ORAL ROTAVIRUS VACCINE

Last updated: March 2025

Indications

• Prevention of rotavirus gastroenteritis in children up to 24 months of age

Composition, forms, route of administration

• Oral suspension, in monodose plastic tube:
  • Rotarix®, 1.5 ml tube, live-attenuated monovalent human rotavirus vaccine (RV1, strain RIX4414)
  • Rotasiil®, 2 ml tube, live-attenuated pentavalent human-bovine reassortant rotavirus vaccine (RV5, G1, G2, G3, G4 and G9)
  • Rotateq®, 2 ml tube, live-attenuated pentavalent human-bovine reassortant rotavirus vaccine (RV5, G1, G2, G3, G4 and P1A[8])
• DO NOT ADMINISTER BY PARENTERAL ROUTE.

Dosage and vaccination schedule

Child 6 weeks to 24 months: 

• Depending on the available vaccine, 2 to 3 doses at least 4 weeks apart
• Shake the plastic tube, squeeze the entire content of the tube into the mouth.
• Recommended schedule:

Contra-indications, adverse effects, precautions

• Do not administer in case of:
  •  acute gastroenteritis, history of intussusception, severe immunodeficiency;
  •  allergic reactions to a previous dose of vaccine.
• Vaccination should be postponed in the event of severe acute febrile illness; minor infections are not contra-indications.
• May cause: 
  • diarrhoea, abdominal pain, irritability; 
  • rarely: intussusception, anaphylactic reactions.
• If the child regurgitates/spits out/vomits the vaccine immediately after administration, wait a few minutes and re-administer the same dose.

Remarks

• Other rotavirus vaccines may be available (e.g. Rotavac®). The vaccination should be completed with the same vaccine when feasible. If not possible, follow national and manufacturer recommendations.
• Rotavirus vaccine can be administered concomitantly with other vaccines recommended in childhood.

Storage