A Study of Swine-origin A/H1N1 Influenza Vaccines in Healthy Europeans Children Aged 6 to 35 Months

Phase 2

Completed

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

• Registration Number: NCT00956046
• 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 vaccines 21 days after each vaccination in all participants.

* To describe the antibody persistence eight months after the first vaccine administration using hemagglutination inhibition (HAI) method in a subset of participants who received two half-doses of either formulation 1 or 2.

* To describe the immune response against the A/H1N1 strain using the HAI method 21 days after last vaccination with the 2010-2011 NH seasonal Trivalent Influenza Vaccine (TIV) administered 13 months after the first vaccination in a subset of subjects who received two half-doses of either t either formulation 1 or 2 of the A/H1N1 influenza vaccines as primary series.

* To describe the safety profile of each vaccine 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 eligible who received two half-doses of either formulation 1 or 2 will also be proposed to receive the 2010-2011 Northern Hemisphere (NH) seasonal Trivalent Influenza Vaccine (TIV) 13 months after the first vaccination as Follows:

* Subjects less than 36 months at the time of TIV injection will receive two half-doses and additional sampling for immunogenicity assessment (one before the first TIV vaccination and one 21 days after last TIV vaccination).

* Subjects aged more than 36 months at the time of TIV injection will receive a full TIV dose and additional sampling for immunogenicity assessment (one before TIV vaccination and one 21 days after TIV vaccination).

Study Timeline

• Study First Submitted: 2009-08-03
• Study First Submitted QC: 2009-08-10
• Study First Posted: 2009-08-11
• Study Start: 2009-09
• Primary Completion: 2011-01
• Study Completion: 2011-06
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-10
• Last Update Posted: 2014-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 401

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

Primary Outcome Measures

Name	Time	Method
Immunogenicity: To provide information concerning the immunogenicity of Swine A/H1N1 influenza vaccines	21 days post vaccination
Safety: To provide information concerning the safety in terms of solicited injection site and systemic reactions of Swine A/H1N1 influenza vaccines.	0-7 days post-vaccination and entire study duration