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RotaTeq was studied in one of the largest vaccine trials
in history, the Rotavirus Efficacy and Safety Trial (REST).6
No increased risk of intussusception
(IS) in REST
- Within 42 days of dose 1, there were no confirmed cases
of IS among vaccine recipients.4
Incidence of serious adverse events (SAEs)
in Phase III
trials
- 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 recipients (2.6%).
Other adverse events in Phase III
trials
In a subset of more than 11,000 infants in 3 placebo-controlled
clinical 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:
Post-marketing experience
In post-marketing experience, intussusception (including death)
and Kawasaki disease have been reported in infants who have
received RotaTeq.
- Click
here for additional safety information.
- 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.
RotaTeq is a registered trademark of Merck & Co., Inc. |
RotaTeq was studied in one of the largest vaccine trials
in history, the Rotavirus Efficacy and Safety Trial (REST).
