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MMRVNS

Phase 3

Measles | Monoclonal antibody | Other |GSK plc|Last Updated: Feb 12, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment1,209
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07406360A 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 AgePHASE3 NOT YET_RECRUITING 1,209Apr 13, 2026Jun 22, 2028Feb 12, 2026 -
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Study Endpoints
Primary Endpoints
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 Endpoints
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)
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
MMRVNS GroupEXPERIMENTALChildren, 15 months to 6 years old, who will receive one dose of MMRVNS on Day 1.
MMRV GroupACTIVE_COMPARATORChildren, 15 months to 6 years old, who will receive one dose of MMRV on Day 1.
Interventions
NameTypeDescription
MMRVNSBIOLOGICALOne dose of MMRVNS administered intramuscularly.
MMRVBIOLOGICALOne dose of MMRV administered intramuscularly.
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Eligibility Criteria
Age Range15 Months — 6 Years
SexALL
Healthy VolunteersYes

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...

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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07406360primaryCompletionDate: changed
LOWMay 24, 2026NCT07406360studyFirstPostDate: changed