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MMRV

Phase 3

Measles | Monoclonal antibody | Infectious Disease |Merck & Company, Inc.|Last Updated: Oct 31, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment1,412

FDA Designations

No designations recorded

Clinical trial landscape

MMRV · 1 trial · 4 indications

Phase 3 1
NCT01536405Safety, Tolerability, and Immunogenicity of Measles, Mumps, Rubella, and Varicella (MMRV) Vaccine Made With an Alternative Manufacturing Process (AMP)(V221-027)Measles
COMPLETED1,412 Analytics
PHASE3COMPLETED
Safety, Tolerability, and Immunogenicity of Measles, Mumps, Rubella, and Varicella (MMRV) Vaccine Made With an Alternative Manufacturing Process (AMP)(V221-027)
MeaslesUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Participants With Varicella Zoster Virus (VZV) Antibody Levels >=5 gpELISA Units/mL
Six weeks after vaccination 1

Sera were tested for VZV Immunoglobulin (IgG) antibody levels by a glycoprotein enzyme-linked immunosorbent assay (gpELISA)

Percentage of Participants With Measles Virus Antibody Levels >=255 mIU/mL
Six weeks after vaccination 1

Sera were tested for measles virus IgG antibody levels by an ELISA

Percentage of Participants With Mumps Virus Antibody Levels >=10 Units/mL
Six weeks after vaccination 1

Sera were tested for mumps virus IgG antibody levels by an enzyme-linked immunosorbent assay (ELISA)

Percentage of Participants With Rubella Virus Antibody Levels >=10 International Units/mL (IU/mL)
Six weeks after vaccination 1

Sera were tested for rubella virus IgG antibody levels by an ELISA

Geometric Mean Titer (GMT) of VZV Antibodies
Six weeks after vaccination 1

Sera were tested for VZV IgG antibody levels by gpELISA

Geometric Mean Titer (GMT) of Measles Virus Antibodies
Six weeks after vaccination 1

Sera were tested for measles virus IgG antibody levels by ELISA

Geometric Mean Titer (GMT) of Mumps Virus Antibodies
Six weeks after vaccination 1

Sera were tested for mumps virus IgG antibody levels by ELISA

Geometric Mean Titer (GMT) of Rubella Virus Antibodies
Six weeks after vaccination 1

Sera were tested for rubella virus IgG antibody levels by ELISA

Percentage of Participants With Fever (>=102.2°F [39.0°C] or Oral Equivalent)
Up to 5 days after vaccination 1

Secondary Endpoints

Percentage of Participants With Fever (>=102.2°F [39.0°C] or Oral Equivalent)
Up to 42 days after each vaccination
Percentage of Participants With Zoster-like Rash
Up to 42 days after each vaccination
Percentage of Participants With Mumps-like Symptoms
Up to 42 days after each vaccination
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
MMRV (AMP)EXPERIMENTALParticipants received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
MMRV (2006 process)ACTIVE_COMPARATORParticipants received two 0.5 mL subcutaneous injections of MMRV vaccine made with the 2006 manufacturing process

Interventions

NameTypeDescription
MMRV (AMP)BIOLOGICALMeasles, mumps, rubella, and VZV vaccine made with an alternative manufacturing process. Participants will receive two 0.5 mL subcutaneous injections.
MMRV (2006 process)BIOLOGICALMeasles, mumps, rubella, and VZV vaccine made with the 2006 manufacturing process. Participants will receive two 0.5 mL subcutaneous injections.
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Eligibility Criteria

Age Range12 Months to 23 Months
SexALL
Healthy VolunteersYes

Inclusion Criteria: * Negative clinical history for measles, mumps, rubella, varicella, and zoster Exclusion Criteria: * Received any measles, mumps, rubella, or varicella vaccine, either alone or in any combination at any time prior to the study, or is anticipated to receive any of these vaccine...

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Frequently asked questions about MMRV

What is MMRV used for?

MMRV is an investigational vaccine being studied for the prevention of measles, mumps, rubella, and varicella. It is currently in Phase 3 clinical development for these infectious diseases, with a focus on measles as a primary indication.

Who makes MMRV?

MMRV is being developed by Merck & Company, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The company is conducting clinical trials to evaluate the vaccine's safety and immunogenicity.

What phase is MMRV in?

MMRV is in Phase 3 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. One Phase 3 trial has been completed, and the vaccine remains under investigation for its intended use.

What clinical trials is MMRV in?

MMRV has one completed Phase 3 clinical trial, identified as NCT01536405. This study evaluated the safety, tolerability, and immunogenicity of the MMRV vaccine made with an alternative manufacturing process, enrolling 1,412 participants aged 12 months and older.

How does MMRV work?

MMRV is a monoclonal antibody designed to target infectious disease pathogens. As a vaccine, it is intended to stimulate an immune response against measles, mumps, rubella, and varicella viruses, although the specific molecular target has not been disclosed.