A Phase II, Observer-blind, Randomized, Controlled Study to Evaluate the Immunogenicity and Safety of a Varicella Vaccine at Various Potencies Compared With Varivax, as a First Dose, Administered in Healthy Children in Their Second Year of Life

Status: Completed
Location: See all (51) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The purpose of this study is to assess immune response and safety of various potencies of an investigational chickenpox vaccine given to healthy children 12 to 15 months of age.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 1
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, 12 and 15 months of age (i.e., from his/her 1 year birthday until the day before age of 16 months) at the time of the administration of the study interventions.

• Written informed consent obtained from the parent(s)/legally authorized representative(s) of the participant prior to performance of any study-specific procedure.

• Participants' parent(s)/legally authorized representative(s), who, in the opinion of the investigator, can and will comply, with the requirements of the protocol (e.g., completion of Electronic Diaries, return for follow-up visits).

• Only for US participants and participants in countries where pneumococcal conjugate vaccine is recommended at 12-15 months of life as per national immunization schedule: Participants who previously received the primary series of pneumococcal conjugate vaccine in their first year of life with the last dose at least 60 days prior to study entry.

Locations
United States
Arkansas
GSK Investigational Site
Bryant
GSK Investigational Site
Jonesboro
GSK Investigational Site
Little Rock
California
GSK Investigational Site
Bellflower
GSK Investigational Site
Downey
GSK Investigational Site
Foothill Ranch
GSK Investigational Site
Huntington Park
GSK Investigational Site
Los Angeles
GSK Investigational Site
West Covina
Florida
GSK Investigational Site
Tampa
Georgia
GSK Investigational Site
Atlanta
Idaho
GSK Investigational Site
Idaho Falls
Louisiana
GSK Investigational Site
New Orleans
Missouri
GSK Investigational Site
Bridgeton
Mississippi
GSK Investigational Site
Gulfport
North Carolina
GSK Investigational Site
Charlotte
Nebraska
GSK Investigational Site
Omaha
GSK Investigational Site
Omaha
Nevada
GSK Investigational Site
Las Vegas
New York
GSK Investigational Site
East Syracuse
GSK Investigational Site
The Bronx
Ohio
GSK Investigational Site
Cleveland
GSK Investigational Site
Dayton
Pennsylvania
GSK Investigational Site
Fort Washington
South Carolina
GSK Investigational Site
Barnwell
Tennessee
GSK Investigational Site
Tullahoma
Texas
GSK Investigational Site
Corpus Christi
GSK Investigational Site
Dallas
GSK Investigational Site
Dickinson
GSK Investigational Site
Houston
GSK Investigational Site
Mcallen
GSK Investigational Site
Pflugerville
GSK Investigational Site
San Antonio
Utah
GSK Investigational Site
Layton
GSK Investigational Site
Provo
GSK Investigational Site
Roy
GSK Investigational Site
South Jordan
GSK Investigational Site
St. George
GSK Investigational Site
Syracuse
Virginia
GSK Investigational Site
Charlottesville
Wisconsin
GSK Investigational Site
Marshfield
Other Locations
Estonia
GSK Investigational Site
Tallinn
GSK Investigational Site
Tartu
Poland
GSK Investigational Site
Bydgoszcz
GSK Investigational Site
Torun
Puerto Rico
GSK Investigational Site
San Juan
GSK Investigational Site
San Juan
Taiwan
GSK Investigational Site
Taichung
GSK Investigational Site
Taipei
GSK Investigational Site
Taoyuan District
United Kingdom
GSK Investigational Site
Ohio
Time Frame
Start Date: 2022-02-03
Completion Date: 2024-06-13
Participants
Target number of participants: 800
Treatments
Experimental: VNS_Low Group
Participants received 1 dose of an investigational varicella vaccine (VNS) of low potency, 1 dose of a measles, mumps, and rubella (MMR) vaccine, 1 dose of a hepatitis A vaccine (Havrix) and 1 dose of a13 valent pneumococcal conjugate vaccine (Prevnar 13) on Day 1.
Experimental: VNS_Med Group
Participants received 1 dose of VNS vaccine of medium potency, 1 dose of MMR vaccine, 1 dose of Havrix vaccine, and 1 dose of Prevnar 13 vaccine on Day 1.
Experimental: VNS_High Group
Participants received 1 dose of VNS vaccine of high potency, 1 dose of MMR vaccine, 1 dose of Havrix vaccine, and 1 dose of Prevnar 13 vaccine on Day 1.
Active_comparator: VV_Lot1 and Lot2 Pooled Group
Participants received 1 dose of a licensed varicella vaccine (VV) of Lot 1 or 1 dose of a licensed vaccine (VV) of Lot 2, 1 dose of MMR vaccine, 1 dose of Havrix vaccine, and 1 dose of Prevnar 13 vaccine on Day 1.
Related Therapeutic Areas
Sponsors
Leads: GlaxoSmithKline

This content was sourced from clinicaltrials.gov