participants
0
   0.0%
0
   0.0%
A/Indonesia at Day 21 Number Analyzed 50 participants 50 participants
19
  38.0%
16
  32.0%
A/Indonesia at Day 182 Number Analyzed 49 participants 50 participants
29
  59.2%
38
  76.0%
9.Secondary Outcome
Title Antibody Titers for Serum Anti-H5N1 Neutralising Antibodies
Hide Description Antibody titers were expressed as Geometric mean titers (GMTs). The H5N1 vaccine strain included A/Indonesia antigen.
Time Frame At Day 0, Day 42 and Day 182
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on According-To-Protocol (ATP) cohort for persistence which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and assay results were available for antibodies against the study vaccine antigen component on Day 182.
Arm/Group Title Influenza A (H5N1) 20-40 Years Group Influenza A (H5N1) 41-64 Years Group
Hide Arm/Group Description:
Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 50 50
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer
A/Indonesia at Day 0 Number Analyzed 50 participants 49 participants
14.4
(13.6 to 15.2)
18.3
(15.4 to 21.8)
A/Indonesia at Day 42 Number Analyzed 50 participants 50 participants
579.6
(466.5 to 720.0)
473.8
(379.9 to 591.0)
A/Indonesia at Day 182 Number Analyzed 49 participants 50 participants
240.5
(210.3 to 275.0)
240.1
(210.0 to 274.5)
10.Secondary Outcome
Title Number of Subjects Seroconverted for Serum Anti-H5N1 Neutralising Antibodies
Hide Description

A seroconverted subject was defined as a subject with a minimum 4 fold increase in titer at post-vaccination for neutralising antibody response at Days 42 and 182.

The H5N1 vaccine strain included A/Indonesia antigen.

Time Frame At Day 42 and Day 182
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on According-To-Protocol (ATP) cohort for persistence which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and assay results were available for antibodies against the study vaccine antigen component on Day 182.
Arm/Group Title Influenza A (H5N1) 20-40 Years Group Influenza A (H5N1) 41-64 Years Group
Hide Arm/Group Description:
Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 50 50
Measure Type: Count of Participants
Unit of Measure: Participants
A/Indonesia at Day 42 Number Analyzed 50 participants 49 participants
49
  98.0%
47
  95.9%
A/Indonesia at Day 182 Number Analyzed 49 participants 49 participants
48
  98.0%
44
  89.8%
11.Secondary Outcome
Title Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
Hide Description Biochemical and haematological parameters assessed in blood samples include alanine aminotransferase (ALT), aspartate aminotransferase (AST), basophils (BAS) and blood urea nitrogen (BUN ). Categories = unknown, below, within, or above the normal ranges.
Time Frame At Day 0, Day 7 and Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.
Arm/Group Title Influenza A (H5N1) 20-40 Years Group Influenza A (H5N1) 41-64 Years Group
Hide Arm/Group Description:
Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 50 50
Measure Type: Count of Participants
Unit of Measure: Participants
ALT [Unknown] at Day 0
0
   0.0%
0
   0.0%
ALT [Unknown] at Day 7
0
   0.0%
0
   0.0%
ALT [Unknown] at Day 42
0
   0.0%
0
   0.0%
ALT [Below] at Day 0
0
   0.0%
0
   0.0%
ALT [Below] at Day 7
1
   2.0%
0
   0.0%
ALT [Below] at Day 42
1
   2.0%
0
   0.0%
ALT [Within] at Day 0
47
  94.0%
46
  92.0%
ALT [Within] at Day 7
47
  94.0%
45
  90.0%
ALT [Within] at Day 42
45
  90.0%
46
  92.0%
ALT [Above] at Day 0
3
   6.0%
4
   8.0%
ALT [Above] at Day 7
2
   4.0%
5
  10.0%
ALT [Above] at Day 42
4
   8.0%
4
   8.0%
AST [Unknown] at Day 0
0
   0.0%
0
   0.0%
AST [Unknown] at Day 7
0
   0.0%
0
   0.0%
AST [Unknown] at Day 42
0
   0.0%
0
   0.0%
AST [Below] at Day 0
0
   0.0%
0
   0.0%
AST [Below] at Day 7
0
   0.0%
0
   0.0%
AST [Below] at Day 42
0
   0.0%
0
   0.0%
AST [Within] at Day 0
49
  98.0%
49
  98.0%
AST [Within] at Day 7
50
 100.0%
49
  98.0%
AST [Within] at Day 42
49
  98.0%
50
 100.0%
AST [Above] at Day 0
1
   2.0%
1
   2.0%
AST [Above] at Day 7
0
   0.0%
1
   2.0%
AST [Above] at Day 42
1
   2.0%
0
   0.0%
BAS [Unknown] at Day 0
0
   0.0%
0
   0.0%
BAS [Unknown] at Day 7
0
   0.0%
0
   0.0%
BAS [Unknown] at Day 42
0
   0.0%
0
   0.0%
BAS [Below] at Day 0
0
   0.0%
0
   0.0%
BAS [Below] at Day 7
0
   0.0%
0
   0.0%
BAS [Below] at Day 42
0
   0.0%
0
   0.0%
BAS [Within] at Day 0
50
 100.0%
49
  98.0%
BAS [Within] at Day 7
50
 100.0%
50
 100.0%
BAS [Within] at Day 42
50
 100.0%
50
 100.0%
BAS [Above] at Day 0
0
   0.0%
1
   2.0%
BAS [Above] at Day 7
0
   0.0%
0
   0.0%
BAS [Above] at Day 42
0
   0.0%
0
   0.0%
BUN [Unknown] at Day 0
0
   0.0%
0
   0.0%
BUN [Unknown] at Day 7
0
   0.0%
0
   0.0%
BUN [Unknown] at Day 42
0
   0.0%
0
   0.0%
BUN [Below] at Day 0
0
   0.0%
1
   2.0%
BUN [Below] at Day 7
0
   0.0%
0
   0.0%
BUN [Below] at Day 42
1
   2.0%
0
   0.0%
BUN [Within] at Day 0
50
 100.0%
48
  96.0%
BUN [Within] at Day 7
50
 100.0%
50
 100.0%
BUN [Within] at Day 42
49
  98.0%
49
  98.0%
BUN [Above] at Day 0
0
   0.0%
1
   2.0%
BUN [Above] at Day 7
0
   0.0%
0
   0.0%
BUN [Above] at Day 42
0
   0.0%
1
   2.0%
12.Secondary Outcome
Title Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
Hide Description

Biochemical and haematological parameters assessed in blood samples include creatinine (CREA), eosinophils (EOS), hemoglobin (HB) and hematocrit (HC).

Categories = unknown, below, within, or above the normal ranges.

Time Frame At Day 0, Day 7 and Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.
Arm/Group Title Influenza A (H5N1) 20-40 Years Group Influenza A (H5N1) 41-64 Years Group
Hide Arm/Group Description:
Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 50 50
Measure Type: Count of Participants
Unit of Measure: Participants
CREA [Unknown] at Day 0
0
   0.0%
0
   0.0%
CREA [Unknown] at Day 7
0
   0.0%
0
   0.0%
CREA [Unknown] at Day 42
0
   0.0%
0
   0.0%
CREA [Below] at Day 0
1
   2.0%
2
   4.0%
CREA [Below] at Day 7
1
   2.0%
3
   6.0%
CREA [Below] at Day 42
2
   4.0%
3
   6.0%
CREA [Within] at Day 0
48
  96.0%
44
  88.0%
CREA [Within] at Day 7
46
  92.0%
44
  88.0%
CREA [Within] at Day 42
47
  94.0%
45
  90.0%
CREA [Above] at Day 0
1
   2.0%
4
   8.0%
CREA [Above] at Day 7
3
   6.0%
3
   6.0%
CREA [Above] at Day 42
1
   2.0%
2
   4.0%
EOS [Unknown] at Day 0
0
   0.0%
0
   0.0%
EOS [Unknown] at Day 7
0
   0.0%
0
   0.0%
EOS [Unknown] at Day 42
0
   0.0%
0
   0.0%
EOS [Below] at Day 0
0
   0.0%
0
   0.0%
EOS [Below] at Day 7
0
   0.0%
0
   0.0%
EOS [Below] at Day 42
0
   0.0%
0
   0.0%
EOS [Within] at Day 0
44
  88.0%
46
  92.0%
EOS [Within] at Day 7
45
  90.0%
46
  92.0%
EOS [Within] at Day 42
47
  94.0%
46
  92.0%
EOS [Above] at Day 0
6
  12.0%
4
   8.0%
EOS [Above] at Day 7
5
  10.0%
4
   8.0%
EOS [Above] at Day 42
3
   6.0%
4
   8.0%
HB [Unknown] at Day 0
0
   0.0%
0
   0.0%
HB [Unknown] at Day 7
0
   0.0%
0
   0.0%
HB [Unknown] at Day 42
0
   0.0%
0
   0.0%
HB [Below] at Day 0
1
   2.0%
4
   8.0%
HB [Below] at Day 7
1
   2.0%
4
   8.0%
HB [Below] at Day 42
2
   4.0%
5
  10.0%
HB [Within] at Day 0
49
  98.0%
45
  90.0%
HB [Within] at Day 7
49
  98.0%
44
  88.0%
HB [Within] at Day 42
48
  96.0%
44
  88.0%
HB [Above] at Day 0
0
   0.0%
1
   2.0%
HB [Above] at Day 7
0
   0.0%
2
   4.0%
HB[Above] at Day 42
0
   0.0%
1
   2.0%
HC [Unknown] at Day 0
0
   0.0%
0
   0.0%
HC [Unknown] at Day 7
0
   0.0%
0
   0.0%
HC[Unknown] at Day 42
0
   0.0%
0
   0.0%
HC [Below] at Day 0
0
   0.0%
1
   2.0%
HC [Below] at Day 7
0
   0.0%
1
   2.0%
HC [Below] at Day 42
0
   0.0%
1
   2.0%
HC [Within] at Day 0
50
 100.0%
45
  90.0%
HC [Within] at Day 7
50
 100.0%
46
  92.0%
HC [Within] at Day 42
49
  98.0%
44
  88.0%
HC [Above] at Day 0
0
   0.0%
4
   8.0%
HC [Above] at Day 7
0
   0.0%
3
   6.0%
HC [Above] at Day 42
1
   2.0%
5
  10.0%
13.Secondary Outcome
Title Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
Hide Description

Biochemical and haematological parameters assessed in blood samples include lymphocytes (LYM), monocytes (MON) and neutrophils (NEU).

Categories = unknown, below, within, or above the normal ranges.

Time Frame At Day 0, Day 7 and Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.
Arm/Group Title Influenza A (H5N1) 20-40 Years Group Influenza A (H5N1) 41-64 Years Group
Hide Arm/Group Description:
Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 50 50
Measure Type: Count of Participants
Unit of Measure: Participants
LYM [Unknown] at Day 0
0
   0.0%
0
   0.0%
LYM [Unknown] at Day 7
0
   0.0%
0
   0.0%
LYM [Unknown] at Day 42
0
   0.0%
0
   0.0%
LYM [Below] at Day 0
0
   0.0%
2
   4.0%
LYM [Below] at Day 7
0
   0.0%
1
   2.0%
LYM [Below] at Day 42
5
  10.0%
1
   2.0%
LYM [Within] at Day 0
50
 100.0%
48
  96.0%
LYM [Within] at Day 7
50
 100.0%
49
  98.0%
LYM [Within] at Day 42
45
  90.0%
49
  98.0%
LYM [Above] at Day 0
0
   0.0%
0
   0.0%
LYM [Above] at Day 7
0
   0.0%
0
   0.0%
LYM [Above] at Day 42
0
   0.0%
0
   0.0%
MON [Unknown] at Day 0
0
   0.0%
0
   0.0%
MON [Unknown] at Day 7
0
   0.0%
0
   0.0%
MON [Unknown] at Day 42
0
   0.0%
0
   0.0%
MON [Below] at Day 0
0
   0.0%
0
   0.0%
MON [Below] at Day 7
0
   0.0%
0
   0.0%
MON [Below] at Day 42
0
   0.0%
0
   0.0%
MON [Within] at Day 0
50
 100.0%
49
  98.0%
MON [Within] at Day 7
48
  96.0%
49
  98.0%
MON [Within] at Day 42
49
  98.0%
50
 100.0%
MON [Above] at Day 0
0
   0.0%
1
   2.0%
MON [Above] at Day 7
2
   4.0%
1
   2.0%
MON [Above] at Day 42
1
   2.0%
0
   0.0%
NEU [Unknown] at Day 0
0
   0.0%
0
   0.0%
NEU [Unknown] at Day 7
0
   0.0%
0
   0.0%
NEU [Unknown] at Day 42
0
   0.0%
0
   0.0%
NEU [Below] at Day 0
0
   0.0%
0
   0.0%
NEU [Below] at Day 7
1
   2.0%
1
   2.0%
NEU [Below] at Day 42
0
   0.0%
0
   0.0%
NEU [Within] at Day 0
50
 100.0%
48
  96.0%
NEU [Within] at Day 7
48
  96.0%
48
  96.0%
NEU [Within] at Day 42
46
  92.0%
49
  98.0%
NEU [Above] at Day 0
0
   0.0%
2
   4.0%
NEU [Above] at Day 7
1
   2.0%
1
   2.0%
NEU [Above] at Day 42
4
   8.0%
1
   2.0%
14.Secondary Outcome
Title Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
Hide Description

Biochemical and haematological parameters assessed in blood samples include lymphocytes (LYM), monocytes (MON) and neutrophils (NEU).

Categories = unknown, below, within, or above the normal ranges.

Time Frame At Day 0, Day 7 and Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.
Arm/Group Title Influenza A (H5N1) 20-40 Years Group. Influenza A (H5N1) 41-64 Years Group.
Hide Arm/Group Description:
Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 50 50
Measure Type: Count of Participants
Unit of Measure: Participants
PLA [Unknown] at Day 0
0
   0.0%
2
   4.0%
PLA [Unknown] at Day 7
0
   0.0%
1
   2.0%
PLA [Unknown] at Day 42
0
   0.0%
0
   0.0%
PLA [Below] at Day 0
0
   0.0%
0
   0.0%
PLA [Below] at Day 7
0
   0.0%
0
   0.0%
PLA [Below] at Day 42
0
   0.0%
0
   0.0%
PLA [Within] at Day 0
50
 100.0%
48
  96.0%
PLA [Within] at Day 7
50
 100.0%
48
  96.0%
PLA [Within] at Day 42
50
 100.0%
50
 100.0%
PLA [Above] at Day 0
0
   0.0%
0
   0.0%
PLA [Above] at Day 7
0
   0.0%
1
   2.0%
PLA [Above] at Day 42
0
   0.0%
0
   0.0%
RBC [Unknown] at Day 0
0
   0.0%
0
   0.0%
RBC [Unknown] at Day 7
0
   0.0%
0
   0.0%
RBC[Unknown] at Day 42
0
   0.0%
0
   0.0%
RBC [Below] at Day 0
2
   4.0%
1
   2.0%
RBC [Below] at Day 7
2
   4.0%
1
   2.0%
RBC [Below] at Day 42
2
   4.0%
0
   0.0%
RBC [Within] at Day 0
48
  96.0%
47
  94.0%
RBC [Within] at Day 7
48
  96.0%
46
  92.0%
RBC [Within] at Day 42
46
  92.0%
48
  96.0%
RBC [Above] at Day 0
0
   0.0%
2
   4.0%
RBC[Above] at Day 7
0
   0.0%
3
   6.0%
RBC[Above] at Day 42
2
   4.0%
2
   4.0%
WBC[Unknown] at Day 0
0
   0.0%
0
   0.0%
WBC [Unknown] at Day 7
0
   0.0%
0
   0.0%
WBC [Unknown] at Day 42
0
   0.0%
0
   0.0%
WBC [Below] at Day 0
2
   4.0%
2
   4.0%
WBC [Below] at Day 7
1
   2.0%
1
   2.0%
WBC [Below] at Day 42
1
   2.0%
1
   2.0%
WBC [Within] at Day 0
47
  94.0%
46
  92.0%
WBC [Within] at Day 7
49
  98.0%
48
  96.0%
WBC [Within] at Day 42
47
  94.0%
47
  94.0%
WBC [Above] at Day 0
1
   2.0%
2
   4.0%
WBC [Above] at Day 7
0
   0.0%
1
   2.0%
WBC [Above] at Day 42
2
   4.0%
2
   4.0%
15.Secondary Outcome
Title Number of Subjects With Any Normal or Abnormal Urine Values
Hide Description Urine parameters assessed were blood, glucose, protein and urobilinogen. Categories = negative, positive
Time Frame At Day 0, Day 7 and Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.
Arm/Group Title Influenza A (H5N1) 20-40 Years Group Influenza A (H5N1) 41-64 Years Group
Hide Arm/Group Description:
Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 50 50
Measure Type: Count of Participants
Unit of Measure: Participants
Blood [Negative] at Day 0
48
  96.0%
44
  88.0%
Blood [Positive] at Day 0
2
   4.0%
6
  12.0%
Blood [Negative] at Day 7
47
  94.0%
43
  86.0%
Blood [Positive] at Day 7
3
   6.0%
7
  14.0%
Blood [Negative] at Day 42
46
  92.0%
46
  92.0%
Blood [Positive] at Day 42
4
   8.0%
4
   8.0%
Glucose [Negative] at Day 0
50
 100.0%
49
  98.0%
Glucose [Positive] at Day 0
0
   0.0%
1
   2.0%
Glucose [Negative] at Day 7
50
 100.0%
47
  94.0%
Glucose [Positive] at Day 7
0
   0.0%
3
   6.0%
Glucose [Negative] at Day 42
50
 100.0%
49
  98.0%
Glucose [Positive] at Day 42
0
   0.0%
1
   2.0%
Protein [Negative] at Day 0
49
  98.0%
50
 100.0%
Protein [Positive] at Day 0
1
   2.0%
0
   0.0%
Protein [Negative] at Day 7
48
  96.0%
50
 100.0%
Protein [Positive] at Day 7
2
   4.0%
0
   0.0%
Protein [Negative] at Day 42
49
  98.0%
49
  98.0%
Protein [Positive] at Day 42
1
   2.0%
1
   2.0%
Urobilinogen [Negative] at Day 0
47
  94.0%
50
 100.0%
Urobilinogen [Positive] at Day 0
3
   6.0%
0
   0.0%
Urobilinogen [Negative] at Day 7
49
  98.0%
50
 100.0%
Urobilinogen [Positive] at Day 7
1
   2.0%
0
   0.0%
Urobilinogen [Negative] at Day 42
49
  98.0%
50
 100.0%
Urobilinogen [Positive] at Day 42
1
   2.0%
0
   0.0%
16.Secondary Outcome
Title Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Hide Description Solicited local symptoms assessed were pain, redness and swelling/induration. Any=any solicited local symptom reported regardless of their intensity. Grade 3 pain= significant pain at rest that prevented normal activities as assessed by inability to attend/do work or school. Grade 3 redness and swelling/induration=redness and swelling/induration above 100 millimetres (mm).
Time Frame During the 7-day post vaccination period (Days 0-6) after any vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.
Arm/Group Title Influenza A (H5N1) 20-40 Years Group Influenza A (H5N1) 41-64 Years Group
Hide Arm/Group Description:
Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 50 50
Measure Type: Count of Participants
Unit of Measure: Participants
Any Pain
49
  98.0%
49
  98.0%
Grade 3 Pain
1
   2.0%
0
   0.0%
Any redness
12
  24.0%
16
  32.0%
Grade 3 redness
2
   4.0%
2
   4.0%
Any swelling/induration
17
  34.0%
23
  46.0%
Grade 3 swelling/induration
3
   6.0%
2
   4.0%
17.Secondary Outcome
Title Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Hide Description Solicited general symptoms assessed were fatigue, headache, joint pain, muscle aches, shivering, increase sweating and fever. Any=any solicited general symptom reported regardless of their intensity grade or their relationship to vaccination. Any fever was ≥ 38.0 degrees celsius (°C). Grade 3 = general symptom that prevented normal everyday activities as assessed by inability to attend/do work or school, or required intervention of a physician/healthcare provider. Grade 3 fever was≥ 39.0°C. Related= general symptom assessed by the investigator as causally related to the study vaccination.
Time Frame During the 7-day post vaccination period (Days 0-6) after any vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.
Arm/Group Title Influenza A (H5N1) 20-40 Years Group Influenza A (H5N1) 41-64 Years Group
Hide Arm/Group Description:
Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 50 50
Measure Type: Count of Participants
Unit of Measure: Participants
Any fatigue
39
  78.0%
32
  64.0%
Grade 3 fatigue
3
   6.0%
0
   0.0%
Related fatigue
39
  78.0%
32
  64.0%
Any headache
30
  60.0%
21
  42.0%
Grade 3 headache
0
   0.0%
0
   0.0%
Related headache
27
  54.0%
21
  42.0%
Any joint pain
16
  32.0%
18
  36.0%
Grade 3 joint pain
1
   2.0%
0
   0.0%
Related joint pain
16
  32.0%
17
  34.0%
Any muscle aches
36
  72.0%
34
  68.0%
Grade 3 muscle aches
1
   2.0%
0
   0.0%
Related muscle aches
36
  72.0%
33
  66.0%
Any shivering
13
  26.0%
7
  14.0%
Grade 3 shivering
2
   4.0%
0
   0.0%
Related shivering
11
  22.0%
7
  14.0%
Any increase sweating
13
  26.0%
8
  16.0%
Grade 3 increase sweating
0
   0.0%
0
   0.0%
Related increase sweating
12
  24.0%
8
  16.0%
Any fever
6
  12.0%
5
  10.0%
Grade 3 fever
1
   2.0%
0
   0.0%
Related fever
6
  12.0%
5
  10.0%
18.Secondary Outcome
Title Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Hide Description Unsolicited AE is any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.
Time Frame During the 21-day (Days 0-20) following vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.
Arm/Group Title Influenza A (H5N1) 20-40 Years Group Influenza A (H5N1) 41-64 Years Group
Hide Arm/Group Description:
Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 50 50
Measure Type: Count of Participants
Unit of Measure: Participants
Any unsolicited AE (s)
27
  54.0%
24
  48.0%
Grade 3 unsolicited AE (s)
3
   6.0%
0
   0.0%
Related unsolicited AE (s)
11
  22.0%
17
  34.0%
19.Secondary Outcome
Title Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs
Hide Description Unsolicited AE is any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.
Time Frame From Day 0 to Day 83 following vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.
Arm/Group Title Influenza A (H5N1) 20-40 Years Group Influenza A (H5N1) 41-64 Years Group
Hide Arm/Group Description:
Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm
Overall Number of Participants Analyzed 50 50
Measure Type: Count of Participants
Unit of Measure: Participants
Any unsolicited AE (s)
33
  66.0%
36
  72.0%
Grade 3 unsolicited AE (s
3
   6.0%
2
   4.0%
Related unsolicited AE (s)
11
  22.0%
17
  34.0%
20.Secondary Outcome
Title Number of Subjects Reporting Any Medically-significant Conditions (MSCs)
Hide Description MSCs were defined as AEs with a medically-attended visit (s) i.e. prompting emergency room (ER) visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination.
Time Frame During the 182-day (Days 0-181) post-vaccination period
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.
Arm/Group Title Influenza A (H5N1) 20-40 Years Group Influenza A (H5N1) 41-64 Years Group
Hide Arm/Group Description:
Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 50 50
Measure Type: Count of Participants
Unit of Measure: Participants
34
  68.0%
26
  52.0%
21.Secondary Outcome
Title Number of Subjects Reporting Serious Adverse Events (SAEs)
Hide Description SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Time Frame During the entire study period (Day 0 to Day 181)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.
Arm/Group Title Influenza A (H5N1) 20-40 Years Group Influenza A (H5N1) 41-64 Years Group
Hide Arm/Group Description:
Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Number of Participants Analyzed 50 50
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
Time Frame Serious Adverse Events = From Days 0-181. 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 Influenza A (H5N1) 20-40 Years Group Influenza A (H5N1) 41-64 Years Group
Hide Arm/Group Description Subjects aged between 20 and 40 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm. Subjects aged between 41 and 64 years inclusive received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted at Days 0 and 21 administered intramuscularly in the deltoid region of the non-dominant arm.
All-Cause Mortality
Influenza A (H5N1) 20-40 Years Group Influenza A (H5N1) 41-64 Years Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Influenza A (H5N1) 20-40 Years Group Influenza A (H5N1) 41-64 Years Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/50 (0.00%)   0/50 (0.00%) 
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) 20-40 Years Group Influenza A (H5N1) 41-64 Years Group
Affected / at Risk (%) Affected / at Risk (%)
Total   50/50 (100.00%)   50/50 (100.00%) 
Gastrointestinal disorders     
Diarrhoea * [1]  3/50 (6.00%)  0/50 (0.00%) 
Abdominal pain upper * [2]  0/50 (0.00%)  3/50 (6.00%) 
Diarrhoea * [2]  3/50 (6.00%)  0/50 (0.00%) 
General disorders     
Pain   49/50 (98.00%)  49/50 (98.00%) 
Redness   12/50 (24.00%)  16/50 (32.00%) 
Swelling/ Induration   17/50 (34.00%)  23/50 (46.00%) 
Fatigue   39/50 (78.00%)  32/50 (64.00%) 
Headache   30/50 (60.00%)  21/50 (42.00%) 
Joint pain   16/50 (32.00%)  18/50 (36.00%) 
Muscle aches   36/50 (72.00%)  34/50 (68.00%) 
Shivering   13/50 (26.00%)  7/50 (14.00%) 
Increase Sweating   13/50 (26.00%)  8/50 (16.00%) 
Fever   6/50 (12.00%)  5/50 (10.00%) 
Injection site pruritus * [1]  5/50 (10.00%)  9/50 (18.00%) 
Injection site warmth * [1]  6/50 (12.00%)  8/50 (16.00%) 
Injection site pruritus * [2]  5/50 (10.00%)  9/50 (18.00%) 
Injection site warmth * [2]  6/50 (12.00%)  8/50 (16.00%) 
Infections and infestations     
Nasopharyngitis * [1]  7/50 (14.00%)  1/50 (2.00%) 
Nasopharyngitis * [2]  9/50 (18.00%)  8/50 (16.00%) 
Bronchitis * [2]  5/50 (10.00%)  1/50 (2.00%) 
Nervous system disorders     
Headache * [2]  3/50 (6.00%)  6/50 (12.00%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
[1]
Assessed during Days 0-20 post vaccination period
[2]
Assessed during Days 0-83 post vaccination period
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: NCT00742885     History of Changes
Other Study ID Numbers: 111756
First Submitted: August 27, 2008
First Posted: August 28, 2008
Results First Submitted: December 20, 2013
Results First Posted: February 24, 2014
Last Update Posted: August 20, 2018