Influenza A Subtype H5N1 Infection
Conditions
Keywords
Influenza, Avian, H5N1, Vaccine
Brief summary
This is a first-in-human study of safety and immunogenicity of an A/H5N1 inactivated whole cell vaccine when given in two injections in two doses (low and high) compared to a placebo in 76 healthy adult subjects in Vietnam. Vaccine and placebo are manufactured by the IVAC in Vietnam.
Detailed description
This is a phase 1, double blinded, randomized, placebo-controlled study. Seventy-six healthy male and female adults, 18 to 30 years of age, will be enrolled into the trial. Subjects will be randomized to one of three treatment allocations: 32 subjects to 7.5 mcg/dose vaccine (low dose), 32 subjects to 15 mcg/dose vaccine (high dose) and 12 subjects to placebo. This sample size was selected to enable at least 30 evaluable subjects in each of the groups receiving active vaccine. The study will utilize a block randomization to assure a balance of 8:8:3 vaccine and placebo when all subjects are enrolled. The study will be double blinded, meaning the study subjects, investigators, and the sponsor will be unaware of the treatment allocated to each subject until the clinical trial database is declared final and locked. Since this is a first-in-human study, all injections of study product will be sequential and staggered and there will be a safety evaluation between a sentinel cohort of 19 subjects and the remaining 57 study subjects for both the 1st and 2nd doses in the study. A sentinel group of 19 participants' enrollment and vaccination will precede the remainder of the study group by approximately 2-3 weeks. Product administration for both injections of vaccine or placebo will be sequential and staggered.
Interventions
BIOLOGICALIVACFLU-A/H5N1, 7.5 mcg
Contains 7.5 mcg HA and 0.6 mg of aluminum hydroxide adjuvant per 0.5 mL dose.
BIOLOGICALIVACFLU-A/H5N1, 15 mcg
Contains 15 mcg HA and 0.6 mg of aluminum hydroxide adjuvant per 0.5 mL dose
OTHERPlacebo Comparator
PBS, pH 7.2 in 0.5 mL single-dose vials.
Sponsors
Department of Health and Human Services
World Health Organization
Institut Pasteur
PATH
Institute of Vaccines and Medical Biologicals, Vietnam
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female adult 18 through 30 years of age at the enrollment visit. * Literate and willing to provide written informed consent. * Healthy adults, as established by the medical history and screening evaluations, including physical examination. * Capable and willing to complete diary cards and willing to return for all follow-up visits. * For females, willing to utilize reliable birth control measures (intrauterine device, hormonal contraception, condoms) through the Day 42 visit
Exclusion criteria
* Participation in another clinical trial involving any therapy within the previous three months or planned enrollment in such a trial during the period of this study. * Receipt of any non-study vaccine within four weeks prior to enrollment or refusal to postpone receipt of such vaccines until after the Day 42 visit. * Current or recent (within two weeks of enrollment) acute illness with or without fever. * Receipt of immune globulin or other blood products within three months prior to study enrollment or planned receipt of such products prior to the Day 42 visit. * Chronic administration (defined as more than 14 consecutively-prescribed days) of immunosuppressants or other immune-modulating therapy within six months prior to study enrollment. (For corticosteroids, this means prednisone or equivalent, ≥ 0.5 mg per kg per day; topical steroids are allowed.) * History of asthma. * Hypersensitivity after previous administration of any vaccine. * Other AE following immunization, at least possibly related to previous receipt of any vaccine. * Suspected or known hypersensitivity to any of the study vaccine components, including chicken or egg protein. * Known hypersensitivities (allergies) to food or the natural environment. * Acute or chronic clinically significant pulmonary, cardiovascular, hepatobiliary, metabolic, neurologic, psychiatric or renal functional abnormality, as determined by medical history, physical examination or clinical laboratory screening tests, which in the opinion of the investigator, might interfere with the study objectives. * History of any blood or solid organ cancer. * History of thrombocytopenic purpura or known bleeding disorder. * History of seizures. * Known or suspected immunosuppressed or immunodeficient condition of any kind. * Known chronic HBV or HCV infection. * Known active tuberculosis or symptoms of active tuberculosis, regardless of cause. * History of chronic alcohol abuse and/or illegal drug use. * Pregnancy or lactation. (A negative pregnancy test will be required before administration of study product for all women of childbearing potential.) * History of Guillain-Barré Syndrome * Any condition that, in the opinion of the investigator, would increase the health risk to the subject if he/she participates in the study or would interfere with the evaluation of the study objectives.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All Serious Adverse Events (SAEs) Occurring Within 3 Weeks of Receipt of Any Dose | Within 3 weeks of any injection | Summary data. Data presented are after 1st and 2nd injections combined. Please see AE reporting section of this report for full details. |
| Immediate Reactions Occurring Within 60 Minutes of Administration of Any Dose | 60 min post injection | Data presented are after 1st and 2nd vaccination combined. All participants were observed for immediate reactions for 60 minutes after administration of study product, with appropriate medical treatment readily available in case of an anaphylactic reaction following the administration of study product. |
| Number of Participants With at Least One Solicted Reactogenicity After Both Injections | Within 7 days after injection | Data presented are after 1st and 2nd vaccination combined. Solicted reactogenicity are local and systemic events that are expected after injection and specifically asked of the participant. Only reported reactogenicity is presented. If not shown, then no participant reported that reaction in any study group. Local reactions are redness, swelling, pain, tenderness, and hardness. Systemic reactions are actual and subjective fever, chills, cough, difficulty breathing, runny nose, nasal congestion, sore throat, hoarseness of voice, headache, confusion. convulsions/seizures, fatigue/malaise, muscle aches (generalized), joint pain, pink or red eyes, sore eyes, itchy eyes, drainage from eyes. ear pain or discharge, rash, abdominal pain, diarrhea, vomiting, and jaundice. |
| Number of Participants With at Least One Unsolicited AE | Within 7 weeks of injection | Summary of number of participants with at least one unsolicited AE after 1st and 2nd vaccination combined. Please see the adverse event section of this report for full details. |
Secondary
| Measure | Time frame |
|---|---|
| The Proportion of Subjects Achieving a Hemagglutination Inhibition (HAI) Titer ≥ 1:40 Pre-vaccination (Day 0) to Post 2nd Vaccination (Day 49) | Day 0 to Day 49 |
| The Proportion of Subjects Achieving a Four-fold Rise in HAI Between Doses or From Baseline to Post-Injection 2 | Days 21 and 42 |
| Geometric Mean Titer (GMT) of Hemagglutination Inhibition After Each Dose | Days 0, 21 and 42 |
| Geometric Mean Titer (GMT) of Neutralizing Antibody After Each Dose | Days 0, 21, and 42 |
Countries
Vietnam
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| IVACFLU-A/H5N1, 7.5 mcg IVACFLU-A/H5N1, 7.5 mcg HA per dose, given by intramuscular (IM) injection at Day 0 and Day 21. | 31 |
| IVACFLU-A/H5N1, 15 mcg IVACFLU-A/H5N1, 15 mcg HA per dose, given IM at Day 0 and Day 21. | 32 |
| Placebo phosphate buffered saline, given IM at Day 0 and Day 21. | 12 |
| Total | 75 |
Baseline characteristics
| Characteristic | Total | IVACFLU-A/H5N1, 7.5 mcg | IVACFLU-A/H5N1, 15 mcg | Placebo |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 75 Participants | 31 Participants | 32 Participants | 12 Participants |
| Age, Continuous | 23.6 years | 23.7 years | 23.5 years | 23.7 years |
| Race/Ethnicity, Customized Asian | 75 Participants | 31 Participants | 32 Participants | 12 Participants |
| Race/Ethnicity, Customized Hoa | 0 participants | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Khmer | 0 participants | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Kinh | 75 participants | 31 participants | 32 participants | 12 participants |
| Race/Ethnicity, Customized Other | 0 participants | 0 participants | 0 participants | 0 participants |
| Region of Enrollment Vietnam | 75 participants | 31 participants | 32 participants | 12 participants |
| Sex: Female, Male Female | 31 Participants | 11 Participants | 13 Participants | 7 Participants |
| Sex: Female, Male Male | 44 Participants | 20 Participants | 19 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 32 | 0 / 12 |
| other Total, other adverse events | 12 / 31 | 12 / 32 | 4 / 12 |
| serious Total, serious adverse events | 0 / 31 | 0 / 32 | 0 / 12 |
Outcome results
Primary
All Serious Adverse Events (SAEs) Occurring Within 3 Weeks of Receipt of Any Dose
Summary data. Data presented are after 1st and 2nd injections combined. Please see AE reporting section of this report for full details.
Time frame: Within 3 weeks of any injection
Population: Table 14.2.2.3.1 Summary of Serious Unsolicited Adverse Events by System Organ Class and Preferred Term (After 1st and 2nd Vaccination Combined) Intention-to-Treat Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IVACFLU-A/H5N1, 7.5 mcg | All Serious Adverse Events (SAEs) Occurring Within 3 Weeks of Receipt of Any Dose | 0 Participants |
| IVACFLU-A/H5N1, 15 mcg | All Serious Adverse Events (SAEs) Occurring Within 3 Weeks of Receipt of Any Dose | 0 Participants |
| Combined Vaccine | All Serious Adverse Events (SAEs) Occurring Within 3 Weeks of Receipt of Any Dose | 0 Participants |
Primary
Immediate Reactions Occurring Within 60 Minutes of Administration of Any Dose
Data presented are after 1st and 2nd vaccination combined. All participants were observed for immediate reactions for 60 minutes after administration of study product, with appropriate medical treatment readily available in case of an anaphylactic reaction following the administration of study product.
Time frame: 60 min post injection
Population: Intent to treat population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IVACFLU-A/H5N1, 7.5 mcg | Immediate Reactions Occurring Within 60 Minutes of Administration of Any Dose | 0 Participants |
| IVACFLU-A/H5N1, 15 mcg | Immediate Reactions Occurring Within 60 Minutes of Administration of Any Dose | 0 Participants |
| Combined Vaccine | Immediate Reactions Occurring Within 60 Minutes of Administration of Any Dose | 0 Participants |
| Placebo | Immediate Reactions Occurring Within 60 Minutes of Administration of Any Dose | 0 Participants |
Primary
Number of Participants With at Least One Solicted Reactogenicity After Both Injections
Data presented are after 1st and 2nd vaccination combined. Solicted reactogenicity are local and systemic events that are expected after injection and specifically asked of the participant. Only reported reactogenicity is presented. If not shown, then no participant reported that reaction in any study group. Local reactions are redness, swelling, pain, tenderness, and hardness. Systemic reactions are actual and subjective fever, chills, cough, difficulty breathing, runny nose, nasal congestion, sore throat, hoarseness of voice, headache, confusion. convulsions/seizures, fatigue/malaise, muscle aches (generalized), joint pain, pink or red eyes, sore eyes, itchy eyes, drainage from eyes. ear pain or discharge, rash, abdominal pain, diarrhea, vomiting, and jaundice.
Time frame: Within 7 days after injection
Population: Participants who were randomized and received study injections
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| IVACFLU-A/H5N1, 7.5 mcg | Number of Participants With at Least One Solicted Reactogenicity After Both Injections | Systemic reactogenicity--Fatigue/Malaise | 3 Participants |
| IVACFLU-A/H5N1, 7.5 mcg | Number of Participants With at Least One Solicted Reactogenicity After Both Injections | Systemic reactogenicity--Abdominal pain | 1 Participants |
| IVACFLU-A/H5N1, 7.5 mcg | Number of Participants With at Least One Solicted Reactogenicity After Both Injections | Systemic reactogenicity--Ear pain/discharge | 0 Participants |
| IVACFLU-A/H5N1, 7.5 mcg | Number of Participants With at Least One Solicted Reactogenicity After Both Injections | Subjects with at least one local solicted AE | 25 Participants |
| IVACFLU-A/H5N1, 7.5 mcg | Number of Participants With at Least One Solicted Reactogenicity After Both Injections | Systemic reactogenicity--Fever | 0 Participants |
| IVACFLU-A/H5N1, 7.5 mcg | Number of Participants With at Least One Solicted Reactogenicity After Both Injections | Systemic reactogenicity--Chills | 1 Participants |
| IVACFLU-A/H5N1, 7.5 mcg | Number of Participants With at Least One Solicted Reactogenicity After Both Injections | Local reactions--Pain | 18 Participants |
| IVACFLU-A/H5N1, 7.5 mcg | Number of Participants With at Least One Solicted Reactogenicity After Both Injections | Subjects with at least one systemic solicited AE | 13 Participants |
| IVACFLU-A/H5N1, 7.5 mcg | Number of Participants With at Least One Solicted Reactogenicity After Both Injections | Local reactions--Tenderness | 21 Participants |
| IVACFLU-A/H5N1, 7.5 mcg | Number of Participants With at Least One Solicted Reactogenicity After Both Injections | Systemic reactogenicity--Cough | 3 Participants |
| IVACFLU-A/H5N1, 7.5 mcg | Number of Participants With at Least One Solicted Reactogenicity After Both Injections | Systemic reactogenicity--Sore eyes | 1 Participants |
| IVACFLU-A/H5N1, 7.5 mcg | Number of Participants With at Least One Solicted Reactogenicity After Both Injections | Subjects with at least one solicted AE | 26 Participants |
| IVACFLU-A/H5N1, 7.5 mcg | Number of Participants With at Least One Solicted Reactogenicity After Both Injections | Systemic reactogenicity--Sore throat | 2 Participants |
| IVACFLU-A/H5N1, 7.5 mcg | Number of Participants With at Least One Solicted Reactogenicity After Both Injections | Systemic reactogenicity--Diarrhea | 0 Participants |
| IVACFLU-A/H5N1, 15 mcg | Number of Participants With at Least One Solicted Reactogenicity After Both Injections | Subjects with at least one local solicted AE | 24 Participants |
| IVACFLU-A/H5N1, 15 mcg | Number of Participants With at Least One Solicted Reactogenicity After Both Injections | Systemic reactogenicity--Sore eyes | 0 Participants |
| IVACFLU-A/H5N1, 15 mcg | Number of Participants With at Least One Solicted Reactogenicity After Both Injections | Systemic reactogenicity--Ear pain/discharge | 1 Participants |
| IVACFLU-A/H5N1, 15 mcg | Number of Participants With at Least One Solicted Reactogenicity After Both Injections | Local reactions--Pain | 16 Participants |
| IVACFLU-A/H5N1, 15 mcg | Number of Participants With at Least One Solicted Reactogenicity After Both Injections | Systemic reactogenicity--Fever | 3 Participants |
| IVACFLU-A/H5N1, 15 mcg | Number of Participants With at Least One Solicted Reactogenicity After Both Injections | Systemic reactogenicity--Fatigue/Malaise | 5 Participants |
| IVACFLU-A/H5N1, 15 mcg | Number of Participants With at Least One Solicted Reactogenicity After Both Injections | Subjects with at least one systemic solicited AE | 14 Participants |
| IVACFLU-A/H5N1, 15 mcg | Number of Participants With at Least One Solicted Reactogenicity After Both Injections | Systemic reactogenicity--Diarrhea | 1 Participants |
| IVACFLU-A/H5N1, 15 mcg | Number of Participants With at Least One Solicted Reactogenicity After Both Injections | Systemic reactogenicity--Abdominal pain | 0 Participants |
| IVACFLU-A/H5N1, 15 mcg | Number of Participants With at Least One Solicted Reactogenicity After Both Injections | Local reactions--Tenderness | 23 Participants |
| IVACFLU-A/H5N1, 15 mcg | Number of Participants With at Least One Solicted Reactogenicity After Both Injections | Subjects with at least one solicted AE | 26 Participants |
| IVACFLU-A/H5N1, 15 mcg | Number of Participants With at Least One Solicted Reactogenicity After Both Injections | Systemic reactogenicity--Chills | 3 Participants |
| IVACFLU-A/H5N1, 15 mcg | Number of Participants With at Least One Solicted Reactogenicity After Both Injections | Systemic reactogenicity--Sore throat | 2 Participants |
| IVACFLU-A/H5N1, 15 mcg | Number of Participants With at Least One Solicted Reactogenicity After Both Injections | Systemic reactogenicity--Cough | 2 Participants |
| Combined Vaccine | Number of Participants With at Least One Solicted Reactogenicity After Both Injections | Subjects with at least one systemic solicited AE | 27 Participants |
| Combined Vaccine | Number of Participants With at Least One Solicted Reactogenicity After Both Injections | Subjects with at least one solicted AE | 52 Participants |
| Combined Vaccine | Number of Participants With at Least One Solicted Reactogenicity After Both Injections | Subjects with at least one local solicted AE | 49 Participants |
| Combined Vaccine | Number of Participants With at Least One Solicted Reactogenicity After Both Injections | Local reactions--Pain | 34 Participants |
| Combined Vaccine | Number of Participants With at Least One Solicted Reactogenicity After Both Injections | Local reactions--Tenderness | 44 Participants |
| Combined Vaccine | Number of Participants With at Least One Solicted Reactogenicity After Both Injections | Systemic reactogenicity--Abdominal pain | 1 Participants |
| Combined Vaccine | Number of Participants With at Least One Solicted Reactogenicity After Both Injections | Systemic reactogenicity--Chills | 4 Participants |
| Combined Vaccine | Number of Participants With at Least One Solicted Reactogenicity After Both Injections | Systemic reactogenicity--Cough | 5 Participants |
| Combined Vaccine | Number of Participants With at Least One Solicted Reactogenicity After Both Injections | Systemic reactogenicity--Diarrhea | 1 Participants |
| Combined Vaccine | Number of Participants With at Least One Solicted Reactogenicity After Both Injections | Systemic reactogenicity--Ear pain/discharge | 1 Participants |
| Combined Vaccine | Number of Participants With at Least One Solicted Reactogenicity After Both Injections | Systemic reactogenicity--Fatigue/Malaise | 8 Participants |
| Combined Vaccine | Number of Participants With at Least One Solicted Reactogenicity After Both Injections | Systemic reactogenicity--Fever | 3 Participants |
| Combined Vaccine | Number of Participants With at Least One Solicted Reactogenicity After Both Injections | Systemic reactogenicity--Sore eyes | 1 Participants |
| Combined Vaccine | Number of Participants With at Least One Solicted Reactogenicity After Both Injections | Systemic reactogenicity--Sore throat | 4 Participants |
| Placebo | Number of Participants With at Least One Solicted Reactogenicity After Both Injections | Systemic reactogenicity--Fever | 0 Participants |
| Placebo | Number of Participants With at Least One Solicted Reactogenicity After Both Injections | Systemic reactogenicity--Diarrhea | 0 Participants |
| Placebo | Number of Participants With at Least One Solicted Reactogenicity After Both Injections | Subjects with at least one solicted AE | 4 Participants |
| Placebo | Number of Participants With at Least One Solicted Reactogenicity After Both Injections | Systemic reactogenicity--Cough | 2 Participants |
| Placebo | Number of Participants With at Least One Solicted Reactogenicity After Both Injections | Systemic reactogenicity--Chills | 0 Participants |
| Placebo | Number of Participants With at Least One Solicted Reactogenicity After Both Injections | Systemic reactogenicity--Sore eyes | 0 Participants |
| Placebo | Number of Participants With at Least One Solicted Reactogenicity After Both Injections | Systemic reactogenicity--Sore throat | 2 Participants |
| Placebo | Number of Participants With at Least One Solicted Reactogenicity After Both Injections | Systemic reactogenicity--Abdominal pain | 0 Participants |
| Placebo | Number of Participants With at Least One Solicted Reactogenicity After Both Injections | Local reactions--Tenderness | 3 Participants |
| Placebo | Number of Participants With at Least One Solicted Reactogenicity After Both Injections | Local reactions--Pain | 1 Participants |
| Placebo | Number of Participants With at Least One Solicted Reactogenicity After Both Injections | Subjects with at least one systemic solicited AE | 4 Participants |
| Placebo | Number of Participants With at Least One Solicted Reactogenicity After Both Injections | Systemic reactogenicity--Fatigue/Malaise | 2 Participants |
| Placebo | Number of Participants With at Least One Solicted Reactogenicity After Both Injections | Systemic reactogenicity--Ear pain/discharge | 0 Participants |
| Placebo | Number of Participants With at Least One Solicted Reactogenicity After Both Injections | Subjects with at least one local solicted AE | 3 Participants |
Primary
Number of Participants With at Least One Unsolicited AE
Summary of number of participants with at least one unsolicited AE after 1st and 2nd vaccination combined. Please see the adverse event section of this report for full details.
Time frame: Within 7 weeks of injection
Population: Intent to treat population. Please see more detail in the AE section of this posting.~Table 14.2.1.2.1 Summary of Unsolicited Adverse Events by System Organ Class and Preferred Term (After 1st and 2nd Vaccination Combined) Intention-to-Treat Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IVACFLU-A/H5N1, 7.5 mcg | Number of Participants With at Least One Unsolicited AE | 12 Participants |
| IVACFLU-A/H5N1, 15 mcg | Number of Participants With at Least One Unsolicited AE | 12 Participants |
| Combined Vaccine | Number of Participants With at Least One Unsolicited AE | 4 Participants |
Secondary
Geometric Mean Titer (GMT) of Hemagglutination Inhibition After Each Dose
Time frame: Days 0, 21 and 42
Population: Per-protocol analysis set--The Per-Protocol Analysis Set (PPAS) contained all study subjects who received 2 doses of vaccine or placebo and completed the Day 42 visit without major protocol violations that were determined to potentially interfere with immune response to the study vaccine.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| IVACFLU-A/H5N1, 7.5 mcg | Geometric Mean Titer (GMT) of Hemagglutination Inhibition After Each Dose | Day 0 | 5.00 Titers |
| IVACFLU-A/H5N1, 7.5 mcg | Geometric Mean Titer (GMT) of Hemagglutination Inhibition After Each Dose | Post vaccination #2 | 24.5 Titers |
| IVACFLU-A/H5N1, 7.5 mcg | Geometric Mean Titer (GMT) of Hemagglutination Inhibition After Each Dose | Post vaccination #1 | 12.8 Titers |
| IVACFLU-A/H5N1, 15 mcg | Geometric Mean Titer (GMT) of Hemagglutination Inhibition After Each Dose | Day 0 | 5.00 Titers |
| IVACFLU-A/H5N1, 15 mcg | Geometric Mean Titer (GMT) of Hemagglutination Inhibition After Each Dose | Post vaccination #2 | 27.1 Titers |
| IVACFLU-A/H5N1, 15 mcg | Geometric Mean Titer (GMT) of Hemagglutination Inhibition After Each Dose | Post vaccination #1 | 11.9 Titers |
| Combined Vaccine | Geometric Mean Titer (GMT) of Hemagglutination Inhibition After Each Dose | Post vaccination #1 | 12.3 Titers |
| Combined Vaccine | Geometric Mean Titer (GMT) of Hemagglutination Inhibition After Each Dose | Day 0 | 5.00 Titers |
| Combined Vaccine | Geometric Mean Titer (GMT) of Hemagglutination Inhibition After Each Dose | Post vaccination #2 | 25.8 Titers |
| Placebo | Geometric Mean Titer (GMT) of Hemagglutination Inhibition After Each Dose | Day 0 | 5.00 Titers |
| Placebo | Geometric Mean Titer (GMT) of Hemagglutination Inhibition After Each Dose | Post vaccination #2 | 5.00 Titers |
| Placebo | Geometric Mean Titer (GMT) of Hemagglutination Inhibition After Each Dose | Post vaccination #1 | 5.00 Titers |
Secondary
Geometric Mean Titer (GMT) of Neutralizing Antibody After Each Dose
Time frame: Days 0, 21, and 42
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| IVACFLU-A/H5N1, 7.5 mcg | Geometric Mean Titer (GMT) of Neutralizing Antibody After Each Dose | Day 0 | 5.00 Titers |
| IVACFLU-A/H5N1, 7.5 mcg | Geometric Mean Titer (GMT) of Neutralizing Antibody After Each Dose | Post vaccination #2 | 21.9 Titers |
| IVACFLU-A/H5N1, 7.5 mcg | Geometric Mean Titer (GMT) of Neutralizing Antibody After Each Dose | Post vaccination #1 | 9.4 Titers |
| IVACFLU-A/H5N1, 15 mcg | Geometric Mean Titer (GMT) of Neutralizing Antibody After Each Dose | Day 0 | 5.00 Titers |
| IVACFLU-A/H5N1, 15 mcg | Geometric Mean Titer (GMT) of Neutralizing Antibody After Each Dose | Post vaccination #2 | 23.3 Titers |
| IVACFLU-A/H5N1, 15 mcg | Geometric Mean Titer (GMT) of Neutralizing Antibody After Each Dose | Post vaccination #1 | 9.4 Titers |
| Combined Vaccine | Geometric Mean Titer (GMT) of Neutralizing Antibody After Each Dose | Post vaccination #1 | 9.4 Titers |
| Combined Vaccine | Geometric Mean Titer (GMT) of Neutralizing Antibody After Each Dose | Day 0 | 5.00 Titers |
| Combined Vaccine | Geometric Mean Titer (GMT) of Neutralizing Antibody After Each Dose | Post vaccination #2 | 22.6 Titers |
| Placebo | Geometric Mean Titer (GMT) of Neutralizing Antibody After Each Dose | Day 0 | 5.00 Titers |
| Placebo | Geometric Mean Titer (GMT) of Neutralizing Antibody After Each Dose | Post vaccination #2 | 5.00 Titers |
| Placebo | Geometric Mean Titer (GMT) of Neutralizing Antibody After Each Dose | Post vaccination #1 | 5.00 Titers |
Secondary
The Proportion of Subjects Achieving a Four-fold Rise in HAI Between Doses or From Baseline to Post-Injection 2
Time frame: Days 21 and 42
Population: Per-protocol analysis set--The Per-Protocol Analysis Set (PPAS) contained all study subjects who received 2 doses of vaccine or placebo and completed the Day 42 visit without major protocol violations that were determined to potentially interfere with immune response to the study vaccine.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| IVACFLU-A/H5N1, 7.5 mcg | The Proportion of Subjects Achieving a Four-fold Rise in HAI Between Doses or From Baseline to Post-Injection 2 | From post 1st- to post 2nd vaccination | 9 Participants |
| IVACFLU-A/H5N1, 7.5 mcg | The Proportion of Subjects Achieving a Four-fold Rise in HAI Between Doses or From Baseline to Post-Injection 2 | Baseline to 2nd vaccination | 21 Participants |
| IVACFLU-A/H5N1, 7.5 mcg | The Proportion of Subjects Achieving a Four-fold Rise in HAI Between Doses or From Baseline to Post-Injection 2 | Baseline to post 1st vaccination | 11 Participants |
| IVACFLU-A/H5N1, 15 mcg | The Proportion of Subjects Achieving a Four-fold Rise in HAI Between Doses or From Baseline to Post-Injection 2 | Baseline to post 1st vaccination | 12 Participants |
| IVACFLU-A/H5N1, 15 mcg | The Proportion of Subjects Achieving a Four-fold Rise in HAI Between Doses or From Baseline to Post-Injection 2 | Baseline to 2nd vaccination | 23 Participants |
| IVACFLU-A/H5N1, 15 mcg | The Proportion of Subjects Achieving a Four-fold Rise in HAI Between Doses or From Baseline to Post-Injection 2 | From post 1st- to post 2nd vaccination | 11 Participants |
| Combined Vaccine | The Proportion of Subjects Achieving a Four-fold Rise in HAI Between Doses or From Baseline to Post-Injection 2 | From post 1st- to post 2nd vaccination | 20 Participants |
| Combined Vaccine | The Proportion of Subjects Achieving a Four-fold Rise in HAI Between Doses or From Baseline to Post-Injection 2 | Baseline to 2nd vaccination | 44 Participants |
| Combined Vaccine | The Proportion of Subjects Achieving a Four-fold Rise in HAI Between Doses or From Baseline to Post-Injection 2 | Baseline to post 1st vaccination | 23 Participants |
| Placebo | The Proportion of Subjects Achieving a Four-fold Rise in HAI Between Doses or From Baseline to Post-Injection 2 | Baseline to post 1st vaccination | 0 Participants |
| Placebo | The Proportion of Subjects Achieving a Four-fold Rise in HAI Between Doses or From Baseline to Post-Injection 2 | Baseline to 2nd vaccination | 0 Participants |
| Placebo | The Proportion of Subjects Achieving a Four-fold Rise in HAI Between Doses or From Baseline to Post-Injection 2 | From post 1st- to post 2nd vaccination | 0 Participants |
Secondary
The Proportion of Subjects Achieving a Hemagglutination Inhibition (HAI) Titer ≥ 1:40 Pre-vaccination (Day 0) to Post 2nd Vaccination (Day 49)
Time frame: Day 0 to Day 49
Population: Per-protocol analysis set--The Per-Protocol Analysis Set (PPAS) contained all study subjects who received 2 doses of vaccine or placebo and completed the Day 42 visit without major protocol violations that were determined to potentially interfere with immune response to the study vaccine.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| IVACFLU-A/H5N1, 7.5 mcg | The Proportion of Subjects Achieving a Hemagglutination Inhibition (HAI) Titer ≥ 1:40 Pre-vaccination (Day 0) to Post 2nd Vaccination (Day 49) | Post vaccination #1 | 7 Participants |
| IVACFLU-A/H5N1, 7.5 mcg | The Proportion of Subjects Achieving a Hemagglutination Inhibition (HAI) Titer ≥ 1:40 Pre-vaccination (Day 0) to Post 2nd Vaccination (Day 49) | Post vaccination #2 | 13 Participants |
| IVACFLU-A/H5N1, 15 mcg | The Proportion of Subjects Achieving a Hemagglutination Inhibition (HAI) Titer ≥ 1:40 Pre-vaccination (Day 0) to Post 2nd Vaccination (Day 49) | Post vaccination #2 | 18 Participants |
| IVACFLU-A/H5N1, 15 mcg | The Proportion of Subjects Achieving a Hemagglutination Inhibition (HAI) Titer ≥ 1:40 Pre-vaccination (Day 0) to Post 2nd Vaccination (Day 49) | Post vaccination #1 | 9 Participants |
| Combined Vaccine | The Proportion of Subjects Achieving a Hemagglutination Inhibition (HAI) Titer ≥ 1:40 Pre-vaccination (Day 0) to Post 2nd Vaccination (Day 49) | Post vaccination #1 | 16 Participants |
| Combined Vaccine | The Proportion of Subjects Achieving a Hemagglutination Inhibition (HAI) Titer ≥ 1:40 Pre-vaccination (Day 0) to Post 2nd Vaccination (Day 49) | Post vaccination #2 | 31 Participants |
| Placebo | The Proportion of Subjects Achieving a Hemagglutination Inhibition (HAI) Titer ≥ 1:40 Pre-vaccination (Day 0) to Post 2nd Vaccination (Day 49) | Post vaccination #1 | 0 Participants |
| Placebo | The Proportion of Subjects Achieving a Hemagglutination Inhibition (HAI) Titer ≥ 1:40 Pre-vaccination (Day 0) to Post 2nd Vaccination (Day 49) | Post vaccination #2 | 0 Participants |