RotaTeq Adverse Reactions

71,725 infants were evaluated in 3 placebo-controlled clinical trials including 36,165 infants who received RotaTeq and 35,560 infants who received placebo. Parents/guardians were contacted on days 7, 14 and 42 after each dose regarding intussusception and any other serious adverse event.
RotaTeq is generally well tolerated.
In the large-scale (34,837 vaccine recipients and 34,788 placebo recipients), placebo-controlled rotavirus efficacy and safety trial (REST), RotaTeq did not increase the risk of intussusception relative to placebo (see Table 2). Active surveillance was employed to identify potential cases of intussusception at days 7, 14 and 42 after each dose and every 6 weeks thereafter for 1 year after dose 1. There were no confirmed cases of intussusception during the 42-day period after dose 1 and there was no clustering of cases among vaccine recipients at any time period after any dose. Following the 1-year safety follow-up period, 4 cases of intussusception were reported in children who had received placebo during the study. (See Table 2.)


Click on icon to see table/diagram/image


Kawasaki's disease was reported in the phase III clinical trials in <0.1% (5/36,150) of vaccine recipients and <0.1% (1/35,536) of placebo recipients within 42 days of any dose (not statistically significant).
In 11,711 infants (6138 recipients of RotaTeq) from the 3 studies, a Vaccination Report Card was used by parents/guardians to record the child's temperature and any episodes of diarrhea and vomiting on a daily basis during the 1st week following each vaccination. Table 2 summarizes the frequencies of these adverse events, regardless of cause. (See Table 3.)


Click on icon to see table/diagram/image


Parents/guardians of the 11,711 infants were also asked to report the presence of other events on the vaccination report card for 42 days after each dose. The following vaccine-related adverse experiences were observed among recipients of RotaTeq at a frequency of at least 0.3% greater than that was observed among placebo recipients.
Very Common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1000, <1/100); rare (≥1/10,000, <1/1000); very rare (<1/10,000).
Infections and Infestations: Uncommon: Nasopharyngitis (0.6% vaccine recipients, 0.3% placebo recipients).
Gastrointestinal Disorders: Very Common: Diarrhea (17.6% vaccine recipients, 15.1% placebo recipients), vomiting (10.1% vaccine recipients, 8.2% placebo recipients).
General Disorders and Administration Site Conditions: Very Common: Pyrexia (20.9% vaccine recipients, 18.7% placebo recipients).
Other Adverse Events: Otitis media and bronchospasm occurred in more vaccine recipients than placebo recipients (14.5% vs 13% and 1.1% vs 0.7%, respectively) overall; however, among cases that were considered to be vaccine-related in the opinion of the study investigator, the incidence was the same for vaccine and placebo recipients for otitis media (0.3%) and bronchospasm (<0.1%).
Administration of other licensed vaccines was permitted in all studies. The safety of RotaTeq when administered concomitantly with prespecified licensed vaccines including Haemophilus influenzae type b and hepatitis B vaccine, diphtheria and tetanus toxoids and acellular pertussis (DTaP) vaccine, inactivated poliovirus vaccine (IPV), pneumococcal conjugate vaccine and hexavalent vaccines was evaluated in a phase III placebo-controlled study. In a subsequent controlled study, the safety of RotaTeq was well tolerated; the frequency of adverse experiences observed was generally similar to that seen in the control group.
Post-Marketing Reports: The following adverse experiences have been spontaneously reported during post-approval use of RotaTeq. Because these experiences were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or to establish a causal relationship to vaccine exposure.
Skin and Subcutaneous Tissue Disorders: Urticaria.