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RotaTeq demonstrated substantial efficacy against RGE caused
by serotypes G1, G2, G3, and G4.3
Through the first rotavirus
season after vaccination (n=5,673):
RotaTeq is indicated for the prevention
of RGE in infants and children caused by serotypes G1, G2,
G3, and G4 when administered
as a 3-dose series to infants between the ages of 6 to 32
weeks. The first dose of RotaTeq should be administered between
6 and 12 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.
Over 71,000 infants were
evaluated in 3 placebo-controlled clinical trials. Serious
adverse events occurred
in 2.4% of recipients
of RotaTeq when
compared to 2.6%
of placebo recipients within the 42-day period
of a dose of RotaTeq. Hematochezia reported as a serious
adverse
event for
RotaTeq
compared to placebo was <0.1%
vs <0.1%. The most frequently reported serious
adverse events for RotaTeq compared to placebo
were bronchiolitis (0.6% vs 0.7%),
gastroenteritis (0.2%
vs 0.3%), pneumonia (0.2% vs 0.2%), fever (0.1%
vs 0.1%), and urinary tract infection (0.1% vs
0.1%).
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%).
In
post-marketing experience, cases of intussusception 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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