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 first dose of RotaTeq should be administered between 6 and 12 weeks of age.

Select safety information

RotaTeq should not be administered to infants with a demonstrated history of hypersensitivity to the vaccine or any component of the vaccine.

Infants who develop symptoms suggestive of hypersensitivity after receiving a dose of RotaTeq should not receive further doses of RotaTeq.

No safety or efficacy data are available for the administration of RotaTeq to infants who are potentially immunocompromised or to infants with a history of gastrointestinal disorders.

Caution is advised when considering whether to administer RotaTeq to individuals with immunodeficient contacts. RotaTeq is a solution of live reassortant rotaviruses and can potentially be transmitted to persons who have contact with the vaccine. The potential risk of transmission of vaccine virus should be weighed against the risk of acquiring and transmitting natural rotavirus. Transmission was not evaluated in clinical trials.

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%).

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%).

In post-marketing experience, cases of intussusception and Kawasaki disease have been reported in infants who have received RotaTeq.

In clinical trials, RotaTeq was routinely administered concomitantly with diphtheria and tetanus toxoids and acellular pertussis (DTaP), inactivated poliovirus vaccine (IPV), H. influenzae type b conjugate vaccine (Hib), hepatitis B vaccine, and pneumococcal conjugate vaccine.

There was no evidence for reduced antibody responses to the diphtheria or tetanus toxoid components of DTaP or to the other vaccines that were concomitantly administered with RotaTeq. However, insufficient immunogenicity data are available to confirm lack of interference of immune responses when RotaTeq is concomitantly administered with childhood vaccines to prevent pertussis.

RotaTeq may not protect all vaccine recipients against rotavirus.

Before administering RotaTeq, please read the Prescribing Information and Patient Product Information

RotaTeq is a registered trademark of Merck & Co., Inc.