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RotaTeq is an oral vaccine that can help protect against rotavirus gastroenteritis, a potentially serious and unpredictable disease.1,2
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RotaTeq is a live, oral pentavalent vaccine that contains 5 live reassortant rotaviruses. |
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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. |
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The first dose of RotaTeq should be administered between 6 and 12 weeks of age.
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RotaTeq should not be administered to infants with a demonstrated history of hypersensitivity to any component of the vaccine.
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 RotaTeq was studied in the Rotavirus Efficacy & Safety Trial (REST)—a trial evaluating nearly 70,000 infants—making it one of the largest prelicensure trials in vaccine history.3
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In REST, RotaTeq did not increase the risk of intussusception (IS) relative to placebo.
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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 in the phase 3 clinical studies of RotaTeq.
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In post-marketing experience, cases of intussusception and Kawasaki disease have been reported in infants who have received RotaTeq.
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RotaTeq demonstrated substantial efficacy against rotavirus gastroenteritis (RGE) caused by the naturally occurring serotypes G1, G2, G3, G4.
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Learn more about the recommendations from the ACIP and AAP. |
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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. |
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The first dose of RotaTeq should be administered
between 6 and 12 weeks of age. |
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RotaTeq should not be administered to infants with
a demonstrated history of hypersensitivity to any component of the vaccine. |
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No safety or efficacy data are available
for the administration of RotaTeq to infants who are potentially immunocompromised,
or with a history of gastrointestinal disorders. |
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Caution is advised when considering whether
to administer RotaTeq to individuals with immunodeficient contacts. |
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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%). |
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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%). |
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In post-marketing experience, cases of intussusception
and Kawasaki disease have been reported in infants who have received RotaTeq. |
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RotaTeq may not protect all vaccine recipients against
rotavirus. |
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Before administering RotaTeq, please read the Prescribing
Information and Patient
Product Information. |
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*Source: Data Available on request from Merck & Co., Inc. Professional Services - DAP, WP1-27, PO Box 4, West Point, PA 19486-0004. Please specify information package
20703731(3)-RTQ.
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| 1. |
Cornell SL. Confronting the consequences of rotavirus: Diarrhea and dehydration. Adv Nurse Pract. 1999;5:41–44.
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Santos N, Hoshino Y. Rev Med Virol. 2005;15:29–56.
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Glass RI, Parashar UD. The promise of new rotavirus vaccines. N Engl J Med. 2006;354:75–77.
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This site is intended only for healthcare professionals
of the United States, its territories, and Puerto Rico.
Healthcare professionals in Canada, click
here.
RotaTeq is a registered trademark of Merck & Co., Inc.
20851290(1)-04/08-RTQ |
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| The Advisory Committee on Immunization Practices (ACIP) and the American Academy of Pediatrics (AAP) recommend routine rotavirus vaccination. |
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| Over twelve million doses have been distributed in the United States since FDA approval on February 3, 2006.* |
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| RotaTeq can be easily incorporated into the routine childhood vaccination schedule and is for oral use. |
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RotaTeq was studied in the Rotavirus Efficacy & Safety Trial (REST)—a trial evaluating nearly 70,000 infants—making it one of the largest prelicensure trials in vaccine history.
