Influenza Clinical Trial
Official title:
A Phase II, Randomized, Two Stage, Double-Blind, Placebo-Controlled, Safety and Immunogenicity Study of an Intramuscular Influenza Vaccine (Multimeric-001) Injected to Healthy Volunteers
This is a multi-center, randomized, two stage, double-blind, placebo-controlled administration study comprising 200 healthy participants.
This is a Phase II multi-center, randomized, two stage, double-blind, placebo-controlled
study comprising 200 participants. Eligible subjects will be randomized to receive one of
the following administrations (as two single IM injections with an interval of 21 days
between each injection Administration A: Prime twice with Adjuvanted Multimeric-001 500 mcg
- 64 subjects.
Administration B: PBS (Placebo) twice - 32 subjects. Administration C: Adjuvanted PBS
(Placebo)twice - 32 subjects. Participants from administrations A and B will be further
immunized with a 15% dose of commercial seasonal trivalent vaccine for 2011 on day 81.
Administration D: Adjuvanted Multimeric-001 500 mcg coadministered once with 15% of TIV dose
- 24 subjects. Administration E: Adjuvanted Multimeric-001 500 mcg coadministered once with
50% of TIV dose - 24 subjects Administration group F: PBS (Placebo) co-administered once
with 50% of TIV dose - 24 subjects
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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