Company:

GlaxoSmithKline

Vaccine

Live, attenuated human G1P[8] rotavirus vaccine; lyophilized pwd for oral administration after reconstitution; preservative-free.

Prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) in infants and children.

Before rotavirus immunization programs were put into effect, most children became infected with this virus before age 5 years. Severe, dehydrating rotavirus gastroenteritis occurred in young children, mostly in those who were 3–35 months old; about 20% of cases before age 6months resulted in hospitalization. Rotarix contains a live, attenuated rotavirus that replicates in the small intestine and induces immunity.

The efficacy of Rotarix in preventing rotavirus gastroenteritis was demonstrated in 2 clinical studies conducted in Europe and Latin America involving over 24,000 infants. In these studies, oral polio vaccine was not administered concurrently, although other childhood vaccines could be coadministered.

A randomized, double-blind, placebo-controlled clinical trial involving 3,994 infants was conduced in Europe. Either Rotarix or placebo was administered to healthy infants as a 2-dose series. The primary efficacy endpoint was the prevention of any grade of rotavirus gastroenteritis caused by natural rotavirus from 2 weeks after the 2nd dose through one rotavirus season. The efficacy of Rotarix against gastroenteritis of any severity through one rotavirus season was 87.1%, while the efficacy against severe gastroenteritis was 95.8%. The protective effect of Rotarix against gastroenteritis of any severity observed in the time period immediately following the 1st dose and before the 2nd dose was 89.8%. The efficacy of Rotarix in reducing hospitalizations for rotavirus gastroenteritis through one rotavirus season was 100%.

Not applicable.

<6 weeks or >24 weeks of age: not recommended. Each oral dose is 1mL. Give 1st dose beginning at 6 weeks of age, 2nd dose at least 4 weeks later; complete 2-dose series by 24th week of age. May give a replacement dose at same vaccination visit if dosing is incomplete or regurgitated.

Uncorrected congenital GI tract malformation (eg, Meckel's diverticulum) (increased risk of intussusception).

Acute diarrhea or vomiting (delay immunization). Chronic GI disorders. Immunodeficiency or immunosuppressed close contacts (live virus shedding may allow transmission to others). Latex allergy. Pregnancy (Cat.C): not applicable.

May give with concomitant vaccines (eg, DTaP, Hep B, Inactivated Poliovirus Vaccine Combined, Hib conjugate). Immunosuppressants (eg, irradiation, chemotherapy, high-dose steroids): may get suboptimal response.

Fussiness/irritability, cough/runny nose, fever, loss of appetite, vomiting, diarrhea, dehydration, pneumonia; rare: Kawasaki disease.

Report adverse events to VAERS at (800) 822-7967 and to GlaxoSmithKline at (888) 825-5249.

Vials—10 (w. prefilled diluent in oral applicator)

8/15/08