NCT00954798

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

Immunogenicity and Safety of Multiple Formulations of an Intramuscular Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine With and Without Adjuvant in Healthy European Adult and Elderly Subjects

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 450 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Influenza
• Swine-origin A/H1N1 Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Swine A/H1N1 influenza vaccine (split virion, inactivated)	0.5 mL, Intramuscular on Day 0 and day 21 (all participants); and 0.5 mL of trivalent influenza vaccine (TIV) at Month 13 (antibody persistence subset)
BIOLOGICAL	Swine A/H1N1 influenza vaccine (split virion, inactivated)	0.5 mL, Intramuscular on Day 0 and day 21 (all participants), and 0.5 mL of trivalent influenza vaccine (TIV) at Month 13 (antibody persistence subset).
BIOLOGICAL	Swine A/H1N1 influenza vaccine (split virion, inactivated)	0.5 mL, Intramuscular on Day 0 and Day 21

Timeline

• Start date: 2009-08-01
• Primary completion: 2010-12-01
• Completion: 2011-03-01
• First posted: 2009-08-07
• Last updated: 2014-01-14

Locations

6 sites across 1 country: France