RotaTeq was studied in one of the largest vaccine trials in
history, the Rotavirus Efficacy and Safety Trial (REST).3,4
> Click
here for more information on REST.
No increased risk of intussusception
(IS) in REST
Among vaccine recipients in REST3:
- There were no confirmed cases of intussusception within
the 42-day
period of dose 1.
- Hematochezia reported
as an SAE for RotaTeq compared to placebo
was <0.1% vs <0.1%.
- During the 3 placebo-controlled
clinical trials, rates of serious adverse events were similar
in infants receiving RotaTeq (2.4%) compared to placebo
(2.6%) recipients.
b SAE = serious adverse event.
Post-marketing experience
In post-marketing experience, cases
of intussusception and Kawasaki disease have been reported
in infants who have received RotaTeq.
Additional 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 a
subset of more than 11,000 infants in these trials, the presence
of adverse events was reported for 42 days after
each dose. Fever was observed at similar rates in vaccine
and placebo recipients (42.6% vs 42.8%). Adverse events that
occurred at a statistically higher incidence within 42 days
of any dose among recipients of RotaTeq as compared with
placebo recipients were diarrhea (24.1% vs 21.3%), vomiting
(15.2% vs 13.6%), otitis media (14.5% vs 13.0%), nasopharyngitis
(6.9% vs 5.8%), and bronchospasm (1.1% vs 0.7%).
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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