MeaslesPhase 3NCT07406360
A Study on the Immune Response and Safety of an Investigational Combined Measles, Mumps, Rubella and Varicella Vaccine, When Administered as Intramuscular Injection to Healthy Children 15 Months to 6 Years of Age
A Phase 3 study testing MMRVNS and MMRV in people with Measles and Measles-Mumps-Rubella+Chickenpox Vaccine, run by GlaxoSmithKline at 17 sites in United States.
Trial summary
This study is evaluating the immunogenicity and safety of intramuscular administration of the investigational MMRVNS vaccine compared to intramuscular administration of the MMRV (Merck's measles, mumps, rubella and varicella) vaccine (ProQuad) that is already licensed for this route, when administered as a second dose… Read more about this study
- Who is it for?
- Ages 15 months to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Measles, Measles-Mumps-Rubella+Chickenpox Vaccine
- What is being tested?
- MMRVNS and MMRV
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,209 participants
- Where
- 17 sitesUnited States
- Study dates
- 11 May 2026to 20 Jul 2028
- Phase
- Phase 3
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 15 months to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
17 sites in 1 country. Contact the study team or a site near you to ask about taking part.
17 sites in 1 country
United States17 sites, 17 recruiting
- Recruiting
GSK Investigational Site
Atlanta, Georgia, 30310
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Birmingham, Alabama, 35235
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Chicago, Illinois, 60621
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Dayton, Ohio, 45406
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Farmington Hills, Michigan, 48334
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Frisco, Texas, 75033
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Houston, Texas, 77065
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Houston, Texas, 77077
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Miami, Florida, 33142
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Miami, Florida, 33182
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Port Lavaca, Texas, 77979
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Provo, Utah, 84604
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Richmond, Texas, 77469
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Richmond, Virginia, 23294
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Simpsonville, South Carolina, 29680
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Spartanburg, South Carolina, 29301
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Walnut Creek, California, 94598
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
About this study
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
This study is evaluating the immunogenicity and safety of intramuscular administration of the investigational MMRVNS vaccine compared to intramuscular administration of the MMRV (Merck's measles, mumps, rubella and varicella) vaccine (ProQuad) that is already licensed for this route, when administered as a second dose in children 15 months to 6 years of age who were previously primed with a first dose of any combination of measles, mumps, rubella and varicella-containing vaccine(s).
- Conditions
- Measles, Measles-Mumps-Rubella+Chickenpox Vaccine
- Being tested
- MMRVNS, MMRV
- Keywords
- Measles, Mumps, Rubella, Varicella, Safety, Immunogenicity
- 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.
MMRVNSBiological
Also called Investigational measles, mumps, rubella and varicella vaccine
One dose of MMRVNS administered intramuscularly.
MMRVBiological
Also called Merck's measles, mumps, rubella and varicella (ProQuad) vaccine
One dose of MMRV administered intramuscularly.
| Study group | Role | What they receive |
|---|---|---|
| MMRVNS Group | Experimental | Children, 15 months to 6 years old, who will receive one dose of MMRVNS on Day 1. Receives: Biological: MMRVNS |
| MMRV Group | Active comparator | Children, 15 months to 6 years old, who will receive one dose of MMRV on Day 1. Receives: Biological: MMRV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroresponse of Immunoglobulin G (IgG) concentrations against measles
Measured: At Day 43
Seroresponse of IgG concentrations against mumps
Measured: At Day 43
Seroresponse of IgG concentrations against rubella
Measured: At Day 43
Seroresponse of IgG concentrations against Varicella zoster virus (VZV)
Measured: At Day 43
IgG concentrations against measles
Measured: At Day 43
IgG concentrations against mumps
Measured: At Day 43
IgG concentrations against rubella
Measured: At Day 43
IgG concentrations against VZV
Measured: At Day 43
Secondary outcomes (5)
Number of participants with any solicited administration site events
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
Number of participants with any solicited systemic events
Solicited systemic events are somnolence (sleepiness/drowsiness), loss of appetite, fever, non-injection site varicella-like rash, measles/rubella-like rash and other rash.
Measured: From Day 1 to Day 15 for somnolence and loss of appetite; Day 1 to Day 22 for fever; and Day 1 to Day 43 for varicella-like rash, measles/rubella-like rash and other rash
Number of participants with any unsolicited adverse events (AEs)
Measured: From Day 1 up to Day 43 (during the 43 days following study intervention administration)
Number of participants with any medically attended adverse events (MAAEs)
Measured: From Day 1 up to Day 181 (during the 181 days following study intervention administration)
Number of participants with any serious AEs (SAEs), fatal SAEs, related SAEs
Measured: From Day 1 up to study end (Day 181)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start11 May 2026
- Primary completion28 Feb 2028 (estimated)
- Study completion20 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MeaslesStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 1,209 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07406360
- Sponsor's protocol ID
- 224349
- Other IDs
- 2025-523274-17-00, 2025
- Status last verified
- Jul 2026
- First submitted
- 6 Feb 2026
- Last updated
- 8 Jul 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/About\_GSK\_Patient\_Level\_Data\_Sharing\_Final\_13July2023.pdf