Recruiting
Phase 3

MMRVNS vs. MMRV

Sponsor:

GlaxoSmithKline

Code:

NCT07406360

Conditions

Measles

Measles-Mumps-Rubella+Chickenpox Vaccine

Eligibility Criteria

Sex: All

Age: 1 - 6

Healthy Volunteers: Accepted

Interventions

MMRVNS

MMRV

Study Details

Brief 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 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

Study ID

NCT07406360

Start date

May 11, 2026

Status verified date

Jul, 2026

Completion date

Jul 20, 2028

Anticipated

Primary completion date

Feb 28, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1 - 6

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

1209 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: MMRVNS Group

Children, 15 months to 6 years old, who will receive one dose of MMRVNS on Day 1.

active comparator: MMRV Group

Children, 15 months to 6 years old, who will receive one dose of MMRV on Day 1.

Interventions

MMRVNS

One dose of MMRVNS administered intramuscularly.

MMRV

One dose of MMRV administered intramuscularly.

Primary outcome measure

  • Seroresponse of Immunoglobulin G (IgG) concentrations against measles [ Time Frame: At Day 43 ]
  • Seroresponse of IgG concentrations against mumps [ Time Frame: At Day 43 ]
  • Seroresponse of IgG concentrations against rubella [ Time Frame: At Day 43 ]
  • Seroresponse of IgG concentrations against Varicella zoster virus (VZV) [ Time Frame: At Day 43 ]
  • IgG concentrations against measles [ Time Frame: At Day 43 ]
  • IgG concentrations against mumps [ Time Frame: At Day 43 ]
  • IgG concentrations against rubella [ Time Frame: At Day 43 ]
  • IgG concentrations against VZV [ Time Frame: At Day 43 ]

Central Contacts and Locations

Central contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

+44 (0) 20 89904466GSKClinicalSupportHD@gsk.com

Locations

GSK Investigational Site

Recruiting

Birmingham, Alabama, United States, 35235

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Max Hale

GSK Investigational Site

Recruiting

Walnut Creek, California, United States, 94598

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Timothy Ryschon

GSK Investigational Site

Recruiting

Miami, Florida, United States, 33142

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Giselle Deiros

GSK Investigational Site

Recruiting

Miami, Florida, United States, 33182

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Guillermo Somodevilla

GSK Investigational Site

Recruiting

Atlanta, Georgia, United States, 30310

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Austin Chan

GSK Investigational Site

Recruiting

Chicago, Illinois, United States, 60621

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Ayoade Akere

GSK Investigational Site

Recruiting

Farmington Hills, Michigan, United States, 48334

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Martin Levinson

GSK Investigational Site

Recruiting

Dayton, Ohio, United States, 45406

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Martin Schear

GSK Investigational Site

Recruiting

Simpsonville, South Carolina, United States, 29680

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Carole Mercer

GSK Investigational Site

Recruiting

Spartanburg, South Carolina, United States, 29301

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Stephen Jones

GSK Investigational Site

Recruiting

Frisco, Texas, United States, 75033

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Malini Hebbur

GSK Investigational Site

Recruiting

Houston, Texas, United States, 77065

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Kashif Ali

GSK Investigational Site

Recruiting

Houston, Texas, United States, 77077

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Amarnath Chamkur

GSK Investigational Site

Recruiting

Port Lavaca, Texas, United States, 77979

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

John Clinton

GSK Investigational Site

Recruiting

Richmond, Texas, United States, 77469

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Michael Bornstein

GSK Investigational Site

Recruiting

Provo, Utah, United States, 84604

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Joshua Fuller

GSK Investigational Site

Recruiting

Richmond, Virginia, United States, 23294

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

John Scott

More Information

Sponsor

GlaxoSmithKline

Last update posted

Jul 8, 2026

Last verified

Jul, 2026

Keywords

  • Measles
  • Mumps
  • Rubella
  • Varicella
  • Safety
  • Immunogenicity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by GlaxoSmithKline on 2026-07-08.