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RotaTeq demonstrated
high-level efficacy against rotavirus gastroenteritis caused
by serotypes G1, G2, G3, or G4 in the Rotavirus
Efficacy and Safety Trial (REST).4
Through the first rotavirus season after vaccination (n=5,673):
- Efficacy against mild, moderate, and severe rotavirus
gastroenteritis caused by rotavirus serotypes G1, G2,
G3, or G4 through the 2 rotavirus seasons after vaccination
was 71%. The efficacy of RotaTeq beyond the second
season postvaccination was not evaluated.
- Click here for more information on REST
- Click here for serotype-specific
efficacy data
- RotaTeq is indicated for the prevention
of rotavirus gastroenteritis in infants and children
caused by the serotypes G1, G2, G3, and G4 when administered
as a 3-dose series to infants between the ages of 6 to
32 weeks.
- The vaccination series consists of 3 ready-to-use liquid
doses of RotaTeq administered orally starting at 6 to 12 weeks of age,
with the subsequent doses administered at 4- to 10-week intervals. The
third dose should not be given after 32 weeks of age.
Select safety information
- RotaTeq should not be administered
to infants with a demonstrated history of hypersensitivity
to the vaccine or any component
of the vaccine.
- No safety or efficacy data are available
for the administration of RotaTeq to infants who are potentially
immunocompromised
or to infants with a history
of
gastrointestinal disorders.
- Caution is advised when considering whether
to administer RotaTeq to individuals with immunodeficient
contacts.
- In clinical trials, the most common adverse events
included diarrhea, vomiting, irritability, otitis media,
nasopharyngitis, and bronchospasm.
- In post-marketing experience,
intussusception (including death) and Kawasaki disease
have been reported in infants who
have received RotaTeq.
- RotaTeq may not protect all vaccine
recipients against rotavirus.
Before administering RotaTeq, please read the Prescribing
Information
and Patient
Product Information.
RotaTeq is a registered trademark of Merck & Co.,
Inc.
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