That study found no increased risk of intussusception in children who received Rotarix (31,673 infants) compared to those who received a placebo (31,552 infants). Increased rates of convulsion and pneumonia-related deaths were observed in the Rotarix recipients in the intussusception study, but these events were not observed in other studies conducted by the manufacturer, the FDA said.
Although the FDA said it has concluded that the available data do not establish that these adverse events are related to the vaccine, the agency has asked GlaxoSmithKline Biologicals to conduct post-marketing safety studies involving more than 40,000 infants to provide additional safety information.
The new FDA approval coincided with the release of results from a clinical trial of a different oral rotavirus vaccine in Latin American infants.
That study found that two doses proved effective against severe rotavirus gastroenteritis for up to two years when given during the first two weeks of life.
The double-blind, placebo-controlled phase III study included 15,183 healthy infants from 10 countries. They were randomly assigned to receive two oral doses of either the RIX4414 vaccine or a placebo.
The children were monitored until they were 2 years old. During that time, 32 of the 7,205 (0.4 percent) of children in the vaccine group had severe rotavirus gastroenteritis, compared with 161 of 7,081 (2.3 percent) of those in the placebo group.
Vaccine effectiveness was 80.5 percent to 82.1 percent against the wild-type G1 rotavirus strain, 77.5 percent against pooled non-G1 strains, and 80.5 percent against pooled non-G1 P(8) strains. Vaccine efficacy for hospital admissions for
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