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

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2009
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.
Epistemonikos ID: aeeeff3be67b07dda2abbdbd5a967330c3f21fc3
First added on: May 05, 2024