Measles, Mumps, Rubella and Varicella vaccine booster in healthy children aged 15 months to 6 years
Official title: A Phase 3a, Observer Blind, Randomized, Controlled Study to Evaluate the Immunogenicity and Safety of Intramuscular Administration of an Investigational Combined Measles, Mumps, Rubella, and Varicella Vaccine Compared With Intramuscular Administration of ProQuad When Administered as a Second Dose to Healthy Children Aged 15 Months to 6 Years of Age
Run by GlaxoSmithKline · NCT07406360 · Data updated 2026-11-12
This study tests whether the investigational MMRVNS vaccine given as a second dose is safe and can provoke an immune response in healthy children who previously received a first MMRV-containing vaccine dose.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 15 Months to 6 Years |
| Sex | All |
| Enrollment | 1209 (estimated) |
| Sponsor | GlaxoSmithKline Industry-sponsored |
| Drugs / interventions | immunotherapy |
| Locations | 17 sites (Birmingham, Alabama and 16 other locations) |
| Status | Recruiting |
| Started | May 11, 2026 |
| Main results expected | February 28, 2028 |
| Study ends | July 20, 2028 |
| Registry record updated | July 8, 2026 |
| Trial ID | NCT07406360 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Healthy children aged 15 months to 6 years who have had a first dose of a measles-mumps-rubella-varicella vaccine and whose guardians consent to participate.
✕Probably not a fit
Some participants may not experience a stronger immune response or may experience adverse effects that limit benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase 3 trial compares the immunogenicity and safety of the investigational MMRVNS vaccine with the licensed MMRV vaccine (ProQuad) when given as a second dose. Participants are healthy children aged 15 months to 6 years who have received a first dose of MMRV-containing vaccine. The study uses intramuscular injections and collects safety data and immune responses after vaccination. The sponsor is GlaxoSmithKline, with sites in Alabama, California, and Florida. The trial includes parental/guardian consent and child assent as appropriate.
Why it matters
Potential benefit: If successful, the vaccine could provide a safe alternative for the second-dose booster against measles, mumps, rubella, and varicella.
How similar studies have gone: Prior vaccines with similar components have shown safety and immunogenicity, but this specific MMRVNS vs. ProQuad second-dose comparison is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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GSK Investigational Site
Birmingham, Alabama, United States Recruiting -
GSK Investigational Site
Walnut Creek, California, United States Recruiting -
GSK Investigational Site
Miami, Florida, United States Recruiting -
GSK Investigational Site
Miami, Florida, United States Recruiting -
GSK Investigational Site
Atlanta, Georgia, United States Recruiting -
GSK Investigational Site
Chicago, Illinois, United States Recruiting
Show 11 more locations
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GSK Investigational Site
Farmington Hills, Michigan, United States Recruiting -
GSK Investigational Site
Dayton, Ohio, United States Recruiting -
GSK Investigational Site
Simpsonville, South Carolina, United States Recruiting -
GSK Investigational Site
Spartanburg, South Carolina, United States Recruiting -
GSK Investigational Site
Frisco, Texas, United States Recruiting -
GSK Investigational Site
Houston, Texas, United States Recruiting -
GSK Investigational Site
Houston, Texas, United States Recruiting -
GSK Investigational Site
Port Lavaca, Texas, United States Recruiting -
GSK Investigational Site
Richmond, Texas, United States Recruiting -
GSK Investigational Site
Provo, Utah, United States Recruiting -
GSK Investigational Site
Richmond, Virginia, United States Recruiting
Study contacts
- Study coordinator: US GSK Clinical Trials Call Center
- Email: GSKClinicalSupportHD@gsk.com
- Phone: 877-379-3718
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.