A Study of a Bivalent Influenza Peptide Conjugate Vaccine in Healthy Adults
Phase 1
Completed
- Conditions
- Influenza
- Interventions
- Biological: V512
- Registration Number
- NCT00851266
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
This is a first in man study evaluating the tolerability and immunogenicity of BIPCV/IMX (V512) at increasing concentrations of influenza viral peptides A/M2+B/HA0 peptides and IMX, a saponin-based adjuvant.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 187
Inclusion Criteria
- Subject is in good physical health
- Subject is not in the category of individuals recommended by the CDC to receive influenza vaccine for the upcoming 2 influenza seasons
- Subject agrees not to seek vaccination with licensed influenza vaccines during the study
- Female subjects agree to use acceptable birth control for 6 weeks prior to first dose of vaccine until 1 month post Dose 3
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Exclusion Criteria
- Subject has a history of allergic reaction to the vaccine components
- Subject has has a fever within 3 days of screening
- Subject had a vaccination with an inactive virus within 14 days of Dose 1
- Subject had a vaccination with a live virus within 30 days of Dose 1
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 V512 V512
- Primary Outcome Measures
Name Time Method Safety: Safety and tolerability of BIPCV/IMX as assessed by vaccine-related SAEs; Immunogenicity: 1) A/M2 specific immunogenicity; 2) B/HA0 specific immunogenicity Safety: 7 months; Immunogenicity: 1) 7 months; 2) 7 months
- Secondary Outcome Measures
Name Time Method Persistence of A/M2 and B/HA0 immunogenicity Months 12, 18, and 24