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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
1,209
One dose of MMRVNS administered intramuscularly.
One dose of MMRV administered intramuscularly.
GSK Investigational Site
Birmingham, Alabama, United States
RECRUITINGGSK Investigational Site
Walnut Creek, California, United States
RECRUITINGGSK Investigational Site
Miami, Florida, United States
RECRUITINGGSK Investigational Site
Miami, Florida, United States
RECRUITINGGSK Investigational Site
Atlanta, Georgia, United States
RECRUITINGGSK Investigational Site
Chicago, Illinois, United States
RECRUITINGGSK Investigational Site
Farmington Hills, Michigan, United States
RECRUITINGGSK Investigational Site
Dayton, Ohio, United States
RECRUITINGGSK Investigational Site
Simpsonville, South Carolina, United States
RECRUITINGGSK Investigational Site
Spartanburg, South Carolina, United States
RECRUITING...and 7 more locations
Seroresponse of Immunoglobulin G (IgG) concentrations against measles
Time frame: At Day 43
Seroresponse of IgG concentrations against mumps
Time frame: At Day 43
Seroresponse of IgG concentrations against rubella
Time frame: At Day 43
Seroresponse of IgG concentrations against Varicella zoster virus (VZV)
Time frame: At Day 43
IgG concentrations against measles
Time frame: At Day 43
IgG concentrations against mumps
Time frame: At Day 43
IgG concentrations against rubella
Time frame: At Day 43
IgG concentrations against VZV
Time frame: At Day 43
Number of participants with any solicited administration site events
Solicited administration site events are injection site redness, pain/tenderness, swelling, and injection site varicella-like rash.
Time frame: From Day 1 to Day 4 for injection site redness, pain/tenderness and swelling; and from Day 1 to Day 43 for injection site varicella-like rash
Number of participants with any solicited systemic events
Solicited systemic events are somnolence (sleepiness/drowsiness), loss of appetite, fever, non-injection site varicella-like rash, measles/rubella-like rash and other rash.
Time frame: From Day 1 to Day 15 for somnolence and loss of appetite; Day 1 to Day 22 for fever; and Day 1 to Day 43 for varicella-like rash, measles/rubella-like rash and other rash
Number of participants with any unsolicited adverse events (AEs)
Time frame: From Day 1 up to Day 43 (during the 43 days following study intervention administration)
Number of participants with any medically attended adverse events (MAAEs)
Time frame: From Day 1 up to Day 181 (during the 181 days following study intervention administration)
Number of participants with any serious AEs (SAEs), fatal SAEs, related SAEs
Time frame: From Day 1 up to study end (Day 181)
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