RecruitingMeaslesMeasles-Mumps-Rubella+Chickenpox Vaccine

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

Eligible age

1.3–6 yrs

Accepts

All genders

Locations

11 states

Healthy volunteers

Yes

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About this study

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).

Sponsor: GlaxoSmithKline

You may qualify if…

✓ 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 to performance of any study specific procedure.
✓ Informed assent obtained from the participants in line with local rules and regulations.
✓ Healthy participants as established by medical history and clinical examination at screening.
✓ For countries where the second dose of measles, mumps, rubella, and varicella vaccination is administered between 4 and 6 years of age:
✓ A male or female participant between and including 4 and 6 years of age at the time of the study intervention administration, and in accordance with local regulations.
✓ Participant who previously received a first dose of varicella-containing vaccine in the second year of life.
✓ Participant who previously received a first dose of measles, mumps, rubella-containing vaccine in the second year of life.

You may not qualify if…

✕ Medical conditions
✕ History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions, including hypersensitivity to neomycin or, gelatin.
✕ Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
✕ Hypersensitivity to latex.
✕ Unstable chronic conditions as determined by medical history and physical examination.
✕ Major congenital defects, as assessed by the investigator.
✕ History of measles, mumps, rubella, or varicella/zoster disease, as evaluated by the investigator.
✕ Recurrent history or uncontrolled neurological disorders or any neuroinflammatory, congenital neurological conditions, encephalopathies, or seizures.