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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02344407 |
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Date of registration:
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22/01/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Partnership for Research on Ebola Vaccines in Liberia (PREVAIL)
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Scientific title:
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Partnership for Research on Ebola Vaccines in Liberia (PREVAIL) |
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Date of first enrolment:
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January 20, 2015 |
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Target sample size:
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1500 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02344407 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Triple (Participant, Care Provider, Investigator).
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Phase:
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Phase 2
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Countries of recruitment
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Liberia
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Contacts
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Name:
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H. Clifford Lane, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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National Institute of Allergy and Infectious Diseases (NIAID) |
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Key inclusion & exclusion criteria
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- INCLUSION CRITERIA:
The inclusion criteria for the study are broad reflecting the target population that would
eventually receive an efficacious vaccine.
- Informed consent
- Age greater than or equal to 18 years
- Likely to be in the surrounding area of the vaccination center for at least one year.
EXCLUSION CRITERIA:
- Fever greater than or equal to 38.0 degrees Celsius
- History of EVD (self-report)
- Current pregnancy (a negative urine pregnancy test is required for women of
child-bearing potential)
- Breast-feeding an infant
- Any condition which would limit the ability of the participant to meet the
requirements of the study protocol
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Ebola Virus
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Intervention(s)
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Biological: VSVG-ZEBOV
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Biological: ChAd3-EBO Z
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Biological: Placebo
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Primary Outcome(s)
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Immunogenicity Measures (ELISA and Neutralization Antigen-specific Assays for Antibody.
[Time Frame: One month]
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Serious Adverse Events.
[Time Frame: One month]
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Secondary ID(s)
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999915071
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15-I-N071
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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