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.

Strains vary season to season7

In the Postvaccination Era, Several Rotavirus Strains Have Been Prevalent in the US

In the postvaccination era, several rotavirus strains have been prevalent in the US.

In 2006, G1P[8] Was Shown to Be the Most Prevalent Rotavirus Strain in a Surveillance Study With a Sample Size of 193
In 2007, G1P[8] and G12P[8] Were Shown to Be the Most Prevalent Rotavirus Strains in a Surveillance Study With a Sample Size of 232
In 2008, G1P[8] Was Shown to Be the Most Prevalent Rotavirus Strain in a Surveillance Study With a Sample Size of 26
In 2009, There Were Multiple Prevalent Rotavirus Strains in a Surveillance Study With a Sample Size of 117
In 2010, The Majority of Prevalent Rotavirus Strains Were Non-Typeable in a Surveillance Study With a Sample Size of 9
In 2011, G3P[8] Was Shown to Be the Most Prevalent Rotavirus Strain in a Surveillance Study With a Sample Size of 80
In 2012, G12P[8] Was Shown to Be the Most Prevalent Rotavirus Strain in a Surveillance Study With a Sample Size of 2
In 2013, G12P[8] Was Shown to Be the Most Prevalent Rotavirus Strain in a Surveillance Study With a Sample Size of 102
In 2014, There Were Multiple Prevalent Rotavirus Strains in a Surveillance Study With a Sample Size of 26
In 2015, G12P[8] Was Shown to Be the Most Prevalent Rotavirus Strain in a Surveillance Study With a Sample Size of 118
In 2016, G12P[8] Was Shown to Be the Most Prevalent Rotavirus Strain in a Surveillance Study With a Sample Size of 23
In an 11-Year Surveillance Study, Several Rotavirus Strains Have Been Prevalent in the US
In an 11-Year Surveillance Study, Several Rotavirus Strains Have Been Prevalent in the US

11-YEAR ACTIVE SURVEILLANCE STUDY SHOWED ROTAVIRUS STRAINS VARIED SIGNIFICANTLY SEASON TO SEASON7


aThe New Vaccine Surveillance Network (NVSN) conducted active surveillance for hospitalization and visits to the emergency department due to acute gastroenteritis in children <3 years of age from 3 US counties during the 2006 to 2016 seasons. Among 6,954 whole stool specimens collected, 928 tested positive for rotavirus and were submitted to the CDC for genotyping.

Mixed, mixed genotypes; n, number of samples genotyped; NT, non-typeable genotypes.
CDC, Centers for Disease Control and Prevention.

ref7

Reference

  1. 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 Feb 15. DOI: 10.1093/cid/ciaa150.

Indications and Usage for RotaTeq

RotaTeq® (Rotavirus Vaccine, Live, Oral, Pentavalent) 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 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.

RotaTeq® (Rotavirus Vaccine, Live, Oral, Pentavalent) 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 accompanying Prescribing Information. The Patient Product Information also is available.

RotaTeq® (Rotavirus Vaccine, Live, Oral, Pentavalent) 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.

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US-ROT-00476 08/21