Stamaril is a live, attenuated vaccine that contains the active substance Yellow fever virus1 17D-204 strain produced in specified pathogen-free chick embryos.
Stamaril is indicated for active immunization against yellow fever for adults and children aged 9 months and older:
- traveling to, passing through or living in an endemic area
- traveling to any country that requires an International Certificate of Vaccination for entry (which may or may not depend on the previous itinerary)
- handling potentially infectious materials (e.g. laboratory personnel)
The vaccine should be given at least 10 days before entering an endemic area since protective immunity may not be achieved until at least this time has elapsed.
Stamaril is given as a single, 0.5-milliliter dose to adults and children from 9 months of age.
Stamaril is given as an injection by a doctor or nurse.
It is usually injected just underneath the skin but it can be given into a muscle. It must not be injected into a blood vessel.
The first dose should be given at least 10 days before protection from yellow fever is needed. This is because it takes 10 days for the first dose of vaccine to work and provide good protection against the yellow fever virus.
The protection provided by this dose is expected to last at least 10 years and may be life-long.
A booster with one dose (0.5 milliliter) may be needed: - if you or your child had an insufficient response to the first dose, - or after at least 10 years if it is required as a condition of entry in some countries.
In order to comply with vaccine regulations and to be officially recognized, yellow fever vaccines must be administered in an approved World Health Organization (WHO) vaccination center and registered on an International Certificate of Vaccination.
The validity period of this Certificate is established according to International Health Regulations (IHR) recommendations, and starts 10 days after primary vaccination and immediately after re-vaccination.
Stamaril is currently registered and distributed in over 70 countries.
However, it is considered investigational in the US, as it is not a US-licensed product. The Expanded Access Program has requirements similar to a clinical trial; thus Sanofi Pasteur can support only a limited number of sites.
Working closely with the CDC, geographically distributed sites throughout the US are identified for inclusion in the program so patients can have continued access to the yellow fever vaccine.
Clinical Trial NCT03541694: Passive Enhanced Safety Surveillance of Stamaril Vaccine in Korea
This is a passive enhance safety surveillance (ESS) of Stamaril vaccine in Korea.
The objective is to collect suspected related adverse events following vaccination with Stamaril in routine practice.