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 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® (Rotavirus Vaccine, Live, Oral, Pentavalent), please read the Prescribing Information. The Patient Product Information also is available.

1. 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.
2. 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.
3. Glass RI, Parashar UD. The promise of new rotavirus vaccines. N Engl J Med. 2006;354(1):75–77.
4. 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.
5. 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.
6. 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.
7. 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.
8. 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.
9. Centers for Disease Control and Prevention (CDC). Recommended immunization schedule for children and adolescents aged 18 years or younger, United States, 2017. http://www.cdc.gov/vaccines/schedules/downloads/
child/0-18yrs-child-combined-schedule.pdf. Effective January 1, 2017. Accessed March 24, 2017.

Efficacy

Primary Efficacy in REST (Study 006)

Efficacy against mild, moderate, and severe rotavirus gastroenteritis infection
High-level efficacy against RGE
  • Caused by common Types G1, G2, G3, G4 through the first rotavirus season postvaccination (n=5,673: 2,834, vaccine; 2,839, placebo):

    98% efficacy against severe RGE

    74% efficacy against mild, moderate, and severe RGE

  • Efficacy against mild, moderate, and severe RGE caused by rotavirus Types G1, G2, G3, and G4 through the 2 rotavirus seasons postvaccination was 71%.
  • Caused by common Types G1, G2, G3, G4 through the first rotavirus season postvaccination (n=5,673: 2,834, vaccine; 2,839, placebo):

    98% efficacy against severe RGE

    74% efficacy against mild, moderate, and severe RGE

  • Efficacy against mild, moderate, and severe RGE caused by rotavirus Types G1, G2, G3, and G4 through the 2 rotavirus seasons postvaccination was 71%.
RGE=rotavirus gastroenteritis.
aStudy design: REST (Study 006) was a double-blind, placebo-controlled, randomized, multinational trial conducted 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 endpoint was safety with regard to intussusception, with nested adverse event and clinical efficacy substudies.1

Hospitalizations or ED Visits

Help reduce hospitalizations due to RGE

RotaTeq substantially reduced hospitalizations or emergency department (ED) visits due to RGE caused by Types G1, G2, G3, and G4 through 2 years postvaccination in REST (Study 006).1,2

~95%
reduction

(N=68,038: 34,035,
vaccine: 34,003,
placebo)

Substantial reductions also demonstrated in
a post hoc analysis from REST (Study 006) through
2 years postvaccination

100% reduction in hospitalizations or ED visits
due to RGE caused by Type G9

(95% CI: 69.6%, 100%) (N=68,038: 34,035, vaccine; 34,003, placebo) (RotaTeq, 0 cases; placebo, 14 cases)2

CI=confidence interval; REST=Rotavirus Efficacy and Safety Trial; RGE=rotavirus gastroenteritis.

Primary Efficacy in Study 029

Efficacy demonstrated against RGE caused by rotavirus Types G1, G2, G3, G4, G-Types associated with P1A[8] (eg, G9)4,b
bStudy design: 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 endpoint was efficacy against RGE caused by rotavirus types present in the vaccine (ie, G1, G2, G3, G4, and G types associated with P1A[8]), occurring at least 14 days post Dose 3. 4

74.5%
efficacy against mild, moderate, and severe RGE

(N=710: 356, vaccine; 354, placebo)

bStudy design: 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 endpoint was efficacy against RGE caused by rotavirus types present in the vaccine (ie, G1, G2, G3, G4, and G types associated with P1A[8]), occurring at least 14 days post Dose 3. 4

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 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® (Rotavirus Vaccine, Live, Oral, Pentavalent), please read the Prescribing Information. The Patient Product Information also is available.

VACC-1175002-0004 06/17