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: Recruiting
Location: See all (10) 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: Accepts Healthy Volunteers
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.
• 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
Arkansas
GSK Investigational Site
Recruiting
Jonesboro
Florida
GSK Investigational Site
Recruiting
Tampa
Kentucky
GSK Investigational Site
Recruiting
Louisville
Nebraska
GSK Investigational Site
Recruiting
Lincoln
Ohio
GSK Investigational Site
Recruiting
Dayton
Tennessee
GSK Investigational Site
Recruiting
Tullahoma
Utah
GSK Investigational Site
Recruiting
Layton
GSK Investigational Site
Recruiting
Provo
GSK Investigational Site
Recruiting
Roy
GSK Investigational Site
Recruiting
South Jordan
Contact Information
Primary
US GSK Clinical Trials Call Center
GSKClinicalSupportHD@gsk.com
877-379-3718
Backup
EU GSK Clinical Trials Call Center
GSKClinicalSupportHD@gsk.com
+44 (0) 20 89904466
Time Frame
Start Date:December 14, 2022
Estimated Completion Date:June 17, 2024
Participants
Target number of participants:800
Treatments
Experimental: MMRV(H)NS Group
Healthy children aged 4 to 6 years of age receive 1 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
Healthy children aged 4 to 6 years of age receive 1 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
Healthy children aged 4 to 6 years of age receive 1 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
Healthy children aged 4 to 6 years of age receive 1 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.