Trial Outcomes & Findings for Safety and Tolerability Study of GlaxoSmithKline (GSK)1557484A Vaccine in Adults at Occupational Risk for Influenza A (H5N1) Exposure (NCT NCT01788228)
NCT ID: NCT01788228
Last Updated: 2020-06-23
Results Overview
Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as significant pain at rest that prevented normal everyday activities. Grade 3 redness and swelling was greater than 100 millimeters (mm) i.e. \>100mm.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
50 participants
Primary outcome timeframe
During a 7-day follow-up period (Days 0-6) after each vaccination
Results posted on
2020-06-23
Participant Flow
Participant milestones
| Measure |
Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group
Subjects 18-64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
|
Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group
Subjects \>64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
|
|---|---|---|
|
Overall Study
STARTED
|
49
|
1
|
|
Overall Study
COMPLETED
|
48
|
1
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group
Subjects 18-64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
|
Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group
Subjects \>64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
|
|---|---|---|
|
Overall Study
Migrated/moved from study area
|
1
|
0
|
Baseline Characteristics
Safety and Tolerability Study of GlaxoSmithKline (GSK)1557484A Vaccine in Adults at Occupational Risk for Influenza A (H5N1) Exposure
Baseline characteristics by cohort
| Measure |
Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group
n=49 Participants
Subjects 18-64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
|
Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group
n=1 Participants
Subjects \>64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.5 Years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
85.0 Years
n=7 Participants
|
43.35 Years
STANDARD_DEVIATION 12.18 • n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: During a 7-day follow-up period (Days 0-6) after each vaccinationPopulation: Analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.
Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as significant pain at rest that prevented normal everyday activities. Grade 3 redness and swelling was greater than 100 millimeters (mm) i.e. \>100mm.
Outcome measures
| Measure |
Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group
n=49 Participants
Subjects 18-64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
|
Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group
n=1 Participants
Subjects \>64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
|
Influenza A (H5N1) Virus Monovalent Vaccine Group
n=50 Participants
Subjects ≥18 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the nondominant armat Day 0 and dominant arm at Day 21.
|
|---|---|---|---|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Overall and by Age Category (18-64 and >64 Years of Age).
Any Pain
|
45 Participants
|
1 Participants
|
46 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Overall and by Age Category (18-64 and >64 Years of Age).
Grade 3 Pain
|
4 Participants
|
0 Participants
|
4 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Overall and by Age Category (18-64 and >64 Years of Age).
Any Redness
|
6 Participants
|
0 Participants
|
6 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Overall and by Age Category (18-64 and >64 Years of Age).
Grade 3 Redness
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Overall and by Age Category (18-64 and >64 Years of Age).
Any Swelling
|
7 Participants
|
0 Participants
|
7 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Overall and by Age Category (18-64 and >64 Years of Age).
Grade 3 Swelling
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: During a 7-day follow-up period (Days 0-6) after each vaccinationPopulation: Analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.
Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache, joint pain, muscle ache, shivering, sweating and fever \[oral temperature above 38.0 degrees Celsius (°C)\]. Gastrointestinal symptoms included nausea, vomiting, diarrhea and/or abdominal pain. Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = axillary temperature ≥ 39.0°C and ≤40°C.
Outcome measures
| Measure |
Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group
n=49 Participants
Subjects 18-64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
|
Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group
n=1 Participants
Subjects \>64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
|
Influenza A (H5N1) Virus Monovalent Vaccine Group
n=50 Participants
Subjects ≥18 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the nondominant armat Day 0 and dominant arm at Day 21.
|
|---|---|---|---|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Overall and by Age Category (18-64 and >64 Years of Age).
Grade 3 Shivering
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Overall and by Age Category (18-64 and >64 Years of Age).
Any Fatigue
|
27 Participants
|
0 Participants
|
27 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Overall and by Age Category (18-64 and >64 Years of Age).
Grade 3 Fatigue
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Overall and by Age Category (18-64 and >64 Years of Age).
Related Fatigue
|
26 Participants
|
0 Participants
|
26 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Overall and by Age Category (18-64 and >64 Years of Age).
Related Shivering
|
8 Participants
|
0 Participants
|
8 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Overall and by Age Category (18-64 and >64 Years of Age).
Any Sweating
|
7 Participants
|
0 Participants
|
7 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Overall and by Age Category (18-64 and >64 Years of Age).
Grade 3 Sweating
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Overall and by Age Category (18-64 and >64 Years of Age).
Related Sweating
|
5 Participants
|
0 Participants
|
5 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Overall and by Age Category (18-64 and >64 Years of Age).
Any Fever (≥38°C)
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Overall and by Age Category (18-64 and >64 Years of Age).
Grade 3 Fever (≥39°C and ≤40°C)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Overall and by Age Category (18-64 and >64 Years of Age).
Related Fever
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Overall and by Age Category (18-64 and >64 Years of Age).
Any Gastrointestinal symptoms
|
12 Participants
|
0 Participants
|
12 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Overall and by Age Category (18-64 and >64 Years of Age).
Grade 3 Gastrointestinal symptoms
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Overall and by Age Category (18-64 and >64 Years of Age).
Related Gastrointestinal symptoms
|
8 Participants
|
0 Participants
|
8 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Overall and by Age Category (18-64 and >64 Years of Age).
Any Headache
|
20 Participants
|
0 Participants
|
20 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Overall and by Age Category (18-64 and >64 Years of Age).
Grade 3 Headache
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Overall and by Age Category (18-64 and >64 Years of Age).
Related Headache
|
17 Participants
|
0 Participants
|
17 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Overall and by Age Category (18-64 and >64 Years of Age).
Any Joint pain
|
14 Participants
|
0 Participants
|
14 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Overall and by Age Category (18-64 and >64 Years of Age).
Grade 3 Joint pain
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Overall and by Age Category (18-64 and >64 Years of Age).
Related Joint pain
|
13 Participants
|
0 Participants
|
13 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Overall and by Age Category (18-64 and >64 Years of Age).
Any Muscle ache
|
33 Participants
|
0 Participants
|
33 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Overall and by Age Category (18-64 and >64 Years of Age).
Grade 3 Muscle ache
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Overall and by Age Category (18-64 and >64 Years of Age).
Related Muscle ache
|
31 Participants
|
0 Participants
|
31 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Overall and by Age Category (18-64 and >64 Years of Age).
Any Shivering
|
10 Participants
|
0 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: During the 21-day (Days 0-20 post dose 1 and Days 21-41 post dose 2) post-vaccination periodPopulation: Analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.
Unsolicited AE covers 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 symptom regardless of intensity grade or relation to vaccination. Related was defined as an unsolicited symptom assessed as causally related to the study vaccination.
Outcome measures
| Measure |
Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group
n=49 Participants
Subjects 18-64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
|
Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group
n=1 Participants
Subjects \>64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
|
Influenza A (H5N1) Virus Monovalent Vaccine Group
n=50 Participants
Subjects ≥18 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the nondominant armat Day 0 and dominant arm at Day 21.
|
|---|---|---|---|
|
Number of Subjects Reporting Any Unsolicited AEs, Overall and by Age Category (18-64 and >64 Years of Age)
Any unsolicited AEs
|
10 Participants
|
0 Participants
|
10 Participants
|
|
Number of Subjects Reporting Any Unsolicited AEs, Overall and by Age Category (18-64 and >64 Years of Age)
Related unsolicited AEs
|
4 Participants
|
0 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: During the entire study period (Day 0 to Day 385)Population: Analysis was performed on the Total Vaccinated cohort included all vaccinated subjects for whom safety data were available.
MAEs refer to events that required medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Related = symptom assessed by the investigator as causally related to the study vaccination.
Outcome measures
| Measure |
Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group
n=49 Participants
Subjects 18-64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
|
Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group
n=1 Participants
Subjects \>64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
|
Influenza A (H5N1) Virus Monovalent Vaccine Group
Subjects ≥18 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the nondominant armat Day 0 and dominant arm at Day 21.
|
|---|---|---|---|
|
Number of Subjects Reporting Any or Related Medically Attended Adverse Events (MAEs)
Any MAEs
|
9 Participants
|
0 Participants
|
—
|
|
Number of Subjects Reporting Any or Related Medically Attended Adverse Events (MAEs)
Related MAEs
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: During the entire study period (Day 0 to Day 385)Population: Analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.
Potential immune-mediated diseases (pIMDs) were defined as a subset of adverse events (AEs) that included autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. Any was defined as occurrence of any pIMD regardless of intensity grade or relation to vaccination. Related was defined as pIMD(s) considered by the investigator to have a causal relationship to vaccination.
Outcome measures
| Measure |
Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group
n=49 Participants
Subjects 18-64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
|
Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group
n=1 Participants
Subjects \>64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
|
Influenza A (H5N1) Virus Monovalent Vaccine Group
Subjects ≥18 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the nondominant armat Day 0 and dominant arm at Day 21.
|
|---|---|---|---|
|
Number of Subjects Reporting Any and Related Potential Immune-Mediated Diseases (pIMDs)
Related pIMDs
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects Reporting Any and Related Potential Immune-Mediated Diseases (pIMDs)
Any pIMDs
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: During the entire study period (Day 0 to Day 385)Population: Analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.
A serious adverse event was any untoward medical occurrence that: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was 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) Virus Monovalent Vaccine 18-64 Years Group
n=49 Participants
Subjects 18-64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
|
Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group
n=1 Participants
Subjects \>64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
|
Influenza A (H5N1) Virus Monovalent Vaccine Group
Subjects ≥18 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the nondominant armat Day 0 and dominant arm at Day 21.
|
|---|---|---|---|
|
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
Any SAEs
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
Related SAEs
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: During the entire study period (Day 0 to Day 385)Population: Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom safety data were available.
Any = Occurrence of any adverse pregnancy outcomes regardless of intensity grade or relation to study vaccination. Related = Adverse pregnancy outcomes assessed by the investigator as causally related to the study vaccination
Outcome measures
| Measure |
Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group
n=49 Participants
Subjects 18-64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
|
Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group
n=1 Participants
Subjects \>64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
|
Influenza A (H5N1) Virus Monovalent Vaccine Group
Subjects ≥18 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the nondominant armat Day 0 and dominant arm at Day 21.
|
|---|---|---|---|
|
Number of Subjects With Reported Adverse Pregnancy Outcomes
Any adverse pregnancy outcome(s)
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Reported Adverse Pregnancy Outcomes
Related adverse pregnancy outcomes
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 0 (baseline) and at each day from Day 1 to Day 7 post first vaccine dosePopulation: Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects. Only the subjects with available score test results were included.
The assessed parameters for change from baseline were Physical functioning (PF), Physical-health related role limitations (RP), Bodily pain (BP), General health (GH), Vitality (VT), Social functioning (SF), Emotional health related role limitations (RE), Mental health (MH) defined as subscale component, and physical (PCS) and mental (MCS) component defined as summary components, and Quality Adjusted Life Years (QALY). See methodology details in outcome 11 description. For all subscale components, scores range from 0 to 100, with high scores indicating high levels of functioning/quality of life. Subscale component scores are averaged to compute the summary component score and QALY score. Median and range of the change from baseline of the SF-36v2 score are presented for each component and time point. Analyses by age category were not performed for the daily SF-36v2 questionnaire results.
Outcome measures
| Measure |
Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group
n=49 Participants
Subjects 18-64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
|
Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group
Subjects \>64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
|
Influenza A (H5N1) Virus Monovalent Vaccine Group
Subjects ≥18 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the nondominant armat Day 0 and dominant arm at Day 21.
|
|---|---|---|---|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores
PF : Day 1
|
0.0000 SF-36 daily score
Interval -17.35 to 28.92
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores
RP : Day 1
|
0.0000 SF-36 daily score
Interval -17.61 to 8.81
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores
BP : Day 1
|
0.0000 SF-36 daily score
Interval -30.79 to 10.26
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores
GH : Day 1
|
-1.3200 SF-36 daily score
Interval -16.77 to 8.82
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores
VT : Day 1
|
0.0000 SF-36 daily score
Interval -21.77 to 21.77
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores
SF : Day 1
|
0.0000 SF-36 daily score
Interval -19.77 to 14.82
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores
RE : Day 1
|
0.0000 SF-36 daily score
Interval -7.64 to 11.45
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores
MH : Day 1
|
0.0000 SF-36 daily score
Interval -22.3 to 14.87
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores
PCS : Day 1
|
-1.0300 SF-36 daily score
Interval -22.52 to 14.89
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores
MCS : Day 1
|
0.0400 SF-36 daily score
Interval -14.85 to 10.79
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores
QALY score : Day 1
|
0.0000 SF-36 daily score
Interval -0.266 to 0.22
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores
PF : Day 2
|
0.0000 SF-36 daily score
Interval -19.28 to 28.92
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores
RP : Day 2
|
0.0000 SF-36 daily score
Interval -26.42 to 8.81
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores
BP : Day 2
|
0.0000 SF-36 daily score
Interval -23.29 to 10.26
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores
GH : Day 2
|
0.0000 SF-36 daily score
Interval -12.36 to 8.82
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores
VT : Day 2
|
0.0000 SF-36 daily score
Interval -21.77 to 21.77
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores
SF : Day 2
|
0.0000 SF-36 daily score
Interval -29.66 to 14.82
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores
RE : Day 2
|
0.0000 SF-36 daily score
Interval -22.9 to 11.45
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores
MH : Day 2
|
0.0000 SF-36 daily score
Interval -32.21 to 9.91
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores
PCS : Day 2
|
-0.5100 SF-36 daily score
Interval -22.31 to 14.74
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores
MCS : Day 2
|
0.4700 SF-36 daily score
Interval -19.35 to 7.32
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores
QALY score : Day 2
|
0.0000 SF-36 daily score
Interval -0.357 to 0.255
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores
PF : Day 3
|
0.0000 SF-36 daily score
Interval -34.71 to 28.92
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores
RP : Day 3
|
0.0000 SF-36 daily score
Interval -30.82 to 8.81
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores
BP : Day 3
|
0.0000 SF-36 daily score
Interval -30.79 to 15.0
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores
GH : Day 3
|
0.0000 SF-36 daily score
Interval -13.24 to 8.82
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores
VT : Day 3
|
0.0000 SF-36 daily score
Interval -19.06 to 13.61
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores
SF : Day 3
|
0.0000 SF-36 daily score
Interval -29.66 to 19.76
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores
RE : Day 3
|
0.0000 SF-36 daily score
Interval -7.64 to 11.45
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores
MH : Day 3
|
0.0000 SF-36 daily score
Interval -9.91 to 7.43
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores
PCS : Day 3
|
0.0800 SF-36 daily score
Interval -38.64 to 13.33
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores
MCS : Day 3
|
0.6200 SF-36 daily score
Interval -9.17 to 9.72
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores
QALY score : Day 3
|
0.0000 SF-36 daily score
Interval -0.403 to 0.249
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores
PF : Day 4
|
0.0000 SF-36 daily score
Interval -34.71 to 28.92
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores
RP : Day 4
|
0.0000 SF-36 daily score
Interval -35.23 to 8.81
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores
BP : Day 4
|
0.0000 SF-36 daily score
Interval -30.79 to 11.05
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores
GH : Day 4
|
0.0000 SF-36 daily score
Interval -13.24 to 8.82
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores
VT : Day 4
|
0.0000 SF-36 daily score
Interval -21.77 to 21.77
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores
SF : Day 4
|
0.0000 SF-36 daily score
Interval -29.66 to 19.76
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores
RE : Day 4
|
0.0000 SF-36 daily score
Interval -30.54 to 11.45
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores
MH : Day 4
|
0.0000 SF-36 daily score
Interval -12.39 to 7.43
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores
PCS : Day 4
|
0.0000 SF-36 daily score
Interval -33.62 to 14.04
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores
MCS : Day 4
|
0.0750 SF-36 daily score
Interval -13.22 to 9.72
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores
QALY score : Day 4
|
0.0000 SF-36 daily score
Interval -0.403 to 0.291
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores
PF : Day 5
|
0.0000 SF-36 daily score
Interval -34.71 to 28.92
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores
RP : Day 5
|
0.0000 SF-36 daily score
Interval -33.03 to 8.81
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores
BP : Day 5
|
0.0000 SF-36 daily score
Interval -30.79 to 15.0
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores
GH : Day 5
|
0.0000 SF-36 daily score
Interval -17.64 to 8.82
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores
VT : Day 5
|
0.0000 SF-36 daily score
Interval -21.77 to 21.77
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores
SF : Day 5
|
0.0000 SF-36 daily score
Interval -24.71 to 19.76
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores
RE : Day 5
|
0.0000 SF-36 daily score
Interval -38.17 to 11.45
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores
MH : Day 5
|
0.0000 SF-36 daily score
Interval -14.86 to 12.39
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores
PCS : Day 5
|
0.0700 SF-36 daily score
Interval -31.26 to 14.04
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores
MCS : Day 5
|
0.6000 SF-36 daily score
Interval -14.2 to 14.05
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores
QALY score : Day 5
|
0.0000 SF-36 daily score
Interval -0.39 to 0.291
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores
PF : Day 6
|
0.0000 SF-36 daily score
Interval -21.21 to 28.92
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores
RP : Day 6
|
0.0000 SF-36 daily score
Interval -17.61 to 8.81
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores
BP : Day 6
|
0.0000 SF-36 daily score
Interval -23.29 to 15.0
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores
GH : Day 6
|
0.0000 SF-36 daily score
Interval -12.36 to 8.82
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores
VT : Day 6
|
0.0000 SF-36 daily score
Interval -24.49 to 21.77
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores
SF : Day 6
|
0.0000 SF-36 daily score
Interval -9.89 to 19.76
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores
RE : Day 6
|
0.0000 SF-36 daily score
Interval -19.09 to 11.45
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores
MH : Day 6
|
0.0000 SF-36 daily score
Interval -12.39 to 7.43
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores
PCS : Day 6
|
0.0800 SF-36 daily score
Interval -20.59 to 14.04
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores
MCS : Day 6
|
0.4000 SF-36 daily score
Interval -8.06 to 9.72
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores
QALY score : Day 6
|
0.0000 SF-36 daily score
Interval -0.342 to 0.291
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores
PF : Day 7
|
0.0000 SF-36 daily score
Interval -7.71 to 28.92
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores
RP : Day 7
|
0.0000 SF-36 daily score
Interval -19.82 to 8.81
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores
BP : Day 7
|
0.0000 SF-36 daily score
Interval -15.0 to 19.34
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores
GH : Day 7
|
0.0000 SF-36 daily score
Interval -11.03 to 8.82
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores
VT : Day 7
|
0.0000 SF-36 daily score
Interval -24.49 to 10.89
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores
SF : Day 7
|
0.0000 SF-36 daily score
Interval -4.95 to 24.71
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores
RE : Day 7
|
0.0000 SF-36 daily score
Interval -15.27 to 11.45
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores
MH : Day 7
|
0.0000 SF-36 daily score
Interval -19.82 to 7.43
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores
PCS : Day 7
|
0.1150 SF-36 daily score
Interval -13.39 to 14.04
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores
MCS : Day 7
|
0.3850 SF-36 daily score
Interval -9.22 to 9.7
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores
QALY score : Day 7
|
0.0000 SF-36 daily score
Interval -0.223 to 0.291
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 0 (baseline) and at Days 7 and 21 QoL evaluation (post dose 1) and Day 28 QoL evaluation (post dose 2)Population: Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects. Only the subjects with available score test results were included.
The assessed parameters for change from baseline were Physical functioning (PF), Physical-health related role limitations (RP), Bodily pain (BP), General health (GH), Vitality (VT), Social functioning (SF), Emotional health related role limitations (RE), Mental health (MH) defined as subscale component. For all subscale components, scores range from 0 to 100, with high scores indicating high levels of functioning/quality of life. Median and range of the change from baseline of the SF-36 score are presented for each component and time point. Analysis was carried out for all subjects regardless of age stratum.
Outcome measures
| Measure |
Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group
n=50 Participants
Subjects 18-64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
|
Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group
Subjects \>64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
|
Influenza A (H5N1) Virus Monovalent Vaccine Group
Subjects ≥18 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the nondominant armat Day 0 and dominant arm at Day 21.
|
|---|---|---|---|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Weekly Health 8-score
PF : Day 7
|
0.000 SF-36 Weekly score
Interval -1.93 to 28.92
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Weekly Health 8-score
PF : Day 21
|
0.000 SF-36 Weekly score
Interval -7.71 to 28.92
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Weekly Health 8-score
PF : Day 28
|
0.000 SF-36 Weekly score
Interval -5.78 to 28.92
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Weekly Health 8-score
RP: Day 7
|
0.000 SF-36 Weekly score
Interval -17.61 to 8.81
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Weekly Health 8-score
RP: Day 21
|
0.000 SF-36 Weekly score
Interval -15.41 to 8.81
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Weekly Health 8-score
RP: Day 28
|
0.000 SF-36 Weekly score
Interval -17.61 to 8.81
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Weekly Health 8-score
BP: Day 7
|
0.000 SF-36 Weekly score
Interval -26.85 to 19.34
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Weekly Health 8-score
BP: Day 21
|
0.000 SF-36 Weekly score
Interval -15.0 to 23.29
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Weekly Health 8-score
BP: Day 28
|
0.000 SF-36 Weekly score
Interval -11.05 to 15.0
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Weekly Health 8-score
GH: Day 7
|
0.000 SF-36 Weekly score
Interval -9.93 to 7.5
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Weekly Health 8-score
GH: Day 21
|
0.000 SF-36 Weekly score
Interval -15.44 to 7.5
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Weekly Health 8-score
GH: Day 28
|
0.000 SF-36 Weekly score
Interval -15.44 to 8.82
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Weekly Health 8-score
VT: Day 7
|
0.000 SF-36 Weekly score
Interval -21.77 to 19.05
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Weekly Health 8-score
VT: Day 21
|
2.720 SF-36 Weekly score
Interval -10.89 to 13.61
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Weekly Health 8-score
VT: Day 28
|
0.000 SF-36 Weekly score
Interval -13.61 to 16.33
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Weekly Health 8-score
SF: Day 7
|
0.000 SF-36 Weekly score
Interval -19.77 to 14.83
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Weekly Health 8-score
SF: Day 21
|
0.000 SF-36 Weekly score
Interval -9.89 to 9.89
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Weekly Health 8-score
SF: Day 28
|
0.000 SF-36 Weekly score
Interval -19.77 to 14.83
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Weekly Health 8-score
RE: Day 7
|
0.000 SF-36 Weekly score
Interval -22.9 to 11.45
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Weekly Health 8-score
RE: Day 21
|
0.000 SF-36 Weekly score
Interval -22.9 to 11.45
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Weekly Health 8-score
RE: Day 28
|
0.000 SF-36 Weekly score
Interval -11.45 to 11.45
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Weekly Health 8-score
MH: Day 7
|
0.000 SF-36 Weekly score
Interval -14.87 to 7.43
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Weekly Health 8-score
MH: Day 21
|
0.000 SF-36 Weekly score
Interval -9.91 to 7.44
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Weekly Health 8-score
MH: Day 28
|
0.000 SF-36 Weekly score
Interval -17.35 to 7.44
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 0 (baseline) and at Days 7 and 21 QoL evaluation (post dose 1) and Day 28 QoL evaluation (post dose 2)Population: Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects. Only the subjects with available score test results were included.
The assessed parameters for change from baseline were physical and mental component defined as summary components (PCS and MCS) or general health scores (GHS). For all subscale component, scores range from 0 to 100, with high scores indicating high levels of functioning/quality of life. Subscale component scores are averaged to compute the summary component score. Median and range of the change from baseline of the SF-36v2 score are presented for each summary component and time point. Analysis was carried out for all subjects regardless of age stratum.
Outcome measures
| Measure |
Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group
n=49 Participants
Subjects 18-64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
|
Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group
Subjects \>64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
|
Influenza A (H5N1) Virus Monovalent Vaccine Group
Subjects ≥18 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the nondominant armat Day 0 and dominant arm at Day 21.
|
|---|---|---|---|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Weekly Questionnaire General Health Scores (Physical and Mental)
PCS, Day 7
|
0.000 SF-36 weekly score
Interval -11.19 to 13.58
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Weekly Questionnaire General Health Scores (Physical and Mental)
PCS, Day 21
|
0.180 SF-36 weekly score
Interval -11.32 to 13.58
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Weekly Questionnaire General Health Scores (Physical and Mental)
PCS, Day 28
|
-0.290 SF-36 weekly score
Interval -6.36 to 13.58
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Weekly Questionnaire General Health Scores (Physical and Mental)
MCS, Day 7
|
0.420 SF-36 weekly score
Interval -11.08 to 11.83
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Weekly Questionnaire General Health Scores (Physical and Mental)
MCS, Day 21
|
0.095 SF-36 weekly score
Interval -5.1 to 7.33
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Weekly Questionnaire General Health Scores (Physical and Mental)
MCS, Day 28
|
0.000 SF-36 weekly score
Interval -7.29 to 11.83
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 0 (baseline) and at Days 7 and 21 QoL evaluation (post dose 1) and Day 28 QoL evaluation (post dose 2)Population: Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects. Only the subjects with available score test results were included.
The assessed parameters for change from baseline were QALY scores. The methodology used for the analysis of the SF-36v2 questionnaire was detailed in Ware et al \[Ware 2008\]. The QualityMetric Health Outcomes Scoring Software was used to generate a Quality of Life analysis dataset based on the SF-36 questionnaire. QoL data were transformed to generate Quality-Adjusted Life Years (QALY) scores. A standard algorithm was developed for processing subjects' answers and producing QALY scores. For all subscale components, scores range from 0 to 100, with high scores indicating high levels of functioning/quality of life. Median and range of the change from baseline of the SF-36v2 score are presented for each time point. Analysis was carried out for all subjects regardless of age stratum.
Outcome measures
| Measure |
Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group
n=48 Participants
Subjects 18-64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
|
Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group
Subjects \>64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
|
Influenza A (H5N1) Virus Monovalent Vaccine Group
Subjects ≥18 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the nondominant armat Day 0 and dominant arm at Day 21.
|
|---|---|---|---|
|
Assessment of Changes From Baseline (Day 0) for Quality Adjusted Life Years (QALY) Weekly Scores
QALY score : Day 7
|
0.000 SF-36 Weekly score
Interval -0.25 to 0.33
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) for Quality Adjusted Life Years (QALY) Weekly Scores
QALY score : Day 21
|
0.000 SF-36 Weekly score
Interval -0.25 to 0.33
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) for Quality Adjusted Life Years (QALY) Weekly Scores
QALY score : Day 28
|
0.000 SF-36 Weekly score
Interval -0.19 to 0.33
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 0 (baseline) and at each day from Day 1 to Day 7 post first vaccine dosePopulation: Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects who reported at least one local or general solicited AE post first vaccination. Only the subjects with available score test results were included.
The assessed parameters for change from baseline were Physical functioning (PF), Physical-health related role limitations (RP), Bodily pain (BP), General health (GH), Vitality (VT), Social functioning (SF), Emotional health related role limitations (RE), Mental health (MH) defined as subscale component, and physical (PCS) and mental (MCS) component defined as summary components, and Quality Adjusted Life Years (QALY). For all subscale component, scores range from 0 to 100, with high scores indicating high levels of functioning/quality of life. Subscale component scores are averaged to compute the summary component score and QALY score. Median and range of the change from baseline of the SF-36v2 score are presented for each component and time point. Analyses by age category were not performed for the daily SF-36v2 questionnaire results.
Outcome measures
| Measure |
Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group
n=47 Participants
Subjects 18-64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
|
Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group
Subjects \>64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
|
Influenza A (H5N1) Virus Monovalent Vaccine Group
Subjects ≥18 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the nondominant armat Day 0 and dominant arm at Day 21.
|
|---|---|---|---|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores for Subjects Who Reported at Least One Local or General Solicited AE Post First Vaccination.
PF : Day 1
|
0.0000 SF-36 daily score
Interval -17.35 to 28.92
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores for Subjects Who Reported at Least One Local or General Solicited AE Post First Vaccination.
RP : Day 1
|
0.0000 SF-36 daily score
Interval -17.61 to 8.81
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores for Subjects Who Reported at Least One Local or General Solicited AE Post First Vaccination.
BP : Day 1
|
-0.7900 SF-36 daily score
Interval -30.79 to 8.68
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores for Subjects Who Reported at Least One Local or General Solicited AE Post First Vaccination.
GH : Day 1
|
-1.3200 SF-36 daily score
Interval -16.77 to 8.82
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores for Subjects Who Reported at Least One Local or General Solicited AE Post First Vaccination.
VT : Day 1
|
0.0000 SF-36 daily score
Interval -21.77 to 21.77
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores for Subjects Who Reported at Least One Local or General Solicited AE Post First Vaccination.
SF : Day 1
|
0.0000 SF-36 daily score
Interval -19.77 to 14.82
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores for Subjects Who Reported at Least One Local or General Solicited AE Post First Vaccination.
RE : Day 1
|
0.0000 SF-36 daily score
Interval -7.64 to 11.45
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores for Subjects Who Reported at Least One Local or General Solicited AE Post First Vaccination.
MH : Day 1
|
0.0000 SF-36 daily score
Interval -22.3 to 14.87
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores for Subjects Who Reported at Least One Local or General Solicited AE Post First Vaccination.
PCS : Day 1
|
-1.1000 SF-36 daily score
Interval -22.52 to 14.89
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores for Subjects Who Reported at Least One Local or General Solicited AE Post First Vaccination.
MCS : Day 1
|
0.0400 SF-36 daily score
Interval -14.85 to 10.79
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores for Subjects Who Reported at Least One Local or General Solicited AE Post First Vaccination.
QALY score : Day 1
|
0.0000 SF-36 daily score
Interval -0.266 to 0.22
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores for Subjects Who Reported at Least One Local or General Solicited AE Post First Vaccination.
PF : Day 2
|
0.0000 SF-36 daily score
Interval -19.28 to 28.92
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores for Subjects Who Reported at Least One Local or General Solicited AE Post First Vaccination.
RP : Day 2
|
0.0000 SF-36 daily score
Interval -26.42 to 8.81
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores for Subjects Who Reported at Least One Local or General Solicited AE Post First Vaccination.
BP : Day 2
|
0.0000 SF-36 daily score
Interval -23.29 to 10.26
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores for Subjects Who Reported at Least One Local or General Solicited AE Post First Vaccination.
GH : Day 2
|
0.0000 SF-36 daily score
Interval -12.36 to 8.82
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores for Subjects Who Reported at Least One Local or General Solicited AE Post First Vaccination.
VT : Day 2
|
0.0000 SF-36 daily score
Interval -21.77 to 21.77
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores for Subjects Who Reported at Least One Local or General Solicited AE Post First Vaccination.
SF : Day 2
|
0.0000 SF-36 daily score
Interval -29.66 to 14.82
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores for Subjects Who Reported at Least One Local or General Solicited AE Post First Vaccination.
RE : Day 2
|
0.0000 SF-36 daily score
Interval -22.9 to 11.45
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores for Subjects Who Reported at Least One Local or General Solicited AE Post First Vaccination.
MH : Day 2
|
0.0000 SF-36 daily score
Interval -32.21 to 4.96
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores for Subjects Who Reported at Least One Local or General Solicited AE Post First Vaccination.
PCS : Day 2
|
-0.5500 SF-36 daily score
Interval -22.31 to 14.74
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores for Subjects Who Reported at Least One Local or General Solicited AE Post First Vaccination.
MCS : Day 2
|
0.3950 SF-36 daily score
Interval -19.35 to 7.32
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores for Subjects Who Reported at Least One Local or General Solicited AE Post First Vaccination.
QALY score : Day 2
|
0.0000 SF-36 daily score
Interval -0.357 to 0.255
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores for Subjects Who Reported at Least One Local or General Solicited AE Post First Vaccination.
PF : Day 3
|
0.0000 SF-36 daily score
Interval -34.71 to 28.92
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores for Subjects Who Reported at Least One Local or General Solicited AE Post First Vaccination.
RP : Day 3
|
0.0000 SF-36 daily score
Interval -30.82 to 8.81
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores for Subjects Who Reported at Least One Local or General Solicited AE Post First Vaccination.
BP : Day 3
|
0.0000 SF-36 daily score
Interval -30.79 to 15.0
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores for Subjects Who Reported at Least One Local or General Solicited AE Post First Vaccination.
GH : Day 3
|
0.0000 SF-36 daily score
Interval -13.24 to 8.82
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores for Subjects Who Reported at Least One Local or General Solicited AE Post First Vaccination.
VT : Day 3
|
0.0000 SF-36 daily score
Interval -19.06 to 13.61
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores for Subjects Who Reported at Least One Local or General Solicited AE Post First Vaccination.
SF : Day 3
|
0.0000 SF-36 daily score
Interval -29.66 to 19.76
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores for Subjects Who Reported at Least One Local or General Solicited AE Post First Vaccination.
RE : Day 3
|
0.0000 SF-36 daily score
Interval -7.64 to 11.45
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores for Subjects Who Reported at Least One Local or General Solicited AE Post First Vaccination.
MH : Day 3
|
0.0000 SF-36 daily score
Interval -9.91 to 7.43
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores for Subjects Who Reported at Least One Local or General Solicited AE Post First Vaccination.
PCS : Day 3
|
0.0800 SF-36 daily score
Interval -38.64 to 13.33
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores for Subjects Who Reported at Least One Local or General Solicited AE Post First Vaccination.
MCS : Day 3
|
0.6000 SF-36 daily score
Interval -9.17 to 9.72
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores for Subjects Who Reported at Least One Local or General Solicited AE Post First Vaccination.
QALY score : Day 3
|
0.0000 SF-36 daily score
Interval -0.403 to 0.249
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores for Subjects Who Reported at Least One Local or General Solicited AE Post First Vaccination.
PF : Day 4
|
0.0000 SF-36 daily score
Interval -34.71 to 28.92
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores for Subjects Who Reported at Least One Local or General Solicited AE Post First Vaccination.
RP : Day 4
|
0.0000 SF-36 daily score
Interval -35.23 to 8.81
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores for Subjects Who Reported at Least One Local or General Solicited AE Post First Vaccination.
BP : Day 4
|
0.0000 SF-36 daily score
Interval -30.79 to 11.05
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores for Subjects Who Reported at Least One Local or General Solicited AE Post First Vaccination.
GH : Day 4
|
0.0000 SF-36 daily score
Interval -13.24 to 8.82
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores for Subjects Who Reported at Least One Local or General Solicited AE Post First Vaccination.
VT : Day 4
|
0.0000 SF-36 daily score
Interval -21.77 to 21.77
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores for Subjects Who Reported at Least One Local or General Solicited AE Post First Vaccination.
SF : Day 4
|
0.0000 SF-36 daily score
Interval -29.66 to 19.76
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores for Subjects Who Reported at Least One Local or General Solicited AE Post First Vaccination.
RE : Day 4
|
0.0000 SF-36 daily score
Interval -30.54 to 11.45
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores for Subjects Who Reported at Least One Local or General Solicited AE Post First Vaccination.
MH : Day 4
|
0.0000 SF-36 daily score
Interval -12.39 to 7.43
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores for Subjects Who Reported at Least One Local or General Solicited AE Post First Vaccination.
PCS : Day 4
|
0.0350 SF-36 daily score
Interval -33.62 to 14.04
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores for Subjects Who Reported at Least One Local or General Solicited AE Post First Vaccination.
MCS : Day 4
|
0.0600 SF-36 daily score
Interval -13.22 to 9.72
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores for Subjects Who Reported at Least One Local or General Solicited AE Post First Vaccination.
QALY score : Day 4
|
0.0000 SF-36 daily score
Interval -0.403 to 0.291
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores for Subjects Who Reported at Least One Local or General Solicited AE Post First Vaccination.
PF : Day 5
|
0.0000 SF-36 daily score
Interval -34.71 to 28.92
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores for Subjects Who Reported at Least One Local or General Solicited AE Post First Vaccination.
RP : Day 5
|
0.0000 SF-36 daily score
Interval -33.03 to 8.81
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores for Subjects Who Reported at Least One Local or General Solicited AE Post First Vaccination.
BP : Day 5
|
0.0000 SF-36 daily score
Interval -30.79 to 15.0
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores for Subjects Who Reported at Least One Local or General Solicited AE Post First Vaccination.
GH : Day 5
|
0.0000 SF-36 daily score
Interval -17.64 to 8.82
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores for Subjects Who Reported at Least One Local or General Solicited AE Post First Vaccination.
VT : Day 5
|
0.0000 SF-36 daily score
Interval -21.77 to 21.77
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores for Subjects Who Reported at Least One Local or General Solicited AE Post First Vaccination.
SF : Day 5
|
0.0000 SF-36 daily score
Interval -24.71 to 19.76
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores for Subjects Who Reported at Least One Local or General Solicited AE Post First Vaccination.
RE : Day 5
|
0.0000 SF-36 daily score
Interval -38.17 to 11.45
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores for Subjects Who Reported at Least One Local or General Solicited AE Post First Vaccination.
MH : Day 5
|
0.0000 SF-36 daily score
Interval -14.86 to 12.39
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores for Subjects Who Reported at Least One Local or General Solicited AE Post First Vaccination.
PCS : Day 5
|
0.0700 SF-36 daily score
Interval -31.26 to 14.04
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores for Subjects Who Reported at Least One Local or General Solicited AE Post First Vaccination.
MCS : Day 5
|
0.3800 SF-36 daily score
Interval -14.2 to 14.05
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores for Subjects Who Reported at Least One Local or General Solicited AE Post First Vaccination.
QALY score : Day 5
|
0.0000 SF-36 daily score
Interval -0.39 to 0.291
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores for Subjects Who Reported at Least One Local or General Solicited AE Post First Vaccination.
PF : Day 6
|
0.0000 SF-36 daily score
Interval -21.21 to 28.92
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores for Subjects Who Reported at Least One Local or General Solicited AE Post First Vaccination.
RP : Day 6
|
0.0000 SF-36 daily score
Interval -17.61 to 8.81
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores for Subjects Who Reported at Least One Local or General Solicited AE Post First Vaccination.
BP : Day 6
|
0.0000 SF-36 daily score
Interval -23.29 to 15.0
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores for Subjects Who Reported at Least One Local or General Solicited AE Post First Vaccination.
GH : Day 6
|
0.0000 SF-36 daily score
Interval -12.36 to 8.82
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores for Subjects Who Reported at Least One Local or General Solicited AE Post First Vaccination.
VT : Day 6
|
0.0000 SF-36 daily score
Interval -24.49 to 21.77
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores for Subjects Who Reported at Least One Local or General Solicited AE Post First Vaccination.
SF : Day 6
|
0.0000 SF-36 daily score
Interval -9.89 to 19.76
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores for Subjects Who Reported at Least One Local or General Solicited AE Post First Vaccination.
RE : Day 6
|
0.0000 SF-36 daily score
Interval -19.09 to 11.45
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores for Subjects Who Reported at Least One Local or General Solicited AE Post First Vaccination.
MH : Day 6
|
0.0000 SF-36 daily score
Interval -12.39 to 7.43
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores for Subjects Who Reported at Least One Local or General Solicited AE Post First Vaccination.
PCS : Day 6
|
0.0800 SF-36 daily score
Interval -20.59 to 14.04
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores for Subjects Who Reported at Least One Local or General Solicited AE Post First Vaccination.
MCS : Day 6
|
0.0700 SF-36 daily score
Interval -8.06 to 9.72
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores for Subjects Who Reported at Least One Local or General Solicited AE Post First Vaccination.
QALY score : Day 6
|
0.0000 SF-36 daily score
Interval -0.342 to 0.291
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores for Subjects Who Reported at Least One Local or General Solicited AE Post First Vaccination.
PF : Day 7
|
0.0000 SF-36 daily score
Interval -7.71 to 28.92
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores for Subjects Who Reported at Least One Local or General Solicited AE Post First Vaccination.
RP : Day 7
|
0.0000 SF-36 daily score
Interval -19.82 to 8.81
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores for Subjects Who Reported at Least One Local or General Solicited AE Post First Vaccination.
BP : Day 7
|
0.0000 SF-36 daily score
Interval -15.0 to 19.34
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores for Subjects Who Reported at Least One Local or General Solicited AE Post First Vaccination.
GH : Day 7
|
0.0000 SF-36 daily score
Interval -11.02 to 8.82
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores for Subjects Who Reported at Least One Local or General Solicited AE Post First Vaccination.
VT : Day 7
|
0.0000 SF-36 daily score
Interval -24.49 to 10.89
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores for Subjects Who Reported at Least One Local or General Solicited AE Post First Vaccination.
SF : Day 7
|
0.0000 SF-36 daily score
Interval -4.95 to 24.71
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores for Subjects Who Reported at Least One Local or General Solicited AE Post First Vaccination.
RE : Day 7
|
0.0000 SF-36 daily score
Interval -15.27 to 11.45
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores for Subjects Who Reported at Least One Local or General Solicited AE Post First Vaccination.
MH : Day 7
|
0.0000 SF-36 daily score
Interval -19.82 to 7.43
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores for Subjects Who Reported at Least One Local or General Solicited AE Post First Vaccination.
PCS : Day 7
|
0.1150 SF-36 daily score
Interval -13.39 to 14.04
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores for Subjects Who Reported at Least One Local or General Solicited AE Post First Vaccination.
MCS : Day 7
|
0.2100 SF-36 daily score
Interval -9.22 to 9.7
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores for Subjects Who Reported at Least One Local or General Solicited AE Post First Vaccination.
QALY score : Day 7
|
0.0000 SF-36 daily score
Interval -0.223 to 0.291
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 0 (baseline) and at Days 7 and 21 QoL evaluation (post dose 1) and Day 28 QoL evaluation (post dose 2)Population: Analysis was performed on the Total Vaccinated cohort (18-64 years of age) which included all vaccinated subjects within 18 to 64 years of age and for whom safety data were available. Only subjects with available score test results were included.
Median and range of the change from baseline of the SF-36v2 score are presented for each component and time point. The assessed parameters for change from baseline were Physical functioning (PF), Physical-health related role limitations (RP), Bodily pain (BP), General health (GH), Vitality (VT), Social functioning (SF), Emotional health related role limitations (RE), Mental health (MH) defined as subscale component. For all subscale component, scores range from 0 to 100, with high scores indicating high levels of functioning/quality of life. There was only 1 study participant \> 64 years of age and that experienced no grade 3 solicited symptoms. Hence, weekly questionnaire was assessed only on the 18-64 age category subjects.
Outcome measures
| Measure |
Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group
n=49 Participants
Subjects 18-64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
|
Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group
Subjects \>64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
|
Influenza A (H5N1) Virus Monovalent Vaccine Group
Subjects ≥18 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the nondominant armat Day 0 and dominant arm at Day 21.
|
|---|---|---|---|
|
Assessment of Changes From Baseline (Day 0) for the SF-36v2 Weekly Health 8-score for All Subjects Who Did and Who Did Not Report Any Grade 3 Solicited Symptoms Post Vaccination.
PF, Grade 3 AE, Day 7
|
0.000 SF-36 Weekly score
Interval 0.0 to 0.0
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) for the SF-36v2 Weekly Health 8-score for All Subjects Who Did and Who Did Not Report Any Grade 3 Solicited Symptoms Post Vaccination.
PF, Grade 3 AE, Day 21
|
0.000 SF-36 Weekly score
Interval 0.0 to 0.0
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) for the SF-36v2 Weekly Health 8-score for All Subjects Who Did and Who Did Not Report Any Grade 3 Solicited Symptoms Post Vaccination.
PF, Grade 3 AE, Day 28
|
0.000 SF-36 Weekly score
Interval -5.78 to 0.0
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) for the SF-36v2 Weekly Health 8-score for All Subjects Who Did and Who Did Not Report Any Grade 3 Solicited Symptoms Post Vaccination.
RP, Grade 3 AE, Day 7
|
0.000 SF-36 Weekly score
Interval -17.61 to 0.0
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) for the SF-36v2 Weekly Health 8-score for All Subjects Who Did and Who Did Not Report Any Grade 3 Solicited Symptoms Post Vaccination.
RP, Grade 3 AE, Day 21
|
0.000 SF-36 Weekly score
Interval 0.0 to 0.0
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) for the SF-36v2 Weekly Health 8-score for All Subjects Who Did and Who Did Not Report Any Grade 3 Solicited Symptoms Post Vaccination.
RP, Grade 3 AE, Day 28
|
0.000 SF-36 Weekly score
Interval -15.41 to 0.0
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) for the SF-36v2 Weekly Health 8-score for All Subjects Who Did and Who Did Not Report Any Grade 3 Solicited Symptoms Post Vaccination.
BP, Grade 3 AE, Day 7
|
0.000 SF-36 Weekly score
Interval -10.26 to 8.29
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) for the SF-36v2 Weekly Health 8-score for All Subjects Who Did and Who Did Not Report Any Grade 3 Solicited Symptoms Post Vaccination.
BP, Grade 3 AE, Day 21
|
0.000 SF-36 Weekly score
Interval -10.26 to 23.29
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) for the SF-36v2 Weekly Health 8-score for All Subjects Who Did and Who Did Not Report Any Grade 3 Solicited Symptoms Post Vaccination.
BP, Grade 3 AE, Day 28
|
0.000 SF-36 Weekly score
Interval -6.32 to 6.32
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) for the SF-36v2 Weekly Health 8-score for All Subjects Who Did and Who Did Not Report Any Grade 3 Solicited Symptoms Post Vaccination.
GH, Grade 3 AE, Day 7
|
0.215 SF-36 Weekly score
Interval -2.21 to 7.5
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) for the SF-36v2 Weekly Health 8-score for All Subjects Who Did and Who Did Not Report Any Grade 3 Solicited Symptoms Post Vaccination.
GH, Grade 3 AE, Day 21
|
0.660 SF-36 Weekly score
Interval -2.21 to 7.5
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) for the SF-36v2 Weekly Health 8-score for All Subjects Who Did and Who Did Not Report Any Grade 3 Solicited Symptoms Post Vaccination.
GH, Grade 3 AE, Day 28
|
0.215 SF-36 Weekly score
Interval -2.21 to 8.82
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) for the SF-36v2 Weekly Health 8-score for All Subjects Who Did and Who Did Not Report Any Grade 3 Solicited Symptoms Post Vaccination.
VT, Grade 3 AE, Day 7
|
0.000 SF-36 Weekly score
Interval -9.97 to 5.44
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) for the SF-36v2 Weekly Health 8-score for All Subjects Who Did and Who Did Not Report Any Grade 3 Solicited Symptoms Post Vaccination.
VT, Grade 3 AE, Day 21
|
1.365 SF-36 Weekly score
Interval -5.44 to 5.44
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) for the SF-36v2 Weekly Health 8-score for All Subjects Who Did and Who Did Not Report Any Grade 3 Solicited Symptoms Post Vaccination.
VT, Grade 3 AE, Day 28
|
1.360 SF-36 Weekly score
Interval -2.72 to 5.44
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) for the SF-36v2 Weekly Health 8-score for All Subjects Who Did and Who Did Not Report Any Grade 3 Solicited Symptoms Post Vaccination.
SF, Grade 3 AE, Day 7
|
-4.945 SF-36 Weekly score
Interval -19.77 to 0.0
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) for the SF-36v2 Weekly Health 8-score for All Subjects Who Did and Who Did Not Report Any Grade 3 Solicited Symptoms Post Vaccination.
SF, Grade 3 AE, Day 21
|
0.000 SF-36 Weekly score
Interval -9.89 to 0.0
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) for the SF-36v2 Weekly Health 8-score for All Subjects Who Did and Who Did Not Report Any Grade 3 Solicited Symptoms Post Vaccination.
SF, Grade 3 AE, Day 28
|
0.000 SF-36 Weekly score
Interval -14.83 to 0.0
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) for the SF-36v2 Weekly Health 8-score for All Subjects Who Did and Who Did Not Report Any Grade 3 Solicited Symptoms Post Vaccination.
RE, Grade 3 AE, Day 7
|
0.000 SF-36 Weekly score
Interval -15.27 to 0.0
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) for the SF-36v2 Weekly Health 8-score for All Subjects Who Did and Who Did Not Report Any Grade 3 Solicited Symptoms Post Vaccination.
RE, Grade 3 AE, Day 21
|
0.000 SF-36 Weekly score
Interval 0.0 to 0.0
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) for the SF-36v2 Weekly Health 8-score for All Subjects Who Did and Who Did Not Report Any Grade 3 Solicited Symptoms Post Vaccination.
RE, Grade 3 AE, Day 28
|
0.000 SF-36 Weekly score
Interval -11.45 to 0.0
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) for the SF-36v2 Weekly Health 8-score for All Subjects Who Did and Who Did Not Report Any Grade 3 Solicited Symptoms Post Vaccination.
MH, Grade 3 AE, Day 7
|
1.235 SF-36 Weekly score
Interval -2.48 to 2.47
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) for the SF-36v2 Weekly Health 8-score for All Subjects Who Did and Who Did Not Report Any Grade 3 Solicited Symptoms Post Vaccination.
MH, Grade 3 AE, Day 21
|
1.235 SF-36 Weekly score
Interval -2.48 to 2.47
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) for the SF-36v2 Weekly Health 8-score for All Subjects Who Did and Who Did Not Report Any Grade 3 Solicited Symptoms Post Vaccination.
MH, Grade 3 AE, Day 28
|
1.235 SF-36 Weekly score
Interval -2.48 to 2.47
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) for the SF-36v2 Weekly Health 8-score for All Subjects Who Did and Who Did Not Report Any Grade 3 Solicited Symptoms Post Vaccination.
PF, No Grade 3 AE, Day 7
|
0.000 SF-36 Weekly score
Interval -1.93 to 28.92
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) for the SF-36v2 Weekly Health 8-score for All Subjects Who Did and Who Did Not Report Any Grade 3 Solicited Symptoms Post Vaccination.
PF, No Grade 3 AE, Day 21
|
0.000 SF-36 Weekly score
Interval -7.71 to 28.92
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) for the SF-36v2 Weekly Health 8-score for All Subjects Who Did and Who Did Not Report Any Grade 3 Solicited Symptoms Post Vaccination.
PF, No Grade 3 AE, Day 28
|
0.000 SF-36 Weekly score
Interval -1.93 to 28.92
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) for the SF-36v2 Weekly Health 8-score for All Subjects Who Did and Who Did Not Report Any Grade 3 Solicited Symptoms Post Vaccination.
RP, No Grade 3 AE, Day 7
|
0.000 SF-36 Weekly score
Interval -15.41 to 8.81
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) for the SF-36v2 Weekly Health 8-score for All Subjects Who Did and Who Did Not Report Any Grade 3 Solicited Symptoms Post Vaccination.
RP, No Grade 3 AE, Day 21
|
0.000 SF-36 Weekly score
Interval -15.41 to 8.81
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) for the SF-36v2 Weekly Health 8-score for All Subjects Who Did and Who Did Not Report Any Grade 3 Solicited Symptoms Post Vaccination.
RP, No Grade 3 AE, Day 28
|
0.000 SF-36 Weekly score
Interval -17.61 to 8.81
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) for the SF-36v2 Weekly Health 8-score for All Subjects Who Did and Who Did Not Report Any Grade 3 Solicited Symptoms Post Vaccination.
BP, No Grade 3 AE, Day 7
|
0.000 SF-36 Weekly score
Interval -26.85 to 19.34
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) for the SF-36v2 Weekly Health 8-score for All Subjects Who Did and Who Did Not Report Any Grade 3 Solicited Symptoms Post Vaccination.
BP, No Grade 3 AE, Day 21
|
0.000 SF-36 Weekly score
Interval -15.0 to 15.0
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) for the SF-36v2 Weekly Health 8-score for All Subjects Who Did and Who Did Not Report Any Grade 3 Solicited Symptoms Post Vaccination.
BP, No Grade 3 AE, Day 28
|
0.000 SF-36 Weekly score
Interval -11.05 to 15.0
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) for the SF-36v2 Weekly Health 8-score for All Subjects Who Did and Who Did Not Report Any Grade 3 Solicited Symptoms Post Vaccination.
GH, No Grade 3 AE, Day 7
|
0.000 SF-36 Weekly score
Interval -9.93 to 6.61
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) for the SF-36v2 Weekly Health 8-score for All Subjects Who Did and Who Did Not Report Any Grade 3 Solicited Symptoms Post Vaccination.
GH, No Grade 3 AE, Day 21
|
0.000 SF-36 Weekly score
Interval -15.44 to 6.61
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) for the SF-36v2 Weekly Health 8-score for All Subjects Who Did and Who Did Not Report Any Grade 3 Solicited Symptoms Post Vaccination.
GH, No Grade 3 AE, Day 28
|
0.000 SF-36 Weekly score
Interval -15.44 to 6.62
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) for the SF-36v2 Weekly Health 8-score for All Subjects Who Did and Who Did Not Report Any Grade 3 Solicited Symptoms Post Vaccination.
VT, No Grade 3 AE, Day 7
|
0.000 SF-36 Weekly score
Interval -21.77 to 19.05
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) for the SF-36v2 Weekly Health 8-score for All Subjects Who Did and Who Did Not Report Any Grade 3 Solicited Symptoms Post Vaccination.
VT, No Grade 3 AE, Day 21
|
2.720 SF-36 Weekly score
Interval -10.89 to 13.61
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) for the SF-36v2 Weekly Health 8-score for All Subjects Who Did and Who Did Not Report Any Grade 3 Solicited Symptoms Post Vaccination.
VT, No Grade 3 AE, Day 28
|
0.000 SF-36 Weekly score
Interval -13.61 to 16.33
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) for the SF-36v2 Weekly Health 8-score for All Subjects Who Did and Who Did Not Report Any Grade 3 Solicited Symptoms Post Vaccination.
SF, No Grade 3 AE, Day 7
|
0.000 SF-36 Weekly score
Interval -19.77 to 14.83
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) for the SF-36v2 Weekly Health 8-score for All Subjects Who Did and Who Did Not Report Any Grade 3 Solicited Symptoms Post Vaccination.
SF, No Grade 3 AE, Day 21
|
0.000 SF-36 Weekly score
Interval -9.89 to 9.89
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) for the SF-36v2 Weekly Health 8-score for All Subjects Who Did and Who Did Not Report Any Grade 3 Solicited Symptoms Post Vaccination.
SF, No Grade 3 AE, Day 28
|
0.000 SF-36 Weekly score
Interval -19.77 to 14.83
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) for the SF-36v2 Weekly Health 8-score for All Subjects Who Did and Who Did Not Report Any Grade 3 Solicited Symptoms Post Vaccination.
RE, No Grade 3 AE, Day 7
|
0.000 SF-36 Weekly score
Interval -22.9 to 11.45
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) for the SF-36v2 Weekly Health 8-score for All Subjects Who Did and Who Did Not Report Any Grade 3 Solicited Symptoms Post Vaccination.
RE, No Grade 3 AE, Day 21
|
0.000 SF-36 Weekly score
Interval -22.9 to 11.45
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) for the SF-36v2 Weekly Health 8-score for All Subjects Who Did and Who Did Not Report Any Grade 3 Solicited Symptoms Post Vaccination.
RE, No Grade 3 AE, Day 28
|
0.000 SF-36 Weekly score
Interval -7.64 to 11.45
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) for the SF-36v2 Weekly Health 8-score for All Subjects Who Did and Who Did Not Report Any Grade 3 Solicited Symptoms Post Vaccination.
MH, No Grade 3 AE, Day 7
|
0.000 SF-36 Weekly score
Interval -14.87 to 7.43
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) for the SF-36v2 Weekly Health 8-score for All Subjects Who Did and Who Did Not Report Any Grade 3 Solicited Symptoms Post Vaccination.
MH, No Grade 3 AE, Day 21
|
0.000 SF-36 Weekly score
Interval -9.91 to 7.44
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) for the SF-36v2 Weekly Health 8-score for All Subjects Who Did and Who Did Not Report Any Grade 3 Solicited Symptoms Post Vaccination.
MH, No Grade 3 AE, Day 28
|
0.000 SF-36 Weekly score
Interval -17.35 to 7.44
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 0 (baseline) and at Days 7 and 21 QoL evaluation (post dose 1) and Day 28 QoL evaluation (post dose 2)Population: Analysis was performed on the Total Vaccinated cohort (18-64 years of age) which included all vaccinated subjects within 18 to 64 years of age and for whom safety data were available. Only the subjects with available score test results were included.
Median and range of the change from baseline of the SF-36v2 score are presented for each component and time point. The assessed parameters for change from baseline were physical and mental component defined as summary components (PCS and MCS) or general health scores (GHS). For all subscale component, scores range from 0 to 100, with high scores indicating high levels of functioning/quality of life. Subscale component scores are averaged to compute the summary component score. There was only 1 study participant \> 64 years of age and that experienced no grade 3 solicited symptoms. Hence, weekly questionnaire was assessed only on the 18-64 age category subjects.
Outcome measures
| Measure |
Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group
n=48 Participants
Subjects 18-64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
|
Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group
Subjects \>64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
|
Influenza A (H5N1) Virus Monovalent Vaccine Group
Subjects ≥18 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the nondominant armat Day 0 and dominant arm at Day 21.
|
|---|---|---|---|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Weekly Questionnaire General Health Scores(Physical and Mental) for Subjects Who Did and Who Did Not Report Any Grade 3 Solicited Symptoms Post Vaccination.
PCS, Grade 3 solicited AE (Day 7)
|
-0.370 SF-36 weekly score
Interval -7.2 to 2.49
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Weekly Questionnaire General Health Scores(Physical and Mental) for Subjects Who Did and Who Did Not Report Any Grade 3 Solicited Symptoms Post Vaccination.
PCS, Grade 3 solicited AE (Day 21)
|
1.170 SF-36 weekly score
Interval -3.73 to 6.34
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Weekly Questionnaire General Health Scores(Physical and Mental) for Subjects Who Did and Who Did Not Report Any Grade 3 Solicited Symptoms Post Vaccination.
PCS, Grade 3 solicited AE (Day 28)
|
-1.220 SF-36 weekly score
Interval -2.82 to 2.55
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Weekly Questionnaire General Health Scores(Physical and Mental) for Subjects Who Did and Who Did Not Report Any Grade 3 Solicited Symptoms Post Vaccination.
PCS, No Grade 3 solicited AE (Day 7)
|
0.000 SF-36 weekly score
Interval -11.19 to 13.58
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Weekly Questionnaire General Health Scores(Physical and Mental) for Subjects Who Did and Who Did Not Report Any Grade 3 Solicited Symptoms Post Vaccination.
PCS, No Grade 3 solicited AE (Day 21)
|
0.180 SF-36 weekly score
Interval -11.32 to 13.58
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Weekly Questionnaire General Health Scores(Physical and Mental) for Subjects Who Did and Who Did Not Report Any Grade 3 Solicited Symptoms Post Vaccination.
PCS, No Grade 3 solicited AE (Day 28)
|
-0.130 SF-36 weekly score
Interval -6.36 to 13.58
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Weekly Questionnaire General Health Scores(Physical and Mental) for Subjects Who Did and Who Did Not Report Any Grade 3 Solicited Symptoms Post Vaccination.
MCS, Grade 3 solicited AE (Day 7)
|
-1.770 SF-36 weekly score
Interval -11.08 to 2.5
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Weekly Questionnaire General Health Scores(Physical and Mental) for Subjects Who Did and Who Did Not Report Any Grade 3 Solicited Symptoms Post Vaccination.
MCS, Grade 3 solicited AE (Day 21)
|
-0.565 SF-36 weekly score
Interval -2.35 to 2.47
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Weekly Questionnaire General Health Scores(Physical and Mental) for Subjects Who Did and Who Did Not Report Any Grade 3 Solicited Symptoms Post Vaccination.
MCS, Grade 3 solicited AE (Day 28)
|
0.015 SF-36 weekly score
Interval -6.24 to 2.5
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Weekly Questionnaire General Health Scores(Physical and Mental) for Subjects Who Did and Who Did Not Report Any Grade 3 Solicited Symptoms Post Vaccination.
MCS, No Grade 3 solicited AE (Day 7)
|
0.480 SF-36 weekly score
Interval -10.43 to 11.83
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Weekly Questionnaire General Health Scores(Physical and Mental) for Subjects Who Did and Who Did Not Report Any Grade 3 Solicited Symptoms Post Vaccination.
MCS, No Grade 3 solicited AE (Day 21)
|
0.140 SF-36 weekly score
Interval -5.1 to 7.33
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Weekly Questionnaire General Health Scores(Physical and Mental) for Subjects Who Did and Who Did Not Report Any Grade 3 Solicited Symptoms Post Vaccination.
MCS, No Grade 3 solicited AE (Day 28)
|
0.000 SF-36 weekly score
Interval -7.29 to 11.83
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 0 (baseline) and at Days 7 and 21 QoL evaluation (post dose 1) and Day 28 QoL evaluation (post dose 2)Population: Analysis were performed on the Total Vaccinated cohort (18-64 years of age) which included all vaccinated subjects within 18 to 64 years of age and for whom safety data were available. Only subjects with score test results were included.
Median and range of the change from baseline of the SF-36v2 score are presented for each time point. The assessed parameters for change from baseline were QALY scores. For all subscale component, scores range from 0 to 100, with high scores indicating high levels of functioning/quality of life. There was only 1 study participant \> 64 years of age and that experienced no grade 3 solicited symptoms. Hence, weekly questionnaire was assessed only on the 18-64 age category subjects.
Outcome measures
| Measure |
Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group
n=48 Participants
Subjects 18-64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
|
Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group
Subjects \>64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
|
Influenza A (H5N1) Virus Monovalent Vaccine Group
Subjects ≥18 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the nondominant armat Day 0 and dominant arm at Day 21.
|
|---|---|---|---|
|
Assessment of Changes From Baseline (Day 0) for Quality Adjusted Life Years (QALY) Weekly Scores for All Subjects Who Did and Who Did Not Report Any Grade 3 Solicited Symptoms Post Vaccination.
QALY score, Grade 3, Day 7
|
0.000 QALY scores
Interval -0.17 to 0.04
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) for Quality Adjusted Life Years (QALY) Weekly Scores for All Subjects Who Did and Who Did Not Report Any Grade 3 Solicited Symptoms Post Vaccination.
QALY score, Grade 3, Day 21
|
0.021 QALY scores
Interval -0.17 to 0.07
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) for Quality Adjusted Life Years (QALY) Weekly Scores for All Subjects Who Did and Who Did Not Report Any Grade 3 Solicited Symptoms Post Vaccination.
QALY score, Grade 3, Day 28
|
-0.021 QALY scores
Interval -0.19 to 0.04
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) for Quality Adjusted Life Years (QALY) Weekly Scores for All Subjects Who Did and Who Did Not Report Any Grade 3 Solicited Symptoms Post Vaccination.
QALY score, No Grade 3, Day 7
|
0.000 QALY scores
Interval -0.25 to 0.33
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) for Quality Adjusted Life Years (QALY) Weekly Scores for All Subjects Who Did and Who Did Not Report Any Grade 3 Solicited Symptoms Post Vaccination.
QALY score, No Grade 3, Day 21
|
0.000 QALY scores
Interval -0.25 to 0.33
|
—
|
—
|
|
Assessment of Changes From Baseline (Day 0) for Quality Adjusted Life Years (QALY) Weekly Scores for All Subjects Who Did and Who Did Not Report Any Grade 3 Solicited Symptoms Post Vaccination.
QALY score, No Grade 3, Day 28
|
0.000 QALY scores
Interval -0.16 to 0.33
|
—
|
—
|
SECONDARY outcome
Timeframe: During the 7 days after Dose 1Population: Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects who reported an unsolicited AE in the 7 days after Dose 1. Only subjects with negative deviations from baseline were analyzed.
The assessed parameters were Physical functioning (PF), Physical-health related role limitations (RP), Bodily pain (BP), General health (GH), Vitality (VT), Social functioning (SF), Emotional health related role limitations (RE), Mental health (MH) and physical and mental component summary measures (PCS, MCS) and QALY for subjects who reported unsolicited AEs in the first 7 days after Dose 1. Only negative deviations from baseline were considered. On any variable, if there was a negative deviation from baseline, then if and only if the value returned to baseline or above within the 7 days after dose 1, the number of days required to return to baseline or above was calculated. On any variable, if there was no variation within the 7 days after dose 1, then nothing was counted. If there was more than one negative deviation from baseline and more than one recovery, then only the first was considered. Analyses by age category were not performed for the daily SF-36v2 questionnaire results.
Outcome measures
| Measure |
Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group
n=29 Participants
Subjects 18-64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
|
Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group
Subjects \>64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
|
Influenza A (H5N1) Virus Monovalent Vaccine Group
Subjects ≥18 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the nondominant armat Day 0 and dominant arm at Day 21.
|
|---|---|---|---|
|
Time Taken to Return to (or go Beyond) the Baseline (Day 0) Value in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores in Subjects Who Reported Unsolicited AEs Post Vaccination Dose 1
PF
|
1.6667 Days
Standard Deviation 0.8997
|
—
|
—
|
|
Time Taken to Return to (or go Beyond) the Baseline (Day 0) Value in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores in Subjects Who Reported Unsolicited AEs Post Vaccination Dose 1
RP
|
1.5455 Days
Standard Deviation 1.2136
|
—
|
—
|
|
Time Taken to Return to (or go Beyond) the Baseline (Day 0) Value in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores in Subjects Who Reported Unsolicited AEs Post Vaccination Dose 1
BP
|
1.7931 Days
Standard Deviation 0.9776
|
—
|
—
|
|
Time Taken to Return to (or go Beyond) the Baseline (Day 0) Value in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores in Subjects Who Reported Unsolicited AEs Post Vaccination Dose 1
GH
|
1.8947 Days
Standard Deviation 1.3289
|
—
|
—
|
|
Time Taken to Return to (or go Beyond) the Baseline (Day 0) Value in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores in Subjects Who Reported Unsolicited AEs Post Vaccination Dose 1
VT
|
1.6522 Days
Standard Deviation 1.1912
|
—
|
—
|
|
Time Taken to Return to (or go Beyond) the Baseline (Day 0) Value in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores in Subjects Who Reported Unsolicited AEs Post Vaccination Dose 1
SF
|
1.5455 Days
Standard Deviation 0.8202
|
—
|
—
|
|
Time Taken to Return to (or go Beyond) the Baseline (Day 0) Value in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores in Subjects Who Reported Unsolicited AEs Post Vaccination Dose 1
RE
|
1.5714 Days
Standard Deviation 1.1339
|
—
|
—
|
|
Time Taken to Return to (or go Beyond) the Baseline (Day 0) Value in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores in Subjects Who Reported Unsolicited AEs Post Vaccination Dose 1
MH
|
1.6000 Days
Standard Deviation 0.9103
|
—
|
—
|
|
Time Taken to Return to (or go Beyond) the Baseline (Day 0) Value in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores in Subjects Who Reported Unsolicited AEs Post Vaccination Dose 1
PCS
|
2.1154 Days
Standard Deviation 1.3365
|
—
|
—
|
|
Time Taken to Return to (or go Beyond) the Baseline (Day 0) Value in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores in Subjects Who Reported Unsolicited AEs Post Vaccination Dose 1
MCS
|
1.8947 Days
Standard Deviation 1.1970
|
—
|
—
|
|
Time Taken to Return to (or go Beyond) the Baseline (Day 0) Value in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores in Subjects Who Reported Unsolicited AEs Post Vaccination Dose 1
QALY
|
1.8400 Days
Standard Deviation 1.2806
|
—
|
—
|
SECONDARY outcome
Timeframe: After the first and second vaccine dosesPopulation: The analysis of Quantitative differences between SF-36v2 questionnaire responses, and the solicited local and general adverse event data provided on diary cards was invalidated as the differences in scale between the measures could not be reconciled.
The analysis of Quantitative differences between SF-36v2 questionnaire responses, and the solicited local and general adverse event data provided on diary cards was invalidated as the differences in scale between the measures could not be reconciled.
Outcome measures
Outcome data not reported
Adverse Events
Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group
Serious events: 0 serious events
Other events: 46 other events
Deaths: 0 deaths
Influenza A (H5N1)Virus Monovalent Vaccine ˃64 Years Group
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group
n=49 participants at risk
Subjects 18-64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
|
Influenza A (H5N1)Virus Monovalent Vaccine ˃64 Years Group
n=1 participants at risk
Subjects ˃64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
|
|---|---|---|
|
General disorders
Pain
|
91.8%
45/49 • Serious Adverse Events: From Day 0 up to Day 385; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period after each vaccination; Unsolicited symptoms: During the 21-day (Day 0-20) post-vaccination period after each vaccination
|
100.0%
1/1 • Serious Adverse Events: From Day 0 up to Day 385; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period after each vaccination; Unsolicited symptoms: During the 21-day (Day 0-20) post-vaccination period after each vaccination
|
|
General disorders
Redness
|
12.2%
6/49 • Serious Adverse Events: From Day 0 up to Day 385; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period after each vaccination; Unsolicited symptoms: During the 21-day (Day 0-20) post-vaccination period after each vaccination
|
0.00%
0/1 • Serious Adverse Events: From Day 0 up to Day 385; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period after each vaccination; Unsolicited symptoms: During the 21-day (Day 0-20) post-vaccination period after each vaccination
|
|
General disorders
Swelling
|
14.3%
7/49 • Serious Adverse Events: From Day 0 up to Day 385; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period after each vaccination; Unsolicited symptoms: During the 21-day (Day 0-20) post-vaccination period after each vaccination
|
0.00%
0/1 • Serious Adverse Events: From Day 0 up to Day 385; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period after each vaccination; Unsolicited symptoms: During the 21-day (Day 0-20) post-vaccination period after each vaccination
|
|
General disorders
Fatigue
|
55.1%
27/49 • Serious Adverse Events: From Day 0 up to Day 385; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period after each vaccination; Unsolicited symptoms: During the 21-day (Day 0-20) post-vaccination period after each vaccination
|
0.00%
0/1 • Serious Adverse Events: From Day 0 up to Day 385; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period after each vaccination; Unsolicited symptoms: During the 21-day (Day 0-20) post-vaccination period after each vaccination
|
|
General disorders
Gastrointestinal symptoms
|
24.5%
12/49 • Serious Adverse Events: From Day 0 up to Day 385; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period after each vaccination; Unsolicited symptoms: During the 21-day (Day 0-20) post-vaccination period after each vaccination
|
0.00%
0/1 • Serious Adverse Events: From Day 0 up to Day 385; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period after each vaccination; Unsolicited symptoms: During the 21-day (Day 0-20) post-vaccination period after each vaccination
|
|
General disorders
Headache
|
40.8%
20/49 • Serious Adverse Events: From Day 0 up to Day 385; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period after each vaccination; Unsolicited symptoms: During the 21-day (Day 0-20) post-vaccination period after each vaccination
|
0.00%
0/1 • Serious Adverse Events: From Day 0 up to Day 385; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period after each vaccination; Unsolicited symptoms: During the 21-day (Day 0-20) post-vaccination period after each vaccination
|
|
General disorders
Joint pain
|
28.6%
14/49 • Serious Adverse Events: From Day 0 up to Day 385; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period after each vaccination; Unsolicited symptoms: During the 21-day (Day 0-20) post-vaccination period after each vaccination
|
0.00%
0/1 • Serious Adverse Events: From Day 0 up to Day 385; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period after each vaccination; Unsolicited symptoms: During the 21-day (Day 0-20) post-vaccination period after each vaccination
|
|
General disorders
Muscle ache
|
67.3%
33/49 • Serious Adverse Events: From Day 0 up to Day 385; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period after each vaccination; Unsolicited symptoms: During the 21-day (Day 0-20) post-vaccination period after each vaccination
|
0.00%
0/1 • Serious Adverse Events: From Day 0 up to Day 385; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period after each vaccination; Unsolicited symptoms: During the 21-day (Day 0-20) post-vaccination period after each vaccination
|
|
General disorders
Shivering
|
20.4%
10/49 • Serious Adverse Events: From Day 0 up to Day 385; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period after each vaccination; Unsolicited symptoms: During the 21-day (Day 0-20) post-vaccination period after each vaccination
|
0.00%
0/1 • Serious Adverse Events: From Day 0 up to Day 385; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period after each vaccination; Unsolicited symptoms: During the 21-day (Day 0-20) post-vaccination period after each vaccination
|
|
General disorders
Sweating
|
14.3%
7/49 • Serious Adverse Events: From Day 0 up to Day 385; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period after each vaccination; Unsolicited symptoms: During the 21-day (Day 0-20) post-vaccination period after each vaccination
|
0.00%
0/1 • Serious Adverse Events: From Day 0 up to Day 385; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period after each vaccination; Unsolicited symptoms: During the 21-day (Day 0-20) post-vaccination period after each vaccination
|
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