Approximately 70,000 infants were evaluated in 12 countries to assess the safety profile of RotaTeq.²

REST (Study 006) was a double-blind, placebo-controlled, randomized trial designed to evaluate safety with respect to IS. Healthy infants 6 to 12 weeks of age were randomized to receive 3 oral doses of RotaTeq or placebo at 4- to 10-week intervals.²

RotaTeq did not increase the risk of IS relative to placebo²

Confirmed IS cases	RotaTeq (n=34,837)	Placebo (n=34,788)
Within 42 days of any dose	6	5
Within 1 year of Dose 1	13	15

In postmarketing experience, IS (including death) and Kawasaki disease have been reported in infants who have received RotaTeq.²

In a subset of more than 11,000 infants in 3 placebo-controlled clinical 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

Adverse event	RotaTeq (n=6,138)	Placebo (n=5,573)
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%

Most frequently reported SAEs

SAE	RotaTeq (n=36,165)	Placebo (n=35,560)
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%

Hematochezia reported as an SAE for RotaTeq compared with placebo was <0.1% vs <0.1%.

During 3 placebo-controlled clinical trials, rates of SAEs within 42 days were similar in infants receiving RotaTeq (2.4%) compared with placebo recipients (2.6%).

SAE, serious adverse event.

Rates of viral shedding in vaccine recipients after Doses 1-3³

Dose 1: 8.9% (n=360; 95% CI: 6.2%, 12.3%)

Dose 2: 0.0% (n=249; 95% CI: 0.0%, 1.5%)

Dose 3: 0.3% (n=385; 95% CI: <0.1%, 1.4%)

In clinical trials, shedding was observed as early as 1 day and as late as 15 days after a dose. Transmission was not evaluated in clinical trials.³

Transmission of vaccine virus strains from vaccinees to nonvaccinated contacts has been observed postmarketing.

The potential risk of transmission of vaccine virus should be weighed against the risk of acquiring and transmitting natural rotavirus.

The safety of RotaTeq was also assessed in two postmarketing studies.

The temporal association between vaccination with RotaTeq and IS was evaluated in the PRISM program, an electronic active surveillance program comprising 3 US health insurance plans.

Cases of IS were observed in temporal association within 21 days following the first dose of RotaTeq, with a clustering of cases in the first 7 days.^a

^aMore than 1.2 million vaccinations of RotaTeq (507,000 of which were first doses) administered to infants 5 through 36 weeks of age were evaluated. From 2004 through 2011, potential cases of IS in either the inpatient or emergency department setting and vaccine exposures were identified through electronic procedure and diagnosis codes. Medical records were reviewed to confirm intussusception and rotavirus vaccination status. The risk of intussusception was assessed using self-controlled risk interval and cohort designs, with adjustment for age. Risk windows of 1 to 7 and 1 to 21 days were evaluated.

FDA, Food and Drug Administration; IS, Intussusception; PRISM, Post-licensure Rapid Immunization Safety Monitoring.

In an earlier prospective postmarketing observational cohort study conducted using a large US medical claims database, the risks of IS or Kawasaki disease resulting in emergency department visits or hospitalizations during the 30 days following any dose of vaccine were analyzed among 85,150 infants receiving 1 or more doses of RotaTeq from February 2006 through March 2009.^b

No statistically significant increased risk of IS after vaccination with RotaTeq was observed.

^bMedical charts were reviewed to confirm these diagnoses. Evaluation included concurrent (n=62,617) and historical (n=100,000 from 2001-2005) control groups of infants who received vaccine DTaP but not RotaTeq. Confirmed intussusception cases in the group receiving RotaTeq were compared with those in the concurrent DTaP control group and in the historical control group. The data were analyzed post dose 1 and post any dose, in both 7-day and 30-day risk windows. In addition, general safety was monitored by electronic search of the automated records database for all emergency department visits and hospitalizations in the 30-day period after each dose of RotaTeq compared with: 1) days 31 to 60 after each dose of RotaTeq (self-matched controls) and 2) the 30-day period after each dose of DTaP vaccine (historical control subset from 2004-2005, n=40,000).

CI, confidence interval; DTaP, Diphtheria, Tetanus, and Pertussis.