The immunologic mechanism by which ROTARIX protects against rotavirus gastro-enteritis is not entirely understood. A relationship between antibody responses to rotavirus vaccination and protection against rotavirus gastro-enteritis has not been established.
ROTARIX, which is derived from the most common human rotavirus type G1P[8], has been demonstrated to induce protective immunity against both the G1P[8] type, and also against other non-G1 prevalent strains (See Clinical Trials).
(VAN’s Note: for the manufacturer’s efficacy trial tables see: http://www.medsafe.govt.nz/profs/datasheet/r/Rotarixvac.pdf).
CONTRAINDICATIONS
ROTARIX should not be administered to subjects with known hypersensitivity to any components of the vaccine (see DESCRIPTION), or to subjects having shown signs of hypersensitivity after previous administration of rotavirus vaccines.
ROTARIX should not be administered to subjects with any history of chronic gastrointestinal disease including any uncorrected congenital malformation (such as Meckel’s diverticulum) of the gastrointestinal tract.
Subjects with Severe Combined Immunodeficiency (SCID) disorder (see ADVERSE REACTIONS).
As with other vaccines, administration of ROTARIX should be postponed in subjects suffering from acute severe febrile illness. The presence of a minor infection, such as a cold, is not a contraindication for immunisation.
PRECAUTIONS
ROTARIX should under no circumstances be injected.
The administration of ROTARIX should be postponed in subjects suffering from diarrhoea or vomiting.
Administration of ROTARIX may be considered with caution in infants with gastrointestinal illnesses, when, in the opinion of the physician, the risk of rotavirus infection by withholding the vaccine entails a greater risk to the infant. No safety or efficacy data are available for the administration of ROTARIX to infants with gastrointestinal illnesses.
The risk of intussusception has been evaluated in a large safety trial (including 63,225 infants) conducted in Latin America and Finland. No increased risk of intussusception was observed in this clinical trial following administration of Rotarix when compared with placebo (See Adverse Reactions).
However, post-marketing safety data indicate a possible increased risk of intussusception in the 31-day period following the administration of the first dose of ROTARIX. It has not been established whether ROTARIX affects the overall incidence of intussusception. (See ADVERSE REACTIONS).
Therefore, as a precaution, healthcare professionals should follow-up on any symptoms indicative of intussusception (severe abdominal pain, persistent vomiting, bloody stools, abdominal bloating and/or high fever). Parents/guardians should be advised to promptly report such symptoms.
Administration of ROTARIX in immunosupressed infants, including infants on immunosuppressive therapy, should be based on careful consideration of potential benefits and risks.
