NCT00971542

Immunogenicity, Safety and Tolerability of Two Doses of Adjuvanted and Non-adjuvanted Swine Origin A/H1N1 Monovalent Influenza Vaccine (Egg-Derived) in Healthy Subjects From 6 Months to 17 Years of Age

A Randomized, Single-blind, Dose-Ranging Study to Evaluate Immunogenicity, Safety and Tolerability of Different Formulations of Adjuvanted and Non Adjuvanted Egg-derived, Inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Subjects From 6 Months to 17 Years of Age

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 778 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: All
• Age: 6 Months – 17 Years
• Healthy volunteers: Accepted

Summary

The present study, randomized, single-blind, dose-ranging, multicenter study, will evaluate immunogenicity, safety and tolerability of two doses of adjuvanted and not-adjuvanted new swine-origin influenza A/H1N1 virus monovalent subunit vaccine in healthy children and adolescents. A booster dose will be administered 12 months after the first vaccination.

Conditions

• Pandemic Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Monovalent A/H1N1 influenza vaccine	This trial will be performed at multiple study sites in a population of healthy children and adolescent. Subjects will be randomized to receive 2 IM injections of low dose of antigen \& adjuvant, or high dose of antigen \& adjuvant, or high dose of antigen, according to the study groups.

Timeline

• Start date: 2009-09-01
• Primary completion: 2010-02-01
• Completion: 2011-07-01
• First posted: 2009-09-03
• Last updated: 2011-10-12

Locations

5 sites across 5 countries: Belgium, Chile, Dominican Republic, Germany, Netherlands