A Study of Swine-origin A/H1N1 Influenza Vaccines in Healthy European Adults and the Elderly

Phase 2

Completed

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

• Registration Number: NCT00954798
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Brief Summary

The purpose of this study is to generate data on immunogenicity and safety of the monovalent H1N1 vaccine in support of the development and registration.

Primary objectives:

* To describe the immune response to study vaccine 21 days after each vaccination.

* To describe the antibody persistence 8 months after the first vaccine administration using hemagglutination inhibition (HAI) method in a randomized subset of adult subjects who received two injections.

* To describe the immune response against the A/H1N1 strain using HAI method 21 days after a vaccination with the 2010-2011 Northern Hemisphere (NH) seasonal trivalent influenza vaccine (TIV) administered 13 months after the first vaccination in a subset subjects who received the A/H1N1 influenza vaccine and in subjects naïve to the swine origin A/H1N1 strain.

* To describe the safety profiles of study vaccines in all participants.

Detailed Description

All participants will receive two injections of their randomized vaccine on Day 0 and Day 21, respectively.

A subset of the participants will receive a third vaccine injection (2010-2011 Northern Hemisphere \[NH\] seasonal trivalent influenza vaccine \[TIV\]) approximately 13 months after the first vaccination; additionally, a subset of participants' naïve to the swine-origin A/H1N1 strain will also receive one vaccine injection of the 2010-2011 NH seasonal TIV.

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-08-03
• Study First Submitted QC: 2009-08-06
• Study First Posted: 2009-08-07
• Primary Completion: 2010-12
• Study Completion: 2011-03
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-10
• Last Update Posted: 2014-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A/H1N1 Vaccine Group 1	Swine A/H1N1 influenza vaccine (split virion, inactivated)	All participants will receive A/H1N1 vaccine formulation 1 at Visits 1 and 2; a subset will receive a trivalent influenza vaccine (TIV) at Month 13.
A/H1N1 Vaccine Group 2	Swine A/H1N1 influenza vaccine (split virion, inactivated)	All participants will receive A/H1N1 vaccine formulation 2 at Visits 1 and 2; a subset will receive a trivalent influenza vaccine (TIV) at Month 13.
A/H1N1 Vaccine Group 3	Swine A/H1N1 influenza vaccine (split virion, inactivated)	Participants will receive A/H1N1 vaccine formulation 3

Primary Outcome Measures

Name	Time	Method
To provide information concerning the immunogenicity of Swine A/H1N1 influenza vaccine	21 days post-vaccination
To provide information concerning the safety in terms of solicited injection site and systemic reactions following vaccination with Swine A/H1N1 influenza vaccine	0 to7 days post-vaccination and entire study duration