Influenza, Influenza Vaccines
Conditions
Keywords
Vaccine, Occupational exposure, Influenza, H5N1
Brief summary
The purpose of this study is to evaluate the safety and tolerability of GSK Biologicals' vaccine GSK1557484A against pandemic avian (H5N1) influenza in adults at occupational risk of exposure to the virus.
Interventions
2 doses administered intramuscularly (IM) in deltoid region of arm at the Day 0 and Day 21 visits.
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subjects who, in the opinion of the investigator can and will comply with the requirements of the protocol. * Male or female adults ≥18 years of age at time of first study vaccination. * Written informed consent obtained from the subject. * Subjects who are at risk of occupational exposure to H5N1 influenza viruses based on exposure, or potential exposure during either (a) laboratory operations with live H5N1 virus, (b) production of H5N1 vaccines, or (c) conduct of epidemiological investigations of H5N1 cases. * Stable health status as defined by absence of a health event satisfying the definition of a serious adverse event, or a change in an ongoing drug therapy due to therapeutic failure or symptoms of drug toxicity, within 30 days prior to enrollment. * Female subjects of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as current tubal ligation, hysterectomy, ovariectomy or post-menopause. * Female subjects of childbearing potential may be enrolled in the study, if they have practiced adequate contraception for 30 days prior to vaccination, and have a negative pregnancy test on the day of vaccination, and agree to practice adequate contraception for two months following the last dose of vaccine.
Exclusion criteria
* Presence or evidence of neurological or psychiatric diagnoses which, although stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports. * Presence of a temperature ≥ 38.0ºC (≥100.4ºF) or acute symptoms greater than mild severity on the scheduled date of first vaccination. NOTE: The subject may be vaccinated at a later date, provided symptoms have resolved, vaccination occurs within the window specified by the protocol, and all other eligibility criteria continue to be satisfied. * Significant risk of complications from intramuscular injections due to disorder of coagulation. Persons receiving prophylactic antiplatelet medications, e.g., low-dose aspirin, and without a clinically-apparent bleeding tendency, are eligible. Assessment of risk of injection complications should be made in the context of individual subject risk of H5N1 virus infection. * An acute evolving neurological disorder or Guillain Barré Syndrome within 42 days of receipt of prior seasonal or pandemic influenza vaccine. * Administration of an inactive vaccine within 14 days or of a live attenuated vaccine within 30 days before the first dose of study vaccine. * Planned administration of any vaccine other than the study vaccine before Day 42. * Any known or suspected allergy to any constituent of influenza vaccines or component used in the manufacturing process of the study vaccine including a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine. * Known pregnancy or a positive urine beta-human chorionic gonadotropin (β-hCG) test result before the first vaccination. * Lactating or nursing women. * Any condition which, in the opinion of the investigator, prevents the subject from participating in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Overall and by Age Category (18-64 and >64 Years of Age). | During a 7-day follow-up period (Days 0-6) after each vaccination | 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. |
| Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Overall and by Age Category (18-64 and >64 Years of Age). | During a 7-day follow-up period (Days 0-6) after each vaccination | 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. |
| Number of Subjects Reporting Any Unsolicited AEs, Overall and by Age Category (18-64 and >64 Years of Age) | During the 21-day (Days 0-20 post dose 1 and Days 21-41 post dose 2) post-vaccination period | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores | Day 0 (baseline) and at each day from Day 1 to Day 7 post first vaccine dose | 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. |
| Number of Subjects With Reported Adverse Pregnancy Outcomes | During the entire study period (Day 0 to Day 385) | 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 |
| Assessment of Changes From Baseline (Day 0) in the SF-36v2 Weekly Health 8-score | Day 0 (baseline) and at Days 7 and 21 QoL evaluation (post dose 1) and Day 28 QoL evaluation (post dose 2) | 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. |
| Assessment of Changes From Baseline (Day 0) in the SF-36v2 Weekly Questionnaire General Health Scores (Physical and Mental) | Day 0 (baseline) and at Days 7 and 21 QoL evaluation (post dose 1) and Day 28 QoL evaluation (post dose 2) | 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. |
| Assessment of Changes From Baseline (Day 0) for Quality Adjusted Life Years (QALY) Weekly Scores | Day 0 (baseline) and at Days 7 and 21 QoL evaluation (post dose 1) and Day 28 QoL evaluation (post dose 2) | 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. |
| Number of Subjects Reporting Any or Related Medically Attended Adverse Events (MAEs) | During the entire study period (Day 0 to Day 385) | 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. |
| 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. | Day 0 (baseline) and at Days 7 and 21 QoL evaluation (post dose 1) and Day 28 QoL evaluation (post dose 2) | 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. |
| 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. | Day 0 (baseline) and at Days 7 and 21 QoL evaluation (post dose 1) and Day 28 QoL evaluation (post dose 2) | 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. |
| 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. | Day 0 (baseline) and at Days 7 and 21 QoL evaluation (post dose 1) and Day 28 QoL evaluation (post dose 2) | 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. |
| 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 | During the 7 days after Dose 1 | 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. |
| Quantitative Differences Between SF-36v2 Questionnaire Responses, and the Solicited Local and General Adverse Event Data Provided on Diary Cards | After the first and second vaccine doses | 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. |
| 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. | Day 0 (baseline) and at each day from Day 1 to Day 7 post first vaccine dose | 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. |
| Number of Subjects Reporting Any and Related Potential Immune-Mediated Diseases (pIMDs) | During the entire study period (Day 0 to Day 385) | 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. |
| Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) | During the entire study period (Day 0 to Day 385) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 49 |
| 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. | 1 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Migrated/moved from study area | 1 | 0 |
Baseline characteristics
| Characteristic | Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group | Total |
|---|---|---|---|
| Age, Continuous | 42.5 Years STANDARD_DEVIATION 10.7 | 85.0 Years | 43.35 Years STANDARD_DEVIATION 12.18 |
| Sex: Female, Male Female | 28 Participants | 0 Participants | 28 Participants |
| Sex: Female, Male Male | 21 Participants | 1 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 49 | 0 / 1 |
| other Total, other adverse events | 46 / 49 | 1 / 1 |
| serious Total, serious adverse events | 0 / 49 | 0 / 1 |
Outcome results
Primary
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Overall and by Age Category (18-64 and >64 Years of Age).
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.
Time frame: During a 7-day follow-up period (Days 0-6) after each vaccination
Population: Analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group | 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 | 0 Participants |
| Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group | 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 | 0 Participants |
| Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group | 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 | 1 Participants |
| Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group | 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 | 0 Participants |
| Influenza A (H5N1) Virus Monovalent Vaccine Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine Group | 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 | 46 Participants |
| Influenza A (H5N1) Virus Monovalent Vaccine Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine Group | 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 |
Primary
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Overall and by Age Category (18-64 and >64 Years of Age).
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.
Time frame: During a 7-day follow-up period (Days 0-6) after each vaccination
Population: Analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group | 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 | 0 Participants |
| Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group | 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 | 0 Participants |
| Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group | 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 | 0 Participants |
| Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group | 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 | 0 Participants |
| Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group | 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 | 0 Participants |
| Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group | 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 | 0 Participants |
| Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group | 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 | 0 Participants |
| Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group | 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 | 0 Participants |
| Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group | 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 | 0 Participants |
| Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group | 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 | 0 Participants |
| Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group | 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 | 0 Participants |
| Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group | 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 | 0 Participants |
| Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group | 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 | 0 Participants |
| Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group | 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 | 0 Participants |
| Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group | 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 | 0 Participants |
| Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group | 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 | 0 Participants |
| Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group | 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) | 0 Participants |
| Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group | 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 | 0 Participants |
| Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group | 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 | 0 Participants |
| Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group | 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 | 0 Participants |
| Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group | 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 | 0 Participants |
| Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group | 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 | 0 Participants |
| Influenza A (H5N1) Virus Monovalent Vaccine Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine Group | 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 |
Primary
Number of Subjects Reporting Any Unsolicited AEs, Overall and by Age Category (18-64 and >64 Years of Age)
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.
Time frame: During the 21-day (Days 0-20 post dose 1 and Days 21-41 post dose 2) post-vaccination period
Population: Analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | Number of Subjects Reporting Any Unsolicited AEs, Overall and by Age Category (18-64 and >64 Years of Age) | Any unsolicited AEs | 10 Participants |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | Number of Subjects Reporting Any Unsolicited AEs, Overall and by Age Category (18-64 and >64 Years of Age) | Related unsolicited AEs | 4 Participants |
| Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group | Number of Subjects Reporting Any Unsolicited AEs, Overall and by Age Category (18-64 and >64 Years of Age) | Any unsolicited AEs | 0 Participants |
| Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group | Number of Subjects Reporting Any Unsolicited AEs, Overall and by Age Category (18-64 and >64 Years of Age) | Related unsolicited AEs | 0 Participants |
| Influenza A (H5N1) Virus Monovalent Vaccine Group | Number of Subjects Reporting Any Unsolicited AEs, Overall and by Age Category (18-64 and >64 Years of Age) | Any unsolicited AEs | 10 Participants |
| Influenza A (H5N1) Virus Monovalent Vaccine Group | Number of Subjects Reporting Any Unsolicited AEs, Overall and by Age Category (18-64 and >64 Years of Age) | Related unsolicited AEs | 4 Participants |
Secondary
Assessment of Changes From Baseline (Day 0) for Quality Adjusted Life Years (QALY) Weekly Scores
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
Secondary
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.
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
Secondary
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.
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
Secondary
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores
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.
Time frame: Day 0 (baseline) and at each day from Day 1 to Day 7 post first vaccine dose
Population: Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects. Only the subjects with available score test results were included.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
Secondary
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.
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.
Time frame: Day 0 (baseline) and at each day from Day 1 to Day 7 post first vaccine dose
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
Secondary
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Weekly Health 8-score
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | Assessment of Changes From Baseline (Day 0) in the SF-36v2 Weekly Health 8-score | PF : Day 7 | 0.000 SF-36 Weekly score |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | Assessment of Changes From Baseline (Day 0) in the SF-36v2 Weekly Health 8-score | PF : Day 21 | 0.000 SF-36 Weekly score |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | Assessment of Changes From Baseline (Day 0) in the SF-36v2 Weekly Health 8-score | PF : Day 28 | 0.000 SF-36 Weekly score |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | Assessment of Changes From Baseline (Day 0) in the SF-36v2 Weekly Health 8-score | RP: Day 7 | 0.000 SF-36 Weekly score |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | Assessment of Changes From Baseline (Day 0) in the SF-36v2 Weekly Health 8-score | RP: Day 21 | 0.000 SF-36 Weekly score |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | Assessment of Changes From Baseline (Day 0) in the SF-36v2 Weekly Health 8-score | RP: Day 28 | 0.000 SF-36 Weekly score |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | Assessment of Changes From Baseline (Day 0) in the SF-36v2 Weekly Health 8-score | BP: Day 7 | 0.000 SF-36 Weekly score |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | Assessment of Changes From Baseline (Day 0) in the SF-36v2 Weekly Health 8-score | BP: Day 21 | 0.000 SF-36 Weekly score |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | Assessment of Changes From Baseline (Day 0) in the SF-36v2 Weekly Health 8-score | BP: Day 28 | 0.000 SF-36 Weekly score |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | Assessment of Changes From Baseline (Day 0) in the SF-36v2 Weekly Health 8-score | GH: Day 7 | 0.000 SF-36 Weekly score |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | Assessment of Changes From Baseline (Day 0) in the SF-36v2 Weekly Health 8-score | GH: Day 21 | 0.000 SF-36 Weekly score |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | Assessment of Changes From Baseline (Day 0) in the SF-36v2 Weekly Health 8-score | GH: Day 28 | 0.000 SF-36 Weekly score |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | Assessment of Changes From Baseline (Day 0) in the SF-36v2 Weekly Health 8-score | VT: Day 7 | 0.000 SF-36 Weekly score |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | Assessment of Changes From Baseline (Day 0) in the SF-36v2 Weekly Health 8-score | VT: Day 21 | 2.720 SF-36 Weekly score |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | Assessment of Changes From Baseline (Day 0) in the SF-36v2 Weekly Health 8-score | VT: Day 28 | 0.000 SF-36 Weekly score |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | Assessment of Changes From Baseline (Day 0) in the SF-36v2 Weekly Health 8-score | SF: Day 7 | 0.000 SF-36 Weekly score |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | Assessment of Changes From Baseline (Day 0) in the SF-36v2 Weekly Health 8-score | SF: Day 21 | 0.000 SF-36 Weekly score |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | Assessment of Changes From Baseline (Day 0) in the SF-36v2 Weekly Health 8-score | SF: Day 28 | 0.000 SF-36 Weekly score |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | Assessment of Changes From Baseline (Day 0) in the SF-36v2 Weekly Health 8-score | RE: Day 7 | 0.000 SF-36 Weekly score |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | Assessment of Changes From Baseline (Day 0) in the SF-36v2 Weekly Health 8-score | RE: Day 21 | 0.000 SF-36 Weekly score |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | Assessment of Changes From Baseline (Day 0) in the SF-36v2 Weekly Health 8-score | RE: Day 28 | 0.000 SF-36 Weekly score |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | Assessment of Changes From Baseline (Day 0) in the SF-36v2 Weekly Health 8-score | MH: Day 7 | 0.000 SF-36 Weekly score |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | Assessment of Changes From Baseline (Day 0) in the SF-36v2 Weekly Health 8-score | MH: Day 21 | 0.000 SF-36 Weekly score |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | Assessment of Changes From Baseline (Day 0) in the SF-36v2 Weekly Health 8-score | MH: Day 28 | 0.000 SF-36 Weekly score |
Secondary
Assessment of Changes From Baseline (Day 0) in the SF-36v2 Weekly Questionnaire General Health Scores (Physical and Mental)
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
Secondary
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.
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
Secondary
Number of Subjects Reporting Any and Related Potential Immune-Mediated Diseases (pIMDs)
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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | Number of Subjects Reporting Any and Related Potential Immune-Mediated Diseases (pIMDs) | Any pIMDs | 0 Participants |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | Number of Subjects Reporting Any and Related Potential Immune-Mediated Diseases (pIMDs) | Related pIMDs | 0 Participants |
| Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group | Number of Subjects Reporting Any and Related Potential Immune-Mediated Diseases (pIMDs) | Any pIMDs | 0 Participants |
| Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group | Number of Subjects Reporting Any and Related Potential Immune-Mediated Diseases (pIMDs) | Related pIMDs | 0 Participants |
Secondary
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) | Related SAEs | 0 Participants |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) | Any SAEs | 0 Participants |
| Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) | Related SAEs | 0 Participants |
| Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) | Any SAEs | 0 Participants |
Secondary
Number of Subjects Reporting Any or Related Medically Attended Adverse Events (MAEs)
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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | Number of Subjects Reporting Any or Related Medically Attended Adverse Events (MAEs) | Any MAEs | 9 Participants |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | Number of Subjects Reporting Any or Related Medically Attended Adverse Events (MAEs) | Related MAEs | 0 Participants |
| Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group | Number of Subjects Reporting Any or Related Medically Attended Adverse Events (MAEs) | Any MAEs | 0 Participants |
| Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group | Number of Subjects Reporting Any or Related Medically Attended Adverse Events (MAEs) | Related MAEs | 0 Participants |
Secondary
Number of Subjects With Reported Adverse Pregnancy Outcomes
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
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | Number of Subjects With Reported Adverse Pregnancy Outcomes | Any adverse pregnancy outcome(s) | 0 Participants |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | Number of Subjects With Reported Adverse Pregnancy Outcomes | Related adverse pregnancy outcomes | 0 Participants |
| Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group | Number of Subjects With Reported Adverse Pregnancy Outcomes | Any adverse pregnancy outcome(s) | 0 Participants |
| Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group | Number of Subjects With Reported Adverse Pregnancy Outcomes | Related adverse pregnancy outcomes | 0 Participants |
Secondary
Quantitative Differences Between SF-36v2 Questionnaire Responses, and the Solicited Local and General Adverse Event Data Provided on Diary Cards
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.
Time frame: After the first and second vaccine doses
Population: 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.
Secondary
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
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.
Time frame: During the 7 days after Dose 1
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 1.197 |
| Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group | 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 |