drugset / Trial / NCT01001026

Rapid Evaluation of Pandemic H1N1 Influenza Vaccine in Aboriginal Children and Adults

NCT01001026

Non-randomizedParallel-groupOpen-labelPrevention

Summary

The purpose of this study is to assess the safety and effectiveness (immune response) to a licensed H1N12009 influenza vaccine in aboriginal children and adults. The study will enroll 200 healthy adults (ages 20-59 years) and 75 healthy children (ages 6-35 months). Adults will receive one dose of a licensed H1N1 vaccine and children will receive two doses of a licensed H1N1 vaccine approximately 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 3 weeks (adults) or 6 weeks (children).

Timeline

Start
2009-11
Primary completion
2010-02
Completion
2010-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Arepanrix Vaccine 0.25 ml Intramuscular
Subject Arepanrix Vaccine 0.5 ml Intramuscular

Indications