EUCTR2020-005566-33-FI
Active, not recruiting
Phase 1
Controlled Study of Immunogenicity and Safety of the Investigational vYF Candidate Vaccine in Comparison to Stamaril® in Adults
ConditionsPrevention of yellow feverMedDRA version: 20.0Level: PTClassification code 10048240Term: Yellow feverSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
DrugsSTAMARIL
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Prevention of yellow fever
- Sponsor
- Sanofi Pasteur
- Enrollment
- 690
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\-Aged 18 years up to 60 years\* on the day of inclusion
- •\-A female participant is eligible to participate if she is not pregnant or
- •breastfeeding and one of the following conditions applies:
- •Is of non\-childbearing potential. To be considered of non\-childbearing
- •potential, a female must be postmenopausal for at least 1 year, or
- •surgically sterile.
- •Is of childbearing potential and agrees to use an effective contraceptive
- •method (1\) or abstinence (1\) from at least 4 weeks prior to study
- •intervention administration until at least 4 weeks (2\) after study
- •intervention administration.
Exclusion Criteria
- •Participants are excluded from the study if any of the following criteria
- •. Participation at the time of study enrollment (or in the 4 weeks
- •preceding the study vaccination) or planned participation during the first
- •2 years of the 5\-year follow\-up in another clinical study investigating a
- •vaccine, drug, medical device, or medical procedure. Enrollment in
- •another study after the first 2 years is permitted, assuming that it does
- •not exclude participation in this study.
- •. Receipt of any vaccine in the 4 weeks preceding the study vaccination
- •or planned receipt of any vaccine in the 4 weeks following the study
- •vaccination (prior to visit 4\), except for influenza vaccination, which may
Outcomes
Primary Outcomes
Not specified
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