A Study on the Immune Response and Safety of Various Potencies of an Investigational Chickenpox Vaccine Compared With a Marketed Chickenpox Vaccine, Given to Healthy Children 12 to 15 Months of Age
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
2 other identifiers
interventional
800
6 countries
51
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2022
51 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 18, 2021
CompletedFirst Posted
Study publicly available on registry
October 19, 2021
CompletedStudy Start
First participant enrolled
February 3, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 9, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 13, 2024
CompletedResults Posted
Study results publicly available
February 28, 2025
CompletedFebruary 28, 2025
February 1, 2025
2 years
October 18, 2021
February 7, 2025
February 7, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Concentrations of Anti-varicella Zoster Virus (VZV) Glycoprotein E (gE) Antibodies
Concentrations of anti-VZV gE antibodies were presented as Geometric Mean Concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL) for each group.
At Day 43
Secondary Outcomes (6)
Percentage of Participants With Seroresponse to VZV gE
At Day 43
Number of Participants Reporting Each Solicited Administration Site Events
Day 1 (post dose) to Day 4
Number of Participants Reporting Each Solicited Systemic Events
Day 1 (post dose) to Day 43
Number of Participants Reporting Each Solicited Systemic Events
Day 1 (post dose) to Day 15
Number of Participants Reporting Unsolicited Adverse Events
Day 1 (post dose) to Day 43
- +1 more secondary outcomes
Study Arms (4)
VNS_Low Group
EXPERIMENTALParticipants 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.
VNS_Med Group
EXPERIMENTALParticipants 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.
VNS_High Group
EXPERIMENTALParticipants 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.
VV_Lot1 and Lot2 Pooled Group
ACTIVE COMPARATORParticipants 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.
Interventions
1 dose of a low-potency investigational varicella vaccine administered subcutaneously.
1 dose of a medium-potency investigational varicella vaccine administered subcutaneously.
1 dose of a high-potency investigational varicella vaccine administered subcutaneously.
1 dose of a licensed varicella vaccine of Lot 1 administered subcutaneously.
1 dose of a licensed varicella vaccine of Lot 2 administered subcutaneously.
1 dose of a measles, mumps, and rubella vaccine administered subcutaneously.
1 dose of a hepatitis A vaccine administered intramuscularly.
1 dose of a 13-valent pneumococcal conjugate vaccine administered intramuscularly.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Medical Conditions
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions including hypersensitivity to neomycin or gelatin.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- Hypersensitivity to latex.
- Major congenital defects, as assessed by the investigator.
- History of varicella.
- Recurrent history of or uncontrolled neurological disorders or seizures.
- Participant with history of SARS-CoV-2 infection who is still symptomatic.
- Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
- Prior and Concomitant Therapy
- Use of any investigational or non-registered product (drug, vaccine or medical device) other than the study interventions during the period beginning 30 days before the dose of study interventions (Day -29 to Day 1), or planned use during the study period.
- Chronic administration (defined as more than 14 days in total) of immunosuppressants, or other immune-modifying drugs during the period starting 90 days prior to the study interventions administration. For corticosteroids, this will mean prednisone equivalent ≥ 0.5 mg/kg/day or 20 mg/day whichever is the maximum dose for pediatric participants, or equivalent. Inhaled and topical steroids are allowed.
- Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 180 days before the dose of study interventions or planned administration during the study period.
- Administration of long-acting immune-modifying drugs at any time during the study period (e.g., infliximab).
- Previous vaccination against measles, mumps, rubella, hepatitis A, and/or varicella virus.
- +28 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (51)
GSK Investigational Site
Bryant, Arkansas, 72022, United States
GSK Investigational Site
Jonesboro, Arkansas, 72401, United States
GSK Investigational Site
Little Rock, Arkansas, 72202, United States
GSK Investigational Site
Bellflower, California, 90706, United States
GSK Investigational Site
Downey, California, 90240, United States
GSK Investigational Site
Foothill Ranch, California, 92610, United States
GSK Investigational Site
Huntington Park, California, 90255, United States
GSK Investigational Site
Los Angeles, California, 90057, United States
GSK Investigational Site
West Covina, California, 91790, United States
GSK Investigational Site
Tampa, Florida, 33613, United States
GSK Investigational Site
Atlanta, Georgia, 30310, United States
GSK Investigational Site
Idaho Falls, Idaho, 83404, United States
GSK Investigational Site
New Orleans, Louisiana, 70006-5322, United States
GSK Investigational Site
Gulfport, Mississippi, 39507, United States
GSK Investigational Site
Bridgeton, Missouri, 63044, United States
GSK Investigational Site
Omaha, Nebraska, 68134, United States
GSK Investigational Site
Omaha, Nebraska, 68198, United States
GSK Investigational Site
Las Vegas, Nevada, 89128, United States
GSK Investigational Site
East Syracuse, New York, 13210, United States
GSK Investigational Site
The Bronx, New York, 10468, United States
GSK Investigational Site
Charlotte, North Carolina, 28203, United States
GSK Investigational Site
Cleveland, Ohio, 44121, United States
GSK Investigational Site
Dayton, Ohio, 45406, United States
GSK Investigational Site
Fort Washington, Pennsylvania, 19034, United States
GSK Investigational Site
Barnwell, South Carolina, 29812, United States
GSK Investigational Site
Tullahoma, Tennessee, 37388, United States
GSK Investigational Site
Corpus Christi, Texas, 78414, United States
GSK Investigational Site
Dallas, Texas, 75230-2571, United States
GSK Investigational Site
Dickinson, Texas, 77539, United States
GSK Investigational Site
Houston, Texas, 77087, United States
GSK Investigational Site
McAllen, Texas, 78504, United States
GSK Investigational Site
Pflugerville, Texas, 78660, United States
GSK Investigational Site
San Antonio, Texas, 78218, United States
GSK Investigational Site
Layton, Utah, 84041, United States
GSK Investigational Site
Provo, Utah, 84604, United States
GSK Investigational Site
Roy, Utah, 84067, United States
GSK Investigational Site
South Jordan, Utah, 84095, United States
GSK Investigational Site
St. George, Utah, 84790, United States
GSK Investigational Site
Syracuse, Utah, 84075, United States
GSK Investigational Site
Charlottesville, Virginia, 22902, United States
GSK Investigational Site
Marshfield, Wisconsin, 54449, United States
GSK Investigational Site
Tallinn, 10617, Estonia
GSK Investigational Site
Tartu, 50106, Estonia
GSK Investigational Site
Bydgoszcz, 85-048, Poland
GSK Investigational Site
Torun, 87-100, Poland
GSK Investigational Site
San Juan, 00907, Puerto Rico
GSK Investigational Site
San Juan, 00918, Puerto Rico
GSK Investigational Site
Taichung, 40447, Taiwan
GSK Investigational Site
Taipei, 10002, Taiwan
GSK Investigational Site
Taoyuan District, 333, Taiwan
GSK Investigational Site
Ohio, 45414, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Observer-blind study. Recipients and study evaluators will be unaware of vaccine administered.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 18, 2021
First Posted
October 19, 2021
Study Start
February 3, 2022
Primary Completion
February 9, 2024
Study Completion
June 13, 2024
Last Updated
February 28, 2025
Results First Posted
February 28, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.
- Access Criteria
- Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
IPD for this study will be made available via the Clinical Study Data Request site.