Infants who receive the rotavirus vaccine, which protects against a severe diarrheal disease, may have a very small risk of developing a serious intestinal disorder called intussusception, a new study finds. In the study, researchers examined...
Read moreROTARIX has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility. Efficacy Studies The data demonstrating the efficacy of ROTARIX in preventing rotavirus gastroenteritis come from 24,163 infants randomized in...
Read moreImmunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune response to ROTARIX. [See Warnings and Precautions...
Read moreIn clinical trials, ROTARIX was administered concomitantly with US-licensed and non-US-licensed vaccines. In a US coadministration study in 484 infants, there was no evidence of interference in the immune responses to any of the antigens when...
Read moreIntussusception (including death), recurrent intussusception (including death), hematochezia, gastroenteritis with vaccine viral shedding in infants with Severe Combined Immunodeficiency Disease (SCID). Blood and Lymphatic System Disorders...
Read moreThe temporal association between vaccination with ROTARIX and intussusception was evaluated in a hospital-based active surveillance study that identified infants with intussusception at participating hospitals in Mexico. Using a self-controlled...
Read moreKawasaki disease has been reported in 18 (0.035%) recipients of ROTARIX and 9 (0.021%) placebo recipients from 16 completed or ongoing clinical trials. Of the 27 cases, 5 occurred following ROTARIX in clinical trials that were either not...
Read moreIn a controlled safety study conducted in Latin America and Finland, the risk of intussusception was evaluated in 63,225 infants (31,673 received ROTARIX and 31,552 received placebo). Infants were monitored by active surveillance including...
Read moreContraindications Hypersensitivity A demonstrated history of hypersensitivity to any component of the vaccine. Infants who develop symptoms suggestive of hypersensitivity after receiving a dose of ROTARIX should not receive further doses of...
Read morePost-marketing data Gastrointestinal disorders: Rare: intussusception* haematochezia gastroenteritis with vaccine viral shedding in infants with Severe Combined Immunodeficiency (SCID) disorder. *Preliminary data from a large post-marketing...
Read moreIn a clinical study, 1009 preterm infants were administered ROTARIX lyophilised formulation or placebo (198 were 27-30 weeks gestational age and 801 were 31-36 weeks gestational age). The first dose was administered from 6 weeks after birth...
Read moreInteractions Co-administration studies have demonstrated that ROTARIX can be given concomitantly with any of the following administered either as monovalent or as combination vaccines: diphtheria-tetanus-acellular pertussis vaccine (DTPa)...
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