A Study on the Immune Response and Safety of a Combined Measles, Mumps, Rubella, Chickenpox Vaccine Compared to a Marketed Combined Vaccine, Given to Healthy Children 4 to 6 Years of Age

A Phase II, Single-blind, Randomized, Controlled Study to Evaluate the Immunogenicity and Safety of a Measles, Mumps, Rubella, Varicella Vaccine Compared With ProQuad, Administered in Healthy Children 4-6 Years of Age

The main purpose of this study is to assess immune response and safety of various potencies of a measles, mumps, rubella, and varicella (MMRVNS) vaccines given to healthy children of 4 to 6 years of age.

Study Overview

• Status: Completed
• Conditions: Measles; Measles; Mumps; Rubella; Chickenpox
• Intervention / Treatment: Biological: Investigational MMRV(H)NS vaccine; Biological: Investigational MM(H)RVNS vaccine; Biological: Investigational M(L)M(L)R(L)V(L)NS vaccine; Biological: Marketed MMRV_Lot 1 and Lot 2 vaccine

Detailed Description

This study is designed to evaluate the immunogenicity and safety of the investigational measles, mumps, rubella, varicella vaccine (referred to as the MMRVNS vaccine) compared with the licensed measles, mumps, rubella, varicella vaccine, ProQuad (referred to as the MMRV vaccine), when given as a second dose to children 4 to 6 years of age who were previously primed with a first dose of any combination of measles, mumps, rubella, and varicella-containing vaccine(s).

This study will evaluate immunogenicity and safety using 3 MMRVNS formulations which vary for some or all the individual virus potencies. The 3 MMRVNS formulations (designated as MMRV(H)NS vaccine, MM(H)RVNS vaccine and M(L)M(L)R(L)V(L)NS vaccine) will be compared with the MMRV vaccine. To ensure representative data on the comparator, participants enrolled in the MMRV group will be randomized to two different lots (designated as MMRV_Lot 1 and MMRV_Lot 2). Throughout the study, the two lots will be analyzed as a pooled group.

• Study Type: Interventional
• Enrollment (Actual): 801
• Phase: Phase 2

Contacts and Locations

Study Locations

• Colombia
  • Barranquilla, Colombia, 760002
    • GSK Investigational Site
  • Barranquilla, Colombia, 080020
    • GSK Investigational Site
  • Bogota, Colombia, 38007
    • GSK Investigational Site
• Latvia
  • Riga, Latvia, LV1002
    • GSK Investigational Site
• Puerto Rico
  • San Juan, Puerto Rico, 00918
    • GSK Investigational Site
  • San Juan, Puerto Rico, 909
    • GSK Investigational Site
  • San Juan, Puerto Rico, 00907
    • GSK Investigational Site
• Taiwan
  • Taichung, Taiwan, 40447
    • GSK Investigational Site
  • Taichung, Taiwan, 407
    • GSK Investigational Site
  • Taipei, Taiwan, 10002
    • GSK Investigational Site
  • Taipei, Taiwan, 10449
    • GSK Investigational Site
  • Taoyuan, Taiwan, 333
    • GSK Investigational Site
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35235
      • GSK Investigational Site
  • Arkansas
    • Jonesboro, Arkansas, United States, 72401
      • GSK Investigational Site
  • California
    • Bellflower, California, United States, 90706
      • GSK Investigational Site
    • Huntington Park, California, United States, 90255
      • GSK Investigational Site
    • Oakland, California, United States, 94611
      • GSK Investigational Site
    • Roseville, California, United States, 95661
      • GSK Investigational Site
    • Sacramento, California, United States, 95823
      • GSK Investigational Site
    • Sacramento, California, United States, 95815
      • GSK Investigational Site
    • San Jose, California, United States, 95119
      • GSK Investigational Site
    • Santa Clara, California, United States, 95051
      • GSK Investigational Site
    • West Covina, California, United States, 91790
      • GSK Investigational Site
  • Florida
    • Miami Lakes, Florida, United States, 33014
      • GSK Investigational Site
    • Tampa, Florida, United States, 33613
      • GSK Investigational Site
  • Idaho
    • Ammon, Idaho, United States, 83406
      • GSK Investigational Site
    • Idaho Falls, Idaho, United States, 83404
      • GSK Investigational Site
  • Kentucky
    • Louisville, Kentucky, United States, 40291
      • GSK Investigational Site
  • Louisiana
    • Lafayette, Louisiana, United States, 70508
      • GSK Investigational Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • GSK Investigational Site
  • Michigan
    • Bingham Farms, Michigan, United States, 48025
      • GSK Investigational Site
    • Detroit, Michigan, United States, 48201
      • GSK Investigational Site
  • Nebraska
    • Lincoln, Nebraska, United States, 68505
      • GSK Investigational Site
    • Lincoln, Nebraska, United States, 68522
      • GSK Investigational Site
    • Omaha, Nebraska, United States, 68114
      • GSK Investigational Site
  • New York
    • Syracuse, New York, United States, 13210
      • GSK Investigational Site
  • Ohio
    • Cleveland, Ohio, United States, 44121
      • GSK Investigational Site
    • Dayton, Ohio, United States, 45414
      • GSK Investigational Site
  • South Carolina
    • Simpsonville, South Carolina, United States, 29681
      • GSK Investigational Site
  • Tennessee
    • Tullahoma, Tennessee, United States, 37388
      • GSK Investigational Site
  • Texas
    • Dickinson, Texas, United States, 77539
      • GSK Investigational Site
    • McAllen, Texas, United States, 78504
      • GSK Investigational Site
    • Richmond, Texas, United States, 77469
      • 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
    • South Jordan, Utah, United States, 84095
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 6 years (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, 4 years and 6 years of age (i.e., from 4 year birthday until the day before the 7-year birthday) at the time of study intervention administration, and in accordance with local regulations.
• Participant who previously received a first dose of varicella-containing vaccine in the second year of life.
• Participant who previously received a single dose of measles-, mumps-, rubella-containing vaccine in the second year of life.
• Written informed consent obtained from the participants' parent(s)/legally acceptable representative(s) (LAR[s]) prior to performance of any study-specific procedure (participant informed assent will be obtained from participants in line with local rules and regulations).
• Participants' parent(s)/LAR(s), who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of electronic diaries [eDiaries], return for follow-up visits).

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 measles, mumps, rubella, or varicella disease.
• Recurrent history of or uncontrolled neurological disorders or seizures.
• Acute disease at the time of enrollment. Acute disease is defined as the presence of a moderate or severe illness with or without fever. Fever is defined as body temperature >=38.0 degrees Celsius (°C) (100.4 degrees Fahrenheit [°F)] by any age-appropriate route. All study interventions can be administered to participants with a minor illness such as diarrhea, mild upper respiratory infection without fever.
• Participant with history of coronavirus disease 2019 (COVID-19) 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 their 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 intervention 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. 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 with a second dose of varicella-containing vaccine or measles-, mumps-, rubella-containing vaccine.

• Administration or planned 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 and,
  • routinely recommended licensed childhood DTPa-containing vaccines which can preferably be co-administered according to the local immunization practices of the participating country.

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

  • In case an 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 government recommendations and that GSK/IQVIA 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: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MMRV(H)NS Group; Participants receive a single dose of an investigational measles, mumps, and rubella (MMR) at release potency and varicella at high (V[H]NS) potency vaccine on Day 1.	Biological: Investigational MMRV(H)NS vaccine; 1 dose of a measles, mumps, and rubella at release potency and VNS at high (H) potency vaccine administered subcutaneously.
Experimental: MM(H)RVNS Group; Participants receive a single dose of an investigational measles, rubella (MR), and varicella (VNS) at release potency and mumps at high (M[H]) potency vaccine on Day 1.	Biological: Investigational MM(H)RVNS vaccine; 1 dose of a measles, rubella, and varicella at release potency and mumps at high (H) potency vaccine administered subcutaneously.
Experimental: M(L)M(L)R(L)V(L)NS Group; Participants receive a single dose of an investigational measles, mumps, rubella (MMR), and varicella (VNS), all at low (L) potency vaccine on Day 1.	Biological: Investigational M(L)M(L)R(L)V(L)NS vaccine; 1 dose of measles, mumps, rubella, and varicella, all at low (L) potency vaccine administered subcutaneously.
Active Comparator: MMRV_Lot 1 and Lot 2 Pooled Group; Participants receive a single dose of a marketed measles, mumps, rubella (MMR), and varicella (V) vaccine of Lot 1 or of 1 vaccine dose of a marketed MMRV vaccine of Lot 2 on Day 1.	Biological: Marketed MMRV_Lot 1 and Lot 2 vaccine; 1 dose of a marketed measles, mumps, rubella, and varicella of Lot 1 or 1 dose of a marketed measles, mumps, rubella, and varicella of Lot 2 vaccine administered subcutaneously.; Other Names: ProQuad

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
GMC of Anti-measles Antibodies at Day 43	Anti-measles antibodies were measured with multiplex luminex based immuno assay and the results were expressed as GMC, in milli international units per milliliter (mIU/mL). Analysis was performed on per protocol set which included all eligible participants who received study intervention as per protocol, were not unblinded, had immunogenicity results pre- and post-dose for at least 1 antigen, complied with blood draw interval between study intervention and post- dose blood sample, without intercurrent medical conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination. Only participants with data available at specified timepoint were included in the analysis.	At Day 43
GMC of Anti-mumps Antibodies at Day 43	Anti-mumps antibodies were measured with multiplex luminex based immuno assay and the results were expressed as GMC, in arbitrary units per milliliter (AU/mL). Analysis was performed on per protocol set. Only participants with data available at specified timepoint were included in the analysis.	At Day 43
GMC of Anti-rubella Antibodies at Day 43	Anti-rubella antibodies were measured with multiplex luminex based immuno assay and the results were expressed as GMC, in international units per milliliter (IU/mL). Analysis was performed on per protocol set. Only participants with data available at specified timepoint were included in the analysis.	At Day 43
GMC of Anti-glycoprotein E (gE) Antibodies at Day 43	Anti-gE antibodies were measured with enzyme linked immunosorbent assay and the results were expressed as GMC, in mIU/mL. Anti-varicella and anti-varicella zoster virus gE were used interchangeably. Analysis was performed on per protocol set. Only participants with data available at specified timepoint were included in the analysis.	At Day 43

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Seroresponse for Measles Antibodies at Day 43	Seroresponse was defined as the participants of participants for whom the Day 43 measles antibodies concentration was >=116 mIU/mL. Analysis was performed on per protocol set. Only participants with data available at specified timepoint were included in the analysis.	At Day 43
Percentage of Participants With Seroresponse for Mumps Antibodies at Day 43	Seroresponse was defined as the participants of participants for whom the Day 43 mumps antibodies concentration was >=296 AU/mL. Analysis was performed on per protocol set. Only participants with data available at specified timepoint were included in the analysis.	At Day 43
Percentage of Participants With Seroresponse for Rubella Antibodies at Day 43	Seroresponse was defined as the participants of participants for whom the Day 43 rubella antibodies concentration was >=24 IU/mL. Analysis was performed on per protocol set. Only participants with data available at specified timepoint were included in the analysis.	At Day 43
Percentage of Participants With Seroresponse for Varicella Antibodies at Day 43	Seroresponse was defined as the participants of participants for whom the Day 43 varicella antibodies concentration was >=300 mIU/mL. Analysis was performed on per protocol set. Only participants with data available at specified timepoint were included in the analysis.	At Day 43
Number of Participants With Solicited Administration Site Adverse Events (AEs) During the 4-day Period After Vaccine Dose Administration	The solicited administration site events after vaccination included pain, erythema/redness, and swelling. Analysis was performed on exposed set which included all participants who received a study intervention. Only those participants with solicited AEs were included in this analysis.	Day 1 to Day 4
Number of Participants With Solicited Systemic AEs During the 4-day Period After Vaccine Dose Administration	The solicited systemic events after vaccination included drowsiness and loss of appetite. Analysis was performed on exposed set. Only those participants with solicited AEs were included in this analysis.	Day 1 to Day 4
Number of Participants With Solicited Systemic AEs During the 43-day Period After Vaccine Dose Administration	The solicited systemic events after vaccination included fever, measles/rubella-like rash, varicella- like rash and other rash (not measles/rubella-like rash or varicella-like rash). Fever was defined as temperature greater than or equal to 38.0 degrees Celsius (100.4 degrees Fahrenheit) by any route (the preferred location for measuring temperature is the axilla). Analysis was performed on exposed set. Only those participants with solicited AEs were included in this analysis.	Day 1 to Day 43
Number of Participants With Unsolicited AEs During the 43-day Period After Vaccine Dose Administration	An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study vaccine, which does not necessarily have a causal relationship with study vaccine. An unsolicited AE was an AE that was either not included in the list of solicited events or was included in the list of solicited events but with an onset outside the specified period of follow- up for solicited events. Unsolicited AEs must have been communicated by participant/participant's caregiver(s) who had signed the informed consent. Unsolicited AEs included both serious adverse events (SAEs) and non-serious AEs. Analysis was performed on exposed set.	Day 1 to Day 43
Number of Participants With SAEs After Vaccine Dose Administration	An SAE was defined as any untoward medical occurrence that, at any dose, resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in congenital anomaly or other significant medical events. Analysis was performed on exposed set.	Throughout the study period (Day 1 to Day 181)

Collaborators and Investigators

• Sponsor: GlaxoSmithKline
• Investigators: Study Director: GSK Clinical Trials, GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2022
• Primary Completion (Actual): June 7, 2024
• Study Completion (Actual): October 14, 2024

Study Registration Dates

• First Submitted: November 24, 2022
• First Submitted That Met QC Criteria: November 24, 2022
• First Posted (Actual): November 30, 2022

Study Record Updates

• Last Update Posted (Actual): June 22, 2025
• Last Update Submitted That Met QC Criteria: June 5, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Measles; Varicella; Mumps; Rubella
• Additional Relevant MeSH Terms: Varicella Zoster Virus Infection; Mouth Diseases; Stomatognathic Diseases; Infections; RNA Virus Infections; Virus Diseases; DNA Virus Infections; Salivary Gland Diseases; Herpesviridae Infections; Paramyxoviridae Infections; Mononegavirales Infections; Morbillivirus Infections; Togaviridae Infections; Rubivirus Infections; Rubulavirus Infections; Parotitis; Parotid Diseases; Measles; Chickenpox; Rubella; Mumps; Immunologic Factors; Physiological Effects of Drugs; Vaccines
• Other Study ID Numbers: 217715; 2022-501564-18 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: GSK will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About_GSK_Patient_Level_Data_Sharing_Final_13July2023.pdf.
• 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