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

Last updated: June 5, 2025
Sponsor: GlaxoSmithKline
Overall Status: Completed

Phase

2

Condition

Shingles

Throat And Tonsil Infections

Rash

Treatment

Investigational MMRV(H)NS vaccine

Marketed MMRV_Lot 1 and Lot 2 vaccine

Investigational M(L)M(L)R(L)V(L)NS vaccine

Clinical Study ID

NCT05630846
217715
2022-501564-18
  • Ages 4-6
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Healthy participants as established by medical history and clinical examinationbefore entering into the study.

  • A male or female between, and including, 4 years and 6 years of age (i.e., from 4year birthday until the day before the 7-year birthday) at the time of studyintervention administration, and in accordance with local regulations.

  • Participant who previously received a first dose of varicella-containing vaccine inthe 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)/legallyacceptable representative(s) (LAR[s]) prior to performance of any study-specificprocedure (participant informed assent will be obtained from participants in linewith local rules and regulations).

  • Participants' parent(s)/LAR(s), who, in the opinion of the investigator, can andwill comply with the requirements of the protocol (e.g., completion of electronicdiaries [eDiaries], return for follow-up visits).

Exclusion

Exclusion Criteria:

Medical Conditions

  • History of any reaction or hypersensitivity likely to be exacerbated by anycomponent of the study interventions including hypersensitivity to neomycin orgelatin.

  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based onmedical 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 ofa moderate or severe illness with or without fever. Fever is defined as bodytemperature >=38.0 degrees Celsius (°C) (100.4 degrees Fahrenheit [°F)] by anyage-appropriate route. All study interventions can be administered to participantswith a minor illness such as diarrhea, mild upper respiratory infection withoutfever.

  • Participant with history of coronavirus disease 2019 (COVID-19) who is stillsymptomatic.

  • Any other clinical condition that, in the opinion of the investigator, might poseadditional 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 medicaldevice) other than the study interventions during the period beginning 30 daysbefore the dose of study interventions (Day -29 to Day 1), or their planned useduring the study period.

  • Chronic administration (defined as more than 14 days in total) of immunosuppressantsor other immune-modifying drugs during the period starting 90 days prior to thestudy intervention administration. For corticosteroids, this will mean prednisoneequivalent >= 0.5 mg/kg/day or 20 mg/day whichever is the maximum dose for pediatricparticipants. Inhaled and topical steroids are allowed.

  • Administration of immunoglobulins and/or any blood products or plasma derivativesduring the period starting 180 days before the dose of study interventions orplanned administration during the study period.

  • Administration of long-acting immune-modifying drugs at any time during the studyperiod (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 studyprotocol in the period starting 30 days before the dose and ending at 43 days afterthe dose of study interventions administration* (Visit 3), with the exception of:

  • inactivated influenza (flu) vaccine which may be given at any time during thestudy and administered at a different location than the study interventionsand,

  • routinely recommended licensed childhood DTPa-containing vaccines which canpreferably be co-administered according to the local immunization practices ofthe participating country.

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

  • In case an emergency mass vaccination for an unforeseen public health threat (e.g., a pandemic) is recommended and/or organized by public health authoritiesoutside the routine immunization program, the time period described above canbe reduced if necessary for that vaccine, provided it is used according to thelocal 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 Design

Total Participants: 801
Treatment Group(s): 4
Primary Treatment: Investigational MMRV(H)NS vaccine
Phase: 2
Study Start date:
December 14, 2022
Estimated Completion Date:
October 14, 2024

Study 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.

Connect with a study center

  • GSK Investigational Site

    Bahia Blanca, Buenos Aires 8001
    Argentina

    Site Not Available

  • GSK Investigational Site

    Buenos Aires, C1430BKC
    Argentina

    Site Not Available

  • GSK Investigational Site

    Ciudad Autónoma de Buenos Aires, C1426BOR
    Argentina

    Site Not Available

  • GSK Investigational Site

    Rio Cuarto, 5800
    Argentina

    Site Not Available

  • GSK Investigational Site

    Macul, 7810000
    Chile

    Site Not Available

  • GSK Investigational Site

    Acacias, 507001
    Colombia

    Site Not Available

  • GSK Investigational Site

    Barranquilla, 760002
    Colombia

    Site Not Available

  • GSK Investigational Site

    Bogota, 38007
    Colombia

    Site Not Available

  • GSK Investigational Site

    Chía, 250001
    Colombia

    Site Not Available

  • GSK Investigational Site

    Medellin, 50034
    Colombia

    Site Not Available

  • GSK Investigational Site

    Yopal, Casanare, 850001
    Colombia

    Site Not Available

  • GSK Investigational Site

    Riga, LV1002
    Latvia

    Site Not Available

  • GSK Investigational Site

    San Juan, 00918
    Puerto Rico

    Site Not Available

  • GSK Investigational Site

    Boadilla Del Monte (Madrid), 28660
    Spain

    Site Not Available

  • GSK Investigational Site

    Madrid, 28007
    Spain

    Site Not Available

  • GSK Investigational Site

    Taichung, 407
    Taiwan

    Site Not Available

  • GSK Investigational Site

    Taipei, 10449
    Taiwan

    Site Not Available

  • GSK Investigational Site

    Taoyuan, 333
    Taiwan

    Site Not Available

  • GSK Investigational Site

    Adana, 1300
    Turkey

    Site Not Available

  • GSK Investigational Site

    Ankara, 6100
    Turkey

    Site Not Available

  • GSK Investigational Site

    Izmir, 35210
    Turkey

    Site Not Available

  • GSK Investigational Site

    Kayseri, 38039
    Turkey

    Site Not Available

  • GSK Investigational Site

    Kocaeli, 41380
    Turkey

    Site Not Available

  • GSK Investigational Site

    Birmingham, Alabama 35235
    United States

    Site Not Available

  • GSK Investigational Site

    Jonesboro, Arkansas 72401
    United States

    Site Not Available

  • GSK Investigational Site

    Bellflower, California 90706
    United States

    Site Not Available

  • GSK Investigational Site

    Huntington Park, California 90255
    United States

    Site Not Available

  • GSK Investigational Site

    Los Angeles, California 90025
    United States

    Site Not Available

  • GSK Investigational Site

    Oakland, California 94611
    United States

    Site Not Available

  • GSK Investigational Site

    Roseville, California 95661
    United States

    Site Not Available

  • GSK Investigational Site

    Sacramento, California 95815
    United States

    Site Not Available

  • GSK Investigational Site

    San Jose, California 95119
    United States

    Site Not Available

  • GSK Investigational Site

    Santa Clara, California 95051
    United States

    Site Not Available

  • GSK Investigational Site

    Walnut Creek, California 94596
    United States

    Site Not Available

  • GSK Investigational Site

    West Covina, California 91790
    United States

    Site Not Available

  • GSK Investigational Site

    Miami Lakes, Florida 33014
    United States

    Site Not Available

  • GSK Investigational Site

    Tampa, Florida 33613
    United States

    Site Not Available

  • GSK Investigational Site

    Ammon, Idaho 83406
    United States

    Site Not Available

  • GSK Investigational Site

    Idaho Falls, Idaho 83404
    United States

    Site Not Available

  • GSK Investigational Site

    Louisville, Kentucky 40291
    United States

    Site Not Available

  • GSK Investigational Site

    Lafayette, Louisiana 70508
    United States

    Site Not Available

  • GSK Investigational Site

    Boston, Massachusetts 02118
    United States

    Site Not Available

  • GSK Investigational Site

    Bingham Farms, Michigan 48025
    United States

    Site Not Available

  • GSK Investigational Site

    Detroit, Michigan 48201
    United States

    Site Not Available

  • GSK Investigational Site

    Lincoln, Nebraska 68522
    United States

    Site Not Available

  • GSK Investigational Site

    Omaha, Nebraska 68114
    United States

    Site Not Available

  • GSK Investigational Site

    East Orange, New Jersey 07108
    United States

    Site Not Available

  • GSK Investigational Site

    Syracuse, New York 13210
    United States

    Site Not Available

  • GSK Investigational Site

    Cleveland, Ohio 44121
    United States

    Site Not Available

  • GSK Investigational Site

    Dayton, Ohio 45414
    United States

    Site Not Available

  • GSK Investigational Site

    Fort Washington, Pennsylvania 19034
    United States

    Site Not Available

  • GSK Investigational Site

    Charleston, South Carolina 29407
    United States

    Site Not Available

  • GSK Investigational Site

    Simpsonville, South Carolina 29681
    United States

    Site Not Available

  • GSK Investigational Site

    Tullahoma, Tennessee 37388
    United States

    Site Not Available

  • GSK Investigational Site

    Dickinson, Texas 77539
    United States

    Site Not Available

  • GSK Investigational Site

    Edinburg, Texas 78542
    United States

    Site Not Available

  • GSK Investigational Site

    Houston, Texas 77008
    United States

    Site Not Available

  • GSK Investigational Site

    McAllen, Texas 78504
    United States

    Site Not Available

  • GSK Investigational Site

    Richmond, Texas 77469
    United States

    Site Not Available

  • GSK Investigational Site

    Layton, Utah 84041
    United States

    Site Not Available

  • GSK Investigational Site

    Murray, Utah 84107
    United States

    Site Not Available

  • GSK Investigational Site

    Provo, Utah 84604
    United States

    Site Not Available

  • GSK Investigational Site

    Roy, Utah 84067
    United States

    Site Not Available

  • GSK Investigational Site

    South Jordan, Utah 84095
    United States

    Site Not Available

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