In 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. Serious adverse events were observed in 5.1% of recipients of ROTARIX as compared with 6.8% of placebo recipients. Similar rates of solicited and unsolicited symptoms were observed in ROTARIX and placebo recipients. No cases of intussusception were reported.
(VAN’s Note: They don’t say what the placebo was. In vaccine trials it is usually another vaccine or aluminium or another adjuvant – NOT a totally unvaccinated control).
Safety in infants with human immunodeficiency (HIV) infection
In a clinical study, 100 infants with HIV infection were administered ROTARIX lyophilised formulation or placebo. The safety profile was similar between ROTARIX and placebo recipients.
(VAN’s Note: This contradicts what they say in the same data sheet about the danger of shedding and other problems in the immuno-compromised).