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MeaslesPhase 3MMRVNS 20-002NCT07742644

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

A Phase 3 study testing MMRVNS vaccine, MMRV vaccine and DTaP-IPV vaccine in people with Measles and Mumps, run by GlaxoSmithKline at 62 sites in 6 countries.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 4 to 6 yearsHealthy volunteers can take part
Conditions the study is for
Measles, Mumps, Rubella
What is being tested?
MMRVNS vaccine, MMRV vaccine and DTaP-IPV vaccine
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,860 participants
Where
62 sitesin 6 countries
Study dates
11 Aug 2026to 21 Nov 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 6 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 36Show fewer
  • 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.

Trial locations and contacts

62 sites in 6 countries. Contact the study team or a site near you to ask about taking part.

US GSK Clinical Trials Call Center contact

877-379-3718

GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center contact

+44 (0) 20 89904466

GSKClinicalSupportHD@gsk.com

62 sites in 6 countries

United States38 sites

  • Medical Research Partners

    Ammon, Idaho, 83406

    Joseph Moore, 843-722-4112, jmoore@ifpeds.com

    Joseph Moore

  • Kentucky Pediatric/ Adult Research

    Bardstown, Kentucky, 40004

    Daniel Finn, 502-349-1569, danieljfinn@yahoo.com

    Daniel Finn

  • Tekton Research - Beaumont, TX

    Beaumont, Texas, 77706

    Robert Bell, 409-234-1678, cbell@tektonresearch.com

    Robert Bell

  • Neighbors Clinical Research

    Charleston, South Carolina, 29407

    John Traynham, 402-934-7563, jtraynham@neighborspeds.com

    John Traynham

  • Atrium Health

    Charlotte, North Carolina, 28203

    Christine Turley, 704-446-1422, christine.turley@advocatehealth.org

    Christine Turley

  • Pediatric Research of Charlottesville, LLC

    Charlottesville, Virginia, 22902

    Paul Wisman, 434-872-9384, ppw1954@gmail.com

    Paul Wisman

  • Ann & Robert H. Lurie Children's Hospital of Chicago

    Chicago, Illinois, 60611-2605

    William Muller, 312-227-6280, wmuller@luriechildrens.org

    William Muller

  • Senders Pediatrics

    Cleveland, Ohio, 44121-4243

    Shelly Senders, 216-291-9210, ssenders@senderspediatrics.com

    Shelly Senders

  • BioMD Clinical Research

    Coral Gables, Florida, 33134

    Ivo Alonso, 305-712-6702, ivoalonsomd@biomdresearch.com

    Ivo Alonso

  • Benchmark Research

    Covington, Louisiana, 70433

    Sherri Casey, 985-231-0737, sherri.casey@avacare.com

    Sherri Casey

  • Pas Research

    Edinburg, Texas, 78539

    Allan Mercado, 813-330-3199, amercadomd@pas-research.com

    Allan Mercado

  • Tribe Clinical Research LLC/Parkside Pediatrics

    Greenville, South Carolina, 29607

    Scott Dobson, 864-334-0141, sdobson@tribecr.com

    Scott Dobson

  • ACC Pediatric Research

    Haughton, Louisiana, 71037

    Stacey Sparks, 318-949-0539, sparksstacey542@yahoo.com

    Stacey Sparks

  • Pediatric Associates

    Houston, Texas, 77087

    Martin Yudovich, 731-777-5343, myudovich@mercurycr.us.com

    Martin Yudovich

  • Century Research Institute Inc

    Huntington Park, California, 90255

    Albert Nassir, 310-593-4119, docnassir@yahoo.com

    Albert Nassir

  • Jefferson City Medical Group PC

    Jefferson City, Missouri, 65109

    Alfred Johnson, 919-998-2279, ajohnson@jcmg.org

    Alfred Johnson

  • Children's Clinic of Jonesboro, AR

    Jonesboro, Arkansas, 72401

    Kevin Rouse, 870-935-6012, krouse@jbrkids.com

    Kevin Rouse

  • Tanner Clinic Kaysville

    Kaysville, Utah, 84037

    Jason Hoagland, 801-773-4840, jason.hoagland@tannerclinic.com

    Jason Hoagland

  • Velocity Clinical Research, Gulfport

    Lafayette, Louisiana, 70508

    Jibran Atwi, 337-451-0663, jiatwi@velocityclinical.com

    Jibran Atwi

  • Tanner Clinic Layton Parkway

    Layton, Utah, 84041

    Brent Eberhard, 801-773-4840, brent.eberhard@tannerclinic.com

    Brent Eberhard

  • Midwest Children's Health Research Institute, LLC

    Lincoln, Nebraska, 68504

    David Meduna, 402-327-6065, dave.meduna@cch-neb.com

    David Meduna

  • Midwest Children's Health Research Institute, LLC

    Lincoln, Nebraska, 68505

    Sue Springman, 402-327-6065, sue.a.springman@gmail.com

    Sue Springman

  • Complete Children's Health

    Lincoln, Nebraska, 68516

    Alexandra Keating, 402-465-5600, alex.keating@cch-neb.com

    Alexandra Keating

  • Complete Children's Health

    Lincoln, Nebraska, 68522-1231

    Luke Anschutz, 402-465-5600, luke.anschutz@cch-neb.com

    Luke Anschutz

  • Applied Research Center of Arkansas

    Little Rock, Arkansas, 72212

    Sarah Bone, 501-954-7822, drbone@arcarkansas.com

    Sarah Bone

  • Matrix Clinical Research

    Los Angeles, California, 90057

    Jose Diaz, 213-413-2222, dr.diaz@matrixcr.com

    Jose Diaz

  • Norton Childrens Research Institute

    Louisville, Kentucky, 40202

    Daniel Blatt, 502-852-3774, daniel.blatt@louisville.edu

    Daniel Blatt

  • D&H Pompano Research Center LLC

    Margate, Florida, 33063

    Yanetsi Landa Colon, 786-375-6210, dryflores@dhnrc.com

    Yanetsi Landa Colon

  • Marshfield Clinic Research Foundation, a Division of Marshfield Clinic, Inc

    Marshfield, Wisconsin, 54449

    Keith Pulvermacher, 715-387-5251, keith.pulvermacher@sanfordhealth.org

    Keith Pulvermacher

  • Boeson Research MSO

    Missoula, Montana, 59804

    Aubrey Remmers, 406-763-8833, dr.remmers@boesonresearch.com

    Aubrey Remmers

  • Meharry Medical College

    Nashville, Tennessee, 37208

    Vladimir Berthaud, 615-293-5241, vberthaud@mmc.edu

    Vladimir Berthaud

  • Ogden Clinic Canyon View

    Ogden, Utah, 84404

    Stephen Bruce, 801-479-7771, stephenbruce@riotrials.com

    Stephen Bruce

  • Clinical Research Partners, LLC

    Richmond, Virginia, 23236

    Richard Bennett, 804-536-1878, rbennettmd@clinicalresearchrva.com

    Richard Bennett

  • Center for Clinical Trials of Sacramento, Inc.

    Sacramento, California, 95823

    Marita Biag, 916-525-3377, drbiag@cctsac.com

    Marita Biag

  • Tribe Clinical Research LLC/Parkside Pediatrics

    Simpsonville, South Carolina, 29681

    Justin Moll, 864-272-0388, drmoll@parksidepediatrics.com

    Justin Moll

  • Carolina Family Care

    Summerville, South Carolina, 29486

    Stephen Stripling, 843-518-5642, stripling@musc.edu

    Stephen Stripling

  • PAS Research

    Tampa, Florida, 33613

    Teena Hughes, 813-903-0060, t.hughes.pas@gmail.com

    Teena Hughes

  • Center for Clinical Trials of San Gabriel

    West Covina, California, 91790

    Holly Lim, 626-960-4942, hollylimmd@cs.com

    Holly Lim

Other trials in United States

Finland8 sites

  • Finnish Vaccine Research, Espoo Clinic

    Espoo

    Benita Ukkonen, +358504377211, benita.ukkonen@fvr.fi

    Benita Ukkonen

  • Finnish Vaccine Research, Helsinki South Clinic

    Helsinki

    Santtu Heinonen, +358962270363, santtu.heinonen@fvr.fi

    Santtu Heinonen

  • Finnish Vaccine Research, Järvenpää Clinic

    Jarvenpaa

    Miia Virta, +358504437254, miia.virta@fvr.fi

    Miia Virta

  • Finnish Vaccine Research, Kokkola Clinic

    Kokkola

    Satu Kokko, +358504336253, satu.kokko@fvr.fi

    Satu Kokko

  • Finnish Vaccine Research, Oulu Clinic

    Oulu

    Satu Kokko, +358504336253, satu.kokko@fvr.fi

    Satu Kokko

  • Finnish Vaccine Research, Seinäjoki Clinic

    Seinäjoki

    Hilkka Liitsola, +358401904119, hilkka.liitsola@fvr.fi

    Hilkka Liitsola

  • Finnish Vaccine Research, Tampere Clinic

    Tampere

    Oskari Pitkanen, +358504437254, oskari.pitkanen@fvr.fi

    Oskari Pitkanen

  • Finnish Vaccine Research, Turku Clinic

    Turku

    Santtu Heinonen, +358962270363, santtu.heinonen@fvr.fi

    Santtu Heinonen

Other trials in Finland

Argentina7 sites

  • Equipo Ciencia

    Buenos Aires

    Gonzalo Perez Marc, +541147765306, gonzaloperezmarc@gmail.com

    Gonzalo Perez Marc

  • Helios Salud

    Ciudad Autonoma Buenos Aires

    Rosa Bologna, +541143084300, bolognar@gmail.com

    Rosa Bologna

  • Clinica Privada del Sol SA

    Córdoba

    Oscar Roldan, oscarroldan1970@yahoo.com.ar

    Oscar Roldan

  • Clinica del Nino y la Familia de Mar del Plata

    Mar del Plata

    Ignacio Uriarte, ignaciouriarte@gmail.com

    Ignacio Uriarte

  • Instituto Medico Rio Cuarto

    Río Cuarto

    Ulises D Andrea Nores, +543585618198, dogoantonio@hotmail.com

    Ulises D Andrea Nores

  • Clinica Mayo de Urgencias Medicas Cruz Blanca SRL

    San Miguel de Tucumán

    Adriana E Soto, +543814276050, adrisoto2000@yahoo.com.ar

    Adriana E Soto

  • Hospital del Nino Jesus

    San Miguel de Tucumán

    Conrado J Llapur, +543814302452, cjllapur@hotmail.com

    Conrado J Llapur

Other trials in Argentina

Taiwan5 sites

  • China Medical University Hospital

    Taichung

    Kao-Pin Hwang, +886422012525, kapihw@mail.cmuh.org.tw

    Kao-Pin Hwang

  • Taichung Veterans General Hospital

    Taichung

    Hui-Hsien Pan, +886422012525, jsee0627@gmail.com

    Hui-Hsien Pan

  • MacKay Memorial Hospital Taipei Branch

    Taipei

    Nan-Chang Chiu, ncc88@mmh.org.tw

    Nan-Chang Chiu

  • National Taiwan University Hospital

    Taipei

    Li-Min Huang, lmhuang@ntu.edu.tw

    Li-Min Huang

  • Chang Gung Memorial Hospital, Linkou

    Taoyuan City

    Cheng-Hsun Chiu, chchiu@cgmh.org.tw

    Cheng-Hsun Chiu

Other trials in Taiwan

Italy3 sites

  • Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari

    Bari

    Silvio Tafuri, +39805594275, silvio.tafuri@uniba.it

    Silvio Tafuri

  • Ospedale D'Avanzo

    Foggia

    Rosa Prato, +39881588036, rosa.prato@unifg.it

    Rosa Prato

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Rome

    Danilo Buonsenso, +393319819715, danilo.buonsenso@policlinicogemelli.it

    Danilo Buonsenso

Other trials in Italy

Puerto Rico1 site

  • Centro Clin-PR

    Corozal

    Hector Acevedo-Denis, 7873374278, hector.acevedo@sanjuanbautista.edu

    Hector Acevedo-Denis

Other trials in Puerto Rico

About this study

Official title: 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.

Being tested
MMRVNS vaccine, MMRV vaccine, DTaP-IPV vaccine
Keywords
Measles, Mumps, Rubella, Varicella (Chickenpox), Combined vaccine, Immunogenicity, Vaccine safety, Children aged 4 to 6 years
Medical subject headings
Measles, Mumps, Rubella, Chickenpox

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MMRVNS vaccineBiological

    MMRVNS vaccine will be administered on Day 1.

  • MMRV vaccineBiological

    Also called ProQuad

    MMRV vaccine will be administered on Day 1.

  • DTaP-IPV vaccineBiological

    Also called Kinrix

    DTaP-IPV vaccine will be administered on Day 1.

Study groups in NCT07742644
Study groupRoleWhat they receive
MMRVNS_Lot 1 groupExperimentalParticipants will receive a single dose of the Lot 1 MMRVNS vaccine and a single dose of the DTaP-IPV vaccine on Day 1.
Receives: Biological: MMRVNS vaccine; Biological: DTaP-IPV vaccine
MMRVNS_Lot 2 groupExperimentalParticipants will receive a single dose of the Lot 2 MMRVNS vaccine and a single dose of the DTaP-IPV vaccine on Day 1.
Receives: Biological: MMRVNS vaccine; Biological: DTaP-IPV vaccine
MMRVNS_Lot 3 groupExperimentalParticipants will receive a single dose of the Lot 3 MMRVNS vaccine and a single dose of the DTaP-IPV vaccine on Day 1.
Receives: Biological: MMRVNS vaccine; Biological: DTaP-IPV vaccine
MMRV groupActive comparatorParticipants will receive a single dose of MMRV vaccine and a single dose of DTaP-IPV vaccine on Day 1.
Receives: Biological: MMRV vaccine; Biological: DTaP-IPV vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    This outcome measure evaluates immunological consistency.

    Measured: At Day 43

  2. Number of participants with seroresponse against measles, mumps, rubella, and VZV gE after MMRVNS or MMRV administration

    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.

    Measured: At Day 43

  3. GMCs of IgG concentrations against measles, mumps, rubella, and VZV gE after MMRVNS or MMRV administration

    This outcome measure evaluates immunological non-inferiority.

    Measured: At Day 43

Secondary outcomes (8)

  1. 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

    This outcome measure evaluates immunological non-inferiority.

    Measured: At Day 43

  2. Geometric mean titers (GMTs) of neutralizing antibodies against poliovirus 1, 2, and 3 after MMRVNS or MMRV administration in a subset of participants

    This outcome measure evaluates immunological non-inferiority.

    Measured: At Day 43

  3. 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

    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.

    Measured: At Day 43

  4. Number of participants with any solicited administration site events following MMRVNS or MMRV administration

    Solicited administration site events are injection site redness, pain/tenderness, swelling, and injection site varicella-like rash.

    Measured: 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

  5. Number of participants with any solicited systemic events following MMRVNS or MMRV administration

    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.

    Measured: 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

  6. Number of participants with any unsolicited adverse events (AEs) following MMRVNS or MMRV administration

    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.

    Measured: From Day 1 to Day 43

  7. Number of participants with any medically attended adverse events (MAAEs) following MMRVNS or MMRV administration

    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).

    Measured: From Day 1 to Day 181

  8. Number of participants with serious adverse events (SAEs), fatal SAEs, and related SAEs following MMRVNS or MMRV administration

    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.

    Measured: From Day 1 to Day 181

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Aug 2026
  2. Study start11 Aug 2026 (estimated)
  3. Primary completion27 Jun 2028 (estimated)
  4. Study completion21 Nov 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,860 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07742644
Sponsor's protocol ID
217717
Other IDs
2025-523277-42-00, 2025
Acronym
MMRVNS 20-002
Status last verified
Jul 2026
First submitted
29 Jul 2026
Last updated
3 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing MMRVNS vaccine, MMRV vaccine and DTaP-IPV vaccine in people with Measles and Mumps, run by GlaxoSmithKline at 62 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 62 sites in United States, Finland, Argentina, Taiwan, Italy and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact US GSK Clinical Trials Call Center (877-379-3718, GSKClinicalSupportHD@gsk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07742644.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.

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