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.

Rotavirus Type G2

The only rotavirus vaccine with an indication that includes G2:

CURRENTLY LICENSED
ROTAVIRUS VACCINES
RotaTeq
Rotarix®
(Rotavirus Vaccine, Live, Oral)4

G-TYPE VACCINE INDICATIONS

Products mentioned are trademarks of their respective owners.

G2 type—genetically distinct from other common rotavirus types5,6

The 5 most common rotavirus strains belong to 2 distinct, minimally related genogroups.5,6

Wa Genogroup
DS-1 Genogroup

  • Of the common types, G1, G3, G4, and G9 are typically associated with protein p[8], while G2 is commonly associated with protein p[4].5,6
  • In other words, G2 strains generally do not share either G or P surface proteins with the other most common rotavirus G types.5,6

G2P[4] was the third most prevalent rotavirus strain identified in the US during seasons 2009–20137,a

Genotypes identified during 5 rotavirus seasons7,b
Genotypes Identified During 5 Rotavirus Seasons
Genotypes Identified During 5 Rotavirus Seasons
G1P[8]
G2P[4]
G3P[8]
G9P[8]
G12P[8]c
Othersd

  1. aThe New Vaccine Surveillance Network (NVSN) conducted active surveillance for acute gastroenteritis in the US from 2008 to 2013. During the study period, 1,523 samples from NVSN sites that tested positive for rotavirus were submitted to the CDC for genotyping.7
  1. bG4 type detected sporadically over the study period.7
  1. cRotateq is not indicated for G12 type.
  1. dOthers=other genotypes, mixed genotypes, nontypeable.7

CDC=Centers for Disease Control and Prevention.

ref1

Reference

  1. Centers for Disease Control and Prevention (CDC). Recommended Child and Adolescent Immunization Schedule for ages 18 years or younger, United States 2019. https://www.cdc.gov/vaccines/schedules/ downloads/child/0-18yrs-child-combined-schedule.pdf. Published February 22, 2019. Accessed October 22, 2019.
ref4

Reference

  1. Rotarix [prescribing information]. Research Triangle Park, NC: GlaxoSmithKline; 2019.
ref5

Reference

  1. 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.
ref6

Reference

  1. Matthijnssens J, Van Ranst M. Genotype constellation and evolution of group A rotaviruses infecting humans. Curr Opin Virol. 2012;2(4):426–433.
ref7

Reference

  1. 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.

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. Postmarketing 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 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.


US-ROT-00187 03/20