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Systems Biology of H5N1 Vaccine With and Without AS03 Adjuvant
NCT01910519Phase 2
Key facts
- Status
- Completed
- Start
- Jul 2013
- Primary completion
- Feb 2015
- Countries
- 1
- Sponsor
- National Institute of Allergy and Infectious Diseases
- Modality
- Vaccines & Immunotherapeutics
- Drugs
- MF59-eH5N1
- Conditions
- Influenza A H5N1 (H5N1)
01
Overview
Phase 2, randomised trial of MF59-eH5N1 in Influenza A H5N1 (H5N1) (2 arms), sponsored by National Institute of Allergy and Infectious Diseases. Primary endpoints: Change in Traditional Immune Parameters Measurements Using Luminex Assays and Gene Expression Measurement Using Microarray Experiments at Day 28, Measurement of Hemagglutination Inhibition Assay (HAI) Titers at Day 42 and 1 more. Started Jul 2013; status: completed.
02
Design
2 arms- Study design
- Randomized
H5N1 vaccine + AS03
Influenza A (H5N1) Virus Monovalent Vaccine with AS03 adjuvant
H5N1 vaccine alone
Influenza A (H5N1) Virus Monovalent Vaccine without adjuvant
03
Who it enrols
Healthy adults with no history of narcolepsy or related sleep disorders, and no HLA-DQB1*06:02 positivity.
04
Endpoints
Primary
Change in Traditional Immune Parameters Measurements Using Luminex Assays and Gene Expression Measurement Using Microarray Experiments
Measurement of Hemagglutination Inhibition Assay (HAI) Titers
Measurement of Microneutralization (MN) Titers
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