Inactivated Influenza A/H5N1 Vaccine in the Elderly
Status:
Completed
Trial end date:
2007-01-01
Target enrollment:
Participant gender:
Summary
The purpose of this research study is to compare how the body reacts to different strengths
of a new H5N1 flu vaccine. Researchers will also look at how antibodies are made after
subjects receive the H5N1 flu vaccine. Participants will include at least 240 healthy males
and females, aged 65 and older. The vaccine is given as an injection or shot in the arm.
Subjects will receive 3 doses of vaccine at Day 0, Month 1 and Month 6. There are 2 different
doses of the new H5N1 vaccine that will be given in this study. There is also a chance that a
subject may receive a placebo (dummy) injection of saltwater instead of the flu vaccine.
Study procedures will include physical exams and blood sample collections. Additionally,
participants will complete a memory aid card to document daily temperatures and any symptoms
experienced for a week after receiving vaccine. The length of participation in this study
will be approximately 14 months.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)