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Demonstrated efficacy of RotaTeq® (Rotavirus Vaccine, Live, Oral, Pentavalent)

RotaTeq helps to protect patients against RGE

In clinical trial (REST – Study 006), RotaTeq helped protect against RGE caused by G1, G2, G3, and G4.

98%98%

efficacy against severe RGE through season 1 postvaccination (N=5,673: 2,834 vaccine; 2839 placebo)a-c

74%74%

efficacy against RGE of any severity through season 1 postvaccination (N=5,673: 2,834 vaccine; 2,839 placebo)a

~71%~71%

efficacy against RGE of any severity through season 2 postvaccinationa

~96%~96%

reduction in rotavirus-associated hospitalizations through season 2 postvaccination (N=68,038: 34,035 vaccine; 34,003 placebo)a

In a post-hoc analysis of REST, RotaTeq also helped protect against RGE caused by G9.

100%100%

reduction in rotavirus-associated hospitalizations or ED visits caused by G9 in a post hoc analysis of health care utilization data. (N=68,038: 34,035 vaccine; 34,003 placebo)a

Study design

REST (Study 006) was a double-blind, placebo-controlled, randomized, multinational trial from 2001 to 2004. 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. The primary end point was safety with regard to intussusception (N=68,038), with nested safety (N=9,605) and clinical efficacy (N=5,673: RotaTeq n=2,834, placebo n=2839) substudies.1

In clinical trial (Study 029)

74.5%74.5%

efficacy against RGE of any severity caused by G1, G2, G3, G4, and G-serotypes associated with type P1A[8] (eg, G9) (N=761: RotaTeq n=380, placebo n=381)

Study design

Study 029 was a multicenter, randomized, double-blind, placebo-controlled, parallel-group trial conducted in Japan. Healthy infants 6 to 12 weeks of age were randomized to receive 3 doses of RotaTeq or placebo at 4- to 10-week intervals with the third dose given by 32 weeks of age. The primary end point was efficacy against RGE caused by rotavirus types present in the vaccine (ie, G1, G2, G3, G4, and G-serotypes associated with P1A[8] [eg, G9]), occurring at least 14 days post dose 3.2

aPer protocol analysis

bEfficacy end point applies to season 1.

cSevere gastroenteritis defined by a clinical scoring system based on intensity and duration of symptoms of fever, vomiting, diarrhea, and behavioral changes.

ED, emergency department; RGE, rotavirus gastroenteritis.

Helping to protect against RGE since 2006

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CDC recommendations

Find out about the CDC recommendations for rotavirus vaccination in pediatric patients.3

See the CDC recommendations

Rotavirus strain coverage

RotaTeq has broad coverage, indicated to help protect against RGE caused by five strains, including G2.

Explore strain coverage

References

  1. 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
  2. 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. doi:10.4161/hv.24846
  3. Advisory Committee on Immunization Practices (ACIP). Recommended child and adolescent immunization schedule for ages 18 years or younger, United States, 2025. Last reviewed October 7, 2025. Accessed October 27, 2025. https://www.cdc.gov/vaccines/hcp/imz-schedules/downloads/child/0-18yrs-child-combined-schedule.pdf
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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 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

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
Selected Safety Information

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

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.