Rotarix (Rotavirus Vaccine, Live, Oral), for oral administration, is a live, attenuated rotavirus vaccine derived from the human 89-12 strain which belongs to G1P type.
This rotavirus strain is propagated on Vero cells. After reconstitution, the final formulation (1 mL) contains at least 106.0 median Cell Culture Infective Dose (CCID50) of live, attenuated rotavirus.
Rotarix is a vaccine indicated for the prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) when administered as a 2-dose series. ROTARIX is approved for use in infants 6 weeks to 24 weeks of age.
The vaccination series consists of two 1-mL doses administered orally.
The first dose should be administered to infants beginning at 6 weeks of age.
There should be an interval of at least 4 weeks between the first and second dose and the 2-dose series should be completed by 24 weeks of age.