Harnessing the Beneficial Non-specific Effects of Measles-mumps-rubella Vaccine in Children on Infection and Allergic Diseases - a Single-centre Phase IV Randomized Controlled Trial

What this Trial Is About

Researchers are conducting a randomized clinical trial to evaluate the effects of a modified measles-mumps-rubella (MMR) vaccine schedule in children. The study aims to determine whether giving MMR vaccine at 6 and 13 months, instead of the current Swiss schedule of 9 and 12 months, can reduce the risk and severity of infections unrelated to measles and allergic diseases such as eczema. The trial also investigates the underlying immune system changes caused by the MMR vaccine. Children in the study will be randomly assigned to one of four groups receiving the MMR vaccine at different times: both doses at the current schedule (9 and 12 months), the first dose at 6 months and the second at 12 months, the first dose at 9 months and the second at 13 months, or both doses at the modified schedule (6 and 13 months). Each dose is given as a 0.5 ml injection into the muscle, either in the arm or thigh. This design allows researchers to study the effects of each dose separately and in combination. Participants will be monitored for up to 18 months after randomization, with a focus on respiratory infections and overall infection rates. Researchers will collect clinical data on infection incidence, duration, severity, antibiotic use, and hospitalizations. Laboratory tests will examine immune responses to understand how the vaccine influences the body's defenses. The primary outcome is the incidence of respiratory infections within 3 months following randomization, with extended follow-up for other related measures throughout the study period.

Non-specific Effects of a Modified Measles Vaccination Schedule to Prevent Allergy and Unrelated Infection in Children