• 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).

• 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).

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).

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).