Influenza
Conditions
Keywords
children, H5N1, observer-blind, Influenza, dose-ranging
Brief summary
The purpose of this study is to assess the safety and immunogenicity of different formulations of GSK Biologicals' influenza candidate vaccine GSK1557484A, in children 6-35 months of age.
Detailed description
Safety and immunogenicity of different formulations administered as a 2-dose schedule in children 6-35 months of age will be evaluated. In addition, the quality of the 2-dose priming will be assessed through the anamnestic response elicited by an antigen challenge (unadjuvanted H5N1) administered 12 months later. The persistence of the immune response approximately 12 months (Day 385) after dose 2 will also be evaluated. Subjects from each group will be enrolled into the CMI sub-cohort comprising of approximately 100 subjects. Within the participating country(ies), these subjects will be enrolled in only selected/qualified sites.
Interventions
BIOLOGICALInfluenza A (H5N1) Virus monovalent vaccine (GSK1557484A).
All subjects will receive intramuscularly a two-dose primary series (adjuvanted) at a 21 day interval, and a booster dose (unadjuvanted) at Day 385 of GSK1557484A vaccine.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Months to 35 Months
Healthy volunteers
Yes
Inclusion criteria
* Subject's parent(s)/ Legally Acceptable Representative(s) \[LAR(s)\] who, in the opinion of the investigator, can and will comply with the requirements of the protocol. * Male or female children 6 months to less than 36 months old at the time of the first vaccination. Children who are not 36 months old as of Day 0, the day of first vaccine dose under this protocol, can be enrolled. * Written informed consent obtained from the parent(s)/legally acceptable representative(s) \[LAR(s)\] of the subject prior to performance of any study specific procedure. * Healthy subjects as established by medical history and standard physical examination before entering into the study. * Born full-term to be confirmed by interview with parent/LAR or available medical records.
Exclusion criteria
* Child in care. * Medical history of physician-confirmed infection with an H5N1 virus. * Previous vaccination at any time with an H5N1 vaccine. * Concurrently participating in another clinical study, or use of an investigational or a non-registered vaccine, pharmaceutical product, or device within 30 days preceding the first dose of study vaccine, or planned use during the study period. * Presence in the parent(s) / LAR(s) of evidence of substance abuse or of neurological or psychiatric diagnoses which, even if stable, are deemed by the investigator to render the parent(s)/LAR(s) unable/unlikely to provide accurate safety reports. * Acute disease and/or fever at the time of enrolment. * Administration of immunoglobulins, any blood products, or long-acting immune-modifying drugs during the period starting 3 months before the first dose of study vaccine, or planned administration during the study period. * History of any neurological disorders or seizures, or Guillain-Barré Syndrome. * Diagnosed with excessive daytime sleepiness or narcolepsy; or history of narcolepsy in a subject's parent or sibling. * Administration of an inactive vaccine within 14 days or of a live attenuated vaccine within 30 days before the first vaccination. * Planned administration of any vaccine not foreseen by the study protocol between Day 0 and Day 42 or planned administration of an inactive vaccine within 14 days or of a live attenuated vaccine within 30 days before through 30 days after the booster vaccination. Note: routine vaccinations may be provided on Day 42 after all study assessments have been performed. * History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine; a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine. * Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe. * Chronic administration of immunosuppressants or other immune-modifying drugs during the period starting six months prior to the first vaccine. For corticosteroids, this will mean a dose of prednisone or equivalent of \> 2 mg/kg/day of body weight or ≥ 20 mg/day (for persons who weigh ≥ 10 kg). Inhaled and topical steroids are allowed. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * Family history of congenital or hereditary immunodeficiency. * Major congenital defects. * Any condition which, in the opinion of the investigator, prevents the subject from participating in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of Vaccine-homologous Haemagglutination Inhibition (HI) Antibody Titers Following Primary Vaccination | At Day 42 | The HI antibody titres were expressed in terms of immunogenicity indices for each group. Immunogenicity index (DGMT) = If the LL of the 95% CI for GMT group ratio is less than 0.25 then DGMT =0. If the LL of the 95% CI for GMT group ratio is greater than 1 then DGMT =1. |
| Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of Vaccine-homologous Microneutralization (MN) Antibody Titers Following Primary Vaccination | At Day 42 | The MN antibody titres were expressed in terms of immunogenicity indices for each group. Immunogenicity index (DGMT) = If the LL of the 95% CI for GMT group ratio is less than 0.25 then DGMT =0. If the LL of the 95% CI for GMT group ratio is greater than 1 then DGMT =1. |
| Evaluation of Fever Index for A/Indonesia/05/2005 (H5N1) Strain in Terms of Vaccine-homologous Haemagglutination Inhibition (HI) Antibody Titers Following Primary Vaccination. | During the 3-day follow-up period (i.e. on the day of vaccination and 2 subsequent days) after Dose 1 and Dose 2. | Fever index was defined as the average temperature for each vaccine group. Fever index (DR) = The average temperature measurement for each vaccine group. Fever index from Days 0-2 after each dose Any temperature \< 38°C (100.4 F) was assigned a value of 0. Any temperature \> 40.5°C was assigned a value of 40.5. DR correspond to 243 minus the sum of recorded temperature values for 3 days after (dose 1 and dose 2)/243. |
| Evaluation of Fever Index for A/Indonesia/05/2005 (H5N1) Strain in Terms of Vaccine-homologous Microneutralization (MN) Antibody Titers Following Primary Vaccination. | During the 3-day follow-up period (i.e. on the day of vaccination and 2 subsequent days) after Dose 1 and Dose 2. | Fever index was defined as the average temperature for each vaccine group. Fever index (DR)= The average temperature measurement for each vaccine group. Fever index from Days 0-2 after each dose Any temperature \< 38°C (100.4 F) was assigned a value of 0. Any temperature \> 40.5°C was assigned a value of 40.5. DR correspond to 243 minus the sum of recorded temperature values for 3 days after (dose 1 and dose 2)/243. |
| Mean Geometric Increase (MGI) for Vaccine Homologous and Heterologous HI Antibody Titers Against Each of the Four Vaccine Influenza Strains. | At Day 392 (relative to Day 385) post booster vaccination | MGI was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer (Day 392) to the pre-vaccination (Day 385) reciprocal HI titer for the vaccine virus. The vaccine strains assessed were Flu A/Indonesia/5/2005 H5N1 (homologous), Flu A/Vietnam/1194/2004 H5N1 (heterologous), Flu A/duck/Bangladesh/19097/2013 H5N1 (heterologous) and Flu A/gyrfalcon/Washington/41088-6/2014 H5N8 (heterologous). |
| Mean Geometric Increase (MGI) for Vaccine Homologous and Heterologous MN Antibody Titers Against Each of the 3 Vaccine Influenza Strains. | At Day 392 (relative to Day 385) post booster vaccination | MGI was defined as the geometric mean of the within-subject ratios of the post-vaccination (Day 392) reciprocal MN titer to the pre-vaccination (Day 385) reciprocal MN titer for the vaccine virus. The vaccine strains assessed were Flu A/Indonesia/5/2005 H5N1 (homologous), Flu A/Vietnam /1194/2004 H5N (heterologous) and Flu A/duck/Bangladesh/19097/2013 H5N1 (heterologous). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vaccine Response Rate (VRR) for Homologous and Heterologous MN Antibodies Against Each of the 3 Vaccine Influenza Strains. | At Day 42, Day 385 (relative to Day 0), Day 392 (relative to Day 0) and D 392 (relative to Day 385) | VRR for MN was defined as the incidence rate of subjects with at least a 4-fold increase in post vaccination reciprocal titer relative to pre vaccination titers. The vaccine strains assessed were Flu A/Indonesia/5/2005 H5N1 (homologous), Flu A/Vietnam /1194/2004 H5N (heterologous) and Flu A/duck/Bangladesh/19097/2013 H5N1 (heterologous). |
| Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | At Days 0, 42, 385 and 392 | Antigen-specific CD4+/CD8+ T Cells identified as CD4/CD8+ were analysed for T cells expressing two or more of the following immune markers: CD40 Ligand, Interleukin (IL)-2, Tumor Necrosis Factor alpha (TNF-a), Interferon-gamma (IFN-g). The frequency was presented as number of cytokine-producing CD4+/CD8+ cells per million CD4+/CD8+ cells repsectively. All doubles = T cell expressing at least 2 cytokines. |
| Number of Subjects Reporting Solicited Local Symptoms | During the 7-day follow-up period (i.e. on the day of vaccination and 6 subsequent days) after any vaccine dose | Solicited local AEs assessed were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb is moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. |
| Duration of Solicited Local Symptoms | During the 7-day follow-up period (i.e. on the day of vaccination and 6 subsequent days) after any vaccine dose | Duration was defined as number of days with any grade of local symptoms. |
| Number of Subjects Reporting Solicited General Symptoms. | During the 7-day follow-up period (i.e. on the day of vaccination and 6 subsequent days) after any vaccine dose | Assessed solicited general symptoms were fever (defined as temperature ≥ 38.0 degrees Celsius (°C) assessed by any route (oral, axillary, rectal)\], irritability/fussiness, drowsiness and. loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 irritability/Fussiness and Drowsiness = Prevented normal activity, Grade3 Loss of appetite = Did not eat at all. Grade 3 fever = fever \> 40.0 °C. Related = symptom assessed by the investigator as related to the vaccination |
| Duration of Solicited General Symptoms. | During the 7-day follow-up period (i.e. on the day of vaccination and 6 subsequent days) after any vaccine dose | Duration was defined as number of days with any grade of general symptoms. |
| Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | At Days 42, 385 and 392 | Seroconversion rate (SCR) was defined as the proportion of subjects who have either a pre-vaccination reciprocal HI titer less than (\<) 10 and a post-vaccination reciprocal titer greater than or equal to (≥) 40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus. The vaccine strains assessed were Flu A/Indonesia/5/2005 H5N1 (homologous), Flu A/Vietnam/1194/2004 H5N1 (heterologous), Flu A/duck/Bangladesh/19097/2013 H5N1 (heterologous) and Flu A/gyrfalcon/Washington/41088-6/2014 H5N8 (heterologous). |
| Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) Post Booster Vaccination | During the 30-day (Day 385-Day 415) follow-up period after vaccination | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the 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 is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevents normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. |
| Number of Subjects Reporting Medically Attended Events (MAEs) | During the entire study period (Day 0 to Day 415 approximately) | MAEs are adverse events with medically-attended visits that were not routine visits for physical examination or vaccination. Any MAE was defined as at least 1 MAE experienced. |
| Number of Subjects Reporting Potential Immune Mediated Diseases (pIMDs) | During the entire study period (Day 0 to Day 415 approximately) | Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. Any pIMD = at least one pIMD experienced by the study subject. Related = pIMD assessed by the investigator to be causally related to the study vaccination. |
| Number of Subjects Reporting Serious Adverse Events (SAEs) | During the entire study period (Day 0 to Day 415 approximately) | A serious adverse event was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination. |
| Number of Subjects Reporting Adverse Events of Special Interest (AESI) | During the entire study period (Day 0 to Day 415 approximately) | AESI are a subset of adverse events defined in the Committee for Medicinal Products for Human Use (CHMP) Risk Management Plan for Pandemic Vaccines for safety monitoring. |
| Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) Post Primary Vaccination. | During the 21-day follow-up period (Day 0-Day 20) after each vaccine dose | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the 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 is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevents normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. |
| Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | At Days 0, 42, 385, 392 | Seroprotection rate (SPR) was defined as the proportion of subjects with H5N1 reciprocal HI titers ≥ 40 against the tested vaccine virus The vaccine strains assessed were Flu A/Indonesia/5/2005 H5N1 (homologous), Flu A/Vietnam/1194/2004 H5N1 (heterologous), Flu A/duck/Bangladesh/19097/2013 H5N1 (heterologous) and Flu A/gyrfalcon/Washington/41088-6/2014 H5N8 (heterologous). |
| Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens | At Days 0, 42 and 385 (post the primary immunization), at Day 392 (7 days post booster dose) | GMTs were defined as the geometric mean antibody titres calculated on all subjects post the primary immunization (at Day 0, 42, 385) and 7 days post booster dose (at Day 392). The aggregate variables were calculated for each group. The vaccine strains assessed were Flu A/Indonesia/5/2005 H5N1 (homologous), Flu A/Vietnam/1194/2004 H5N1 (heterologous), Flu A/duck/Bangladesh/19097/2013 H5N1 (heterologous) and Flu A/gyrfalcon/Washington/41088-6/2014 H5N8 (heterologous). |
| Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains | At Day 42 (relative to Day 0), at Day 385 (relative to Day 0) and at Day 392 (relative to Day 0) | MGI was defined as the geometric mean of the within-subject ratios of the post-vaccination (Day 42) reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer for the vaccine virus. The vaccine strains assessed were Flu A/Indonesia/5/2005 H5N1 (homologous), Flu A/Vietnam/1194/2004 H5N1 (heterologous), Flu A/duck/Bangladesh/19097/2013 H5N1 (heterologous) and Flu A/gyrfalcon/Washington/41088-6/2014 H5N8 (heterologous). |
| Mean Geometric Increase (MGI) for MN Antibodies Against the 3 Vaccine Influenza Strains. | At Day 385 (relative to Day 0) | MGI was defined as the geometric mean of the within-subject ratios of the post-vaccination (Day 385) reciprocal MN titer to the pre-vaccination (Day 0) reciprocal MN titer for the vaccine virus. The vaccine strains assessed were Flu A/Indonesia/5/2005 H5N1 (homologous), Flu A/Vietnam /1194/2004 H5N (heterologous) and Flu A/duck/Bangladesh/19097/2013 H5N1 (heterologous). |
| Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of MN Antibodies Against Vaccine-homologous/Heterologous Antigens | At Days 0, 42, 385 and Day 392 | MN antibody titers were expressed as Geometric Mean Titers (GMTs). The cut-off of the assay was the seropositivity cut-off of ≥ 1:28. The vaccine strains assessed were Flu A/Indonesia/5/2005 H5N1 (homologous), Flu A/Vietnam /1194/2004 H5N (heterologous) and Flu A/duck/Bangladesh/19097/2013 H5N1 (heterologous). |
Countries
Taiwan, Thailand
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| H5N1 Formulation 1 Group Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 1 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered intramuscularly (IM) in anterolateral thigh. | 38 |
| H5N1 Formulation 2 Group Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 2 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh. | 37 |
| H5N1 Formulation 3 Group Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 3 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh. | 38 |
| H5N1 Formulation 4 Group Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 4 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh. | 37 |
| H5N1 Formulation 5 Group Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 5 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh. | 35 |
| Total | 185 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Consent withdrawal | 0 | 2 | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 1 | 1 | 0 | 0 | 0 |
| Overall Study | Migrated/moved from study area | 0 | 0 | 0 | 0 | 2 |
Baseline characteristics
| Characteristic | H5N1 Formulation 1 Group | H5N1 Formulation 2 Group | H5N1 Formulation 3 Group | H5N1 Formulation 4 Group | H5N1 Formulation 5 Group | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 21.9 Months STANDARD_DEVIATION 8 | 22.6 Months STANDARD_DEVIATION 8.1 | 21.6 Months STANDARD_DEVIATION 9.2 | 20.8 Months STANDARD_DEVIATION 8.3 | 20.3 Months STANDARD_DEVIATION 7.8 | 21.4 Months STANDARD_DEVIATION 8.2 |
| Race/Ethnicity, Customized Asian - East Asian Heritage | 21 Participants | 21 Participants | 22 Participants | 21 Participants | 19 Participants | 104 Participants |
| Race/Ethnicity, Customized Asian - South East Asian Heritage | 16 Participants | 16 Participants | 16 Participants | 16 Participants | 16 Participants | 80 Participants |
| Race/Ethnicity, Customized Unspecified | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Female | 17 Participants | 14 Participants | 16 Participants | 23 Participants | 18 Participants | 88 Participants |
| Sex: Female, Male Male | 21 Participants | 23 Participants | 22 Participants | 14 Participants | 17 Participants | 97 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 |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 38 | 0 / 37 | 0 / 38 | 0 / 37 | 0 / 35 |
| other Total, other adverse events | 36 / 38 | 31 / 37 | 35 / 38 | 35 / 37 | 32 / 35 |
| serious Total, serious adverse events | 5 / 38 | 6 / 37 | 10 / 38 | 4 / 37 | 4 / 35 |
Outcome results
Primary
Evaluation of Fever Index for A/Indonesia/05/2005 (H5N1) Strain in Terms of Vaccine-homologous Haemagglutination Inhibition (HI) Antibody Titers Following Primary Vaccination.
Fever index was defined as the average temperature for each vaccine group. Fever index (DR) = The average temperature measurement for each vaccine group. Fever index from Days 0-2 after each dose Any temperature \< 38°C (100.4 F) was assigned a value of 0. Any temperature \> 40.5°C was assigned a value of 40.5. DR correspond to 243 minus the sum of recorded temperature values for 3 days after (dose 1 and dose 2)/243.
Time frame: During the 3-day follow-up period (i.e. on the day of vaccination and 2 subsequent days) after Dose 1 and Dose 2.
Population: Analysis was performed on cohort for analysis of the immunogenicity-fever score which included all subjects who have received all study vaccine dose(s) at Day 42 for whom temperature measurements are available during the first 3 days after both vaccine doses 1 and 2.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| H5N1 Formulation 1 Group | Evaluation of Fever Index for A/Indonesia/05/2005 (H5N1) Strain in Terms of Vaccine-homologous Haemagglutination Inhibition (HI) Antibody Titers Following Primary Vaccination. | 0.84 Degrees Celsius |
| H5N1 Formulation 2 Group | Evaluation of Fever Index for A/Indonesia/05/2005 (H5N1) Strain in Terms of Vaccine-homologous Haemagglutination Inhibition (HI) Antibody Titers Following Primary Vaccination. | 0.91 Degrees Celsius |
| H5N1 Formulation 3 Group | Evaluation of Fever Index for A/Indonesia/05/2005 (H5N1) Strain in Terms of Vaccine-homologous Haemagglutination Inhibition (HI) Antibody Titers Following Primary Vaccination. | 0.95 Degrees Celsius |
| H5N1 Formulation 4 Group | Evaluation of Fever Index for A/Indonesia/05/2005 (H5N1) Strain in Terms of Vaccine-homologous Haemagglutination Inhibition (HI) Antibody Titers Following Primary Vaccination. | 0.93 Degrees Celsius |
| H5N1 Formulation 5 Group | Evaluation of Fever Index for A/Indonesia/05/2005 (H5N1) Strain in Terms of Vaccine-homologous Haemagglutination Inhibition (HI) Antibody Titers Following Primary Vaccination. | 0.94 Degrees Celsius |
Primary
Evaluation of Fever Index for A/Indonesia/05/2005 (H5N1) Strain in Terms of Vaccine-homologous Microneutralization (MN) Antibody Titers Following Primary Vaccination.
Fever index was defined as the average temperature for each vaccine group. Fever index (DR)= The average temperature measurement for each vaccine group. Fever index from Days 0-2 after each dose Any temperature \< 38°C (100.4 F) was assigned a value of 0. Any temperature \> 40.5°C was assigned a value of 40.5. DR correspond to 243 minus the sum of recorded temperature values for 3 days after (dose 1 and dose 2)/243.
Time frame: During the 3-day follow-up period (i.e. on the day of vaccination and 2 subsequent days) after Dose 1 and Dose 2.
Population: Analysis was performed on cohort for analysis of the immunogenicity-fever score which included all subjects who have received all study vaccine dose(s) at Day 42 for whom temperature measurements are available during the first 3 days after both vaccine doses 1 and 2.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| H5N1 Formulation 1 Group | Evaluation of Fever Index for A/Indonesia/05/2005 (H5N1) Strain in Terms of Vaccine-homologous Microneutralization (MN) Antibody Titers Following Primary Vaccination. | 0.84 Degrees Celsius |
| H5N1 Formulation 2 Group | Evaluation of Fever Index for A/Indonesia/05/2005 (H5N1) Strain in Terms of Vaccine-homologous Microneutralization (MN) Antibody Titers Following Primary Vaccination. | 0.91 Degrees Celsius |
| H5N1 Formulation 3 Group | Evaluation of Fever Index for A/Indonesia/05/2005 (H5N1) Strain in Terms of Vaccine-homologous Microneutralization (MN) Antibody Titers Following Primary Vaccination. | 0.95 Degrees Celsius |
| H5N1 Formulation 4 Group | Evaluation of Fever Index for A/Indonesia/05/2005 (H5N1) Strain in Terms of Vaccine-homologous Microneutralization (MN) Antibody Titers Following Primary Vaccination. | 0.93 Degrees Celsius |
| H5N1 Formulation 5 Group | Evaluation of Fever Index for A/Indonesia/05/2005 (H5N1) Strain in Terms of Vaccine-homologous Microneutralization (MN) Antibody Titers Following Primary Vaccination. | 0.94 Degrees Celsius |
Primary
Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of Vaccine-homologous Haemagglutination Inhibition (HI) Antibody Titers Following Primary Vaccination
The HI antibody titres were expressed in terms of immunogenicity indices for each group. Immunogenicity index (DGMT) = If the LL of the 95% CI for GMT group ratio is less than 0.25 then DGMT =0. If the LL of the 95% CI for GMT group ratio is greater than 1 then DGMT =1.
Time frame: At Day 42
Population: Analysis was performed on cohort for analysis of the immunogenicity-fever score which included all subjects who have received all study vaccine dose(s) at Day 42 for whom temperature measurements are available during the first 3 days after both vaccine doses 1 and 2.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| H5N1 Formulation 1 Group | Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of Vaccine-homologous Haemagglutination Inhibition (HI) Antibody Titers Following Primary Vaccination | 1 Immunogenicity Index |
| H5N1 Formulation 2 Group | Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of Vaccine-homologous Haemagglutination Inhibition (HI) Antibody Titers Following Primary Vaccination | 0.54 Immunogenicity Index |
| H5N1 Formulation 3 Group | Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of Vaccine-homologous Haemagglutination Inhibition (HI) Antibody Titers Following Primary Vaccination | 0.57 Immunogenicity Index |
| H5N1 Formulation 4 Group | Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of Vaccine-homologous Haemagglutination Inhibition (HI) Antibody Titers Following Primary Vaccination | 0.40 Immunogenicity Index |
| H5N1 Formulation 5 Group | Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of Vaccine-homologous Haemagglutination Inhibition (HI) Antibody Titers Following Primary Vaccination | 0.34 Immunogenicity Index |
Primary
Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of Vaccine-homologous Microneutralization (MN) Antibody Titers Following Primary Vaccination
The MN antibody titres were expressed in terms of immunogenicity indices for each group. Immunogenicity index (DGMT) = If the LL of the 95% CI for GMT group ratio is less than 0.25 then DGMT =0. If the LL of the 95% CI for GMT group ratio is greater than 1 then DGMT =1.
Time frame: At Day 42
Population: Analysis was performed on cohort for analysis of the immunogenicity-fever score which included all subjects who have received all study vaccine dose(s) at Day 42 for whom temperature measurements are available during the first 3 days after both vaccine doses 1 \& 2 and with pre \& post immune result of antibody of interest.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| H5N1 Formulation 1 Group | Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of Vaccine-homologous Microneutralization (MN) Antibody Titers Following Primary Vaccination | 1 Immunogenicity Index |
| H5N1 Formulation 2 Group | Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of Vaccine-homologous Microneutralization (MN) Antibody Titers Following Primary Vaccination | 0.56 Immunogenicity Index |
| H5N1 Formulation 3 Group | Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of Vaccine-homologous Microneutralization (MN) Antibody Titers Following Primary Vaccination | 0.57 Immunogenicity Index |
| H5N1 Formulation 4 Group | Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of Vaccine-homologous Microneutralization (MN) Antibody Titers Following Primary Vaccination | 0.32 Immunogenicity Index |
| H5N1 Formulation 5 Group | Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of Vaccine-homologous Microneutralization (MN) Antibody Titers Following Primary Vaccination | 0.33 Immunogenicity Index |
Primary
Mean Geometric Increase (MGI) for Vaccine Homologous and Heterologous HI Antibody Titers Against Each of the Four Vaccine Influenza Strains.
MGI was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer (Day 392) to the pre-vaccination (Day 385) reciprocal HI titer for the vaccine virus. The vaccine strains assessed were Flu A/Indonesia/5/2005 H5N1 (homologous), Flu A/Vietnam/1194/2004 H5N1 (heterologous), Flu A/duck/Bangladesh/19097/2013 H5N1 (heterologous) and Flu A/gyrfalcon/Washington/41088-6/2014 H5N8 (heterologous).
Time frame: At Day 392 (relative to Day 385) post booster vaccination
Population: Analysis was performed on the Adapted According to Protocol (ATP) cohort for immunogenicity which included all vaccinated subjects who had results available for the relevant assay (HI and MN) for all blood samples collected during relevant analysis intervals for ATP-Day 42; ATP-Day 385 (persistence); ATP-Day 392 post booster dose (ATP-booster)
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| H5N1 Formulation 1 Group | Mean Geometric Increase (MGI) for Vaccine Homologous and Heterologous HI Antibody Titers Against Each of the Four Vaccine Influenza Strains. | Flu A/Indonesia/5/2005 H5N1 HI | 4.9 Fold change |
| H5N1 Formulation 1 Group | Mean Geometric Increase (MGI) for Vaccine Homologous and Heterologous HI Antibody Titers Against Each of the Four Vaccine Influenza Strains. | Flu A/duck/Bangladesh/19097/2013 H5N1 HI | 5.2 Fold change |
| H5N1 Formulation 1 Group | Mean Geometric Increase (MGI) for Vaccine Homologous and Heterologous HI Antibody Titers Against Each of the Four Vaccine Influenza Strains. | Flu A/Vietnam/1194/2004 H5N1 HI | 5.0 Fold change |
| H5N1 Formulation 1 Group | Mean Geometric Increase (MGI) for Vaccine Homologous and Heterologous HI Antibody Titers Against Each of the Four Vaccine Influenza Strains. | Flu A/gyrfalcon/Washington/41088-6/2014 H5N8 HI | 4.5 Fold change |
| H5N1 Formulation 2 Group | Mean Geometric Increase (MGI) for Vaccine Homologous and Heterologous HI Antibody Titers Against Each of the Four Vaccine Influenza Strains. | Flu A/Indonesia/5/2005 H5N1 HI | 6.6 Fold change |
| H5N1 Formulation 2 Group | Mean Geometric Increase (MGI) for Vaccine Homologous and Heterologous HI Antibody Titers Against Each of the Four Vaccine Influenza Strains. | Flu A/gyrfalcon/Washington/41088-6/2014 H5N8 HI | 4.9 Fold change |
| H5N1 Formulation 2 Group | Mean Geometric Increase (MGI) for Vaccine Homologous and Heterologous HI Antibody Titers Against Each of the Four Vaccine Influenza Strains. | Flu A/duck/Bangladesh/19097/2013 H5N1 HI | 6.0 Fold change |
| H5N1 Formulation 2 Group | Mean Geometric Increase (MGI) for Vaccine Homologous and Heterologous HI Antibody Titers Against Each of the Four Vaccine Influenza Strains. | Flu A/Vietnam/1194/2004 H5N1 HI | 6.3 Fold change |
| H5N1 Formulation 3 Group | Mean Geometric Increase (MGI) for Vaccine Homologous and Heterologous HI Antibody Titers Against Each of the Four Vaccine Influenza Strains. | Flu A/gyrfalcon/Washington/41088-6/2014 H5N8 HI | 3.1 Fold change |
| H5N1 Formulation 3 Group | Mean Geometric Increase (MGI) for Vaccine Homologous and Heterologous HI Antibody Titers Against Each of the Four Vaccine Influenza Strains. | Flu A/duck/Bangladesh/19097/2013 H5N1 HI | 4.0 Fold change |
| H5N1 Formulation 3 Group | Mean Geometric Increase (MGI) for Vaccine Homologous and Heterologous HI Antibody Titers Against Each of the Four Vaccine Influenza Strains. | Flu A/Vietnam/1194/2004 H5N1 HI | 3.8 Fold change |
| H5N1 Formulation 3 Group | Mean Geometric Increase (MGI) for Vaccine Homologous and Heterologous HI Antibody Titers Against Each of the Four Vaccine Influenza Strains. | Flu A/Indonesia/5/2005 H5N1 HI | 4.2 Fold change |
| H5N1 Formulation 4 Group | Mean Geometric Increase (MGI) for Vaccine Homologous and Heterologous HI Antibody Titers Against Each of the Four Vaccine Influenza Strains. | Flu A/Indonesia/5/2005 H5N1 HI | 3.6 Fold change |
| H5N1 Formulation 4 Group | Mean Geometric Increase (MGI) for Vaccine Homologous and Heterologous HI Antibody Titers Against Each of the Four Vaccine Influenza Strains. | Flu A/duck/Bangladesh/19097/2013 H5N1 HI | 3.4 Fold change |
| H5N1 Formulation 4 Group | Mean Geometric Increase (MGI) for Vaccine Homologous and Heterologous HI Antibody Titers Against Each of the Four Vaccine Influenza Strains. | Flu A/gyrfalcon/Washington/41088-6/2014 H5N8 HI | 2.9 Fold change |
| H5N1 Formulation 4 Group | Mean Geometric Increase (MGI) for Vaccine Homologous and Heterologous HI Antibody Titers Against Each of the Four Vaccine Influenza Strains. | Flu A/Vietnam/1194/2004 H5N1 HI | 3.6 Fold change |
| H5N1 Formulation 5 Group | Mean Geometric Increase (MGI) for Vaccine Homologous and Heterologous HI Antibody Titers Against Each of the Four Vaccine Influenza Strains. | Flu A/gyrfalcon/Washington/41088-6/2014 H5N8 HI | 2.4 Fold change |
| H5N1 Formulation 5 Group | Mean Geometric Increase (MGI) for Vaccine Homologous and Heterologous HI Antibody Titers Against Each of the Four Vaccine Influenza Strains. | Flu A/Vietnam/1194/2004 H5N1 HI | 2.8 Fold change |
| H5N1 Formulation 5 Group | Mean Geometric Increase (MGI) for Vaccine Homologous and Heterologous HI Antibody Titers Against Each of the Four Vaccine Influenza Strains. | Flu A/duck/Bangladesh/19097/2013 H5N1 HI | 2.7 Fold change |
| H5N1 Formulation 5 Group | Mean Geometric Increase (MGI) for Vaccine Homologous and Heterologous HI Antibody Titers Against Each of the Four Vaccine Influenza Strains. | Flu A/Indonesia/5/2005 H5N1 HI | 3.4 Fold change |
Primary
Mean Geometric Increase (MGI) for Vaccine Homologous and Heterologous MN Antibody Titers Against Each of the 3 Vaccine Influenza Strains.
MGI was defined as the geometric mean of the within-subject ratios of the post-vaccination (Day 392) reciprocal MN titer to the pre-vaccination (Day 385) reciprocal MN titer for the vaccine virus. The vaccine strains assessed were Flu A/Indonesia/5/2005 H5N1 (homologous), Flu A/Vietnam /1194/2004 H5N (heterologous) and Flu A/duck/Bangladesh/19097/2013 H5N1 (heterologous).
Time frame: At Day 392 (relative to Day 385) post booster vaccination
Population: Analysis was performed on the Adapted According to Protocol (ATP) cohort for immunogenicity which included all vaccinated subjects who had results available for the relevant assay (HI and MN) for all blood samples collected during relevant analysis intervals for ATP-Day 42; ATP-Day 385 (persistence); ATP-Day 392 post booster dose (ATP-booster)
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| H5N1 Formulation 1 Group | Mean Geometric Increase (MGI) for Vaccine Homologous and Heterologous MN Antibody Titers Against Each of the 3 Vaccine Influenza Strains. | Flu A/Indonesia/5/2005 H5N1 MN | 4.3 Fold change |
| H5N1 Formulation 1 Group | Mean Geometric Increase (MGI) for Vaccine Homologous and Heterologous MN Antibody Titers Against Each of the 3 Vaccine Influenza Strains. | Flu A/duck/Bangladesh/19097/2013 H5N1 MN | 2.6 Fold change |
| H5N1 Formulation 1 Group | Mean Geometric Increase (MGI) for Vaccine Homologous and Heterologous MN Antibody Titers Against Each of the 3 Vaccine Influenza Strains. | Flu A/Vietnam/1194/2004 H5N1 MN | 2.9 Fold change |
| H5N1 Formulation 2 Group | Mean Geometric Increase (MGI) for Vaccine Homologous and Heterologous MN Antibody Titers Against Each of the 3 Vaccine Influenza Strains. | Flu A/Vietnam/1194/2004 H5N1 MN | 2.9 Fold change |
| H5N1 Formulation 2 Group | Mean Geometric Increase (MGI) for Vaccine Homologous and Heterologous MN Antibody Titers Against Each of the 3 Vaccine Influenza Strains. | Flu A/Indonesia/5/2005 H5N1 MN | 4.8 Fold change |
| H5N1 Formulation 2 Group | Mean Geometric Increase (MGI) for Vaccine Homologous and Heterologous MN Antibody Titers Against Each of the 3 Vaccine Influenza Strains. | Flu A/duck/Bangladesh/19097/2013 H5N1 MN | 3.0 Fold change |
| H5N1 Formulation 3 Group | Mean Geometric Increase (MGI) for Vaccine Homologous and Heterologous MN Antibody Titers Against Each of the 3 Vaccine Influenza Strains. | Flu A/Vietnam/1194/2004 H5N1 MN | 2.9 Fold change |
| H5N1 Formulation 3 Group | Mean Geometric Increase (MGI) for Vaccine Homologous and Heterologous MN Antibody Titers Against Each of the 3 Vaccine Influenza Strains. | Flu A/Indonesia/5/2005 H5N1 MN | 3.2 Fold change |
| H5N1 Formulation 3 Group | Mean Geometric Increase (MGI) for Vaccine Homologous and Heterologous MN Antibody Titers Against Each of the 3 Vaccine Influenza Strains. | Flu A/duck/Bangladesh/19097/2013 H5N1 MN | 2.6 Fold change |
| H5N1 Formulation 4 Group | Mean Geometric Increase (MGI) for Vaccine Homologous and Heterologous MN Antibody Titers Against Each of the 3 Vaccine Influenza Strains. | Flu A/Indonesia/5/2005 H5N1 MN | 2.8 Fold change |
| H5N1 Formulation 4 Group | Mean Geometric Increase (MGI) for Vaccine Homologous and Heterologous MN Antibody Titers Against Each of the 3 Vaccine Influenza Strains. | Flu A/duck/Bangladesh/19097/2013 H5N1 MN | 2.1 Fold change |
| H5N1 Formulation 4 Group | Mean Geometric Increase (MGI) for Vaccine Homologous and Heterologous MN Antibody Titers Against Each of the 3 Vaccine Influenza Strains. | Flu A/Vietnam/1194/2004 H5N1 MN | 2.6 Fold change |
| H5N1 Formulation 5 Group | Mean Geometric Increase (MGI) for Vaccine Homologous and Heterologous MN Antibody Titers Against Each of the 3 Vaccine Influenza Strains. | Flu A/Vietnam/1194/2004 H5N1 MN | 2.4 Fold change |
| H5N1 Formulation 5 Group | Mean Geometric Increase (MGI) for Vaccine Homologous and Heterologous MN Antibody Titers Against Each of the 3 Vaccine Influenza Strains. | Flu A/Indonesia/5/2005 H5N1 MN | 2.5 Fold change |
| H5N1 Formulation 5 Group | Mean Geometric Increase (MGI) for Vaccine Homologous and Heterologous MN Antibody Titers Against Each of the 3 Vaccine Influenza Strains. | Flu A/duck/Bangladesh/19097/2013 H5N1 MN | 2.8 Fold change |
Secondary
Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen.
Antigen-specific CD4+/CD8+ T Cells identified as CD4/CD8+ were analysed for T cells expressing two or more of the following immune markers: CD40 Ligand, Interleukin (IL)-2, Tumor Necrosis Factor alpha (TNF-a), Interferon-gamma (IFN-g). The frequency was presented as number of cytokine-producing CD4+/CD8+ cells per million CD4+/CD8+ cells repsectively. All doubles = T cell expressing at least 2 cytokines.
Time frame: At Days 0, 42, 385 and 392
Population: Analysis was performed on the Total Vaccinated cohort (CMI sub-cohort) which included all vaccinated subjects for whom data were available. The CMI sub-cohort included approximately 20 vaccinated subjects per group.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| H5N1 Formulation 1 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_TNFα, Day 0 | 120.5 cells/million T cells |
| H5N1 Formulation 1 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_CD40L, Day 392 | 40.0 cells/million T cells |
| H5N1 Formulation 1 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_IL2, Day 42 | 3399.5 cells/million T cells |
| H5N1 Formulation 1 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_IL2, Day 385 | 1.0 cells/million T cells |
| H5N1 Formulation 1 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_TNFα, Day 42 | 3023.0 cells/million T cells |
| H5N1 Formulation 1 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_IL2, Day 392 | 1502.5 cells/million T cells |
| H5N1 Formulation 1 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_IFNγ, Day 0 | 41.5 cells/million T cells |
| H5N1 Formulation 1 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_IFNγ, Day 392 | 459.5 cells/million T cells |
| H5N1 Formulation 1 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_All (Polypositives), Day 385 | 33.5 cells/million T cells |
| H5N1 Formulation 1 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_All (Polypositives), Day 42 | 48.0 cells/million T cells |
| H5N1 Formulation 1 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_All (Polypositives), Day 42 | 2711.0 cells/million T cells |
| H5N1 Formulation 1 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_IFNγ, Day 42 | 32.0 cells/million T cells |
| H5N1 Formulation 1 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_CD40L, Day 42 | 1671.0 cells/million T cells |
| H5N1 Formulation 1 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_All (Polypositives), Day 392 | 1417.0 cells/million T cells |
| H5N1 Formulation 1 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_CD40L, Day 385 | 1074.0 cells/million T cells |
| H5N1 Formulation 1 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_IL2, Day 392 | 63.0 cells/million T cells |
| H5N1 Formulation 1 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_IFNγ, Day 385 | 99.5 cells/million T cells |
| H5N1 Formulation 1 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_TNFα, Day 0 | 49.5 cells/million T cells |
| H5N1 Formulation 1 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_TNFα, Day 42 | 192.0 cells/million T cells |
| H5N1 Formulation 1 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_TNFα, Day 392 | 1743.5 cells/million T cells |
| H5N1 Formulation 1 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_All (Polypositives), Day 385 | 1530.0 cells/million T cells |
| H5N1 Formulation 1 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_IFNγ, Day 392 | 52.0 cells/million T cells |
| H5N1 Formulation 1 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_TNFα, Day 385 | 77.5 cells/million T cells |
| H5N1 Formulation 1 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_TNFα, Day 392 | 217.0 cells/million T cells |
| H5N1 Formulation 1 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_All (Polypositives), Day 392 | 63.0 cells/million T cells |
| H5N1 Formulation 1 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_CD40L, Day 42 | 108.0 cells/million T cells |
| H5N1 Formulation 1 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_CD40L, Day 392 | 1130.5 cells/million T cells |
| H5N1 Formulation 1 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_IFNγ, Day 0 | 47.0 cells/million T cells |
| H5N1 Formulation 1 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_IL2, Day 0 | 1.0 cells/million T cells |
| H5N1 Formulation 1 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_IL2, Day 385 | 1676.5 cells/million T cells |
| H5N1 Formulation 1 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_CD40L, Day 0 | 23.0 cells/million T cells |
| H5N1 Formulation 1 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_CD40L, Day 0 | 1.0 cells/million T cells |
| H5N1 Formulation 1 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_IFNγ, Day 42 | 803.0 cells/million T cells |
| H5N1 Formulation 1 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_TNFα, Day 385 | 1339.0 cells/million T cells |
| H5N1 Formulation 1 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_All (Polypositives), Day 0 | 55.5 cells/million T cells |
| H5N1 Formulation 1 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_IL2, Day 42 | 1.0 cells/million T cells |
| H5N1 Formulation 1 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_CD40L, Day 385 | 88.0 cells/million T cells |
| H5N1 Formulation 1 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_IFNγ, Day 385 | 200.0 cells/million T cells |
| H5N1 Formulation 1 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_IL2, Day 0 | 89.5 cells/million T cells |
| H5N1 Formulation 1 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_All (Polypositives), Day 0 | 3.5 cells/million T cells |
| H5N1 Formulation 2 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_IL2, Day 385 | 32.5 cells/million T cells |
| H5N1 Formulation 2 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_IFNγ, Day 392 | 329.0 cells/million T cells |
| H5N1 Formulation 2 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_All (Polypositives), Day 392 | 33.0 cells/million T cells |
| H5N1 Formulation 2 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_All (Polypositives), Day 0 | 5.0 cells/million T cells |
| H5N1 Formulation 2 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_IL2, Day 0 | 72.0 cells/million T cells |
| H5N1 Formulation 2 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_All (Polypositives), Day 385 | 62.5 cells/million T cells |
| H5N1 Formulation 2 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_All (Polypositives), Day 0 | 42.0 cells/million T cells |
| H5N1 Formulation 2 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_CD40L, Day 0 | 1.0 cells/million T cells |
| H5N1 Formulation 2 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_IL2, Day 42 | 2438.0 cells/million T cells |
| H5N1 Formulation 2 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_CD40L, Day 42 | 1341.0 cells/million T cells |
| H5N1 Formulation 2 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_IL2, Day 385 | 1394.0 cells/million T cells |
| H5N1 Formulation 2 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_TNFα, Day 385 | 366.5 cells/million T cells |
| H5N1 Formulation 2 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_CD40L, Day 385 | 70.5 cells/million T cells |
| H5N1 Formulation 2 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_IL2, Day 392 | 1455.0 cells/million T cells |
| H5N1 Formulation 2 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_TNFα, Day 42 | 396.0 cells/million T cells |
| H5N1 Formulation 2 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_TNFα, Day 0 | 98.0 cells/million T cells |
| H5N1 Formulation 2 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_All (Polypositives), Day 42 | 63.0 cells/million T cells |
| H5N1 Formulation 2 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_IL2, Day 0 | 22.0 cells/million T cells |
| H5N1 Formulation 2 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_TNFα, Day 392 | 130.0 cells/million T cells |
| H5N1 Formulation 2 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_IL2, Day 42 | 48.0 cells/million T cells |
| H5N1 Formulation 2 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_CD40L, Day 42 | 25.0 cells/million T cells |
| H5N1 Formulation 2 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_CD40L, Day 392 | 18.0 cells/million T cells |
| H5N1 Formulation 2 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_CD40L, Day 385 | 844.0 cells/million T cells |
| H5N1 Formulation 2 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_IFNγ, Day 0 | 33.0 cells/million T cells |
| H5N1 Formulation 2 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_TNFα, Day 0 | 103.0 cells/million T cells |
| H5N1 Formulation 2 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_TNFα, Day 42 | 1970.0 cells/million T cells |
| H5N1 Formulation 2 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_IFNγ, Day 42 | 77.0 cells/million T cells |
| H5N1 Formulation 2 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_IFNγ, Day 385 | 103.0 cells/million T cells |
| H5N1 Formulation 2 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_All (Polypositives), Day 392 | 1129.0 cells/million T cells |
| H5N1 Formulation 2 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_IL2, Day 392 | 99.0 cells/million T cells |
| H5N1 Formulation 2 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_IFNγ, Day 392 | 174.0 cells/million T cells |
| H5N1 Formulation 2 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_TNFα, Day 385 | 1233.0 cells/million T cells |
| H5N1 Formulation 2 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_TNFα, Day 392 | 1257.0 cells/million T cells |
| H5N1 Formulation 2 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_IFNγ, Day 0 | 49.0 cells/million T cells |
| H5N1 Formulation 2 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_All (Polypositives), Day 42 | 1629.0 cells/million T cells |
| H5N1 Formulation 2 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_CD40L, Day 392 | 986.0 cells/million T cells |
| H5N1 Formulation 2 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_IFNγ, Day 42 | 406.0 cells/million T cells |
| H5N1 Formulation 2 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_CD40L, Day 0 | 19.0 cells/million T cells |
| H5N1 Formulation 2 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_All (Polypositives), Day 385 | 1255.0 cells/million T cells |
| H5N1 Formulation 2 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_IFNγ, Day 385 | 316.5 cells/million T cells |
| H5N1 Formulation 3 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_IL2, Day 392 | 893.0 cells/million T cells |
| H5N1 Formulation 3 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_CD40L, Day 385 | 53.0 cells/million T cells |
| H5N1 Formulation 3 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_IL2, Day 385 | 16.0 cells/million T cells |
| H5N1 Formulation 3 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_All (Polypositives), Day 0 | 43.0 cells/million T cells |
| H5N1 Formulation 3 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_IL2, Day 392 | 1.0 cells/million T cells |
| H5N1 Formulation 3 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_All (Polypositives), Day 385 | 1.0 cells/million T cells |
| H5N1 Formulation 3 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_All (Polypositives), Day 385 | 1413.0 cells/million T cells |
| H5N1 Formulation 3 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_CD40L, Day 42 | 514.0 cells/million T cells |
| H5N1 Formulation 3 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_TNFα, Day 0 | 34.0 cells/million T cells |
| H5N1 Formulation 3 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_All (Polypositives), Day 392 | 731.0 cells/million T cells |
| H5N1 Formulation 3 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_CD40L, Day 0 | 5.0 cells/million T cells |
| H5N1 Formulation 3 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_All (Polypositives), Day 42 | 960.0 cells/million T cells |
| H5N1 Formulation 3 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_TNFα, Day 42 | 125.0 cells/million T cells |
| H5N1 Formulation 3 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_TNFα, Day 385 | 81.0 cells/million T cells |
| H5N1 Formulation 3 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_All (Polypositives), Day 392 | 25.0 cells/million T cells |
| H5N1 Formulation 3 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_CD40L, Day 392 | 14.0 cells/million T cells |
| H5N1 Formulation 3 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_IFNγ, Day 0 | 22.0 cells/million T cells |
| H5N1 Formulation 3 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_CD40L, Day 385 | 722.0 cells/million T cells |
| H5N1 Formulation 3 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_IFNγ, Day 42 | 67.0 cells/million T cells |
| H5N1 Formulation 3 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_TNFα, Day 42 | 840.0 cells/million T cells |
| H5N1 Formulation 3 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_IFNγ, Day 385 | 31.0 cells/million T cells |
| H5N1 Formulation 3 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_TNFα, Day 385 | 1277.5 cells/million T cells |
| H5N1 Formulation 3 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_IFNγ, Day 392 | 31.0 cells/million T cells |
| H5N1 Formulation 3 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_CD40L, Day 392 | 660.0 cells/million T cells |
| H5N1 Formulation 3 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_IFNγ, Day 0 | 24.0 cells/million T cells |
| H5N1 Formulation 3 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_TNFα, Day 392 | 740.0 cells/million T cells |
| H5N1 Formulation 3 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_IFNγ, Day 42 | 266.0 cells/million T cells |
| H5N1 Formulation 3 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_IFNγ, Day 385 | 248.5 cells/million T cells |
| H5N1 Formulation 3 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_IFNγ, Day 392 | 123.0 cells/million T cells |
| H5N1 Formulation 3 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_IL2, Day 0 | 50.0 cells/million T cells |
| H5N1 Formulation 3 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_All (Polypositives), Day 0 | 30.0 cells/million T cells |
| H5N1 Formulation 3 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_IL2, Day 42 | 1344.0 cells/million T cells |
| H5N1 Formulation 3 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_CD40L, Day 42 | 1.0 cells/million T cells |
| H5N1 Formulation 3 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_CD40L, Day 0 | 1.0 cells/million T cells |
| H5N1 Formulation 3 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_IL2, Day 385 | 1366.5 cells/million T cells |
| H5N1 Formulation 3 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_TNFα, Day 392 | 121.0 cells/million T cells |
| H5N1 Formulation 3 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_IL2, Day 42 | 53.0 cells/million T cells |
| H5N1 Formulation 3 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_TNFα, Day 0 | 62.0 cells/million T cells |
| H5N1 Formulation 3 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_All (Polypositives), Day 42 | 45.0 cells/million T cells |
| H5N1 Formulation 3 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_IL2, Day 0 | 1.0 cells/million T cells |
| H5N1 Formulation 4 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_IL2, Day 385 | 870.5 cells/million T cells |
| H5N1 Formulation 4 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_TNFα, Day 392 | 310.0 cells/million T cells |
| H5N1 Formulation 4 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_TNFα, Day 42 | 1353.0 cells/million T cells |
| H5N1 Formulation 4 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_CD40L, Day 42 | 516.0 cells/million T cells |
| H5N1 Formulation 4 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_TNFα, Day 385 | 1097.5 cells/million T cells |
| H5N1 Formulation 4 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_CD40L, Day 42 | 7.5 cells/million T cells |
| H5N1 Formulation 4 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_TNFα, Day 42 | 351.5 cells/million T cells |
| H5N1 Formulation 4 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_TNFα, Day 392 | 726.5 cells/million T cells |
| H5N1 Formulation 4 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_All (Polypositives), Day 0 | 47.0 cells/million T cells |
| H5N1 Formulation 4 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_All (Polypositives), Day 42 | 125.0 cells/million T cells |
| H5N1 Formulation 4 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_All (Polypositives), Day 385 | 56.0 cells/million T cells |
| H5N1 Formulation 4 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_CD40L, Day 385 | 4.0 cells/million T cells |
| H5N1 Formulation 4 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_All (Polypositives), Day 42 | 1337.5 cells/million T cells |
| H5N1 Formulation 4 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_CD40L, Day 392 | 80.0 cells/million T cells |
| H5N1 Formulation 4 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_IFNγ, Day 0 | 78.0 cells/million T cells |
| H5N1 Formulation 4 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_IFNγ, Day 42 | 191.5 cells/million T cells |
| H5N1 Formulation 4 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_CD40L, Day 385 | 315.0 cells/million T cells |
| H5N1 Formulation 4 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_IFNγ, Day 385 | 165.5 cells/million T cells |
| H5N1 Formulation 4 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_CD40L, Day 392 | 424.0 cells/million T cells |
| H5N1 Formulation 4 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_IFNγ, Day 0 | 40.5 cells/million T cells |
| H5N1 Formulation 4 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_IFNγ, Day 42 | 863.5 cells/million T cells |
| H5N1 Formulation 4 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_All (Polypositives), Day 392 | 60.5 cells/million T cells |
| H5N1 Formulation 4 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_IFNγ, Day 385 | 589.5 cells/million T cells |
| H5N1 Formulation 4 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_IFNγ, Day 392 | 423.5 cells/million T cells |
| H5N1 Formulation 4 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_IL2, Day 0 | 47.0 cells/million T cells |
| H5N1 Formulation 4 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_IL2, Day 42 | 1448.0 cells/million T cells |
| H5N1 Formulation 4 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_CD40L, Day 0 | 46.0 cells/million T cells |
| H5N1 Formulation 4 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_IL2, Day 392 | 840.0 cells/million T cells |
| H5N1 Formulation 4 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_TNFα, Day 0 | 52.0 cells/million T cells |
| H5N1 Formulation 4 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_IFNγ, Day 392 | 119.0 cells/million T cells |
| H5N1 Formulation 4 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_IL2, Day 0 | 1.0 cells/million T cells |
| H5N1 Formulation 4 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_IL2, Day 42 | 65.5 cells/million T cells |
| H5N1 Formulation 4 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_IL2, Day 385 | 14.0 cells/million T cells |
| H5N1 Formulation 4 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_IL2, Day 392 | 64.0 cells/million T cells |
| H5N1 Formulation 4 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_All (Polypositives), Day 0 | 89.5 cells/million T cells |
| H5N1 Formulation 4 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_All (Polypositives), Day 385 | 954.0 cells/million T cells |
| H5N1 Formulation 4 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_TNFα, Day 0 | 163.5 cells/million T cells |
| H5N1 Formulation 4 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_All (Polypositives), Day 392 | 722.5 cells/million T cells |
| H5N1 Formulation 4 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_CD40L, Day 0 | 36.0 cells/million T cells |
| H5N1 Formulation 4 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_TNFα, Day 385 | 301.5 cells/million T cells |
| H5N1 Formulation 5 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_CD40L, Day 42 | 717.0 cells/million T cells |
| H5N1 Formulation 5 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_TNFα, Day 42 | 756.0 cells/million T cells |
| H5N1 Formulation 5 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_CD40L, Day 385 | 588.0 cells/million T cells |
| H5N1 Formulation 5 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_All (Polypositives), Day 392 | 26.0 cells/million T cells |
| H5N1 Formulation 5 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_CD40L, Day 0 | 1.0 cells/million T cells |
| H5N1 Formulation 5 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_All (Polypositives), Day 42 | 1372.5 cells/million T cells |
| H5N1 Formulation 5 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_CD40L, Day 42 | 83.0 cells/million T cells |
| H5N1 Formulation 5 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_CD40L, Day 385 | 1.0 cells/million T cells |
| H5N1 Formulation 5 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_CD40L, Day 392 | 10.0 cells/million T cells |
| H5N1 Formulation 5 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_IFNγ, Day 0 | 1.0 cells/million T cells |
| H5N1 Formulation 5 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_IFNγ, Day 42 | 131.0 cells/million T cells |
| H5N1 Formulation 5 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_IFNγ, Day 385 | 1.0 cells/million T cells |
| H5N1 Formulation 5 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_CD40L, Day 392 | 325.0 cells/million T cells |
| H5N1 Formulation 5 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_IFNγ, Day 0 | 12.0 cells/million T cells |
| H5N1 Formulation 5 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_IFNγ, Day 42 | 437.5 cells/million T cells |
| H5N1 Formulation 5 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_IFNγ, Day 385 | 163.0 cells/million T cells |
| H5N1 Formulation 5 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_IFNγ, Day 392 | 253.0 cells/million T cells |
| H5N1 Formulation 5 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_IL2, Day 0 | 75.0 cells/million T cells |
| H5N1 Formulation 5 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_IL2, Day 42 | 1761.5 cells/million T cells |
| H5N1 Formulation 5 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_IL2, Day 385 | 621.0 cells/million T cells |
| H5N1 Formulation 5 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_IL2, Day 392 | 882.0 cells/million T cells |
| H5N1 Formulation 5 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_IFNγ, Day 392 | 28.0 cells/million T cells |
| H5N1 Formulation 5 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_IL2, Day 0 | 1.0 cells/million T cells |
| H5N1 Formulation 5 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_IL2, Day 42 | 1.0 cells/million T cells |
| H5N1 Formulation 5 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_IL2, Day 385 | 1.0 cells/million T cells |
| H5N1 Formulation 5 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_IL2, Day 392 | 45.0 cells/million T cells |
| H5N1 Formulation 5 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_All (Polypositives), Day 385 | 596.0 cells/million T cells |
| H5N1 Formulation 5 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_All (Polypositives), Day 392 | 832.0 cells/million T cells |
| H5N1 Formulation 5 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_TNFα, Day 0 | 116.0 cells/million T cells |
| H5N1 Formulation 5 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_CD40L, Day 0 | 26.0 cells/million T cells |
| H5N1 Formulation 5 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_TNFα, Day 385 | 212.0 cells/million T cells |
| H5N1 Formulation 5 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_TNFα, Day 392 | 207.0 cells/million T cells |
| H5N1 Formulation 5 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_TNFα, Day 0 | 71.0 cells/million T cells |
| H5N1 Formulation 5 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_TNFα, Day 42 | 1204.5 cells/million T cells |
| H5N1 Formulation 5 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_All (Polypositives), Day 0 | 74.0 cells/million T cells |
| H5N1 Formulation 5 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_TNFα, Day 385 | 678.0 cells/million T cells |
| H5N1 Formulation 5 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD4 dble_TNFα, Day 392 | 908.0 cells/million T cells |
| H5N1 Formulation 5 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_All (Polypositives), Day 0 | 1.0 cells/million T cells |
| H5N1 Formulation 5 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_All (Polypositives), Day 42 | 128.0 cells/million T cells |
| H5N1 Formulation 5 Group | Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. | CD8 dble_All (Polypositives), Day 385 | 1.0 cells/million T cells |
Secondary
Duration of Solicited General Symptoms.
Duration was defined as number of days with any grade of general symptoms.
Time frame: During the 7-day follow-up period (i.e. on the day of vaccination and 6 subsequent days) after any vaccine dose
Population: Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| H5N1 Formulation 1 Group | Duration of Solicited General Symptoms. | Temperature, Dose 3 | 1.0 Days |
| H5N1 Formulation 1 Group | Duration of Solicited General Symptoms. | Drowsiness, Dose 3 | 2.0 Days |
| H5N1 Formulation 1 Group | Duration of Solicited General Symptoms. | Drowsiness, Dose 2 | 1.0 Days |
| H5N1 Formulation 1 Group | Duration of Solicited General Symptoms. | Irritability / fussiness, Dose 2 | 2.0 Days |
| H5N1 Formulation 1 Group | Duration of Solicited General Symptoms. | Drowsiness, Dose 1 | 2.0 Days |
| H5N1 Formulation 1 Group | Duration of Solicited General Symptoms. | Irritability / fussiness, Dose 1 | 2.0 Days |
| H5N1 Formulation 1 Group | Duration of Solicited General Symptoms. | Irritability / fussiness, Dose 3 | 2.0 Days |
| H5N1 Formulation 1 Group | Duration of Solicited General Symptoms. | Loss of appetite, Dose 3 | 2.0 Days |
| H5N1 Formulation 1 Group | Duration of Solicited General Symptoms. | Loss of appetite, Dose 2 | 2.0 Days |
| H5N1 Formulation 1 Group | Duration of Solicited General Symptoms. | Loss of appetite, Dose 1 | 2.0 Days |
| H5N1 Formulation 1 Group | Duration of Solicited General Symptoms. | Temperature, Dose 2 | 1.0 Days |
| H5N1 Formulation 1 Group | Duration of Solicited General Symptoms. | Temperature, Dose 1 | 1.0 Days |
| H5N1 Formulation 2 Group | Duration of Solicited General Symptoms. | Temperature, Dose 3 | 2.0 Days |
| H5N1 Formulation 2 Group | Duration of Solicited General Symptoms. | Temperature, Dose 1 | 2.0 Days |
| H5N1 Formulation 2 Group | Duration of Solicited General Symptoms. | Loss of appetite, Dose 2 | 2.0 Days |
| H5N1 Formulation 2 Group | Duration of Solicited General Symptoms. | Loss of appetite, Dose 3 | 2.5 Days |
| H5N1 Formulation 2 Group | Duration of Solicited General Symptoms. | Drowsiness, Dose 2 | 2.0 Days |
| H5N1 Formulation 2 Group | Duration of Solicited General Symptoms. | Drowsiness, Dose 3 | 2.0 Days |
| H5N1 Formulation 2 Group | Duration of Solicited General Symptoms. | Irritability / fussiness, Dose 1 | 2.0 Days |
| H5N1 Formulation 2 Group | Duration of Solicited General Symptoms. | Drowsiness, Dose 1 | 1.5 Days |
| H5N1 Formulation 2 Group | Duration of Solicited General Symptoms. | Temperature, Dose 2 | 1.0 Days |
| H5N1 Formulation 2 Group | Duration of Solicited General Symptoms. | Irritability / fussiness, Dose 2 | 2.0 Days |
| H5N1 Formulation 2 Group | Duration of Solicited General Symptoms. | Irritability / fussiness, Dose 3 | 3.0 Days |
| H5N1 Formulation 2 Group | Duration of Solicited General Symptoms. | Loss of appetite, Dose 1 | 3.0 Days |
| H5N1 Formulation 3 Group | Duration of Solicited General Symptoms. | Loss of appetite, Dose 2 | 3.0 Days |
| H5N1 Formulation 3 Group | Duration of Solicited General Symptoms. | Irritability / fussiness, Dose 2 | 2.0 Days |
| H5N1 Formulation 3 Group | Duration of Solicited General Symptoms. | Drowsiness, Dose 1 | 2.0 Days |
| H5N1 Formulation 3 Group | Duration of Solicited General Symptoms. | Drowsiness, Dose 2 | 2.0 Days |
| H5N1 Formulation 3 Group | Duration of Solicited General Symptoms. | Loss of appetite, Dose 3 | 2.0 Days |
| H5N1 Formulation 3 Group | Duration of Solicited General Symptoms. | Loss of appetite, Dose 1 | 2.0 Days |
| H5N1 Formulation 3 Group | Duration of Solicited General Symptoms. | Temperature, Dose 2 | 1.0 Days |
| H5N1 Formulation 3 Group | Duration of Solicited General Symptoms. | Irritability / fussiness, Dose 3 | 1.0 Days |
| H5N1 Formulation 3 Group | Duration of Solicited General Symptoms. | Irritability / fussiness, Dose 1 | 1.0 Days |
| H5N1 Formulation 3 Group | Duration of Solicited General Symptoms. | Temperature, Dose 3 | 1.0 Days |
| H5N1 Formulation 3 Group | Duration of Solicited General Symptoms. | Temperature, Dose 1 | 1.0 Days |
| H5N1 Formulation 3 Group | Duration of Solicited General Symptoms. | Drowsiness, Dose 3 | 2.0 Days |
| H5N1 Formulation 4 Group | Duration of Solicited General Symptoms. | Loss of appetite, Dose 1 | 2.5 Days |
| H5N1 Formulation 4 Group | Duration of Solicited General Symptoms. | Drowsiness, Dose 1 | 2.0 Days |
| H5N1 Formulation 4 Group | Duration of Solicited General Symptoms. | Drowsiness, Dose 2 | 2.0 Days |
| H5N1 Formulation 4 Group | Duration of Solicited General Symptoms. | Drowsiness, Dose 3 | 2.5 Days |
| H5N1 Formulation 4 Group | Duration of Solicited General Symptoms. | Irritability / fussiness, Dose 1 | 2.0 Days |
| H5N1 Formulation 4 Group | Duration of Solicited General Symptoms. | Irritability / fussiness, Dose 2 | 2.0 Days |
| H5N1 Formulation 4 Group | Duration of Solicited General Symptoms. | Irritability / fussiness, Dose 3 | 4.0 Days |
| H5N1 Formulation 4 Group | Duration of Solicited General Symptoms. | Loss of appetite, Dose 3 | 3.0 Days |
| H5N1 Formulation 4 Group | Duration of Solicited General Symptoms. | Loss of appetite, Dose 2 | 2.0 Days |
| H5N1 Formulation 4 Group | Duration of Solicited General Symptoms. | Temperature, Dose 1 | 2.0 Days |
| H5N1 Formulation 4 Group | Duration of Solicited General Symptoms. | Temperature, Dose 2 | 1.0 Days |
| H5N1 Formulation 4 Group | Duration of Solicited General Symptoms. | Temperature, Dose 3 | 3.0 Days |
| H5N1 Formulation 5 Group | Duration of Solicited General Symptoms. | Drowsiness, Dose 1 | 1.0 Days |
| H5N1 Formulation 5 Group | Duration of Solicited General Symptoms. | Temperature, Dose 1 | 1.0 Days |
| H5N1 Formulation 5 Group | Duration of Solicited General Symptoms. | Irritability / fussiness, Dose 2 | 2.0 Days |
| H5N1 Formulation 5 Group | Duration of Solicited General Symptoms. | Irritability / fussiness, Dose 1 | 2.0 Days |
| H5N1 Formulation 5 Group | Duration of Solicited General Symptoms. | Drowsiness, Dose 3 | 1.0 Days |
| H5N1 Formulation 5 Group | Duration of Solicited General Symptoms. | Loss of appetite, Dose 3 | 2.0 Days |
| H5N1 Formulation 5 Group | Duration of Solicited General Symptoms. | Temperature, Dose 2 | 1.0 Days |
| H5N1 Formulation 5 Group | Duration of Solicited General Symptoms. | Drowsiness, Dose 2 | 1.5 Days |
| H5N1 Formulation 5 Group | Duration of Solicited General Symptoms. | Loss of appetite, Dose 2 | 2.0 Days |
| H5N1 Formulation 5 Group | Duration of Solicited General Symptoms. | Loss of appetite, Dose 1 | 1.5 Days |
| H5N1 Formulation 5 Group | Duration of Solicited General Symptoms. | Irritability / fussiness, Dose 3 | 1.5 Days |
Secondary
Duration of Solicited Local Symptoms
Duration was defined as number of days with any grade of local symptoms.
Time frame: During the 7-day follow-up period (i.e. on the day of vaccination and 6 subsequent days) after any vaccine dose
Population: Analysis was performed on the Total Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.cohort which included all vaccinated subjects for whom data were available.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| H5N1 Formulation 1 Group | Duration of Solicited Local Symptoms | Pain, Dose 3 | 1.0 Days |
| H5N1 Formulation 1 Group | Duration of Solicited Local Symptoms | Pain, Dose 1 | 3.0 Days |
| H5N1 Formulation 1 Group | Duration of Solicited Local Symptoms | Pain, Dose 2 | 2.0 Days |
| H5N1 Formulation 2 Group | Duration of Solicited Local Symptoms | Pain, Dose 2 | 2.0 Days |
| H5N1 Formulation 2 Group | Duration of Solicited Local Symptoms | Pain, Dose 3 | 1.0 Days |
| H5N1 Formulation 2 Group | Duration of Solicited Local Symptoms | Pain, Dose 1 | 2.0 Days |
| H5N1 Formulation 3 Group | Duration of Solicited Local Symptoms | Pain, Dose 1 | 1.0 Days |
| H5N1 Formulation 3 Group | Duration of Solicited Local Symptoms | Pain, Dose 2 | 1.5 Days |
| H5N1 Formulation 3 Group | Duration of Solicited Local Symptoms | Pain, Dose 3 | 2.0 Days |
| H5N1 Formulation 4 Group | Duration of Solicited Local Symptoms | Swelling, Dose 1 | 3.0 Days |
| H5N1 Formulation 4 Group | Duration of Solicited Local Symptoms | Pain, Dose 1 | 1.0 Days |
| H5N1 Formulation 4 Group | Duration of Solicited Local Symptoms | Pain, Dose 2 | 1.5 Days |
| H5N1 Formulation 4 Group | Duration of Solicited Local Symptoms | Pain, Dose 3 | 2.0 Days |
| H5N1 Formulation 5 Group | Duration of Solicited Local Symptoms | Pain, Dose 1 | 1.0 Days |
| H5N1 Formulation 5 Group | Duration of Solicited Local Symptoms | Pain, Dose 3 | 1.5 Days |
| H5N1 Formulation 5 Group | Duration of Solicited Local Symptoms | Pain, Dose 2 | 1.0 Days |
Secondary
Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens
GMTs were defined as the geometric mean antibody titres calculated on all subjects post the primary immunization (at Day 0, 42, 385) and 7 days post booster dose (at Day 392). The aggregate variables were calculated for each group. The vaccine strains assessed were Flu A/Indonesia/5/2005 H5N1 (homologous), Flu A/Vietnam/1194/2004 H5N1 (heterologous), Flu A/duck/Bangladesh/19097/2013 H5N1 (heterologous) and Flu A/gyrfalcon/Washington/41088-6/2014 H5N8 (heterologous).
Time frame: At Days 0, 42 and 385 (post the primary immunization), at Day 392 (7 days post booster dose)
Population: Analysis was performed on the Adapted According to Protocol (ATP) cohort for immunogenicity which included all vaccinated subjects who had results available for the relevant assay (HI and MN) for all blood samples collected during relevant analysis intervals for ATP-Day 42; ATP-Day 385 (persistence); ATP-Day 392 post booster dose (ATP-booster).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| H5N1 Formulation 1 Group | Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 42 | 167.1 Titers |
| H5N1 Formulation 1 Group | Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/Indonesia/5/2005 H5N1 HI, Day 42 | 1118.6 Titers |
| H5N1 Formulation 1 Group | Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/Indonesia/5/2005 H5N1 HI, Day 392 | 476.2 Titers |
| H5N1 Formulation 1 Group | Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 0 | 5.3 Titers |
| H5N1 Formulation 1 Group | Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 385 | 23.4 Titers |
| H5N1 Formulation 1 Group | Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/Vietnam/1194/2004 H5N1 HI, Day 392 | 133.9 Titers |
| H5N1 Formulation 1 Group | Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 385 | 9.2 Titers |
| H5N1 Formulation 1 Group | Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 0 | 5.3 Titers |
| H5N1 Formulation 1 Group | Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/Vietnam/1194/2004 H5N1 HI, Day 385 | 26.0 Titers |
| H5N1 Formulation 1 Group | Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/Indonesia/5/2005 H5N1 HI, Day 0 | 5.1 Titers |
| H5N1 Formulation 1 Group | Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/Vietnam/1194/2004 H5N1 HI, Day 0 | 5.3 Titers |
| H5N1 Formulation 1 Group | Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 42 | 35.8 Titers |
| H5N1 Formulation 1 Group | Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 392 | 42.6 Titers |
| H5N1 Formulation 1 Group | Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/Indonesia/5/2005 H5N1 HI, Day 385 | 98.1 Titers |
| H5N1 Formulation 1 Group | Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/Vietnam/1194/2004 H5N1 HI, Day 42 | 128.9 Titers |
| H5N1 Formulation 1 Group | Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 392 | 125.6 Titers |
| H5N1 Formulation 2 Group | Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/Vietnam/1194/2004 H5N1 HI, Day 42 | 104.7 Titers |
| H5N1 Formulation 2 Group | Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/Indonesia/5/2005 H5N1 HI, Day 42 | 858.8 Titers |
| H5N1 Formulation 2 Group | Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 0 | 5.0 Titers |
| H5N1 Formulation 2 Group | Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/Vietnam/1194/2004 H5N1 HI, Day 385 | 21.5 Titers |
| H5N1 Formulation 2 Group | Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/Vietnam/1194/2004 H5N1 HI, Day 392 | 137.5 Titers |
| H5N1 Formulation 2 Group | Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/Indonesia/5/2005 H5N1 HI, Day 385 | 61.5 Titers |
| H5N1 Formulation 2 Group | Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 385 | 8.0 Titers |
| H5N1 Formulation 2 Group | Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/Indonesia/5/2005 H5N1 HI, Day 392 | 407.6 Titers |
| H5N1 Formulation 2 Group | Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 392 | 37.0 Titers |
| H5N1 Formulation 2 Group | Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 0 | 5.4 Titers |
| H5N1 Formulation 2 Group | Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 42 | 135.3 Titers |
| H5N1 Formulation 2 Group | Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/Indonesia/5/2005 H5N1 HI, Day 0 | 5.1 Titers |
| H5N1 Formulation 2 Group | Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 385 | 20.8 Titers |
| H5N1 Formulation 2 Group | Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 42 | 27.8 Titers |
| H5N1 Formulation 2 Group | Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 392 | 126.1 Titers |
| H5N1 Formulation 2 Group | Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/Vietnam/1194/2004 H5N1 HI, Day 0 | 5.0 Titers |
| H5N1 Formulation 3 Group | Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/Indonesia/5/2005 H5N1 HI, Day 42 | 913.6 Titers |
| H5N1 Formulation 3 Group | Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 385 | 17.8 Titers |
| H5N1 Formulation 3 Group | Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/Indonesia/5/2005 H5N1 HI, Day 0 | 5.1 Titers |
| H5N1 Formulation 3 Group | Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 0 | 5.1 Titers |
| H5N1 Formulation 3 Group | Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/Indonesia/5/2005 H5N1 HI, Day 385 | 72.1 Titers |
| H5N1 Formulation 3 Group | Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/Vietnam/1194/2004 H5N1 HI, Day 385 | 18.4 Titers |
| H5N1 Formulation 3 Group | Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 392 | 77.6 Titers |
| H5N1 Formulation 3 Group | Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 385 | 7.4 Titers |
| H5N1 Formulation 3 Group | Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 392 | 24.0 Titers |
| H5N1 Formulation 3 Group | Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/Vietnam/1194/2004 H5N1 HI, Day 392 | 76.2 Titers |
| H5N1 Formulation 3 Group | Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 0 | 5.3 Titers |
| H5N1 Formulation 3 Group | Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/Vietnam/1194/2004 H5N1 HI, Day 42 | 88.9 Titers |
| H5N1 Formulation 3 Group | Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 42 | 109.9 Titers |
| H5N1 Formulation 3 Group | Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/Vietnam/1194/2004 H5N1 HI, Day 0 | 5.1 Titers |
| H5N1 Formulation 3 Group | Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 42 | 22.8 Titers |
| H5N1 Formulation 3 Group | Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/Indonesia/5/2005 H5N1 HI, Day 392 | 305.4 Titers |
| H5N1 Formulation 4 Group | Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/Vietnam/1194/2004 H5N1 HI, Day 392 | 76.5 Titers |
| H5N1 Formulation 4 Group | Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/Indonesia/5/2005 H5N1 HI, Day 42 | 640.0 Titers |
| H5N1 Formulation 4 Group | Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/Indonesia/5/2005 H5N1 HI, Day 385 | 79.1 Titers |
| H5N1 Formulation 4 Group | Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/Indonesia/5/2005 H5N1 HI, Day 392 | 286.2 Titers |
| H5N1 Formulation 4 Group | Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 0 | 5.0 Titers |
| H5N1 Formulation 4 Group | Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 42 | 91.5 Titers |
| H5N1 Formulation 4 Group | Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 385 | 20.9 Titers |
| H5N1 Formulation 4 Group | Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 392 | 70.7 Titers |
| H5N1 Formulation 4 Group | Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/Vietnam/1194/2004 H5N1 HI, Day 0 | 5.1 Titers |
| H5N1 Formulation 4 Group | Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/Vietnam/1194/2004 H5N1 HI, Day 42 | 77.2 Titers |
| H5N1 Formulation 4 Group | Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/Vietnam/1194/2004 H5N1 HI, Day 385 | 21.3 Titers |
| H5N1 Formulation 4 Group | Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/Indonesia/5/2005 H5N1 HI, Day 0 | 5.0 Titers |
| H5N1 Formulation 4 Group | Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 0 | 5.2 Titers |
| H5N1 Formulation 4 Group | Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 42 | 21.6 Titers |
| H5N1 Formulation 4 Group | Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 385 | 7.7 Titers |
| H5N1 Formulation 4 Group | Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 392 | 22.6 Titers |
| H5N1 Formulation 5 Group | Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 385 | 7.2 Titers |
| H5N1 Formulation 5 Group | Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 0 | 5.3 Titers |
| H5N1 Formulation 5 Group | Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 392 | 53.5 Titers |
| H5N1 Formulation 5 Group | Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 385 | 19.5 Titers |
| H5N1 Formulation 5 Group | Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 42 | 78.5 Titers |
| H5N1 Formulation 5 Group | Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 0 | 6.1 Titers |
| H5N1 Formulation 5 Group | Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 42 | 19.9 Titers |
| H5N1 Formulation 5 Group | Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/Indonesia/5/2005 H5N1 HI, Day 392 | 201.0 Titers |
| H5N1 Formulation 5 Group | Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/Indonesia/5/2005 H5N1 HI, Day 385 | 59.6 Titers |
| H5N1 Formulation 5 Group | Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/Indonesia/5/2005 H5N1 HI, Day 42 | 568.4 Titers |
| H5N1 Formulation 5 Group | Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 392 | 17.9 Titers |
| H5N1 Formulation 5 Group | Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/Indonesia/5/2005 H5N1 HI, Day 0 | 5.6 Titers |
| H5N1 Formulation 5 Group | Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/Vietnam/1194/2004 H5N1 HI, Day 392 | 57.8 Titers |
| H5N1 Formulation 5 Group | Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/Vietnam/1194/2004 H5N1 HI, Day 385 | 20.6 Titers |
| H5N1 Formulation 5 Group | Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/Vietnam/1194/2004 H5N1 HI, Day 42 | 69.0 Titers |
| H5N1 Formulation 5 Group | Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/Vietnam/1194/2004 H5N1 HI, Day 0 | 5.8 Titers |
Secondary
Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of MN Antibodies Against Vaccine-homologous/Heterologous Antigens
MN antibody titers were expressed as Geometric Mean Titers (GMTs). The cut-off of the assay was the seropositivity cut-off of ≥ 1:28. The vaccine strains assessed were Flu A/Indonesia/5/2005 H5N1 (homologous), Flu A/Vietnam /1194/2004 H5N (heterologous) and Flu A/duck/Bangladesh/19097/2013 H5N1 (heterologous).
Time frame: At Days 0, 42, 385 and Day 392
Population: Analysis was performed on the Adapted According to Protocol (ATP) cohort for immunogenicity which included all vaccinated subjects who had results available for the relevant assay (HI and MN) for all blood samples collected during relevant analysis intervals for ATP-Day 42; ATP-Day 385 (persistence); ATP-Day 392 post booster dose (ATP-booster).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| H5N1 Formulation 1 Group | Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of MN Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/Indonesia/5/2005 H5N1 MN, Day 385 | 250.3 Titers |
| H5N1 Formulation 1 Group | Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of MN Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/Vietnam/1194/2004 H5N1 MN, Day 392 | 320.0 Titers |
| H5N1 Formulation 1 Group | Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of MN Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/duck/Bangladesh/19097/2013 H5N1 MN, Day 0 | 14.6 Titers |
| H5N1 Formulation 1 Group | Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of MN Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/Indonesia/5/2005 H5N1 MN, Day 42 | 1498.5 Titers |
| H5N1 Formulation 1 Group | Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of MN Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/duck/Bangladesh/19097/2013 H5N1 MN, Day 42 | 179.4 Titers |
| H5N1 Formulation 1 Group | Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of MN Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/duck/Bangladesh/19097/2013 H5N1 MN, Day 392 | 262.5 Titers |
| H5N1 Formulation 1 Group | Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of MN Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/Indonesia/5/2005 H5N1 MN, Day 392 | 1085.0 Titers |
| H5N1 Formulation 1 Group | Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of MN Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/Vietnam/1194/2004 H5N1 MN, Day 0 | 14.6 Titers |
| H5N1 Formulation 1 Group | Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of MN Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/Indonesia/5/2005 H5N1 MN, Day 0 | 14.3 Titers |
| H5N1 Formulation 1 Group | Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of MN Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/duck/Bangladesh/19097/2013 H5N1 MN, Day 385 | 102.0 Titers |
| H5N1 Formulation 1 Group | Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of MN Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/Vietnam/1194/2004 H5N1 MN, Day 42 | 217.6 Titers |
| H5N1 Formulation 1 Group | Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of MN Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/Vietnam/1194/2004 H5N1 MN, Day 385 | 113.0 Titers |
| H5N1 Formulation 2 Group | Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of MN Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/Vietnam/1194/2004 H5N1 MN, Day 0 | 14.6 Titers |
| H5N1 Formulation 2 Group | Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of MN Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/duck/Bangladesh/19097/2013 H5N1 MN, Day 42 | 161.6 Titers |
| H5N1 Formulation 2 Group | Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of MN Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/Indonesia/5/2005 H5N1 MN, Day 385 | 203.6 Titers |
| H5N1 Formulation 2 Group | Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of MN Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/Vietnam/1194/2004 H5N1 MN, Day 392 | 256.6 Titers |
| H5N1 Formulation 2 Group | Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of MN Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/Indonesia/5/2005 H5N1 MN, Day 0 | 14.0 Titers |
| H5N1 Formulation 2 Group | Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of MN Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/duck/Bangladesh/19097/2013 H5N1 MN, Day 392 | 240.9 Titers |
| H5N1 Formulation 2 Group | Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of MN Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/Vietnam/1194/2004 H5N1 MN, Day 385 | 88.0 Titers |
| H5N1 Formulation 2 Group | Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of MN Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/duck/Bangladesh/19097/2013 H5N1 MN, Day 0 | 14.3 Titers |
| H5N1 Formulation 2 Group | Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of MN Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/duck/Bangladesh/19097/2013 H5N1 MN, Day 385 | 79.2 Titers |
| H5N1 Formulation 2 Group | Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of MN Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/Vietnam/1194/2004 H5N1 MN, Day 42 | 195.2 Titers |
| H5N1 Formulation 2 Group | Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of MN Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/Indonesia/5/2005 H5N1 MN, Day 42 | 1214.3 Titers |
| H5N1 Formulation 2 Group | Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of MN Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/Indonesia/5/2005 H5N1 MN, Day 392 | 969.1 Titers |
| H5N1 Formulation 3 Group | Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of MN Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/Indonesia/5/2005 H5N1 MN, Day 42 | 1211.6 Titers |
| H5N1 Formulation 3 Group | Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of MN Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/Vietnam/1194/2004 H5N1 MN, Day 42 | 177.3 Titers |
| H5N1 Formulation 3 Group | Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of MN Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/Indonesia/5/2005 H5N1 MN, Day 385 | 213.8 Titers |
| H5N1 Formulation 3 Group | Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of MN Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/duck/Bangladesh/19097/2013 H5N1 MN, Day 392 | 194.8 Titers |
| H5N1 Formulation 3 Group | Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of MN Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/duck/Bangladesh/19097/2013 H5N1 MN, Day 385 | 76.3 Titers |
| H5N1 Formulation 3 Group | Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of MN Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/Indonesia/5/2005 H5N1 MN, Day 392 | 674.2 Titers |
| H5N1 Formulation 3 Group | Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of MN Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/duck/Bangladesh/19097/2013 H5N1 MN, Day 0 | 14.5 Titers |
| H5N1 Formulation 3 Group | Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of MN Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/duck/Bangladesh/19097/2013 H5N1 MN, Day 42 | 147.1 Titers |
| H5N1 Formulation 3 Group | Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of MN Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/Vietnam/1194/2004 H5N1 MN, Day 385 | 80.7 Titers |
| H5N1 Formulation 3 Group | Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of MN Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/Vietnam/1194/2004 H5N1 MN, Day 392 | 239.2 Titers |
| H5N1 Formulation 3 Group | Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of MN Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/Indonesia/5/2005 H5N1 MN, Day 0 | 14.0 Titers |
| H5N1 Formulation 3 Group | Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of MN Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/Vietnam/1194/2004 H5N1 MN, Day 0 | 14.8 Titers |
| H5N1 Formulation 4 Group | Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of MN Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/Vietnam/1194/2004 H5N1 MN, Day 42 | 176.9 Titers |
| H5N1 Formulation 4 Group | Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of MN Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/Indonesia/5/2005 H5N1 MN, Day 0 | 14.0 Titers |
| H5N1 Formulation 4 Group | Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of MN Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/Indonesia/5/2005 H5N1 MN, Day 42 | 707.1 Titers |
| H5N1 Formulation 4 Group | Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of MN Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/Indonesia/5/2005 H5N1 MN, Day 385 | 247.2 Titers |
| H5N1 Formulation 4 Group | Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of MN Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/Indonesia/5/2005 H5N1 MN, Day 392 | 681.0 Titers |
| H5N1 Formulation 4 Group | Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of MN Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/Vietnam/1194/2004 H5N1 MN, Day 0 | 14.0 Titers |
| H5N1 Formulation 4 Group | Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of MN Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/duck/Bangladesh/19097/2013 H5N1 MN, Day 385 | 100.7 Titers |
| H5N1 Formulation 4 Group | Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of MN Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/Vietnam/1194/2004 H5N1 MN, Day 385 | 103.6 Titers |
| H5N1 Formulation 4 Group | Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of MN Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/Vietnam/1194/2004 H5N1 MN, Day 392 | 270.4 Titers |
| H5N1 Formulation 4 Group | Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of MN Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/duck/Bangladesh/19097/2013 H5N1 MN, Day 0 | 14.6 Titers |
| H5N1 Formulation 4 Group | Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of MN Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/duck/Bangladesh/19097/2013 H5N1 MN, Day 42 | 161.8 Titers |
| H5N1 Formulation 4 Group | Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of MN Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/duck/Bangladesh/19097/2013 H5N1 MN, Day 392 | 202.2 Titers |
| H5N1 Formulation 5 Group | Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of MN Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/Vietnam/1194/2004 H5N1 MN, Day 42 | 149.3 Titers |
| H5N1 Formulation 5 Group | Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of MN Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/duck/Bangladesh/19097/2013 H5N1 MN, Day 392 | 174.5 Titers |
| H5N1 Formulation 5 Group | Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of MN Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/duck/Bangladesh/19097/2013 H5N1 MN, Day 42 | 140.6 Titers |
| H5N1 Formulation 5 Group | Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of MN Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/Vietnam/1194/2004 H5N1 MN, Day 0 | 15.2 Titers |
| H5N1 Formulation 5 Group | Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of MN Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/Indonesia/5/2005 H5N1 MN, Day 392 | 489.6 Titers |
| H5N1 Formulation 5 Group | Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of MN Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/Indonesia/5/2005 H5N1 MN, Day 385 | 198.5 Titers |
| H5N1 Formulation 5 Group | Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of MN Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/duck/Bangladesh/19097/2013 H5N1 MN, Day 385 | 63.0 Titers |
| H5N1 Formulation 5 Group | Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of MN Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/Indonesia/5/2005 H5N1 MN, Day 42 | 727.4 Titers |
| H5N1 Formulation 5 Group | Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of MN Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/Indonesia/5/2005 H5N1 MN, Day 0 | 14.0 Titers |
| H5N1 Formulation 5 Group | Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of MN Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/Vietnam/1194/2004 H5N1 MN, Day 392 | 216.5 Titers |
| H5N1 Formulation 5 Group | Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of MN Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/duck/Bangladesh/19097/2013 H5N1 MN, Day 0 | 15.2 Titers |
| H5N1 Formulation 5 Group | Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of MN Antibodies Against Vaccine-homologous/Heterologous Antigens | Flu A/Vietnam/1194/2004 H5N1 MN, Day 385 | 89.0 Titers |
Secondary
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains
MGI was defined as the geometric mean of the within-subject ratios of the post-vaccination (Day 42) reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer for the vaccine virus. The vaccine strains assessed were Flu A/Indonesia/5/2005 H5N1 (homologous), Flu A/Vietnam/1194/2004 H5N1 (heterologous), Flu A/duck/Bangladesh/19097/2013 H5N1 (heterologous) and Flu A/gyrfalcon/Washington/41088-6/2014 H5N8 (heterologous).
Time frame: At Day 42 (relative to Day 0), at Day 385 (relative to Day 0) and at Day 392 (relative to Day 0)
Population: Analysis was performed on the Adapted According to Protocol (ATP) cohort for immunogenicity which included all vaccinated subjects who had results available for the relevant assay (HI and MN) for all blood samples collected during relevant analysis intervals for ATP-Day 42; ATP-Day 385 (persistence); ATP-Day 392 post booster dose (ATP-booster).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| H5N1 Formulation 1 Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains | Flu A/Vietnam/1194/2004 H5N1 HI, Day 392 | 25.1 Fold change |
| H5N1 Formulation 1 Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains | Flu A/Indonesia/5/2005 H5N1 HI, Day 392 | 93.3 Fold change |
| H5N1 Formulation 1 Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains | Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 385 | 1.7 Fold change |
| H5N1 Formulation 1 Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains | Flu A/Indonesia/5/2005 H5N1 HI, Day 42 | 219.5 Fold change |
| H5N1 Formulation 1 Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains | Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 392 | 23.4 Fold change |
| H5N1 Formulation 1 Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains | Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 42 | 31.3 Fold change |
| H5N1 Formulation 1 Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains | Flu A/Indonesia/5/2005 H5N1 HI, Day 385 | 19.2 Fold change |
| H5N1 Formulation 1 Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains | Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 392 | 8.1 Fold change |
| H5N1 Formulation 1 Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains | Flu A/Vietnam/1194/2004 H5N1 HI, Day 385 | 4.7 Fold change |
| H5N1 Formulation 1 Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains | Flu A/Vietnam/1194/2004 H5N1 HI, Day 42 | 24.3 Fold change |
| H5N1 Formulation 1 Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains | Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 385 | 4.2 Fold change |
| H5N1 Formulation 1 Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains | Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 42 | 6.7 Fold change |
| H5N1 Formulation 2 Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains | Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 385 | 3.6 Fold change |
| H5N1 Formulation 2 Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains | Flu A/Vietnam/1194/2004 H5N1 HI, Day 385 | 4.1 Fold change |
| H5N1 Formulation 2 Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains | Flu A/Vietnam/1194/2004 H5N1 HI, Day 392 | 27.1 Fold change |
| H5N1 Formulation 2 Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains | Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 42 | 22.9 Fold change |
| H5N1 Formulation 2 Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains | Flu A/Indonesia/5/2005 H5N1 HI, Day 392 | 79.8 Fold change |
| H5N1 Formulation 2 Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains | Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 385 | 1.5 Fold change |
| H5N1 Formulation 2 Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains | Flu A/Indonesia/5/2005 H5N1 HI, Day 42 | 168.2 Fold change |
| H5N1 Formulation 2 Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains | Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 392 | 7.1 Fold change |
| H5N1 Formulation 2 Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains | Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 392 | 22.9 Fold change |
| H5N1 Formulation 2 Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains | Flu A/Indonesia/5/2005 H5N1 HI, Day 385 | 12.0 Fold change |
| H5N1 Formulation 2 Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains | Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 42 | 5.5 Fold change |
| H5N1 Formulation 2 Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains | Flu A/Vietnam/1194/2004 H5N1 HI, Day 42 | 20.1 Fold change |
| H5N1 Formulation 3 Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains | Flu A/Vietnam/1194/2004 H5N1 HI, Day 42 | 16.7 Fold change |
| H5N1 Formulation 3 Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains | Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 42 | 4.3 Fold change |
| H5N1 Formulation 3 Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains | Flu A/Indonesia/5/2005 H5N1 HI, Day 392 | 59.4 Fold change |
| H5N1 Formulation 3 Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains | Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 42 | 20.4 Fold change |
| H5N1 Formulation 3 Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains | Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 385 | 3.3 Fold change |
| H5N1 Formulation 3 Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains | Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 392 | 14.5 Fold change |
| H5N1 Formulation 3 Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains | Flu A/Vietnam/1194/2004 H5N1 HI, Day 385 | 3.5 Fold change |
| H5N1 Formulation 3 Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains | Flu A/Vietnam/1194/2004 H5N1 HI, Day 392 | 14.5 Fold change |
| H5N1 Formulation 3 Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains | Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 392 | 4.7 Fold change |
| H5N1 Formulation 3 Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains | Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 385 | 1.4 Fold change |
| H5N1 Formulation 3 Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains | Flu A/Indonesia/5/2005 H5N1 HI, Day 42 | 177.7 Fold change |
| H5N1 Formulation 3 Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains | Flu A/Indonesia/5/2005 H5N1 HI, Day 385 | 14.0 Fold change |
| H5N1 Formulation 4 Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains | Flu A/Vietnam/1194/2004 H5N1 HI, Day 42 | 15.1 Fold change |
| H5N1 Formulation 4 Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains | Flu A/Vietnam/1194/2004 H5N1 HI, Day 392 | 14.5 Fold change |
| H5N1 Formulation 4 Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains | Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 392 | 13.9 Fold change |
| H5N1 Formulation 4 Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains | Flu A/Indonesia/5/2005 H5N1 HI, Day 392 | 57.2 Fold change |
| H5N1 Formulation 4 Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains | Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 392 | 4.2 Fold change |
| H5N1 Formulation 4 Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains | Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 42 | 4.1 Fold change |
| H5N1 Formulation 4 Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains | Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 385 | 3.9 Fold change |
| H5N1 Formulation 4 Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains | Flu A/Indonesia/5/2005 H5N1 HI, Day 385 | 15.8 Fold change |
| H5N1 Formulation 4 Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains | Flu A/Indonesia/5/2005 H5N1 HI, Day 42 | 128.0 Fold change |
| H5N1 Formulation 4 Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains | Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 42 | 18.9 Fold change |
| H5N1 Formulation 4 Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains | Flu A/Vietnam/1194/2004 H5N1 HI, Day 385 | 3.9 Fold change |
| H5N1 Formulation 4 Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains | Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 385 | 1.5 Fold change |
| H5N1 Formulation 5 Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains | Flu A/Vietnam/1194/2004 H5N1 HI, Day 42 | 11.4 Fold change |
| H5N1 Formulation 5 Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains | Flu A/Indonesia/5/2005 H5N1 HI, Day 392 | 35.3 Fold change |
| H5N1 Formulation 5 Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains | Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 42 | 12.6 Fold change |
| H5N1 Formulation 5 Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains | Flu A/Vietnam/1194/2004 H5N1 HI, Day 392 | 10.1 Fold change |
| H5N1 Formulation 5 Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains | Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 392 | 9.1 Fold change |
| H5N1 Formulation 5 Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains | Flu A/Vietnam/1194/2004 H5N1 HI, Day 385 | 3.6 Fold change |
| H5N1 Formulation 5 Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains | Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 385 | 3.3 Fold change |
| H5N1 Formulation 5 Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains | Flu A/Indonesia/5/2005 H5N1 HI, Day 385 | 10.5 Fold change |
| H5N1 Formulation 5 Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains | Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 385 | 1.3 Fold change |
| H5N1 Formulation 5 Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains | Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 392 | 3.2 Fold change |
| H5N1 Formulation 5 Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains | Flu A/Indonesia/5/2005 H5N1 HI, Day 42 | 101.0 Fold change |
| H5N1 Formulation 5 Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains | Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 42 | 3.5 Fold change |
Secondary
Mean Geometric Increase (MGI) for MN Antibodies Against the 3 Vaccine Influenza Strains.
MGI was defined as the geometric mean of the within-subject ratios of the post-vaccination (Day 385) reciprocal MN titer to the pre-vaccination (Day 0) reciprocal MN titer for the vaccine virus. The vaccine strains assessed were Flu A/Indonesia/5/2005 H5N1 (homologous), Flu A/Vietnam /1194/2004 H5N (heterologous) and Flu A/duck/Bangladesh/19097/2013 H5N1 (heterologous).
Time frame: At Day 385 (relative to Day 0)
Population: Analysis was performed on the Adapted According to Protocol (ATP) cohort for immunogenicity which included all vaccinated subjects who had results available for the relevant assay (HI and MN) for all blood samples collected during relevant analysis intervals for ATP-Day 42; ATP-Day 385 (persistence); ATP-Day 392 post booster dose (ATP-booster).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| H5N1 Formulation 1 Group | Mean Geometric Increase (MGI) for MN Antibodies Against the 3 Vaccine Influenza Strains. | Flu A/Indonesia/5/2005 H5N1 MN | 17.5 Fold change |
| H5N1 Formulation 1 Group | Mean Geometric Increase (MGI) for MN Antibodies Against the 3 Vaccine Influenza Strains. | Flu A/duck/Bangladesh/19097/2013 H5N1 MN | 7.0 Fold change |
| H5N1 Formulation 1 Group | Mean Geometric Increase (MGI) for MN Antibodies Against the 3 Vaccine Influenza Strains. | Flu A/Vietnam/1194/2004 H5N1 MN | 7.6 Fold change |
| H5N1 Formulation 2 Group | Mean Geometric Increase (MGI) for MN Antibodies Against the 3 Vaccine Influenza Strains. | Flu A/Vietnam/1194/2004 H5N1 MN | 5.8 Fold change |
| H5N1 Formulation 2 Group | Mean Geometric Increase (MGI) for MN Antibodies Against the 3 Vaccine Influenza Strains. | Flu A/Indonesia/5/2005 H5N1 MN | 14.8 Fold change |
| H5N1 Formulation 2 Group | Mean Geometric Increase (MGI) for MN Antibodies Against the 3 Vaccine Influenza Strains. | Flu A/duck/Bangladesh/19097/2013 H5N1 MN | 5.5 Fold change |
| H5N1 Formulation 3 Group | Mean Geometric Increase (MGI) for MN Antibodies Against the 3 Vaccine Influenza Strains. | Flu A/Vietnam/1194/2004 H5N1 MN | 5.4 Fold change |
| H5N1 Formulation 3 Group | Mean Geometric Increase (MGI) for MN Antibodies Against the 3 Vaccine Influenza Strains. | Flu A/Indonesia/5/2005 H5N1 MN | 15.3 Fold change |
| H5N1 Formulation 3 Group | Mean Geometric Increase (MGI) for MN Antibodies Against the 3 Vaccine Influenza Strains. | Flu A/duck/Bangladesh/19097/2013 H5N1 MN | 5.3 Fold change |
| H5N1 Formulation 4 Group | Mean Geometric Increase (MGI) for MN Antibodies Against the 3 Vaccine Influenza Strains. | Flu A/Indonesia/5/2005 H5N1 MN | 17.8 Fold change |
| H5N1 Formulation 4 Group | Mean Geometric Increase (MGI) for MN Antibodies Against the 3 Vaccine Influenza Strains. | Flu A/duck/Bangladesh/19097/2013 H5N1 MN | 6.9 Fold change |
| H5N1 Formulation 4 Group | Mean Geometric Increase (MGI) for MN Antibodies Against the 3 Vaccine Influenza Strains. | Flu A/Vietnam/1194/2004 H5N1 MN | 7.5 Fold change |
| H5N1 Formulation 5 Group | Mean Geometric Increase (MGI) for MN Antibodies Against the 3 Vaccine Influenza Strains. | Flu A/Vietnam/1194/2004 H5N1 MN | 6.1 Fold change |
| H5N1 Formulation 5 Group | Mean Geometric Increase (MGI) for MN Antibodies Against the 3 Vaccine Influenza Strains. | Flu A/Indonesia/5/2005 H5N1 MN | 14.2 Fold change |
| H5N1 Formulation 5 Group | Mean Geometric Increase (MGI) for MN Antibodies Against the 3 Vaccine Influenza Strains. | Flu A/duck/Bangladesh/19097/2013 H5N1 MN | 4.2 Fold change |
Secondary
Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains.
Seroconversion rate (SCR) was defined as the proportion of subjects who have either a pre-vaccination reciprocal HI titer less than (\<) 10 and a post-vaccination reciprocal titer greater than or equal to (≥) 40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus. The vaccine strains assessed were Flu A/Indonesia/5/2005 H5N1 (homologous), Flu A/Vietnam/1194/2004 H5N1 (heterologous), Flu A/duck/Bangladesh/19097/2013 H5N1 (heterologous) and Flu A/gyrfalcon/Washington/41088-6/2014 H5N8 (heterologous).
Time frame: At Days 42, 385 and 392
Population: Analysis was performed on the Adapted According to Protocol (ATP) cohort for immunogenicity which included all vaccinated subjects who had results available for the relevant assay (HI and MN) for all blood samples collected during relevant analysis intervals for ATP-Day 42; ATP-Day 385 (persistence); ATP-Day 392 post booster dose (ATP-booster)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| H5N1 Formulation 1 Group | Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/Indonesia/5/2005 H5N1 HI, Day 385 | 33 Participants |
| H5N1 Formulation 1 Group | Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/Vietnam/1194/2004 H5N1 HI, Day 392 | 29 Participants |
| H5N1 Formulation 1 Group | Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/Indonesia/5/2005 H5N1 HI, Day 42 | 36 Participants |
| H5N1 Formulation 1 Group | Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/Vietnam/1194/2004 H5N1 HI, Day 42 | 30 Participants |
| H5N1 Formulation 1 Group | Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 42 | 17 Participants |
| H5N1 Formulation 1 Group | Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 392 | 27 Participants |
| H5N1 Formulation 1 Group | Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 385 | 1 Participants |
| H5N1 Formulation 1 Group | Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 385 | 7 Participants |
| H5N1 Formulation 1 Group | Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 42 | 30 Participants |
| H5N1 Formulation 1 Group | Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 392 | 18 Participants |
| H5N1 Formulation 1 Group | Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/Indonesia/5/2005 H5N1 HI, Day 392 | 34 Participants |
| H5N1 Formulation 1 Group | Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/Vietnam/1194/2004 H5N1 HI, Day 385 | 12 Participants |
| H5N1 Formulation 2 Group | Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 392 | 15 Participants |
| H5N1 Formulation 2 Group | Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 385 | 0 Participants |
| H5N1 Formulation 2 Group | Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/Vietnam/1194/2004 H5N1 HI, Day 392 | 29 Participants |
| H5N1 Formulation 2 Group | Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/Vietnam/1194/2004 H5N1 HI, Day 42 | 22 Participants |
| H5N1 Formulation 2 Group | Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/Vietnam/1194/2004 H5N1 HI, Day 385 | 8 Participants |
| H5N1 Formulation 2 Group | Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/Indonesia/5/2005 H5N1 HI, Day 42 | 33 Participants |
| H5N1 Formulation 2 Group | Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 42 | 22 Participants |
| H5N1 Formulation 2 Group | Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/Indonesia/5/2005 H5N1 HI, Day 392 | 33 Participants |
| H5N1 Formulation 2 Group | Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 42 | 9 Participants |
| H5N1 Formulation 2 Group | Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 392 | 29 Participants |
| H5N1 Formulation 2 Group | Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/Indonesia/5/2005 H5N1 HI, Day 385 | 26 Participants |
| H5N1 Formulation 2 Group | Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 385 | 6 Participants |
| H5N1 Formulation 3 Group | Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 385 | 1 Participants |
| H5N1 Formulation 3 Group | Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/Vietnam/1194/2004 H5N1 HI, Day 42 | 29 Participants |
| H5N1 Formulation 3 Group | Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 42 | 10 Participants |
| H5N1 Formulation 3 Group | Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 392 | 16 Participants |
| H5N1 Formulation 3 Group | Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/Vietnam/1194/2004 H5N1 HI, Day 385 | 9 Participants |
| H5N1 Formulation 3 Group | Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/Vietnam/1194/2004 H5N1 HI, Day 392 | 28 Participants |
| H5N1 Formulation 3 Group | Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/Indonesia/5/2005 H5N1 HI, Day 42 | 37 Participants |
| H5N1 Formulation 3 Group | Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/Indonesia/5/2005 H5N1 HI, Day 385 | 28 Participants |
| H5N1 Formulation 3 Group | Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/Indonesia/5/2005 H5N1 HI, Day 392 | 37 Participants |
| H5N1 Formulation 3 Group | Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 42 | 33 Participants |
| H5N1 Formulation 3 Group | Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 385 | 7 Participants |
| H5N1 Formulation 3 Group | Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 392 | 26 Participants |
| H5N1 Formulation 4 Group | Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/Indonesia/5/2005 H5N1 HI, Day 385 | 28 Participants |
| H5N1 Formulation 4 Group | Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 392 | 9 Participants |
| H5N1 Formulation 4 Group | Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/Vietnam/1194/2004 H5N1 HI, Day 392 | 22 Participants |
| H5N1 Formulation 4 Group | Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/Indonesia/5/2005 H5N1 HI, Day 392 | 31 Participants |
| H5N1 Formulation 4 Group | Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 385 | 0 Participants |
| H5N1 Formulation 4 Group | Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 42 | 23 Participants |
| H5N1 Formulation 4 Group | Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 385 | 5 Participants |
| H5N1 Formulation 4 Group | Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/Vietnam/1194/2004 H5N1 HI, Day 42 | 21 Participants |
| H5N1 Formulation 4 Group | Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 42 | 5 Participants |
| H5N1 Formulation 4 Group | Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 392 | 21 Participants |
| H5N1 Formulation 4 Group | Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/Indonesia/5/2005 H5N1 HI, Day 42 | 31 Participants |
| H5N1 Formulation 4 Group | Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/Vietnam/1194/2004 H5N1 HI, Day 385 | 5 Participants |
| H5N1 Formulation 5 Group | Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 392 | 18 Participants |
| H5N1 Formulation 5 Group | Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/Indonesia/5/2005 H5N1 HI, Day 385 | 21 Participants |
| H5N1 Formulation 5 Group | Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 392 | 6 Participants |
| H5N1 Formulation 5 Group | Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 42 | 8 Participants |
| H5N1 Formulation 5 Group | Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/Vietnam/1194/2004 H5N1 HI, Day 392 | 20 Participants |
| H5N1 Formulation 5 Group | Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/Indonesia/5/2005 H5N1 HI, Day 42 | 35 Participants |
| H5N1 Formulation 5 Group | Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/Indonesia/5/2005 H5N1 HI, Day 392 | 32 Participants |
| H5N1 Formulation 5 Group | Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 385 | 0 Participants |
| H5N1 Formulation 5 Group | Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 385 | 6 Participants |
| H5N1 Formulation 5 Group | Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/Vietnam/1194/2004 H5N1 HI, Day 42 | 24 Participants |
| H5N1 Formulation 5 Group | Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/Vietnam/1194/2004 H5N1 HI, Day 385 | 6 Participants |
| H5N1 Formulation 5 Group | Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 42 | 25 Participants |
Secondary
Number of Subjects Reporting Adverse Events of Special Interest (AESI)
AESI are a subset of adverse events defined in the Committee for Medicinal Products for Human Use (CHMP) Risk Management Plan for Pandemic Vaccines for safety monitoring.
Time frame: During the entire study period (Day 0 to Day 415 approximately)
Population: Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| H5N1 Formulation 1 Group | Number of Subjects Reporting Adverse Events of Special Interest (AESI) | Related | 1 Participants |
| H5N1 Formulation 1 Group | Number of Subjects Reporting Adverse Events of Special Interest (AESI) | Any | 4 Participants |
| H5N1 Formulation 2 Group | Number of Subjects Reporting Adverse Events of Special Interest (AESI) | Related | 0 Participants |
| H5N1 Formulation 2 Group | Number of Subjects Reporting Adverse Events of Special Interest (AESI) | Any | 3 Participants |
| H5N1 Formulation 3 Group | Number of Subjects Reporting Adverse Events of Special Interest (AESI) | Any | 3 Participants |
| H5N1 Formulation 3 Group | Number of Subjects Reporting Adverse Events of Special Interest (AESI) | Related | 1 Participants |
| H5N1 Formulation 4 Group | Number of Subjects Reporting Adverse Events of Special Interest (AESI) | Any | 2 Participants |
| H5N1 Formulation 4 Group | Number of Subjects Reporting Adverse Events of Special Interest (AESI) | Related | 1 Participants |
| H5N1 Formulation 5 Group | Number of Subjects Reporting Adverse Events of Special Interest (AESI) | Any | 2 Participants |
| H5N1 Formulation 5 Group | Number of Subjects Reporting Adverse Events of Special Interest (AESI) | Related | 0 Participants |
Secondary
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) Post Booster Vaccination
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the 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 is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevents normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Time frame: During the 30-day (Day 385-Day 415) follow-up period after vaccination
Population: Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| H5N1 Formulation 1 Group | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) Post Booster Vaccination | Any | 16 Participants |
| H5N1 Formulation 1 Group | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) Post Booster Vaccination | Related | 1 Participants |
| H5N1 Formulation 1 Group | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) Post Booster Vaccination | Grade 3 | 1 Participants |
| H5N1 Formulation 2 Group | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) Post Booster Vaccination | Grade 3 | 0 Participants |
| H5N1 Formulation 2 Group | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) Post Booster Vaccination | Any | 8 Participants |
| H5N1 Formulation 2 Group | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) Post Booster Vaccination | Related | 0 Participants |
| H5N1 Formulation 3 Group | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) Post Booster Vaccination | Grade 3 | 0 Participants |
| H5N1 Formulation 3 Group | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) Post Booster Vaccination | Any | 16 Participants |
| H5N1 Formulation 3 Group | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) Post Booster Vaccination | Related | 1 Participants |
| H5N1 Formulation 4 Group | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) Post Booster Vaccination | Any | 19 Participants |
| H5N1 Formulation 4 Group | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) Post Booster Vaccination | Related | 0 Participants |
| H5N1 Formulation 4 Group | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) Post Booster Vaccination | Grade 3 | 1 Participants |
| H5N1 Formulation 5 Group | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) Post Booster Vaccination | Grade 3 | 0 Participants |
| H5N1 Formulation 5 Group | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) Post Booster Vaccination | Any | 14 Participants |
| H5N1 Formulation 5 Group | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) Post Booster Vaccination | Related | 0 Participants |
Secondary
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) Post Primary Vaccination.
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the 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 is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevents normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Time frame: During the 21-day follow-up period (Day 0-Day 20) after each vaccine dose
Population: Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| H5N1 Formulation 1 Group | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) Post Primary Vaccination. | Any | 21 Participants |
| H5N1 Formulation 1 Group | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) Post Primary Vaccination. | Related | 2 Participants |
| H5N1 Formulation 1 Group | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) Post Primary Vaccination. | Grade 3 | 3 Participants |
| H5N1 Formulation 2 Group | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) Post Primary Vaccination. | Related | 0 Participants |
| H5N1 Formulation 2 Group | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) Post Primary Vaccination. | Any | 20 Participants |
| H5N1 Formulation 2 Group | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) Post Primary Vaccination. | Grade 3 | 1 Participants |
| H5N1 Formulation 3 Group | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) Post Primary Vaccination. | Grade 3 | 1 Participants |
| H5N1 Formulation 3 Group | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) Post Primary Vaccination. | Related | 1 Participants |
| H5N1 Formulation 3 Group | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) Post Primary Vaccination. | Any | 23 Participants |
| H5N1 Formulation 4 Group | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) Post Primary Vaccination. | Any | 20 Participants |
| H5N1 Formulation 4 Group | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) Post Primary Vaccination. | Related | 1 Participants |
| H5N1 Formulation 4 Group | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) Post Primary Vaccination. | Grade 3 | 3 Participants |
| H5N1 Formulation 5 Group | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) Post Primary Vaccination. | Related | 3 Participants |
| H5N1 Formulation 5 Group | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) Post Primary Vaccination. | Any | 21 Participants |
| H5N1 Formulation 5 Group | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) Post Primary Vaccination. | Grade 3 | 5 Participants |
Secondary
Number of Subjects Reporting Medically Attended Events (MAEs)
MAEs are adverse events with medically-attended visits that were not routine visits for physical examination or vaccination. Any MAE was defined as at least 1 MAE experienced.
Time frame: During the entire study period (Day 0 to Day 415 approximately)
Population: Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| H5N1 Formulation 1 Group | Number of Subjects Reporting Medically Attended Events (MAEs) | Any | 29 Participants |
| H5N1 Formulation 1 Group | Number of Subjects Reporting Medically Attended Events (MAEs) | Related | 1 Participants |
| H5N1 Formulation 2 Group | Number of Subjects Reporting Medically Attended Events (MAEs) | Any | 28 Participants |
| H5N1 Formulation 2 Group | Number of Subjects Reporting Medically Attended Events (MAEs) | Related | 0 Participants |
| H5N1 Formulation 3 Group | Number of Subjects Reporting Medically Attended Events (MAEs) | Any | 33 Participants |
| H5N1 Formulation 3 Group | Number of Subjects Reporting Medically Attended Events (MAEs) | Related | 0 Participants |
| H5N1 Formulation 4 Group | Number of Subjects Reporting Medically Attended Events (MAEs) | Related | 1 Participants |
| H5N1 Formulation 4 Group | Number of Subjects Reporting Medically Attended Events (MAEs) | Any | 27 Participants |
| H5N1 Formulation 5 Group | Number of Subjects Reporting Medically Attended Events (MAEs) | Any | 26 Participants |
| H5N1 Formulation 5 Group | Number of Subjects Reporting Medically Attended Events (MAEs) | Related | 0 Participants |
Secondary
Number of Subjects Reporting Potential Immune Mediated Diseases (pIMDs)
Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. Any pIMD = at least one pIMD experienced by the study subject. Related = pIMD assessed by the investigator to be causally related to the study vaccination.
Time frame: During the entire study period (Day 0 to Day 415 approximately)
Population: Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| H5N1 Formulation 1 Group | Number of Subjects Reporting Potential Immune Mediated Diseases (pIMDs) | Any | 0 Participants |
| H5N1 Formulation 1 Group | Number of Subjects Reporting Potential Immune Mediated Diseases (pIMDs) | Related | 0 Participants |
| H5N1 Formulation 2 Group | Number of Subjects Reporting Potential Immune Mediated Diseases (pIMDs) | Any | 0 Participants |
| H5N1 Formulation 2 Group | Number of Subjects Reporting Potential Immune Mediated Diseases (pIMDs) | Related | 0 Participants |
| H5N1 Formulation 3 Group | Number of Subjects Reporting Potential Immune Mediated Diseases (pIMDs) | Any | 1 Participants |
| H5N1 Formulation 3 Group | Number of Subjects Reporting Potential Immune Mediated Diseases (pIMDs) | Related | 0 Participants |
| H5N1 Formulation 4 Group | Number of Subjects Reporting Potential Immune Mediated Diseases (pIMDs) | Related | 0 Participants |
| H5N1 Formulation 4 Group | Number of Subjects Reporting Potential Immune Mediated Diseases (pIMDs) | Any | 0 Participants |
| H5N1 Formulation 5 Group | Number of Subjects Reporting Potential Immune Mediated Diseases (pIMDs) | Any | 0 Participants |
| H5N1 Formulation 5 Group | Number of Subjects Reporting Potential Immune Mediated Diseases (pIMDs) | Related | 0 Participants |
Secondary
Number of Subjects Reporting Serious Adverse Events (SAEs)
A serious adverse event was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
Time frame: During the entire study period (Day 0 to Day 415 approximately)
Population: Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| H5N1 Formulation 1 Group | Number of Subjects Reporting Serious Adverse Events (SAEs) | Any | 5 Participants |
| H5N1 Formulation 1 Group | Number of Subjects Reporting Serious Adverse Events (SAEs) | Related | 0 Participants |
| H5N1 Formulation 2 Group | Number of Subjects Reporting Serious Adverse Events (SAEs) | Any | 6 Participants |
| H5N1 Formulation 2 Group | Number of Subjects Reporting Serious Adverse Events (SAEs) | Related | 0 Participants |
| H5N1 Formulation 3 Group | Number of Subjects Reporting Serious Adverse Events (SAEs) | Any | 10 Participants |
| H5N1 Formulation 3 Group | Number of Subjects Reporting Serious Adverse Events (SAEs) | Related | 0 Participants |
| H5N1 Formulation 4 Group | Number of Subjects Reporting Serious Adverse Events (SAEs) | Related | 0 Participants |
| H5N1 Formulation 4 Group | Number of Subjects Reporting Serious Adverse Events (SAEs) | Any | 4 Participants |
| H5N1 Formulation 5 Group | Number of Subjects Reporting Serious Adverse Events (SAEs) | Any | 4 Participants |
| H5N1 Formulation 5 Group | Number of Subjects Reporting Serious Adverse Events (SAEs) | Related | 0 Participants |
Secondary
Number of Subjects Reporting Solicited General Symptoms.
Assessed solicited general symptoms were fever (defined as temperature ≥ 38.0 degrees Celsius (°C) assessed by any route (oral, axillary, rectal)\], irritability/fussiness, drowsiness and. loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 irritability/Fussiness and Drowsiness = Prevented normal activity, Grade3 Loss of appetite = Did not eat at all. Grade 3 fever = fever \> 40.0 °C. Related = symptom assessed by the investigator as related to the vaccination
Time frame: During the 7-day follow-up period (i.e. on the day of vaccination and 6 subsequent days) after any vaccine dose
Population: Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| H5N1 Formulation 1 Group | Number of Subjects Reporting Solicited General Symptoms. | Temperature/(Axillary) (°C), Grade 3 | 0 Participants |
| H5N1 Formulation 1 Group | Number of Subjects Reporting Solicited General Symptoms. | Drowsiness, Related | 22 Participants |
| H5N1 Formulation 1 Group | Number of Subjects Reporting Solicited General Symptoms. | Drowsiness, Any | 25 Participants |
| H5N1 Formulation 1 Group | Number of Subjects Reporting Solicited General Symptoms. | Temperature/(Axillary) (°C), Any | 24 Participants |
| H5N1 Formulation 1 Group | Number of Subjects Reporting Solicited General Symptoms. | Loss Of Appetite, Related | 21 Participants |
| H5N1 Formulation 1 Group | Number of Subjects Reporting Solicited General Symptoms. | Loss Of Appetite, Grade 3 | 0 Participants |
| H5N1 Formulation 1 Group | Number of Subjects Reporting Solicited General Symptoms. | Loss Of Appetite, Any | 24 Participants |
| H5N1 Formulation 1 Group | Number of Subjects Reporting Solicited General Symptoms. | Drowsiness, Grade 3 | 2 Participants |
| H5N1 Formulation 1 Group | Number of Subjects Reporting Solicited General Symptoms. | Irritability / Fussiness, Related | 22 Participants |
| H5N1 Formulation 1 Group | Number of Subjects Reporting Solicited General Symptoms. | Irritability / Fussiness, Grade 3 | 3 Participants |
| H5N1 Formulation 1 Group | Number of Subjects Reporting Solicited General Symptoms. | Irritability / Fussiness, Any | 24 Participants |
| H5N1 Formulation 1 Group | Number of Subjects Reporting Solicited General Symptoms. | Temperature/(Axillary) (°C), Related | 22 Participants |
| H5N1 Formulation 2 Group | Number of Subjects Reporting Solicited General Symptoms. | Drowsiness, Grade 3 | 3 Participants |
| H5N1 Formulation 2 Group | Number of Subjects Reporting Solicited General Symptoms. | Temperature/(Axillary) (°C), Any | 17 Participants |
| H5N1 Formulation 2 Group | Number of Subjects Reporting Solicited General Symptoms. | Temperature/(Axillary) (°C), Related | 12 Participants |
| H5N1 Formulation 2 Group | Number of Subjects Reporting Solicited General Symptoms. | Drowsiness, Any | 18 Participants |
| H5N1 Formulation 2 Group | Number of Subjects Reporting Solicited General Symptoms. | Drowsiness, Related | 14 Participants |
| H5N1 Formulation 2 Group | Number of Subjects Reporting Solicited General Symptoms. | Irritability / Fussiness, Any | 17 Participants |
| H5N1 Formulation 2 Group | Number of Subjects Reporting Solicited General Symptoms. | Irritability / Fussiness, Grade 3 | 2 Participants |
| H5N1 Formulation 2 Group | Number of Subjects Reporting Solicited General Symptoms. | Irritability / Fussiness, Related | 14 Participants |
| H5N1 Formulation 2 Group | Number of Subjects Reporting Solicited General Symptoms. | Loss Of Appetite, Any | 13 Participants |
| H5N1 Formulation 2 Group | Number of Subjects Reporting Solicited General Symptoms. | Loss Of Appetite, Grade 3 | 1 Participants |
| H5N1 Formulation 2 Group | Number of Subjects Reporting Solicited General Symptoms. | Loss Of Appetite, Related | 7 Participants |
| H5N1 Formulation 2 Group | Number of Subjects Reporting Solicited General Symptoms. | Temperature/(Axillary) (°C), Grade 3 | 0 Participants |
| H5N1 Formulation 3 Group | Number of Subjects Reporting Solicited General Symptoms. | Temperature/(Axillary) (°C), Any | 14 Participants |
| H5N1 Formulation 3 Group | Number of Subjects Reporting Solicited General Symptoms. | Temperature/(Axillary) (°C), Grade 3 | 1 Participants |
| H5N1 Formulation 3 Group | Number of Subjects Reporting Solicited General Symptoms. | Loss Of Appetite, Any | 14 Participants |
| H5N1 Formulation 3 Group | Number of Subjects Reporting Solicited General Symptoms. | Irritability / Fussiness, Any | 19 Participants |
| H5N1 Formulation 3 Group | Number of Subjects Reporting Solicited General Symptoms. | Drowsiness, Grade 3 | 1 Participants |
| H5N1 Formulation 3 Group | Number of Subjects Reporting Solicited General Symptoms. | Irritability / Fussiness, Grade 3 | 3 Participants |
| H5N1 Formulation 3 Group | Number of Subjects Reporting Solicited General Symptoms. | Temperature/(Axillary) (°C), Related | 12 Participants |
| H5N1 Formulation 3 Group | Number of Subjects Reporting Solicited General Symptoms. | Loss Of Appetite, Grade 3 | 2 Participants |
| H5N1 Formulation 3 Group | Number of Subjects Reporting Solicited General Symptoms. | Irritability / Fussiness, Related | 17 Participants |
| H5N1 Formulation 3 Group | Number of Subjects Reporting Solicited General Symptoms. | Drowsiness, Any | 13 Participants |
| H5N1 Formulation 3 Group | Number of Subjects Reporting Solicited General Symptoms. | Drowsiness, Related | 12 Participants |
| H5N1 Formulation 3 Group | Number of Subjects Reporting Solicited General Symptoms. | Loss Of Appetite, Related | 11 Participants |
| H5N1 Formulation 4 Group | Number of Subjects Reporting Solicited General Symptoms. | Temperature/(Axillary) (°C), Related | 14 Participants |
| H5N1 Formulation 4 Group | Number of Subjects Reporting Solicited General Symptoms. | Irritability / Fussiness, Any | 22 Participants |
| H5N1 Formulation 4 Group | Number of Subjects Reporting Solicited General Symptoms. | Loss Of Appetite, Related | 15 Participants |
| H5N1 Formulation 4 Group | Number of Subjects Reporting Solicited General Symptoms. | Drowsiness, Any | 17 Participants |
| H5N1 Formulation 4 Group | Number of Subjects Reporting Solicited General Symptoms. | Drowsiness, Grade 3 | 1 Participants |
| H5N1 Formulation 4 Group | Number of Subjects Reporting Solicited General Symptoms. | Temperature/(Axillary) (°C), Any | 14 Participants |
| H5N1 Formulation 4 Group | Number of Subjects Reporting Solicited General Symptoms. | Irritability / Fussiness, Related | 16 Participants |
| H5N1 Formulation 4 Group | Number of Subjects Reporting Solicited General Symptoms. | Temperature/(Axillary) (°C), Grade 3 | 0 Participants |
| H5N1 Formulation 4 Group | Number of Subjects Reporting Solicited General Symptoms. | Loss Of Appetite, Any | 20 Participants |
| H5N1 Formulation 4 Group | Number of Subjects Reporting Solicited General Symptoms. | Loss Of Appetite, Grade 3 | 2 Participants |
| H5N1 Formulation 4 Group | Number of Subjects Reporting Solicited General Symptoms. | Irritability / Fussiness, Grade 3 | 2 Participants |
| H5N1 Formulation 4 Group | Number of Subjects Reporting Solicited General Symptoms. | Drowsiness, Related | 13 Participants |
| H5N1 Formulation 5 Group | Number of Subjects Reporting Solicited General Symptoms. | Temperature/(Axillary) (°C), Grade 3 | 0 Participants |
| H5N1 Formulation 5 Group | Number of Subjects Reporting Solicited General Symptoms. | Irritability / Fussiness, Any | 21 Participants |
| H5N1 Formulation 5 Group | Number of Subjects Reporting Solicited General Symptoms. | Irritability / Fussiness, Grade 3 | 0 Participants |
| H5N1 Formulation 5 Group | Number of Subjects Reporting Solicited General Symptoms. | Temperature/(Axillary) (°C), Related | 10 Participants |
| H5N1 Formulation 5 Group | Number of Subjects Reporting Solicited General Symptoms. | Irritability / Fussiness, Related | 19 Participants |
| H5N1 Formulation 5 Group | Number of Subjects Reporting Solicited General Symptoms. | Loss Of Appetite, Any | 13 Participants |
| H5N1 Formulation 5 Group | Number of Subjects Reporting Solicited General Symptoms. | Loss Of Appetite, Grade 3 | 0 Participants |
| H5N1 Formulation 5 Group | Number of Subjects Reporting Solicited General Symptoms. | Loss Of Appetite, Related | 10 Participants |
| H5N1 Formulation 5 Group | Number of Subjects Reporting Solicited General Symptoms. | Drowsiness, Any | 16 Participants |
| H5N1 Formulation 5 Group | Number of Subjects Reporting Solicited General Symptoms. | Drowsiness, Grade 3 | 0 Participants |
| H5N1 Formulation 5 Group | Number of Subjects Reporting Solicited General Symptoms. | Drowsiness, Related | 14 Participants |
| H5N1 Formulation 5 Group | Number of Subjects Reporting Solicited General Symptoms. | Temperature/(Axillary) (°C), Any | 10 Participants |
Secondary
Number of Subjects Reporting Solicited Local Symptoms
Solicited local AEs assessed were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb is moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
Time frame: During the 7-day follow-up period (i.e. on the day of vaccination and 6 subsequent days) after any vaccine dose
Population: Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| H5N1 Formulation 1 Group | Number of Subjects Reporting Solicited Local Symptoms | Swelling (mm), Any | 0 Participants |
| H5N1 Formulation 1 Group | Number of Subjects Reporting Solicited Local Symptoms | Pain, Grade 3 | 2 Participants |
| H5N1 Formulation 1 Group | Number of Subjects Reporting Solicited Local Symptoms | Redness (mm), Grade 3 | 0 Participants |
| H5N1 Formulation 1 Group | Number of Subjects Reporting Solicited Local Symptoms | Redness (mm), Any | 0 Participants |
| H5N1 Formulation 1 Group | Number of Subjects Reporting Solicited Local Symptoms | Swelling (mm), Grade 3 | 0 Participants |
| H5N1 Formulation 1 Group | Number of Subjects Reporting Solicited Local Symptoms | Pain, Any | 20 Participants |
| H5N1 Formulation 2 Group | Number of Subjects Reporting Solicited Local Symptoms | Pain, Grade 3 | 1 Participants |
| H5N1 Formulation 2 Group | Number of Subjects Reporting Solicited Local Symptoms | Pain, Any | 15 Participants |
| H5N1 Formulation 2 Group | Number of Subjects Reporting Solicited Local Symptoms | Redness (mm), Any | 0 Participants |
| H5N1 Formulation 2 Group | Number of Subjects Reporting Solicited Local Symptoms | Redness (mm), Grade 3 | 0 Participants |
| H5N1 Formulation 2 Group | Number of Subjects Reporting Solicited Local Symptoms | Swelling (mm), Any | 0 Participants |
| H5N1 Formulation 2 Group | Number of Subjects Reporting Solicited Local Symptoms | Swelling (mm), Grade 3 | 0 Participants |
| H5N1 Formulation 3 Group | Number of Subjects Reporting Solicited Local Symptoms | Pain, Grade 3 | 1 Participants |
| H5N1 Formulation 3 Group | Number of Subjects Reporting Solicited Local Symptoms | Redness (mm), Any | 0 Participants |
| H5N1 Formulation 3 Group | Number of Subjects Reporting Solicited Local Symptoms | Swelling (mm), Grade 3 | 0 Participants |
| H5N1 Formulation 3 Group | Number of Subjects Reporting Solicited Local Symptoms | Redness (mm), Grade 3 | 0 Participants |
| H5N1 Formulation 3 Group | Number of Subjects Reporting Solicited Local Symptoms | Swelling (mm), Any | 0 Participants |
| H5N1 Formulation 3 Group | Number of Subjects Reporting Solicited Local Symptoms | Pain, Any | 16 Participants |
| H5N1 Formulation 4 Group | Number of Subjects Reporting Solicited Local Symptoms | Redness (mm), Any | 0 Participants |
| H5N1 Formulation 4 Group | Number of Subjects Reporting Solicited Local Symptoms | Swelling (mm), Any | 1 Participants |
| H5N1 Formulation 4 Group | Number of Subjects Reporting Solicited Local Symptoms | Pain, Any | 20 Participants |
| H5N1 Formulation 4 Group | Number of Subjects Reporting Solicited Local Symptoms | Redness (mm), Grade 3 | 0 Participants |
| H5N1 Formulation 4 Group | Number of Subjects Reporting Solicited Local Symptoms | Pain, Grade 3 | 1 Participants |
| H5N1 Formulation 4 Group | Number of Subjects Reporting Solicited Local Symptoms | Swelling (mm), Grade 3 | 0 Participants |
| H5N1 Formulation 5 Group | Number of Subjects Reporting Solicited Local Symptoms | Redness (mm), Any | 0 Participants |
| H5N1 Formulation 5 Group | Number of Subjects Reporting Solicited Local Symptoms | Pain, Grade 3 | 2 Participants |
| H5N1 Formulation 5 Group | Number of Subjects Reporting Solicited Local Symptoms | Swelling (mm), Any | 0 Participants |
| H5N1 Formulation 5 Group | Number of Subjects Reporting Solicited Local Symptoms | Pain, Any | 17 Participants |
| H5N1 Formulation 5 Group | Number of Subjects Reporting Solicited Local Symptoms | Swelling (mm), Grade 3 | 0 Participants |
| H5N1 Formulation 5 Group | Number of Subjects Reporting Solicited Local Symptoms | Redness (mm), Grade 3 | 0 Participants |
Secondary
Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains.
Seroprotection rate (SPR) was defined as the proportion of subjects with H5N1 reciprocal HI titers ≥ 40 against the tested vaccine virus The vaccine strains assessed were Flu A/Indonesia/5/2005 H5N1 (homologous), Flu A/Vietnam/1194/2004 H5N1 (heterologous), Flu A/duck/Bangladesh/19097/2013 H5N1 (heterologous) and Flu A/gyrfalcon/Washington/41088-6/2014 H5N8 (heterologous).
Time frame: At Days 0, 42, 385, 392
Population: Analysis was performed on the Adapted According to Protocol (ATP) cohort for immunogenicity which included all vaccinated subjects who had results available for the relevant assay (HI and MN) for all blood samples collected during relevant analysis intervals for ATP-Day 42; ATP-Day 385 (persistence); ATP-Day 392 post booster dose (ATP-booster)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| H5N1 Formulation 1 Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 392 | 20 Participants |
| H5N1 Formulation 1 Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/Indonesia/5/2005 H5N1 HI, Day 392 | 34 Participants |
| H5N1 Formulation 1 Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 0 | 0 Participants |
| H5N1 Formulation 1 Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 392 | 30 Participants |
| H5N1 Formulation 1 Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 385 | 9 Participants |
| H5N1 Formulation 1 Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/Vietnam/1194/2004 H5N1 HI, Day 392 | 32 Participants |
| H5N1 Formulation 1 Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 0 | 0 Participants |
| H5N1 Formulation 1 Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/Vietnam/1194/2004 H5N1 HI, Day 385 | 15 Participants |
| H5N1 Formulation 1 Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 42 | 32 Participants |
| H5N1 Formulation 1 Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 385 | 1 Participants |
| H5N1 Formulation 1 Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/Vietnam/1194/2004 H5N1 HI, Day 0 | 0 Participants |
| H5N1 Formulation 1 Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/Vietnam/1194/2004 H5N1 HI, Day 42 | 32 Participants |
| H5N1 Formulation 1 Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/Indonesia/5/2005 H5N1 HI, Day 385 | 33 Participants |
| H5N1 Formulation 1 Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 42 | 19 Participants |
| H5N1 Formulation 1 Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/Indonesia/5/2005 H5N1 HI, Day 42 | 36 Participants |
| H5N1 Formulation 1 Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/Indonesia/5/2005 H5N1 HI, Day 0 | 0 Participants |
| H5N1 Formulation 2 Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/Vietnam/1194/2004 H5N1 HI, Day 42 | 25 Participants |
| H5N1 Formulation 2 Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 0 | 0 Participants |
| H5N1 Formulation 2 Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/Vietnam/1194/2004 H5N1 HI, Day 385 | 10 Participants |
| H5N1 Formulation 2 Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/Vietnam/1194/2004 H5N1 HI, Day 392 | 32 Participants |
| H5N1 Formulation 2 Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 392 | 18 Participants |
| H5N1 Formulation 2 Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/Indonesia/5/2005 H5N1 HI, Day 385 | 26 Participants |
| H5N1 Formulation 2 Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/Indonesia/5/2005 H5N1 HI, Day 0 | 0 Participants |
| H5N1 Formulation 2 Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/Indonesia/5/2005 H5N1 HI, Day 392 | 33 Participants |
| H5N1 Formulation 2 Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 385 | 1 Participants |
| H5N1 Formulation 2 Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 0 | 0 Participants |
| H5N1 Formulation 2 Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 42 | 25 Participants |
| H5N1 Formulation 2 Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 385 | 8 Participants |
| H5N1 Formulation 2 Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 42 | 10 Participants |
| H5N1 Formulation 2 Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 392 | 32 Participants |
| H5N1 Formulation 2 Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/Vietnam/1194/2004 H5N1 HI, Day 0 | 0 Participants |
| H5N1 Formulation 2 Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/Indonesia/5/2005 H5N1 HI, Day 42 | 33 Participants |
| H5N1 Formulation 3 Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 385 | 1 Participants |
| H5N1 Formulation 3 Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/Vietnam/1194/2004 H5N1 HI, Day 0 | 0 Participants |
| H5N1 Formulation 3 Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 385 | 8 Participants |
| H5N1 Formulation 3 Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 392 | 16 Participants |
| H5N1 Formulation 3 Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/Vietnam/1194/2004 H5N1 HI, Day 42 | 31 Participants |
| H5N1 Formulation 3 Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/Indonesia/5/2005 H5N1 HI, Day 392 | 37 Participants |
| H5N1 Formulation 3 Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/Vietnam/1194/2004 H5N1 HI, Day 385 | 10 Participants |
| H5N1 Formulation 3 Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 392 | 27 Participants |
| H5N1 Formulation 3 Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/Indonesia/5/2005 H5N1 HI, Day 385 | 28 Participants |
| H5N1 Formulation 3 Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/Vietnam/1194/2004 H5N1 HI, Day 392 | 29 Participants |
| H5N1 Formulation 3 Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/Indonesia/5/2005 H5N1 HI, Day 0 | 0 Participants |
| H5N1 Formulation 3 Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 0 | 0 Participants |
| H5N1 Formulation 3 Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/Indonesia/5/2005 H5N1 HI, Day 42 | 37 Participants |
| H5N1 Formulation 3 Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 42 | 35 Participants |
| H5N1 Formulation 3 Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 0 | 0 Participants |
| H5N1 Formulation 3 Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 42 | 11 Participants |
| H5N1 Formulation 4 Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/Indonesia/5/2005 H5N1 HI, Day 392 | 31 Participants |
| H5N1 Formulation 4 Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/Indonesia/5/2005 H5N1 HI, Day 0 | 0 Participants |
| H5N1 Formulation 4 Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/Indonesia/5/2005 H5N1 HI, Day 42 | 31 Participants |
| H5N1 Formulation 4 Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/Indonesia/5/2005 H5N1 HI, Day 385 | 28 Participants |
| H5N1 Formulation 4 Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 0 | 0 Participants |
| H5N1 Formulation 4 Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 42 | 28 Participants |
| H5N1 Formulation 4 Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 385 | 7 Participants |
| H5N1 Formulation 4 Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 392 | 27 Participants |
| H5N1 Formulation 4 Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/Vietnam/1194/2004 H5N1 HI, Day 0 | 0 Participants |
| H5N1 Formulation 4 Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/Vietnam/1194/2004 H5N1 HI, Day 42 | 26 Participants |
| H5N1 Formulation 4 Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/Vietnam/1194/2004 H5N1 HI, Day 385 | 7 Participants |
| H5N1 Formulation 4 Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/Vietnam/1194/2004 H5N1 HI, Day 392 | 28 Participants |
| H5N1 Formulation 4 Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 0 | 0 Participants |
| H5N1 Formulation 4 Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 42 | 7 Participants |
| H5N1 Formulation 4 Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 385 | 0 Participants |
| H5N1 Formulation 4 Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 392 | 10 Participants |
| H5N1 Formulation 5 Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 0 | 0 Participants |
| H5N1 Formulation 5 Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/Vietnam/1194/2004 H5N1 HI, Day 0 | 2 Participants |
| H5N1 Formulation 5 Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 385 | 6 Participants |
| H5N1 Formulation 5 Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 42 | 31 Participants |
| H5N1 Formulation 5 Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/Indonesia/5/2005 H5N1 HI, Day 0 | 0 Participants |
| H5N1 Formulation 5 Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 42 | 9 Participants |
| H5N1 Formulation 5 Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 0 | 2 Participants |
| H5N1 Formulation 5 Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/Indonesia/5/2005 H5N1 HI, Day 392 | 32 Participants |
| H5N1 Formulation 5 Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 392 | 22 Participants |
| H5N1 Formulation 5 Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 392 | 8 Participants |
| H5N1 Formulation 5 Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 385 | 1 Participants |
| H5N1 Formulation 5 Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/Indonesia/5/2005 H5N1 HI, Day 385 | 23 Participants |
| H5N1 Formulation 5 Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/Vietnam/1194/2004 H5N1 HI, Day 392 | 24 Participants |
| H5N1 Formulation 5 Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/Vietnam/1194/2004 H5N1 HI, Day 385 | 8 Participants |
| H5N1 Formulation 5 Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/Vietnam/1194/2004 H5N1 HI, Day 42 | 29 Participants |
| H5N1 Formulation 5 Group | Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. | Flu A/Indonesia/5/2005 H5N1 HI, Day 42 | 35 Participants |
Secondary
Vaccine Response Rate (VRR) for Homologous and Heterologous MN Antibodies Against Each of the 3 Vaccine Influenza Strains.
VRR for MN was defined as the incidence rate of subjects with at least a 4-fold increase in post vaccination reciprocal titer relative to pre vaccination titers. The vaccine strains assessed were Flu A/Indonesia/5/2005 H5N1 (homologous), Flu A/Vietnam /1194/2004 H5N (heterologous) and Flu A/duck/Bangladesh/19097/2013 H5N1 (heterologous).
Time frame: At Day 42, Day 385 (relative to Day 0), Day 392 (relative to Day 0) and D 392 (relative to Day 385)
Population: Analysis was performed on the Adapted According to Protocol (ATP) cohort for immunogenicity which included all vaccinated subjects who had results available for the relevant assay (HI and MN) for all blood samples collected during relevant analysis intervals for ATP-Day 42; ATP-Day 385 (persistence); ATP-Day 392 post booster dose (ATP-booster).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| H5N1 Formulation 1 Group | Vaccine Response Rate (VRR) for Homologous and Heterologous MN Antibodies Against Each of the 3 Vaccine Influenza Strains. | Flu A/Vietnam/1194/2004 H5N1 MN, Day 385 | 27 Participants |
| H5N1 Formulation 1 Group | Vaccine Response Rate (VRR) for Homologous and Heterologous MN Antibodies Against Each of the 3 Vaccine Influenza Strains. | Flu A/Vietnam/1194/2004 H5N1 MN, D 392 | 10 Participants |
| H5N1 Formulation 1 Group | Vaccine Response Rate (VRR) for Homologous and Heterologous MN Antibodies Against Each of the 3 Vaccine Influenza Strains. | Flu A/Vietnam/1194/2004 H5N1 MN, Day 392 | 31 Participants |
| H5N1 Formulation 1 Group | Vaccine Response Rate (VRR) for Homologous and Heterologous MN Antibodies Against Each of the 3 Vaccine Influenza Strains. | Flu A/Indonesia/5/2005 H5N1 MN, Day 392 | 34 Participants |
| H5N1 Formulation 1 Group | Vaccine Response Rate (VRR) for Homologous and Heterologous MN Antibodies Against Each of the 3 Vaccine Influenza Strains. | Flu A/duck/Bangladesh/19097/2013 H5N1 MN, Day 42 | 34 Participants |
| H5N1 Formulation 1 Group | Vaccine Response Rate (VRR) for Homologous and Heterologous MN Antibodies Against Each of the 3 Vaccine Influenza Strains. | Flu A/duck/Bangladesh/19097/2013 H5N1 MN, Day 392 | 33 Participants |
| H5N1 Formulation 1 Group | Vaccine Response Rate (VRR) for Homologous and Heterologous MN Antibodies Against Each of the 3 Vaccine Influenza Strains. | Flu A/duck/Bangladesh/19097/2013 H5N1 MN, D 392 | 9 Participants |
| H5N1 Formulation 1 Group | Vaccine Response Rate (VRR) for Homologous and Heterologous MN Antibodies Against Each of the 3 Vaccine Influenza Strains. | Flu A/Indonesia/5/2005 H5N1 MN, D 392 | 21 Participants |
| H5N1 Formulation 1 Group | Vaccine Response Rate (VRR) for Homologous and Heterologous MN Antibodies Against Each of the 3 Vaccine Influenza Strains. | Flu A/duck/Bangladesh/19097/2013 H5N1 MN, Day 385 | 28 Participants |
| H5N1 Formulation 1 Group | Vaccine Response Rate (VRR) for Homologous and Heterologous MN Antibodies Against Each of the 3 Vaccine Influenza Strains. | Flu A/Indonesia/5/2005 H5N1 MN, Day 385 | 34 Participants |
| H5N1 Formulation 1 Group | Vaccine Response Rate (VRR) for Homologous and Heterologous MN Antibodies Against Each of the 3 Vaccine Influenza Strains. | Flu A/Vietnam/1194/2004 H5N1 MN, Day 42 | 34 Participants |
| H5N1 Formulation 1 Group | Vaccine Response Rate (VRR) for Homologous and Heterologous MN Antibodies Against Each of the 3 Vaccine Influenza Strains. | Flu A/Indonesia/5/2005 H5N1 MN, Day 42 | 36 Participants |
| H5N1 Formulation 2 Group | Vaccine Response Rate (VRR) for Homologous and Heterologous MN Antibodies Against Each of the 3 Vaccine Influenza Strains. | Flu A/Vietnam/1194/2004 H5N1 MN, Day 42 | 31 Participants |
| H5N1 Formulation 2 Group | Vaccine Response Rate (VRR) for Homologous and Heterologous MN Antibodies Against Each of the 3 Vaccine Influenza Strains. | Flu A/Vietnam/1194/2004 H5N1 MN, D 392 | 10 Participants |
| H5N1 Formulation 2 Group | Vaccine Response Rate (VRR) for Homologous and Heterologous MN Antibodies Against Each of the 3 Vaccine Influenza Strains. | Flu A/Vietnam/1194/2004 H5N1 MN, Day 385 | 27 Participants |
| H5N1 Formulation 2 Group | Vaccine Response Rate (VRR) for Homologous and Heterologous MN Antibodies Against Each of the 3 Vaccine Influenza Strains. | Flu A/Indonesia/5/2005 H5N1 MN, Day 42 | 31 Participants |
| H5N1 Formulation 2 Group | Vaccine Response Rate (VRR) for Homologous and Heterologous MN Antibodies Against Each of the 3 Vaccine Influenza Strains. | Flu A/duck/Bangladesh/19097/2013 H5N1 MN, D 392 | 10 Participants |
| H5N1 Formulation 2 Group | Vaccine Response Rate (VRR) for Homologous and Heterologous MN Antibodies Against Each of the 3 Vaccine Influenza Strains. | Flu A/Vietnam/1194/2004 H5N1 MN, Day 392 | 31 Participants |
| H5N1 Formulation 2 Group | Vaccine Response Rate (VRR) for Homologous and Heterologous MN Antibodies Against Each of the 3 Vaccine Influenza Strains. | Flu A/Indonesia/5/2005 H5N1 MN, Day 385 | 32 Participants |
| H5N1 Formulation 2 Group | Vaccine Response Rate (VRR) for Homologous and Heterologous MN Antibodies Against Each of the 3 Vaccine Influenza Strains. | Flu A/duck/Bangladesh/19097/2013 H5N1 MN, Day 392 | 32 Participants |
| H5N1 Formulation 2 Group | Vaccine Response Rate (VRR) for Homologous and Heterologous MN Antibodies Against Each of the 3 Vaccine Influenza Strains. | Flu A/Indonesia/5/2005 H5N1 MN, Day 392 | 32 Participants |
| H5N1 Formulation 2 Group | Vaccine Response Rate (VRR) for Homologous and Heterologous MN Antibodies Against Each of the 3 Vaccine Influenza Strains. | Flu A/Indonesia/5/2005 H5N1 MN, D 392 | 24 Participants |
| H5N1 Formulation 2 Group | Vaccine Response Rate (VRR) for Homologous and Heterologous MN Antibodies Against Each of the 3 Vaccine Influenza Strains. | Flu A/duck/Bangladesh/19097/2013 H5N1 MN, Day 385 | 27 Participants |
| H5N1 Formulation 2 Group | Vaccine Response Rate (VRR) for Homologous and Heterologous MN Antibodies Against Each of the 3 Vaccine Influenza Strains. | Flu A/duck/Bangladesh/19097/2013 H5N1 MN, Day 42 | 31 Participants |
| H5N1 Formulation 3 Group | Vaccine Response Rate (VRR) for Homologous and Heterologous MN Antibodies Against Each of the 3 Vaccine Influenza Strains. | Flu A/duck/Bangladesh/19097/2013 H5N1 MN, Day 392 | 36 Participants |
| H5N1 Formulation 3 Group | Vaccine Response Rate (VRR) for Homologous and Heterologous MN Antibodies Against Each of the 3 Vaccine Influenza Strains. | Flu A/Indonesia/5/2005 H5N1 MN, D 392 | 14 Participants |
| H5N1 Formulation 3 Group | Vaccine Response Rate (VRR) for Homologous and Heterologous MN Antibodies Against Each of the 3 Vaccine Influenza Strains. | Flu A/Vietnam/1194/2004 H5N1 MN, Day 392 | 37 Participants |
| H5N1 Formulation 3 Group | Vaccine Response Rate (VRR) for Homologous and Heterologous MN Antibodies Against Each of the 3 Vaccine Influenza Strains. | Flu A/Indonesia/5/2005 H5N1 MN, Day 42 | 37 Participants |
| H5N1 Formulation 3 Group | Vaccine Response Rate (VRR) for Homologous and Heterologous MN Antibodies Against Each of the 3 Vaccine Influenza Strains. | Flu A/Indonesia/5/2005 H5N1 MN, Day 385 | 37 Participants |
| H5N1 Formulation 3 Group | Vaccine Response Rate (VRR) for Homologous and Heterologous MN Antibodies Against Each of the 3 Vaccine Influenza Strains. | Flu A/Indonesia/5/2005 H5N1 MN, Day 392 | 37 Participants |
| H5N1 Formulation 3 Group | Vaccine Response Rate (VRR) for Homologous and Heterologous MN Antibodies Against Each of the 3 Vaccine Influenza Strains. | Flu A/Vietnam/1194/2004 H5N1 MN, Day 42 | 36 Participants |
| H5N1 Formulation 3 Group | Vaccine Response Rate (VRR) for Homologous and Heterologous MN Antibodies Against Each of the 3 Vaccine Influenza Strains. | Flu A/Vietnam/1194/2004 H5N1 MN, Day 385 | 27 Participants |
| H5N1 Formulation 3 Group | Vaccine Response Rate (VRR) for Homologous and Heterologous MN Antibodies Against Each of the 3 Vaccine Influenza Strains. | Flu A/Vietnam/1194/2004 H5N1 MN, D 392 | 10 Participants |
| H5N1 Formulation 3 Group | Vaccine Response Rate (VRR) for Homologous and Heterologous MN Antibodies Against Each of the 3 Vaccine Influenza Strains. | Flu A/duck/Bangladesh/19097/2013 H5N1 MN, Day 42 | 35 Participants |
| H5N1 Formulation 3 Group | Vaccine Response Rate (VRR) for Homologous and Heterologous MN Antibodies Against Each of the 3 Vaccine Influenza Strains. | Flu A/duck/Bangladesh/19097/2013 H5N1 MN, Day 385 | 29 Participants |
| H5N1 Formulation 3 Group | Vaccine Response Rate (VRR) for Homologous and Heterologous MN Antibodies Against Each of the 3 Vaccine Influenza Strains. | Flu A/duck/Bangladesh/19097/2013 H5N1 MN, D 392 | 8 Participants |
| H5N1 Formulation 4 Group | Vaccine Response Rate (VRR) for Homologous and Heterologous MN Antibodies Against Each of the 3 Vaccine Influenza Strains. | Flu A/Vietnam/1194/2004 H5N1 MN, Day 385 | 28 Participants |
| H5N1 Formulation 4 Group | Vaccine Response Rate (VRR) for Homologous and Heterologous MN Antibodies Against Each of the 3 Vaccine Influenza Strains. | Flu A/Indonesia/5/2005 H5N1 MN, Day 42 | 29 Participants |
| H5N1 Formulation 4 Group | Vaccine Response Rate (VRR) for Homologous and Heterologous MN Antibodies Against Each of the 3 Vaccine Influenza Strains. | Flu A/Vietnam/1194/2004 H5N1 MN, D 392 | 7 Participants |
| H5N1 Formulation 4 Group | Vaccine Response Rate (VRR) for Homologous and Heterologous MN Antibodies Against Each of the 3 Vaccine Influenza Strains. | Flu A/Vietnam/1194/2004 H5N1 MN, Day 42 | 29 Participants |
| H5N1 Formulation 4 Group | Vaccine Response Rate (VRR) for Homologous and Heterologous MN Antibodies Against Each of the 3 Vaccine Influenza Strains. | Flu A/duck/Bangladesh/19097/2013 H5N1 MN, Day 42 | 31 Participants |
| H5N1 Formulation 4 Group | Vaccine Response Rate (VRR) for Homologous and Heterologous MN Antibodies Against Each of the 3 Vaccine Influenza Strains. | Flu A/Indonesia/5/2005 H5N1 MN, D 392 | 15 Participants |
| H5N1 Formulation 4 Group | Vaccine Response Rate (VRR) for Homologous and Heterologous MN Antibodies Against Each of the 3 Vaccine Influenza Strains. | Flu A/duck/Bangladesh/19097/2013 H5N1 MN, D 392 | 6 Participants |
| H5N1 Formulation 4 Group | Vaccine Response Rate (VRR) for Homologous and Heterologous MN Antibodies Against Each of the 3 Vaccine Influenza Strains. | Flu A/duck/Bangladesh/19097/2013 H5N1 MN, Day 385 | 25 Participants |
| H5N1 Formulation 4 Group | Vaccine Response Rate (VRR) for Homologous and Heterologous MN Antibodies Against Each of the 3 Vaccine Influenza Strains. | Flu A/Indonesia/5/2005 H5N1 MN, Day 392 | 29 Participants |
| H5N1 Formulation 4 Group | Vaccine Response Rate (VRR) for Homologous and Heterologous MN Antibodies Against Each of the 3 Vaccine Influenza Strains. | Flu A/Indonesia/5/2005 H5N1 MN, Day 385 | 29 Participants |
| H5N1 Formulation 4 Group | Vaccine Response Rate (VRR) for Homologous and Heterologous MN Antibodies Against Each of the 3 Vaccine Influenza Strains. | Flu A/duck/Bangladesh/19097/2013 H5N1 MN, Day 392 | 31 Participants |
| H5N1 Formulation 4 Group | Vaccine Response Rate (VRR) for Homologous and Heterologous MN Antibodies Against Each of the 3 Vaccine Influenza Strains. | Flu A/Vietnam/1194/2004 H5N1 MN, Day 392 | 30 Participants |
| H5N1 Formulation 5 Group | Vaccine Response Rate (VRR) for Homologous and Heterologous MN Antibodies Against Each of the 3 Vaccine Influenza Strains. | Flu A/Indonesia/5/2005 H5N1 MN, Day 42 | 35 Participants |
| H5N1 Formulation 5 Group | Vaccine Response Rate (VRR) for Homologous and Heterologous MN Antibodies Against Each of the 3 Vaccine Influenza Strains. | Flu A/duck/Bangladesh/19097/2013 H5N1 MN, Day 385 | 23 Participants |
| H5N1 Formulation 5 Group | Vaccine Response Rate (VRR) for Homologous and Heterologous MN Antibodies Against Each of the 3 Vaccine Influenza Strains. | Flu A/Vietnam/1194/2004 H5N1 MN, Day 385 | 25 Participants |
| H5N1 Formulation 5 Group | Vaccine Response Rate (VRR) for Homologous and Heterologous MN Antibodies Against Each of the 3 Vaccine Influenza Strains. | Flu A/Vietnam/1194/2004 H5N1 MN, D 392 | 6 Participants |
| H5N1 Formulation 5 Group | Vaccine Response Rate (VRR) for Homologous and Heterologous MN Antibodies Against Each of the 3 Vaccine Influenza Strains. | Flu A/Indonesia/5/2005 H5N1 MN, Day 385 | 32 Participants |
| H5N1 Formulation 5 Group | Vaccine Response Rate (VRR) for Homologous and Heterologous MN Antibodies Against Each of the 3 Vaccine Influenza Strains. | Flu A/Indonesia/5/2005 H5N1 MN, D 392 | 13 Participants |
| H5N1 Formulation 5 Group | Vaccine Response Rate (VRR) for Homologous and Heterologous MN Antibodies Against Each of the 3 Vaccine Influenza Strains. | Flu A/duck/Bangladesh/19097/2013 H5N1 MN, D 392 | 9 Participants |
| H5N1 Formulation 5 Group | Vaccine Response Rate (VRR) for Homologous and Heterologous MN Antibodies Against Each of the 3 Vaccine Influenza Strains. | Flu A/Vietnam/1194/2004 H5N1 MN, Day 42 | 32 Participants |
| H5N1 Formulation 5 Group | Vaccine Response Rate (VRR) for Homologous and Heterologous MN Antibodies Against Each of the 3 Vaccine Influenza Strains. | Flu A/duck/Bangladesh/19097/2013 H5N1 MN, Day 42 | 32 Participants |
| H5N1 Formulation 5 Group | Vaccine Response Rate (VRR) for Homologous and Heterologous MN Antibodies Against Each of the 3 Vaccine Influenza Strains. | Flu A/Vietnam/1194/2004 H5N1 MN, Day 392 | 30 Participants |
| H5N1 Formulation 5 Group | Vaccine Response Rate (VRR) for Homologous and Heterologous MN Antibodies Against Each of the 3 Vaccine Influenza Strains. | Flu A/Indonesia/5/2005 H5N1 MN, Day 392 | 32 Participants |
| H5N1 Formulation 5 Group | Vaccine Response Rate (VRR) for Homologous and Heterologous MN Antibodies Against Each of the 3 Vaccine Influenza Strains. | Flu A/duck/Bangladesh/19097/2013 H5N1 MN, Day 392 | 30 Participants |