A Study of the Immunogenicity of Swine-origin A/H1N1 Influenza Vaccine in Healthy Adults

Phase 2

Completed

• Conditions: Influenza; Swine-origin A/H1N1 Influenza
• Interventions: Biological: Swine A/H1N1 influenza vaccine (split virion, inactivated)

• Registration Number: NCT01089660
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Brief Summary

This study is designed to describe the immunogenicity of a pandemic A/H1N1 influenza vaccine in healthy adults given a lower vaccine dose and in a similar group given a full dose of the vaccine.

The primary objective is to describe describe the immune response of the inactivated, split-virion swine-origin A/H1N1 influenza vaccine without adjuvant.

Detailed Description

All participants will receive a single dose of study vaccine and will also be monitored for serious adverse events and adverse events of special interest occurring from Days 0 to 21 and at 6 months post-vaccination.

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-03-17
• Study First Submitted QC: 2010-03-17
• Study First Posted: 2010-03-18
• Primary Completion: 2010-09
• Study Completion: 2010-12
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-10
• Last Update Posted: 2014-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 202

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study Group 1	Swine A/H1N1 influenza vaccine (split virion, inactivated)	Swine-origin A/H1N1 Vaccine Low-dose
Study Group 2	Swine A/H1N1 influenza vaccine (split virion, inactivated)	Swine-origin A/H1N1 Vaccine High-dose

Primary Outcome Measures

Name	Time	Method
To provide information concerning the immunogenicity in terms of anti-hemagglutinin (HA) antibody titers against non-adjuvanted pandemic A/H1N1 influenza vaccine.	21 days post-vaccination