Pandemic H5N1 Influenza
Conditions
Keywords
Influenza, Pandemic, H5N1, Adults
Brief summary
Evaluate Safety, Tolerability and Immune Response of Adjuvanted H5N1 Cell Culture Derived Influenza Vaccine in Adult Subjects.
Interventions
Comparison of two doses of aH5N1c vaccine
Sponsors
Department of Health and Human Services
Novartis Vaccines
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy adult subjects 18 to 64 years of age, 2. Individuals willing to provide written informed consent, 3. Individuals in good health, 4. Individuals willing to allow for their serum samples to be stored beyond the study period.
Exclusion criteria
1. Individuals not able to understand and follow study procedures, 2. History of any significant illness, 3. History of any chronic medical condition or progressive disease, 4. Presence of medically significant cancer, 5. Known or suspected impairment/alteration of immune function, 6. Presence of any progressive or severe neurologic disorder, 7. Presence of any bleeding disorders or conditions that prolongs bleeding time, 8. History of allergy to vaccine components, 9. Receipt of any other investigational product within 30 days prior to entry into the study, 10. History of previous H5N1 vaccination, 11. Receipt of any other type of seasonal vaccination within 2 months prior to entry into the study, 12. Receipt of any other vaccine within 2 weeks prior to entry into the study 13. Body temperature ≥38°C.0 (≥100.4° F) and/or acute illness within 3 days of intended study vaccination, 14. Pregnant or breast feeding, 15. Females of childbearing potential refusing to use acceptable method of birth control, 16. Body mass index (BMI) ≥ 35 kg/m2, 17. History of drug or alcohol abuse, 18. Any planned surgery during study period, 19. Individuals conducting the study and their immediate family members, 20. Individuals with behavioral or cognitive impairment or psychiatric diseases.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentages Of Subjects Achieving Hemagglutinin Inhibition (HI) Titers ≥40 Against A/H5N1 Strain. | Three weeks after 2nd vaccination (day 43) | The optimal aH5N1c vaccine formulation was evaluated in terms of percentages of subjects achieving HI titers ≥40 against homologous A/H5N1 strain, three weeks after second vaccination with either low dose or high dose of aH5N1c vaccine, according to the Center for Biologics Evaluation and Research (CBER) criterion. CBER criterion for the adult population is met if the lower limit of the two-sided 95% confidence interval (CI) for the percentages of subjects achieving HI titer ≥40 meets or exceeds 70%. |
| Percentages Of Subjects Achieving Seroconversion Against A/H5N1 Strain. | Three weeks after 2nd vaccination (day 43) | Immunogenicity was measured in terms of the percentages of subjects achieving seroconversion or significant increase in HI titer against the vaccine strain, three weeks after receiving two injections of low dose or high dose of aH5N1c vaccine according to the CBER criterion. Seroconversion is defined as either a) in subjects with a prevaccination HI titer \<10, a postvaccination titer ≥40; or b) in subjects with prevaccination HI titer ≥10, a minimum four-fold rise in postvaccination HI antibody titer. CBER criterion for the adult population is met if the lower limit of the two-sided 95% CI for the percentages of subjects achieving seroconversion for HI antibody titer meets or exceeds 40%. |
| Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AE), After Any Vaccination. | From day 1 through day 7 after any vaccination. | Safety was assessed using the number of subjects who reported solicited local and systemic AEs following vaccination with either low or high dose of aH5N1c vaccine. |
| Number of Subjects Reporting Unsolicited AEs After Any Vaccination. | Any unsolicited AEs - day 1 through day 22 after any vaccination. SAEs, NOCDs. medically attended AEs, AESIs, AEs leading to study withdrawal- day 1 to day 387 | Safety was assessed using the number of subjects who reported any unsolicited adverse events, adverse events possibly or probably related to study vaccine, serious adverse events (SAEs), new onset of chronic diseases (NOCDs), medically attended AEs, AEs of special interest (AESIs), AEs leading to withdrawal from study following vaccination with either low or high dose of aH5N1c vaccine. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentages Of Subjects With HI Titers ≥40 Against A/H5N1 Strain. | Day 1, day 22, day 43 and day 387 | Immunogenicity was assessed in terms of percentage of subjects achieving HI titers ≥40, 3 weeks after first vaccination, 3 weeks after second vaccination and 12 months after second vaccination of either low dose or high dose of aH5N1c according to the CHMP criterion. European Licensure (CHMP) criterion is met if the percentage of subjects achieving (at day 43) HI titers ≥40 is \>70%. |
| Percentages Of Subjects Achieving Seroconversion Against A/H5N1 Strain. | Day 22, day 43 and day 387 | Immunogenicity was assessed in terms of percentages of subjects achieving seroconversion in HI titers, 3 weeks after first vaccination, 3 weeks after second vaccination and 12 months after second vaccination of either low dose or high dose aH5N1c vaccine according to the CHMP criterion. Seroconversion is defined as: a) for subjects with a prevaccination HI titer \<10, a postvaccination titer ≥40; or b) for subjects with prevaccination HI titer ≥10, a minimum four-fold rise in postvaccination HI antibody titer. The criterion is met according to the European (CHMP) guideline if the percentage of subjects achieving seroconversion (at day 43) is \>40%. |
| Geometric Mean Ratios Against A/H5N1 Strain Following 2-dose Vaccination Schedule of Either Low Dose or High Dose aH5N1c Vaccine. | Day 1; day 22; day 43 and day 387 | Immunogenicity was measured as the geometric mean ratio (GMR). The ratio of postvaccination to prevaccination HI GMTs, 3 weeks after first vaccination, 3 weeks after second vaccination and 12 months after second vaccination of either low dose or high dose of aH5N1c is reported. The criterion is met according to the European Committee for Medicinal Products for Human Use (CHMP) criterion if the geometric mean increase GMR (day 43/day 1) in HI antibody titer is \>2.5 for subjects 18-60 years of age. |
Countries
Australia, Thailand, United States
Participant flow
Recruitment details
Subjects were enrolled at 4 centers in the US, 3 centers in Australia and 1 center in Thailand.
Pre-assignment details
All enrolled subjects were included in the trial.
Participants by arm
| Arm | Count |
|---|---|
| High Dose Subjects received 2 injections of a high dose MF59 adjuvanted cell-culture derived monovalent H5N1 vaccine three weeks apart. | 488 |
| Low Dose Subjects received 2 injections of a low dose MF59 adjuvanted cell-culture derived monovalent H5N1 vaccine three weeks apart. | 491 |
| Total | 979 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Administrative Reason | 6 | 2 |
| Overall Study | Death | 4 | 0 |
| Overall Study | Lost to Follow-up | 27 | 48 |
| Overall Study | Protocol Violation | 2 | 1 |
| Overall Study | Unclassified | 5 | 4 |
| Overall Study | Withdrawal by Subject | 12 | 20 |
Baseline characteristics
| Characteristic | High Dose | Low Dose | Total |
|---|---|---|---|
| Age, Continuous | 39.0 years STANDARD_DEVIATION 13.7 | 38.4 years STANDARD_DEVIATION 14.2 | 38.7 years STANDARD_DEVIATION 14 |
| Sex: Female, Male Female | 285 Participants | 259 Participants | 544 Participants |
| Sex: Female, Male Male | 203 Participants | 232 Participants | 435 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 371 / 485 | 324 / 490 | 695 / 975 |
| serious Total, serious adverse events | 20 / 485 | 8 / 490 | 28 / 975 |
Outcome results
Primary
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AE), After Any Vaccination.
Safety was assessed using the number of subjects who reported solicited local and systemic AEs following vaccination with either low or high dose of aH5N1c vaccine.
Time frame: From day 1 through day 7 after any vaccination.
Population: Analysis was done on the safety dataset, i.e. the subjects in the exposed population who provided postvaccination safety data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| High Dose | Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AE), After Any Vaccination. | Prevention of pain and (or) fever(N=471,470) | 7 Number of subjects |
| High Dose | Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AE), After Any Vaccination. | Arthralgia(N=471,467) | 70 Number of subjects |
| High Dose | Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AE), After Any Vaccination. | Loss of Appetite(N=472,469) | 53 Number of subjects |
| High Dose | Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AE), After Any Vaccination. | Fever (≥40°C)(N=472,469) | 1 Number of subjects |
| High Dose | Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AE), After Any Vaccination. | Any Local | 322 Number of subjects |
| High Dose | Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AE), After Any Vaccination. | Injection site Erythema(N=471,471) | 4 Number of subjects |
| High Dose | Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AE), After Any Vaccination. | Injection site Induration(N=471,471) | 54 Number of subjects |
| High Dose | Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AE), After Any Vaccination. | Injection site Ecchymosis(N=472,471) | 9 Number of subjects |
| High Dose | Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AE), After Any Vaccination. | Injection site Pain(N=471,470) | 318 Number of subjects |
| High Dose | Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AE), After Any Vaccination. | Any Systemic | 223 Number of subjects |
| High Dose | Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AE), After Any Vaccination. | Nausea(N=472,471) | 54 Number of subjects |
| High Dose | Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AE), After Any Vaccination. | Headache(N=471,469) | 126 Number of subjects |
| High Dose | Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AE), After Any Vaccination. | Fatigue(N=471,469) | 125 Number of subjects |
| High Dose | Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AE), After Any Vaccination. | Malaise(N=472,467) | 117 Number of subjects |
| High Dose | Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AE), After Any Vaccination. | Fever (≥38°C)(N=472,469) | 11 Number of subjects |
| High Dose | Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AE), After Any Vaccination. | Treatment of pain and (or) fever(N=471,470) | 40 Number of subjects |
| High Dose | Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AE), After Any Vaccination. | Myalgia(N=472,469) | 108 Number of subjects |
| Low Dose | Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AE), After Any Vaccination. | Loss of Appetite(N=472,469) | 38 Number of subjects |
| Low Dose | Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AE), After Any Vaccination. | Any Systemic | 209 Number of subjects |
| Low Dose | Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AE), After Any Vaccination. | Fatigue(N=471,469) | 108 Number of subjects |
| Low Dose | Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AE), After Any Vaccination. | Fever (≥38°C)(N=472,469) | 9 Number of subjects |
| Low Dose | Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AE), After Any Vaccination. | Prevention of pain and (or) fever(N=471,470) | 14 Number of subjects |
| Low Dose | Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AE), After Any Vaccination. | Nausea(N=472,471) | 48 Number of subjects |
| Low Dose | Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AE), After Any Vaccination. | Fever (≥40°C)(N=472,469) | 0 Number of subjects |
| Low Dose | Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AE), After Any Vaccination. | Myalgia(N=472,469) | 78 Number of subjects |
| Low Dose | Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AE), After Any Vaccination. | Any Local | 236 Number of subjects |
| Low Dose | Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AE), After Any Vaccination. | Arthralgia(N=471,467) | 52 Number of subjects |
| Low Dose | Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AE), After Any Vaccination. | Injection site Erythema(N=471,471) | 0 Number of subjects |
| Low Dose | Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AE), After Any Vaccination. | Malaise(N=472,467) | 97 Number of subjects |
| Low Dose | Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AE), After Any Vaccination. | Injection site Induration(N=471,471) | 35 Number of subjects |
| Low Dose | Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AE), After Any Vaccination. | Headache(N=471,469) | 114 Number of subjects |
| Low Dose | Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AE), After Any Vaccination. | Injection site Ecchymosis(N=472,471) | 6 Number of subjects |
| Low Dose | Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AE), After Any Vaccination. | Treatment of pain and (or) fever(N=471,470) | 31 Number of subjects |
| Low Dose | Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AE), After Any Vaccination. | Injection site Pain(N=471,470) | 235 Number of subjects |
Primary
Number of Subjects Reporting Unsolicited AEs After Any Vaccination.
Safety was assessed using the number of subjects who reported any unsolicited adverse events, adverse events possibly or probably related to study vaccine, serious adverse events (SAEs), new onset of chronic diseases (NOCDs), medically attended AEs, AEs of special interest (AESIs), AEs leading to withdrawal from study following vaccination with either low or high dose of aH5N1c vaccine.
Time frame: Any unsolicited AEs - day 1 through day 22 after any vaccination. SAEs, NOCDs. medically attended AEs, AESIs, AEs leading to study withdrawal- day 1 to day 387
Population: Analysis was done on the safety dataset, i.e. the subjects in the exposed population who provided postvaccination safety data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| High Dose | Number of Subjects Reporting Unsolicited AEs After Any Vaccination. | Any AEs | 94 Number of subjects |
| High Dose | Number of Subjects Reporting Unsolicited AEs After Any Vaccination. | At least possibly related AEs | 39 Number of subjects |
| High Dose | Number of Subjects Reporting Unsolicited AEs After Any Vaccination. | Any SAEs | 20 Number of subjects |
| High Dose | Number of Subjects Reporting Unsolicited AEs After Any Vaccination. | Deaths | 4 Number of subjects |
| High Dose | Number of Subjects Reporting Unsolicited AEs After Any Vaccination. | Medically attended AEs | 171 Number of subjects |
| High Dose | Number of Subjects Reporting Unsolicited AEs After Any Vaccination. | AEs resulting in premature withdrawal from study | 4 Number of subjects |
| High Dose | Number of Subjects Reporting Unsolicited AEs After Any Vaccination. | AEs of Special Interest | 1 Number of subjects |
| High Dose | Number of Subjects Reporting Unsolicited AEs After Any Vaccination. | AEs leading to New Onset of Chronic Disease | 11 Number of subjects |
| Low Dose | Number of Subjects Reporting Unsolicited AEs After Any Vaccination. | AEs leading to New Onset of Chronic Disease | 14 Number of subjects |
| Low Dose | Number of Subjects Reporting Unsolicited AEs After Any Vaccination. | Any AEs | 92 Number of subjects |
| Low Dose | Number of Subjects Reporting Unsolicited AEs After Any Vaccination. | Medically attended AEs | 153 Number of subjects |
| Low Dose | Number of Subjects Reporting Unsolicited AEs After Any Vaccination. | At least possibly related AEs | 31 Number of subjects |
| Low Dose | Number of Subjects Reporting Unsolicited AEs After Any Vaccination. | AEs of Special Interest | 0 Number of subjects |
| Low Dose | Number of Subjects Reporting Unsolicited AEs After Any Vaccination. | Any SAEs | 8 Number of subjects |
| Low Dose | Number of Subjects Reporting Unsolicited AEs After Any Vaccination. | AEs resulting in premature withdrawal from study | 0 Number of subjects |
| Low Dose | Number of Subjects Reporting Unsolicited AEs After Any Vaccination. | Deaths | 0 Number of subjects |
Primary
Percentages Of Subjects Achieving Hemagglutinin Inhibition (HI) Titers ≥40 Against A/H5N1 Strain.
The optimal aH5N1c vaccine formulation was evaluated in terms of percentages of subjects achieving HI titers ≥40 against homologous A/H5N1 strain, three weeks after second vaccination with either low dose or high dose of aH5N1c vaccine, according to the Center for Biologics Evaluation and Research (CBER) criterion. CBER criterion for the adult population is met if the lower limit of the two-sided 95% confidence interval (CI) for the percentages of subjects achieving HI titer ≥40 meets or exceeds 70%.
Time frame: Three weeks after 2nd vaccination (day 43)
Population: Analysis was done on the Full Analysis Set (FAS) i.e., the subjects who actually receive at least one dose of study vaccination and provide at least one evaluable serum sample both before (baseline) and after vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| High Dose | Percentages Of Subjects Achieving Hemagglutinin Inhibition (HI) Titers ≥40 Against A/H5N1 Strain. | Day 1 | 4 Percentages of subjects |
| High Dose | Percentages Of Subjects Achieving Hemagglutinin Inhibition (HI) Titers ≥40 Against A/H5N1 Strain. | Day 43 (N=451,440) | 85 Percentages of subjects |
| Low Dose | Percentages Of Subjects Achieving Hemagglutinin Inhibition (HI) Titers ≥40 Against A/H5N1 Strain. | Day 1 | 4 Percentages of subjects |
| Low Dose | Percentages Of Subjects Achieving Hemagglutinin Inhibition (HI) Titers ≥40 Against A/H5N1 Strain. | Day 43 (N=451,440) | 63 Percentages of subjects |
Primary
Percentages Of Subjects Achieving Seroconversion Against A/H5N1 Strain.
Immunogenicity was measured in terms of the percentages of subjects achieving seroconversion or significant increase in HI titer against the vaccine strain, three weeks after receiving two injections of low dose or high dose of aH5N1c vaccine according to the CBER criterion. Seroconversion is defined as either a) in subjects with a prevaccination HI titer \<10, a postvaccination titer ≥40; or b) in subjects with prevaccination HI titer ≥10, a minimum four-fold rise in postvaccination HI antibody titer. CBER criterion for the adult population is met if the lower limit of the two-sided 95% CI for the percentages of subjects achieving seroconversion for HI antibody titer meets or exceeds 40%.
Time frame: Three weeks after 2nd vaccination (day 43)
Population: This analysis was done on the FAS population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| High Dose | Percentages Of Subjects Achieving Seroconversion Against A/H5N1 Strain. | 83 Percentages of subjects |
| Low Dose | Percentages Of Subjects Achieving Seroconversion Against A/H5N1 Strain. | 61 Percentages of subjects |
Secondary
Geometric Mean Ratios Against A/H5N1 Strain Following 2-dose Vaccination Schedule of Either Low Dose or High Dose aH5N1c Vaccine.
Immunogenicity was measured as the geometric mean ratio (GMR). The ratio of postvaccination to prevaccination HI GMTs, 3 weeks after first vaccination, 3 weeks after second vaccination and 12 months after second vaccination of either low dose or high dose of aH5N1c is reported. The criterion is met according to the European Committee for Medicinal Products for Human Use (CHMP) criterion if the geometric mean increase GMR (day 43/day 1) in HI antibody titer is \>2.5 for subjects 18-60 years of age.
Time frame: Day 1; day 22; day 43 and day 387
Population: Analysis was done on the FAS set.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| High Dose | Geometric Mean Ratios Against A/H5N1 Strain Following 2-dose Vaccination Schedule of Either Low Dose or High Dose aH5N1c Vaccine. | Day22/Day1 | 5.37 Ratio |
| High Dose | Geometric Mean Ratios Against A/H5N1 Strain Following 2-dose Vaccination Schedule of Either Low Dose or High Dose aH5N1c Vaccine. | Day43/Day1 (N=451,440) | 41 Ratio |
| High Dose | Geometric Mean Ratios Against A/H5N1 Strain Following 2-dose Vaccination Schedule of Either Low Dose or High Dose aH5N1c Vaccine. | Day387/Day1 (N=411,395) | 1.95 Ratio |
| Low Dose | Geometric Mean Ratios Against A/H5N1 Strain Following 2-dose Vaccination Schedule of Either Low Dose or High Dose aH5N1c Vaccine. | Day22/Day1 | 2.43 Ratio |
| Low Dose | Geometric Mean Ratios Against A/H5N1 Strain Following 2-dose Vaccination Schedule of Either Low Dose or High Dose aH5N1c Vaccine. | Day43/Day1 (N=451,440) | 11 Ratio |
| Low Dose | Geometric Mean Ratios Against A/H5N1 Strain Following 2-dose Vaccination Schedule of Either Low Dose or High Dose aH5N1c Vaccine. | Day387/Day1 (N=411,395) | 1.24 Ratio |
Secondary
Percentages Of Subjects Achieving Seroconversion Against A/H5N1 Strain.
Immunogenicity was assessed in terms of percentages of subjects achieving seroconversion in HI titers, 3 weeks after first vaccination, 3 weeks after second vaccination and 12 months after second vaccination of either low dose or high dose aH5N1c vaccine according to the CHMP criterion. Seroconversion is defined as: a) for subjects with a prevaccination HI titer \<10, a postvaccination titer ≥40; or b) for subjects with prevaccination HI titer ≥10, a minimum four-fold rise in postvaccination HI antibody titer. The criterion is met according to the European (CHMP) guideline if the percentage of subjects achieving seroconversion (at day 43) is \>40%.
Time frame: Day 22, day 43 and day 387
Population: Analysis was done on the FAS set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| High Dose | Percentages Of Subjects Achieving Seroconversion Against A/H5N1 Strain. | Day 22 | 48 Percentages of subjects |
| High Dose | Percentages Of Subjects Achieving Seroconversion Against A/H5N1 Strain. | Day 43 (N=451,440) | 83 Percentages of subjects |
| High Dose | Percentages Of Subjects Achieving Seroconversion Against A/H5N1 Strain. | Day 387 (N=411,395) | 22 Percentages of subjects |
| Low Dose | Percentages Of Subjects Achieving Seroconversion Against A/H5N1 Strain. | Day 22 | 27 Percentages of subjects |
| Low Dose | Percentages Of Subjects Achieving Seroconversion Against A/H5N1 Strain. | Day 43 (N=451,440) | 61 Percentages of subjects |
| Low Dose | Percentages Of Subjects Achieving Seroconversion Against A/H5N1 Strain. | Day 387 (N=411,395) | 9 Percentages of subjects |
Secondary
Percentages Of Subjects With HI Titers ≥40 Against A/H5N1 Strain.
Immunogenicity was assessed in terms of percentage of subjects achieving HI titers ≥40, 3 weeks after first vaccination, 3 weeks after second vaccination and 12 months after second vaccination of either low dose or high dose of aH5N1c according to the CHMP criterion. European Licensure (CHMP) criterion is met if the percentage of subjects achieving (at day 43) HI titers ≥40 is \>70%.
Time frame: Day 1, day 22, day 43 and day 387
Population: Analysis was done on the FAS set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| High Dose | Percentages Of Subjects With HI Titers ≥40 Against A/H5N1 Strain. | Day 1 | 4 Percentages of subjects |
| High Dose | Percentages Of Subjects With HI Titers ≥40 Against A/H5N1 Strain. | Day 43 (N=451,440) | 85 Percentages of subjects |
| High Dose | Percentages Of Subjects With HI Titers ≥40 Against A/H5N1 Strain. | Day 22 (N=464,461) | 52 Percentages of subjects |
| High Dose | Percentages Of Subjects With HI Titers ≥40 Against A/H5N1 Strain. | Day 387 (N=411,395) | 27 Percentages of subjects |
| Low Dose | Percentages Of Subjects With HI Titers ≥40 Against A/H5N1 Strain. | Day 22 (N=464,461) | 30 Percentages of subjects |
| Low Dose | Percentages Of Subjects With HI Titers ≥40 Against A/H5N1 Strain. | Day 1 | 4 Percentages of subjects |
| Low Dose | Percentages Of Subjects With HI Titers ≥40 Against A/H5N1 Strain. | Day 387 (N=411,395) | 11 Percentages of subjects |
| Low Dose | Percentages Of Subjects With HI Titers ≥40 Against A/H5N1 Strain. | Day 43 (N=451,440) | 63 Percentages of subjects |