Trial Outcomes & Findings for Immunogenicity and Safety of GSK Biologicals' (Pre-) Pandemic Influenza Candidate Vaccine (NCT NCT00742885)
NCT ID: NCT00742885
Last Updated: 2018-08-20
Results Overview
Antibody titers were expressed as Geometric mean titers (GMTs). The H5N1 vaccine strain included A/Indonesia/05/2005 antigen (A/Indonesia).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
100 participants
Primary outcome timeframe
At Day 0 and Day 42
Results posted on
2018-08-20
Participant Flow
Participant milestones
| Measure |
Influenza A (H5N1) 20-40 Years Group
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.
|
Influenza A (H5N1) 41-64 Years Group
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 Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
49
|
50
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Influenza A (H5N1) 20-40 Years Group
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.
|
Influenza A (H5N1) 41-64 Years Group
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 Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Immunogenicity and Safety of GSK Biologicals' (Pre-) Pandemic Influenza Candidate Vaccine
Baseline characteristics by cohort
| Measure |
Influenza A (H5N1) 20-40 Years Group
n=50 Participants
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.
|
Influenza A (H5N1) 41-64 Years Group
n=50 Participants
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
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31.1 Years
STANDARD_DEVIATION 5.69 • n=5 Participants
|
49.6 Years
STANDARD_DEVIATION 6.04 • n=7 Participants
|
40.3 Years
STANDARD_DEVIATION 10.98 • n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At Day 0 and Day 42Population: 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.
Antibody titers were expressed as Geometric mean titers (GMTs). The H5N1 vaccine strain included A/Indonesia/05/2005 antigen (A/Indonesia).
Outcome measures
| Measure |
Influenza A (H5N1) 20-40 Years Group
n=50 Participants
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.
|
Influenza A (H5N1) 41-64 Years Group
n=50 Participants
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.
|
|---|---|---|
|
Haemagglutination Inhibition (HI) Antibody Titers for the H5N1 Vaccine Strain
A/Indonesia at Day 0
|
5.0 Titer
Interval 5.0 to 5.0
|
5.4 Titer
Interval 5.0 to 5.8
|
|
Haemagglutination Inhibition (HI) Antibody Titers for the H5N1 Vaccine Strain
A/Indonesia at Day 42
|
156.8 Titer
Interval 105.8 to 232.3
|
142.1 Titer
Interval 104.0 to 194.3
|
PRIMARY outcome
Timeframe: At Day 42Population: 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.
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.
Outcome measures
| Measure |
Influenza A (H5N1) 20-40 Years Group
n=50 Participants
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.
|
Influenza A (H5N1) 41-64 Years Group
n=50 Participants
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.
|
|---|---|---|
|
Number of Subjects Seroconverted for H5N1 HI Antibodies
|
45 Participants
|
46 Participants
|
PRIMARY outcome
Timeframe: At Day 0 and Day 42Population: 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.
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.
Outcome measures
| Measure |
Influenza A (H5N1) 20-40 Years Group
n=50 Participants
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.
|
Influenza A (H5N1) 41-64 Years Group
n=50 Participants
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.
|
|---|---|---|
|
HI Antibody Seroconversion Factors for H5N1 HI Antibodies
|
31.4 Fold Increase
Interval 21.2 to 46.5
|
26.2 Fold Increase
Interval 19.2 to 35.8
|
PRIMARY outcome
Timeframe: At Day 42Population: 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.
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.
Outcome measures
| Measure |
Influenza A (H5N1) 20-40 Years Group
n=50 Participants
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.
|
Influenza A (H5N1) 41-64 Years Group
n=50 Participants
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.
|
|---|---|---|
|
Number of Subjects Seroprotected for H5N1 HI Antibodies
|
45 Participants
|
46 Participants
|
PRIMARY outcome
Timeframe: At Day 0, Day 21 and Day 182Population: 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.
Antibody titers were expressed as Geometric mean titers (GMTs). The H5N1 vaccine strain included A/Indonesia antigen.
Outcome measures
| Measure |
Influenza A (H5N1) 20-40 Years Group
n=50 Participants
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.
|
Influenza A (H5N1) 41-64 Years Group
n=50 Participants
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.
|
|---|---|---|
|
Haemagglutination Inhibition (HI) Antibody Titers for the H5N1 Vaccine Strain
A/Indonesia at Day 0
|
5.0 Titer
Interval 5.0 to 5.0
|
5.4 Titer
Interval 5.0 to 5.8
|
|
Haemagglutination Inhibition (HI) Antibody Titers for the H5N1 Vaccine Strain
A/Indonesia at Day 21
|
15.8 Titer
Interval 11.0 to 22.8
|
15.4 Titer
Interval 10.7 to 22.0
|
|
Haemagglutination Inhibition (HI) Antibody Titers for the H5N1 Vaccine Strain
A/Indonesia at Day 182
|
25.6 Titer
Interval 17.3 to 38.1
|
37.4 Titer
Interval 27.5 to 50.8
|
SECONDARY outcome
Timeframe: At Day 21 and Day 182Population: 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.
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.
Outcome measures
| Measure |
Influenza A (H5N1) 20-40 Years Group
n=50 Participants
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.
|
Influenza A (H5N1) 41-64 Years Group
n=50 Participants
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.
|
|---|---|---|
|
Number of Subjects Seroconverted for H5N1 HI Antibodies
A/Indonesia at Day 21
|
19 Participants
|
16 Participants
|
|
Number of Subjects Seroconverted for H5N1 HI Antibodies
A/Indonesia at Day 182
|
29 Participants
|
38 Participants
|
SECONDARY outcome
Timeframe: At Day 21 and Day 182Population: 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.
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.
Outcome measures
| Measure |
Influenza A (H5N1) 20-40 Years Group
n=50 Participants
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.
|
Influenza A (H5N1) 41-64 Years Group
n=50 Participants
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.
|
|---|---|---|
|
Seroconversion Factors for H5N1 HI Antibodies
A/Indonesia at Day 21
|
3.2 Fold Increase
Interval 2.2 to 4.6
|
2.8 Fold Increase
Interval 2.0 to 4.0
|
|
Seroconversion Factors for H5N1 HI Antibodies
A/Indonesia at Day 182
|
5.1 Fold Increase
Interval 3.5 to 7.6
|
6.9 Fold Increase
Interval 5.1 to 9.2
|
SECONDARY outcome
Timeframe: At Day 0, Day 21 and Day 182Population: 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.
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.
Outcome measures
| Measure |
Influenza A (H5N1) 20-40 Years Group
n=50 Participants
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.
|
Influenza A (H5N1) 41-64 Years Group
n=50 Participants
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.
|
|---|---|---|
|
Number of Subjects Seroprotected for H5N1 HI Antibodies
A/Indonesia at Day 0
|
0 Participants
|
0 Participants
|
|
Number of Subjects Seroprotected for H5N1 HI Antibodies
A/Indonesia at Day 21
|
19 Participants
|
16 Participants
|
|
Number of Subjects Seroprotected for H5N1 HI Antibodies
A/Indonesia at Day 182
|
29 Participants
|
38 Participants
|
SECONDARY outcome
Timeframe: At Day 0, Day 42 and Day 182Population: 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.
Antibody titers were expressed as Geometric mean titers (GMTs). The H5N1 vaccine strain included A/Indonesia antigen.
Outcome measures
| Measure |
Influenza A (H5N1) 20-40 Years Group
n=50 Participants
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.
|
Influenza A (H5N1) 41-64 Years Group
n=50 Participants
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.
|
|---|---|---|
|
Antibody Titers for Serum Anti-H5N1 Neutralising Antibodies
A/Indonesia at Day 0
|
14.4 Titer
Interval 13.6 to 15.2
|
18.3 Titer
Interval 15.4 to 21.8
|
|
Antibody Titers for Serum Anti-H5N1 Neutralising Antibodies
A/Indonesia at Day 42
|
579.6 Titer
Interval 466.5 to 720.0
|
473.8 Titer
Interval 379.9 to 591.0
|
|
Antibody Titers for Serum Anti-H5N1 Neutralising Antibodies
A/Indonesia at Day 182
|
240.5 Titer
Interval 210.3 to 275.0
|
240.1 Titer
Interval 210.0 to 274.5
|
SECONDARY outcome
Timeframe: At Day 42 and Day 182Population: 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.
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.
Outcome measures
| Measure |
Influenza A (H5N1) 20-40 Years Group
n=50 Participants
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.
|
Influenza A (H5N1) 41-64 Years Group
n=50 Participants
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.
|
|---|---|---|
|
Number of Subjects Seroconverted for Serum Anti-H5N1 Neutralising Antibodies
A/Indonesia at Day 42
|
49 Participants
|
47 Participants
|
|
Number of Subjects Seroconverted for Serum Anti-H5N1 Neutralising Antibodies
A/Indonesia at Day 182
|
48 Participants
|
44 Participants
|
SECONDARY outcome
Timeframe: At Day 0, Day 7 and Day 42Population: Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.
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.
Outcome measures
| Measure |
Influenza A (H5N1) 20-40 Years Group
n=50 Participants
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.
|
Influenza A (H5N1) 41-64 Years Group
n=50 Participants
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.
|
|---|---|---|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
ALT [Unknown] at Day 0
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
ALT [Unknown] at Day 7
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
ALT [Unknown] at Day 42
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
ALT [Below] at Day 0
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
ALT [Below] at Day 7
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
ALT [Below] at Day 42
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
ALT [Within] at Day 0
|
47 Participants
|
46 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
ALT [Within] at Day 7
|
47 Participants
|
45 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
ALT [Within] at Day 42
|
45 Participants
|
46 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
ALT [Above] at Day 0
|
3 Participants
|
4 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
ALT [Above] at Day 7
|
2 Participants
|
5 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
ALT [Above] at Day 42
|
4 Participants
|
4 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
AST [Unknown] at Day 0
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
AST [Unknown] at Day 7
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
AST [Unknown] at Day 42
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
AST [Below] at Day 0
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
AST [Below] at Day 7
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
AST [Below] at Day 42
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
AST [Within] at Day 0
|
49 Participants
|
49 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
AST [Within] at Day 7
|
50 Participants
|
49 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
AST [Within] at Day 42
|
49 Participants
|
50 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
AST [Above] at Day 0
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
AST [Above] at Day 7
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
AST [Above] at Day 42
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
BAS [Unknown] at Day 0
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
BAS [Unknown] at Day 7
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
BAS [Unknown] at Day 42
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
BAS [Below] at Day 0
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
BAS [Below] at Day 7
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
BAS [Below] at Day 42
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
BAS [Within] at Day 0
|
50 Participants
|
49 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
BAS [Within] at Day 7
|
50 Participants
|
50 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
BAS [Within] at Day 42
|
50 Participants
|
50 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
BAS [Above] at Day 0
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
BAS [Above] at Day 7
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
BAS [Above] at Day 42
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
BUN [Unknown] at Day 0
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
BUN [Unknown] at Day 7
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
BUN [Unknown] at Day 42
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
BUN [Below] at Day 0
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
BUN [Below] at Day 7
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
BUN [Below] at Day 42
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
BUN [Within] at Day 0
|
50 Participants
|
48 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
BUN [Within] at Day 7
|
50 Participants
|
50 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
BUN [Within] at Day 42
|
49 Participants
|
49 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
BUN [Above] at Day 0
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
BUN [Above] at Day 7
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
BUN [Above] at Day 42
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: At Day 0, Day 7 and Day 42Population: Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.
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.
Outcome measures
| Measure |
Influenza A (H5N1) 20-40 Years Group
n=50 Participants
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.
|
Influenza A (H5N1) 41-64 Years Group
n=50 Participants
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.
|
|---|---|---|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
CREA [Unknown] at Day 0
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
CREA [Unknown] at Day 7
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
CREA [Unknown] at Day 42
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
CREA [Below] at Day 0
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
CREA [Below] at Day 7
|
1 Participants
|
3 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
CREA [Below] at Day 42
|
2 Participants
|
3 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
CREA [Within] at Day 0
|
48 Participants
|
44 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
CREA [Within] at Day 7
|
46 Participants
|
44 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
CREA [Within] at Day 42
|
47 Participants
|
45 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
CREA [Above] at Day 0
|
1 Participants
|
4 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
CREA [Above] at Day 7
|
3 Participants
|
3 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
CREA [Above] at Day 42
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
EOS [Unknown] at Day 0
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
EOS [Unknown] at Day 7
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
EOS [Unknown] at Day 42
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
EOS [Below] at Day 0
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
EOS [Below] at Day 7
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
EOS [Below] at Day 42
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
EOS [Within] at Day 0
|
44 Participants
|
46 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
EOS [Within] at Day 7
|
45 Participants
|
46 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
EOS [Within] at Day 42
|
47 Participants
|
46 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
EOS [Above] at Day 0
|
6 Participants
|
4 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
EOS [Above] at Day 7
|
5 Participants
|
4 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
EOS [Above] at Day 42
|
3 Participants
|
4 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
HB [Unknown] at Day 0
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
HB [Unknown] at Day 7
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
HB [Unknown] at Day 42
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
HB [Below] at Day 0
|
1 Participants
|
4 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
HB [Below] at Day 7
|
1 Participants
|
4 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
HB [Below] at Day 42
|
2 Participants
|
5 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
HB [Within] at Day 0
|
49 Participants
|
45 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
HB [Within] at Day 7
|
49 Participants
|
44 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
HB [Within] at Day 42
|
48 Participants
|
44 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
HB [Above] at Day 0
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
HB [Above] at Day 7
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
HB[Above] at Day 42
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
HC [Unknown] at Day 0
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
HC [Unknown] at Day 7
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
HC[Unknown] at Day 42
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
HC [Below] at Day 0
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
HC [Below] at Day 7
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
HC [Below] at Day 42
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
HC [Within] at Day 0
|
50 Participants
|
45 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
HC [Within] at Day 7
|
50 Participants
|
46 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
HC [Within] at Day 42
|
49 Participants
|
44 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
HC [Above] at Day 0
|
0 Participants
|
4 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
HC [Above] at Day 7
|
0 Participants
|
3 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
HC [Above] at Day 42
|
1 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: At Day 0, Day 7 and Day 42Population: Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.
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.
Outcome measures
| Measure |
Influenza A (H5N1) 20-40 Years Group
n=50 Participants
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.
|
Influenza A (H5N1) 41-64 Years Group
n=50 Participants
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.
|
|---|---|---|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
LYM [Unknown] at Day 0
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
LYM [Unknown] at Day 7
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
LYM [Unknown] at Day 42
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
LYM [Below] at Day 0
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
LYM [Below] at Day 7
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
LYM [Below] at Day 42
|
5 Participants
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
LYM [Within] at Day 0
|
50 Participants
|
48 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
LYM [Within] at Day 7
|
50 Participants
|
49 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
LYM [Within] at Day 42
|
45 Participants
|
49 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
LYM [Above] at Day 0
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
LYM [Above] at Day 7
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
LYM [Above] at Day 42
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
MON [Unknown] at Day 0
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
MON [Unknown] at Day 7
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
MON [Unknown] at Day 42
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
MON [Below] at Day 0
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
MON [Below] at Day 7
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
MON [Below] at Day 42
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
MON [Within] at Day 0
|
50 Participants
|
49 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
MON [Within] at Day 7
|
48 Participants
|
49 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
MON [Within] at Day 42
|
49 Participants
|
50 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
MON [Above] at Day 0
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
MON [Above] at Day 7
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
MON [Above] at Day 42
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
NEU [Unknown] at Day 0
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
NEU [Unknown] at Day 7
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
NEU [Unknown] at Day 42
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
NEU [Below] at Day 0
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
NEU [Below] at Day 7
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
NEU [Below] at Day 42
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
NEU [Within] at Day 0
|
50 Participants
|
48 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
NEU [Within] at Day 7
|
48 Participants
|
48 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
NEU [Within] at Day 42
|
46 Participants
|
49 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
NEU [Above] at Day 0
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
NEU [Above] at Day 7
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
NEU [Above] at Day 42
|
4 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: At Day 0, Day 7 and Day 42Population: Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.
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.
Outcome measures
| Measure |
Influenza A (H5N1) 20-40 Years Group
n=50 Participants
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.
|
Influenza A (H5N1) 41-64 Years Group
n=50 Participants
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.
|
|---|---|---|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
PLA [Unknown] at Day 0
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
PLA [Unknown] at Day 7
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
PLA [Unknown] at Day 42
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
PLA [Below] at Day 0
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
PLA [Below] at Day 7
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
PLA [Below] at Day 42
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
PLA [Within] at Day 0
|
50 Participants
|
48 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
PLA [Within] at Day 7
|
50 Participants
|
48 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
PLA [Within] at Day 42
|
50 Participants
|
50 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
PLA [Above] at Day 0
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
PLA [Above] at Day 7
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
PLA [Above] at Day 42
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
RBC [Unknown] at Day 0
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
RBC [Unknown] at Day 7
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
RBC[Unknown] at Day 42
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
RBC [Below] at Day 0
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
RBC [Below] at Day 7
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
RBC [Below] at Day 42
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
RBC [Within] at Day 0
|
48 Participants
|
47 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
RBC [Within] at Day 7
|
48 Participants
|
46 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
RBC [Within] at Day 42
|
46 Participants
|
48 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
RBC [Above] at Day 0
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
RBC[Above] at Day 7
|
0 Participants
|
3 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
RBC[Above] at Day 42
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
WBC[Unknown] at Day 0
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
WBC [Unknown] at Day 7
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
WBC [Unknown] at Day 42
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
WBC [Below] at Day 0
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
WBC [Below] at Day 7
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
WBC [Below] at Day 42
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
WBC [Within] at Day 0
|
47 Participants
|
46 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
WBC [Within] at Day 7
|
49 Participants
|
48 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
WBC [Within] at Day 42
|
47 Participants
|
47 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
WBC [Above] at Day 0
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
WBC [Above] at Day 7
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
WBC [Above] at Day 42
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: At Day 0, Day 7 and Day 42Population: Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.
Urine parameters assessed were blood, glucose, protein and urobilinogen. Categories = negative, positive
Outcome measures
| Measure |
Influenza A (H5N1) 20-40 Years Group
n=50 Participants
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.
|
Influenza A (H5N1) 41-64 Years Group
n=50 Participants
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.
|
|---|---|---|
|
Number of Subjects With Any Normal or Abnormal Urine Values
Blood [Negative] at Day 0
|
48 Participants
|
44 Participants
|
|
Number of Subjects With Any Normal or Abnormal Urine Values
Blood [Positive] at Day 0
|
2 Participants
|
6 Participants
|
|
Number of Subjects With Any Normal or Abnormal Urine Values
Blood [Negative] at Day 7
|
47 Participants
|
43 Participants
|
|
Number of Subjects With Any Normal or Abnormal Urine Values
Blood [Positive] at Day 7
|
3 Participants
|
7 Participants
|
|
Number of Subjects With Any Normal or Abnormal Urine Values
Blood [Negative] at Day 42
|
46 Participants
|
46 Participants
|
|
Number of Subjects With Any Normal or Abnormal Urine Values
Blood [Positive] at Day 42
|
4 Participants
|
4 Participants
|
|
Number of Subjects With Any Normal or Abnormal Urine Values
Glucose [Negative] at Day 0
|
50 Participants
|
49 Participants
|
|
Number of Subjects With Any Normal or Abnormal Urine Values
Glucose [Positive] at Day 0
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any Normal or Abnormal Urine Values
Glucose [Negative] at Day 7
|
50 Participants
|
47 Participants
|
|
Number of Subjects With Any Normal or Abnormal Urine Values
Glucose [Positive] at Day 7
|
0 Participants
|
3 Participants
|
|
Number of Subjects With Any Normal or Abnormal Urine Values
Glucose [Negative] at Day 42
|
50 Participants
|
49 Participants
|
|
Number of Subjects With Any Normal or Abnormal Urine Values
Glucose [Positive] at Day 42
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any Normal or Abnormal Urine Values
Protein [Negative] at Day 0
|
49 Participants
|
50 Participants
|
|
Number of Subjects With Any Normal or Abnormal Urine Values
Protein [Positive] at Day 0
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any Normal or Abnormal Urine Values
Protein [Negative] at Day 7
|
48 Participants
|
50 Participants
|
|
Number of Subjects With Any Normal or Abnormal Urine Values
Protein [Positive] at Day 7
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Any Normal or Abnormal Urine Values
Protein [Negative] at Day 42
|
49 Participants
|
49 Participants
|
|
Number of Subjects With Any Normal or Abnormal Urine Values
Protein [Positive] at Day 42
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any Normal or Abnormal Urine Values
Urobilinogen [Negative] at Day 0
|
47 Participants
|
50 Participants
|
|
Number of Subjects With Any Normal or Abnormal Urine Values
Urobilinogen [Positive] at Day 0
|
3 Participants
|
0 Participants
|
|
Number of Subjects With Any Normal or Abnormal Urine Values
Urobilinogen [Negative] at Day 7
|
49 Participants
|
50 Participants
|
|
Number of Subjects With Any Normal or Abnormal Urine Values
Urobilinogen [Positive] at Day 7
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any Normal or Abnormal Urine Values
Urobilinogen [Negative] at Day 42
|
49 Participants
|
50 Participants
|
|
Number of Subjects With Any Normal or Abnormal Urine Values
Urobilinogen [Positive] at Day 42
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: During the 7-day post vaccination period (Days 0-6) after any vaccinationPopulation: Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.
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).
Outcome measures
| Measure |
Influenza A (H5N1) 20-40 Years Group
n=50 Participants
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.
|
Influenza A (H5N1) 41-64 Years Group
n=50 Participants
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.
|
|---|---|---|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Any Pain
|
49 Participants
|
49 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Any redness
|
12 Participants
|
16 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Grade 3 redness
|
2 Participants
|
2 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Any swelling/induration
|
17 Participants
|
23 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Grade 3 swelling/induration
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: During the 7-day post vaccination period (Days 0-6) after any vaccinationPopulation: Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.
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.
Outcome measures
| Measure |
Influenza A (H5N1) 20-40 Years Group
n=50 Participants
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.
|
Influenza A (H5N1) 41-64 Years Group
n=50 Participants
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.
|
|---|---|---|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any fatigue
|
39 Participants
|
32 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 fatigue
|
3 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related fatigue
|
39 Participants
|
32 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any headache
|
30 Participants
|
21 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 headache
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related headache
|
27 Participants
|
21 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any joint pain
|
16 Participants
|
18 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 joint pain
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related joint pain
|
16 Participants
|
17 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any muscle aches
|
36 Participants
|
34 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 muscle aches
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related muscle aches
|
36 Participants
|
33 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any shivering
|
13 Participants
|
7 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 shivering
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related shivering
|
11 Participants
|
7 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any increase sweating
|
13 Participants
|
8 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 increase sweating
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related increase sweating
|
12 Participants
|
8 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any fever
|
6 Participants
|
5 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 fever
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related fever
|
6 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: During the 21-day (Days 0-20) following vaccinationPopulation: Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.
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.
Outcome measures
| Measure |
Influenza A (H5N1) 20-40 Years Group
n=50 Participants
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.
|
Influenza A (H5N1) 41-64 Years Group
n=50 Participants
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.
|
|---|---|---|
|
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Any unsolicited AE (s)
|
27 Participants
|
24 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Grade 3 unsolicited AE (s)
|
3 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Related unsolicited AE (s)
|
11 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: From Day 0 to Day 83 following vaccinationPopulation: Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.
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.
Outcome measures
| Measure |
Influenza A (H5N1) 20-40 Years Group
n=50 Participants
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.
|
Influenza A (H5N1) 41-64 Years Group
n=50 Participants
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.
|
|---|---|---|
|
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs
Any unsolicited AE (s)
|
33 Participants
|
36 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs
Grade 3 unsolicited AE (s
|
3 Participants
|
2 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs
Related unsolicited AE (s)
|
11 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: During the 182-day (Days 0-181) post-vaccination periodPopulation: Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.
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.
Outcome measures
| Measure |
Influenza A (H5N1) 20-40 Years Group
n=50 Participants
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.
|
Influenza A (H5N1) 41-64 Years Group
n=50 Participants
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.
|
|---|---|---|
|
Number of Subjects Reporting Any Medically-significant Conditions (MSCs)
|
34 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: During the entire study period (Day 0 to Day 181)Population: Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.
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.
Outcome measures
| Measure |
Influenza A (H5N1) 20-40 Years Group
n=50 Participants
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.
|
Influenza A (H5N1) 41-64 Years Group
n=50 Participants
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.
|
|---|---|---|
|
Number of Subjects Reporting Serious Adverse Events (SAEs)
|
0 Participants
|
0 Participants
|
Adverse Events
Influenza A (H5N1) 20-40 Years Group
Serious events: 0 serious events
Other events: 50 other events
Deaths: 0 deaths
Influenza A (H5N1) 41-64 Years Group
Serious events: 0 serious events
Other events: 50 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Influenza A (H5N1) 20-40 Years Group
n=50 participants at risk
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.
|
Influenza A (H5N1) 41-64 Years Group
n=50 participants at risk
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.
|
|---|---|---|
|
General disorders
Pain
|
98.0%
49/50 • 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.
|
98.0%
49/50 • 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.
|
|
General disorders
Redness
|
24.0%
12/50 • 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.
|
32.0%
16/50 • 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.
|
|
General disorders
Swelling/ Induration
|
34.0%
17/50 • 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.
|
46.0%
23/50 • 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.
|
|
General disorders
Fatigue
|
78.0%
39/50 • 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.
|
64.0%
32/50 • 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.
|
|
General disorders
Headache
|
60.0%
30/50 • 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.
|
42.0%
21/50 • 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.
|
|
General disorders
Joint pain
|
32.0%
16/50 • 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.
|
36.0%
18/50 • 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.
|
|
General disorders
Muscle aches
|
72.0%
36/50 • 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.
|
68.0%
34/50 • 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.
|
|
General disorders
Shivering
|
26.0%
13/50 • 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.
|
14.0%
7/50 • 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.
|
|
General disorders
Increase Sweating
|
26.0%
13/50 • 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.
|
16.0%
8/50 • 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.
|
|
General disorders
Fever
|
12.0%
6/50 • 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.
|
10.0%
5/50 • 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.
|
|
General disorders
Injection site pruritus
|
10.0%
5/50 • 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.
|
18.0%
9/50 • 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.
|
|
General disorders
Injection site warmth
|
12.0%
6/50 • 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.
|
16.0%
8/50 • 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.
|
|
Infections and infestations
Nasopharyngitis
|
18.0%
9/50 • 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.
|
16.0%
8/50 • 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.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.0%
3/50 • 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.
|
0.00%
0/50 • 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.
|
|
Nervous system disorders
Headache
|
6.0%
3/50 • 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.
|
12.0%
6/50 • 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.
|
|
Infections and infestations
Bronchitis
|
10.0%
5/50 • 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.
|
2.0%
1/50 • 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.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/50 • 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.
|
6.0%
3/50 • 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.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER