NCT07406360

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).

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,209

participants targeted

Target at P75+ for phase_3

Timeline
26mo left

Started Apr 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress3%
Apr 2026Jun 2028

First Submitted

Initial submission to the registry

February 6, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 12, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

April 13, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2028

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 22, 2028

Last Updated

February 12, 2026

Status Verified

February 1, 2026

Enrollment Period

1.8 years

First QC Date

February 6, 2026

Last Update Submit

February 6, 2026

Conditions

Measles

Keywords

MeaslesMumpsRubellaVaricellaSafetyImmunogenicity

Outcome Measures

Primary Outcomes (8)

  • Seroresponse of Immunoglobulin G (IgG) concentrations against measles

    At Day 43

  • Seroresponse of IgG concentrations against mumps

    At Day 43

  • Seroresponse of IgG concentrations against rubella

    At Day 43

  • Seroresponse of IgG concentrations against Varicella zoster virus (VZV)

    At Day 43

  • IgG concentrations against measles

    At Day 43

  • IgG concentrations against mumps

    At Day 43

  • IgG concentrations against rubella

    At Day 43

  • IgG concentrations against VZV

    At Day 43

Secondary Outcomes (5)

  • Number of participants with any solicited administration site events

    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

    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)

    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)

    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

    From Day 1 up to study end (Day 181)

Study Arms (2)

MMRVNS Group

EXPERIMENTAL

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

Biological: MMRVNS

MMRV Group

ACTIVE COMPARATOR

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

Biological: MMRV

Interventions

MMRVNSBIOLOGICAL

One dose of MMRVNS administered intramuscularly.

Also known as: Investigational measles, mumps, rubella and varicella vaccine
MMRVNS Group
MMRVBIOLOGICAL

One dose of MMRV administered intramuscularly.

Also known as: Merck's measles, mumps, rubella and varicella (ProQuad) vaccine
MMRV Group

Eligibility Criteria

Age15 Months - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +18 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

MeaslesMumpsRubellaChickenpox

Interventions

Chickenpox Vaccinemeasles, mumps, rubella, varicella vaccineVaccines

Condition Hierarchy (Ancestors)

Morbillivirus InfectionsParamyxoviridae InfectionsMononegavirales InfectionsRNA Virus InfectionsVirus DiseasesInfectionsRubulavirus InfectionsParotitisParotid DiseasesSalivary Gland DiseasesMouth DiseasesStomatognathic DiseasesRubivirus InfectionsTogaviridae InfectionsVaricella Zoster Virus InfectionHerpesviridae InfectionsDNA Virus Infections

Intervention Hierarchy (Ancestors)

Herpesvirus VaccinesViral VaccinesBiological ProductsComplex Mixtures

Central Study Contacts

US GSK Clinical Trials Call Center

CONTACT

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Study is observer-blind, participants care providers investigators and outcomes assessors are blinded but Investigational Medicinal Product administrators are unblinded.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2026

First Posted

February 12, 2026

Study Start

April 13, 2026

Primary Completion (Estimated)

January 31, 2028

Study Completion (Estimated)

June 22, 2028

Last Updated

February 12, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
Access Criteria
Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.
More information