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A Study of the Immunogenicity of Swine-origin A/H1N1 Influenza Vaccine in Healthy Adults

2014-08-27 03:15:05 | BioPortfolio

Summary

This study is designed to describe the immunogenicity of a pandemic A/H1N1 influenza vaccine in healthy adults given a lower vaccine dose and in a similar group given a full dose of the vaccine.

The primary objective is to describe describe the immune response of the inactivated, split-virion swine-origin A/H1N1 influenza vaccine without adjuvant.

Description

All participants will receive a single dose of study vaccine and will also be monitored for serious adverse events and adverse events of special interest occurring from Days 0 to 21 and at 6 months post-vaccination.

Study Design

Allocation: Randomized, Control: Dose Comparison, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Conditions

Influenza

Intervention

Swine A/H1N1 influenza vaccine (split virion, inactivated), Swine A/H1N1 influenza vaccine (split virion, inactivated)

Location

Rennes
France
35000

Status

Active, not recruiting

Source

Sanofi-Aventis

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:05-0400

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