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

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.

Study Overview

• Status: Completed
• Conditions: Chickenpox
• Intervention / Treatment: Biological: Investigational varicella vaccine low potency; Biological: Measles, mumps, and rubella vaccine; Biological: Hepatitis A vaccine; Biological: 13-valent pneumococcal conjugate vaccine; Biological: Investigational varicella vaccine medium potency; Biological: Investigational varicella vaccine high potency; Biological: Licensed varicella vaccine Lot 1; Biological: Licensed varicella vaccine Lot 2

Detailed Description

The study aims to demonstrate the immunogenicity of the investigational VNS vaccine at three potencies (VNS_Low, VNS_Med, and VNS_High) compared to the licensed varicella vaccine, Varivax (VV), as a first dose for children aged 12 to 15 months in the US. To ensure more representative data, participants in the VV group are randomized into two lots (VV_Lot1 and VV_Lot2), which are analyzed as pooled lots throughout the study. Besides assessing immunogenicity, the study also seeks to generate safety data.

In the US, participants will receive additional vaccines: a measles, mumps, and rubella vaccine (MMR), a hepatitis A vaccine (Havrix), and a 13-valent pneumococcal conjugate vaccine (Prevnar 13). Participants outside the US will receive an MMR vaccine (M-M-R II or M-M-RVaxPro, depending on the country), Havrix, and, in some cases, Prevnar 13, but only in countries where it's recommended for children 12-15 months according to local immunization schedules.

At the end of the study, or shortly after, GSK provided re-vaccination with a dose of Varivax (VV) to participants who did not meet the pre-specified seroresponse threshold of anti-gE antibody concentration was greater than or equal to (>=) 300 mIU/mL. Additionally, a second dose of VV and/or Havrix was offered to participants in non-US countries where local health departments do not routinely provide varicella and/or hepatitis A vaccines.

• Study Type: Interventional
• Enrollment (Actual): 800
• Phase: Phase 2

Contacts and Locations

Study Locations

• Estonia
  • Tallinn, Estonia, 10617
    • GSK Investigational Site
  • Tartu, Estonia, 50106
    • GSK Investigational Site
• Poland
  • Bydgoszcz, Poland, 85-048
    • GSK Investigational Site
  • Torun, Poland, 87-100
    • GSK Investigational Site
• Puerto Rico
  • San Juan, Puerto Rico, 00918
    • GSK Investigational Site
  • San Juan, Puerto Rico, 00907
    • GSK Investigational Site
• Taiwan
  • Taichung, Taiwan, 40447
    • GSK Investigational Site
  • Taipei, Taiwan, 10002
    • GSK Investigational Site
  • Taoyuan, Taiwan, 333
    • GSK Investigational Site
• United Kingdom
  • Ohio, United Kingdom, 45414
    • GSK Investigational Site
• United States
  • Arkansas
    • Bryant, Arkansas, United States, 72022
      • GSK Investigational Site
    • Jonesboro, Arkansas, United States, 72401
      • GSK Investigational Site
    • Little Rock, Arkansas, United States, 72202
      • GSK Investigational Site
  • California
    • Bellflower, California, United States, 90706
      • GSK Investigational Site
    • Downey, California, United States, 90240
      • GSK Investigational Site
    • Foothill Ranch, California, United States, 92610
      • GSK Investigational Site
    • Huntington Park, California, United States, 90255
      • GSK Investigational Site
    • Los Angeles, California, United States, 90057
      • GSK Investigational Site
    • West Covina, California, United States, 91790
      • GSK Investigational Site
  • Florida
    • Tampa, Florida, United States, 33613
      • GSK Investigational Site
  • Georgia
    • Atlanta, Georgia, United States, 30310
      • GSK Investigational Site
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • GSK Investigational Site
  • Louisiana
    • New Orleans, Louisiana, United States, 70006-5322
      • GSK Investigational Site
  • Mississippi
    • Gulfport, Mississippi, United States, 39507
      • GSK Investigational Site
  • Missouri
    • Bridgeton, Missouri, United States, 63044
      • GSK Investigational Site
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • GSK Investigational Site
    • Omaha, Nebraska, United States, 68134
      • GSK Investigational Site
  • Nevada
    • Las Vegas, Nevada, United States, 89128
      • GSK Investigational Site
  • New York
    • Bronx, New York, United States, 10468
      • GSK Investigational Site
    • East Syracuse, New York, United States, 13210
      • GSK Investigational Site
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • GSK Investigational Site
  • Ohio
    • Cleveland, Ohio, United States, 44121
      • GSK Investigational Site
    • Dayton, Ohio, United States, 45406
      • GSK Investigational Site
  • Pennsylvania
    • Fort Washington, Pennsylvania, United States, 19034
      • GSK Investigational Site
  • South Carolina
    • Barnwell, South Carolina, United States, 29812
      • GSK Investigational Site
  • Tennessee
    • Tullahoma, Tennessee, United States, 37388
      • GSK Investigational Site
  • Texas
    • Corpus Christi, Texas, United States, 78414
      • GSK Investigational Site
    • Dallas, Texas, United States, 75230-2571
      • GSK Investigational Site
    • Dickinson, Texas, United States, 77539
      • GSK Investigational Site
    • Houston, Texas, United States, 77087
      • GSK Investigational Site
    • McAllen, Texas, United States, 78504
      • GSK Investigational Site
    • Pflugerville, Texas, United States, 78660
      • GSK Investigational Site
    • San Antonio, Texas, United States, 78218
      • GSK Investigational Site
  • Utah
    • Layton, Utah, United States, 84041
      • GSK Investigational Site
    • Provo, Utah, United States, 84604
      • GSK Investigational Site
    • Roy, Utah, United States, 84067
      • GSK Investigational Site
    • Saint George, Utah, United States, 84790
      • GSK Investigational Site
    • South Jordan, Utah, United States, 84095
      • GSK Investigational Site
    • Syracuse, Utah, United States, 84075
      • GSK Investigational Site
  • Virginia
    • Charlottesville, Virginia, United States, 22902
      • GSK Investigational Site
  • Wisconsin
    • Marshfield, Wisconsin, United States, 54449
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 1 year (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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.

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.
• Previous administration of a booster dose of any pneumococcal conjugate vaccine.
• Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the dose and ending at 43 days after the dose of study interventions administration* (Visit 3) with the exception of inactivated influenza (flu) vaccine which may be given at any time during the study and administered at a different location than the study interventions.

• Any other age appropriate vaccine may be given starting at Visit 3 and anytime thereafter.

  • In case of emergency mass vaccination for an unforeseen public health threat (e.g., a pandemic) is recommended and/or organized by public health authorities outside the routine immunization program, the time period described above can be reduced if necessary for that vaccine, provided it is used according to the local governmental recommendations and that the Sponsor/designee is notified accordingly.

Prior/Concurrent Clinical Study Experience

• Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non investigational intervention (drug/invasive medical device).

Other Exclusions

• Child in care.
• Any study personnel's immediate dependents, family, or household members.

• Participants with the following high-risk individuals in their household:

  • Immunocompromised individuals.
  • Pregnant women without documented history of varicella.
  • Newborn infants of mothers without documented history of varicella.
  • Newborn infants born <28 weeks of gestation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Biological: Investigational varicella vaccine low potency; 1 dose of a low-potency investigational varicella vaccine administered subcutaneously.; Biological: Measles, mumps, and rubella vaccine; 1 dose of a measles, mumps, and rubella vaccine administered subcutaneously.; Biological: Hepatitis A vaccine; 1 dose of a hepatitis A vaccine administered intramuscularly.; Biological: 13-valent pneumococcal conjugate vaccine; 1 dose of a 13-valent pneumococcal conjugate vaccine administered intramuscularly.
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.	Biological: Measles, mumps, and rubella vaccine; 1 dose of a measles, mumps, and rubella vaccine administered subcutaneously.; Biological: Hepatitis A vaccine; 1 dose of a hepatitis A vaccine administered intramuscularly.; Biological: 13-valent pneumococcal conjugate vaccine; 1 dose of a 13-valent pneumococcal conjugate vaccine administered intramuscularly.; Biological: Investigational varicella vaccine medium potency; 1 dose of a medium-potency investigational varicella vaccine administered subcutaneously.
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.	Biological: Measles, mumps, and rubella vaccine; 1 dose of a measles, mumps, and rubella vaccine administered subcutaneously.; Biological: Hepatitis A vaccine; 1 dose of a hepatitis A vaccine administered intramuscularly.; Biological: 13-valent pneumococcal conjugate vaccine; 1 dose of a 13-valent pneumococcal conjugate vaccine administered intramuscularly.; Biological: Investigational varicella vaccine high potency; 1 dose of a high-potency investigational varicella vaccine administered subcutaneously.
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.	Biological: Measles, mumps, and rubella vaccine; 1 dose of a measles, mumps, and rubella vaccine administered subcutaneously.; Biological: Hepatitis A vaccine; 1 dose of a hepatitis A vaccine administered intramuscularly.; Biological: 13-valent pneumococcal conjugate vaccine; 1 dose of a 13-valent pneumococcal conjugate vaccine administered intramuscularly.; Biological: Licensed varicella vaccine Lot 1; 1 dose of a licensed varicella vaccine of Lot 1 administered subcutaneously.; Biological: Licensed varicella vaccine Lot 2; 1 dose of a licensed varicella vaccine of Lot 2 administered subcutaneously.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Seroresponse to VZV gE	Seroresponse was defined as the percentage of participants for whom the post-dose of anti VZV gE antibody concentration was greater than or equal to (>=) 300 mIU/mL for each group.	At Day 43
Number of Participants Reporting Each Solicited Administration Site Events	Assessed solicited administration site events included injection site redness, pain and swelling.	Day 1 (post dose) to Day 4
Number of Participants Reporting Each Solicited Systemic Events	Solicited systemic events included fever, varicella like rash (including injection site varicella-like rash), and general rash (not varicella-like) after the administration of all vaccines for each group. Fever was defined as temperature >= 38.0 °C (100.4°F) by any route (the preferred location for measuring temperature is the axilla). A typical varicella-like rash manifests as a rash/lesion that may appear within several weeks after the varicella vaccination. Lesions may contain spots, bumps, blisters, or crusts. Includes injection site varicella-like rash.	Day 1 (post dose) to Day 43
Number of Participants Reporting Each Solicited Systemic Events	Solicited systemic events included drowsiness, loss of appetite, and irritability after the administration of all vaccines for each group.	Day 1 (post dose) to Day 15
Number of Participants Reporting Unsolicited Adverse Events	Unsolicited adverse events (AEs) included any AE reported in addition to solicited events during the study, or any "solicited" symptoms with onset outside of the specified period of follow-up for solicited symptoms; these were assessed for each group after the administration of all vaccines. Unsolicited AEs included both serious and non-serious AEs.	Day 1 (post dose) to Day 43
Number of Participants Reporting Serious Adverse Events (SAEs)	A SAE was defined as an AE which was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, or other situations that were considered serious per medical or scientific judgment.	From Day 1 to Day 181 (Study end)

Collaborators and Investigators

• Sponsor: GlaxoSmithKline
• Collaborators: IQVIA, USA

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2022
• Primary Completion (Actual): February 9, 2024
• Study Completion (Actual): June 13, 2024

Study Registration Dates

• First Submitted: October 18, 2021
• First Submitted That Met QC Criteria: October 18, 2021
• First Posted (Actual): October 19, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 7, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Varicella; Chickenpox
• Additional Relevant MeSH Terms: Varicella Zoster Virus Infection; Infections; Virus Diseases; DNA Virus Infections; Herpesviridae Infections; Chickenpox; Immunologic Factors; Physiological Effects of Drugs; Heptavalent Pneumococcal Conjugate Vaccine; Vaccines
• Other Study ID Numbers: 217212; 2022-001910-21 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
• IPD Sharing 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.
• IPD Sharing 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 Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No