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RotaTeq
was studied in the Rotavirus Efficacy & Safety Trial (REST), which evaluated nearly 70,000 infants.
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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 |
13 |
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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In post-marketing experience, cases of intussusception and Kawasaki disease have been reported in infants who have received RotaTeq. |
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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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| RotaTeq has convenient scheduling and peel-off labels for easy record keeping. |
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Over 71,000 infants were evaluated in 3 placebo-controlled clinical trials. During these trials, rates of serious adverse events were similar in infants receiving RotaTeq compared to placebo recipients. 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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Hematochezia reported as a serious adverse event for RotaTeq compared to placebo was <0.1% vs <0.1%. |
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The most frequently reported serious adverse events for vaccine compared to placebo were:
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| Bronchiolitis |
0.6% |
0.7% |
| Gastroenteritis |
0.2% |
0.3% |
| Pneumonia |
0.2% |
0.2% |
| Fever |
0.1% |
0.1% |
| Urinary tract infection |
0.1% |
0.1% |
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In more than 11,000 infants in 3 clinical trials, a Vaccination Report Card was used to report the presence of adverse events 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:
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| Diarrhea |
24.1% |
21.3% |
| Vomiting |
15.2% |
13.6% |
| Otitis media |
14.5% |
13.0% |
| Nasopharyngitis |
6.9% |
5.8% |
| Bronchospasm |
1.1% |
0.7% |
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For additional information on adverse reactions, please read the Prescribing Information. |
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Before administering RotaTeq, please read the Prescribing Information and Patient Product Information. |
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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, Bresee JS, Parashar U, et al. Arch Pediatr.
2005;12:844–847.
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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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