Phase 3 Study Comparing Intramuscular Chickenpox and MMR Vaccines to Standard Subcutaneous Vaccines in Healthy Children Aged 12 to 15 Months

What this Trial Is About

Researchers are evaluating the immune response and safety of GlaxoSmithKlines investigational chickenpox vaccine and a marketed measles, mumps, and rubella MMR vaccine when given to healthy children aged 12 to 15 months. The study compares these vaccines administered by muscle injection to Mercks chickenpox vaccine given just under the skin. It also assesses the immune response and safety when the GSK vaccines are given together with other routine childhood vaccines. Participants are randomly assigned to receive either the candidate varicella vaccine intramuscularly along with MMR, hepatitis A virus HAV vaccine, and a pneumococcal conjugate vaccine PCV, or the marketed varicella vaccine subcutaneously with the same additional vaccines. The PCV given may be PCV 13, Vaxneuvance, or PCV 20 depending on availability and national recommendations. All vaccines are given on Day 1. Throughout the study, children are monitored for immune responses by measuring antibody levels against varicella zoster virus and MMR antigens at Day 43. Safety is evaluated by tracking any local and systemic reactions in the days following vaccination, as well as any adverse events up to six months after the dose. The study aims to understand both the immune response and safety profile over this period in healthy young children receiving these vaccines.

A Study on the Immune Response and Safety of an Investigational Chickenpox Vaccine and a Marketed Measles, Mumps and Rubella Vaccine When Administered as Intramuscular Injection to Healthy Children 12 to 15 Months of Age