Safety, Reactogenicity, and Immunogenicity of Inactivated Influenza A/H7/N7 Vaccine in Healthy Adults
Status:
Completed
Trial end date:
2009-02-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to evaluate the safety, any adverse events or side effects, and
the body's immune response to an experimental flu vaccine [Inactivated Influenza A/H7N7
Vaccine] being given in increasing doses. Researchers will try to find the smallest dose of
flu vaccine needed to cause antibody responses against the flu virus in both single and
repeat doses. The study will enroll 125 healthy adults ranging in age from 18 to 40 years
old. Subjects will be given 2 doses of the vaccine 28 days apart. Study procedures will
include obtaining a medical history, physical exam, blood sample collections, and use of
patient memory aids. The volunteers will be in the study for about 7 months.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)