Trial Outcomes & Findings for Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Monovalent Pandemic H5N1 Vaccine in Adults (NCT NCT01416571)
NCT ID: NCT01416571
Last Updated: 2018-09-21
Results Overview
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal HI titer less than (\<) 1:10 and a post-vaccination reciprocal HI titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal HI titer ≥ 1:10 and at least a four-fold increase in post-vaccination reciprocal titer against the vaccine virus.
COMPLETED
PHASE2
78 participants
At Day 42
2018-09-21
Participant Flow
This study was conducted in two phases: the Primary Vaccination Phase (up to Day 84) and the Immunogenicity and Safety follow-up Phase (up to Day 385).
Participant milestones
| Measure |
Influenza A (H5N1) Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
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|---|---|
|
Overall Study
STARTED
|
78
|
|
Overall Study
COMPLETED
|
76
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Influenza A (H5N1) Group
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
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|---|---|
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Overall Study
Lost to Follow-up
|
2
|
Baseline Characteristics
Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Monovalent Pandemic H5N1 Vaccine in Adults
Baseline characteristics by cohort
| Measure |
Influenza A (H5N1) Group
n=78 Participants
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
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|---|---|
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Age, Continuous
|
40.6 Years
STANDARD_DEVIATION 13.05 • n=5 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At Day 42Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who received the study vaccine doses and for whom the assay results for antibodies against vaccine-homologous H5N1 Hemagglutinin (HA) antigen for the blood samples taken at Day 0, and Day 42 were available.
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal HI titer less than (\<) 1:10 and a post-vaccination reciprocal HI titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal HI titer ≥ 1:10 and at least a four-fold increase in post-vaccination reciprocal titer against the vaccine virus.
Outcome measures
| Measure |
Influenza A (H5N1) Group
n=75 Participants
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
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|---|---|
|
Number of Seroconverted Subjects Against the H5N1 Strain of Influenza Disease.
|
72 Participants
|
PRIMARY outcome
Timeframe: At Day 42Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who received the study vaccine doses and for whom the assay results for antibodies against vaccine-homologous H5N1 Hemagglutinin (HA) antigen for the blood samples taken at Day 0, and Day 42 were available.
MGI was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer for the vaccine virus.
Outcome measures
| Measure |
Influenza A (H5N1) Group
n=75 Participants
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
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|---|---|
|
Mean Geometric Increase (MGI) for the H5N1 Strain of Influenza Disease.
|
41.7 ratio
Interval 32.0 to 54.3
|
PRIMARY outcome
Timeframe: At Day 42Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who received the study vaccine doses and for whom the assay results for antibodies against vaccine-homologous H5N1 Hemagglutinin (HA) antigen for the blood samples taken at Day 0, and Day 42 were available.
A seroprotected subject was defined as a vaccinated subject who had H5N1 reciprocal HI titers ≥ 1:40 against the vaccine-homologous virus.
Outcome measures
| Measure |
Influenza A (H5N1) Group
n=75 Participants
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
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|---|---|
|
Number of Seroprotected Subjects Against the H5N1 Strain of Influenza Disease.
|
74 Participants
|
SECONDARY outcome
Timeframe: At Day 0 and Day 42Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who received the study vaccine doses and for whom the assay results for antibodies against vaccine-homologous H5N1 Hemagglutinin (HA) antigen for the blood samples taken at Day 0, and Day 42 were available.
A seropositive subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:10.
Outcome measures
| Measure |
Influenza A (H5N1) Group
n=75 Participants
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
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|---|---|
|
Number of Seropositive Subjects Against the H5N1 Strain of Influenza Disease.
H5N1 at Day 0
|
26 Participants
|
|
Number of Seropositive Subjects Against the H5N1 Strain of Influenza Disease.
H5N1 at Day 42
|
75 Participants
|
SECONDARY outcome
Timeframe: At Day 0 and Day 42Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who received the study vaccine doses and for whom the assay results for antibodies against vaccine-homologous H5N1 Hemagglutinin (HA) antigen for the blood samples taken at Day 0, and Day 42 were available.
Titers are presented as geometric mean titers (GMTs).
Outcome measures
| Measure |
Influenza A (H5N1) Group
n=75 Participants
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
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|---|---|
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Titers for Serum HI Antibodies Against the H5N1 Strain of Influenza Disease.
H5N1 at Day 0
|
7.5 titers
Interval 6.5 to 8.6
|
|
Titers for Serum HI Antibodies Against the H5N1 Strain of Influenza Disease.
H5N1 at Day 42
|
311.3 titers
Interval 249.2 to 389.0
|
SECONDARY outcome
Timeframe: At Day 0 and Day 182Population: The analysis was performed on the According-to-Protocol (ATP) cohort for persistence at Day 182, which included all evaluable subjects who received the study vaccine doses and for whom the assay results for antibodies against the vaccine-homologous H5N1 HA antigen for the blood samples taken at Day 0 and Day 182 were available.
A seropositive subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:10.
Outcome measures
| Measure |
Influenza A (H5N1) Group
n=74 Participants
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
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|---|---|
|
Number of Seropositive Subjects Against the H5N1 Strain of Influenza Disease.
H5N1 at Day 0
|
27 Participants
|
|
Number of Seropositive Subjects Against the H5N1 Strain of Influenza Disease.
H5N1 at Day 182
|
73 Participants
|
SECONDARY outcome
Timeframe: At Day 0 and Day 182Population: The analysis was performed on the According-to-Protocol (ATP) cohort for persistence at Day 182, which included all evaluable subjects who received the study vaccine doses and for whom the assay results for antibodies against the vaccine-homologous H5N1 HA antigen for the blood samples taken at Day 0 and Day 182 were available.
Titers are presented as geometric mean titers (GMTs).
Outcome measures
| Measure |
Influenza A (H5N1) Group
n=74 Participants
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
|
|---|---|
|
Titers for Serum HI Antibodies Against the H5N1 Strain of Influenza Disease.
H5N1 at Day 0
|
7.8 titers
Interval 6.6 to 9.1
|
|
Titers for Serum HI Antibodies Against the H5N1 Strain of Influenza Disease.
H5N1 at Day 182
|
56.3 titers
Interval 47.0 to 67.5
|
SECONDARY outcome
Timeframe: At Day 0 and Day 182Population: The analysis was performed on the According-to-Protocol (ATP) cohort for persistence at Day 182, which included all evaluable subjects who received the study vaccine doses and for whom the assay results for antibodies against the vaccine-homologous H5N1 HA antigen for the blood samples taken at Day 0 and Day 182 were available.
A seroprotected subject was defined as a vaccinated subject who had H5N1 reciprocal HI titers ≥ 1:40 against the vaccine-homologous virus.
Outcome measures
| Measure |
Influenza A (H5N1) Group
n=74 Participants
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
|
|---|---|
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Number of Seroprotected Subjects Against the H5N1 Strain of Influenza Disease.
H5N1 at Day 0
|
3 Participants
|
|
Number of Seroprotected Subjects Against the H5N1 Strain of Influenza Disease.
H5N1 at Day 182
|
56 Participants
|
SECONDARY outcome
Timeframe: At Day 182Population: The analysis was performed on the According-to-Protocol (ATP) cohort for persistence at Day 182, which included all evaluable subjects who received the study vaccine doses and for whom the assay results for antibodies against the vaccine-homologous H5N1 HA antigen for the blood samples taken at Day 0 and Day 182 were available.
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal HI titer \< 1:10 and a post-vaccination reciprocal HI titer (≥) 1:40 or a pre-vaccination reciprocal HI titer ≥ 1:10 and at least a four-fold increase in post-vaccination reciprocal titer against the vaccine virus.
Outcome measures
| Measure |
Influenza A (H5N1) Group
n=73 Participants
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
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|---|---|
|
Number of Seroconverted Subjects Against the H5N1 Strain of Influenza Disease.
|
48 Participants
|
SECONDARY outcome
Timeframe: At Day 182Population: The analysis was performed on the According-to-Protocol (ATP) cohort for persistence at Day 182, which included all evaluable subjects who received the study vaccine doses and for whom the assay results for antibodies against the vaccine-homologous H5N1 HA antigen for the blood samples taken at Day 0 and Day 182 were available.
MGI was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer for the vaccine virus.
Outcome measures
| Measure |
Influenza A (H5N1) Group
n=73 Participants
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
|
|---|---|
|
Mean Geometric Increase (MGI) for the H5N1 Strain of Influenza Disease.
|
7.2 ratio
Interval 5.8 to 9.0
|
SECONDARY outcome
Timeframe: During the 7-day follow-up period (Days 0-6) after any vaccinationPopulation: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination.
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any solicited local symptoms regardless of intensity grade. Grade 3 pain = significant pain at rest; prevented normal activities. Grade 3 Redness/Swelling = Redness/Swelling \>100 millimeters (mm).
Outcome measures
| Measure |
Influenza A (H5N1) Group
n=78 Participants
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
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|---|---|
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Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain
|
71 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness
|
7 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling
|
12 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain
|
6 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling
|
0 Participants
|
SECONDARY outcome
Timeframe: During the 7-day (Days 0-6) post-vaccination period following each dosePopulation: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination, on subjects who experienced the specific symptom.
Assessed solicited local symptoms were pain, redness and swelling. Duration was defined as the number of days with any grade of local symptoms.
Outcome measures
| Measure |
Influenza A (H5N1) Group
n=70 Participants
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
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|---|---|
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Duration of Solicited Local Symptoms After Vaccination.
Swelling, Dose 2
|
1.0 days
Interval 1.0 to 2.0
|
|
Duration of Solicited Local Symptoms After Vaccination.
Pain, Dose 1
|
3.0 days
Interval 2.0 to 4.0
|
|
Duration of Solicited Local Symptoms After Vaccination.
Pain, Dose 2
|
3.0 days
Interval 2.0 to 3.0
|
|
Duration of Solicited Local Symptoms After Vaccination.
Redness, Dose1
|
2.0 days
Interval 1.0 to 2.0
|
|
Duration of Solicited Local Symptoms After Vaccination.
Redness, Dose 2
|
3.0 days
Interval 1.0 to 4.0
|
|
Duration of Solicited Local Symptoms After Vaccination.
Swelling, Dose 1
|
2.0 days
Interval 1.0 to 3.0
|
SECONDARY outcome
Timeframe: During the 7-day follow-up period (Days 0-6) after any vaccinationPopulation: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination.
Assessed solicited general symptoms were fatigue, gastrointestinal, headache, joint pain at other location (joint pain), muscle aches, shivering, sweating and fever. Any = occurrence of any solicited general symptoms regardless of intensity grade or relationship to vaccination. Any fever was defined as axillary temperature ≥ 38 degrees Celsius (°C). Grade 3 = general symptom that prevented normal activities. Grade 3 fever = fever ≥ 39.0°C. Related = general symptom assessed by the investigator as causally related to the vaccination.
Outcome measures
| Measure |
Influenza A (H5N1) Group
n=78 Participants
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
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|---|---|
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Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Headache
|
28 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Headache
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Headache
|
20 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Joint Pain
|
13 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Joint Pain
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Joint Pain
|
13 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Muscle Aches
|
31 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Muscle Aches
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Muscle Aches
|
27 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Shivering
|
10 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Shivering
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Shivering
|
10 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Sweating
|
11 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Sweating
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Sweating
|
8 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fever
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fever
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fever
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fatigue
|
35 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fatigue
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fatigue
|
26 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Gastrointestinal
|
13 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Gastrointestinal
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Gastrointestinal
|
6 Participants
|
SECONDARY outcome
Timeframe: During the 7-day (Days 0-6) post-vaccination period following each dosePopulation: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination, on subjects who experienced the specific symptom.
Assessed solicited general symptoms were fatigue, gastrointestinal, headache, joint pain at other location (joint pain), muscle aches, increased sweating and shivering. Duration was defined as the number of days with any grade of general symptoms.
Outcome measures
| Measure |
Influenza A (H5N1) Group
n=26 Participants
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
|
|---|---|
|
Duration of Solicited General Symptoms After Vaccination.
Fatigue, Dose 1
|
2.0 days
Interval 1.0 to 3.0
|
|
Duration of Solicited General Symptoms After Vaccination.
Fatigue, Dose 2
|
2.0 days
Interval 1.0 to 3.0
|
|
Duration of Solicited General Symptoms After Vaccination.
Gastrointestinal, Dose 1
|
2.0 days
Interval 1.0 to 3.0
|
|
Duration of Solicited General Symptoms After Vaccination.
Gastrointestinal, Dose 2
|
2.0 days
Interval 2.0 to 3.0
|
|
Duration of Solicited General Symptoms After Vaccination.
Headache, Dose 1
|
1.5 days
Interval 1.0 to 2.0
|
|
Duration of Solicited General Symptoms After Vaccination.
Headache, Dose 2
|
1.5 days
Interval 1.0 to 2.0
|
|
Duration of Solicited General Symptoms After Vaccination.
Joint Pain, Dose 1
|
1.5 days
Interval 1.0 to 3.0
|
|
Duration of Solicited General Symptoms After Vaccination.
Joint Pain, Dose 2
|
2.0 days
Interval 1.5 to 3.0
|
|
Duration of Solicited General Symptoms After Vaccination.
Muscle aches, Dose 1
|
2.0 days
Interval 1.0 to 3.0
|
|
Duration of Solicited General Symptoms After Vaccination.
Muscle aches, Dose 2
|
2.0 days
Interval 1.0 to 2.5
|
|
Duration of Solicited General Symptoms After Vaccination.
Increased sweating, Dose 1
|
2.0 days
Interval 1.0 to 3.0
|
|
Duration of Solicited General Symptoms After Vaccination.
Increased sweating, Dose 2
|
2.5 days
Interval 1.0 to 3.0
|
|
Duration of Solicited General Symptoms After Vaccination.
Shivering, Dose 1
|
2.0 days
Interval 1.0 to 3.0
|
|
Duration of Solicited General Symptoms After Vaccination.
Shivering, Dose 2
|
1.0 days
Interval 1.0 to 1.0
|
SECONDARY outcome
Timeframe: From Day 0 to Day 84Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination.
MAE was defined as any unsolicited symptom that received medical attention such as hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any = occurrence of any MAEs regardless of intensity grade or relationship to vaccination. Grade 3 = event which prevented normal activities Related = event assessed by the investigator as causally related to the study vaccination.
Outcome measures
| Measure |
Influenza A (H5N1) Group
n=78 Participants
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
|
|---|---|
|
Number of Subjects With Any, Grade 3 and Related Medically Attended Adverse Events (MAEs).
Any MAEs
|
20 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Medically Attended Adverse Events (MAEs).
Grade 3 MAEs
|
6 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Medically Attended Adverse Events (MAEs).
Related MAEs
|
0 Participants
|
SECONDARY outcome
Timeframe: From Day 0 to Day 385Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination.
MAE was defined as any unsolicited symptom that received medical attention such as hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel for any reason. Any = occurrence of any MAEs regardless of intensity grade or relationship to vaccination. Grade 3 = event which prevented normal activities. Related = event assessed by the investigator as causally related to the study vaccination.
Outcome measures
| Measure |
Influenza A (H5N1) Group
n=78 Participants
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
|
|---|---|
|
Number of Subjects With Any, Grade 3 and Related Medically Attended Adverse Events (MAEs).
Any MAEs
|
49 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Medically Attended Adverse Events (MAEs).
Grade 3 MAEs
|
9 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Medically Attended Adverse Events (MAEs).
Related MAEs
|
0 Participants
|
SECONDARY outcome
Timeframe: From Day 0 to Day 84 and from Day 0 to Day 385Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination.
pIMDs are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune aetiology.
Outcome measures
| Measure |
Influenza A (H5N1) Group
n=78 Participants
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
|
|---|---|
|
Number of Subjects With Potential Immune Mediated Disease (s) (pIMDs).
pIMD(s), Day 0 to Day 84
|
0 Participants
|
|
Number of Subjects With Potential Immune Mediated Disease (s) (pIMDs).
pIMD(s), Day 0 to Day 385
|
0 Participants
|
SECONDARY outcome
Timeframe: At Day 0 and Day 42Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination.
Assessed biochemical and haematological parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), basophils (BAS), blood urea nitrogen (BUN), creatinine (CREA), eosinophils (EOS), haematocrit (HCRIT), haemoglobin (HBIN), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC), total bilirubin (Total BIR), bilirubin conjugated/direct (BIL con/dir). Per parameter, it was assessed whether subjects had laboratory values unknown, below, within or above the normal ranges. This outcome presents BAS, EOS and HCRIT results.
Outcome measures
| Measure |
Influenza A (H5N1) Group
n=78 Participants
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
|
|---|---|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
BAS, unknown, Day 0
|
1 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
BAS, unknown, Day 42
|
1 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
BAS, below, Day 0
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
BAS, below, Day 42
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
BAS, within, Day 0
|
77 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
BAS, within, Day 42
|
76 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
BAS, above, Day 0
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
BAS, above, Day 42
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
EOS, unknown, Day 0
|
1 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
EOS, unknown, Day 42
|
1 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
EOS, below, Day 0
|
23 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
EOS, below, Day 42
|
12 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
EOS, within, Day 0
|
53 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
EOS, within, Day 42
|
64 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
EOS, above, Day 0
|
1 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
EOS, above, Day 42
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
HCRIT, unknown, Day 0
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
HCRIT, unknown, Day 42
|
1 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
HCRIT, below, Day 0
|
2 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
HCRIT, below, Day 42
|
5 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
HCRIT, within, Day 0
|
68 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
HCRIT, within, Day 42
|
66 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
HCRIT, above, Day 0
|
8 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
HCRIT, above, Day 42
|
5 Participants
|
SECONDARY outcome
Timeframe: At Day 0 and Day 42Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination.
Assessed biochemical and haematological parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), basophils (BAS), blood urea nitrogen (BUN), creatinine (CREA), eosinophils (EOS), haematocrit (HCRIT), haemoglobin (HBIN), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC), total bilirubin (Total BIR), bilirubin conjugated/direct (BIL con/dir). Per parameter, it was assessed whether subjects had laboratory values unknown, below, within or above the normal ranges. This outcome presents HBIN, LYM and MON results.
Outcome measures
| Measure |
Influenza A (H5N1) Group
n=78 Participants
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
|
|---|---|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
HBIN, unknown, Day 0
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
HBIN, unknown, Day 42
|
1 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
HBIN, below, Day 0
|
7 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
HBIN, below, Day 42
|
6 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
HBIN, within, Day 0
|
68 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
HBIN, within, Day 42
|
68 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
HBIN, above, Day 0
|
3 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
HBIN, above, Day 42
|
2 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
LYM, unknown, Day 0
|
1 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
LYM, unknown, Day 42
|
1 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
LYM, below, Day 0
|
2 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
LYM, below, Day 42
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
LYM, within, Day 0
|
75 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
LYM, within, Day 42
|
76 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
LYM, above, Day 0
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
LYM, above, Day 42
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
MON, unknown, Day 0
|
1 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
MON, unknown, Day 42
|
1 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
MON, below, Day 0
|
46 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
MON, below, Day 42
|
9 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
MON, within, Day 0
|
31 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
MON, within, Day 42
|
67 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
MON, above, Day 0
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
MON, above, Day 42
|
0 Participants
|
SECONDARY outcome
Timeframe: At Day 0 and Day 42Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination.
Assessed biochemical and haematological parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), basophils (BAS), blood urea nitrogen (BUN), creatinine (CREA), eosinophils (EOS), haematocrit (HCRIT), haemoglobin (HBIN), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC), total bilirubin (Total BIR), bilirubin conjugated/direct (BIL con/dir). Per parameter, it was assessed whether subjects had laboratory values unknown, below, within or above the normal ranges. This outcome presents NEU, PLA and RBC results.
Outcome measures
| Measure |
Influenza A (H5N1) Group
n=78 Participants
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
|
|---|---|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
NEU, unknown, Day 0
|
1 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
NEU, unknown, Day 42
|
1 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
NEU, below, Day 0
|
2 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
NEU, below, Day 42
|
1 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
NEU, within, Day 0
|
71 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
NEU, within, Day 42
|
75 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
NEU, above, Day 0
|
4 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
NEU, above, Day 42
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
PLA, unknown, Day 0
|
3 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
PLA, unknown, Day 42
|
2 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
PLA, below, Day 0
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
PLA, below, Day 42
|
1 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
PLA, within, Day 0
|
74 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
PLA, within, Day 42
|
74 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
PLA, above, Day 0
|
1 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
PLA, above, Day 42
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
RBC, unknown, Day 0
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
RBC, unknown, Day 42
|
1 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
RBC, below, Day 0
|
5 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
RBC, below, Day 42
|
3 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
RBC, within, Day 0
|
72 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
RBC, within, Day 42
|
72 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
RBC, above, Day 0
|
1 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
RBC, above, Day 42
|
1 Participants
|
SECONDARY outcome
Timeframe: At Day 0 and Day 42Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination.
Assessed biochemical and haematological parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), basophils (BAS), blood urea nitrogen (BUN), creatinine (CREA), eosinophils (EOS), haematocrit (HCRIT), haemoglobin (HBIN), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC), total bilirubin (Total BIR), bilirubin conjugated/direct (BIL con/dir). Per parameter, it was assessed whether subjects had laboratory values unknown, below, within or above the normal ranges. This outcome presents WBC, ALT and AST results.
Outcome measures
| Measure |
Influenza A (H5N1) Group
n=78 Participants
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
|
|---|---|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
WBC, unknown, Day 0
|
1 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
WBC, unknown, Day 42
|
1 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
WBC, below, Day 0
|
2 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
WBC, below, Day 42
|
2 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
WBC, within, Day 0
|
72 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
WBC, within, Day 42
|
74 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
WBC, above, Day 0
|
3 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
WBC, above, Day 42
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
ALT, unknown, Day 0
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
ALT, unknown, Day 42
|
2 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
ALT, below, Day 0
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
ALT, below, Day 42
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
ALT, within, Day 0
|
76 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
ALT, within, Day 42
|
73 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
ALT, above, Day 0
|
2 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
ALT, above, Day 42
|
2 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
AST, unknown, Day 0
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
AST, unknown, Day 42
|
2 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
AST, below, Day 0
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
AST, below, Day 42
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
AST, within, Day 0
|
78 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
AST, within, Day 42
|
74 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
AST, above, Day 0
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
AST, above, Day 42
|
1 Participants
|
SECONDARY outcome
Timeframe: At Day 0 and Day 42Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination.
Assessed biochemical and haematological parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), basophils (BAS), blood urea nitrogen (BUN), creatinine (CREA), eosinophils (EOS), haematocrit (HCRIT), haemoglobin (HBIN), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC), total bilirubin (Total BIL), bilirubin conjugated/direct (BIL con/dir). Per parameter, it was assessed whether subjects had laboratory values unknown, below, within or above the normal ranges. This outcome presents Total BIL, BIL con/dir, CREA and BUN results.
Outcome measures
| Measure |
Influenza A (H5N1) Group
n=78 Participants
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
|
|---|---|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
Total BIL, unknown, Day 0
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
Total BIL, unknown, Day 42
|
2 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
Total BIL, below, Day 0
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
Total BIL, below, Day 42
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
Total BIL, within, Day 0
|
76 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
Total BIL, within, Day 42
|
74 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
Total BIL, above, Day 0
|
2 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
Total BIL, above, Day 42
|
1 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
BIL con/dir, unknown, Day 0
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
BIL con/dir, unknown, Day 42
|
2 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
BIL con/dir, below, Day 0
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
BIL con/dir, below, Day 42
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
BIL con/dir, within, Day 0
|
78 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
BIL con/dir, within, Day 42
|
75 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
BIL con/dir, above, Day 0
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
BIL con/dir, above, Day 42
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
CREA, unknown, Day 0
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
CREA, unknown, Day 42
|
2 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
CREA, below, Day 0
|
5 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
CREA, below, Day 42
|
5 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
CREA, within, Day 0
|
73 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
CREA, within, Day 42
|
68 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
CREA, above, Day 0
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
CREA, above, Day 42
|
2 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
BUN, unknown, Day 0
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
BUN, unknown, Day 42
|
2 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
BUN, below, Day 0
|
1 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
BUN, below, Day 42
|
0 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
BUN, within, Day 0
|
76 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
BUN, within, Day 42
|
74 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
BUN, above, Day 0
|
1 Participants
|
|
Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
BUN, above, Day 42
|
1 Participants
|
SECONDARY outcome
Timeframe: From Day 0 to Day 20 and from Day 0 to Day 84.Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination.
An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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 = occurrence of an unsolicited AE regardless of intensity grade or relationship to vaccination. Grade 3 = event which prevented normal activities. Related = event assessed by the investigator as causally related to the study vaccination.
Outcome measures
| Measure |
Influenza A (H5N1) Group
n=78 Participants
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
|
|---|---|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Any unsolicited AEs [Days 0-20]
|
38 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Grade 3 unsolicited AEs [Days 0-20]
|
5 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Related unsolicited AEs [Days 0-20]
|
7 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Any unsolicited AEs [Days 0-84]
|
46 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Grade 3 unsolicited AEs [Days 0-84]
|
7 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Related unsolicited AEs [Days 0-84]
|
7 Participants
|
SECONDARY outcome
Timeframe: From Day 0 to Day 84 and from Day 0 to Day 385Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination.
A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or resulted in a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
Outcome measures
| Measure |
Influenza A (H5N1) Group
n=78 Participants
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
|
|---|---|
|
Number of Subjects With Any and Related Serious Adverse Events (SAEs)
Any SAEs [Days 0-84]
|
2 Participants
|
|
Number of Subjects With Any and Related Serious Adverse Events (SAEs)
Any SAEs [Days 0-385]
|
3 Participants
|
|
Number of Subjects With Any and Related Serious Adverse Events (SAEs)
Related SAEs [Days 0-84]
|
0 Participants
|
|
Number of Subjects With Any and Related Serious Adverse Events (SAEs)
Related SAEs [Days 0-385]
|
0 Participants
|
Adverse Events
Influenza A (H5N1) Group
Serious adverse events
| Measure |
Influenza A (H5N1) Group
n=78 participants at risk
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
|
|---|---|
|
General disorders
Hernia obstructive
|
1.3%
1/78 • Solicited local and general symptoms: Within the 7-day period after primary vaccination. Unsolicited AEs: From Day 0 to Day 84. SAEs: from Day 0 to Day 385.
|
|
Infections and infestations
Pneumonia
|
1.3%
1/78 • Solicited local and general symptoms: Within the 7-day period after primary vaccination. Unsolicited AEs: From Day 0 to Day 84. SAEs: from Day 0 to Day 385.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
1.3%
1/78 • Solicited local and general symptoms: Within the 7-day period after primary vaccination. Unsolicited AEs: From Day 0 to Day 84. SAEs: from Day 0 to Day 385.
|
Other adverse events
| Measure |
Influenza A (H5N1) Group
n=78 participants at risk
Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
|
|---|---|
|
General disorders
Pain
|
91.0%
71/78 • Solicited local and general symptoms: Within the 7-day period after primary vaccination. Unsolicited AEs: From Day 0 to Day 84. SAEs: from Day 0 to Day 385.
|
|
General disorders
Redness
|
9.0%
7/78 • Solicited local and general symptoms: Within the 7-day period after primary vaccination. Unsolicited AEs: From Day 0 to Day 84. SAEs: from Day 0 to Day 385.
|
|
General disorders
Swelling
|
15.4%
12/78 • Solicited local and general symptoms: Within the 7-day period after primary vaccination. Unsolicited AEs: From Day 0 to Day 84. SAEs: from Day 0 to Day 385.
|
|
General disorders
Fatigue
|
44.9%
35/78 • Solicited local and general symptoms: Within the 7-day period after primary vaccination. Unsolicited AEs: From Day 0 to Day 84. SAEs: from Day 0 to Day 385.
|
|
General disorders
Gastrointestinal
|
16.7%
13/78 • Solicited local and general symptoms: Within the 7-day period after primary vaccination. Unsolicited AEs: From Day 0 to Day 84. SAEs: from Day 0 to Day 385.
|
|
General disorders
Headache
|
35.9%
28/78 • Solicited local and general symptoms: Within the 7-day period after primary vaccination. Unsolicited AEs: From Day 0 to Day 84. SAEs: from Day 0 to Day 385.
|
|
General disorders
Joint pain
|
16.7%
13/78 • Solicited local and general symptoms: Within the 7-day period after primary vaccination. Unsolicited AEs: From Day 0 to Day 84. SAEs: from Day 0 to Day 385.
|
|
General disorders
Muscle aches
|
39.7%
31/78 • Solicited local and general symptoms: Within the 7-day period after primary vaccination. Unsolicited AEs: From Day 0 to Day 84. SAEs: from Day 0 to Day 385.
|
|
General disorders
Shivering
|
12.8%
10/78 • Solicited local and general symptoms: Within the 7-day period after primary vaccination. Unsolicited AEs: From Day 0 to Day 84. SAEs: from Day 0 to Day 385.
|
|
General disorders
Sweating
|
14.1%
11/78 • Solicited local and general symptoms: Within the 7-day period after primary vaccination. Unsolicited AEs: From Day 0 to Day 84. SAEs: from Day 0 to Day 385.
|
|
Infections and infestations
Nasopharyngitis
|
12.8%
10/78 • Solicited local and general symptoms: Within the 7-day period after primary vaccination. Unsolicited AEs: From Day 0 to Day 84. SAEs: from Day 0 to Day 385.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.4%
5/78 • Solicited local and general symptoms: Within the 7-day period after primary vaccination. Unsolicited AEs: From Day 0 to Day 84. SAEs: from Day 0 to Day 385.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.1%
4/78 • Solicited local and general symptoms: Within the 7-day period after primary vaccination. Unsolicited AEs: From Day 0 to Day 84. SAEs: from Day 0 to Day 385.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.1%
4/78 • Solicited local and general symptoms: Within the 7-day period after primary vaccination. Unsolicited AEs: From Day 0 to Day 84. SAEs: from Day 0 to Day 385.
|
Additional Information
GSK Response Center
GlaxoSmithKline
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