Pandemic H5N1 Influenza
Conditions
Keywords
Influenza, Pandemic, H5N1, Elderly adults
Brief summary
Evaluate Safety, Tolerability and Immune response of adjuvanted H5N1 cell culture derived influenza vaccine in elderly 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
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Healthy elderly subjects ≥65 years, 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 serious 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. Body mass index (BMI) ≥ 35 kg/m2, 15. History of drug or alcohol abuse, 16. Any planned surgery during study period, 17. Individuals conducting the study and their immediate family members, 18. Individuals with behavioral or cognitive impairment or psychiatric diseases.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Percentages Of Subjects Achieving Hemagglutination Inhibition (HI) Titers ≥40 Against A/H5N1 Strain. | Baseline (day 1) and 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. The CBER criterion for the elderly 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 60%. |
| The 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, a postvaccination titer ≥40 in subjects with a prevaccination HI titer \<10; or in subjects with prevaccination HI titer ≥10, a minimum four-fold rise in postvaccination HI antibody titer. The CBER criterion for the elderly 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 30%. |
| Number of Subjects Reporting Solicited Local and Systemic Adverse Events, After Any Vaccination. | From day 1 through day 7 after any vaccination. | Safety was assessed as the number of subjects who reported solicited local and systemic adverse events following vaccination with either low or high dose of aH5N1c vaccine. |
| Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination. | Day 1 through day 387 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 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, three weeks after second vaccination with aH5N1c according to the CHMP criterion. The European Licensure (CHMP) criterion is met if the percentage of subjects achieving HI titers ≥40 is \>60%. |
| The 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, three weeks after receiving two injections of either low dose or high dose aH5N1c vaccine according to the CHMP criterion. Seroconversion is defined as a postvaccination titer ≥40 in subjects with a prevaccination HI titer \<10; or in 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 is \>30%. |
| Geometric Mean Ratios (GMR) 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 GMR. The ratio of postvaccination to prevaccination HI geometric mean titers (GMTs) 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 \>2.0 for subjects \>60 years of age. |
Countries
Australia, New Zealand, Thailand, United States
Participant flow
Recruitment details
1393 subjects were enrolled at 12 centers in the US, 5 centers in Australia, 2 centers in New Zealand and 4 centers 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 of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart. | 700 |
| Low Dose Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart. | 693 |
| Total | 1,393 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Administrative Reason | 5 | 5 |
| Overall Study | Death | 1 | 1 |
| Overall Study | Lost to Follow-up | 1 | 3 |
| Overall Study | Protocol Violation | 1 | 1 |
| Overall Study | Unclassified | 2 | 2 |
| Overall Study | Withdrawal by Subject | 14 | 5 |
Baseline characteristics
| Characteristic | High Dose | Low Dose | Total |
|---|---|---|---|
| Age, Continuous | 71.2 year STANDARD_DEVIATION 5.1 | 70.7 year STANDARD_DEVIATION 4.7 | 71.0 year STANDARD_DEVIATION 4.9 |
| Sex: Female, Male FEMALE | 407 Participants | 418 Participants | 825 Participants |
| Sex: Female, Male MALE | 293 Participants | 275 Participants | 568 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 | 481 / 699 | 427 / 689 | 908 / 1,388 |
| serious Total, serious adverse events | 43 / 699 | 51 / 689 | 94 / 1,388 |
Outcome results
Primary
Number of Subjects Reporting Solicited Local and Systemic Adverse Events, After Any Vaccination.
Safety was assessed as the number of subjects who reported solicited local and systemic adverse events 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 solicited safety population, i.e. All subjects in the exposed set with solicited (local/systemic) AE data..
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| High Dose | Number of Subjects Reporting Solicited Local and Systemic Adverse Events, After Any Vaccination. | Any Local | 314 Number of subjects |
| High Dose | Number of Subjects Reporting Solicited Local and Systemic Adverse Events, After Any Vaccination. | Arthralgia (N=692,681) | 65 Number of subjects |
| High Dose | Number of Subjects Reporting Solicited Local and Systemic Adverse Events, After Any Vaccination. | Injection site Pain (N=693,681) | 309 Number of subjects |
| High Dose | Number of Subjects Reporting Solicited Local and Systemic Adverse Events, After Any Vaccination. | Headache (N=692,678) | 92 Number of subjects |
| High Dose | Number of Subjects Reporting Solicited Local and Systemic Adverse Events, After Any Vaccination. | Injection site Induration (N=693,683) | 20 Number of subjects |
| High Dose | Number of Subjects Reporting Solicited Local and Systemic Adverse Events, After Any Vaccination. | Fatigue (N=692,681) | 116 Number of subjects |
| High Dose | Number of Subjects Reporting Solicited Local and Systemic Adverse Events, After Any Vaccination. | Any Systemic | 250 Number of subjects |
| High Dose | Number of Subjects Reporting Solicited Local and Systemic Adverse Events, After Any Vaccination. | Loss of Appetite (N=683,673) | 40 Number of subjects |
| High Dose | Number of Subjects Reporting Solicited Local and Systemic Adverse Events, After Any Vaccination. | Injection site Erythema (N=693,681) | 17 Number of subjects |
| High Dose | Number of Subjects Reporting Solicited Local and Systemic Adverse Events, After Any Vaccination. | Malaise (N=692,680) | 116 Number of subjects |
| High Dose | Number of Subjects Reporting Solicited Local and Systemic Adverse Events, After Any Vaccination. | Nausea (N=692,681) | 45 Number of subjects |
| High Dose | Number of Subjects Reporting Solicited Local and Systemic Adverse Events, After Any Vaccination. | Fever (≥38°C; N=693,681) | 16 Number of subjects |
| High Dose | Number of Subjects Reporting Solicited Local and Systemic Adverse Events, After Any Vaccination. | Injection site Ecchymosis (N=692,682) | 7 Number of subjects |
| High Dose | Number of Subjects Reporting Solicited Local and Systemic Adverse Events, After Any Vaccination. | Prevention of Pain and (or) Fever (N=691,682) | 18 Number of subjects |
| High Dose | Number of Subjects Reporting Solicited Local and Systemic Adverse Events, After Any Vaccination. | Myalgia (N=691,681) | 91 Number of subjects |
| High Dose | Number of Subjects Reporting Solicited Local and Systemic Adverse Events, After Any Vaccination. | Treatment of Pain and (or) Fever (N=691,682) | 56 Number of subjects |
| Low Dose | Number of Subjects Reporting Solicited Local and Systemic Adverse Events, After Any Vaccination. | Treatment of Pain and (or) Fever (N=691,682) | 46 Number of subjects |
| Low Dose | Number of Subjects Reporting Solicited Local and Systemic Adverse Events, After Any Vaccination. | Any Local | 212 Number of subjects |
| Low Dose | Number of Subjects Reporting Solicited Local and Systemic Adverse Events, After Any Vaccination. | Injection site Erythema (N=693,681) | 5 Number of subjects |
| Low Dose | Number of Subjects Reporting Solicited Local and Systemic Adverse Events, After Any Vaccination. | Injection site Induration (N=693,683) | 11 Number of subjects |
| Low Dose | Number of Subjects Reporting Solicited Local and Systemic Adverse Events, After Any Vaccination. | Injection site Ecchymosis (N=692,682) | 10 Number of subjects |
| Low Dose | Number of Subjects Reporting Solicited Local and Systemic Adverse Events, After Any Vaccination. | Injection site Pain (N=693,681) | 203 Number of subjects |
| Low Dose | Number of Subjects Reporting Solicited Local and Systemic Adverse Events, After Any Vaccination. | Any Systemic | 228 Number of subjects |
| Low Dose | Number of Subjects Reporting Solicited Local and Systemic Adverse Events, After Any Vaccination. | Nausea (N=692,681) | 44 Number of subjects |
| Low Dose | Number of Subjects Reporting Solicited Local and Systemic Adverse Events, After Any Vaccination. | Myalgia (N=691,681) | 85 Number of subjects |
| Low Dose | Number of Subjects Reporting Solicited Local and Systemic Adverse Events, After Any Vaccination. | Arthralgia (N=692,681) | 69 Number of subjects |
| Low Dose | Number of Subjects Reporting Solicited Local and Systemic Adverse Events, After Any Vaccination. | Headache (N=692,678) | 89 Number of subjects |
| Low Dose | Number of Subjects Reporting Solicited Local and Systemic Adverse Events, After Any Vaccination. | Fatigue (N=692,681) | 112 Number of subjects |
| Low Dose | Number of Subjects Reporting Solicited Local and Systemic Adverse Events, After Any Vaccination. | Loss of Appetite (N=683,673) | 42 Number of subjects |
| Low Dose | Number of Subjects Reporting Solicited Local and Systemic Adverse Events, After Any Vaccination. | Malaise (N=692,680) | 117 Number of subjects |
| Low Dose | Number of Subjects Reporting Solicited Local and Systemic Adverse Events, After Any Vaccination. | Fever (≥38°C; N=693,681) | 4 Number of subjects |
| Low Dose | Number of Subjects Reporting Solicited Local and Systemic Adverse Events, After Any Vaccination. | Prevention of Pain and (or) Fever (N=691,682) | 26 Number of subjects |
Primary
Number of Subjects Reporting Unsolicited Adverse Events 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 aH5N1c vaccine
Time frame: Day 1 through day 387 after any vaccination
Population: Analysis was done unsolicited safety population, i.e. subjects in the exposed set with unsolicited AE data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| High Dose | Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination. | Any AEs (Day 1 to 22; N=694,685) | 147 Number of subjects |
| High Dose | Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination. | At least possibly related AEs(Day1to22;N=694,685) | 56 Number of subjects |
| High Dose | Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination. | Any AEs (Day 23 to 43; N=689,681) | 101 Number of subjects |
| High Dose | Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination. | At least possibly related AEs(Day23to43;N=689,681) | 21 Number of subjects |
| High Dose | Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination. | Any SAEs | 43 Number of subjects |
| High Dose | Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination. | Deaths | 1 Number of subjects |
| High Dose | Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination. | Medically attended AEs | 383 Number of subjects |
| High Dose | Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination. | Premature withdrawal from study | 1 Number of subjects |
| High Dose | Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination. | AESIs | 2 Number of subjects |
| High Dose | Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination. | NOCD | 108 Number of subjects |
| Low Dose | Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination. | Premature withdrawal from study | 1 Number of subjects |
| Low Dose | Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination. | Any AEs (Day 1 to 22; N=694,685) | 149 Number of subjects |
| Low Dose | Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination. | Deaths | 1 Number of subjects |
| Low Dose | Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination. | At least possibly related AEs(Day1to22;N=694,685) | 61 Number of subjects |
| Low Dose | Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination. | NOCD | 92 Number of subjects |
| Low Dose | Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination. | Any AEs (Day 23 to 43; N=689,681) | 123 Number of subjects |
| Low Dose | Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination. | Medically attended AEs | 373 Number of subjects |
| Low Dose | Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination. | At least possibly related AEs(Day23to43;N=689,681) | 37 Number of subjects |
| Low Dose | Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination. | AESIs | 0 Number of subjects |
| Low Dose | Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination. | Any SAEs | 53 Number of subjects |
Primary
The Percentages Of Subjects Achieving Hemagglutination 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. The CBER criterion for the elderly 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 60%.
Time frame: Baseline (day 1) and Three weeks after 2nd vaccination (day 43)
Population: Analysis was done on the Full Analysis Set (FAS) i.e., 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 | The Percentages Of Subjects Achieving Hemagglutination Inhibition (HI) Titers ≥40 Against A/H5N1 Strain. | Day 1 | 12 Percentages of subjects |
| High Dose | The Percentages Of Subjects Achieving Hemagglutination Inhibition (HI) Titers ≥40 Against A/H5N1 Strain. | Day 43 (N=673,664) | 81 Percentages of subjects |
| Low Dose | The Percentages Of Subjects Achieving Hemagglutination Inhibition (HI) Titers ≥40 Against A/H5N1 Strain. | Day 43 (N=673,664) | 63 Percentages of subjects |
| Low Dose | The Percentages Of Subjects Achieving Hemagglutination Inhibition (HI) Titers ≥40 Against A/H5N1 Strain. | Day 1 | 10 Percentages of subjects |
Primary
The 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, a postvaccination titer ≥40 in subjects with a prevaccination HI titer \<10; or in subjects with prevaccination HI titer ≥10, a minimum four-fold rise in postvaccination HI antibody titer. The CBER criterion for the elderly 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 30%.
Time frame: Three weeks after 2nd vaccination (day 43)
Population: This analysis was done on the FAS.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| High Dose | The Percentages Of Subjects Achieving Seroconversion Against A/H5N1 Strain. | 74 Percentages of subjects |
| Low Dose | The Percentages Of Subjects Achieving Seroconversion Against A/H5N1 Strain. | 52 Percentages of subjects |
Secondary
Geometric Mean Ratios (GMR) Against A/H5N1 Strain Following 2-dose Vaccination Schedule of Either Low Dose or High Dose aH5N1c Vaccine.
Immunogenicity was measured as the GMR. The ratio of postvaccination to prevaccination HI geometric mean titers (GMTs) 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 \>2.0 for subjects \>60 years of age.
Time frame: Day 1; day 22; day 43 and day 387
Population: Analysis was done on the FAS.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| High Dose | Geometric Mean Ratios (GMR) Against A/H5N1 Strain Following 2-dose Vaccination Schedule of Either Low Dose or High Dose aH5N1c Vaccine. | A/H5N1 (Day22/Day1) | 3.21 Ratio |
| High Dose | Geometric Mean Ratios (GMR) Against A/H5N1 Strain Following 2-dose Vaccination Schedule of Either Low Dose or High Dose aH5N1c Vaccine. | A/H5N1 (Day43/Day1; N=673,664) | 16 Ratio |
| High Dose | Geometric Mean Ratios (GMR) Against A/H5N1 Strain Following 2-dose Vaccination Schedule of Either Low Dose or High Dose aH5N1c Vaccine. | A/H5N1 (Day387/Day1; N=658,651) | 1.97 Ratio |
| Low Dose | Geometric Mean Ratios (GMR) Against A/H5N1 Strain Following 2-dose Vaccination Schedule of Either Low Dose or High Dose aH5N1c Vaccine. | A/H5N1 (Day43/Day1; N=673,664) | 5.72 Ratio |
| Low Dose | Geometric Mean Ratios (GMR) Against A/H5N1 Strain Following 2-dose Vaccination Schedule of Either Low Dose or High Dose aH5N1c Vaccine. | A/H5N1 (Day22/Day1) | 2.01 Ratio |
| Low Dose | Geometric Mean Ratios (GMR) Against A/H5N1 Strain Following 2-dose Vaccination Schedule of Either Low Dose or High Dose aH5N1c Vaccine. | A/H5N1 (Day387/Day1; N=658,651) | 1.3 Ratio |
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, three weeks after second vaccination with aH5N1c according to the CHMP criterion. The European Licensure (CHMP) criterion is met if the percentage of subjects achieving HI titers ≥40 is \>60%.
Time frame: Day 1, day 22, day 43 and day 387.
Population: Analysis was done on the FAS.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| High Dose | Percentages Of Subjects With HI Titers ≥40 Against A/H5N1 Strain | Day 1 | 12 Percentages of subjects |
| High Dose | Percentages Of Subjects With HI Titers ≥40 Against A/H5N1 Strain | Day 43 (N=673,664) | 81 Percentages of subjects |
| High Dose | Percentages Of Subjects With HI Titers ≥40 Against A/H5N1 Strain | Day 22 (N=681,673) | 49 Percentages of subjects |
| High Dose | Percentages Of Subjects With HI Titers ≥40 Against A/H5N1 Strain | Day 387 (N=658,651) | 35 Percentages of subjects |
| Low Dose | Percentages Of Subjects With HI Titers ≥40 Against A/H5N1 Strain | Day 22 (N=681,673) | 32 Percentages of subjects |
| Low Dose | Percentages Of Subjects With HI Titers ≥40 Against A/H5N1 Strain | Day 1 | 10 Percentages of subjects |
| Low Dose | Percentages Of Subjects With HI Titers ≥40 Against A/H5N1 Strain | Day 387 (N=658,651) | 16 Percentages of subjects |
| Low Dose | Percentages Of Subjects With HI Titers ≥40 Against A/H5N1 Strain | Day 43 (N=673,664) | 63 Percentages of subjects |
Secondary
The Percentages Of Subjects Achieving Seroconversion Against A/H5N1 Strain
Immunogenicity was assessed in terms of percentages of subjects achieving seroconversion in HI titers, three weeks after receiving two injections of either low dose or high dose aH5N1c vaccine according to the CHMP criterion. Seroconversion is defined as a postvaccination titer ≥40 in subjects with a prevaccination HI titer \<10; or in 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 is \>30%.
Time frame: Day 22, day 43 and day 387
Population: Analysis was done on the FAS.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| High Dose | The Percentages Of Subjects Achieving Seroconversion Against A/H5N1 Strain | Day 22 | 36 Percentages of subjects |
| High Dose | The Percentages Of Subjects Achieving Seroconversion Against A/H5N1 Strain | Day 43 (N=673,664) | 74 Percentages of subjects |
| High Dose | The Percentages Of Subjects Achieving Seroconversion Against A/H5N1 Strain | Day 387 (N=658,651) | 23 Percentages of subjects |
| Low Dose | The Percentages Of Subjects Achieving Seroconversion Against A/H5N1 Strain | Day 22 | 21 Percentages of subjects |
| Low Dose | The Percentages Of Subjects Achieving Seroconversion Against A/H5N1 Strain | Day 43 (N=673,664) | 52 Percentages of subjects |
| Low Dose | The Percentages Of Subjects Achieving Seroconversion Against A/H5N1 Strain | Day 387 (N=658,651) | 10 Percentages of subjects |