NCT00973700

Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Children, Adolescents and Adults (3 to 64 Years)

A Randomized, Open Label, Single Center, Dose- and Regimen-Ranging Study to Evaluate Immunogenicity, Safety and Tolerability of Different Formulations of an Adjuvanted and Non-Adjuvanted Egg-Derived, Inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Children and Adults Ages 3 to 64 Years

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 784 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: All
• Age: 3 Years – 64 Years
• Healthy volunteers: Accepted

Summary

This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 S-OIV (swine flu) vaccine in healthy young children, adolescents, and adults.

Conditions

• Novel 2009 Influenza H1N1

Interventions

Type	Name	Description
BIOLOGICAL	MF59-eH1N1_f	MF59 adjuvanted (adj) egg-derived A/H1N1 with traces of Thiomersal
BIOLOGICAL	eH1N1_f	Unadjuvanted egg-derived A/H1N1 with traces of Thiomersal

Timeline

• Start date: 2009-08-01
• Primary completion: 2009-10-01
• Completion: 2010-10-01
• First posted: 2009-09-09
• Last updated: 2015-12-02
• Results posted: 2011-05-23

Locations

1 site across 1 country: Costa Rica