Status and phase
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About
The primary objective of the study is to demonstrate the non-inferiority of the antibody response in terms of seroconversion rate 28 days after vaccine administration of one dose of yellow fever vaccine (vYF) compared to the antibody response after one dose of the YF-VAX control vaccine in yellow fever naïve participants.
The secondary objectives of the study are:
Full description
The duration of each participant's participation will be approximately 5 years.
Enrollment
Sex
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Volunteers
Inclusion criteria
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.
OR Is of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination. A participant of childbearing potential must have a negative highly sensitive pregnancy test (urine or serum as required by local regulation) before any dose of study intervention on Day 1 and will be repeated on Day 29 to confirm the participant is still not pregnant within the 28 days of vaccine administration.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
567 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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