NCT01053143

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

Bridging Study on Safety and Immunogenicity of an Intramuscular Inactivated, Split Virion Swine-Origin A/H1N1 Influenza Non-Adjuvanted Vaccine in Healthy Adults in India

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

Each study participant will receive one dose of the study vaccine on Day 0, provide pre- and post-vaccination blood samples at 21 and 180 days for immunogenicity testing and undergo safety follow-up for 6 months post-vaccination.

Conditions

• Influenza
• Pandemic Influenza
• Influenza A Virus, H1N1 Subtype

Interventions

Type	Name	Description
BIOLOGICAL	A/H1N1 pandemic influenza vaccine (non- adjuvanted)	0.5 mL, Intramuscular

Timeline

• Start date: 2010-01-01
• Primary completion: 2010-08-01
• Completion: 2010-09-01
• First posted: 2010-01-21
• Last updated: 2014-01-14

Locations

3 sites across 1 country: India