Influenza Clinical Trial
Official title:
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
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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