A Phase 3a, Observer-blind, Randomized, Controlled Study to Demonstrate Lot-to-lot Consistency and Evaluate the Immunogenicity and Safety of an Investigational Varicella Vaccine Compared With Varivax, Administered as a First Dose to Healthy Children 12 to 15 Months of Age
Status: Recruiting
Location: See all (90) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The purpose of this study is to assess the consistency of immune response to three different lots of GSK's investigational varicella vaccine (VNS Vaccine), and to compare the safety and immune response of VNS vaccine to an already approved varicella vaccine (VV) known as Varivax. The study will be conducted in healthy children aged 12 to 15 months, who have neither contracted varicella nor received a varicella vaccination.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 1
Healthy Volunteers: t
View:
• Participant's parent(s) Legally acceptable representatives /(LAR\[s\]), who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the eDiaries, return for follow-up visits).
• Written or witnessed/thumb printed informed consent obtained from the participant's parent(s)/LAR(s) prior to performance of any study-specific procedure.
• Healthy participants as established by medical history and clinical examination before entering into the study.
• A male or female between, and including, 12 to 15 months of age (i.e., from the day of 1-year birthday until the day before 16 months of age) at the time of the administration of study interventions.
• Only for children in countries where PCV is recommended at 12 to 15 months of age as per national immunization schedule and provided as part of the study interventions:
⁃ Participant who previously received the primary series of PCV in the first year of life with last dose at least 60 days prior to study entry.
Locations
United States
Alabama
GSK Investigational Site
RECRUITING
Mobile
Arkansas
GSK Investigational Site
RECRUITING
Hot Springs
GSK Investigational Site
RECRUITING
Sherwood
California
GSK Investigational Site
RECRUITING
Canoga Park
GSK Investigational Site
RECRUITING
Covina
GSK Investigational Site
WITHDRAWN
Fullerton
GSK Investigational Site
WITHDRAWN
Long Beach
GSK Investigational Site
RECRUITING
Los Angeles
GSK Investigational Site
WITHDRAWN
Paramount
GSK Investigational Site
RECRUITING
Sacramento
GSK Investigational Site
RECRUITING
Ventura
GSK Investigational Site
RECRUITING
Walnut Creek
GSK Investigational Site
RECRUITING
Winnetka
Florida
GSK Investigational Site
RECRUITING
Miami
GSK Investigational Site
WITHDRAWN
Miami
GSK Investigational Site
RECRUITING
Miami Lakes
GSK Investigational Site
RECRUITING
Spring Hill
GSK Investigational Site
RECRUITING
Tampa
Georgia
GSK Investigational Site
RECRUITING
Covington
Idaho
GSK Investigational Site
RECRUITING
Ammon
Illinois
GSK Investigational Site
RECRUITING
Moline
Indiana
GSK Investigational Site
RECRUITING
South Bend
Kansas
GSK Investigational Site
RECRUITING
Topeka
Kentucky
GSK Investigational Site
RECRUITING
Bardstown
GSK Investigational Site
RECRUITING
Louisville
Louisiana
GSK Investigational Site
RECRUITING
Haughton
Massachusetts
GSK Investigational Site
RECRUITING
Fall River
Michigan
GSK Investigational Site
RECRUITING
Bingham Farms
Missouri
GSK Investigational Site
RECRUITING
Jefferson City
North Carolina
GSK Investigational Site
RECRUITING
Charlotte
GSK Investigational Site
WITHDRAWN
Monroe
Nebraska
GSK Investigational Site
RECRUITING
Lincoln
GSK Investigational Site
WITHDRAWN
Lincoln
GSK Investigational Site
RECRUITING
Lincoln
New York
GSK Investigational Site
RECRUITING
The Bronx
Ohio
GSK Investigational Site
RECRUITING
Cleveland
GSK Investigational Site
RECRUITING
Dayton
Oklahoma
GSK Investigational Site
RECRUITING
Chickasha
GSK Investigational Site
RECRUITING
Tulsa
Oregon
GSK Investigational Site
RECRUITING
Gresham
South Carolina
GSK Investigational Site
RECRUITING
Charleston
GSK Investigational Site
RECRUITING
Charleston
GSK Investigational Site
RECRUITING
Greenville
GSK Investigational Site
RECRUITING
Simpsonville
Texas
GSK Investigational Site
RECRUITING
Beaumont
GSK Investigational Site
WITHDRAWN
Burleson
GSK Investigational Site
RECRUITING
Corpus Christi
GSK Investigational Site
WITHDRAWN
Dallas
GSK Investigational Site
RECRUITING
Dallas
GSK Investigational Site
RECRUITING
Houston
GSK Investigational Site
RECRUITING
Houston
GSK Investigational Site
RECRUITING
Mcallen
GSK Investigational Site
RECRUITING
Mesquite
Utah
GSK Investigational Site
COMPLETED
Layton
GSK Investigational Site
RECRUITING
Layton
GSK Investigational Site
RECRUITING
Murray
GSK Investigational Site
RECRUITING
Pleasant View
GSK Investigational Site
RECRUITING
South Jordan
GSK Investigational Site
WITHDRAWN
West Jordan
Virginia
GSK Investigational Site
RECRUITING
Richmond
Other Locations
Belgium
GSK Investigational Site
RECRUITING
Brussels
GSK Investigational Site
RECRUITING
Ghent
GSK Investigational Site
RECRUITING
Gozée
GSK Investigational Site
RECRUITING
Leuven
GSK Investigational Site
RECRUITING
Liège
Colombia
GSK Investigational Site
RECRUITING
Cali
GSK Investigational Site
RECRUITING
Medellín
Dominican Republic
GSK Investigational Site
RECRUITING
Santo Domingo
GSK Investigational Site
RECRUITING
Santo Domingo
GSK Investigational Site
RECRUITING
Santo Domingo Oeste
Estonia
GSK Investigational Site
RECRUITING
Paide
GSK Investigational Site
RECRUITING
Tartu
Mexico
GSK Investigational Site
RECRUITING
Acapulco
GSK Investigational Site
RECRUITING
Hidalgo
GSK Investigational Site
RECRUITING
Mexico City
GSK Investigational Site
RECRUITING
Mexico City
GSK Investigational Site
RECRUITING
Veracruz
Poland
GSK Investigational Site
RECRUITING
Bydgoszcz
GSK Investigational Site
RECRUITING
Częstochowa
GSK Investigational Site
RECRUITING
Krakow
GSK Investigational Site
RECRUITING
Siemianowice Śląskie
GSK Investigational Site
RECRUITING
Torun
Puerto Rico
GSK Investigational Site
RECRUITING
Caguas
GSK Investigational Site
RECRUITING
Ponce
GSK Investigational Site
RECRUITING
San Juan
GSK Investigational Site
RECRUITING
San Juan
Thailand
GSK Investigational Site
RECRUITING
Bangkok
GSK Investigational Site
RECRUITING
Rajathevee
United Arab Emirates
GSK Investigational Site
RECRUITING
Abu Dhabi
GSK Investigational Site
RECRUITING
Al Ain City
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:2025-01-10
Estimated Completion Date:2027-05-17
Participants
Target number of participants:1840
Treatments
Experimental: VNS_Lot 1 Group
Participants receive 1 dose of the investigational VNS vaccine of Lot 1, 1 dose of measles, mumps, and rubella (MMR) vaccine, 1 dose of hepatitis A vaccine (HAV), and 1 dose of PCV (either PCV 13 or Vaxneuvance or PCV 20) on Day 1.
Experimental: VNS_Lot 2 Group
Participants receive 1 dose of the investigational VNS vaccine of Lot 2, 1 dose of MMR vaccine, 1 dose of HAV vaccine, and 1 dose of PCV (either PCV 13 or Vaxneuvance or PCV 20) on Day 1.
Experimental: VNS_Lot 3 Group
Participants receive 1 dose of the investigational VNS vaccine of Lot 3, 1 dose of MMR vaccine, 1 dose of HAV vaccine, and 1 dose of PCV (either PCV 13 or Vaxneuvance or PCV 20) on Day 1.
Active_comparator: VV_Lot 1 Group
Participants receive 1 dose of a marketed varicella vaccine (VV) of Lot 1, 1 dose of MMR vaccine, 1 dose of HAV vaccine, and 1 dose of PCV (either PCV 13 or Vaxneuvance or PCV 20) on Day 1.
Active_comparator: VV_Lot 2 Group
Participants receive 1 dose of a marketed VV of Lot 2, 1 dose of MMR vaccine, 1 dose of HAV vaccine, and 1 dose of PCV (either PCV 13 or Vaxneuvance or PCV 20) on Day 1.