Overall, the clinical studies of Rotarix involved over 75,000 babies and took place in various countries worldwide. The main study compared Rotarix with placebo (a dummy vaccine) in over 63,000 babies who were born at full term (after a pregnancy of at least 36 weeks). The study was very large because it was designed to see if the vaccine caused a very rare, serious side effect called intussusception, a condition in which part of the bowel becomes enfolded within another part of the bowel, leading to a blockage. The benefit of the vaccine was measured by looking at how many babies developed severe rotavirus gastroenteritis in the months after they had been vaccinated and before they had reached one year of age.
A further study looked at the safety of Rotarix and its ability to stimulate the production of antibodies in 1,009 babies born up to 13 weeks prematurely. These results were compared with the findings of a study in babies born at full term who were vaccinated with Rotarix.
Four additional studies were carried out in over 3,000 infants, to confirm that the two forms of the vaccine were as safe and as effective as each other in stimulating the production of antibodies against rotavirus.