The Efficacy of Oral Rotavirus Vaccine 116E (ROTAVAC 5D) in Chilean Infants

This study is testing a new medicine called ROTAVAC 5D, which is an oral vaccine for rotavirus—a virus that causes diarrhea in babies. A total of 5,800 healthy babies from Chile, aged 6-8 weeks, will take part. They will be randomly given either the vaccine or a placebo (a look-alike with no medicine) to compare the results. In the study, 300 babies will have their blood checked to see how their bodies respond to the vaccine. This is called checking the immune response, which is how the body fights off diseases. Babies must be healthy, not have had a rotavirus vaccine before, and not plan to move for 12 months to join. Some conditions, like having a serious illness or allergy, mean a baby can't join. Blood and stool samples will be collected during the study for testing.

• The study involves taking the vaccine or placebo over a period of time.
• Blood and stool samples will be taken to check health effects.
• Parents will not get paid, but the study helps understand vaccine safety and effectiveness.