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MeMuRu-OKA

Phase 3

Measles | Vaccine | Infectious Disease |GSK plc|Trials Updated: Oct 7, 2016

MeMuRu-OKA target and mechanism

ModalityVaccine

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 Trials3
Total Enrollment1,176

FDA Designations

No designations recorded

MeMuRu-OKA clinical trials

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
MeaslesUnlock trial analytics

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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Frequently asked questions about MeMuRu-OKA

What is MeMuRu-OKA?

MeMuRu-OKA is an investigational combination vaccine developed by GSK plc for protection against measles, mumps, rubella, and varicella. It is designed to deliver all four antigens in a single product, and it has been studied in healthy infants and young children from about 11 to 15 months of age.

What is MeMuRu-OKA used for?

MeMuRu-OKA is being developed for immunization against measles, mumps, rubella, and varicella in young children. Clinical studies enrolled healthy volunteers starting at 11 to 15 months of age, evaluating the combined vaccine against a regimen of Priorix given together with Varilrix.

Who makes MeMuRu-OKA?

MeMuRu-OKA is developed by GSK plc, which trades under the ticker GSK. GSK sponsored the clinical studies of the vaccine, including the Phase 2 and Phase 3 trials conducted in France, Germany, Italy, and Canada.

What phase is MeMuRu-OKA in?

MeMuRu-OKA has reached Phase 3 clinical development. One Phase 3 study, NCT00351923, evaluated the vaccine using two different administration routes in Germany. Two earlier Phase 2 studies, NCT00353288 and NCT00352898, compared it with Priorix given with Varilrix. It is investigational and not approved.

What clinical trials is MeMuRu-OKA in?

MeMuRu-OKA has been studied in three completed trials. NCT00353288 and NCT00352898 were Phase 2 immunogenicity and safety studies comparing it with Priorix plus Varilrix, and NCT00351923 was a Phase 3 study of two administration routes. All three trials have completed.

Is MeMuRu-OKA the same as the study vaccine MeMuRu-OKA?

Yes. MeMuRu-OKA is also referred to as MeMuRu-OKA (study vacc), MeMuRu-OKA (study vac), and MeMuRu-OKA (study vaccine). These are alternate labels for the same GSK combination vaccine against measles, mumps, rubella, and varicella, so searches using those names refer to this asset.