drugset / Trial / NCT01000831

Rapid Evaluation of Pandemic H1N1 Influenza Vaccines in Young Children

NCT01000831

NaSingle-groupOpen-labelPrevention

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Comparator Arepanrix Vaccine 1.9 ug
Comparator Arepanrix Vaccine 0.25 ml

Indications