A Phase II, Single-blind, Randomized, Controlled Study to Evaluate the Immunogenicity and Safety of a Measles, Mumps, Rubella, Varicella Vaccine Compared With ProQuad, Administered in Healthy Children 4-6 Years of Age
Status: Completed
Location: See all (47) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
The main purpose of this study is to assess immune response and safety of various potencies of a measles, mumps, rubella, and varicella (MMRVNS) vaccines given to healthy children of 4 to 6 years of age.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 4
Maximum Age: 6
Healthy Volunteers: t
View:
• Healthy participants as established by medical history and clinical examination before entering into the study.
• A male or female between, and including, 4 years and 6 years of age (i.e., from 4 year birthday until the day before the 7-year birthday) at the time of 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 single dose of measles-, mumps-, rubella-containing vaccine in the second year of life.
• Written informed consent obtained from the participants' parent(s)/legally acceptable representative(s) (LAR\[s\]) prior to performance of any study-specific procedure (participant informed assent will be obtained from participants in line with local rules and regulations).
• Participants' parent(s)/LAR(s), who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of electronic diaries \[eDiaries\], return for follow-up visits).
Locations
United States
Alabama
GSK Investigational Site
Birmingham
Arkansas
GSK Investigational Site
Jonesboro
California
GSK Investigational Site
Bellflower
GSK Investigational Site
Huntington Park
GSK Investigational Site
Oakland
GSK Investigational Site
Roseville
GSK Investigational Site
Sacramento
GSK Investigational Site
Sacramento
GSK Investigational Site
San Jose
GSK Investigational Site
Santa Clara
GSK Investigational Site
West Covina
Florida
GSK Investigational Site
Miami Lakes
GSK Investigational Site
Tampa
Idaho
GSK Investigational Site
Ammon
GSK Investigational Site
Idaho Falls
Kentucky
GSK Investigational Site
Louisville
Louisiana
GSK Investigational Site
Lafayette
Massachusetts
GSK Investigational Site
Boston
Michigan
GSK Investigational Site
Bingham Farms
GSK Investigational Site
Detroit
Nebraska
GSK Investigational Site
Lincoln
GSK Investigational Site
Lincoln
GSK Investigational Site
Omaha
New York
GSK Investigational Site
Syracuse
Ohio
GSK Investigational Site
Cleveland
GSK Investigational Site
Dayton
South Carolina
GSK Investigational Site
Simpsonville
Tennessee
GSK Investigational Site
Tullahoma
Texas
GSK Investigational Site
Dickinson
GSK Investigational Site
Mcallen
GSK Investigational Site
Richmond
Utah
GSK Investigational Site
Layton
GSK Investigational Site
Provo
GSK Investigational Site
Roy
GSK Investigational Site
South Jordan
Other Locations
Colombia
GSK Investigational Site
Barranquilla
GSK Investigational Site
Barranquilla
GSK Investigational Site
Bogotá
Latvia
GSK Investigational Site
Riga
Puerto Rico
GSK Investigational Site
San Juan
GSK Investigational Site
San Juan
GSK Investigational Site
San Juan
Taiwan
GSK Investigational Site
Taichung
GSK Investigational Site
Taichung
GSK Investigational Site
Taipei
GSK Investigational Site
Taipei
GSK Investigational Site
Taoyuan District
Time Frame
Start Date:2022-12-14
Completion Date:2024-10-14
Participants
Target number of participants:801
Treatments
Experimental: MMRV(H)NS Group
Participants receive a single dose of an investigational measles, mumps, and rubella (MMR) at release potency and varicella at high (V\[H\]NS) potency vaccine on Day 1.
Experimental: MM(H)RVNS Group
Participants receive a single dose of an investigational measles, rubella (MR), and varicella (VNS) at release potency and mumps at high (M\[H\]) potency vaccine on Day 1.
Experimental: M(L)M(L)R(L)V(L)NS Group
Participants receive a single dose of an investigational measles, mumps, rubella (MMR), and varicella (VNS), all at low (L) potency vaccine on Day 1.
Active_comparator: MMRV_Lot 1 and Lot 2 Pooled Group
Participants receive a single dose of a marketed measles, mumps, rubella (MMR), and varicella (V) vaccine of Lot 1 or of 1 vaccine dose of a marketed MMRV vaccine of Lot 2 on Day 1.