NCT00971542View on ClinicalTrials.gov

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

PHASE3CompletedINTERVENTIONAL
Enrollment

778

Participants

Timeline

Start Date

September 30, 2009

Primary Completion Date

February 28, 2010

Study Completion Date

July 31, 2011

Conditions
Pandemic Influenza
Interventions
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.

Trial Locations (5)

Unknown

Gent, Antwerpen

Santigo de chile, Santiago

Gazcue Santo Domingo, Gazcue Santo Domingo

Wurzburg, Fulda, Neumunster, Balve, Stuttgart-Feuerbach, Leipzig, Rostock, Mainz, Detmold, Alsfeld, Mainz

Rotterdam

Sponsors

Lead Sponsor

Novartis Vaccines
All Listed Sponsors
lead

Novartis Vaccines

INDUSTRY

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 | Biotech Hunter | Biotech Hunter