A Phase 3a, Observer-blind, Randomized, Controlled, Study to Evaluate the Immunogenicity and Safety of an Investigational Varicella Vaccine Compared With Varivax, When Given as a Second Dose to Healthy Children, 3 Months After the Administration of a First Dose at 12 to 15 Months of Age
Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The purpose of this study is to evaluate the immune response and safety of GSKs investigational varicella vaccine (VNS Vaccine) compared to an already approved varicella vaccine, Varivax (VV), when administered as second dose to healthy children. 3 months after first dose at 12 to 15 months. The study will be conducted in children who have not previously contracted varicella or 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 representative (LAR)(s), who, in the opinion of the investigator, can and will comply with the requirements of the protocol
• 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 the first 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
Other Locations
Dominican Republic
GSK Investigational Site
RECRUITING
Constanza
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:2025-05-15
Estimated Completion Date:2027-04-02
Participants
Target number of participants:600
Treatments
Active_comparator: VV-VV Group
Participants receive 2 doses of a VV vaccine on Day 1 and Day 91. 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. A second dose of MMR vaccine will be co-administered to the participants in countries where a second dose of MMR is recommended at 15 to 18 months of age, as per national immunization schedule.
Experimental: VNS-VNS Group
Participants receive 2 doses of a VNS vaccine on Day 1 and Day 91. 1 doses of MMR vaccine, 1 dose of HAV vaccine, and 1 dose of PCV (either PCV 13, Vaxneuvance or PCV 20) on Day 1. A second dose of MMR vaccine will be co-administered to the participants in countries where second dose of MMR is recommended at 15 to 18 months of age, as per national immunization schedule.
Experimental: VV-VNS Group
Participants receive 1 dose of VV vaccine on Day 1, 1 dose of VNS Vaccine on Day 91. 1 doses of MMR vaccine, 1 dose of HAV, and 1 dose of PCV (either PCV 13, Vaxneuvance or PCV 20) on Day 1. A second dose of MMR vaccine will be co-administered to the participants in countries where second dose of MMR is recommended at 15 to 18 months of age, as per national immunization schedule.