A Phase III Control Study of the Safety and Immunogenicity of vYF in Pediatric Population
Recruiting
Phase 3
Interventional Study
Yellow Fever Immunization
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 9 Months – 5
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 2,440 (estimated)
- Sponsor
- Sanofi · Industry
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About This Trial
The purpose of this study is to determine whether vYF (investigational vaccine) is safe and can help the body to develop antibodies (immunogenicity) compared with Stamaril vaccine and YF-VAX vaccine (both licensed vaccines) and when they are co-administered with Measles Mumps Rubella (MMR) vaccines in infants aged 11-15 months.
Number of Participants:
A total of 2440 participants is planned to b…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Aged 9 months to 5 years on the day of inclusion\*
\* "9 months to 5 years" means from the day of the 9th month after birth to the day before the 6th year birthday
* Aged 11 to 15 months\* on the day of inclusion for participants enrolled in the MMR co-administration group
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Contacts
Trial Transparency email recommended (Toll free for US & Canada)
800-633-1610
CONTACT