Influenza
Conditions
Keywords
Influenza, H5N1, Avian, Vaccines, Safety, Immunogenicity, Pandemic, Human
Brief summary
The purpose of this study is to determine whether GSK's avian flu vaccine GSK 1557484A is immunogenic and safe when given to adults aged \>=18 years. This Protocol Posting has been updated following Amendments 1-3 of the Protocol, Dec 2009. The impacted sections are study design and outcome measures.
Detailed description
All subjects will receive 3 doses of study vaccine, including 2 doses of active vaccine and 1 dose of placebo. All subjects will attend formal study center visits for safety and immunogenicity assessments on Days 0, 10, 42, 182, 192, 224, 549, 559, 591, and 729. A telephone contact to assess safety will be made at Day 364 and Day 909.
Interventions
BIOLOGICALA/turkey H5N1 vaccine
Administered as an intramuscular (IM) injection
Administered as an intramuscular (IM) injection
BIOLOGICALPlacebo
Administered as an intramuscular (IM) injection
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* A male or female 18 years of age or older at the time of the first vaccination. * Written informed consent obtained from the subject. * Stable health status as defined by absence of a health event satisfying the definition of a serious adverse event, or a change in an ongoing drug therapy due to therapeutic failure or symptoms of drug toxicity, within 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. * Persons with a history of cancer who are disease-free without treatment for 3 years or more are eligible. * Persons with a history of histologically-confirmed basal cell carcinoma of the skin successfully treated with local excision only are excepted and may enroll within 3 years of diagnosis, but other histologic types of skin cancer require a 3 year untreated and disease-free window as above. * Women who are disease-free 3 years or more after treatment for breast cancer and receiving long-term prophylactic tamoxifen are excepted and may enroll. * Presence of an oral temperature ≥ 37.8ºC, or acute symptoms greater than mild severity on the scheduled date of first vaccination. * Any confirmed or suspected immunosuppressive or immunodeficient 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. * 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 18 months following the first test article dose. 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 6 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 (including egg proteins or mercurial preservatives); 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 treatments. * Known receipt of analgesic or antipyretic medication with the specific intent of prophylaxis of vaccine reactogenicity on the day of first or any treatment. Subjects on stable chronic regimens of potentially analgesic or anti-pyretic medications for pre-existing diagnoses are not required to discontinue them (to do so would represent evaluation of combined vaccine reactogenicity AND treatment withdrawal - which is not the intent of the protocol).
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 559 | 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. Pre-vaccination for this outcome measure corresponds to Day 549. This outcome concerns solely subjects in the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4 and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups. |
| Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain. | At Days 549 and 559 | HI antibody titers against the A/turkey virus strain were expressed as geometric mean titers (GMTs). This outcome concerns solely subjects in the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4 and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups. |
| Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. | At Days 549 and 559 | A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (≥) 1:40. This outcome concerns solely subjects in the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4 and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups. |
| Number of Subjects With Solicited Local Symptoms | Within the 7-day (Days 0-6) post vaccination periods | Assessed solicited local symptoms were pain, redness and swelling. Any was defined as an occurrence of the specified solicited local symptom regardless of its intensity. |
| Number of Subjects With Solicited General Symptoms | Within the 7-day (Days 0-6) post vaccination periods | Solicited general symptoms assessed were fatigue, headache, joint pain at other locations (joint pain), muscle aches, shivering, sweating and fever. Any was defined as an occurrence of the specified solicited general symptom, irrespective of its intensity or relationship to vaccination. Any fever was defined as oral temperature higher than or equal to (≥) 38.0 degrees Celsius (°C). |
| Number of Subjects With Medically-attended Adverse Events (MAEs) | From Day 0 to Day 909 | 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 With Unsolicited Adverse Events (AEs) | Within the 43-day (Days 0-42) post-vaccination periods | 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 any occurrence of an unsolicited AE in a subject, regardless of intensity grade or relation to vaccination. |
| Number of Subjects With Serious Adverse Events (SAEs) | From Day 0 to Day 909 | 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 an occurrence of an SAE, regardless its relationship to vaccination. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/Indonesia/5/05 (A/Indo) Virus Strain. | At Day 0, Day 10, Day 42, Day 182 and Day 549 | A seroprotected subject was defined as a vaccinated subject with HI antibody reciprocal titers against the A/Indo virus strain greater than or equal to (≥) 1:40. This outcome measure solely concerns the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo and Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo groups. |
| Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain | At Days 0, 182, 549, 559, 591 and 729 | A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (≥) 1:40. This outcome measure concerns solely the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4, and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups. |
| Number of Seroconverted Subjects for HI Antibodies Against the A/Indo Virus Strain. | At Days 10 and 42 | 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. Pre-vaccination for this outcome measure corresponds to Day 0. This outcome measure only concerns the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo, Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4 and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups. |
| Haemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/5/05 (A/Indo) Virus Strain. | At Days 0, 10, 42, 182 and 549 | HI antibody titers against the A/Indo virus strain were expressed as geometric mean titers (GMTs). This outcome measure solely concerns the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo and Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo groups. |
| Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. | At Day 192 | 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. Pre-vaccination for this outcome measure corresponds to Day 182. This outcome measure solely concerns subjects in the Naïve Placebo-A/turkey H5N1-Formulation 3 Group. |
| Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey Virus Strain. | At Days 182 and 192 | HI antibody titers against the A/turkey virus strain were expressed as geometric mean titers (GMTs). This outcome measure solely concerns subjects in the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo and Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo groups. |
| Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. | At Days 182 and 192 | A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (≥) 1:40. This outcome measure solely concerns subjects in the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo and Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo groups. |
| Geometric Mean Fold Rise (GMFR) as Regards Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain | At Days 192 and 224 | GMFR was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the baseline reciprocal HI titer. Baseline for this outcome measure corresponds to Day 182. This outcome measure solely concerns subjects in the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo, Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo, and Naïve Placebo-A/turkey H5N1-Formulation 3 groups. |
| Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain. | At Days 0, 182,192, 224, 549 and 729 | HI antibody titers against the A/turkey virus strain were expressed as geometric mean titers (GMTs). This outcome measure concerns solely the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo and Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo groups. |
| Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain. | At Days 0, 182,192, 224, 549 and 729 | A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (≥) 1:40. This outcome measure concerns solely the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo and Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo groups. |
Countries
Canada, United States
Participant flow
Recruitment details
Study duration was of approximately 909 days for all subjects.
Participants by arm
| Arm | Count |
|---|---|
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F1-Placebo Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm. | 120 |
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F2-Placebo Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm. | 121 |
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm. | 119 |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm. | 119 |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm. | 122 |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm. | 120 |
| Naïve Placebo-A/Turkey Influenza (H5N1)-F3-Group Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549. Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm. | 120 |
| Total | 841 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 5 | 1 | 2 | 2 | 1 | 4 | 4 |
| Overall Study | Lost to Follow-up | 14 | 10 | 8 | 9 | 10 | 9 | 9 |
| Overall Study | Other | 1 | 0 | 1 | 2 | 0 | 2 | 1 |
| Overall Study | Protocol Violation | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 12 | 14 | 9 | 10 | 16 | 18 | 14 |
Baseline characteristics
| Characteristic | A/Indonesia Primed-A/Turkey Influenza (H5N1)-F1-Placebo Group | A/Indonesia Primed-A/Turkey Influenza (H5N1)-F2-Placebo Group | A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group | A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group | A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group | Naïve Placebo-A/Turkey Influenza (H5N1)-F3-Group | Total |
|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 49.8 Years STANDARD_DEVIATION 18.01 | 49.6 Years STANDARD_DEVIATION 17.93 | 50.7 Years STANDARD_DEVIATION 17.67 | 49.2 Years STANDARD_DEVIATION 17.75 | 50.3 Years STANDARD_DEVIATION 17.77 | 50.1 Years STANDARD_DEVIATION 18.92 | 50.0 Years STANDARD_DEVIATION 18.03 | 49.95 Years STANDARD_DEVIATION 17.99 |
| Sex: Female, Male Female | 80 Participants | 73 Participants | 69 Participants | 70 Participants | 68 Participants | 70 Participants | 75 Participants | 505 Participants |
| Sex: Female, Male Male | 40 Participants | 48 Participants | 50 Participants | 49 Participants | 54 Participants | 50 Participants | 45 Participants | 336 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 |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 106 / 120 | 109 / 121 | 106 / 119 | 103 / 119 | 106 / 122 | 101 / 120 | 106 / 120 |
| serious Total, serious adverse events | 12 / 120 | 14 / 121 | 11 / 119 | 9 / 119 | 11 / 122 | 15 / 120 | 12 / 120 |
Outcome results
Primary
Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain.
HI antibody titers against the A/turkey virus strain were expressed as geometric mean titers (GMTs). This outcome concerns solely subjects in the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4 and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.
Time frame: At Days 549 and 559
Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain. | A/turkey, Day 549 (N=83,88,81,72) | 11.1 Titers |
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain. | A/turkey, Day 559 (N= 83,88,81,72) | 356.7 Titers |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain. | A/turkey, Day 559 (N= 83,88,81,72) | 266.4 Titers |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain. | A/turkey, Day 549 (N=83,88,81,72) | 8.3 Titers |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain. | A/turkey, Day 549 (N=83,88,81,72) | 9.2 Titers |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain. | A/turkey, Day 559 (N= 83,88,81,72) | 446.6 Titers |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain. | A/turkey, Day 549 (N=83,88,81,72) | 11.4 Titers |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain. | A/turkey, Day 559 (N= 83,88,81,72) | 343.9 Titers |
Primary
Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain.
HI antibody titers against the A/turkey virus strain were expressed as geometric mean titers (GMTs). This outcome concerns solely subjects in the Naïve Placebo-A/turkey H5N1-Formulation 3 Group.
Time frame: At Days 182 and 192
Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain. | A/turkey strain, Day 182 (N=100) | 10.8 Titers |
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain. | A/turkey strain, Day 192 (N=99) | 43.5 Titers |
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 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. Pre-vaccination for this outcome measure corresponds to Day 182. This outcome concerns solely subjects in the Naïve Placebo-A/turkey H5N1-Formulation 3 Group
Time frame: At Day 192
Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. | 44 Subjects |
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 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. Pre-vaccination for this outcome measure corresponds to Day 549. This outcome concerns solely subjects in the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4 and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.
Time frame: At Day 559
Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. | 71 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group | Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. | 81 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group | Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. | 73 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group | Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. | 65 Subjects |
Primary
Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.
A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (≥) 1:40. This outcome concerns solely subjects in the Naïve Placebo-A/turkey H5N1-Formulation 3 Group.
Time frame: At Days 182 and 192
Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. | A/turkey strain, Day 182 (N=100) | 24 Subjects |
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. | A/turkey strain, Day 192 (N=99) | 64 Subjects |
Primary
Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.
A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (≥) 1:40. This outcome concerns solely subjects in the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4 and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.
Time frame: At Days 549 and 559
Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. | A/turkey, Day 549 (N=83,88,81,72) | 15 Subjects |
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. | A/turkey, Day 559 (N= 83,87,80,72) | 79 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group | Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. | A/turkey, Day 559 (N= 83,87,80,72) | 83 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group | Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. | A/turkey, Day 549 (N=83,88,81,72) | 8 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group | Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. | A/turkey, Day 549 (N=83,88,81,72) | 10 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group | Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. | A/turkey, Day 559 (N= 83,87,80,72) | 77 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group | Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. | A/turkey, Day 549 (N=83,88,81,72) | 13 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group | Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. | A/turkey, Day 559 (N= 83,87,80,72) | 69 Subjects |
Primary
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 909
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine for whom any post-vaccination data were available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Number of Subjects With Medically-attended Adverse Events (MAEs) | 68 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group | Number of Subjects With Medically-attended Adverse Events (MAEs) | 66 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group | Number of Subjects With Medically-attended Adverse Events (MAEs) | 77 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group | Number of Subjects With Medically-attended Adverse Events (MAEs) | 75 Subjects |
| Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group | Number of Subjects With Medically-attended Adverse Events (MAEs) | 62 Subjects |
| Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group | Number of Subjects With Medically-attended Adverse Events (MAEs) | 63 Subjects |
| Naïve Placebo-A/Turkey H5N1-Formulation 3 Group | Number of Subjects With Medically-attended Adverse Events (MAEs) | 70 Subjects |
Primary
Number of Subjects With 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 an occurrence of an SAE, regardless its relationship to vaccination.
Time frame: From Day 0 to Day 909
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine for whom any post-vaccination data were available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Number of Subjects With Serious Adverse Events (SAEs) | 12 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group | Number of Subjects With Serious Adverse Events (SAEs) | 14 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group | Number of Subjects With Serious Adverse Events (SAEs) | 11 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group | Number of Subjects With Serious Adverse Events (SAEs) | 9 Subjects |
| Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group | Number of Subjects With Serious Adverse Events (SAEs) | 11 Subjects |
| Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group | Number of Subjects With Serious Adverse Events (SAEs) | 15 Subjects |
| Naïve Placebo-A/Turkey H5N1-Formulation 3 Group | Number of Subjects With Serious Adverse Events (SAEs) | 12 Subjects |
Primary
Number of Subjects With Solicited General Symptoms
Solicited general symptoms assessed were fatigue, headache, joint pain at other locations (joint pain), muscle aches, shivering, sweating and fever. Any was defined as an occurrence of the specified solicited general symptom, irrespective of its intensity or relationship to vaccination. Any fever was defined as oral temperature higher than or equal to (≥) 38.0 degrees Celsius (°C).
Time frame: Within the 7-day (Days 0-6) post vaccination periods
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine for whom any post-vaccination data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Number of Subjects With Solicited General Symptoms | Any Muscle aches | 54 Subjects |
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Number of Subjects With Solicited General Symptoms | Any Fatigue | 45 Subjects |
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Number of Subjects With Solicited General Symptoms | Any Fever | 2 Subjects |
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Number of Subjects With Solicited General Symptoms | Any Headache | 44 Subjects |
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Number of Subjects With Solicited General Symptoms | Any Sweating | 15 Subjects |
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Number of Subjects With Solicited General Symptoms | Any Joint pain | 33 Subjects |
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Number of Subjects With Solicited General Symptoms | Any Shivering | 12 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group | Number of Subjects With Solicited General Symptoms | Any Fatigue | 50 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group | Number of Subjects With Solicited General Symptoms | Any Headache | 50 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group | Number of Subjects With Solicited General Symptoms | Any Sweating | 20 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group | Number of Subjects With Solicited General Symptoms | Any Shivering | 18 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group | Number of Subjects With Solicited General Symptoms | Any Muscle aches | 52 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group | Number of Subjects With Solicited General Symptoms | Any Joint pain | 37 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group | Number of Subjects With Solicited General Symptoms | Any Fever | 5 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group | Number of Subjects With Solicited General Symptoms | Any Joint pain | 36 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group | Number of Subjects With Solicited General Symptoms | Any Fever | 6 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group | Number of Subjects With Solicited General Symptoms | Any Headache | 42 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group | Number of Subjects With Solicited General Symptoms | Any Fatigue | 47 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group | Number of Subjects With Solicited General Symptoms | Any Sweating | 15 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group | Number of Subjects With Solicited General Symptoms | Any Muscle aches | 59 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group | Number of Subjects With Solicited General Symptoms | Any Shivering | 16 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group | Number of Subjects With Solicited General Symptoms | Any Muscle aches | 49 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group | Number of Subjects With Solicited General Symptoms | Any Fatigue | 44 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group | Number of Subjects With Solicited General Symptoms | Any Headache | 44 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group | Number of Subjects With Solicited General Symptoms | Any Joint pain | 26 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group | Number of Subjects With Solicited General Symptoms | Any Shivering | 8 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group | Number of Subjects With Solicited General Symptoms | Any Sweating | 11 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group | Number of Subjects With Solicited General Symptoms | Any Fever | 3 Subjects |
| Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group | Number of Subjects With Solicited General Symptoms | Any Fever | 8 Subjects |
| Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group | Number of Subjects With Solicited General Symptoms | Any Fatigue | 42 Subjects |
| Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group | Number of Subjects With Solicited General Symptoms | Any Muscle aches | 48 Subjects |
| Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group | Number of Subjects With Solicited General Symptoms | Any Joint pain | 28 Subjects |
| Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group | Number of Subjects With Solicited General Symptoms | Any Headache | 44 Subjects |
| Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group | Number of Subjects With Solicited General Symptoms | Any Sweating | 14 Subjects |
| Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group | Number of Subjects With Solicited General Symptoms | Any Shivering | 20 Subjects |
| Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group | Number of Subjects With Solicited General Symptoms | Any Fever | 2 Subjects |
| Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group | Number of Subjects With Solicited General Symptoms | Any Fatigue | 39 Subjects |
| Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group | Number of Subjects With Solicited General Symptoms | Any Headache | 35 Subjects |
| Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group | Number of Subjects With Solicited General Symptoms | Any Shivering | 10 Subjects |
| Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group | Number of Subjects With Solicited General Symptoms | Any Sweating | 10 Subjects |
| Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group | Number of Subjects With Solicited General Symptoms | Any Muscle aches | 42 Subjects |
| Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group | Number of Subjects With Solicited General Symptoms | Any Joint pain | 16 Subjects |
| Naïve Placebo-A/Turkey H5N1-Formulation 3 Group | Number of Subjects With Solicited General Symptoms | Any Muscle aches | 55 Subjects |
| Naïve Placebo-A/Turkey H5N1-Formulation 3 Group | Number of Subjects With Solicited General Symptoms | Any Shivering | 18 Subjects |
| Naïve Placebo-A/Turkey H5N1-Formulation 3 Group | Number of Subjects With Solicited General Symptoms | Any Headache | 47 Subjects |
| Naïve Placebo-A/Turkey H5N1-Formulation 3 Group | Number of Subjects With Solicited General Symptoms | Any Sweating | 11 Subjects |
| Naïve Placebo-A/Turkey H5N1-Formulation 3 Group | Number of Subjects With Solicited General Symptoms | Any Fatigue | 47 Subjects |
| Naïve Placebo-A/Turkey H5N1-Formulation 3 Group | Number of Subjects With Solicited General Symptoms | Any Fever | 2 Subjects |
| Naïve Placebo-A/Turkey H5N1-Formulation 3 Group | Number of Subjects With Solicited General Symptoms | Any Joint pain | 30 Subjects |
Primary
Number of Subjects With Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any was defined as an occurrence of the specified solicited local symptom regardless of its intensity.
Time frame: Within the 7-day (Days 0-6) post vaccination periods
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine for whom any post-vaccination data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Number of Subjects With Solicited Local Symptoms | Any Swelling | 6 Subjects |
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Number of Subjects With Solicited Local Symptoms | Any Redness | 8 Subjects |
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Number of Subjects With Solicited Local Symptoms | Any Pain | 98 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group | Number of Subjects With Solicited Local Symptoms | Any Redness | 4 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group | Number of Subjects With Solicited Local Symptoms | Any Pain | 100 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group | Number of Subjects With Solicited Local Symptoms | Any Swelling | 7 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group | Number of Subjects With Solicited Local Symptoms | Any Swelling | 15 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group | Number of Subjects With Solicited Local Symptoms | Any Pain | 101 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group | Number of Subjects With Solicited Local Symptoms | Any Redness | 12 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group | Number of Subjects With Solicited Local Symptoms | Any Redness | 9 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group | Number of Subjects With Solicited Local Symptoms | Any Pain | 93 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group | Number of Subjects With Solicited Local Symptoms | Any Swelling | 4 Subjects |
| Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group | Number of Subjects With Solicited Local Symptoms | Any Redness | 14 Subjects |
| Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group | Number of Subjects With Solicited Local Symptoms | Any Pain | 102 Subjects |
| Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group | Number of Subjects With Solicited Local Symptoms | Any Swelling | 16 Subjects |
| Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group | Number of Subjects With Solicited Local Symptoms | Any Pain | 90 Subjects |
| Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group | Number of Subjects With Solicited Local Symptoms | Any Swelling | 9 Subjects |
| Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group | Number of Subjects With Solicited Local Symptoms | Any Redness | 4 Subjects |
| Naïve Placebo-A/Turkey H5N1-Formulation 3 Group | Number of Subjects With Solicited Local Symptoms | Any Swelling | 11 Subjects |
| Naïve Placebo-A/Turkey H5N1-Formulation 3 Group | Number of Subjects With Solicited Local Symptoms | Any Redness | 8 Subjects |
| Naïve Placebo-A/Turkey H5N1-Formulation 3 Group | Number of Subjects With Solicited Local Symptoms | Any Pain | 95 Subjects |
Primary
Number of Subjects With 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 any occurrence of an unsolicited AE in a subject, regardless of intensity grade or relation to vaccination.
Time frame: Within the 43-day (Days 0-42) post-vaccination periods
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine for whom any post-vaccination data were available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 70 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 72 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 78 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 68 Subjects |
| Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 67 Subjects |
| Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 68 Subjects |
| Naïve Placebo-A/Turkey H5N1-Formulation 3 Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 75 Subjects |
Secondary
Geometric Mean Fold Rise (GMFR) as Regards Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain
GMFR was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the baseline reciprocal HI titer. Baseline for this outcome measure corresponds to Day 182. This outcome measure solely concerns subjects in the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo, Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo, and Naïve Placebo-A/turkey H5N1-Formulation 3 groups.
Time frame: At Days 192 and 224
Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Geometric Mean Fold Rise (GMFR) as Regards Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain | A/turkey, Day 192 (N=94,86,99) | 17.8 Fold increase |
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Geometric Mean Fold Rise (GMFR) as Regards Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain | A/turkey, Day 224 (N=89,86,98) | 11.2 Fold increase |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group | Geometric Mean Fold Rise (GMFR) as Regards Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain | A/turkey, Day 192 (N=94,86,99) | 30.2 Fold increase |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group | Geometric Mean Fold Rise (GMFR) as Regards Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain | A/turkey, Day 224 (N=89,86,98) | 17.2 Fold increase |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group | Geometric Mean Fold Rise (GMFR) as Regards Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain | A/turkey, Day 192 (N=94,86,99) | 4.0 Fold increase |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group | Geometric Mean Fold Rise (GMFR) as Regards Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain | A/turkey, Day 224 (N=89,86,98) | 4.2 Fold increase |
Secondary
Geometric Mean Fold Rise (GMFR) as Regards Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain
GMFR was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the baseline reciprocal HI titer. Baseline for this outcome measure corresponds to Day 549. This outcome measure solely concerns subjects in the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 and Naïve Placebo-A/turkey H5N1-Formulation 3 groups.
Time frame: At Day 559
Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Geometric Mean Fold Rise (GMFR) as Regards Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain | A/turkey, Day 559 (N=83,87,80,72,81) | 32.0 Fold increase |
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Geometric Mean Fold Rise (GMFR) as Regards Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain | A/turkey, Day 591 (N=82,88,80,71,81) | 26.7 Fold increase |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group | Geometric Mean Fold Rise (GMFR) as Regards Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain | A/turkey, Day 559 (N=83,87,80,72,81) | 32.0 Fold increase |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group | Geometric Mean Fold Rise (GMFR) as Regards Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain | A/turkey, Day 591 (N=82,88,80,71,81) | 29.1 Fold increase |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group | Geometric Mean Fold Rise (GMFR) as Regards Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain | A/turkey, Day 559 (N=83,87,80,72,81) | 48.1 Fold increase |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group | Geometric Mean Fold Rise (GMFR) as Regards Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain | A/turkey, Day 591 (N=82,88,80,71,81) | 35.2 Fold increase |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group | Geometric Mean Fold Rise (GMFR) as Regards Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain | A/turkey, Day 591 (N=82,88,80,71,81) | 22.0 Fold increase |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group | Geometric Mean Fold Rise (GMFR) as Regards Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain | A/turkey, Day 559 (N=83,87,80,72,81) | 30.1 Fold increase |
| Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group | Geometric Mean Fold Rise (GMFR) as Regards Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain | A/turkey, Day 559 (N=83,87,80,72,81) | 19.5 Fold increase |
| Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group | Geometric Mean Fold Rise (GMFR) as Regards Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain | A/turkey, Day 591 (N=82,88,80,71,81) | 14.8 Fold increase |
Secondary
Haemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/5/05 (A/Indo) Virus Strain.
HI antibody titers against the A/Indo virus strain were expressed as geometric mean titers (GMTs). This outcome measure solely concerns the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2, and Naïve Placebo-A/turkey H5N1-Formulation 3 groups.
Time frame: At Days 0, 10, 42, 182, 549 and 559
Population: The analysis was performed on the Day 729 According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus), as well as with HI titers results available up to the Day 729 time point, for any virus strain.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/5/05 (A/Indo) Virus Strain. | A/Indo, Day 0 (N=90,96,99,89,99) | 5.9 Titers |
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/5/05 (A/Indo) Virus Strain. | A/Indo, Day 10 (N=89,95,98,87,97) | 27.0 Titers |
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/5/05 (A/Indo) Virus Strain. | A/Indo, Day 42 (N=87,94,96,87,97) | 37.5 Titers |
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/5/05 (A/Indo) Virus Strain. | A/Indo, Day 182 (N=90,96,99,89,99) | 16.4 Titers |
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/5/05 (A/Indo) Virus Strain. | A/Indo, Day 549 (N=83,86,81,72,81) | 8.1 Titers |
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/5/05 (A/Indo) Virus Strain. | A/Indo, Day 559 (N=83,85,81,72,80) | 304.3 Titers |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/5/05 (A/Indo) Virus Strain. | A/Indo, Day 549 (N=83,86,81,72,81) | 7.9 Titers |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/5/05 (A/Indo) Virus Strain. | A/Indo, Day 559 (N=83,85,81,72,80) | 231.9 Titers |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/5/05 (A/Indo) Virus Strain. | A/Indo, Day 0 (N=90,96,99,89,99) | 5.7 Titers |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/5/05 (A/Indo) Virus Strain. | A/Indo, Day 42 (N=87,94,96,87,97) | 27.3 Titers |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/5/05 (A/Indo) Virus Strain. | A/Indo, Day 182 (N=90,96,99,89,99) | 13.7 Titers |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/5/05 (A/Indo) Virus Strain. | A/Indo, Day 10 (N=89,95,98,87,97) | 17.2 Titers |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/5/05 (A/Indo) Virus Strain. | A/Indo, Day 182 (N=90,96,99,89,99) | 17.8 Titers |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/5/05 (A/Indo) Virus Strain. | A/Indo, Day 549 (N=83,86,81,72,81) | 7.8 Titers |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/5/05 (A/Indo) Virus Strain. | A/Indo, Day 0 (N=90,96,99,89,99) | 5.7 Titers |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/5/05 (A/Indo) Virus Strain. | A/Indo, Day 42 (N=87,94,96,87,97) | 45.7 Titers |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/5/05 (A/Indo) Virus Strain. | A/Indo, Day 10 (N=89,95,98,87,97) | 31.7 Titers |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/5/05 (A/Indo) Virus Strain. | A/Indo, Day 559 (N=83,85,81,72,80) | 376.6 Titers |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/5/05 (A/Indo) Virus Strain. | A/Indo, Day 182 (N=90,96,99,89,99) | 16.2 Titers |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/5/05 (A/Indo) Virus Strain. | A/Indo, Day 10 (N=89,95,98,87,97) | 26.2 Titers |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/5/05 (A/Indo) Virus Strain. | A/Indo, Day 42 (N=87,94,96,87,97) | 36.6 Titers |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/5/05 (A/Indo) Virus Strain. | A/Indo, Day 559 (N=83,85,81,72,80) | 289.2 Titers |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/5/05 (A/Indo) Virus Strain. | A/Indo, Day 549 (N=83,86,81,72,81) | 9.2 Titers |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/5/05 (A/Indo) Virus Strain. | A/Indo, Day 0 (N=90,96,99,89,99) | 5.6 Titers |
| Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/5/05 (A/Indo) Virus Strain. | A/Indo, Day 549 (N=83,86,81,72,81) | 6.2 Titers |
| Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/5/05 (A/Indo) Virus Strain. | A/Indo, Day 42 (N=87,94,96,87,97) | 6.2 Titers |
| Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/5/05 (A/Indo) Virus Strain. | A/Indo, Day 10 (N=89,95,98,87,97) | 6.3 Titers |
| Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/5/05 (A/Indo) Virus Strain. | A/Indo, Day 559 (N=83,85,81,72,80) | 113.1 Titers |
| Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/5/05 (A/Indo) Virus Strain. | A/Indo, Day 182 (N=90,96,99,89,99) | 6.7 Titers |
| Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/5/05 (A/Indo) Virus Strain. | A/Indo, Day 0 (N=90,96,99,89,99) | 5.9 Titers |
Secondary
Haemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/5/05 (A/Indo) Virus Strain.
HI antibody titers against the A/Indo virus strain were expressed as geometric mean titers (GMTs). This outcome measure solely concerns the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo and Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo groups.
Time frame: At Days 0, 10, 42, 182 and 549
Population: The analysis was performed on the Day 729 According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus), as well as with HI titers results available up to the Day 729 time point, for any virus strain.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/5/05 (A/Indo) Virus Strain. | A/Indo, Day 10 (N=95,92) | 32.3 Titers |
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/5/05 (A/Indo) Virus Strain. | A/Indo, Day 182 (N=95,92) | 22.4 Titers |
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/5/05 (A/Indo) Virus Strain. | A/Indo, Day 42 (N=93,88) | 44.1 Titers |
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/5/05 (A/Indo) Virus Strain. | A/Indo, Day 549 (N=84,81) | 24.0 Titers |
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/5/05 (A/Indo) Virus Strain. | A/Indo, Day 0 (N=95,92) | 6.7 Titers |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/5/05 (A/Indo) Virus Strain. | A/Indo, Day 549 (N=84,81) | 22.7 Titers |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/5/05 (A/Indo) Virus Strain. | A/Indo, Day 0 (N=95,92) | 5.9 Titers |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/5/05 (A/Indo) Virus Strain. | A/Indo, Day 10 (N=95,92) | 30.7 Titers |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/5/05 (A/Indo) Virus Strain. | A/Indo, Day 42 (N=93,88) | 44.8 Titers |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/5/05 (A/Indo) Virus Strain. | A/Indo, Day 182 (N=95,92) | 15.7 Titers |
Secondary
Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain.
HI antibody titers against the A/turkey virus strain were expressed as geometric mean titers (GMTs). This outcome measure concerns solely the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo and Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo groups.
Time frame: At Days 0, 182,192, 224, 549 and 729
Population: The analysis was performed on the Day 729 According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus), as well as with HI titers results available up to the Day 729 time point, for any virus strain.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain. | A/turkey, Day 0 (N= 95,92) | 9.2 Titers |
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain. | A/turkey, Day 182 (N=95,92) | 17.6 Titers |
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain. | A/turkey, Day 192 (N=94,86) | 308.4 Titers |
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain. | A/turkey, Day 224 (N=93,91) | 195.0 Titers |
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain. | A/turkey, Day 549 (N=84,81) | 32.7 Titers |
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain. | A/turkey, Day 729 (N=78,78) | 41.8 Titers |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain. | A/turkey, Day 549 (N=84,81) | 28.7 Titers |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain. | A/turkey, Day 0 (N= 95,92) | 6.6 Titers |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain. | A/turkey, Day 224 (N=93,91) | 213.7 Titers |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain. | A/turkey, Day 182 (N=95,92) | 12.2 Titers |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain. | A/turkey, Day 729 (N=78,78) | 31.2 Titers |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain. | A/turkey, Day 192 (N=94,86) | 374.4 Titers |
Secondary
Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain.
HI antibody titers against the A/turkey virus strain were expressed as geometric mean titers (GMTs). This outcome measure concerns solely the Naïve Placebo-A/turkey H5N1-Formulation 3 Group.
Time frame: At Days 0, 182, 192, 224, 549, 559, 591 and 729
Population: The analysis was performed on the Day 729 According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus), as well as with HI titers results available up to the Day 729 time point, for any virus strain.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain. | A/turkey, Day 0 (N=99) | 8.0 Titers |
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain. | A/turkey, Day 182 (N=99) | 10.6 Titers |
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain. | A/turkey, Day 192 (N=98) | 43.4 Titers |
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain. | A/turkey, Day 224 (N=98) | 43.7 Titers |
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain. | A/turkey, Day 549 (N=81) | 15.6 Titers |
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain. | A/turkey, Day 559 (N=80) | 314.4 Titers |
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain. | A/turkey, Day 591 (N=80) | 236.2 Titers |
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain. | A/turkey, Day 729 (N=80) | 98.1 Titers |
Secondary
Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain.
HI antibody titers against the A/turkey virus strain were expressed as geometric mean titers (GMTs). This outcome measure concerns solely the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4, and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.
Time frame: At Days 0, 182, 549, 559, 591 and 729
Population: The analysis was performed on the Day 729 According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus), as well as with HI titers results available up to the Day 729 time point, for any virus strain.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain. | A/turkey, Day 0 (N=90,96,99,89) | 8.0 Titers |
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain. | A/turkey, Day 182 (N=90,96,99,89) | 13.5 Titers |
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain. | A/turkey, Day 549 (N=83,86,81,72) | 11.1 Titers |
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain. | A/turkey, Day 559 (N=83,85,80,72) | 356.7 Titers |
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain. | A/turkey, Day 591 (N=82,86,80,71) | 300.3 Titers |
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain. | A/turkey, Day 729 (N=81,83,79,70) | 119.2 Titers |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain. | A/turkey, Day 729 (N=81,83,79,70) | 96.6 Titers |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain. | A/turkey, Day 559 (N=83,85,80,72) | 266.4 Titers |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain. | A/turkey, Day 0 (N=90,96,99,89) | 7.1 Titers |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain. | A/turkey, Day 549 (N=83,86,81,72) | 8.4 Titers |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain. | A/turkey, Day 182 (N=90,96,99,89) | 10.8 Titers |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain. | A/turkey, Day 591 (N=82,86,80,71) | 242.4 Titers |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain. | A/turkey, Day 182 (N=90,96,99,89) | 12.8 Titers |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain. | A/turkey, Day 549 (N=83,86,81,72) | 9.2 Titers |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain. | A/turkey, Day 559 (N=83,85,80,72) | 446.6 Titers |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain. | A/turkey, Day 729 (N=81,83,79,70) | 134.8 Titers |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain. | A/turkey, Day 591 (N=82,86,80,71) | 326.9 Titers |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain. | A/turkey, Day 0 (N=90,96,99,89) | 6.6 Titers |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain. | A/turkey, Day 591 (N=82,86,80,71) | 254.4 Titers |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain. | A/turkey, Day 729 (N=81,83,79,70) | 105.6 Titers |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain. | A/turkey, Day 182 (N=90,96,99,89) | 13.7 Titers |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain. | A/turkey, Day 559 (N=83,85,80,72) | 343.9 Titers |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain. | A/turkey, Day 0 (N=90,96,99,89) | 6.9 Titers |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain. | A/turkey, Day 549 (N=83,86,81,72) | 11.4 Titers |
Secondary
Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey Virus Strain.
HI antibody titers against the A/turkey virus strain were expressed as geometric mean titers (GMTs). This outcome measure solely concerns subjects in the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo and Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo groups.
Time frame: At Days 182 and 192
Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey Virus Strain. | A/turkey, Day 182 (N=95,92) | 17.6 Titers |
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey Virus Strain. | A/turkey, Day 192 (N=94,86) | 308.4 Titers |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey Virus Strain. | A/turkey, Day 182 (N=95,92) | 12.2 Titers |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group | Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey Virus Strain. | A/turkey, Day 192 (N=94,86) | 374.4 Titers |
Secondary
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 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. Pre-vaccination for this outcome measure corresponds to Day 182. This outcome measure solely concerns subjects in the Naïve Placebo-A/turkey H5N1-Formulation 3 Group.
Time frame: At Day 192
Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. | 44 Subjects |
Secondary
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 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. Pre-vaccination for this outcome measure corresponds to Day 549. This outcome concerns solely subjects in the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4 and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.
Time frame: At Day 591
Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. | 69 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group | Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. | 80 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group | Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. | 70 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group | Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. | 61 Subjects |
Secondary
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 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. Pre-vaccination for this outcome measure corresponds to Day 182. This outcome measure solely concerns subjects in the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo, Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo, and Naïve Placebo-A/turkey H5N1-Formulation 3 groups.
Time frame: At Day 224
Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. | 64 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group | Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. | 75 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group | Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. | 42 Subjects |
Secondary
Number of Seroconverted Subjects for HI Antibodies Against the A/Indo Virus Strain.
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. Pre-vaccination for this outcome measure corresponds to Day 0. This outcome measure only concerns the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo, Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4 and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.
Time frame: At Days 10 and 42
Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Number of Seroconverted Subjects for HI Antibodies Against the A/Indo Virus Strain. | A/Indo, Day 10 (N=95,92,89,97,98,87) | 42 Subjects |
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Number of Seroconverted Subjects for HI Antibodies Against the A/Indo Virus Strain. | A/Indo, Day 42 (N=93,88,87,96,96,87) | 50 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group | Number of Seroconverted Subjects for HI Antibodies Against the A/Indo Virus Strain. | A/Indo, Day 10 (N=95,92,89,97,98,87) | 50 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group | Number of Seroconverted Subjects for HI Antibodies Against the A/Indo Virus Strain. | A/Indo, Day 42 (N=93,88,87,96,96,87) | 61 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group | Number of Seroconverted Subjects for HI Antibodies Against the A/Indo Virus Strain. | A/Indo, Day 10 (N=95,92,89,97,98,87) | 38 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group | Number of Seroconverted Subjects for HI Antibodies Against the A/Indo Virus Strain. | A/Indo, Day 42 (N=93,88,87,96,96,87) | 49 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group | Number of Seroconverted Subjects for HI Antibodies Against the A/Indo Virus Strain. | A/Indo, Day 10 (N=95,92,89,97,98,87) | 33 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group | Number of Seroconverted Subjects for HI Antibodies Against the A/Indo Virus Strain. | A/Indo, Day 42 (N=93,88,87,96,96,87) | 51 Subjects |
| Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group | Number of Seroconverted Subjects for HI Antibodies Against the A/Indo Virus Strain. | A/Indo, Day 10 (N=95,92,89,97,98,87) | 52 Subjects |
| Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group | Number of Seroconverted Subjects for HI Antibodies Against the A/Indo Virus Strain. | A/Indo, Day 42 (N=93,88,87,96,96,87) | 64 Subjects |
| Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group | Number of Seroconverted Subjects for HI Antibodies Against the A/Indo Virus Strain. | A/Indo, Day 10 (N=95,92,89,97,98,87) | 40 Subjects |
| Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group | Number of Seroconverted Subjects for HI Antibodies Against the A/Indo Virus Strain. | A/Indo, Day 42 (N=93,88,87,96,96,87) | 51 Subjects |
Secondary
Number of Seroconverted Subjects for HI Antibodies Against the A/Indo Virus Strain.
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. This outcome measure only concerns the Naïve Placebo-A/turkey H5N1-Formulation 3 Group, for whom the pre-vaccination time point corresponds to the Day 192 time point.
Time frame: At Days 192 and 224
Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Number of Seroconverted Subjects for HI Antibodies Against the A/Indo Virus Strain. | A/Indo, Day 192 | 8 Subjects |
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Number of Seroconverted Subjects for HI Antibodies Against the A/Indo Virus Strain. | A/Indo, Day 224 | 3 Subjects |
Secondary
Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/Indonesia/5/05 (A/Indo) Virus Strain.
A seroprotected subject was defined as a vaccinated subject with HI antibody reciprocal titers against the A/Indo virus strain greater than or equal to (≥) 1:40. This outcome measure solely concerns the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2, and Naïve Placebo-A/turkey H5N1-Formulation 3 groups.
Time frame: At Day 0, Day 10, Day 42, Day 182, Day 549, and Day 559
Population: The analysis was performed on the Day 729 According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus), as well as with HI titers results available up to the Day 729 time point, for any virus strain.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/Indonesia/5/05 (A/Indo) Virus Strain. | A/Indo, Day 0 (N=90,96,99,89,99) | 1 Subjects |
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/Indonesia/5/05 (A/Indo) Virus Strain. | A/Indo, Day 10 (N=89,95,98,87,97) | 41 Subjects |
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/Indonesia/5/05 (A/Indo) Virus Strain. | A/Indo, Day 42 (N=87,94,96,87,97) | 50 Subjects |
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/Indonesia/5/05 (A/Indo) Virus Strain. | A/Indo, Day 182 (N=90,96,99,89,99) | 28 Subjects |
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/Indonesia/5/05 (A/Indo) Virus Strain. | A/Indo, Day 549 (N=83,86,81,72,81) | 9 Subjects |
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/Indonesia/5/05 (A/Indo) Virus Strain. | A/Indo, Day 559 (N=83,85,81,72,80) | 79 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group | Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/Indonesia/5/05 (A/Indo) Virus Strain. | A/Indo, Day 549 (N=83,86,81,72,81) | 9 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group | Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/Indonesia/5/05 (A/Indo) Virus Strain. | A/Indo, Day 559 (N=83,85,81,72,80) | 80 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group | Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/Indonesia/5/05 (A/Indo) Virus Strain. | A/Indo, Day 0 (N=90,96,99,89,99) | 0 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group | Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/Indonesia/5/05 (A/Indo) Virus Strain. | A/Indo, Day 42 (N=87,94,96,87,97) | 51 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group | Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/Indonesia/5/05 (A/Indo) Virus Strain. | A/Indo, Day 182 (N=90,96,99,89,99) | 29 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group | Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/Indonesia/5/05 (A/Indo) Virus Strain. | A/Indo, Day 10 (N=89,95,98,87,97) | 36 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group | Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/Indonesia/5/05 (A/Indo) Virus Strain. | A/Indo, Day 182 (N=90,96,99,89,99) | 35 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group | Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/Indonesia/5/05 (A/Indo) Virus Strain. | A/Indo, Day 549 (N=83,86,81,72,81) | 7 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group | Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/Indonesia/5/05 (A/Indo) Virus Strain. | A/Indo, Day 0 (N=90,96,99,89,99) | 3 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group | Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/Indonesia/5/05 (A/Indo) Virus Strain. | A/Indo, Day 42 (N=87,94,96,87,97) | 68 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group | Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/Indonesia/5/05 (A/Indo) Virus Strain. | A/Indo, Day 10 (N=89,95,98,87,97) | 56 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group | Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/Indonesia/5/05 (A/Indo) Virus Strain. | A/Indo, Day 559 (N=83,85,81,72,80) | 77 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group | Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/Indonesia/5/05 (A/Indo) Virus Strain. | A/Indo, Day 182 (N=90,96,99,89,99) | 32 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group | Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/Indonesia/5/05 (A/Indo) Virus Strain. | A/Indo, Day 10 (N=89,95,98,87,97) | 44 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group | Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/Indonesia/5/05 (A/Indo) Virus Strain. | A/Indo, Day 42 (N=87,94,96,87,97) | 53 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group | Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/Indonesia/5/05 (A/Indo) Virus Strain. | A/Indo, Day 559 (N=83,85,81,72,80) | 68 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group | Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/Indonesia/5/05 (A/Indo) Virus Strain. | A/Indo, Day 549 (N=83,86,81,72,81) | 11 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group | Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/Indonesia/5/05 (A/Indo) Virus Strain. | A/Indo, Day 0 (N=90,96,99,89,99) | 2 Subjects |
| Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group | Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/Indonesia/5/05 (A/Indo) Virus Strain. | A/Indo, Day 549 (N=83,86,81,72,81) | 2 Subjects |
| Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group | Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/Indonesia/5/05 (A/Indo) Virus Strain. | A/Indo, Day 42 (N=87,94,96,87,97) | 3 Subjects |
| Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group | Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/Indonesia/5/05 (A/Indo) Virus Strain. | A/Indo, Day 10 (N=89,95,98,87,97) | 4 Subjects |
| Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group | Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/Indonesia/5/05 (A/Indo) Virus Strain. | A/Indo, Day 559 (N=83,85,81,72,80) | 68 Subjects |
| Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group | Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/Indonesia/5/05 (A/Indo) Virus Strain. | A/Indo, Day 182 (N=90,96,99,89,99) | 9 Subjects |
| Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group | Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/Indonesia/5/05 (A/Indo) Virus Strain. | A/Indo, Day 0 (N=90,96,99,89,99) | 2 Subjects |
Secondary
Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/Indonesia/5/05 (A/Indo) Virus Strain.
A seroprotected subject was defined as a vaccinated subject with HI antibody reciprocal titers against the A/Indo virus strain greater than or equal to (≥) 1:40. This outcome measure solely concerns the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo and Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo groups.
Time frame: At Day 0, Day 10, Day 42, Day 182 and Day 549
Population: The analysis was performed on the Day 729 According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus), as well as with HI titers results available up to the Day 729 time point, for any virus strain.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/Indonesia/5/05 (A/Indo) Virus Strain. | A/Indo, Day 182 (N=95,92) | 42 Subjects |
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/Indonesia/5/05 (A/Indo) Virus Strain. | A/Indo, Day 42 (N=93,88) | 57 Subjects |
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/Indonesia/5/05 (A/Indo) Virus Strain. | A/Indo, Day 0 (N=95,92) | 6 Subjects |
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/Indonesia/5/05 (A/Indo) Virus Strain. | A/Indo, Day 10 (N=95,92) | 50 Subjects |
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/Indonesia/5/05 (A/Indo) Virus Strain. | A/Indo, Day 549 (N=84,81) | 38 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group | Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/Indonesia/5/05 (A/Indo) Virus Strain. | A/Indo, Day 42 (N=93,88) | 44.1 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group | Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/Indonesia/5/05 (A/Indo) Virus Strain. | A/Indo, Day 0 (N=95,92) | 6.7 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group | Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/Indonesia/5/05 (A/Indo) Virus Strain. | A/Indo, Day 10 (N=95,92) | 32.3 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group | Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/Indonesia/5/05 (A/Indo) Virus Strain. | A/Indo, Day 182 (N=95,92) | 22.4 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group | Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/Indonesia/5/05 (A/Indo) Virus Strain. | A/Indo, Day 549 (N=84,81) | 24.0 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group | Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/Indonesia/5/05 (A/Indo) Virus Strain. | A/Indo, Day 549 (N=84,81) | 2 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group | Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/Indonesia/5/05 (A/Indo) Virus Strain. | A/Indo, Day 182 (N=95,92) | 9 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group | Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/Indonesia/5/05 (A/Indo) Virus Strain. | A/Indo, Day 0 (N=95,92) | 2 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group | Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/Indonesia/5/05 (A/Indo) Virus Strain. | A/Indo, Day 42 (N=93,88) | 3 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group | Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/Indonesia/5/05 (A/Indo) Virus Strain. | A/Indo, Day 10 (N=95,92) | 4 Subjects |
Secondary
Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.
A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (≥) 1:40. This outcome measure solely concerns subjects in the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo and Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo groups.
Time frame: At Days 182 and 192
Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. | A/turkey, Day 182 (N=95,92) | 30 Subjects |
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. | A/turkey, Day 192 (N=94,86) | 89 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group | Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. | A/turkey, Day 182 (N=95,92) | 25 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group | Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. | A/turkey, Day 192 (N=94,86) | 85 Subjects |
Secondary
Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.
A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (≥) 1:40. This outcome concerns solely subjects in the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4 and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.
Time frame: At Day 591
Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. | 77 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group | Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. | 83 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group | Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. | 75 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group | Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. | 67 Subjects |
Secondary
Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.
A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (≥) 1:40. This outcome measure solely concerns subjects in the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo, Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo, and Naïve Placebo-A/turkey H5N1-Formulation 3 groups.
Time frame: At Day 224
Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. | 82 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group | Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. | 82 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group | Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. | 60 Subjects |
Secondary
Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain
A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (≥) 1:40. This outcome measure concerns solely the Naïve Placebo-A/turkey H5N1-Formulation 3 Group.
Time frame: At Days 0, 182, 192, 224, 549, 559, 591 and 729
Population: The analysis was performed on the Day 729 According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus), as well as with HI titers results available up to the Day 729 time point, for any virus strain.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain | A/turkey, Day 0 (N=99) | 8 Subjects |
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain | A/turkey, Day 182 (N=99) | 23 Subjects |
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain | A/turkey, Day 192 (N=98) | 63 Subjects |
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain | A/turkey, Day 224 (N=98) | 59 Subjects |
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain | A/turkey, Day 549 (N=81) | 21 Subjects |
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain | A/turkey, Day 559 (N=80) | 76 Subjects |
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain | A/turkey, Day 591 (N=80) | 73 Subjects |
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain | A/turkey, Day 729 (N=80) | 70 Subjects |
Secondary
Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain
A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (≥) 1:40. This outcome measure concerns solely the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4, and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.
Time frame: At Days 0, 182, 549, 559, 591 and 729
Population: The analysis was performed on the Day 729 According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus), as well as with HI titers results available up to the Day 729 time point, for any virus strain.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain | A/turkey, Day 0 (N=90,96,99,89) | 11 Subjects |
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain | A/turkey, Day 182 (N=90,96,99,89) | 25 Subjects |
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain | A/turkey, Day 549 (N=83,86,81,72) | 15 Subjects |
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain | A/turkey, Day 559 (N=83,85,80,72) | 79 Subjects |
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain | A/turkey, Day 591 (N=82,86,80,71) | 77 Subjects |
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain | A/turkey, Day 729 (N=81,83,79,70) | 75 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group | Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain | A/turkey, Day 729 (N=81,83,79,70) | 73 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group | Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain | A/turkey, Day 559 (N=83,85,80,72) | 81 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group | Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain | A/turkey, Day 0 (N=90,96,99,89) | 8 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group | Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain | A/turkey, Day 549 (N=83,86,81,72) | 8 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group | Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain | A/turkey, Day 182 (N=90,96,99,89) | 20 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group | Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain | A/turkey, Day 591 (N=82,86,80,71) | 82 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group | Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain | A/turkey, Day 182 (N=90,96,99,89) | 28 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group | Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain | A/turkey, Day 549 (N=83,86,81,72) | 10 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group | Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain | A/turkey, Day 559 (N=83,85,80,72) | 77 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group | Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain | A/turkey, Day 729 (N=81,83,79,70) | 71 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group | Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain | A/turkey, Day 591 (N=82,86,80,71) | 75 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group | Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain | A/turkey, Day 0 (N=90,96,99,89) | 8 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group | Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain | A/turkey, Day 591 (N=82,86,80,71) | 67 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group | Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain | A/turkey, Day 729 (N=81,83,79,70) | 66 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group | Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain | A/turkey, Day 182 (N=90,96,99,89) | 31 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group | Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain | A/turkey, Day 559 (N=83,85,80,72) | 69 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group | Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain | A/turkey, Day 0 (N=90,96,99,89) | 6 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group | Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain | A/turkey, Day 549 (N=83,86,81,72) | 13 Subjects |
Secondary
Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain.
A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (≥) 1:40. This outcome measure concerns solely the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo and Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo groups.
Time frame: At Days 0, 182,192, 224, 549 and 729
Population: The analysis was performed on the Day 729 According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus), as well as with HI titers results available up to the Day 729 time point, for any virus strain.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain. | A/turkey, Day 182 (N=95,92) | 30 Subjects |
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain. | A/turkey, Day 224 (N=93,91) | 86 Subjects |
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain. | A/turkey, Day 0 (N= 95,92) | 16 Subjects |
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain. | A/turkey, Day 549 (N=84,81) | 42 Subjects |
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain. | A/turkey, Day 729 (N=78,78) | 47 Subjects |
| A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group | Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain. | A/turkey, Day 192 (N=94,86) | 89 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group | Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain. | A/turkey, Day 729 (N=78,78) | 49 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group | Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain. | A/turkey, Day 0 (N= 95,92) | 7 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group | Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain. | A/turkey, Day 182 (N=95,92) | 25 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group | Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain. | A/turkey, Day 192 (N=94,86) | 85 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group | Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain. | A/turkey, Day 224 (N=93,91) | 87 Subjects |
| A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group | Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain. | A/turkey, Day 549 (N=84,81) | 40 Subjects |