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drugset / Trial / NCT01053143

Study of Swine-Origin A/H1N1 Influenza Non-Adjuvanted Vaccine in Healthy Adults in India

NCT01053143 ↗

Phase 3 Completed 100 enrolled Sanofi Pasteur, a Sanofi Company
Non-randomizedSingle-groupOpen-labelPrevention

Summary

The purpose of this study is to assess the safety and immunogenicity of one dose of A/H1N1 non-adjuvanted pandemic vaccine to support registration of the vaccine in India. Primary Objective: * To describe the safety profile (injection site reactions and systemic events) of the vaccine within 21 days following vaccination, and serious adverse events throughout the study in all subjects Secondary Objectives: * To describe the immune response to the vaccine 21 days after vaccination by hemagglutination inhibition (HAI) testing in all subjects * To describe the antibody persistence 6 months after vaccination by HAI testing in all subjects.

Timeline

Start
2010-01
Primary completion
2010-08
Completion
2010-09

Drugs

EvaluationDrugModalityDoseRoute
Subject A/H1N1 pandemic influenza vaccine (non- adjuvanted) Vaccine 0.5 ml Intramuscular

Indications

swine influenza