Indications and Usage
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
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 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® (Rotavirus Vaccine, Live, Oral, Pentavalent), please read the Prescribing Information. The Patient Product Information also is available.
1. | Rotarix [prescribing information]. Research Triangle Park, NC: GlaxoSmithKline; 2016. |
2. | Glass RI, Parashar UD. The promise of new rotavirus vaccines. N Engl J Med. 2006;354(1):75–77. |
3. | Dennis AF, McDonald SM, Payne DC, et al. Molecular epidemiology of contemporary G2P[4] human rotaviruses cocirculating in a single U.S. community: footprints of a globally transitioning genotype. J Virol. 2014;88(7):3789–3801. |
4. | Matthijnssens J, Van Ranst M. Genotype constellation and evolution of group A rotaviruses infecting humans. Curr Opin Virol. 2012;2(4):426–433. |
5. | Bowen MD, Mijatovic-Rustempasic S, Esona MD, et al. Rotavirus strain trends during the postlicensure vaccine era: United States, 2008–2013. J Infect Dis. 2016;214(5):732–738. |
6. | Vesikari T, Matson DO, Dennehy P, et al; For the 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(1):23–33. |
7. | Itzler R, Koch G, Matson DO, et al. Robustness of healthcare utilization results from the Rotavirus Efficacy and Safety Trial (REST) evaluating the human-bovine (WC3) reassortant pentavalent rotavirus vaccine (RV5). BMC Pediatr. 2010;10:42. |
8. | Iwata S, Nakata S, Ukae S, et al. Efficacy and safety of pentavalent rotavirus vaccine in Japan: a randomized, double-blind, placebo-controlled, multicenter trial. Hum Vaccin Immunother. 2013;9(8):1626–1633. |
9. | Dennehy PH, Goveia MG, Dallas MJ, et al. The integrated Phase III safety profile of the pentavalent human-bovine (WC3) reassortant rotavirus vaccine. Int J Infect Dis. 2007;11(suppl 2):S36–S42. |
10. | Centers for Disease Control and Prevention (CDC). Recommended immunization schedule for children and adolescents aged 18 years or younger, United States, 2018. https://www.cdc.gov/vaccines/schedules/ downloads/child/0-18yrs-child-combined-schedule.pdf. Accessed May 9, 2018. |
11. | Centers for Disease Control and Prevention (CDC). Advisory Committee on Immunization Practices, Vaccines for Children program, Vaccines to prevent rotavirus gastroenteritis. https://www.cdc.gov/vaccines/programs/vfc/downloads/resolutions/0608-rotavirus.pdf. Effective June 25, 2008. Accessed May 9, 2018. |
12. | Centers for Disease Control and Prevention (CDC). Storage and handling. In: Hamborsky J, Kroger A, Wolfe S, eds. Epidemiology and Prevention of Vaccine-Preventable Diseases. 13th ed. Washington, DC: Public Health Foundation; 2015:63–78. |
13. | Committee on Infectious Diseases; American Academy of Pediatrics (AAP). Prevention of rotavirus disease: updated guidelines for use of rotavirus vaccine. Pediatrics. 2009;123(5):1412–1420. |
14. | Centers for Disease Control and Prevention (CDC). Prevention of rotavirus gastroenteritis among infants and children: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2009;58(RR-2):1–25. |
Selected Safety Information for RotaTeq® (Rotavirus Vaccine, Live, Oral, Pentavalent)
Selected Safety Information for
- 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® (Rotavirus Vaccine, Live, Oral, Pentavalent), please read the Prescribing Information. The Patient Product Information also is available.