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

Recruiting Phase 3 Interventional Study
Measles Measles-Mumps-Rubella+Chickenpox Vaccine
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
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At a Glance
Age
15 Months – 6
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Prevention
Participants needed
1,209 (estimated)
Sponsor
GlaxoSmithKline · Industry
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About This Trial
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 …
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Participants' parent(s)/legally acceptable representative(s) (LAR(s)) who, in the opinion of the investigator, can and will comply with the requirements of the protocol. * Written or witnessed/thumb printed informed consent obtained from the participants parent(s)/LAR(s) prior…
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