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

Phase 3

Completed

• Conditions: Influenza; Pandemic Influenza; Influenza A Virus, H1N1 Subtype
• Interventions: Biological: A/H1N1 pandemic influenza vaccine (non- adjuvanted)

• Registration Number: NCT01053143
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Brief 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.

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-01-19
• Study First Submitted QC: 2010-01-19
• Study First Posted: 2010-01-21
• Primary Completion: 2010-08
• Study Completion: 2010-09
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-10
• Last Update Posted: 2014-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study Group	A/H1N1 pandemic influenza vaccine (non- adjuvanted)	Participants aged 18 years and older at enrollment.

Primary Outcome Measures

Name	Time	Method
To provide information concerning the safety profile in terms of solicited injection site reactions, systemic events, and serious adverse events after administration of A/H1N1 pandemic influenza vaccine.	7 days post-vaccination and entire study duration

Secondary Outcome Measures

Name	Time	Method
To provide information concerning antibody persistence 6 months after vaccination with A/H1N1 pandemic influenza vaccine.	6 months post-vaccination
To provide information concerning the immune response to A/H1N1 pandemic influenza vaccine.	21 days post-vaccination