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M-M-RII manufactured with recombinant Human Albumin and VARIVAX

Phase 3

Measles | Monoclonal antibody | Infectious Disease |Merck & Company, Inc.|Trials Updated: Oct 18, 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment752

FDA Designations

No designations recorded

M-M-RII manufactured with recombinant Human Albumin and VARIVAX clinical trials

M-M-RII manufactured with recombinant Human Albumin and VARIVAX · 1 trial · 3 indications

Phase 3 1
NCT00432523Immunogenicity and Safety of Concomitant Administration of MMR™ rHA and VARIVAX® by Intramuscular Versus Subcutaneous Route (V205C-011)Measles
COMPLETED752 Analytics
PHASE3COMPLETED
Immunogenicity and Safety of Concomitant Administration of MMR™ rHA and VARIVAX® by Intramuscular Versus Subcutaneous Route (V205C-011)
MeaslesUnlock trial analytics

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL

Interventions

NameTypeDescription
M-M-R™II manufactured with recombinant Human Albumin (rHA) and VARIVAX®BIOLOGICAL -
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Eligibility Criteria

Age Range12 Months to 18 Months
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: 1. Healthy subject of either gender, 2. Age 12 to 18 months , 3. Consent form signed by both parent(s) or by the legal representative properly informed about the study, 4. Parent(s) / legal representative able to understand the protocol requirements and to fill in the Diary Card...

Countries:FranceGermany
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Frequently asked questions about M-M-RII manufactured with recombinant Human Albumin and VARIVAX

What is M-M-RII manufactured with recombinant Human Albumin and VARIVAX?

M-M-RII manufactured with recombinant Human Albumin and VARIVAX is a combination vaccine regimen developed by Merck & Company, Inc. (MRK) for protection against measles, mumps, and varicella. It pairs M-M-RII, a measles, mumps, and rubella vaccine formulated with recombinant human albumin, with VARIVAX, the varicella vaccine. The program targets infectious disease prevention.

What is M-M-RII manufactured with recombinant Human Albumin and VARIVAX used for?

It is used for immunization against measles, mumps, and varicella. The combination covers measles and mumps through the M-M-RII component and varicella through VARIVAX. Clinical work has studied giving both vaccines together, including by intramuscular versus subcutaneous route, in children from 12 months of age.

Who makes M-M-RII manufactured with recombinant Human Albumin and VARIVAX?

Merck & Company, Inc., which trades under the ticker MRK, develops and manufactures M-M-RII manufactured with recombinant Human Albumin and VARIVAX. Merck is the sponsor behind the combination vaccine program and the associated Phase 3 study conducted in France and Germany.

What phase is M-M-RII manufactured with recombinant Human Albumin and VARIVAX in?

The program is in Phase 3 clinical development. It is investigational and has not been established as approved. One Phase 3 trial has been completed, and no trials are currently active. That completed study enrolled 752 participants and evaluated immunogenicity and safety of concomitant administration of the two vaccines.

What clinical trials is M-M-RII manufactured with recombinant Human Albumin and VARIVAX in?

The program has been studied in one completed Phase 3 trial, NCT00432523, titled Immunogenicity and Safety of Concomitant Administration of MMR rHA and VARIVAX by Intramuscular Versus Subcutaneous Route. It enrolled 752 healthy volunteers aged 12 months and older across France and Germany, used a randomized design, and evaluated measles, mumps, and varicella.