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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Influenza

Treatments: Biological: V512; Biological: Comparator: Placebo to V512

Study type: Interventional

Funder types: Industry

Identifiers

NCT00851266

V512-002

2009_550

Details and patient eligibility

About

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.

Enrollment: 187 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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187 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

V512

Treatment:

Biological: V512

2

Placebo Comparator group

Description:

Placebo to V512

Treatment:

Biological: Comparator: Placebo to V512