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MeMuRu-OKA

Phase 3

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

Target and mechanism

ModalityMonoclonal antibody

Also known as MeMuRu-OKA (study vacc), MeMuRu-OKA (study vac), MeMuRu-OKA (study vaccine)

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment330

FDA Designations

No designations recorded

Clinical trial landscape

MeMuRu-OKA · 3 trials · 4 indications

Phase 3 1Phase 2 2
NCT00351923Immunogenicity/Safety of Measles-Mumps-Rubella-Varicella Vaccine (MeMuRu-OKA): Using Two Different Administration RoutesMeasles
COMPLETED330 Analytics
PHASE3COMPLETED
Immunogenicity/Safety of Measles-Mumps-Rubella-Varicella Vaccine (MeMuRu-OKA): Using Two Different Administration Routes
Measles
NCT00351923330
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Study Endpoints

Primary Endpoints

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

Secondary Endpoints

Antibody titres; safety: solicited local/ general, unsolicited AEs (42 days), SAEs (whole study)
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 vaccine)BIOLOGICAL -
MeMuRu-OKA (study vac)BIOLOGICAL -
MMR, Varicella vacc (control)BIOLOGICAL -
MeMuRu-OKA (study vacc)BIOLOGICAL -
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Eligibility Criteria

Age Range11 Months to 22 Months
SexALL
Healthy VolunteersYes
Study Sites20

Inclusion Criteria: * Children must be healthy and have a birth weight \> 2000 g to participate Exclusion Criteria: * confirmed or suspected tuberculosis, immunosuppressive (including HIV) conditions, neurological disorders, history of allergic disease or reaction, major congenital defects, chron...

Countries:GermanyCanadaItalyFrance
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