NCT00970177View on ClinicalTrials.gov

Immunogenicity, Safety and Tolerability of Two Doses of Adjuvanted and Non-adjuvanted Swine Origin A/H1N1 Monovalent Influenza Vaccine in Healthy Subjects 18 or More Years of Age

PHASE3CompletedINTERVENTIONAL
Enrollment

812

Participants

Timeline

Start Date

August 31, 2009

Primary Completion Date

October 31, 2009

Study Completion Date

March 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 adults and elderly. Subjects will be randomized to receive two 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 (3)

Unknown

Gent, Antwerpen

Wurzburg, Fulda, Neumunster, Balve, Leipzig, Magdeburg, München

Zurich

Sponsors

Lead Sponsor

Novartis Vaccines
All Listed Sponsors
lead

Novartis Vaccines

INDUSTRY

NCT00970177 - Immunogenicity, Safety and Tolerability of Two Doses of Adjuvanted and Non-adjuvanted Swine Origin A/H1N1 Monovalent Influenza Vaccine in Healthy Subjects 18 or More Years of Age | Biotech Hunter | Biotech Hunter