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Vaccine Detail

ROTARIX
Vaccine Information
  • Vaccine Name: ROTARIX
  • Target Pathogen: Rotavirus
  • Target Disease: Gastroenteritis
  • Product Name: Rotavirus Vaccine, Live, Oral
  • Tradename: ROTARIX
  • Manufacturer: GlaxoSmithKline Biologicals
  • Vaccine Ontology ID: VO_0000093
  • CDC CVX code: 119
  • Type: Live, attenuated vaccine
  • Status: Licensed
  • Location Licensed: The USA (License #1617)
  • Host Species for Licensed Use: Human
  • Antigen: A live, attenuated rotavirus vaccine derived from the human 89-12 strain which belongs to G1P[8] type.
  • Preparation: ROTARIX is a live, attenuated rotavirus vaccine derived from the human 89-12 strain which belongs to G1P[8] type. The rotavirus strain is propagated on Vero cells. The lyophilized vaccine contains amino acids, dextran, Dulbecco’s Modified Eagle Medium (DMEM), sorbitol, and sucrose. The liquid diluent contains calcium carbonate, sterile water, and xanthan. The diluent includes an antacid component (calcium carbonate) to protect the vaccine during passage through the stomach and prevent its inactivation due to the acidic environment of the stomach. ROTARIX contains no preservatives (FDA: ROTARIX).
  • Storage: Store the vials of lyophilized ROTARIX refrigerated at 2° to 8°C (36° to 46°F). The diluent may be stored at a controlled room temperature 20° to 25°C (68° to 77°F). Do not freeze.
  • Approved Age for Licensed Use: 6 to 24 months
  • Contraindication: History of uncorrected congenital malformation of the gastrointestinal tract that would predispose the infant to intussusception.
  • Description: Indication: Prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) in infants and children when administered as a two-dose series between the ages of 6-24 weeks (FDA: ROTARIX).
Host Response

Human Response

  • Immune Response: Seroconversion was defined as the appearance of anti-rotavirus IgA antibodies (concentration ≥20 U/mL) post-vaccination in the serum of infants previously negative for rotavirus. In one clinical trial, it was recorded that 86.5% of 787 recipients of ROTARIX seroconverted compared with 6.7% of 420 placebo recipients and 76.8% of 393 recipients of ROTARIX seroconverted compared with 9.7% of 341 placebo recipients (FDA: ROTARIX).
  • Side Effects: Side effects of vaccination include: fussiness/irritability, cough/runny nose, fever, loss of appetite, and vomiting.

Human Response

  • Vaccination Protocol: A randomized, double-blind, placebo-controlled study was conducted in 6 European countries. A total of 3,994 infants were enrolled to receive ROTARIX or placebo. Analyses were also done to evaluate the efficacy of ROTARIX against rotavirus gastroenteritis among infants who received at least one vaccination (FDA: ROTARIX).
  • Efficacy: In this study, the efficacy of ROTARIX against any grade of severity of rotavirus gastroenteritis through one rotavirus seasons was 87.1% and for ROTARIX against any grade of severity of rotavirus gastroenteritis through two rotavirus seasons was 78.9% (FDA: ROTARIX).
References
FDA: ROTARIX: FDA: ROTARIX vaccine information [http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm133920.htm]