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Cell-Mediated Immune Responses to H5N1 Vaccine
NCT00311727Phase 2
Key facts
- Status
- Completed
- Start
- Oct 2005
- Primary completion
- Mar 2006
- Countries
- 1
- Sponsor
- National Institute of Allergy and Infectious Diseases
- Modality
- Vaccines & Immunotherapeutics
- Drugs
- inactivated influenza a vaccine A/H5N1
- Conditions
- Avian influenza H5N1 (H5N1)
01
Overview
Phase 2, randomised, double-blind trial of inactivated influenza a vaccine A/H5N1 in Avian influenza H5N1 (H5N1), sponsored by National Institute of Allergy and Infectious Diseases. Primary endpoint: Cell-Mediated Immune Response. Started Oct 2005; status: completed.
02
Design
1 arm- Study design
- RandomizedDouble-blind
Influenza A/H5N1
Subjects receiving Influenza A/H5N1 vaccine
03
Who it enrols
Healthy adults (18-64) and elderly (65+) enrolled in the main monovalent subvirion H5 vaccine trials (DMID 04-063 and 04-076).
04
Endpoints
Primary
Cell-Mediated Immune Response
Secondary
Humoral Immunogenicity
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