H5 Vaccine Alone or With Adjuvant in Healthy Adults
Status:
Completed
Trial end date:
2006-12-01
Target enrollment:
Participant gender:
Summary
This randomized, controlled, double-blinded, dose-ranging, Phase I-II study in 600 healthy
adults, 18 to 49 years old, is designed to investigate the safety, reactogenicity, and
dose-related immunogenicity of an investigational inactivated influenza A/H5N1 virus vaccine
when given alone or combined with aluminum hydroxide. A secondary goal is to guide selection
of vaccine dosage levels for expanded Phase II trials based on reactogenicity and
immunogenicity profiles. This dose optimization will be applied to both younger and older
subject populations in subsequent studies. Subjects who meet the entry criteria for the study
will be enrolled at one of 4 study sites and will be randomized into one of 8 groups to
receive 2 doses of influenza A/H5N1 vaccine containing 3.75, 7.5, 15, or 45 mcg of HA with or
without aluminum hydroxide adjuvant by intramuscular injection. Participants may be involved
in study related procedures for up to 8 months.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)