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Safety profile for RotaTeq® (Rotavirus Vaccine, Live, Oral, Pentavalent)

RotaTeq® (Rotavirus Vaccine, Live, Oral, Pentavalent) was studied in one of the largest pediatric vaccine trials in history1

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

No increased risk of intussusception (IS)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 casesRotaTeq
(n=34,837)
Placebo
(n=34,788)
Within 42 days of any dose65
Within 1 year of Dose 11315

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

Adverse events from Phase III trials

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 eventRotaTeq
(n=6,138)
Placebo
(n=5,573)
Diarrhea24.1%21.3%
Vomiting15.2%13.6%
Otitis media14.5%13.0%
Nasopharyngitis6.9%5.8%
Bronchospasm1.1%0.7%

Most frequently reported SAEs

SAERotaTeq
(n=36,165)
Placebo
(n=35,560)
Bronchiolitis0.6%0.7%
Gastroenteritis0.2%0.3%
Pneumonia0.2%0.2%
Fever0.1%0.1%
Urinary tract infection0.1%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.

Low rates of transmission and shedding

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.

Postmarketing observational safety surveillance studies

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

FDA’s PRISM Study

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.

Merck’s postmarketing safety study

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.

  • One confirmed case of Kawasaki disease (23 days post dose 3) was identified among infants vaccinated with RotaTeq, and one confirmed case of Kawasaki disease (22 days post dose 2) was identified among concurrent DTaP controls (relative risk = 0.7; 95% CI: 0.01-55.56).
  • In safety analyses evaluating multiple follow-up windows after vaccination (days: 0-7, 1-7, 8-14, and 0-30), no safety concerns were identified for infants vaccinated with RotaTeq when compared with self-matched controls and the historical control subset.

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.


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ACIP recommendations

Find out about the ACIP recommendations for rotavirus vaccination in pediatric patients.4

See the ACIP recommendations

Dosing and administration

Review the dosing schedule and administration of RotaTeq.

Learn more

References

  1. Glass RI, Parashar UD. The promise of new rotavirus vaccines. N Engl J Med. 2006;354(1):75-77. doi:10.1056/NEJMe058285
  2. Vesikari T, Matson DO, Dennehy P, et al; Rotavirus Efficacy and Safety Trial (REST) study team. Safety and efficacy of a pentavalent human-bovine (WC3) reassortant rotavirus vaccine. N Engl J Med. 2006;354(7):23-33. doi:10.1056/NEJMoa052664
  3. Dennehy PH, Goveia MG, Dallas MJ, et al. The integrated phase III safety profile of the pentavalent human-bovine (WC3) reassortant vaccine. Int J Infect Dis. 2007;11(suppl 2):S36-S42. doi:10.1016/S1201-9712(07)60020-4
  4. Advisory Committee on Immunization Practices (ACIP). Recommended child and adolescent immunization schedule for ages 18 years or younger, United States, 2024. Accessed May 29, 2024. https://www.cdc.gov/vaccines/schedules/downloads/child/0-18yrs-child-combined-schedule.pdf
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Indications and Usage for RotaTeq® (Rotavirus Vaccine, Live, Oral, Pentavalent)

RotaTeq is indicated for the prevention of rotavirus gastroenteritis in infants and children caused by Types G1, G2, G3, G4, and G9 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.

 

The vaccination series consists of 3 ready-to-use liquid doses of RotaTeq administered orally starting at 6 to 12 weeks of age, with the subsequent doses administered at 4- to 10-week intervals. The third dose should not be given after 32 weeks of age.

Selected Safety Information for RotaTeq® (Rotavirus Vaccine, Live, Oral, Pentavalent)

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

 

Infants with Severe Combined Immunodeficiency Disease (SCID) should not receive RotaTeq. Post-marketing reports of gastroenteritis, including severe diarrhea and prolonged shedding of vaccine virus, have been reported in infants who were administered RotaTeq and later identified as having SCID.

 

Infants with a history of intussusception should not receive RotaTeq.

 

No safety or efficacy data are available from clinical trials regarding the administration of RotaTeq to infants who are potentially immunocompromised.

 

In a post-marketing observational study in the US, cases of intussusception were observed in temporal association within 21 days following the first dose of RotaTeq, with a clustering of cases in the first 7 days.

 

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

 

Vaccine virus transmission from vaccine recipient to nonvaccinated contacts has been reported. Caution is advised when considering whether to administer RotaTeq to individuals with immunodeficient contacts.

 

In clinical trials, the most common adverse events included diarrhea, vomiting, irritability, otitis media, nasopharyngitis, and bronchospasm.

 

In post-marketing experience, intussusception (including death) and Kawasaki disease have been reported in infants who have received RotaTeq.

 

RotaTeq may not protect all vaccine recipients against rotavirus.

 

Before administering RotaTeq, please read the accompanying Prescribing Information. The Patient Product Information also is available.

Indications and Usage for RotaTeq® (Rotavirus Vaccine, Live, Oral, Pentavalent)

RotaTeq is indicated for the prevention of rotavirus gastroenteritis in infants and children caused by Types G1, G2, G3, G4, and G9 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.

 

The vaccination series consists of 3 ready-to-use liquid doses of RotaTeq administered orally starting at 6 to 12 weeks of age, with the subsequent doses administered at 4- to 10-week intervals. The third dose should not be given after 32 weeks of age.

RotaTeq is indicated for the prevention of rotavirus gastroenteritis in infants and children

RotaTeq is indicated for the prevention of rotavirus gastroenteritis in infants and children caused by Types G1, G2, G3, G4, and G9 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.

Selected Safety Information for RotaTeq® (Rotavirus Vaccine, Live, Oral, Pentavalent)

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

 

Infants with Severe Combined Immunodeficiency Disease (SCID) should not receive RotaTeq. Post-marketing reports of gastroenteritis, including severe diarrhea and prolonged shedding of vaccine virus, have been reported in infants who were administered RotaTeq and later identified as having SCID.

 

Infants with a history of intussusception should not receive RotaTeq.

 

No safety or efficacy data are available from clinical trials regarding the administration of RotaTeq to infants who are potentially immunocompromised.

 

In a post-marketing observational study in the US, cases of intussusception were observed in temporal association within 21 days following the first dose of RotaTeq, with a clustering of cases in the first 7 days.

 

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

 

Vaccine virus transmission from vaccine recipient to nonvaccinated contacts has been reported. Caution is advised when considering whether to administer RotaTeq to individuals with immunodeficient contacts.

 

In clinical trials, the most common adverse events included diarrhea, vomiting, irritability, otitis media, nasopharyngitis, and bronchospasm.

 

In post-marketing experience, intussusception (including death) and Kawasaki disease have been reported in infants who have received RotaTeq.

 

RotaTeq may not protect all vaccine recipients against rotavirus.

 

Before administering RotaTeq, please read the accompanying Prescribing Information. The Patient Product Information also is available.

RotaTeq should not be administered to infants with a demonstrated history of hypersensitivity

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

Infants with Severe Combined Immunodeficiency Disease (SCID) should not receive RotaTeq. Post-marketing reports of gastroenteritis, including severe diarrhea and prolonged