NCT00976469

A/H1N1 Immunogenicity and Safety in Infants, Children and Adolescents

An Open-Label Phase 1/2 Study to Assess the Immunogenicity and Safety of Two Different Dose Levels of H1N1 Pandemic Influenza Vaccine in Healthy Infants, Children and Adolescents Aged 6 Months to 17 Years

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Alachua Government Services, Inc. · Industry
• Sex: All
• Age: 6 Months – 17 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Influenza
• Pandemic Influenza

Interventions

Type	Name	Description
BIOLOGICAL	H1N1 pandemic influenza vaccine (whole virion, Vero cell-derived, inactivated)	2-dose priming at a 21-day interval, intramuscular injection in either the upper arm or thigh, depending on the subject´s age
BIOLOGICAL	Seasonal trivalent influenza vaccine (licensed) for the season 2010/2011	Booster vaccination at Day 360 after first vaccination (only in subjects who received the 7.5 µg dose of the H1N1 pandemic influenza vaccine)

Timeline

• Start date: 2009-09-01
• Primary completion: 2010-04-01
• Completion: 2011-03-01
• First posted: 2009-09-14
• Last updated: 2015-10-09

Locations

6 sites across 2 countries: Austria, Germany