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Phase 3 Trial of Serbian Seasonal Influenza Vaccine

2016-10-18 02:08:21 | BioPortfolio

Summary

A Phase 3, double-blind, randomized, placebo-controlled trial of a seasonal, trivalent, split, inactivated influenza vaccine produced by Torlak.

Description

This is a phase 3, double-blind, randomized, placebo- controlled trial with two groups of participants to receive seasonal trivalent split, inactivated influenza vaccine (A/H1N1; A/H3N2 and B) or placebo (phosphate buffered saline). A total of about 480 healthy male and female adults 18 through 65 years of age; 320 participants will be randomized to receive vaccine and160 will receive placebo (a 2:1 ratio). At least 25% of the participants (N=120) will be >/= 45 years of age (80 vaccine and 40 placebo recipients).

Safety will be assessed in all participants through Day 91. Immunogenicity will be assessed in serum samples obtained at baseline and 21 days after vaccination in a subset of at least 100 individuals randomized to study vaccine and 50 placebo recipients.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Conditions

Influenza

Intervention

vaccine, Phosphate Buffered Saline

Status

Not yet recruiting

Source

Institute of Virology, Vaccines and Sera, Torlak

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-10-18T02:08:21-0400

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