Rapid Evaluation of Pandemic H1N1 Influenza Vaccines in Young Children

Status Completed

Clinical Trial Summary

The purpose of this study is to compare the safety and effectiveness (immune response) to one or two doses of adjuvanted H1N12009 influenza vaccine in young children. An adjuvant is an additive that can boost the immune response. The study will enroll 300 children (ages 6-35 months). Participants will receive 2 doses of adjuvanted H1N12009 vaccine 3 weeks apart. Study procedures include: medical history, blood samples and completing a memory aid. Participants will be involved in study related procedures for approximately 6 weeks.

Clinical Trial Description

The goal of this study is to determine if one or two doses of the H1N12009 influenza vaccine are needed in young children, a population group at high risk of influenza infection and subsequent hospitalization.

The objectives of this study are two-fold:

1. To compare the safety and immunogenicity of 1 and 2 doses of adjuvanted H1N12009 influenza vaccine in children 6-35 months of age.

2. To conduct the trial soon after the vaccines become available and share the observations with health officials and the public as soon as possible. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01000831
Study type	Interventional
Source	University of British Columbia
Contact
Status	Completed
Phase	Phase 4
Start date	November 2009
Completion date	February 2010

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