Status:
COMPLETED
Cell-Mediated Immune Responses to Influenza A/H5N1 Vaccine
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Influenza
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study may determine whether laboratory studies of people's blood cells, who have received vaccines against H5 influenza, or "bird flu," will help to decide if the vaccines are going to be prevent...
Detailed Description
This study is linked to DMID protocol 04-063 and 04-076, "A Randomized, Double Blinded, Placebo-ontrolled, Phase I/II, Dose-Ranging Study of the Safety, Reactogenicity, and Immunogenicity of Intramusc...
Eligibility Criteria
Inclusion
- All subjects who are eligible and enrolled in the main monovalent subvirion H5 vaccine trials \[Division of Microbiology and Infectious Diseases (DMID) studies 04-063 and 04-076\] and have agreed to the extra blood draws for the cell-mediated immunity (CMI) sub-study will be enrolled.
- Subjects will not be recruited outside the main vaccine trials or future DMID sponsored influenza A/H5N1 studies.
- Subjects who understand and sign the consent form for this study.
- Subjects who meet pre-screening qualifications for the DMID study will be eligible for the initial pre-vaccination blood draw.
- Subjects who meet all inclusion criteria for the DMID study and who are vaccinated will be allowed to participate in the remaining portions of this study.
Exclusion
- 1\. All subjects who are ineligible for the main monovalent subvirion H5 vaccine trials will not be eligible for the cell-mediated immunity (CMI) sub-study.
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2006
Estimated Enrollment :
339 Patients enrolled
Trial Details
Trial ID
NCT00311727
Start Date
October 1 2005
End Date
March 1 2006
Last Update
August 16 2013
Active Locations (3)
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1
University of Maryland Baltimore
Baltimore, Maryland, United States, 21201
2
University of Rochester
Rochester, New York, United States, 14642
3
Vanderbilt University
Nashville, Tennessee, United States, 37232-2581