NCT00956046

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

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 6 to 35 Months

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 401 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 6 Months – 35 Months
• 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 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).

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: 2009-09-01
• Primary completion: 2011-01-01
• Completion: 2011-06-01
• First posted: 2009-08-11
• Last updated: 2014-01-14

Locations

15 sites across 1 country: Finland