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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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Please read the Select Safety Information
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RotaTeq—efficacy and
safety as demonstrated in the landmark REST study.
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| Population: |
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Nearly 70,000 subjects evaluated 1
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| Objectives: |
To evaluate the safety of RotaTeq
with regard to intussusception (IS) and other adverse events and
its efficacy in the prevention of rotavirus gastroenteritis (RGE)
and the associated use of healthcare resources1
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| Methods: |
Double-blind (with sponsor blinding),
placebo-controlled, randomized1
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| Facts: |
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One of the largest prelicensure trials
in vaccine history2
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Conducted from 2001 to 2004 in 11 countries, with
approximately 34,000 subjects enrolled in the United States1,3
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Active surveillance was used to gather safety data
with respect to IS and other serious adverse events, as well as information
on acute gastroenteritis-related hospitalizations and emergency department
visits. Parents of legal guardians were contacted on days 7, 14, and 42
after each dose and every 6 weeks thereafter for 1 year after the first
dose.
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RotaTeq may not protect all vaccine recipients against
rotavirus. |
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Visit MerckVaccines.com and
request a copy of the REST Reprint to learn more about this landmark trial. |
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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 71.3%.
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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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RotaTeq may not protect all vaccine recipients against
rotavirus.
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Please read the Select Safety Information
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Following the administration of a previously
licensed live rhesus rotavirus-based vaccine, an increased risk of intussusception
was observed.
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REST was specifically designed to evaluate
safety with respect to intussusception, an uncommon but naturally occurring
event, and also evaluated safety with regard to other adverse events.1
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| Confirmed IS cases within 1
year of dose 1 |
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15 |
| Confirmed IS cases within 42
days of any dose |
6 |
5 |
Among vaccine recipients:
• No confirmed cases of IS within the 42-day period of dose
1 |
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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 safety and efficacy of RotaTeq have not been established in infants less than 6 weeks of age or greater than 32 weeks of age.
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For additional information on adverse reactions, please read the Prescribing Information.
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Please read the Select Safety Information. |
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| RotaTeq is fully liquid and ready to use. |
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| RotaTeq can be easily incorporated into the routine childhood vaccination schedule and your practice needs. |
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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. |
Glass RI, Parashar UD, The promise of new rotavirus vaccines. N Engl J Med. 2006;354:75–77.
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| 3. |
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 20603702(1)-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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