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

Sanofi Pasteur, a Sanofi Company0 sites100 target enrollmentJanuary 2010

ConditionsInfluenza Pandemic Influenza Influenza A Virus, H1N1 Subtype

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Influenza
Sponsor: Sanofi Pasteur, a Sanofi Company
Enrollment: 100
Primary Endpoint: 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.
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2010

End Date

September 2010

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Sanofi Pasteur, a Sanofi Company

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

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.

Time Frame: 7 days post-vaccination and entire study duration

Secondary Outcomes

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)