The purpose of this study is to determine the preferred dose of H1N1 pandemic influenza vaccine in a pediatric population, aged 6 months to 17 years, based upon assessments of immunogenicity and safety.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
400
2-dose priming at a 21-day interval, intramuscular injection in either the upper arm or thigh, depending on the subject´s age
Booster vaccination at Day 360 after first vaccination (only in subjects who received the 7.5 µg dose of the H1N1 pandemic influenza vaccine)
General Practice
Eferding, Upper Austria, Austria
General Practice
Wels, Upper Austria, Austria
Allgemeines Krankenhaus (AKH) der Stadt Wien (General Hospital Vienna)
Vienna, Austria
General Practice
Ettenheim, Germany
To assess the immune response to two different dose levels of a H1N1 pandemic influenza vaccine in healthy infants, children and adolescents aged 6 months to 17 years
Time frame: 42 days
To assess the safety of two different dose levels of a H1N1 pandemic influenza vaccine in healthy infants, children and adolescents aged 6 months to 17 years
Time frame: Within 7 days after each vaccination
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General Practice
Kehl, Germany
General Practice
Mönchengladbach, Germany