New combo vaccine for kids could replace current shot
NCT ID NCT07406360
First seen Jun 26, 2026 · Last updated Jul 09, 2026 · Updated 3 times
Summary
This study tests a new vaccine that protects against measles, mumps, rubella, and chickenpox (MMRV) in healthy children aged 15 months to 6 years. It compares the new vaccine to an already approved one (ProQuad) to see if it works as well and is safe. About 1,200 children will receive a second dose of either vaccine.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Investigational measles, mumps, rubella, and varicella vaccine (MMRVNS)
- What this could lead to
- If successful, this could provide a safe and effective alternative to the current MMRV vaccine for children.
- What could go wrong
- This is a phase 3 trial, but it is not yet recruiting. The new vaccine may not be as effective or safe as the existing one, and results may not apply to all children.
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 1,209 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2026
- Expected to finish
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Jul 2028
An estimate. End dates often move.
- Lead sponsor
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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
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15 months to 6 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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: * Participants' parent(s)/legally acceptable representative(s) (LAR(s)) who, in the opinion of the investigator, can and will comply with the requirements of the protocol. * Written or witnessed/thumb printed informed consent obtained from the participants parent(s)/LAR(s) prior to performance of any study specific procedure. * Informed assent obtained from the participants in line with local rules and regulations. * Healthy participants as established by medical history and clinical examination at screening. For countries where the second dose of measles, mumps, rubella, and varicella vaccination is administered between 4 and 6 years of age: * A male or female participant between and including 4 and 6 years of age at the time of the study intervention administration, and in accordance with local regulations. * Participant who previously received a first dose of varicella-containing vaccine in the second year of life. * Participant who previously received a first dose of measles, mumps, rubella-containing vaccine in the second year of life. For other countries: * A male or female participant between and including 15 months to 6 years of age at the time of study intervention administration, and in accordance with local regulations. * Participant who previously received a first dose of varicella-containing vaccine in the second year of life, or earlier at 11 months of age in accordance with national vaccination schedule following official recommendation, at least 3 months before study entry. * Participant who previously received a first dose of measles, mumps, rubella-containing vaccine in the second year of life, or earlier at 11 months of age in accordance with national vaccination schedule following official recommendation, at least 1 month before study entry. Exclusion Criteria: Medical conditions * History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions, including hypersensitivity to neomycin or, gelatin. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * Hypersensitivity to latex. * Unstable chronic conditions as determined by medical history and physical examination. * Major congenital defects, as assessed by the investigator. * History of measles, mumps, rubella, or varicella/zoster disease, as evaluated by the investigator. * Recurrent history or uncontrolled neurological disorders or any neuroinflammatory, congenital neurological conditions, encephalopathies, or seizures. * History of febrile seizures, for participant under 4 years of age. * Active untreated tuberculosis. * Condition that, in the judgement of the investigator, would make intramuscular injection unsafe. * 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. Prior/Concomitant therapy * Use of any investigational or non-registered product other than the study interventions during the period beginning 30 days before the dose of study intervention, or their planned use during the study period. * Administration of immunoglobulins or other blood products or plasma derivates during the period starting 90 days before the study intervention or planned administration during the study period. * 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: systemic corticosteroid. * Up to 180 days prior to study intervention administration: long-acting immune-modifying drugs including among others immunotherapy, monoclonal antibodies, antitumoral medication. * Previous vaccination with a second dose of varicella containing vaccine or measles, mumps, rubella-containing vaccine. * Use of salicylates or salicylate-containing products or its planned use during the period of 6 weeks following study intervention administration. * 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 intervention administration, with the exception of: * Inactivated influenza vaccine, which may be given at any time during the study and administered at a different location than the study intervention, and * Diphtheria, tetanus, acellular pertussis-containing vaccines may be administrated according to the local immunization practices of each participating country. It has to be administered on the same day as the study intervention administration at a different location. However, other than protocol-specified DTaP brand and diphtheria, tetanus, whole cell pertussis-containing vaccines are not allowed. If emergency mass vaccination for an unforeseen public health threat 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. Prior/Concurrent clinical study participation • Concurrently participating in another clinical study, at any time during the study period, Other exclusion criteria * Any study personnel's immediate dependents, family, or household members. * Child in care. * 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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
17 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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GSK Investigational Site
RECRUITINGBirmingham, Alabama, 35235, United States
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GSK Investigational Site
RECRUITINGWalnut Creek, California, 94598, United States
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GSK Investigational Site
RECRUITINGMiami, Florida, 33142, United States
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GSK Investigational Site
RECRUITINGMiami, Florida, 33182, United States
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GSK Investigational Site
RECRUITINGAtlanta, Georgia, 30310, United States
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GSK Investigational Site
RECRUITINGChicago, Illinois, 60621, United States
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GSK Investigational Site
RECRUITINGFarmington Hills, Michigan, 48334, United States
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GSK Investigational Site
RECRUITINGDayton, Ohio, 45406, United States
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GSK Investigational Site
RECRUITINGSimpsonville, South Carolina, 29680, United States
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GSK Investigational Site
RECRUITINGSpartanburg, South Carolina, 29301, United States
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GSK Investigational Site
RECRUITINGFrisco, Texas, 75033, United States
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GSK Investigational Site
RECRUITINGHouston, Texas, 77065, United States
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GSK Investigational Site
RECRUITINGHouston, Texas, 77077, United States
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GSK Investigational Site
RECRUITINGPort Lavaca, Texas, 77979, United States
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GSK Investigational Site
RECRUITINGRichmond, Texas, 77469, United States
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GSK Investigational Site
RECRUITINGProvo, Utah, 84604, United States
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GSK Investigational Site
RECRUITINGRichmond, Virginia, 23294, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A finger-prick test that could outpace measles outbreaks
- Can a new Four-in-One vaccine match the gold standard for childhood protection?
- Breastfeeding after MMR shot: is it safe for baby?
- Do childhood vaccines last? 5-year follow-up study launched in china
- 10,000 people tested: Cambodia's massive disease hunt begins