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MMR, Varicella vacc

Phase 2

Mumps | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: Oct 7, 2016

Target and mechanism

ModalityMonoclonal antibody

Also known as MMR vaccine

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment400

FDA Designations

No designations recorded

Clinical trial landscape

MMR, Varicella vacc · 2 trials · 4 indications

Phase 2 2
NCT00352898Immunogenicity, Safety of Measles-mumps-rubella-varicella Vaccine (MeMuRu-OKA) Compared to Priorix™ Given With Varilrix™Mumps
COMPLETED400 Analytics
NCT00353288Immunogenicity, Safety of Measles-mumps-rubella-varicella Vaccine (MeMuRu-OKA) Compared to Priorix™ Given With Varilrix™Varicella
COMPLETED446 Analytics
PHASE2COMPLETED
Immunogenicity, Safety of Measles-mumps-rubella-varicella Vaccine (MeMuRu-OKA) Compared to Priorix™ Given With Varilrix™
MumpsUnlock trial analytics
PHASE2COMPLETED
Immunogenicity, Safety of Measles-mumps-rubella-varicella Vaccine (MeMuRu-OKA) Compared to Priorix™ Given With Varilrix™
VaricellaUnlock trial analytics

Study Endpoints

Primary Endpoints

Varicella, MMR titres at 42-56 days after first vaccination
Varicella seroconversion and MMR titres at 42-56 days after first vaccination

Secondary Endpoints

Seropositivity rates. Safety: solicited local/general, unsolicited AEs (42 days), SAEs (whole study)
Safety: solicited local/general, unsolicited AEs (42 days), SAEs (whole study)
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION

Interventions

NameTypeDescription
MeMuRu-OKA (study vac)BIOLOGICAL -
MMR, Varicella vacc (control)BIOLOGICAL -
MeMuRu-OKA (study vacc)BIOLOGICAL -
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Eligibility Criteria

Age Range15 Months to 6 Years
SexALL
Healthy VolunteersYes
Study Sites6

Inclusion Criteria: * Children must be healthy to participate Exclusion Criteria: * immunosuppressive (including HIV) conditions, allergic diseases, neurological disorders, known anaphylactic reaction to MMR vaccine, and fever (axillary temperature ³ 37.5°C at the time of vaccination) are excludi...

Countries:CanadaItalyFranceGermany
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Frequently asked questions about MMR, Varicella vacc

What is MMR, Varicella vacc used for?

MMR, Varicella vacc is an investigational combination vaccine being studied for the prevention of mumps and varicella, as well as measles and rubella. It is in Phase 2 clinical development for use in infectious disease prevention.

Who makes MMR, Varicella vacc?

MMR, Varicella vacc is being developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. The vaccine is currently in Phase 2 clinical trials.

What phase is MMR, Varicella vacc in?

MMR, Varicella vacc is in Phase 2 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. Two Phase 2 trials have been completed to evaluate its immunogenicity and safety.

What clinical trials is MMR, Varicella vacc in?

MMR, Varicella vacc has been studied in two completed Phase 2 clinical trials: NCT00352898 and NCT00353288. Both trials compared the combination vaccine to Priorix given with Varilrix in healthy children aged 15 months and older, across countries including Canada, Italy, France, and Germany.

Is MMR, Varicella vacc the same as MMR vaccine?

MMR, Varicella vacc is also known as the MMR vaccine, but it is a combination vaccine that includes varicella in addition to measles, mumps, and rubella components. It is being developed to provide protection against all four diseases in a single shot.