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Clinical Studies Experience
71,725 infants were evaluated in 3 placebo-controlled clinical trials including 36,165 infants in the group that received RotaTeq (rotavirus vaccine, live, oral, pentavalent) and 35,560 infants in the group that received placebo. Parents/guardians were contacted on days 7, 14, and 42 after each dose regarding intussusception and any other serious adverse events. The racial distribution was as follows: White (69% in both groups); Hispanic-American (14% in both groups); Black (8% in both groups); Multiracial (5% in both groups); Asian (2% in both groups); Native American (RotaTeq (rotavirus vaccine, live, oral, pentavalent) 2%, placebo 1%); and Other ( < 1% in both groups). The gender distribution was 51% male and 49% female in both vaccination groups.
Because clinical trials are conducted under conditions that may not be typical of those observed in clinical practice, the adverse reaction rates presented below may not be reflective of those observed in clinical practice.
Serious Adverse Events
Serious adverse events occurred in 2.4% of recipients of RotaTeq (rotavirus vaccine, live, oral, pentavalent) when compared to 2.6% of placebo recipients within the 42-day period of a dose in the phase 3 clinical studies of RotaTeq (rotavirus vaccine, live, oral, pentavalent) . The most frequently reported serious adverse events for RotaTeq (rotavirus vaccine, live, oral, pentavalent) compared to placebo were:
bronchiolitis (0.6% RotaTeq (rotavirus vaccine, live, oral, pentavalent) vs. 0.7% Placebo),
gastroenteritis (0.2% RotaTeq (rotavirus vaccine, live, oral, pentavalent) vs. 0.3% Placebo),
pneumonia (0.2% RotaTeq (rotavirus vaccine, live, oral, pentavalent) vs. 0.2% Placebo),
fever (0.1% RotaTeq (rotavirus vaccine, live, oral, pentavalent) vs. 0.1% Placebo), and
urinary tract infection (0.1% RotaTeq (rotavirus vaccine, live, oral, pentavalent) vs. 0.1% Placebo).
Across the clinical studies, 52 deaths were reported. There were 25 deaths in the RotaTeq (rotavirus vaccine, live, oral, pentavalent) recipients compared to 27 deaths in the placebo recipients. The most commonly reported cause of death was sudden infant death syndrome, which was observed in 8 recipients of RotaTeq (rotavirus vaccine, live, oral, pentavalent) and 9 placebo recipients.
In REST, 34,837 vaccine recipients and 34,788 placebo recipients were monitored by active surveillance to identify potential cases of intussusception at 7, 14, and 42 days after each dose, and every 6 weeks thereafter for 1 year after the first dose.
For the primary safety outcome, cases of intussusception occurring within 42 days of any dose, there were 6 cases among RotaTeq (rotavirus vaccine, live, oral, pentavalent) recipients and 5 cases among placebo recipients (see Table 1). The data did not suggest an increased risk of intussusception relative to placebo.
Table 1: Confirmed cases of intussusception in recipients
of RotaTeq (rotavirus vaccine, live, oral, pentavalent) as compared with placebo recipients during REST
|Confirmed intussusception cases within 42 days of any dose
Relative risk (95% CI) *
|1.6 (0.4, 6.4)|
|Confirmed intussusception cases within 365 days of dose
Relative risk (95% CI)
|0.9 (0.4, 1.9)|
|*Relative risk and 95% confidence interval based upon group sequential design stopping criteria employed in REST.|
Among vaccine recipients, there were no confirmed cases of intussusception within the 42-day period after the first dose, which was the period of highest risk for the rhesus rotavirus-based product (see Table 2).
Table 2: Intussusception cases by day range in relation to
dose in REST
|Day Range||Dose1||Dose 2||Dose 3||Any Dose|
All of the children who developed intussusception recovered without sequelae with the exception of a 9-month-old male who developed intussusception 98 days after dose 3 and died of post-operative sepsis. There was a single case of intussusception among 2,470 recipients of RotaTeq (rotavirus vaccine, live, oral, pentavalent) in a 7-month-old male in the phase 1 and 2 studies (716 placebo recipients).
Hematochezia reported as an adverse experience occurred in 0.6% (39/6,130) of vaccine and 0.6% (34/5,560) of placebo recipients within 42 days of any dose. Hematochezia reported as a serious adverse experience occurred in < 0.1% (4/36,150) of vaccine and < 0.1% (7/35,536) of placebo recipients within 42 days of any dose.
All seizures reported in the phase 3 trials of RotaTeq (rotavirus vaccine, live, oral, pentavalent) (by vaccination group and interval after dose) are shown in Table 3.
Table 3: Seizures reported by day range in relation to any
dose in the phase 3 trials of RotaTeq (rotavirus vaccine, live, oral, pentavalent)
Seizures reported as serious adverse experiences occurred in < 0.1% (27/36,150) of vaccine and < 0.1% (18/35,536) of placebo recipients (not significant). Ten febrile seizures were reported as serious adverse experiences, 5 were observed in vaccine recipients and 5 in placebo recipients.
In the phase 3 clinical trials, infants were followed for up to 42 days of vaccine dose. Kawasaki disease was reported in 5 of 36,150 vaccine recipients and in 1 of 35,536 placebo recipients with unadjusted relative risk 4.9 (95% CI 0.6, 239.1).
Most Common Adverse Events
Solicited Adverse Events
Detailed safety information was collected from 11,711 infants (6,138 recipients of RotaTeq (rotavirus vaccine, live, oral, pentavalent) ) which included a subset of subjects in REST and all subjects from Studies 007 and 009 (Detailed Safety Cohort). 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 first week following each vaccination. Table 4 summarizes the frequencies of these adverse events and irritability.
Table 4: Solicited adverse experiences within the first week
after doses 1, 2, and 3 (Detailed Safety Cohort)
||Dose 1||Dose 2||Dose 3|
|*Temperature ≥ 100.5°F [38.1°C] rectal equivalent obtained by adding 1 degree F to otic and oral temperatures and 2 degrees F to axillary temperatures|
Other Adverse Events
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.
Fever was observed at similar rates in vaccine (N=6,138) and placebo (N=5,573) recipients (42.6% vs. 42.8%). Adverse events that occurred at a statistically higher incidence (i.e., 2-sided p-value < 0.05) within the 42 days of any dose among recipients of RotaTeq (rotavirus vaccine, live, oral, pentavalent) as compared with placebo recipients are shown in Table 5.
Table 5: Adverse events that occurred at a statistically higher incidence within 42 days of any dose among recipients of RotaTeq (rotavirus vaccine, live, oral, pentavalent) as compared with placebo recipients
|Adverse event||RotaTeq (rotavirus vaccine, live, oral, pentavalent)
|Diarrhea||1,479 (24.1%)||1,186 (21.3%)|
|Vomiting||929 (15.2%)||758 (13.6%)|
|Otitis media||887 (14.5%)||724 (13.0%)|
|Nasopharyngitis||422 (6.9%)||325 (5.8%)|
|Bronchospasm||66 (1.1%)||40 (0.7%)|
Safety in Pre-Term Infants
RotaTeq (rotavirus vaccine, live, oral, pentavalent) or placebo was administered to 2,070 pre-term infants (25 to 36 weeks gestational age, median 34 weeks) according to their age in weeks since birth in REST. All pre-term infants were followed for serious adverse experiences; a subset of 308 infants was monitored for all adverse experiences. There were 4 deaths throughout the study, 2 among vaccine recipients (1 SIDS and 1 motor vehicle accident) and 2 among placebo recipients (1 SIDS and 1 unknown cause). No cases of intussusception were reported. Serious adverse experiences occurred in 5.5% of vaccine and 5.8% of placebo recipients. The most common serious adverse experience was bronchiolitis, which occurred in 1.4% of vaccine and 2.0% of placebo recipients. Parents/guardians were asked to record the child's temperature and any episodes of vomiting and diarrhea daily for the first week following vaccination. The frequencies of these adverse experiences and irritability within the week after dose 1 are summarized in Table 6.
Table 6: Solicited adverse experiences within the first week
of doses 1, 2, and 3 among pre-term infants
|Adverse event||Dose 1||Dose 2||Dose 3|
|*Temperature 100.5°F [38.1°C] rectal equivalent obtained by adding 1 degree F to otic and oral temperatures and 2 degrees F to axillary temperatures|
The following adverse events have been identified during post-approval use of RotaTeq (rotavirus vaccine, live, oral, pentavalent) from reports to the Vaccine Adverse Event Reporting System (VAERS).
Reporting of adverse events following immunization to VAERS is voluntary, and the number of doses of vaccine administered is not known; therefore, it is not always possible to reliably estimate the adverse event frequency or establish a causal relationship to vaccine exposure using VAERS data.
In post-marketing experience, the following adverse events have been reported in infants who have received RotaTeq (rotavirus vaccine, live, oral, pentavalent) :
Intussusception (including death)
Skin and subcutaneous tissue disorders
Infections and infestations
Reporting Adverse Events
Parents or guardians should be instructed to report any adverse reactions to their health care provider.
Health care providers should report all adverse events to the U.S. Department of Health and Human Services' Vaccine Adverse Events Reporting System (VAERS).
VAERS accepts all reports of suspected adverse events after the administration of any vaccine, including but not limited to the reporting of events required by the National Childhood Vaccine Injury Act of 1986. For information or a copy of the vaccine reporting form, call the VAERS toll-free number at 1-800-822-7967 or report on line to www.vaers.hhs.gov.2
Read the RotaTeq (rotavirus vaccine, live, oral, pentavalent) Side Effects Center for a complete guide to possible side effects »
Immunosuppressive therapies including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids (used in greater than physiologic doses), may reduce the immune response to vaccines.
Concomitant Vaccine Administration
In clinical trials, RotaTeq (rotavirus vaccine, live, oral, pentavalent) was administered concomitantly with diphtheria and tetanus toxoids and acellular pertussis (DTaP), inactivated poliovirus vaccine (IPV), H. influenzae type b conjugate (Hib), hepatitis B vaccine, and pneumococcal conjugate vaccine [see Clinical Studies]. The safety data available are in the ADVERSE REACTIONS section [see ADVERSE REACTIONS].
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 (rotavirus vaccine, live, oral, pentavalent) . However, insufficient immunogenicity data are available to confirm lack of interference of immune responses when RotaTeq (rotavirus vaccine, live, oral, pentavalent) is concomitantly administered with childhood vaccines to prevent pertussis.
Last reviewed on RxList: 8/28/2008
This monograph has been modified to include the generic and brand name in many instances.
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