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Safety and Immunogenicity of an Intramuscular Pandemic Influenza Vaccine in Adults and the Elderly

2014-08-27 03:40:59 | BioPortfolio

Summary

Based on the results from a previous formulation/dosage ranging trial, this phase II multicenter, open trial was designed to determine the safety and immunogenicity of two vaccine formulation/dosages with and without adjuvant 21 days after each vaccination in adults (18 to 60 years and in the elderly (> 60 years) as required by the European Medicines Agency (EMEA) guideline. The antibody persistence until the booster vaccination at 6 or 12 months will also be evaluated.

Study Design

Allocation: Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Conditions

Influenza

Intervention

A/H5N1 inactivated, split-virion influenza virus, A/H5N1 inactivated, split-virion influenza virus

Location

Ghent
Belgium

Status

Completed

Source

Sanofi-Aventis

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:40:59-0400

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