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MMRV

Phase 3

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

MMRV development status

Highest phase Phase 3
Registered trials 3 across 2 sponsors since Dec 2006

MMRV target and mechanism

ModalityMonoclonal antibody

Also known as MMRV (AMP)

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

MMRV clinical trials

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)
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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?

MMRV is an investigational combination vaccine developed by Merck & Company, Inc. (ticker MRK) that targets measles, mumps, rubella, and varicella in a single product. It is made using an alternative manufacturing process, abbreviated AMP, and is being studied in children from 12 months of age.

What is MMRV used for in measles?

MMRV is being developed to protect against measles together with mumps, rubella, and varicella in one combination vaccine. The Phase 3 trial enrolled healthy children starting at 12 months of age and evaluated safety, tolerability, and immunogenicity against all four diseases, including measles.

Who makes MMRV?

Merck & Company, Inc., which trades under the ticker MRK, is the developer of MMRV. The vaccine is produced using an alternative manufacturing process, which is why the program is also referred to as MMRV (AMP). Merck sponsored the Phase 3 study of the candidate.

What phase is MMRV in?

MMRV is in Phase 3 development. The program's single registered trial, NCT01536405, is a completed Phase 3 study, and no trials are currently listed as active. MMRV is an investigational vaccine candidate and has not been established as approved for use.

What clinical trials is MMRV in?

MMRV has been studied in one clinical trial, NCT01536405, titled Safety, Tolerability, and Immunogenicity of Measles, Mumps, Rubella, and Varicella (MMRV) Vaccine Made With an Alternative Manufacturing Process (AMP). It was a completed Phase 3 randomized, double-blind, active-controlled study that enrolled 1,412 healthy volunteers.

Is MMRV the same as MMRV (AMP)?

Yes. MMRV (AMP) is another name for MMRV, with AMP standing for alternative manufacturing process. Both names refer to the same Merck & Company, Inc. (ticker MRK) Phase 3 combination vaccine candidate against measles, mumps, rubella, and varicella.