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Efficacy against any grade of severity
of rotavirus gastroenteritis caused by the rotavirus serotypes
G1, G2, G3, G4 through the two rotavirus seasons after vaccination
was 71.3%.
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The level of protection provided by only
1 or 2 doses of RotaTeq was not studied in clinical trials.
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Vaccination with RotaTeq
may not result in complete protection in all recipients.
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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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Efficacy against any grade of severity of rotavirus
gastroenteritis caused by the rotavirus serotypes G1, G2, G3, G4 through
the two rotavirus seasons after vaccination was 71%.
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The level of protection provided by only 1 or 2 doses
of RotaTeq was not studied in clinical trials.
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RotaTeq may not protect all vaccine recipients against rotavirus.
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Based on disease burden estimates from the Centers for Disease Control and
Prevention and using an economic model, which includes direct and societal
costs, the total cost of RGE disease is estimated to be between $1 and
$1.3 billion per year in the United States.2,3
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Applying the efficacy results for RotaTeq in REST to this economic model, universal
vaccination with RotaTeq would potentially result in:
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>50% reduction in the 2.7 million
rotavirus gastroenteritis episodes occurring annually3
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86% reduction in episodes involving urgent care episodes such as hospitalizations
and emergency department visits3
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$754 to $951 million net reduction in total costs*3
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Reductions in healthcare costs ranging from $189
to $238 per child vaccinated3
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*In 2006 dollars,
excluding the cost of the vaccine or administration fees |
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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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| The Advisory Committee on Immunization Practices (ACIP) and the American Academy of Pediatrics (AAP) recommend routine rotavirus vaccination. |
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| Virtually all infants will be infected with rotavirus |
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| RotaTeq is fully liquid and ready to use. |
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| 1. |
Vesikari T, Matson DO, Dennehy P, et al. Safety and efficacy of pentavalent human-bovine (W3C) reassortant rotavirus vaccine. N Engl J Med. 2006;354:23–33.
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| 2. |
Tucker AW, Haddix AC, Bresee JS, et al. JAMA. 1998;279:1371–1376.
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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 20603852-RTQ. |
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This site is intended only for healthcare professionals
of the United States, its territories, and Puerto Rico.
RotaTeq is a registered trademark of Merck & Co., Inc.
20753585(2)-01/08-RTQ
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