Status:

COMPLETED

A Study of a Bivalent Influenza Peptide Conjugate Vaccine in Healthy Adults

Lead Sponsor:

Merck Sharp & Dohme LLC

Conditions:

Influenza

Eligibility:

All Genders

18-35 years

Phase:

PHASE1

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 ad...

Eligibility Criteria

Inclusion

  • 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

Exclusion

  • 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

Key Trial Info

Start Date :

October 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 1 2009

Estimated Enrollment :

187 Patients enrolled

Trial Details

Trial ID

NCT00851266

Start Date

October 1 2006

End Date

January 1 2009

Last Update

February 12 2015

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