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Vaccine Detail

RotaTeq
Vaccine Information
  • Vaccine Name: RotaTeq
  • Target Pathogen: Rotavirus
  • Target Disease: Gastroenteritis
  • Product Name: Rotavirus Vaccine, Live, Oral, Pentavalent
  • Tradename: RotaTeq
  • Manufacturer: Merck & Co., Inc, USA License #0002
  • Vaccine Ontology ID: VO_0000097
  • CDC CVX code: 116
  • Type: Live, attenuated vaccine
  • Status: Licensed
  • Location Licensed: USA (License #0002)
  • Host Species for Licensed Use: Human
  • Antigen: 5 live reassortant rotaviruses: Four reassortant rotaviruses express one of the outer capsid proteins (G1, G2, G3, or G4) from the human rotavirus parent strain and the attachment protein (serotype P7) from the bovine rotavirus parent strain. The fifth reassortant virus expresses the attachment protein, P1A (genotype P[8]), herein referred to as serotype P1A[8], from the human rotavirus parent strain and the outer capsid protein of serotype G6 from the ovine rotavirus parent strain (FDA: ROTARIX).
  • Preparation: RotaTeq is a live, oral pentavalent vaccine that contains 5 live reassortant rotaviruses. The reassortants are propagated in Vero cells using standard cell culture techniques in the absence of antifungal agents. The reassortants are suspended in a buffered stabilizer solution. RotaTeq contains no preservatives (FDA: ROTARIX).
  • Storage: Store and transport refrigerated at 2-8°C (36-46°F).
  • Contraindication: A demonstrated history of hypersensitivity to any component of the vaccine. Infants who develop symptoms suggestive of hypersensitivity after receiving a dose of ROTATEQ should not receive further doses of ROTATEQ.
  • Description: Indication: Prevention of rotavirus gastroenteritis in infants and children caused by the serotypes G1, G2, G3, and G4 when administered as a 3-dose series to infants between the ages of 6 to 32 weeks (FDA: ROTARIX).
Host Response

Human Response

  • Vaccination Protocol: 71,725 infants were evaluated in 3 placebo-controlled clinical trials including 36,165 infants who received RotaTeq and 35,560 infants who received placebo (FDA: RotaTeq).
  • Side Effects: Possible side effects of vaccinations include: intussusception, vomiting, diarrhea, irrittability

Human Response

  • Vaccination Protocol: 72,324 infants were randomized in 3 placebo-controlled, phase 3 studies conducted in 11 countries on 3 continents. The vaccine was given as a three-dose series to healthy infants with the first dose administered between 6 and 12 weeks of age and followed by two additional doses administered at 4- to 10-week intervals (FDA: RotaTeq).
  • Immune Response: 92.9% to 100% of 439 recipients of RotaTeq achieved a 3-fold or more rise in serum anti-rotavirus IgA after a three-dose regimen.
  • Efficacy: Primary efficacy against any grade of severity of rotavirus gastroenteritis caused by naturally occurring serotypes G1, G2, G3, or G4 through the first rotavirus season after vaccination was 74.0% (FDA: RotaTeq).
References
FDA: ROTARIX: FDA: ROTARIX vaccine information [http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm133920.htm]
FDA: RotaTeq: FDA: RotaTeq vaccine information [http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm094063.htm]