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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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8 January 2024 |
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Main ID: |
NCT02661464 |
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Date of registration:
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08/01/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Long-term Safety Follow-up of Participants Exposed to the Candidate Ebola Vaccines Ad26.ZEBOV and/or MVA-BN-Filo
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Scientific title:
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A Multi-country, Prospective, Clinical Safety Study of Subjects Exposed to the Candidate Ebola Vaccines Ad26.ZEBOV and/or MVA-BN-Filo |
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Date of first enrolment:
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May 31, 2016 |
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Target sample size:
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677 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT02661464 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Prevention. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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Burkina Faso
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Côte D'Ivoire
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France
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Kenya
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Mozambique
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Nigeria
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Rwanda
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Sierra Leone
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Tanzania
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Uganda
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United Kingdom
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United States
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Contacts
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Name:
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Janssen Vaccines & Prevention B.V. Clinical Trial |
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Address:
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Telephone:
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Email:
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Affiliation:
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Janssen Vaccines & Prevention B.V. |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Male or female who participated in a Phase 1, 2 or 3 clinical study with Human
adenovirus serotype 26 (Ad26) expressing the Ebola virus Mayinga variant glycoprotein
(Ad26.ZEBOV) and/or Modified Vaccinia Virus Ankara - Bavarian Nordic Filo-vector
(MVA-BN-Filo) and has been exposed to Ad26.ZEBOV and/or MVA-BN-Filo (Cohort 1)
- Female who participated in a Phase 1, 2 or 3 clinical study with Ad26.ZEBOV and/or
MVA-BN-Filo and became pregnant with estimated conception within 28 days after
vaccination with MVA-BN-Filo or within 3 months after vaccination with Ad26.ZEBOV
(Cohort 2)
- Child born to female participants exposed to Ad26.ZEBOV and/or MVA-BN-Filo in a Phase
1, 2, or 3 clinical study who became pregnant with estimated conception within 28 days
after vaccination with MVA-BN-Filo or within 3 months after vaccination with
Ad26.ZEBOV (Cohort 3)
- Must sign an informed consent form for the current study (or their legally acceptable
representative must sign) indicating that he or she understands the purpose of, and
procedures required for, the study and is willing to participate in the study (or let
their child participate); Assent is also required of children capable of understanding
the nature of the study (typically 7 years of age and older)
Exclusion Criteria:
- No exclusions beyond those that are not meeting the inclusion criteria
Age minimum:
0 Years
Age maximum:
71 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Hemorrhagic Fever, Ebola
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Intervention(s)
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Biological: MVA-BN-Filo
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Biological: Ad26.ZEBOV
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Primary Outcome(s)
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Cohorts 1 and 3: Number of Participants With Serious Adverse Events (SAEs)
[Time Frame: Up to 60 months]
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Secondary ID(s)
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CR108112
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VAC52150EBL4001
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2015-004139-11
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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