Phase 3 Study Comparing Safety and Immune Response of a New Combined Measles, Mumps, Rubella, and Varicella Vaccine to ProQuad in Healthy Children Aged 15 Months to 6 Years

What this Trial Is About

Researchers are evaluating the immune response and safety of an investigational combined measles, mumps, rubella, and varicella vaccine MMRVNS compared to the already licensed MMRV vaccine ProQuad. The study focuses on healthy children aged 15 months to 6 years who have previously received a first dose of any measles, mumps, rubella, and varicella-containing vaccine. This Phase 3a, randomized, observer-blind trial aims to assess prevention by comparing these two vaccines when given as a second dose intramuscularly. Participants receive a single intramuscular dose of either the investigational MMRVNS vaccine or the licensed MMRV vaccine on Day 1. The study uses a parallel design with two groups one receiving MMRVNS and the other receiving MMRV. The vaccines are administered as a second dose to children previously vaccinated according to their countrys immunization schedule. The study monitors participants closely for immune response and safety after vaccination. Throughout the study, children undergo assessments including blood tests to measure Immunoglobulin G IgG responses against measles, mumps, rubella, and varicella at Day 43. Safety evaluations include monitoring for injection site reactions, systemic events, and adverse events up to 181 days after vaccination. The study tracks solicited and unsolicited adverse events and serious adverse events to understand the safety profile. Participation lasts until study completion, with multiple follow-up periods to ensure thorough monitoring.

A Study on the Immune Response and Safety of an Investigational Combined Measles, Mumps, Rubella and Varicella Vaccine, When Administered as Intramuscular Injection to Healthy Children 15 Months to 6 Years of Age