A Study on the Immune Response and Safety of an Investigational Combined Measles, Mumps, Rubella and Varicella Vaccine, When Given to Healthy Children 4 to 6 Years of Age (MMRVNS 20-002)

July 29, 2026 updated by: GlaxoSmithKline

A Phase 3a, Observer-blind, Randomized, Controlled Study to Demonstrate Lot-to-lot Consistency and Evaluate the Immunogenicity and Safety of an Investigational Combined Measles, Mumps, Rubella and Varicella Vaccine Compared With ProQuad, Administered as a Second Dose in Healthy Children 4-6 Years of Age

The purpose of this study is to evaluate how consistently 3 different manufacturing lots of the GSK's investigational measles, mumps, rubella, and varicella (MMRVNS) vaccine will produce an immune response. It will also compare the overall immune response to the MMRVNS vaccine with that of the Merck licensed measles, mumps, rubella, and varicella (MMRV) vaccine.

The vaccines will be given as a second dose to children aged 4 to 6 years who have previously received a first dose of any combination of measles, mumps, rubella, and varicella-containing vaccine(s).

The study will also assess the immune response and safety of the MMRVNS and MMRV vaccines when given at the same time as a diphtheria, tetanus, acellular pertussis, and inactivated poliovirus (DTaP-IPV) vaccine. The DTaP-IPV vaccine used is licensed as Kinrix in the United States.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1860

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Equipo Ciencia
        • Contact:
        • Principal Investigator:
          • Gonzalo Perez Marc
      • Ciudad Autonoma Buenos Aires, Argentina
        • Helios Salud
        • Contact:
        • Principal Investigator:
          • Rosa Bologna
      • Córdoba, Argentina
      • Mar del Plata, Argentina
        • Clinica del Nino y la Familia de Mar del Plata
        • Contact:
        • Principal Investigator:
          • Ignacio Uriarte
      • Río Cuarto, Argentina
        • Instituto Médico Río Cuarto
        • Contact:
        • Principal Investigator:
          • Ulises D Andrea Nores
      • San Miguel de Tucumán, Argentina
        • Clinica Mayo de Urgencias Medicas Cruz Blanca SRL
        • Contact:
        • Principal Investigator:
          • Adriana E Soto
      • San Miguel de Tucumán, Argentina
        • Hospital del Nino Jesus
        • Contact:
        • Principal Investigator:
          • Conrado J Llapur
  • Finland
      • Espoo, Finland
        • Finnish Vaccine Research, Espoo Clinic
        • Contact:
        • Principal Investigator:
          • Benita Ukkonen
      • Helsinki, Finland
        • Finnish Vaccine Research, Helsinki South Clinic
        • Contact:
        • Principal Investigator:
          • Santtu Heinonen
      • Jarvenpaa, Finland
        • Finnish Vaccine Research, Järvenpää Clinic
        • Principal Investigator:
          • Miia Virta
        • Contact:
      • Kokkola, Finland
        • Finnish Vaccine Research, Kokkola Clinic
        • Principal Investigator:
          • Satu Kokko
        • Contact:
      • Oulu, Finland
        • Finnish Vaccine Research, Oulu Clinic
        • Principal Investigator:
          • Satu Kokko
        • Contact:
      • Seinäjoki, Finland
        • Finnish Vaccine Research, Seinäjoki Clinic
        • Principal Investigator:
          • Hilkka Liitsola
        • Contact:
      • Tampere, Finland
        • Finnish Vaccine Research, Tampere Clinic
        • Principal Investigator:
          • Oskari Pitkanen
        • Contact:
      • Turku, Finland
        • Finnish Vaccine Research, Turku Clinic
        • Contact:
        • Principal Investigator:
          • Santtu Heinonen
  • Italy
      • Bari, Italy
        • Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
        • Principal Investigator:
          • Silvio Tafuri
        • Contact:
      • Foggia, Italy
        • Ospedale D'Avanzo
        • Principal Investigator:
          • Rosa Prato
        • Contact:
      • Rome, Italy
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
        • Contact:
        • Principal Investigator:
          • Danilo Buonsenso
  • Puerto Rico
      • Corozal, Puerto Rico
  • Taiwan
      • Taichung, Taiwan
        • China Medical University Hospital
        • Contact:
        • Principal Investigator:
          • Kao-Pin Hwang
      • Taichung, Taiwan
        • Taichung Veterans General Hospital
        • Contact:
        • Principal Investigator:
          • Hui-Hsien Pan
      • Taipei, Taiwan
        • National Taiwan University Hospital
        • Contact:
        • Principal Investigator:
          • Li-Min Huang
      • Taipei, Taiwan
        • MacKay Memorial Hospital Taipei Branch
        • Contact:
        • Principal Investigator:
          • Nan-Chang Chiu
      • Taoyuan City, Taiwan
        • Chang Gung Memorial Hospital, Linkou
        • Contact:
        • Principal Investigator:
          • Cheng-Hsun Chiu
  • United States
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • Children's Clinic of Jonesboro, AR
        • Principal Investigator:
          • Kevin Rouse
        • Contact:
      • Little Rock, Arkansas, United States, 72212
        • Applied Research Center of Arkansas
        • Contact:
        • Principal Investigator:
          • Sarah Bone
    • California
      • Huntington Park, California, United States, 90255
        • Century Research Institute Inc
        • Principal Investigator:
          • Albert Nassir
        • Contact:
      • Los Angeles, California, United States, 90057
        • Matrix Clinical Research
        • Principal Investigator:
          • Jose Diaz
        • Contact:
      • Sacramento, California, United States, 95823
        • Center for Clinical Trials of Sacramento, Inc.
        • Principal Investigator:
          • Marita Biag
        • Contact:
      • West Covina, California, United States, 91790
        • Center for Clinical Trials of San Gabriel
        • Principal Investigator:
          • Holly Lim
        • Contact:
    • Florida
      • Coral Gables, Florida, United States, 33134
      • Margate, Florida, United States, 33063
        • D&H Pompano Research Center LLC
        • Contact:
        • Principal Investigator:
          • Yanetsi Landa Colon
      • Tampa, Florida, United States, 33613
        • PAS Research
        • Principal Investigator:
          • Teena Hughes
        • Contact:
    • Idaho
      • Ammon, Idaho, United States, 83406
        • Medical Research Partners
        • Principal Investigator:
          • Joseph Moore
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60611-2605
        • Ann & Robert H. Lurie Children's Hospital of Chicago
        • Principal Investigator:
          • William Muller
        • Contact:
    • Kentucky
      • Bardstown, Kentucky, United States, 40004
        • Kentucky Pediatric/ Adult Research
        • Principal Investigator:
          • Daniel Finn
        • Contact:
      • Louisville, Kentucky, United States, 40202
        • Norton Childrens Research Institute
        • Contact:
        • Principal Investigator:
          • Daniel Blatt
    • Louisiana
      • Covington, Louisiana, United States, 70433
        • Benchmark Research
        • Principal Investigator:
          • Sherri Casey
        • Contact:
      • Haughton, Louisiana, United States, 71037
        • ACC Pediatric Research
        • Principal Investigator:
          • Stacey Sparks
        • Contact:
      • Lafayette, Louisiana, United States, 70508
        • Velocity Clinical Research, Gulfport
        • Principal Investigator:
          • Jibran Atwi
        • Contact:
    • Missouri
      • Jefferson City, Missouri, United States, 65109
        • Jefferson City Medical Group PC
        • Principal Investigator:
          • Alfred Johnson
        • Contact:
    • Montana
      • Missoula, Montana, United States, 59804
        • Boeson Research MSO
        • Principal Investigator:
          • Aubrey Remmers
        • Contact:
    • Nebraska
      • Lincoln, Nebraska, United States, 68504
        • Midwest Children's Health Research Institute, LLC
        • Principal Investigator:
          • David Meduna
        • Contact:
      • Lincoln, Nebraska, United States, 68505
        • Midwest Children's Health Research Institute, LLC
        • Contact:
        • Principal Investigator:
          • Sue Springman
      • Lincoln, Nebraska, United States, 68516
        • Complete Children's Health
        • Contact:
        • Principal Investigator:
          • Alexandra Keating
      • Lincoln, Nebraska, United States, 68522-1231
        • Complete Children's Health
        • Principal Investigator:
          • Luke Anschutz
        • Contact:
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
    • Ohio
      • Cleveland, Ohio, United States, 44121-4243
    • South Carolina
      • Charleston, South Carolina, United States, 29407
        • Neighbors Clinical Research
        • Principal Investigator:
          • John Traynham
        • Contact:
      • Greenville, South Carolina, United States, 29607
        • Tribe Clinical Research LLC/Parkside Pediatrics
        • Principal Investigator:
          • Scott Dobson
        • Contact:
      • Simpsonville, South Carolina, United States, 29681
        • Tribe Clinical Research LLC/Parkside Pediatrics
        • Contact:
        • Principal Investigator:
          • Justin Moll
      • Summerville, South Carolina, United States, 29486
        • Carolina Family Care
        • Principal Investigator:
          • Stephen Stripling
        • Contact:
    • Tennessee
      • Nashville, Tennessee, United States, 37208
        • Meharry Medical College
        • Principal Investigator:
          • Vladimir Berthaud
        • Contact:
    • Texas
      • Beaumont, Texas, United States, 77706
        • Tekton Research - Beaumont, TX
        • Principal Investigator:
          • Robert Bell
        • Contact:
      • Edinburg, Texas, United States, 78539
        • PAS Research
        • Contact:
        • Principal Investigator:
          • Allan Mercado
      • Houston, Texas, United States, 77087
        • Pediatric Associates
        • Principal Investigator:
          • Martin Yudovich
        • Contact:
    • Utah
      • Kaysville, Utah, United States, 84037
      • Layton, Utah, United States, 84041
        • Tanner Clinic Layton Parkway
        • Principal Investigator:
          • Brent Eberhard
        • Contact:
      • Ogden, Utah, United States, 84404
        • Ogden Clinic Canyon View
        • Principal Investigator:
          • Stephen Bruce
        • Contact:
    • Virginia
      • Charlottesville, Virginia, United States, 22902
        • Pediatric Research of Charlottesville, LLC
        • Contact:
        • Principal Investigator:
          • Paul Wisman
      • Richmond, Virginia, United States, 23236
    • Wisconsin
      • Marshfield, Wisconsin, United States, 54449
        • Marshfield Clinic Research Foundation, a Division of Marshfield Clinic, Inc
        • Contact:
        • Principal Investigator:
          • Keith Pulvermacher

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria (INC):

  • INC#1 Participant's 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 the eDiaries, return for follow-up visits).
  • INC#2 Written or witnessed/thumb printed or digital informed consent obtained from the participant's parent(s)/LAR(s) prior to performance of any study specific procedure.
  • INC#3 Informed assent obtained from the participants in line with local rules and regulations.
  • INC#4 Healthy participants as established by medical history and clinical examination at screening.
  • INC#5 A male or female participant between and including 4 and 6 years of age (i.e., from fourth birthday until the day before the seventh birthday) at the time of the study interventions administration, and in accordance with local regulations.
  • INC#6 Participant who previously received a first dose of varicella-containing vaccine in the second year of life (i.e., from first birthday at 12 months of age until the day before the second birthday at 24 months of age).
  • INC#7 Participant who previously received a first dose of measles, mumps, rubella containing vaccine in the second year of life (i.e., from first birthday at 12 months of age until the day before the second birthday at 24 months of age).
  • INC#8 Participant who previously received 3 or 4 doses of any combined DTP (DTaP/DTwP) vaccine (diphtheria and tetanus toxoids and pertussis antigens whether or not combined with hepatitis B, inactivated poliovirus or Haemophilus influenzae type b antigens) according to the local recommendations.

Exclusion Criteria (EXC):

  • EXC#1 History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions, including hypersensitivity to neomycin or gelatin.
  • EXC#2 Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
  • EXC#3 Hypersensitivity to latex.
  • EXC#4 Unstable chronic conditions as determined by medical history and physical examination.
  • EXC#5 Major congenital defects, as assessed by the investigator.
  • EXC#6 History of measles, mumps, rubella or varicella/zoster disease as evaluated by the investigator.
  • EXC#7 History of diphtheria, tetanus, pertussis, and/or poliomyelitis disease.
  • EXC#8 Recurrent history or uncontrolled neurological disorders or any neuroinflammatory (including, but not limited to: demyelinating disorders, encephalitis or myelitis of any origin), congenital neurological conditions, encephalopathies, or seizures (including all subtypes, such as: absence seizures, generalized tonic-clonic seizures, partial complex seizures, partial simple seizures).
  • EXC#9 Active untreated tuberculosis.
  • EXC#10 Condition that, in the judgment of the investigator, would make intramuscular injection unsafe.
  • EXC#11 Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the clinical study.
  • EXC#12 Use of any investigational or non-registered product (drug, vaccine, or invasive medical device in the country of enrollment) 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.
  • EXC#13 Administration of immunoglobulins or other blood products or plasma derivatives during the period starting 90 days before the study intervention or planned administration during the study period.

  • EXC#14 Chronic administration of immune-modifying drugs (defined as more than 14 consecutive days in total) and/or planned use of long-acting immune modifying treatments at any time up to the end of the study.

    • Up to 90 days prior to the study interventions administration.

      • For corticosteroids, this will mean prednisone equivalent ≥0.5 mg/kg/day with maximum of 20 mg/day for pediatric participants. Inhaled, intra-articular/intra-bursal and topical steroids are allowed.
    • Up to 180 days prior to study interventions administration: long-acting immune-modifying drugs including among others immunotherapy (e.g., tumor necrosis factor-inhibitors), monoclonal antibodies (except the ones not interfering with the immune response to the study interventions, e.g., nirsevimab), antitumoral medication.
  • EXC#15 Previous vaccination with a second dose of varicella-containing vaccine or measles, mumps, rubella containing vaccine.
  • EXC#16 Vaccination against diphtheria, tetanus, pertussis, and/or poliomyelitis given after the second year of life (i.e., after the second birthday at 24 months of age).

  • EXC#17 Occurrence of any of the following events after a previous administration of DTP vaccine:

    • Encephalopathy of unknown etiology occurring during the period starting within 7 days of vaccination of a previous administration of DTP vaccine.
    • A temperature (≥40.6°C [≥105°F]) during the period starting 48 hours after vaccination not due to another identifiable cause.
  • EXC#18 Use of salicylates (aspirin) or salicylate-containing products or its planned use, during the period of 6 weeks following study interventions administration.
  • EXC#19 Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the dose and ending 43 days after the dose of study interventions administration* (Visit 2), with the exception of

Influenza vaccines:

  • Inactivated influenza vaccine must not be administered in the period starting 28 days before the dose and ending 28 days after the dose of study intervention administration. If administered outside this prohibited period, it should be administered at a different location than the study intervention.

  • Live attenuated influenza vaccine must not be administered during the period starting 30 days before the dose and ending 43 days after the dose of study intervention administration (Visit 2).

    • If 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, provided it is used according to the local governmental recommendations and sponsor is notified.

      • EXC#20 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/vaccine/invasive medical device).
      • EXC#21 Any study personnel's immediate dependents, family, or household members.
      • EXC#22 Child in care.

      • EXC#23 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: MMRVNS_Lot 1 group
Participants will receive a single dose of the Lot 1 MMRVNS vaccine and a single dose of the DTaP-IPV vaccine on Day 1.
Biological: MMRVNS vaccine
MMRVNS vaccine will be administered on Day 1.
Biological: DTaP-IPV vaccine
DTaP-IPV vaccine will be administered on Day 1.
Other Names:
  • Kinrix
Experimental: MMRVNS_Lot 2 group
Participants will receive a single dose of the Lot 2 MMRVNS vaccine and a single dose of the DTaP-IPV vaccine on Day 1.
Biological: MMRVNS vaccine
MMRVNS vaccine will be administered on Day 1.
Biological: DTaP-IPV vaccine
DTaP-IPV vaccine will be administered on Day 1.
Other Names:
  • Kinrix
Experimental: MMRVNS_Lot 3 group
Participants will receive a single dose of the Lot 3 MMRVNS vaccine and a single dose of the DTaP-IPV vaccine on Day 1.
Biological: MMRVNS vaccine
MMRVNS vaccine will be administered on Day 1.
Biological: DTaP-IPV vaccine
DTaP-IPV vaccine will be administered on Day 1.
Other Names:
  • Kinrix
Active Comparator: MMRV group
Participants will receive a single dose of MMRV vaccine and a single dose of DTaP-IPV vaccine on Day 1.
Biological: DTaP-IPV vaccine
DTaP-IPV vaccine will be administered on Day 1.
Other Names:
  • Kinrix
Biological: MMRV vaccine
MMRV vaccine will be administered on Day 1.
Other Names:
  • ProQuad

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Geometric mean concentrations (GMCs) of immunoglobulin G (IgG) antibodies against measles, mumps, rubella, and varicella zoster virus (VZV) glycoprotein E (gE) after MMRVNS vaccine administration
Time Frame: At Day 43
This outcome measure evaluates immunological consistency.
At Day 43
Number of participants with seroresponse against measles, mumps, rubella, and VZV gE after MMRVNS or MMRV administration
Time Frame: At Day 43

This outcome measure evaluates immunological non-inferiority.

Seroresponse is defined as post-vaccination IgG antibody concentrations equal to or above threshold values as follows:

The seroresponse of a participant is:

  • zero (non-seroresponder) if the IgG concentration is below the seroresponse threshold of the assay,
  • One (seroresponder) if the IgG concentration is above or equal to the seroresponse threshold.
At Day 43
GMCs of IgG concentrations against measles, mumps, rubella, and VZV gE after MMRVNS or MMRV administration
Time Frame: At Day 43
This outcome measure evaluates immunological non-inferiority.
At Day 43

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
GMCs of IgG antibodies against diphtheria, tetanus, and pertussis antigens (Bordetella pertussis toxin, filamentous hemagglutinin, and outer membrane protein pertactin) after MMRVNS or MMRV administration in a subset of participants
Time Frame: At Day 43
This outcome measure evaluates immunological non-inferiority.
At Day 43
Geometric mean titers (GMTs) of neutralizing antibodies against poliovirus 1, 2, and 3 after MMRVNS or MMRV administration in a subset of participants
Time Frame: At Day 43
This outcome measure evaluates immunological non-inferiority.
At Day 43
Booster response of IgG concentrations against pertussis antigens (Bordetella pertussis toxin, filamentous hemagglutinin, and outer membrane pertactin) after DTaP-IPV co-administration with MMRVNS or MMRV in a subset of participants
Time Frame: At Day 43

The booster response of a participant is:

One (responder) if:

- the pre-vaccination antibody concentration is below the assay cut-off, and the post-vaccination antibody concentration is >=4 times the assay cut-off.

or, - the pre-vaccination antibody concentration is between the assay cut-off and 4 times the assay cut-off, and the post-vaccination antibody concentration is >=4 times the pre vaccination antibody concentration.

or,

- the pre-vaccination antibody concentration is greater or equal to 4 times the assay cut-off, and the post vaccination antibody concentration is >=2 times the pre-vaccination antibody concentration.

Zero (non-responder) in all other cases.
At Day 43
Number of participants with any solicited administration site events following MMRVNS or MMRV administration
Time Frame: From Day 1 to Day 4 for injection site redness, pain/tenderness, and swelling; and from Day 1 to Day 43 for injection site varicella-like rash
Solicited administration site events are injection site redness, pain/tenderness, swelling, and injection site varicella-like rash.
From Day 1 to Day 4 for injection site redness, pain/tenderness, and swelling; and from Day 1 to Day 43 for injection site varicella-like rash
Number of participants with any solicited systemic events following MMRVNS or MMRV administration
Time Frame: From Day 1 to Day 15 for somnolence and loss of appetite; Day 1 to Day 22 for fever; Day 1 to Day 43 for varicella-like rash (non-injection site), measles/rubella-like rash, and other rash
Solicited systemic events are somnolence (sleepiness/drowsiness), loss of appetite, fever, varicella-like rash (non-injection site), measles/rubella-like rash, and other rash that is not varicella-like or measles/rubella-like rash.
From Day 1 to Day 15 for somnolence and loss of appetite; Day 1 to Day 22 for fever; Day 1 to Day 43 for varicella-like rash (non-injection site), measles/rubella-like rash, and other rash
Number of participants with any unsolicited adverse events (AEs) following MMRVNS or MMRV administration
Time Frame: From Day 1 to Day 43
An unsolicited AE is an AE that is either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow- up for solicited events.
From Day 1 to Day 43
Number of participants with any medically attended adverse events (MAAEs) following MMRVNS or MMRV administration
Time Frame: From Day 1 to Day 181
MAAEs are solicited AEs and unsolicited nonserious AEs for which the participant received medical attention (an unscheduled visit to or from medical personnel for any reason, including emergency room visits).
From Day 1 to Day 181
Number of participants with serious adverse events (SAEs), fatal SAEs, and related SAEs following MMRVNS or MMRV administration
Time Frame: From Day 1 to Day 181
An SAE is defined as any untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, or other medically significant events.
From Day 1 to Day 181

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 11, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 27, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 21, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 29, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 3, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 217717
  • 2025-523277-42-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study Sponsor 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/gsk-patient-level-data-sharing-july2025.pdf

IPD Sharing Time Frame

Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.

IPD Sharing Access Criteria

Anonymized IPD is shared with researchers whose proposals are approved by an 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 may be granted, when justified, for up to 6 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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