NCT00956202

A Study of Inactivated Swine-Origin A/H1N1 Influenza Vaccines in Healthy European Subjects Aged 3 to 17 Years

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 Subjects Aged 3 to 17 Years

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 303 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 3 Years – 17 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 vaccines 21 days after each vaccination in all participants. * To describe the antibody persistence eight months after the first vaccine administration using HAI method, in a subset of participants 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 NH seasonal TIV administered approximately 13 months after the first vaccination in the subset of participants who received two injections. * 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 children and adolescents participants eligible for the antibody persistence evaluation were sampled 8 months after the first vaccination, they will also be proposed to receive the 2010-2011 Northern Hemisphere (NH) seasonal Trivalent Influenza Vaccine (TIV) 13 months after the first vaccination. Immunogenicity response will be evaluated before vaccination and 21 days after vaccination with TIV, respectively.

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

Timeline

• Start date: 2009-08-01
• Primary completion: 2010-09-01
• Completion: 2010-11-01
• First posted: 2009-08-11
• Last updated: 2014-01-14

Locations

15 sites across 1 country: Finland