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Demonstrated efficacy of RotaTeq

RotaTeq helps to protect patients against RGE

In clinical trials, RotaTeq helped protect against RGE caused by G1, G2, G3, and G4.

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

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

against RGE of any severity through season 2 postvaccinationa

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

In clinical trials, RotaTeq also helped protect against RGE caused by G9.

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

efficacy against RGE of any severity caused by G1, G2, G3, G4, and G-serotypes associated with type P1A[8] (eg, G9) (N=761: 380 vaccine; 381 placebo)2,a

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 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

aRotavirus season is defined as December through June.3

ED, emergency department; RGE, rotavirus gastroenteritis.

Helping to protect against RGE since 2006

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ACIP recommendations

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

See the ACIP recommendations

Rotavirus strain coverage

Learn why broad coverage matters and how RotaTeq helps protect against RGE caused by 5 strains of rotavirus, including G2.5

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. Centers for Disease Control and Prevention (CDC). Rotavirus, about the vaccine. Updated March 25, 2021. Accessed May 29, 2024. https://www.cdc.gov/vaccines/vpd/rotavirus/hcp/about-vaccine.html
  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
  5. Staat MA, Payne DC, Halasa N, et al. Continued evidence of the impact of rotavirus vaccine in children less than 3 years of age from the United States New Vaccine Surveillance Network: a multisite active surveillance program, 2006-2016. Clin Infect Dis. 2020;71(9):e421-e429. doi:10.1093/cid/ciaa150
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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