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 NoteThey 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).

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