NCT07406360

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

A Phase 3a, Observer Blind, Randomized, Controlled Study to Evaluate the Immunogenicity and Safety of Intramuscular Administration of an Investigational Combined Measles, Mumps, Rubella, and Varicella Vaccine Compared With Intramuscular Administration of ProQuad When Administered as a Second Dose to Healthy Children Aged 15 Months to 6 Years of Age

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,209 (estimated)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 15 Months – 6 Years
• Healthy volunteers: Accepted

Summary

This study is evaluating the immunogenicity and safety of intramuscular administration of the investigational MMRVNS vaccine compared to intramuscular administration of the MMRV (Merck's measles, mumps, rubella and varicella) vaccine (ProQuad) that is already licensed for this route, when administered as a second dose in children 15 months to 6 years of age who were previously primed with a first dose of any combination of measles, mumps, rubella and varicella-containing vaccine(s).

Conditions

• Measles

Interventions

Type	Name	Description
BIOLOGICAL	MMRVNS	One dose of MMRVNS administered intramuscularly.
BIOLOGICAL	MMRV	One dose of MMRV administered intramuscularly.

Timeline

• Start date: 2026-04-13
• Primary completion: 2028-01-31
• Completion: 2028-06-22
• First posted: 2026-02-12
• Last updated: 2026-02-12

Regulatory

• FDA-regulated drug study