Influenza
Conditions
Keywords
human, Avian, safety, vaccines, influenza, pandemic, immunogenicity, H5N1
Brief summary
The purpose of this observer-blind study is to determine whether GSK's avian flu vaccine GSK 1557484A is immunogenic when given to adults aged 18-64 years.
Detailed description
All enrolled subjects will receive 1 dose of study vaccine. All subjects will attend formal study center visits for safety and immunogenicity assessments on Days 0, 10, 42, 84, and 182 with a telephone safety contact on Day 364. This Protocol Posting has been updated according to Protocol amendment, 8 Dec 08
Interventions
BIOLOGICALGSK A/turkey H5N1 Influenza vaccine
One dose administered intramuscularly (IM) in the deltoid region. Different formulations are tested.
Sponsors
GlaxoSmithKline
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
* Male and female adults 18 to 64 years of age at time of first vaccination, inclusive. * Written informed consent obtained from the subject. * Stable health status as defined by absence of a health event satisfying the definition of a SAE, or a change in an ongoing drug therapy due to therapeutic failure or symptoms of drug toxicity, within 1 month prior to enrollment. * Access to a consistent means of telephone contact, which may be either in the home or at the workplace, land line, or mobile, but NOT a pay phone or other multiple-user device. * Comprehension of the study requirements, expressed availability for the required study period, and ability to attend scheduled visits. * Subjects who the investigator believes can and will comply with the requirements of the protocol.
Exclusion criteria
* Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, even if clinically stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports. * Diagnosed with cancer, or treatment for cancer, within 3 years. * Presence of an oral temperature \>= 37.8ºC, or acute symptoms greater than mild severity on the scheduled date of vaccination. * Any confirmed or suspected immunosuppressive or immunodeficiency condition including history of human immunodeficiency virus (HIV) infection. * Receipt of systemic glucocorticoids (prednisone \>= 10 mg/day for more than 14 consecutive days) within 1 month prior to study enrollment, or any other cytotoxic or immunosuppressive drug within 6 months of study enrollment. * An acute evolving neurological disorder or history of Guillain-Barré syndrome within 6 weeks of receipt of seasonal influenza vaccine. * Any significant disorder of coagulation or treatment with Coumadin derivatives or heparin. * Administration of any vaccines within 30 days before the first study vaccine dose. * Previous administration of any H5N1 vaccine. * Use of any investigational or non-registered product (drug or vaccine) or planned participation in another investigational study within 30 days prior to study enrollment, or during the 12 months following test article administration. Use of any investigational or non-registered product with immunosuppressive properties is exclusionary at any time during the trial. * Receipt of any immunoglobulins and/or any blood products within 3 months of study enrollment or planned administration of any of these products during the study period. * Any known or suspected allergy to any constituent of influenza vaccines; 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 prior to vaccination. * Lactating or nursing. * Women of child bearing potential (who lack a history of reliable contraceptive practices. The provision of this history does NOT replace the requirement to perform, and obtain negative results in pregnancy urine tests prior to vaccination. * Known receipt of analgesic or antipyretic medication with the specific intent of prophylaxis of vaccine reactogenicity on the day of vaccination. Subjects on stable chronic regimens of potentially analgesic or anti-pyretic medications for pre-existing diagnoses are not required to discontinue them.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. | At Day 10 | A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination (Day 0) titer less than (\<) 1:10 for HI and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40, or a pre-vaccination reciprocal titer ≥ 1:10 for HI and at least a 4-fold increase in post-vaccination reciprocal titer. |
| Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain | At Day 10 | A seroprotected subject against the A/turkey virus strain was defined as a subject with serum HI antibody reciprocal titer ≥ 1:40 post-vaccination, a level of HI antibodies that may correlate with benefit in protection against influenza. |
| Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. | At Day 10 | HI antibody titers were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of ≥ 1:10. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HI Antibody Titers Against the A/Indonesia/5/2005 (A/Indo) Virus Strain. | At Day 0, Day 10, Day 42 and Day 182 | Titers were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of ≥ 1:10 |
| Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) and A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains. | At Day 0, Day 10, Day 42 and Day 182 for A/Indo and at Day 0, Day 42 and Day 182 for A/turkey virus strains. | A seroprotected subject was defined as a subject with serum HI antibody reciprocal titer ≥ 1:40 post-vaccination, a level of HI antibodies that may correlate with benefit in protection against influenza. |
| Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) Virus Strains. | At Day 0 to Day 10, Day 42 and Day 182 | A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (\<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. |
| HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Indonesia/5/2005 (A/Indo) Virus Strains. | At Day 10, Day 42 and Day 182 | GMFR were defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer. |
| Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | At Day 0, Day 10, Day 42 and Day 182 | MN antibody titers were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of ≥ 1:28. |
| Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | At Day 0, Day 10, Day 42 and Day 182 | A seropositive subject was defined as a vaccinated subject who had a MN antibody titer ≥ the cut-off value of 1:28. |
| Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains. | At Day 0 to Day 42 and at Day 0 to Day 182 | A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination (Day 0) titer less than (\<) 1:10 for HI and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40, or a pre-vaccination reciprocal titer ≥ 1:10 for HI and at least a 4-fold increase in post-vaccination reciprocal titer. |
| Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains | At Day 42 | VRR was defined as a 4-fold rise from a detectable baseline titer or a rise from undetectable (\< 1:28, recorded 1:14 if \< 1:28) to ≥ 1:56 in the subjects. |
| Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Within the 7-day (Days 0-6) post vaccination period. | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any solicited local symptoms regardless of their intensity grade. |
| Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms. | Within the 7-day (Days 0-6) post vaccination period. | Solicited general symptoms assessed were fatigue, headache, joint pain at other location (joint pain), muscle aches, shivering, sweating and fever. Any =occurrence of any solicited general symptoms reported irrespective of intensity grade and relationship to vaccination. Any fever = oral temperature ≥ 38.0 degrees Celsius (°C). |
| Number of Subjects With Medically-attended Adverse Events (MAEs). | From Day 0 to Day 378 | MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s). |
| Number of Subjects Reporting Any Unsolicited Adverse Events (AEs). | From Day 0 to Day 42 | An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and 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. |
| Number of Subjects Reporting Serious Adverse Events (SAEs). | From Day 0 to Day 378 | A SAE was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of 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. |
| Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | At Day 10 | VRR was defined as a 4-fold rise from a detectable baseline titer or a rise from undetectable (\< 1:28, recorded 1:14 if \< 1:28) to ≥ 1:56 in the subjects. |
| Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 Virus Strain. | At Day 0, Day 10, Day 42 and Day 182 | Titers were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of ≥ 1:10 |
| HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. | At Day 0 to Day 10, Day 42 and Day 182 | GMFR were defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer. |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| A/Turkey H5N1 Influenza Formulation A Group Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | 49 |
| A/Turkey H5N1 Influenza Formulation B1 Group Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | 72 |
| A/Turkey H5N1 Influenza Formulation B2 Group Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | 41 |
| A/Turkey H5N1 Influenza Formulation C1 Group Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | 60 |
| A/Turkey H5N1 Influenza Formulation C2 Group Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | 40 |
| A/Turkey H5N1 Influenza Formulation D1 Group Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | 61 |
| A/Turkey H5N1 Influenza Formulation D2 Group Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | 46 |
| A/Turkey H5N1 Influenza Formulation E1 Group Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | 59 |
| A/Turkey H5N1 Influenza Formulation E2 Group Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | 41 |
| Total | 469 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 |
|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 | 1 | 1 | 0 | 1 | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | A/Turkey H5N1 Influenza Formulation A Group | A/Turkey H5N1 Influenza Formulation B1 Group | A/Turkey H5N1 Influenza Formulation B2 Group | A/Turkey H5N1 Influenza Formulation C1 Group | A/Turkey H5N1 Influenza Formulation C2 Group | A/Turkey H5N1 Influenza Formulation D1 Group | A/Turkey H5N1 Influenza Formulation D2 Group | A/Turkey H5N1 Influenza Formulation E1 Group | A/Turkey H5N1 Influenza Formulation E2 Group | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 42.3 Years STANDARD_DEVIATION 11.47 | 40.6 Years STANDARD_DEVIATION 12.02 | 41.1 Years STANDARD_DEVIATION 11.82 | 41.2 Years STANDARD_DEVIATION 12.33 | 41.1 Years STANDARD_DEVIATION 12.46 | 42.4 Years STANDARD_DEVIATION 11.15 | 41.2 Years STANDARD_DEVIATION 9.78 | 40.6 Years STANDARD_DEVIATION 12.01 | 41.6 Years STANDARD_DEVIATION 11.6 | 41.3 Years STANDARD_DEVIATION 11.55 |
| Sex: Female, Male Female | 29 Participants | 42 Participants | 20 Participants | 38 Participants | 21 Participants | 40 Participants | 31 Participants | 37 Participants | 19 Participants | 277 Participants |
| Sex: Female, Male Male | 20 Participants | 30 Participants | 21 Participants | 22 Participants | 19 Participants | 21 Participants | 15 Participants | 22 Participants | 22 Participants | 192 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 45 / 49 | 60 / 72 | 15 / 41 | 54 / 60 | 19 / 40 | 52 / 61 | 21 / 46 | 51 / 59 | 21 / 41 |
| serious Total, serious adverse events | 1 / 49 | 0 / 72 | 1 / 41 | 1 / 60 | 3 / 40 | 1 / 61 | 1 / 46 | 0 / 59 | 0 / 41 |
Outcome results
Primary
Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.
HI antibody titers were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of ≥ 1:10.
Time frame: At Day 10
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| A/Turkey H5N1 Influenza A Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. | 229.6 Titer |
| A/Turkey H5N1 Influenza B1 + D1 Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. | 847.3 Titer |
| A/Turkey H5N1 Influenza C1 + E1 Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. | 810.5 Titer |
| A/Turkey H5N1 Influenza B2 + D2 Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. | 121.9 Titer |
| A/Turkey H5N1 Influenza C2 + E2 Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. | 86.9 Titer |
| A/Turkey H5N1 Influenza B1 + C1 Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. | 838.5 Titer |
| A/Turkey H5N1 Influenza D1 + E1 Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. | 819.8 Titer |
| A/Turkey H5N1 Influenza B2 + C2 Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. | 97.9 Titer |
| A/Turkey H5N1 Influenza D2 + E2 Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. | 108.6 Titer |
Primary
Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination (Day 0) titer less than (\<) 1:10 for HI and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40, or a pre-vaccination reciprocal titer ≥ 1:10 for HI and at least a 4-fold increase in post-vaccination reciprocal titer.
Time frame: At Day 10
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| A/Turkey H5N1 Influenza A Group | Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. | 43 Participants |
| A/Turkey H5N1 Influenza B1 + D1 Group | Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. | 121 Participants |
| A/Turkey H5N1 Influenza C1 + E1 Group | Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. | 109 Participants |
| A/Turkey H5N1 Influenza B2 + D2 Group | Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. | 57 Participants |
| A/Turkey H5N1 Influenza C2 + E2 Group | Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. | 56 Participants |
| A/Turkey H5N1 Influenza B1 + C1 Group | Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. | 122 Participants |
| A/Turkey H5N1 Influenza D1 + E1 Group | Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. | 108 Participants |
| A/Turkey H5N1 Influenza B2 + C2 Group | Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. | 51 Participants |
| A/Turkey H5N1 Influenza D2 + E2 Group | Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. | 62 Participants |
Primary
Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain
A seroprotected subject against the A/turkey virus strain was defined as a subject with serum HI antibody reciprocal titer ≥ 1:40 post-vaccination, a level of HI antibodies that may correlate with benefit in protection against influenza.
Time frame: At Day 10
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| A/Turkey H5N1 Influenza A Group | Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain | 44 Participants |
| A/Turkey H5N1 Influenza B1 + D1 Group | Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain | 125 Participants |
| A/Turkey H5N1 Influenza C1 + E1 Group | Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain | 113 Participants |
| A/Turkey H5N1 Influenza B2 + D2 Group | Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain | 76 Participants |
| A/Turkey H5N1 Influenza C2 + E2 Group | Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain | 67 Participants |
| A/Turkey H5N1 Influenza B1 + C1 Group | Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain | 127 Participants |
| A/Turkey H5N1 Influenza D1 + E1 Group | Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain | 111 Participants |
| A/Turkey H5N1 Influenza B2 + C2 Group | Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain | 69 Participants |
| A/Turkey H5N1 Influenza D2 + E2 Group | Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain | 74 Participants |
Secondary
Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 Virus Strain.
Titers were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of ≥ 1:10
Time frame: At Day 0, Day 10, Day 42 and Day 182
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| A/Turkey H5N1 Influenza A Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 Virus Strain. | A/turkey, D 42 | 155.4 Titer |
| A/Turkey H5N1 Influenza A Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 Virus Strain. | A/turkey, D 182 | 40.9 Titer |
| A/Turkey H5N1 Influenza A Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 Virus Strain. | A/turkey, D 10 | 229.6 Titer |
| A/Turkey H5N1 Influenza A Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 Virus Strain. | A/turkey, D 0 | 6.1 Titer |
| A/Turkey H5N1 Influenza B1 + D1 Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 Virus Strain. | A/turkey, D 0 | 13.5 Titer |
| A/Turkey H5N1 Influenza B1 + D1 Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 Virus Strain. | A/turkey, D 182 | 221.5 Titer |
| A/Turkey H5N1 Influenza B1 + D1 Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 Virus Strain. | A/turkey, D 42 | 652.2 Titer |
| A/Turkey H5N1 Influenza B1 + D1 Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 Virus Strain. | A/turkey, D 10 | 847.3 Titer |
| A/Turkey H5N1 Influenza C1 + E1 Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 Virus Strain. | A/turkey, D 182 | 238.4 Titer |
| A/Turkey H5N1 Influenza C1 + E1 Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 Virus Strain. | A/turkey, D 42 | 699.5 Titer |
| A/Turkey H5N1 Influenza C1 + E1 Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 Virus Strain. | A/turkey, D 10 | 810.5 Titer |
| A/Turkey H5N1 Influenza C1 + E1 Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 Virus Strain. | A/turkey, D 0 | 14.4 Titer |
| A/Turkey H5N1 Influenza B2 + D2 Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 Virus Strain. | A/turkey, D 182 | 62.7 Titer |
| A/Turkey H5N1 Influenza B2 + D2 Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 Virus Strain. | A/turkey, D 10 | 121.9 Titer |
| A/Turkey H5N1 Influenza B2 + D2 Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 Virus Strain. | A/turkey, D 42 | 126.3 Titer |
| A/Turkey H5N1 Influenza B2 + D2 Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 Virus Strain. | A/turkey, D 0 | 14.2 Titer |
| A/Turkey H5N1 Influenza C2 + E2 Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 Virus Strain. | A/turkey, D 182 | 42.9 Titer |
| A/Turkey H5N1 Influenza C2 + E2 Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 Virus Strain. | A/turkey, D 0 | 10.9 Titer |
| A/Turkey H5N1 Influenza C2 + E2 Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 Virus Strain. | A/turkey, D 10 | 86.9 Titer |
| A/Turkey H5N1 Influenza C2 + E2 Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 Virus Strain. | A/turkey, D 42 | 81.4 Titer |
| A/Turkey H5N1 Influenza B1 + C1 Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 Virus Strain. | A/turkey, D 182 | 213.3 Titer |
| A/Turkey H5N1 Influenza B1 + C1 Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 Virus Strain. | A/turkey, D 0 | 14.1 Titer |
| A/Turkey H5N1 Influenza B1 + C1 Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 Virus Strain. | A/turkey, D 10 | 838.5 Titer |
| A/Turkey H5N1 Influenza B1 + C1 Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 Virus Strain. | A/turkey, D 42 | 653.9 Titer |
| A/Turkey H5N1 Influenza D1 + E1 Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 Virus Strain. | A/turkey, D 42 | 697.8 Titer |
| A/Turkey H5N1 Influenza D1 + E1 Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 Virus Strain. | A/turkey, D 0 | 13.7 Titer |
| A/Turkey H5N1 Influenza D1 + E1 Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 Virus Strain. | A/turkey, D 10 | 819.8 Titer |
| A/Turkey H5N1 Influenza D1 + E1 Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 Virus Strain. | A/turkey, D 182 | 249.1 Titer |
| A/Turkey H5N1 Influenza B2 + C2 Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 Virus Strain. | A/turkey, D 10 | 97.9 Titer |
| A/Turkey H5N1 Influenza B2 + C2 Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 Virus Strain. | A/turkey, D 42 | 90.9 Titer |
| A/Turkey H5N1 Influenza B2 + C2 Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 Virus Strain. | A/turkey, D 0 | 13.2 Titer |
| A/Turkey H5N1 Influenza B2 + C2 Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 Virus Strain. | A/turkey, D 182 | 51.1 Titer |
| A/Turkey H5N1 Influenza D2 + E2 Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 Virus Strain. | A/turkey, D 182 | 53.2 Titer |
| A/Turkey H5N1 Influenza D2 + E2 Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 Virus Strain. | A/turkey, D 0 | 11.8 Titer |
| A/Turkey H5N1 Influenza D2 + E2 Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 Virus Strain. | A/turkey, D 10 | 108.6 Titer |
| A/Turkey H5N1 Influenza D2 + E2 Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 Virus Strain. | A/turkey, D 42 | 113.6 Titer |
Secondary
HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Indonesia/5/2005 (A/Indo) Virus Strains.
GMFR were defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer.
Time frame: At Day 10, Day 42 and Day 182
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| A/Turkey H5N1 Influenza A Group | HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Indonesia/5/2005 (A/Indo) Virus Strains. | A/Indo, D 10 | 39.3 fold change |
| A/Turkey H5N1 Influenza A Group | HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Indonesia/5/2005 (A/Indo) Virus Strains. | A/Indo, D 182 | 4.8 fold change |
| A/Turkey H5N1 Influenza A Group | HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Indonesia/5/2005 (A/Indo) Virus Strains. | A/Indo, D 42 | 26.4 fold change |
| A/Turkey H5N1 Influenza B1 + D1 Group | HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Indonesia/5/2005 (A/Indo) Virus Strains. | A/Indo, D 182 | 8.2 fold change |
| A/Turkey H5N1 Influenza B1 + D1 Group | HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Indonesia/5/2005 (A/Indo) Virus Strains. | A/Indo, D 42 | 28.4 fold change |
| A/Turkey H5N1 Influenza B1 + D1 Group | HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Indonesia/5/2005 (A/Indo) Virus Strains. | A/Indo, D 10 | 34.7 fold change |
| A/Turkey H5N1 Influenza C1 + E1 Group | HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Indonesia/5/2005 (A/Indo) Virus Strains. | A/Indo, D 42 | 33.5 fold change |
| A/Turkey H5N1 Influenza C1 + E1 Group | HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Indonesia/5/2005 (A/Indo) Virus Strains. | A/Indo, D 10 | 37.3 fold change |
| A/Turkey H5N1 Influenza C1 + E1 Group | HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Indonesia/5/2005 (A/Indo) Virus Strains. | A/Indo, D 182 | 9.4 fold change |
| A/Turkey H5N1 Influenza B2 + D2 Group | HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Indonesia/5/2005 (A/Indo) Virus Strains. | A/Indo, D 182 | 2.3 fold change |
| A/Turkey H5N1 Influenza B2 + D2 Group | HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Indonesia/5/2005 (A/Indo) Virus Strains. | A/Indo, D 10 | 6.8 fold change |
| A/Turkey H5N1 Influenza B2 + D2 Group | HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Indonesia/5/2005 (A/Indo) Virus Strains. | A/Indo, D 42 | 6.6 fold change |
| A/Turkey H5N1 Influenza C2 + E2 Group | HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Indonesia/5/2005 (A/Indo) Virus Strains. | A/Indo, D 42 | 5.9 fold change |
| A/Turkey H5N1 Influenza C2 + E2 Group | HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Indonesia/5/2005 (A/Indo) Virus Strains. | A/Indo, D 10 | 6.1 fold change |
| A/Turkey H5N1 Influenza C2 + E2 Group | HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Indonesia/5/2005 (A/Indo) Virus Strains. | A/Indo, D 182 | 2.1 fold change |
| A/Turkey H5N1 Influenza B1 + C1 Group | HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Indonesia/5/2005 (A/Indo) Virus Strains. | A/Indo, D 42 | 28.6 fold change |
| A/Turkey H5N1 Influenza B1 + C1 Group | HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Indonesia/5/2005 (A/Indo) Virus Strains. | A/Indo, D 10 | 34.3 fold change |
| A/Turkey H5N1 Influenza B1 + C1 Group | HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Indonesia/5/2005 (A/Indo) Virus Strains. | A/Indo, D 182 | 7.7 fold change |
| A/Turkey H5N1 Influenza D1 + E1 Group | HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Indonesia/5/2005 (A/Indo) Virus Strains. | A/Indo, D 182 | 10.1 fold change |
| A/Turkey H5N1 Influenza D1 + E1 Group | HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Indonesia/5/2005 (A/Indo) Virus Strains. | A/Indo, D 10 | 37.8 fold change |
| A/Turkey H5N1 Influenza D1 + E1 Group | HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Indonesia/5/2005 (A/Indo) Virus Strains. | A/Indo, D 42 | 33.3 fold change |
| A/Turkey H5N1 Influenza B2 + C2 Group | HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Indonesia/5/2005 (A/Indo) Virus Strains. | A/Indo, D 42 | 4.9 fold change |
| A/Turkey H5N1 Influenza B2 + C2 Group | HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Indonesia/5/2005 (A/Indo) Virus Strains. | A/Indo, D 182 | 1.9 fold change |
| A/Turkey H5N1 Influenza B2 + C2 Group | HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Indonesia/5/2005 (A/Indo) Virus Strains. | A/Indo, D 10 | 5.7 fold change |
| A/Turkey H5N1 Influenza D2 + E2 Group | HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Indonesia/5/2005 (A/Indo) Virus Strains. | A/Indo, D 42 | 7.8 fold change |
| A/Turkey H5N1 Influenza D2 + E2 Group | HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Indonesia/5/2005 (A/Indo) Virus Strains. | A/Indo, D 182 | 2.5 fold change |
| A/Turkey H5N1 Influenza D2 + E2 Group | HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Indonesia/5/2005 (A/Indo) Virus Strains. | A/Indo, D 10 | 7.3 fold change |
Secondary
HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.
GMFR were defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer.
Time frame: At Day 0 to Day 10, Day 42 and Day 182
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| A/Turkey H5N1 Influenza A Group | HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. | A/turkey, D 10 | 37.4 fold change |
| A/Turkey H5N1 Influenza A Group | HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. | A/turkey, D 182 | 6.7 fold change |
| A/Turkey H5N1 Influenza A Group | HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. | A/turkey, D 42 | 25.3 fold change |
| A/Turkey H5N1 Influenza B1 + D1 Group | HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. | A/turkey, D 182 | 16.4 fold change |
| A/Turkey H5N1 Influenza B1 + D1 Group | HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. | A/turkey, D 42 | 48.2 fold change |
| A/Turkey H5N1 Influenza B1 + D1 Group | HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. | A/turkey, D 10 | 61.6 fold change |
| A/Turkey H5N1 Influenza C1 + E1 Group | HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. | A/turkey, D 42 | 48.6 fold change |
| A/Turkey H5N1 Influenza C1 + E1 Group | HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. | A/turkey, D 10 | 56.3 fold change |
| A/Turkey H5N1 Influenza C1 + E1 Group | HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. | A/turkey, D 182 | 16.6 fold change |
| A/Turkey H5N1 Influenza B2 + D2 Group | HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. | A/turkey, D 182 | 4.4 fold change |
| A/Turkey H5N1 Influenza B2 + D2 Group | HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. | A/turkey, D 10 | 8.5 fold change |
| A/Turkey H5N1 Influenza B2 + D2 Group | HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. | A/turkey, D 42 | 8.9 fold change |
| A/Turkey H5N1 Influenza C2 + E2 Group | HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. | A/turkey, D 42 | 7.5 fold change |
| A/Turkey H5N1 Influenza C2 + E2 Group | HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. | A/turkey, D 10 | 8.0 fold change |
| A/Turkey H5N1 Influenza C2 + E2 Group | HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. | A/turkey, D 182 | 3.9 fold change |
| A/Turkey H5N1 Influenza B1 + C1 Group | HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. | A/turkey, D 42 | 46.3 fold change |
| A/Turkey H5N1 Influenza B1 + C1 Group | HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. | A/turkey, D 10 | 58.4 fold change |
| A/Turkey H5N1 Influenza B1 + C1 Group | HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. | A/turkey, D 182 | 15.1 fold change |
| A/Turkey H5N1 Influenza D1 + E1 Group | HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. | A/turkey, D 182 | 18.2 fold change |
| A/Turkey H5N1 Influenza D1 + E1 Group | HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. | A/turkey, D 10 | 59.8 fold change |
| A/Turkey H5N1 Influenza D1 + E1 Group | HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. | A/turkey, D 42 | 50.9 fold change |
| A/Turkey H5N1 Influenza B2 + C2 Group | HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. | A/turkey, D 42 | 6.9 fold change |
| A/Turkey H5N1 Influenza B2 + C2 Group | HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. | A/turkey, D 182 | 3.9 fold change |
| A/Turkey H5N1 Influenza B2 + C2 Group | HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. | A/turkey, D 10 | 7.4 fold change |
| A/Turkey H5N1 Influenza D2 + E2 Group | HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. | A/turkey, D 42 | 9.6 fold change |
| A/Turkey H5N1 Influenza D2 + E2 Group | HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. | A/turkey, D 182 | 4.4 fold change |
| A/Turkey H5N1 Influenza D2 + E2 Group | HI Antibody Geometric Mean Fold Rise (GMFR) Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. | A/turkey, D 10 | 9.1 fold change |
Secondary
HI Antibody Titers Against the A/Indonesia/5/2005 (A/Indo) Virus Strain.
Titers were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of ≥ 1:10
Time frame: At Day 0, Day 10, Day 42 and Day 182
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| A/Turkey H5N1 Influenza A Group | HI Antibody Titers Against the A/Indonesia/5/2005 (A/Indo) Virus Strain. | A/Indo, D 0 | 7.3 Titer |
| A/Turkey H5N1 Influenza A Group | HI Antibody Titers Against the A/Indonesia/5/2005 (A/Indo) Virus Strain. | A/Indo, D 10 | 286.5 Titer |
| A/Turkey H5N1 Influenza A Group | HI Antibody Titers Against the A/Indonesia/5/2005 (A/Indo) Virus Strain. | A/Indo, D 42 | 192.3 Titer |
| A/Turkey H5N1 Influenza A Group | HI Antibody Titers Against the A/Indonesia/5/2005 (A/Indo) Virus Strain. | A/Indo, D182 | 34.8 Titer |
| A/Turkey H5N1 Influenza B1 + D1 Group | HI Antibody Titers Against the A/Indonesia/5/2005 (A/Indo) Virus Strain. | A/Indo, D182 | 213.8 Titer |
| A/Turkey H5N1 Influenza B1 + D1 Group | HI Antibody Titers Against the A/Indonesia/5/2005 (A/Indo) Virus Strain. | A/Indo, D 0 | 26.1 Titer |
| A/Turkey H5N1 Influenza B1 + D1 Group | HI Antibody Titers Against the A/Indonesia/5/2005 (A/Indo) Virus Strain. | A/Indo, D 10 | 905.0 Titer |
| A/Turkey H5N1 Influenza B1 + D1 Group | HI Antibody Titers Against the A/Indonesia/5/2005 (A/Indo) Virus Strain. | A/Indo, D 42 | 740.8 Titer |
| A/Turkey H5N1 Influenza C1 + E1 Group | HI Antibody Titers Against the A/Indonesia/5/2005 (A/Indo) Virus Strain. | A/Indo, D 10 | 888.6 Titer |
| A/Turkey H5N1 Influenza C1 + E1 Group | HI Antibody Titers Against the A/Indonesia/5/2005 (A/Indo) Virus Strain. | A/Indo, D182 | 224.2 Titer |
| A/Turkey H5N1 Influenza C1 + E1 Group | HI Antibody Titers Against the A/Indonesia/5/2005 (A/Indo) Virus Strain. | A/Indo, D 42 | 798.1 Titer |
| A/Turkey H5N1 Influenza C1 + E1 Group | HI Antibody Titers Against the A/Indonesia/5/2005 (A/Indo) Virus Strain. | A/Indo, D 0 | 23.8 Titer |
| A/Turkey H5N1 Influenza B2 + D2 Group | HI Antibody Titers Against the A/Indonesia/5/2005 (A/Indo) Virus Strain. | A/Indo, D 0 | 25.5 Titer |
| A/Turkey H5N1 Influenza B2 + D2 Group | HI Antibody Titers Against the A/Indonesia/5/2005 (A/Indo) Virus Strain. | A/Indo, D 10 | 176.7 Titer |
| A/Turkey H5N1 Influenza B2 + D2 Group | HI Antibody Titers Against the A/Indonesia/5/2005 (A/Indo) Virus Strain. | A/Indo, D 42 | 168.7 Titer |
| A/Turkey H5N1 Influenza B2 + D2 Group | HI Antibody Titers Against the A/Indonesia/5/2005 (A/Indo) Virus Strain. | A/Indo, D182 | 58.7 Titer |
| A/Turkey H5N1 Influenza C2 + E2 Group | HI Antibody Titers Against the A/Indonesia/5/2005 (A/Indo) Virus Strain. | A/Indo, D 42 | 108.8 Titer |
| A/Turkey H5N1 Influenza C2 + E2 Group | HI Antibody Titers Against the A/Indonesia/5/2005 (A/Indo) Virus Strain. | A/Indo, D 10 | 113.6 Titer |
| A/Turkey H5N1 Influenza C2 + E2 Group | HI Antibody Titers Against the A/Indonesia/5/2005 (A/Indo) Virus Strain. | A/Indo, D 0 | 18.5 Titer |
| A/Turkey H5N1 Influenza C2 + E2 Group | HI Antibody Titers Against the A/Indonesia/5/2005 (A/Indo) Virus Strain. | A/Indo, D182 | 38.6 Titer |
| A/Turkey H5N1 Influenza B1 + C1 Group | HI Antibody Titers Against the A/Indonesia/5/2005 (A/Indo) Virus Strain. | A/Indo, D182 | 197.3 Titer |
| A/Turkey H5N1 Influenza B1 + C1 Group | HI Antibody Titers Against the A/Indonesia/5/2005 (A/Indo) Virus Strain. | A/Indo, D 0 | 25.5 Titer |
| A/Turkey H5N1 Influenza B1 + C1 Group | HI Antibody Titers Against the A/Indonesia/5/2005 (A/Indo) Virus Strain. | A/Indo, D 42 | 728.1 Titer |
| A/Turkey H5N1 Influenza B1 + C1 Group | HI Antibody Titers Against the A/Indonesia/5/2005 (A/Indo) Virus Strain. | A/Indo, D 10 | 873.5 Titer |
| A/Turkey H5N1 Influenza D1 + E1 Group | HI Antibody Titers Against the A/Indonesia/5/2005 (A/Indo) Virus Strain. | A/Indo, D 42 | 814.6 Titer |
| A/Turkey H5N1 Influenza D1 + E1 Group | HI Antibody Titers Against the A/Indonesia/5/2005 (A/Indo) Virus Strain. | A/Indo, D 10 | 924.9 Titer |
| A/Turkey H5N1 Influenza D1 + E1 Group | HI Antibody Titers Against the A/Indonesia/5/2005 (A/Indo) Virus Strain. | A/Indo, D182 | 246.0 Titer |
| A/Turkey H5N1 Influenza D1 + E1 Group | HI Antibody Titers Against the A/Indonesia/5/2005 (A/Indo) Virus Strain. | A/Indo, D 0 | 24.5 Titer |
| A/Turkey H5N1 Influenza B2 + C2 Group | HI Antibody Titers Against the A/Indonesia/5/2005 (A/Indo) Virus Strain. | A/Indo, D 10 | 124.6 Titer |
| A/Turkey H5N1 Influenza B2 + C2 Group | HI Antibody Titers Against the A/Indonesia/5/2005 (A/Indo) Virus Strain. | A/Indo, D182 | 42.7 Titer |
| A/Turkey H5N1 Influenza B2 + C2 Group | HI Antibody Titers Against the A/Indonesia/5/2005 (A/Indo) Virus Strain. | A/Indo, D 42 | 107.8 Titer |
| A/Turkey H5N1 Influenza B2 + C2 Group | HI Antibody Titers Against the A/Indonesia/5/2005 (A/Indo) Virus Strain. | A/Indo, D 0 | 22.0 Titer |
| A/Turkey H5N1 Influenza D2 + E2 Group | HI Antibody Titers Against the A/Indonesia/5/2005 (A/Indo) Virus Strain. | A/Indo, D 0 | 21.7 Titer |
| A/Turkey H5N1 Influenza D2 + E2 Group | HI Antibody Titers Against the A/Indonesia/5/2005 (A/Indo) Virus Strain. | A/Indo, D182 | 53.4 Titer |
| A/Turkey H5N1 Influenza D2 + E2 Group | HI Antibody Titers Against the A/Indonesia/5/2005 (A/Indo) Virus Strain. | A/Indo, D 42 | 169.3 Titer |
| A/Turkey H5N1 Influenza D2 + E2 Group | HI Antibody Titers Against the A/Indonesia/5/2005 (A/Indo) Virus Strain. | A/Indo, D 10 | 161.3 Titer |
Secondary
Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains.
MN antibody titers were expressed as geometric mean titers (GMTs). The cut-off of the assay was the seropositivity cut-off of ≥ 1:28.
Time frame: At Day 0, Day 10, Day 42 and Day 182
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| A/Turkey H5N1 Influenza A Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, D 0 | 72.8 Titer |
| A/Turkey H5N1 Influenza A Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, D 10 | 2211.5 Titer |
| A/Turkey H5N1 Influenza A Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, D 0 | 181.3 Titer |
| A/Turkey H5N1 Influenza A Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, D 10 | 2311.5 Titer |
| A/Turkey H5N1 Influenza A Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, D 182 | 380.8 Titer |
| A/Turkey H5N1 Influenza A Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, D 0 | 27.5 Titer |
| A/Turkey H5N1 Influenza A Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, D 42 | 1582.9 Titer |
| A/Turkey H5N1 Influenza A Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, D 42 | 529.3 Titer |
| A/Turkey H5N1 Influenza A Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, D 42 | 1622.0 Titer |
| A/Turkey H5N1 Influenza A Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, D 182 | 349.7 Titer |
| A/Turkey H5N1 Influenza A Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, D 10 | 662.5 Titer |
| A/Turkey H5N1 Influenza A Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, D 182 | 112.5 Titer |
| A/Turkey H5N1 Influenza B1 + D1 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, D 42 | 4777.7 Titer |
| A/Turkey H5N1 Influenza B1 + D1 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, D 0 | 326.0 Titer |
| A/Turkey H5N1 Influenza B1 + D1 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, D 42 | 1213.8 Titer |
| A/Turkey H5N1 Influenza B1 + D1 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, D 182 | 432.5 Titer |
| A/Turkey H5N1 Influenza B1 + D1 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, D 10 | 5367.7 Titer |
| A/Turkey H5N1 Influenza B1 + D1 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, D 10 | 1564.1 Titer |
| A/Turkey H5N1 Influenza B1 + D1 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, D 42 | 5080.1 Titer |
| A/Turkey H5N1 Influenza B1 + D1 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, D 0 | 115.4 Titer |
| A/Turkey H5N1 Influenza B1 + D1 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, D 182 | 1482.3 Titer |
| A/Turkey H5N1 Influenza B1 + D1 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, D 0 | 210.1 Titer |
| A/Turkey H5N1 Influenza B1 + D1 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, D 10 | 5807.1 Titer |
| A/Turkey H5N1 Influenza B1 + D1 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, D 182 | 1509.9 Titer |
| A/Turkey H5N1 Influenza C1 + E1 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, D 10 | 5680.0 Titer |
| A/Turkey H5N1 Influenza C1 + E1 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, D 0 | 114.6 Titer |
| A/Turkey H5N1 Influenza C1 + E1 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, D 182 | 1484.8 Titer |
| A/Turkey H5N1 Influenza C1 + E1 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, D 182 | 324.9 Titer |
| A/Turkey H5N1 Influenza C1 + E1 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, D 42 | 1249.3 Titer |
| A/Turkey H5N1 Influenza C1 + E1 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, D 42 | 4649.4 Titer |
| A/Turkey H5N1 Influenza C1 + E1 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, D 42 | 5054.1 Titer |
| A/Turkey H5N1 Influenza C1 + E1 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, D 0 | 249.0 Titer |
| A/Turkey H5N1 Influenza C1 + E1 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, D 0 | 300.2 Titer |
| A/Turkey H5N1 Influenza C1 + E1 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, D 10 | 1350.1 Titer |
| A/Turkey H5N1 Influenza C1 + E1 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, D 10 | 5191.4 Titer |
| A/Turkey H5N1 Influenza C1 + E1 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, D 182 | 1556.0 Titer |
| A/Turkey H5N1 Influenza B2 + D2 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, D 182 | 471.5 Titer |
| A/Turkey H5N1 Influenza B2 + D2 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, D 42 | 1537.2 Titer |
| A/Turkey H5N1 Influenza B2 + D2 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, D 10 | 1276.2 Titer |
| A/Turkey H5N1 Influenza B2 + D2 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, D 42 | 589.4 Titer |
| A/Turkey H5N1 Influenza B2 + D2 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, D 42 | 1261.2 Titer |
| A/Turkey H5N1 Influenza B2 + D2 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, D 0 | 102.9 Titer |
| A/Turkey H5N1 Influenza B2 + D2 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, D 10 | 552.0 Titer |
| A/Turkey H5N1 Influenza B2 + D2 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, D 10 | 1516.5 Titer |
| A/Turkey H5N1 Influenza B2 + D2 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, D 0 | 197.3 Titer |
| A/Turkey H5N1 Influenza B2 + D2 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, D 0 | 343.4 Titer |
| A/Turkey H5N1 Influenza B2 + D2 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, D 182 | 172.7 Titer |
| A/Turkey H5N1 Influenza B2 + D2 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, D 182 | 535.5 Titer |
| A/Turkey H5N1 Influenza C2 + E2 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, D 42 | 377.8 Titer |
| A/Turkey H5N1 Influenza C2 + E2 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, D 0 | 94.9 Titer |
| A/Turkey H5N1 Influenza C2 + E2 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, D 10 | 976.0 Titer |
| A/Turkey H5N1 Influenza C2 + E2 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, D 42 | 906.0 Titer |
| A/Turkey H5N1 Influenza C2 + E2 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, D 182 | 342.2 Titer |
| A/Turkey H5N1 Influenza C2 + E2 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, D 0 | 262.0 Titer |
| A/Turkey H5N1 Influenza C2 + E2 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, D 10 | 1250.0 Titer |
| A/Turkey H5N1 Influenza C2 + E2 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, D 42 | 1194.5 Titer |
| A/Turkey H5N1 Influenza C2 + E2 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, D 182 | 378.4 Titer |
| A/Turkey H5N1 Influenza C2 + E2 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, D 0 | 205.5 Titer |
| A/Turkey H5N1 Influenza C2 + E2 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, D 10 | 430.5 Titer |
| A/Turkey H5N1 Influenza C2 + E2 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, D 182 | 144.1 Titer |
| A/Turkey H5N1 Influenza B1 + C1 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, D 0 | 308.1 Titer |
| A/Turkey H5N1 Influenza B1 + C1 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, D 182 | 1375.0 Titer |
| A/Turkey H5N1 Influenza B1 + C1 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, D 0 | 237.5 Titer |
| A/Turkey H5N1 Influenza B1 + C1 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, D 10 | 6011.0 Titer |
| A/Turkey H5N1 Influenza B1 + C1 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, D 42 | 1168.1 Titer |
| A/Turkey H5N1 Influenza B1 + C1 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, D 10 | 5670.5 Titer |
| A/Turkey H5N1 Influenza B1 + C1 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, D 42 | 5157.1 Titer |
| A/Turkey H5N1 Influenza B1 + C1 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, D 182 | 371.4 Titer |
| A/Turkey H5N1 Influenza B1 + C1 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, D 182 | 1358.2 Titer |
| A/Turkey H5N1 Influenza B1 + C1 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, D 0 | 115.0 Titer |
| A/Turkey H5N1 Influenza B1 + C1 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, D 42 | 4915.6 Titer |
| A/Turkey H5N1 Influenza B1 + C1 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, D 10 | 1485.0 Titer |
| A/Turkey H5N1 Influenza D1 + E1 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, D 42 | 4498.4 Titer |
| A/Turkey H5N1 Influenza D1 + E1 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, D 0 | 320.1 Titer |
| A/Turkey H5N1 Influenza D1 + E1 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, D 182 | 1721.5 Titer |
| A/Turkey H5N1 Influenza D1 + E1 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, D 182 | 1653.6 Titer |
| A/Turkey H5N1 Influenza D1 + E1 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, D 182 | 386.3 Titer |
| A/Turkey H5N1 Influenza D1 + E1 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, D 0 | 216.5 Titer |
| A/Turkey H5N1 Influenza D1 + E1 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, D 42 | 4967.0 Titer |
| A/Turkey H5N1 Influenza D1 + E1 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, D 10 | 1430.0 Titer |
| A/Turkey H5N1 Influenza D1 + E1 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, D 10 | 4876.8 Titer |
| A/Turkey H5N1 Influenza D1 + E1 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, D 42 | 1306.0 Titer |
| A/Turkey H5N1 Influenza D1 + E1 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, D 0 | 115.1 Titer |
| A/Turkey H5N1 Influenza D1 + E1 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, D 10 | 5460.9 Titer |
| A/Turkey H5N1 Influenza B2 + C2 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, D 42 | 935.7 Titer |
| A/Turkey H5N1 Influenza B2 + C2 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, D 182 | 151.7 Titer |
| A/Turkey H5N1 Influenza B2 + C2 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, D 10 | 509.3 Titer |
| A/Turkey H5N1 Influenza B2 + C2 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, D 182 | 379.4 Titer |
| A/Turkey H5N1 Influenza B2 + C2 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, D 10 | 1026.9 Titer |
| A/Turkey H5N1 Influenza B2 + C2 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, D 10 | 1240.9 Titer |
| A/Turkey H5N1 Influenza B2 + C2 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, D 0 | 288.1 Titer |
| A/Turkey H5N1 Influenza B2 + C2 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, D 42 | 1178.0 Titer |
| A/Turkey H5N1 Influenza B2 + C2 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, D 42 | 481.8 Titer |
| A/Turkey H5N1 Influenza B2 + C2 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, D 0 | 95.9 Titer |
| A/Turkey H5N1 Influenza B2 + C2 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, D 182 | 332.3 Titer |
| A/Turkey H5N1 Influenza B2 + C2 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, D 0 | 198.7 Titer |
| A/Turkey H5N1 Influenza D2 + E2 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, D 42 | 1552.4 Titer |
| A/Turkey H5N1 Influenza D2 + E2 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, D 0 | 203.7 Titer |
| A/Turkey H5N1 Influenza D2 + E2 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, D 182 | 534.2 Titer |
| A/Turkey H5N1 Influenza D2 + E2 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, D 10 | 1523.4 Titer |
| A/Turkey H5N1 Influenza D2 + E2 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, D 42 | 469.0 Titer |
| A/Turkey H5N1 Influenza D2 + E2 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, D 10 | 470.8 Titer |
| A/Turkey H5N1 Influenza D2 + E2 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, D 0 | 101.9 Titer |
| A/Turkey H5N1 Influenza D2 + E2 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, D 10 | 1213.4 Titer |
| A/Turkey H5N1 Influenza D2 + E2 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, D 182 | 484.8 Titer |
| A/Turkey H5N1 Influenza D2 + E2 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, D 42 | 1223.9 Titer |
| A/Turkey H5N1 Influenza D2 + E2 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, D 182 | 164.5 Titer |
| A/Turkey H5N1 Influenza D2 + E2 Group | Microneutralization (MN) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, D 0 | 313.7 Titer |
Secondary
Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) Virus Strains.
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (\<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.
Time frame: At Day 0 to Day 10, Day 42 and Day 182
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| A/Turkey H5N1 Influenza A Group | Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) Virus Strains. | A/Indo, D 10 | 42 Participants |
| A/Turkey H5N1 Influenza A Group | Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) Virus Strains. | A/Indo, D 182 | 25 Participants |
| A/Turkey H5N1 Influenza A Group | Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) Virus Strains. | A/Indo, D 42 | 42 Participants |
| A/Turkey H5N1 Influenza B1 + D1 Group | Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) Virus Strains. | A/Indo, D 182 | 91 Participants |
| A/Turkey H5N1 Influenza B1 + D1 Group | Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) Virus Strains. | A/Indo, D 42 | 120 Participants |
| A/Turkey H5N1 Influenza B1 + D1 Group | Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) Virus Strains. | A/Indo, D 10 | 122 Participants |
| A/Turkey H5N1 Influenza C1 + E1 Group | Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) Virus Strains. | A/Indo, D 42 | 105 Participants |
| A/Turkey H5N1 Influenza C1 + E1 Group | Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) Virus Strains. | A/Indo, D 10 | 108 Participants |
| A/Turkey H5N1 Influenza C1 + E1 Group | Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) Virus Strains. | A/Indo, D 182 | 84 Participants |
| A/Turkey H5N1 Influenza B2 + D2 Group | Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) Virus Strains. | A/Indo, D 182 | 24 Participants |
| A/Turkey H5N1 Influenza B2 + D2 Group | Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) Virus Strains. | A/Indo, D 10 | 50 Participants |
| A/Turkey H5N1 Influenza B2 + D2 Group | Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) Virus Strains. | A/Indo, D 42 | 48 Participants |
| A/Turkey H5N1 Influenza C2 + E2 Group | Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) Virus Strains. | A/Indo, D 42 | 43 Participants |
| A/Turkey H5N1 Influenza C2 + E2 Group | Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) Virus Strains. | A/Indo, D 10 | 44 Participants |
| A/Turkey H5N1 Influenza C2 + E2 Group | Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) Virus Strains. | A/Indo, D 182 | 22 Participants |
| A/Turkey H5N1 Influenza B1 + C1 Group | Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) Virus Strains. | A/Indo, D 42 | 121 Participants |
| A/Turkey H5N1 Influenza B1 + C1 Group | Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) Virus Strains. | A/Indo, D 10 | 122 Participants |
| A/Turkey H5N1 Influenza B1 + C1 Group | Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) Virus Strains. | A/Indo, D 182 | 96 Participants |
| A/Turkey H5N1 Influenza D1 + E1 Group | Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) Virus Strains. | A/Indo, D 182 | 79 Participants |
| A/Turkey H5N1 Influenza D1 + E1 Group | Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) Virus Strains. | A/Indo, D 10 | 108 Participants |
| A/Turkey H5N1 Influenza D1 + E1 Group | Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) Virus Strains. | A/Indo, D 42 | 104 Participants |
| A/Turkey H5N1 Influenza B2 + C2 Group | Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) Virus Strains. | A/Indo, D 42 | 38 Participants |
| A/Turkey H5N1 Influenza B2 + C2 Group | Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) Virus Strains. | A/Indo, D 182 | 20 Participants |
| A/Turkey H5N1 Influenza B2 + C2 Group | Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) Virus Strains. | A/Indo, D 10 | 41 Participants |
| A/Turkey H5N1 Influenza D2 + E2 Group | Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) Virus Strains. | A/Indo, D 42 | 53 Participants |
| A/Turkey H5N1 Influenza D2 + E2 Group | Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) Virus Strains. | A/Indo, D 182 | 26 Participants |
| A/Turkey H5N1 Influenza D2 + E2 Group | Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) Virus Strains. | A/Indo, D 10 | 53 Participants |
Secondary
Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains.
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination (Day 0) titer less than (\<) 1:10 for HI and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40, or a pre-vaccination reciprocal titer ≥ 1:10 for HI and at least a 4-fold increase in post-vaccination reciprocal titer.
Time frame: At Day 0 to Day 42 and at Day 0 to Day 182
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| A/Turkey H5N1 Influenza A Group | Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains. | A/turkey, D 182 | 28 Participants |
| A/Turkey H5N1 Influenza A Group | Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains. | A/turkey, D 42 | 41 Participants |
| A/Turkey H5N1 Influenza B1 + D1 Group | Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains. | A/turkey, D 42 | 123 Participants |
| A/Turkey H5N1 Influenza B1 + D1 Group | Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains. | A/turkey, D 182 | 105 Participants |
| A/Turkey H5N1 Influenza C1 + E1 Group | Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains. | A/turkey, D 42 | 108 Participants |
| A/Turkey H5N1 Influenza C1 + E1 Group | Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains. | A/turkey, D 182 | 90 Participants |
| A/Turkey H5N1 Influenza B2 + D2 Group | Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains. | A/turkey, D 182 | 38 Participants |
| A/Turkey H5N1 Influenza B2 + D2 Group | Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains. | A/turkey, D 42 | 55 Participants |
| A/Turkey H5N1 Influenza C2 + E2 Group | Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains. | A/turkey, D 42 | 51 Participants |
| A/Turkey H5N1 Influenza C2 + E2 Group | Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains. | A/turkey, D 182 | 38 Participants |
| A/Turkey H5N1 Influenza B1 + C1 Group | Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains. | A/turkey, D 42 | 123 Participants |
| A/Turkey H5N1 Influenza B1 + C1 Group | Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains. | A/turkey, D 182 | 103 Participants |
| A/Turkey H5N1 Influenza D1 + E1 Group | Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains. | A/turkey, D 182 | 92 Participants |
| A/Turkey H5N1 Influenza D1 + E1 Group | Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains. | A/turkey, D 42 | 108 Participants |
| A/Turkey H5N1 Influenza B2 + C2 Group | Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains. | A/turkey, D 42 | 45 Participants |
| A/Turkey H5N1 Influenza B2 + C2 Group | Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains. | A/turkey, D 182 | 31 Participants |
| A/Turkey H5N1 Influenza D2 + E2 Group | Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains. | A/turkey, D 42 | 61 Participants |
| A/Turkey H5N1 Influenza D2 + E2 Group | Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains. | A/turkey, D 182 | 45 Participants |
Secondary
Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms.
Solicited general symptoms assessed were fatigue, headache, joint pain at other location (joint pain), muscle aches, shivering, sweating and fever. Any =occurrence of any solicited general symptoms reported irrespective of intensity grade and relationship to vaccination. Any fever = oral temperature ≥ 38.0 degrees Celsius (°C).
Time frame: Within the 7-day (Days 0-6) post vaccination period.
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects who received study vaccine and for whom any post-vaccination data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| A/Turkey H5N1 Influenza A Group | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms. | Any Shivering | 3 Participants |
| A/Turkey H5N1 Influenza A Group | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms. | Any Fever | 0 Participants |
| A/Turkey H5N1 Influenza A Group | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms. | Any Headache | 11 Participants |
| A/Turkey H5N1 Influenza A Group | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms. | Any Fatigue | 10 Participants |
| A/Turkey H5N1 Influenza A Group | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms. | Any Muscle aches | 10 Participants |
| A/Turkey H5N1 Influenza A Group | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms. | Any Joint pain | 5 Participants |
| A/Turkey H5N1 Influenza A Group | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms. | Any Sweating | 4 Participants |
| A/Turkey H5N1 Influenza B1 + D1 Group | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms. | Any Muscle aches | 29 Participants |
| A/Turkey H5N1 Influenza B1 + D1 Group | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms. | Any Fatigue | 18 Participants |
| A/Turkey H5N1 Influenza B1 + D1 Group | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms. | Any Fever | 1 Participants |
| A/Turkey H5N1 Influenza B1 + D1 Group | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms. | Any Headache | 22 Participants |
| A/Turkey H5N1 Influenza B1 + D1 Group | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms. | Any Sweating | 4 Participants |
| A/Turkey H5N1 Influenza B1 + D1 Group | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms. | Any Joint pain | 16 Participants |
| A/Turkey H5N1 Influenza B1 + D1 Group | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms. | Any Shivering | 9 Participants |
| A/Turkey H5N1 Influenza C1 + E1 Group | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms. | Any Fever | 0 Participants |
| A/Turkey H5N1 Influenza C1 + E1 Group | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms. | Any Sweating | 0 Participants |
| A/Turkey H5N1 Influenza C1 + E1 Group | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms. | Any Muscle aches | 3 Participants |
| A/Turkey H5N1 Influenza C1 + E1 Group | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms. | Any Shivering | 1 Participants |
| A/Turkey H5N1 Influenza C1 + E1 Group | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms. | Any Headache | 4 Participants |
| A/Turkey H5N1 Influenza C1 + E1 Group | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms. | Any Joint pain | 1 Participants |
| A/Turkey H5N1 Influenza C1 + E1 Group | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms. | Any Fatigue | 3 Participants |
| A/Turkey H5N1 Influenza B2 + D2 Group | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms. | Any Joint pain | 10 Participants |
| A/Turkey H5N1 Influenza B2 + D2 Group | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms. | Any Fever | 0 Participants |
| A/Turkey H5N1 Influenza B2 + D2 Group | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms. | Any Muscle aches | 17 Participants |
| A/Turkey H5N1 Influenza B2 + D2 Group | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms. | Any Sweating | 5 Participants |
| A/Turkey H5N1 Influenza B2 + D2 Group | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms. | Any Fatigue | 20 Participants |
| A/Turkey H5N1 Influenza B2 + D2 Group | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms. | Any Shivering | 8 Participants |
| A/Turkey H5N1 Influenza B2 + D2 Group | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms. | Any Headache | 25 Participants |
| A/Turkey H5N1 Influenza C2 + E2 Group | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms. | Any Muscle aches | 7 Participants |
| A/Turkey H5N1 Influenza C2 + E2 Group | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms. | Any Fatigue | 6 Participants |
| A/Turkey H5N1 Influenza C2 + E2 Group | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms. | Any Headache | 5 Participants |
| A/Turkey H5N1 Influenza C2 + E2 Group | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms. | Any Joint pain | 4 Participants |
| A/Turkey H5N1 Influenza C2 + E2 Group | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms. | Any Shivering | 0 Participants |
| A/Turkey H5N1 Influenza C2 + E2 Group | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms. | Any Sweating | 0 Participants |
| A/Turkey H5N1 Influenza C2 + E2 Group | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms. | Any Fever | 0 Participants |
| A/Turkey H5N1 Influenza B1 + C1 Group | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms. | Any Joint pain | 12 Participants |
| A/Turkey H5N1 Influenza B1 + C1 Group | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms. | Any Sweating | 3 Participants |
| A/Turkey H5N1 Influenza B1 + C1 Group | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms. | Any Fatigue | 18 Participants |
| A/Turkey H5N1 Influenza B1 + C1 Group | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms. | Any Shivering | 7 Participants |
| A/Turkey H5N1 Influenza B1 + C1 Group | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms. | Any Muscle aches | 21 Participants |
| A/Turkey H5N1 Influenza B1 + C1 Group | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms. | Any Fever | 4 Participants |
| A/Turkey H5N1 Influenza B1 + C1 Group | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms. | Any Headache | 17 Participants |
| A/Turkey H5N1 Influenza D1 + E1 Group | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms. | Any Shivering | 1 Participants |
| A/Turkey H5N1 Influenza D1 + E1 Group | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms. | Any Muscle aches | 8 Participants |
| A/Turkey H5N1 Influenza D1 + E1 Group | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms. | Any Sweating | 1 Participants |
| A/Turkey H5N1 Influenza D1 + E1 Group | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms. | Any Fever | 0 Participants |
| A/Turkey H5N1 Influenza D1 + E1 Group | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms. | Any Joint pain | 2 Participants |
| A/Turkey H5N1 Influenza D1 + E1 Group | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms. | Any Fatigue | 4 Participants |
| A/Turkey H5N1 Influenza D1 + E1 Group | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms. | Any Headache | 8 Participants |
| A/Turkey H5N1 Influenza B2 + C2 Group | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms. | Any Muscle aches | 28 Participants |
| A/Turkey H5N1 Influenza B2 + C2 Group | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms. | Any Joint pain | 19 Participants |
| A/Turkey H5N1 Influenza B2 + C2 Group | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms. | Any Shivering | 9 Participants |
| A/Turkey H5N1 Influenza B2 + C2 Group | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms. | Any Headache | 17 Participants |
| A/Turkey H5N1 Influenza B2 + C2 Group | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms. | Any Fever | 4 Participants |
| A/Turkey H5N1 Influenza B2 + C2 Group | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms. | Any Sweating | 6 Participants |
| A/Turkey H5N1 Influenza B2 + C2 Group | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms. | Any Fatigue | 23 Participants |
| A/Turkey H5N1 Influenza D2 + E2 Group | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms. | Any Fatigue | 11 Participants |
| A/Turkey H5N1 Influenza D2 + E2 Group | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms. | Any Sweating | 2 Participants |
| A/Turkey H5N1 Influenza D2 + E2 Group | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms. | Any Fever | 0 Participants |
| A/Turkey H5N1 Influenza D2 + E2 Group | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms. | Any Headache | 10 Participants |
| A/Turkey H5N1 Influenza D2 + E2 Group | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms. | Any Shivering | 2 Participants |
| A/Turkey H5N1 Influenza D2 + E2 Group | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms. | Any Joint pain | 4 Participants |
| A/Turkey H5N1 Influenza D2 + E2 Group | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms. | Any Muscle aches | 8 Participants |
Secondary
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any solicited local symptoms regardless of their intensity grade.
Time frame: Within the 7-day (Days 0-6) post vaccination period.
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects who received study vaccine and for whom any post-vaccination data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| A/Turkey H5N1 Influenza A Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Any Redness | 1 Participants |
| A/Turkey H5N1 Influenza A Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Any Swelling | 6 Participants |
| A/Turkey H5N1 Influenza A Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Any Pain | 41 Participants |
| A/Turkey H5N1 Influenza B1 + D1 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Any Redness | 3 Participants |
| A/Turkey H5N1 Influenza B1 + D1 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Any Swelling | 2 Participants |
| A/Turkey H5N1 Influenza B1 + D1 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Any Pain | 59 Participants |
| A/Turkey H5N1 Influenza C1 + E1 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Any Pain | 9 Participants |
| A/Turkey H5N1 Influenza C1 + E1 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Any Redness | 0 Participants |
| A/Turkey H5N1 Influenza C1 + E1 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Any Swelling | 0 Participants |
| A/Turkey H5N1 Influenza B2 + D2 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Any Redness | 4 Participants |
| A/Turkey H5N1 Influenza B2 + D2 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Any Pain | 53 Participants |
| A/Turkey H5N1 Influenza B2 + D2 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Any Swelling | 4 Participants |
| A/Turkey H5N1 Influenza C2 + E2 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Any Redness | 0 Participants |
| A/Turkey H5N1 Influenza C2 + E2 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Any Pain | 10 Participants |
| A/Turkey H5N1 Influenza C2 + E2 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Any Swelling | 0 Participants |
| A/Turkey H5N1 Influenza B1 + C1 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Any Pain | 48 Participants |
| A/Turkey H5N1 Influenza B1 + C1 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Any Redness | 4 Participants |
| A/Turkey H5N1 Influenza B1 + C1 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Any Swelling | 5 Participants |
| A/Turkey H5N1 Influenza D1 + E1 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Any Redness | 0 Participants |
| A/Turkey H5N1 Influenza D1 + E1 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Any Pain | 13 Participants |
| A/Turkey H5N1 Influenza D1 + E1 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Any Swelling | 1 Participants |
| A/Turkey H5N1 Influenza B2 + C2 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Any Redness | 1 Participants |
| A/Turkey H5N1 Influenza B2 + C2 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Any Swelling | 2 Participants |
| A/Turkey H5N1 Influenza B2 + C2 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Any Pain | 46 Participants |
| A/Turkey H5N1 Influenza D2 + E2 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Any Pain | 6 Participants |
| A/Turkey H5N1 Influenza D2 + E2 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Any Swelling | 0 Participants |
| A/Turkey H5N1 Influenza D2 + E2 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Any Redness | 0 Participants |
Secondary
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).
An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and 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.
Time frame: From Day 0 to Day 42
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects who received study vaccine and for whom any post-vaccination data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| A/Turkey H5N1 Influenza A Group | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs). | 9 Participants |
| A/Turkey H5N1 Influenza B1 + D1 Group | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs). | 27 Participants |
| A/Turkey H5N1 Influenza C1 + E1 Group | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs). | 12 Participants |
| A/Turkey H5N1 Influenza B2 + D2 Group | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs). | 26 Participants |
| A/Turkey H5N1 Influenza C2 + E2 Group | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs). | 11 Participants |
| A/Turkey H5N1 Influenza B1 + C1 Group | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs). | 21 Participants |
| A/Turkey H5N1 Influenza D1 + E1 Group | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs). | 12 Participants |
| A/Turkey H5N1 Influenza B2 + C2 Group | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs). | 23 Participants |
| A/Turkey H5N1 Influenza D2 + E2 Group | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs). | 9 Participants |
Secondary
Number of Subjects Reporting Serious Adverse Events (SAEs).
A SAE was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of 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.
Time frame: From Day 0 to Day 378
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects who received study vaccine and for whom any post-vaccination data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| A/Turkey H5N1 Influenza A Group | Number of Subjects Reporting Serious Adverse Events (SAEs). | 1 Participants |
| A/Turkey H5N1 Influenza B1 + D1 Group | Number of Subjects Reporting Serious Adverse Events (SAEs). | 0 Participants |
| A/Turkey H5N1 Influenza C1 + E1 Group | Number of Subjects Reporting Serious Adverse Events (SAEs). | 1 Participants |
| A/Turkey H5N1 Influenza B2 + D2 Group | Number of Subjects Reporting Serious Adverse Events (SAEs). | 1 Participants |
| A/Turkey H5N1 Influenza C2 + E2 Group | Number of Subjects Reporting Serious Adverse Events (SAEs). | 3 Participants |
| A/Turkey H5N1 Influenza B1 + C1 Group | Number of Subjects Reporting Serious Adverse Events (SAEs). | 1 Participants |
| A/Turkey H5N1 Influenza D1 + E1 Group | Number of Subjects Reporting Serious Adverse Events (SAEs). | 1 Participants |
| A/Turkey H5N1 Influenza B2 + C2 Group | Number of Subjects Reporting Serious Adverse Events (SAEs). | 0 Participants |
| A/Turkey H5N1 Influenza D2 + E2 Group | Number of Subjects Reporting Serious Adverse Events (SAEs). | 0 Participants |
Secondary
Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains.
A seropositive subject was defined as a vaccinated subject who had a MN antibody titer ≥ the cut-off value of 1:28.
Time frame: At Day 0, Day 10, Day 42 and Day 182
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| A/Turkey H5N1 Influenza A Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, D 0 | 36 Participants |
| A/Turkey H5N1 Influenza A Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, D 10 | 47 Participants |
| A/Turkey H5N1 Influenza A Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, D 0 | 46 Participants |
| A/Turkey H5N1 Influenza A Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, D 10 | 47 Participants |
| A/Turkey H5N1 Influenza A Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, D 182 | 46 Participants |
| A/Turkey H5N1 Influenza A Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, D 0 | 20 Participants |
| A/Turkey H5N1 Influenza A Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, D 42 | 47 Participants |
| A/Turkey H5N1 Influenza A Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, D 42 | 47 Participants |
| A/Turkey H5N1 Influenza A Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, D 42 | 46 Participants |
| A/Turkey H5N1 Influenza A Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, D 182 | 46 Participants |
| A/Turkey H5N1 Influenza A Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, D10 | 47 Participants |
| A/Turkey H5N1 Influenza A Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, D 182 | 44 Participants |
| A/Turkey H5N1 Influenza B1 + D1 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, D 42 | 128 Participants |
| A/Turkey H5N1 Influenza B1 + D1 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, D 0 | 126 Participants |
| A/Turkey H5N1 Influenza B1 + D1 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, D 42 | 128 Participants |
| A/Turkey H5N1 Influenza B1 + D1 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, D 182 | 126 Participants |
| A/Turkey H5N1 Influenza B1 + D1 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, D 10 | 126 Participants |
| A/Turkey H5N1 Influenza B1 + D1 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, D10 | 126 Participants |
| A/Turkey H5N1 Influenza B1 + D1 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, D 42 | 128 Participants |
| A/Turkey H5N1 Influenza B1 + D1 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, D 0 | 116 Participants |
| A/Turkey H5N1 Influenza B1 + D1 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, D 182 | 128 Participants |
| A/Turkey H5N1 Influenza B1 + D1 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, D 0 | 120 Participants |
| A/Turkey H5N1 Influenza B1 + D1 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, D 10 | 126 Participants |
| A/Turkey H5N1 Influenza B1 + D1 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, D 182 | 128 Participants |
| A/Turkey H5N1 Influenza C1 + E1 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, D 10 | 113 Participants |
| A/Turkey H5N1 Influenza C1 + E1 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, D 0 | 102 Participants |
| A/Turkey H5N1 Influenza C1 + E1 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, D 182 | 111 Participants |
| A/Turkey H5N1 Influenza C1 + E1 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, D 182 | 106 Participants |
| A/Turkey H5N1 Influenza C1 + E1 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, D 42 | 112 Participants |
| A/Turkey H5N1 Influenza C1 + E1 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, D 42 | 113 Participants |
| A/Turkey H5N1 Influenza C1 + E1 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, D 42 | 113 Participants |
| A/Turkey H5N1 Influenza C1 + E1 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, D 0 | 112 Participants |
| A/Turkey H5N1 Influenza C1 + E1 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, D 0 | 112 Participants |
| A/Turkey H5N1 Influenza C1 + E1 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, D10 | 113 Participants |
| A/Turkey H5N1 Influenza C1 + E1 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, D 10 | 113 Participants |
| A/Turkey H5N1 Influenza C1 + E1 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, D 182 | 112 Participants |
| A/Turkey H5N1 Influenza B2 + D2 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, D 182 | 82 Participants |
| A/Turkey H5N1 Influenza B2 + D2 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, D 42 | 85 Participants |
| A/Turkey H5N1 Influenza B2 + D2 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, D 10 | 84 Participants |
| A/Turkey H5N1 Influenza B2 + D2 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, D 42 | 85 Participants |
| A/Turkey H5N1 Influenza B2 + D2 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, D 42 | 85 Participants |
| A/Turkey H5N1 Influenza B2 + D2 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, D 0 | 80 Participants |
| A/Turkey H5N1 Influenza B2 + D2 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, D10 | 84 Participants |
| A/Turkey H5N1 Influenza B2 + D2 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, D 10 | 84 Participants |
| A/Turkey H5N1 Influenza B2 + D2 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, D 0 | 80 Participants |
| A/Turkey H5N1 Influenza B2 + D2 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, D 0 | 85 Participants |
| A/Turkey H5N1 Influenza B2 + D2 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, D 182 | 80 Participants |
| A/Turkey H5N1 Influenza B2 + D2 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, D 182 | 83 Participants |
| A/Turkey H5N1 Influenza C2 + E2 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, D 42 | 80 Participants |
| A/Turkey H5N1 Influenza C2 + E2 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, D 0 | 68 Participants |
| A/Turkey H5N1 Influenza C2 + E2 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, D 10 | 80 Participants |
| A/Turkey H5N1 Influenza C2 + E2 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, D 42 | 79 Participants |
| A/Turkey H5N1 Influenza C2 + E2 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, D 182 | 77 Participants |
| A/Turkey H5N1 Influenza C2 + E2 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, D 0 | 79 Participants |
| A/Turkey H5N1 Influenza C2 + E2 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, D 10 | 80 Participants |
| A/Turkey H5N1 Influenza C2 + E2 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, D 42 | 80 Participants |
| A/Turkey H5N1 Influenza C2 + E2 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, D 182 | 78 Participants |
| A/Turkey H5N1 Influenza C2 + E2 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, D 0 | 76 Participants |
| A/Turkey H5N1 Influenza C2 + E2 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, D10 | 80 Participants |
| A/Turkey H5N1 Influenza C2 + E2 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, D 182 | 77 Participants |
| A/Turkey H5N1 Influenza B1 + C1 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, D 0 | 127 Participants |
| A/Turkey H5N1 Influenza B1 + C1 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, D 182 | 127 Participants |
| A/Turkey H5N1 Influenza B1 + C1 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, D 0 | 126 Participants |
| A/Turkey H5N1 Influenza B1 + C1 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, D 10 | 127 Participants |
| A/Turkey H5N1 Influenza B1 + C1 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, D 42 | 128 Participants |
| A/Turkey H5N1 Influenza B1 + C1 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, D 10 | 127 Participants |
| A/Turkey H5N1 Influenza B1 + C1 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, D 42 | 129 Participants |
| A/Turkey H5N1 Influenza B1 + C1 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, D 182 | 124 Participants |
| A/Turkey H5N1 Influenza B1 + C1 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, D 182 | 128 Participants |
| A/Turkey H5N1 Influenza B1 + C1 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, D 0 | 114 Participants |
| A/Turkey H5N1 Influenza B1 + C1 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, D 42 | 129 Participants |
| A/Turkey H5N1 Influenza B1 + C1 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, D10 | 127 Participants |
| A/Turkey H5N1 Influenza D1 + E1 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, D 42 | 112 Participants |
| A/Turkey H5N1 Influenza D1 + E1 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, D 0 | 111 Participants |
| A/Turkey H5N1 Influenza D1 + E1 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, D 182 | 112 Participants |
| A/Turkey H5N1 Influenza D1 + E1 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, D 182 | 112 Participants |
| A/Turkey H5N1 Influenza D1 + E1 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, D 182 | 108 Participants |
| A/Turkey H5N1 Influenza D1 + E1 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, D 0 | 106 Participants |
| A/Turkey H5N1 Influenza D1 + E1 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, D 42 | 112 Participants |
| A/Turkey H5N1 Influenza D1 + E1 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, D10 | 112 Participants |
| A/Turkey H5N1 Influenza D1 + E1 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, D 10 | 112 Participants |
| A/Turkey H5N1 Influenza D1 + E1 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, D 42 | 112 Participants |
| A/Turkey H5N1 Influenza D1 + E1 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, D 0 | 104 Participants |
| A/Turkey H5N1 Influenza D1 + E1 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, D 10 | 112 Participants |
| A/Turkey H5N1 Influenza B2 + C2 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, D 42 | 79 Participants |
| A/Turkey H5N1 Influenza B2 + C2 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, D 182 | 74 Participants |
| A/Turkey H5N1 Influenza B2 + C2 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, D10 | 79 Participants |
| A/Turkey H5N1 Influenza B2 + C2 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, D 182 | 78 Participants |
| A/Turkey H5N1 Influenza B2 + C2 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, D 10 | 79 Participants |
| A/Turkey H5N1 Influenza B2 + C2 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, D 10 | 79 Participants |
| A/Turkey H5N1 Influenza B2 + C2 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, D 0 | 78 Participants |
| A/Turkey H5N1 Influenza B2 + C2 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, D 42 | 79 Participants |
| A/Turkey H5N1 Influenza B2 + C2 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, D 42 | 79 Participants |
| A/Turkey H5N1 Influenza B2 + C2 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, D 0 | 71 Participants |
| A/Turkey H5N1 Influenza B2 + C2 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, D 182 | 75 Participants |
| A/Turkey H5N1 Influenza B2 + C2 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, D 0 | 73 Participants |
| A/Turkey H5N1 Influenza D2 + E2 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, D 42 | 86 Participants |
| A/Turkey H5N1 Influenza D2 + E2 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, D 0 | 83 Participants |
| A/Turkey H5N1 Influenza D2 + E2 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, D 182 | 83 Participants |
| A/Turkey H5N1 Influenza D2 + E2 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, D 10 | 85 Participants |
| A/Turkey H5N1 Influenza D2 + E2 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, D 42 | 86 Participants |
| A/Turkey H5N1 Influenza D2 + E2 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, D10 | 85 Participants |
| A/Turkey H5N1 Influenza D2 + E2 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, D 0 | 77 Participants |
| A/Turkey H5N1 Influenza D2 + E2 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, D 10 | 85 Participants |
| A/Turkey H5N1 Influenza D2 + E2 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, D 182 | 84 Participants |
| A/Turkey H5N1 Influenza D2 + E2 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, D 42 | 85 Participants |
| A/Turkey H5N1 Influenza D2 + E2 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, D 182 | 83 Participants |
| A/Turkey H5N1 Influenza D2 + E2 Group | Number of Subjects Seropositive for MN Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, D 0 | 86 Participants |
Secondary
Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) and A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains.
A seroprotected subject was defined as a subject with serum HI antibody reciprocal titer ≥ 1:40 post-vaccination, a level of HI antibodies that may correlate with benefit in protection against influenza.
Time frame: At Day 0, Day 10, Day 42 and Day 182 for A/Indo and at Day 0, Day 42 and Day 182 for A/turkey virus strains.
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| A/Turkey H5N1 Influenza A Group | Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) and A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains. | A/turkey, D 0 | 3 Participants |
| A/Turkey H5N1 Influenza A Group | Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) and A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains. | A/turkey, D 182 | 31 Participants |
| A/Turkey H5N1 Influenza A Group | Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) and A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains. | A/Indo, D 10 | 44 Participants |
| A/Turkey H5N1 Influenza A Group | Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) and A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains. | A/Indo, D 0 | 5 Participants |
| A/Turkey H5N1 Influenza A Group | Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) and A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains. | A/Indo, D 182 | 28 Participants |
| A/Turkey H5N1 Influenza A Group | Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) and A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains. | A/Indo, D 42 | 44 Participants |
| A/Turkey H5N1 Influenza A Group | Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) and A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains. | A/turkey, D 42 | 41 Participants |
| A/Turkey H5N1 Influenza B1 + D1 Group | Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) and A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains. | A/Indo, D 182 | 116 Participants |
| A/Turkey H5N1 Influenza B1 + D1 Group | Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) and A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains. | A/Indo, D 0 | 70 Participants |
| A/Turkey H5N1 Influenza B1 + D1 Group | Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) and A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains. | A/turkey, D 182 | 119 Participants |
| A/Turkey H5N1 Influenza B1 + D1 Group | Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) and A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains. | A/Indo, D 10 | 125 Participants |
| A/Turkey H5N1 Influenza B1 + D1 Group | Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) and A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains. | A/turkey, D 42 | 126 Participants |
| A/Turkey H5N1 Influenza B1 + D1 Group | Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) and A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains. | A/Indo, D 42 | 126 Participants |
| A/Turkey H5N1 Influenza B1 + D1 Group | Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) and A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains. | A/turkey, D 0 | 32 Participants |
| A/Turkey H5N1 Influenza C1 + E1 Group | Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) and A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains. | A/turkey, D 182 | 106 Participants |
| A/Turkey H5N1 Influenza C1 + E1 Group | Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) and A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains. | A/turkey, D 42 | 113 Participants |
| A/Turkey H5N1 Influenza C1 + E1 Group | Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) and A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains. | A/Indo, D 182 | 106 Participants |
| A/Turkey H5N1 Influenza C1 + E1 Group | Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) and A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains. | A/turkey, D 0 | 35 Participants |
| A/Turkey H5N1 Influenza C1 + E1 Group | Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) and A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains. | A/Indo, D 10 | 113 Participants |
| A/Turkey H5N1 Influenza C1 + E1 Group | Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) and A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains. | A/Indo, D 42 | 113 Participants |
| A/Turkey H5N1 Influenza C1 + E1 Group | Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) and A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains. | A/Indo, D 0 | 56 Participants |
| A/Turkey H5N1 Influenza B2 + D2 Group | Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) and A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains. | A/Indo, D 42 | 78 Participants |
| A/Turkey H5N1 Influenza B2 + D2 Group | Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) and A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains. | A/turkey, D 182 | 58 Participants |
| A/Turkey H5N1 Influenza B2 + D2 Group | Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) and A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains. | A/Indo, D 182 | 58 Participants |
| A/Turkey H5N1 Influenza B2 + D2 Group | Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) and A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains. | A/turkey, D 42 | 74 Participants |
| A/Turkey H5N1 Influenza B2 + D2 Group | Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) and A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains. | A/Indo, D 0 | 44 Participants |
| A/Turkey H5N1 Influenza B2 + D2 Group | Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) and A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains. | A/turkey, D 0 | 25 Participants |
| A/Turkey H5N1 Influenza B2 + D2 Group | Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) and A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains. | A/Indo, D 10 | 79 Participants |
| A/Turkey H5N1 Influenza C2 + E2 Group | Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) and A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains. | A/Indo, D 182 | 47 Participants |
| A/Turkey H5N1 Influenza C2 + E2 Group | Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) and A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains. | A/Indo, D 0 | 31 Participants |
| A/Turkey H5N1 Influenza C2 + E2 Group | Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) and A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains. | A/Indo, D 10 | 68 Participants |
| A/Turkey H5N1 Influenza C2 + E2 Group | Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) and A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains. | A/Indo, D 42 | 67 Participants |
| A/Turkey H5N1 Influenza C2 + E2 Group | Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) and A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains. | A/turkey, D 0 | 16 Participants |
| A/Turkey H5N1 Influenza C2 + E2 Group | Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) and A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains. | A/turkey, D 42 | 62 Participants |
| A/Turkey H5N1 Influenza C2 + E2 Group | Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) and A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains. | A/turkey, D 182 | 53 Participants |
| A/Turkey H5N1 Influenza B1 + C1 Group | Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) and A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains. | A/Indo, D 42 | 129 Participants |
| A/Turkey H5N1 Influenza B1 + C1 Group | Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) and A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains. | A/turkey, D 42 | 129 Participants |
| A/Turkey H5N1 Influenza B1 + C1 Group | Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) and A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains. | A/Indo, D 0 | 68 Participants |
| A/Turkey H5N1 Influenza B1 + C1 Group | Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) and A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains. | A/turkey, D 0 | 36 Participants |
| A/Turkey H5N1 Influenza B1 + C1 Group | Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) and A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains. | A/Indo, D 182 | 121 Participants |
| A/Turkey H5N1 Influenza B1 + C1 Group | Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) and A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains. | A/turkey, D 182 | 122 Participants |
| A/Turkey H5N1 Influenza B1 + C1 Group | Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) and A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains. | A/Indo, D 10 | 127 Participants |
| A/Turkey H5N1 Influenza D1 + E1 Group | Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) and A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains. | A/turkey, D 0 | 31 Participants |
| A/Turkey H5N1 Influenza D1 + E1 Group | Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) and A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains. | A/Indo, D 182 | 101 Participants |
| A/Turkey H5N1 Influenza D1 + E1 Group | Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) and A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains. | A/turkey, D 42 | 110 Participants |
| A/Turkey H5N1 Influenza D1 + E1 Group | Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) and A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains. | A/turkey, D 182 | 103 Participants |
| A/Turkey H5N1 Influenza D1 + E1 Group | Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) and A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains. | A/Indo, D 42 | 110 Participants |
| A/Turkey H5N1 Influenza D1 + E1 Group | Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) and A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains. | A/Indo, D 0 | 58 Participants |
| A/Turkey H5N1 Influenza D1 + E1 Group | Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) and A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains. | A/Indo, D 10 | 111 Participants |
| A/Turkey H5N1 Influenza B2 + C2 Group | Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) and A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains. | A/Indo, D 182 | 48 Participants |
| A/Turkey H5N1 Influenza B2 + C2 Group | Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) and A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains. | A/Indo, D 42 | 66 Participants |
| A/Turkey H5N1 Influenza B2 + C2 Group | Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) and A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains. | A/turkey, D 0 | 23 Participants |
| A/Turkey H5N1 Influenza B2 + C2 Group | Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) and A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains. | A/Indo, D 10 | 69 Participants |
| A/Turkey H5N1 Influenza B2 + C2 Group | Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) and A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains. | A/turkey, D 182 | 54 Participants |
| A/Turkey H5N1 Influenza B2 + C2 Group | Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) and A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains. | A/turkey, D 42 | 64 Participants |
| A/Turkey H5N1 Influenza B2 + C2 Group | Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) and A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains. | A/Indo, D 0 | 34 Participants |
| A/Turkey H5N1 Influenza D2 + E2 Group | Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) and A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains. | A/Indo, D 0 | 41 Participants |
| A/Turkey H5N1 Influenza D2 + E2 Group | Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) and A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains. | A/turkey, D 42 | 72 Participants |
| A/Turkey H5N1 Influenza D2 + E2 Group | Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) and A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains. | A/turkey, D 182 | 57 Participants |
| A/Turkey H5N1 Influenza D2 + E2 Group | Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) and A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains. | A/Indo, D 10 | 78 Participants |
| A/Turkey H5N1 Influenza D2 + E2 Group | Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) and A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains. | A/turkey, D 0 | 18 Participants |
| A/Turkey H5N1 Influenza D2 + E2 Group | Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) and A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains. | A/Indo, D 42 | 79 Participants |
| A/Turkey H5N1 Influenza D2 + E2 Group | Number of Subjects Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (A/Indo) and A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strains. | A/Indo, D 182 | 57 Participants |
Secondary
Number of Subjects With Medically-attended Adverse Events (MAEs).
MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s).
Time frame: From Day 0 to Day 378
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects who received study vaccine and for whom any post-vaccination data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| A/Turkey H5N1 Influenza A Group | Number of Subjects With Medically-attended Adverse Events (MAEs). | 17 Participants |
| A/Turkey H5N1 Influenza B1 + D1 Group | Number of Subjects With Medically-attended Adverse Events (MAEs). | 24 Participants |
| A/Turkey H5N1 Influenza C1 + E1 Group | Number of Subjects With Medically-attended Adverse Events (MAEs). | 13 Participants |
| A/Turkey H5N1 Influenza B2 + D2 Group | Number of Subjects With Medically-attended Adverse Events (MAEs). | 18 Participants |
| A/Turkey H5N1 Influenza C2 + E2 Group | Number of Subjects With Medically-attended Adverse Events (MAEs). | 13 Participants |
| A/Turkey H5N1 Influenza B1 + C1 Group | Number of Subjects With Medically-attended Adverse Events (MAEs). | 21 Participants |
| A/Turkey H5N1 Influenza D1 + E1 Group | Number of Subjects With Medically-attended Adverse Events (MAEs). | 16 Participants |
| A/Turkey H5N1 Influenza B2 + C2 Group | Number of Subjects With Medically-attended Adverse Events (MAEs). | 20 Participants |
| A/Turkey H5N1 Influenza D2 + E2 Group | Number of Subjects With Medically-attended Adverse Events (MAEs). | 10 Participants |
Secondary
Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains
VRR was defined as a 4-fold rise from a detectable baseline titer or a rise from undetectable (\< 1:28, recorded 1:14 if \< 1:28) to ≥ 1:56 in the subjects.
Time frame: At Day 42
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| A/Turkey H5N1 Influenza A Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains | A/turkey, Day 42 | 46 Participants |
| A/Turkey H5N1 Influenza A Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains | A/Vie, D 42 | 15 Participants |
| A/Turkey H5N1 Influenza A Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains | A/Indo, D 42 | 41 Participants |
| A/Turkey H5N1 Influenza B1 + D1 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains | A/Vie, D 42 | 73 Participants |
| A/Turkey H5N1 Influenza B1 + D1 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains | A/Indo, D 42 | 118 Participants |
| A/Turkey H5N1 Influenza B1 + D1 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains | A/turkey, Day 42 | 121 Participants |
| A/Turkey H5N1 Influenza C1 + E1 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains | A/Indo, D 42 | 103 Participants |
| A/Turkey H5N1 Influenza C1 + E1 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains | A/turkey, Day 42 | 110 Participants |
| A/Turkey H5N1 Influenza C1 + E1 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains | A/Vie, D 42 | 65 Participants |
| A/Turkey H5N1 Influenza B2 + D2 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains | A/Vie, D 42 | 32 Participants |
| A/Turkey H5N1 Influenza B2 + D2 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains | A/turkey, Day 42 | 67 Participants |
| A/Turkey H5N1 Influenza B2 + D2 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains | A/Indo, D 42 | 39 Participants |
| A/Turkey H5N1 Influenza C2 + E2 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains | A/Indo, D 42 | 38 Participants |
| A/Turkey H5N1 Influenza C2 + E2 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains | A/turkey, Day 42 | 58 Participants |
| A/Turkey H5N1 Influenza C2 + E2 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains | A/Vie, D 42 | 15 Participants |
| A/Turkey H5N1 Influenza B1 + C1 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains | A/Indo, D 42 | 119 Participants |
| A/Turkey H5N1 Influenza B1 + C1 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains | A/turkey, Day 42 | 122 Participants |
| A/Turkey H5N1 Influenza B1 + C1 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains | A/Vie, D 42 | 71 Participants |
| A/Turkey H5N1 Influenza D1 + E1 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains | A/Vie, D 42 | 67 Participants |
| A/Turkey H5N1 Influenza D1 + E1 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains | A/turkey, Day 42 | 109 Participants |
| A/Turkey H5N1 Influenza D1 + E1 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains | A/Indo, D 42 | 102 Participants |
| A/Turkey H5N1 Influenza B2 + C2 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains | A/Indo, D 42 | 31 Participants |
| A/Turkey H5N1 Influenza B2 + C2 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains | A/Vie, D 42 | 25 Participants |
| A/Turkey H5N1 Influenza B2 + C2 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains | A/turkey, Day 42 | 56 Participants |
| A/Turkey H5N1 Influenza D2 + E2 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains | A/Indo, D 42 | 46 Participants |
| A/Turkey H5N1 Influenza D2 + E2 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains | A/Vie, D 42 | 22 Participants |
| A/Turkey H5N1 Influenza D2 + E2 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains | A/turkey, Day 42 | 69 Participants |
Secondary
Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains.
VRR was defined as a 4-fold rise from a detectable baseline titer or a rise from undetectable (\< 1:28, recorded 1:14 if \< 1:28) to ≥ 1:56 in the subjects.
Time frame: At Day 182
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| A/Turkey H5N1 Influenza A Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, Day 182 | 34 Participants |
| A/Turkey H5N1 Influenza A Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, Day 182 | 5 Participants |
| A/Turkey H5N1 Influenza A Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, Day 182 | 28 Participants |
| A/Turkey H5N1 Influenza B1 + D1 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, Day 182 | 32 Participants |
| A/Turkey H5N1 Influenza B1 + D1 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, Day 182 | 68 Participants |
| A/Turkey H5N1 Influenza B1 + D1 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, Day 182 | 103 Participants |
| A/Turkey H5N1 Influenza C1 + E1 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, Day 182 | 72 Participants |
| A/Turkey H5N1 Influenza C1 + E1 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, Day 182 | 89 Participants |
| A/Turkey H5N1 Influenza C1 + E1 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, Day 182 | 22 Participants |
| A/Turkey H5N1 Influenza B2 + D2 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, Day 182 | 11 Participants |
| A/Turkey H5N1 Influenza B2 + D2 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, Day 182 | 43 Participants |
| A/Turkey H5N1 Influenza B2 + D2 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, Day 182 | 15 Participants |
| A/Turkey H5N1 Influenza C2 + E2 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, Day 182 | 17 Participants |
| A/Turkey H5N1 Influenza C2 + E2 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, Day 182 | 36 Participants |
| A/Turkey H5N1 Influenza C2 + E2 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, Day 182 | 5 Participants |
| A/Turkey H5N1 Influenza B1 + C1 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, Day 182 | 71 Participants |
| A/Turkey H5N1 Influenza B1 + C1 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, Day 182 | 102 Participants |
| A/Turkey H5N1 Influenza B1 + C1 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, Day 182 | 24 Participants |
| A/Turkey H5N1 Influenza D1 + E1 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, Day 182 | 30 Participants |
| A/Turkey H5N1 Influenza D1 + E1 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, Day 182 | 90 Participants |
| A/Turkey H5N1 Influenza D1 + E1 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, Day 182 | 69 Participants |
| A/Turkey H5N1 Influenza B2 + C2 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, Day 182 | 13 Participants |
| A/Turkey H5N1 Influenza B2 + C2 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, Day 182 | 7 Participants |
| A/Turkey H5N1 Influenza B2 + C2 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, Day 182 | 35 Participants |
| A/Turkey H5N1 Influenza D2 + E2 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, Day 182 | 19 Participants |
| A/Turkey H5N1 Influenza D2 + E2 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, Day 182 | 9 Participants |
| A/Turkey H5N1 Influenza D2 + E2 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, Day 182 | 44 Participants |
Secondary
Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains.
VRR was defined as a 4-fold rise from a detectable baseline titer or a rise from undetectable (\< 1:28, recorded 1:14 if \< 1:28) to ≥ 1:56 in the subjects.
Time frame: At Day 10
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom a complete set of immunogenicity data required for the primary endpoint were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| A/Turkey H5N1 Influenza A Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, Day 10 | 46 Participants |
| A/Turkey H5N1 Influenza A Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, Day 10 | 19 Participants |
| A/Turkey H5N1 Influenza A Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, Day 10 | 45 Participants |
| A/Turkey H5N1 Influenza B1 + D1 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, Day 10 | 84 Participants |
| A/Turkey H5N1 Influenza B1 + D1 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, Day 10 | 121 Participants |
| A/Turkey H5N1 Influenza B1 + D1 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, Day 10 | 122 Participants |
| A/Turkey H5N1 Influenza C1 + E1 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, Day 10 | 105 Participants |
| A/Turkey H5N1 Influenza C1 + E1 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, Day 10 | 112 Participants |
| A/Turkey H5N1 Influenza C1 + E1 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, Day 10 | 64 Participants |
| A/Turkey H5N1 Influenza B2 + D2 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, Day 10 | 29 Participants |
| A/Turkey H5N1 Influenza B2 + D2 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, Day 10 | 66 Participants |
| A/Turkey H5N1 Influenza B2 + D2 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, Day 10 | 36 Participants |
| A/Turkey H5N1 Influenza C2 + E2 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, Day 10 | 40 Participants |
| A/Turkey H5N1 Influenza C2 + E2 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, Day 10 | 56 Participants |
| A/Turkey H5N1 Influenza C2 + E2 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, Day 10 | 18 Participants |
| A/Turkey H5N1 Influenza B1 + C1 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, Day 10 | 122 Participants |
| A/Turkey H5N1 Influenza B1 + C1 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, Day 10 | 124 Participants |
| A/Turkey H5N1 Influenza B1 + C1 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, Day 10 | 75 Participants |
| A/Turkey H5N1 Influenza D1 + E1 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, Day 10 | 73 Participants |
| A/Turkey H5N1 Influenza D1 + E1 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, Day 10 | 110 Participants |
| A/Turkey H5N1 Influenza D1 + E1 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, Day 10 | 104 Participants |
| A/Turkey H5N1 Influenza B2 + C2 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, Day 10 | 32 Participants |
| A/Turkey H5N1 Influenza B2 + C2 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, Day 10 | 24 Participants |
| A/Turkey H5N1 Influenza B2 + C2 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, Day 10 | 55 Participants |
| A/Turkey H5N1 Influenza D2 + E2 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Indo, Day 10 | 44 Participants |
| A/Turkey H5N1 Influenza D2 + E2 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/Vie, Day 10 | 23 Participants |
| A/Turkey H5N1 Influenza D2 + E2 Group | Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey), A/Indonesia/5/2005 (A/Indo) and A/Vietnam/1194/2004 (A/Vie) Virus Strains. | A/turkey, Day 10 | 67 Participants |