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Can a new Four-in-One vaccine match the gold standard for childhood protection?

NCT ID NCT07742644

Prevention Sponsor: GlaxoSmithKline Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 03, 2026 · Last updated Aug 04, 2026 · Updated 1 time

Summary

This study tests an investigational vaccine that combines protection against measles, mumps, rubella, and chickenpox (varicella) in a single shot. It will be given as a second dose to healthy children aged 4 to 6 years who have already received a first dose of a similar vaccine. The trial aims to see if the new vaccine produces a consistent immune response across different manufacturing lots and whether it works as well as an existing licensed vaccine. It will also check if the vaccine can be safely given at the same time as another routine childhood vaccine.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
an investigational combined measles, mumps, rubella, and varicella (MMRVNS) vaccine
What this could lead to
If successful, this could provide a new option for protecting children against four common childhood diseases with a single shot, potentially matching the effectiveness of existing vaccines.
What could go wrong
This is an early-stage trial, so the vaccine may not produce a strong enough immune response or could cause unexpected side effects. Results from this study will need further confirmation.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 1,860 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Nov 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

4 to 6 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

chickenpox measles mumps infectious disease rubella

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Measles Measles-mumps-rubella+chickenpox vaccine Mumps Rubella Varicella (chickenpox)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    62 sites in 6 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • ACC Pediatric Research

    Haughton, Louisiana, 71037, United States

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

    Chicago, Illinois, 60611-2605, United States

  • Applied Research Center of Arkansas

    Little Rock, Arkansas, 72212, United States

  • Atrium Health

    Charlotte, North Carolina, 28203, United States

  • Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari

    Bari, Italy

  • Benchmark Research

    Covington, Louisiana, 70433, United States

  • BioMD Clinical Research

    Coral Gables, Florida, 33134, United States

  • Boeson Research MSO

    Missoula, Montana, 59804, United States

  • Carolina Family Care

    Summerville, South Carolina, 29486, United States

  • Center for Clinical Trials of Sacramento, Inc.

    Sacramento, California, 95823, United States

  • Center for Clinical Trials of San Gabriel

    West Covina, California, 91790, United States

  • Centro Clin-PR

    Corozal, Puerto Rico

  • Century Research Institute Inc

    Huntington Park, California, 90255, United States

  • Chang Gung Memorial Hospital, Linkou

    Taoyuan City, Taiwan

  • Children's Clinic of Jonesboro, AR

    Jonesboro, Arkansas, 72401, United States

  • China Medical University Hospital

    Taichung, Taiwan

  • Clinica Mayo de Urgencias Medicas Cruz Blanca SRL

    San Miguel de Tucumán, Argentina

  • Clinica Privada del Sol SA

    Córdoba, Argentina

  • Clinica del Nino y la Familia de Mar del Plata

    Mar del Plata, Argentina

  • Clinical Research Partners, LLC

    Richmond, Virginia, 23236, United States

  • Complete Children's Health

    Lincoln, Nebraska, 68516, United States

  • Complete Children's Health

    Lincoln, Nebraska, 68522-1231, United States

  • D&H Pompano Research Center LLC

    Margate, Florida, 33063, United States

  • Equipo Ciencia

    Buenos Aires, Argentina

  • Finnish Vaccine Research, Espoo Clinic

    Espoo, Finland

  • Finnish Vaccine Research, Helsinki South Clinic

    Helsinki, Finland

  • Finnish Vaccine Research, Järvenpää Clinic

    Jarvenpaa, Finland

  • Finnish Vaccine Research, Kokkola Clinic

    Kokkola, Finland

  • Finnish Vaccine Research, Oulu Clinic

    Oulu, Finland

  • Finnish Vaccine Research, Seinäjoki Clinic

    Seinäjoki, Finland

  • Finnish Vaccine Research, Tampere Clinic

    Tampere, Finland

  • Finnish Vaccine Research, Turku Clinic

    Turku, Finland

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Rome, Italy

  • Helios Salud

    Ciudad Autonoma Buenos Aires, Argentina

  • Hospital del Nino Jesus

    San Miguel de Tucumán, Argentina

  • Instituto Medico Rio Cuarto

    Río Cuarto, Argentina

  • Jefferson City Medical Group PC

    Jefferson City, Missouri, 65109, United States

  • Kentucky Pediatric/ Adult Research

    Bardstown, Kentucky, 40004, United States

  • MacKay Memorial Hospital Taipei Branch

    Taipei, Taiwan

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

    Marshfield, Wisconsin, 54449, United States

  • Matrix Clinical Research

    Los Angeles, California, 90057, United States

  • Medical Research Partners

    Ammon, Idaho, 83406, United States

  • Meharry Medical College

    Nashville, Tennessee, 37208, United States

  • Midwest Children's Health Research Institute, LLC

    Lincoln, Nebraska, 68504, United States

  • Midwest Children's Health Research Institute, LLC

    Lincoln, Nebraska, 68505, United States

  • National Taiwan University Hospital

    Taipei, Taiwan

  • Neighbors Clinical Research

    Charleston, South Carolina, 29407, United States

  • Norton Childrens Research Institute

    Louisville, Kentucky, 40202, United States

  • Ogden Clinic Canyon View

    Ogden, Utah, 84404, United States

  • Ospedale D'Avanzo

    Foggia, Italy

  • PAS Research

    Tampa, Florida, 33613, United States

  • Pas Research

    Edinburg, Texas, 78539, United States

  • Pediatric Associates

    Houston, Texas, 77087, United States

  • Pediatric Research of Charlottesville, LLC

    Charlottesville, Virginia, 22902, United States

  • Senders Pediatrics

    Cleveland, Ohio, 44121-4243, United States

  • Taichung Veterans General Hospital

    Taichung, Taiwan

  • Tanner Clinic Kaysville

    Kaysville, Utah, 84037, United States

  • Tanner Clinic Layton Parkway

    Layton, Utah, 84041, United States

  • Tekton Research - Beaumont, TX

    Beaumont, Texas, 77706, United States

  • Tribe Clinical Research LLC/Parkside Pediatrics

    Greenville, South Carolina, 29607, United States

  • Tribe Clinical Research LLC/Parkside Pediatrics

    Simpsonville, South Carolina, 29681, United States

  • Velocity Clinical Research, Gulfport

    Lafayette, Louisiana, 70508, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.