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A Study on the Immune Response and Safety of an Investigational Combined Measles, Mumps, Rubella and Varicella Vaccine, When Given to Healthy Children 4 to 6 Years of Age
Sponsor: GlaxoSmithKline
Summary
The purpose of this study is to evaluate how consistently 3 different manufacturing lots of the GSK's investigational measles, mumps, rubella, and varicella (MMRVNS) vaccine will produce an immune response. It will also compare the overall immune response to the MMRVNS vaccine with that of the Merck licensed measles, mumps, rubella, and varicella (MMRV) vaccine. The vaccines will be given as a second dose to children aged 4 to 6 years who have previously received a first dose of any combination of measles, mumps, rubella, and varicella-containing vaccine(s). The study will also assess the immune response and safety of the MMRVNS and MMRV vaccines when given at the same time as a diphtheria, tetanus, acellular pertussis, and inactivated poliovirus (DTaP-IPV) vaccine. The DTaP-IPV vaccine used is licensed as Kinrix in the United States.
Official title: A Phase 3a, Observer-blind, Randomized, Controlled Study to Demonstrate Lot-to-lot Consistency and Evaluate the Immunogenicity and Safety of an Investigational Combined Measles, Mumps, Rubella and Varicella Vaccine Compared With ProQuad, Administered as a Second Dose in Healthy Children 4-6 Years of Age
Key Details
Gender
All
Age Range
4 Years - 6 Years
Study Type
INTERVENTIONAL
Enrollment
1860
Start Date
2026-08-11
Completion Date
2028-11-21
Last Updated
2026-08-03
Healthy Volunteers
Yes
Interventions
MMRVNS vaccine
MMRVNS vaccine will be administered on Day 1.
MMRV vaccine
MMRV vaccine will be administered on Day 1.
DTaP-IPV vaccine
DTaP-IPV vaccine will be administered on Day 1.
Locations (62)
Children's Clinic of Jonesboro, AR
Jonesboro, Arkansas, United States
Applied Research Center of Arkansas
Little Rock, Arkansas, United States
Century Research Institute Inc
Huntington Park, California, United States
Matrix Clinical Research
Los Angeles, California, United States
Center for Clinical Trials of Sacramento, Inc.
Sacramento, California, United States
Center for Clinical Trials of San Gabriel
West Covina, California, United States
BioMD Clinical Research
Coral Gables, Florida, United States
D&H Pompano Research Center LLC
Margate, Florida, United States
PAS Research
Tampa, Florida, United States
Medical Research Partners
Ammon, Idaho, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Kentucky Pediatric/ Adult Research
Bardstown, Kentucky, United States
Norton Childrens Research Institute
Louisville, Kentucky, United States
Benchmark Research
Covington, Louisiana, United States
ACC Pediatric Research
Haughton, Louisiana, United States
Velocity Clinical Research, Gulfport
Lafayette, Louisiana, United States
Jefferson City Medical Group PC
Jefferson City, Missouri, United States
Boeson Research MSO
Missoula, Montana, United States
Midwest Children's Health Research Institute, LLC
Lincoln, Nebraska, United States
Midwest Children's Health Research Institute, LLC
Lincoln, Nebraska, United States
Complete Children's Health
Lincoln, Nebraska, United States
Complete Children's Health
Lincoln, Nebraska, United States
Atrium Health
Charlotte, North Carolina, United States
Senders Pediatrics
Cleveland, Ohio, United States
Neighbors Clinical Research
Charleston, South Carolina, United States
Tribe Clinical Research LLC/Parkside Pediatrics
Greenville, South Carolina, United States
Tribe Clinical Research LLC/Parkside Pediatrics
Simpsonville, South Carolina, United States
Carolina Family Care
Summerville, South Carolina, United States
Meharry Medical College
Nashville, Tennessee, United States
Tekton Research - Beaumont, TX
Beaumont, Texas, United States
Pas Research
Edinburg, Texas, United States
Pediatric Associates
Houston, Texas, United States
Tanner Clinic Kaysville
Kaysville, Utah, United States
Tanner Clinic Layton Parkway
Layton, Utah, United States
Ogden Clinic Canyon View
Ogden, Utah, United States
Pediatric Research of Charlottesville, LLC
Charlottesville, Virginia, United States
Clinical Research Partners, LLC
Richmond, Virginia, United States
Marshfield Clinic Research Foundation, a Division of Marshfield Clinic, Inc
Marshfield, Wisconsin, United States
Equipo Ciencia
Buenos Aires, Argentina
Helios Salud
Ciudad Autonoma Buenos Aires, Argentina
Clinica Privada del Sol SA
Córdoba, Argentina
Clinica del Nino y la Familia de Mar del Plata
Mar del Plata, Argentina
Instituto Medico Rio Cuarto
Río Cuarto, Argentina
Clinica Mayo de Urgencias Medicas Cruz Blanca SRL
San Miguel de Tucumán, Argentina
Hospital del Nino Jesus
San Miguel de Tucumán, Argentina
Finnish Vaccine Research, Espoo Clinic
Espoo, Finland
Finnish Vaccine Research, Helsinki South Clinic
Helsinki, Finland
Finnish Vaccine Research, Järvenpää Clinic
Jarvenpaa, Finland
Finnish Vaccine Research, Kokkola Clinic
Kokkola, Finland
Finnish Vaccine Research, Oulu Clinic
Oulu, Finland
Finnish Vaccine Research, Seinäjoki Clinic
Seinäjoki, Finland
Finnish Vaccine Research, Tampere Clinic
Tampere, Finland
Finnish Vaccine Research, Turku Clinic
Turku, Finland
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
Bari, Italy
Ospedale D'Avanzo
Foggia, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Italy
Centro Clin-PR
Corozal, Puerto Rico
China Medical University Hospital
Taichung, Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan
MacKay Memorial Hospital Taipei Branch
Taipei, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Chang Gung Memorial Hospital, Linkou
Taoyuan City, Taiwan