A Phase I Dose-Escalation Study to Investigate the Safety and Immunogenicity of the Fusion Protein Recombinant Influenza A (HAC1) Vaccine Derived From Influenza A/California/04/09 (H1N1) in Healthy Adults

NCT01177202 Phase 1 COMPLETED

The Purpose Of This Study Is To Assess The Safety, Immunogenicity, And Tolerability Of A H1N1 Vaccine In Healthy Adults

Details

Lead sponsor	Fraunhofer, Center for Molecular Biotechnology
Phase	Phase 1
Status	COMPLETED
Enrolment	80
Start date	2010-09
Completion	2012-10

Conditions

• H1N1 Flu

Interventions

• HAC1 Vaccine

Primary outcomes

• To assess the safety, reactogenicity, and tolerability of the HAC1 vaccine formulations. — Six Months
  The primary objective of this study is to assess the safety, reactogenicity, and tolerability of the HAC1 vaccine formulations delivered intramuscularly at doses of 15 μg, 45 μg or 90 µg (unadjuvanted or adjuvanted) in healthy adults 18 - 50 years of age.

Countries

United States