Immunogenicity and Safety Study of a Booster Vaccination With a Recombinant H5N1 Influenza HA Vaccine in Primed Adults

Study Overview
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Brief Summary
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The study is designed to assess the immunogenicity and safety of one booster vaccination with 45 μg of a recombinant H5N1 influenza (A/Indonesia/05/2005) HA vaccine in healthy young adults, previously primed with a two-vaccination of 3 different doses of a recombinant H5N1 influenza (A/Vietnam/1203/2004) HA vaccine in a priming study (JPIP501-01a, NCT00980447).

Official Title
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A Multicenter, Open-Label Study to Assess the Immunogenicity and Safety of a Booster Vaccination With a Recombinant H5N1 Influenza HA Vaccine in Healthy Young Adults Primed With a Two-Vaccination of a Recombinant H5N1 Influenza HA Vaccine

Conditions
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Influenza

Intervention / Treatment
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* Biological: Recombinant Influenza HA Vaccine (H5N1)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who completed a priming study (JPIP501-01a, NCT00980447) Male and female healthy adults Written informed consent obtained from the subject before study entry Exclusion Criteria: History of H5N1 influenza or vaccination of other H5N1 influenza vaccines Clinically diagnosed cardiovascular, hematological, psychological, neurological, hepatic, renal, pulmonary (including asthma), endocrinological or gastrointestinal disorder Confirmed immune deficiency conditions, or diagnosed autoimmune diseases such as rheumatoid arthritis and systemic lupus erythematosus Severe allergic reactions or anaphylaxis to foods or drugs (including vaccines) Treatment with disallowed drugs including other study drugs Pregnant or nursing (lactating) women Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 41 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Recombinant Influenza HA Vaccine (H5N1)|one booster dose of 45 μg rHA derived from A/Indonesia/05/2005 strain|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects achieving seroconversion 21 days after a booster vaccination, as measured by hemagglutination inhibition (HI) assay against H5N1 influenza viruses (A/Indonesia/05/2005 & A/Vietnam/1203/2004) |  | Day 21 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects achieving seroprotection or significant increase in antibody titer on each blood sampling days after a booster vaccination, as measured by HI and microneutralization assays against the H5N1 influenza viruses |  | Days 7, 21 | 
| Incidence of adverse events including solicited local or systemic reactions until 21 days after a booster vaccination |  | 21 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Avian influenza, H5N1, pandemic, recombinant HA vaccine