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MMR Bio-Manguinhos

Phase 3

Measles | Monoclonal antibody | Other |GSK plc|Last Updated: Jul 11, 2016

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment1,560
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01991899Study of Immunogenicity, Reactogenicity and Safety of the Combined Measles, Mumps and Rubella Vaccine Produced by Bio-Manguinhos/Fiocruz in Children 12-15 Months of Age, Followed by Tetraviral Vaccine in Children 15-18 Months.PHASE3 COMPLETED 1,560Feb 1, 2015Jul 1, 2016Jul 11, 20161 Brazil
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Study Endpoints
Primary Endpoints
Immunogenicity comparing the 3 lots of MMR vaccine produced totally in Brazil and reference vaccine.
Thirty days after MMR vaccine

Difference seroprotection for each of the antigens in the vaccines under test and reference vaccines or greater - 10%, one-tailed analysis. More precisely, the lower limit of 95% of the difference between the seroprotection rates in the vaccine test and reference vaccine should be greater than 10% (e.g. 4%, -3%, etc. .) evaluate the immunogenicity• Ratio of the geometric mean titers for each of the antigens ≥ 0.5 (for Bio-Manguinhos vaccine and reference vaccine). The analysis of non-inferiority will take into account three batches of vaccines TV1, TV2, TV3 and that will be compared together with the reference vaccine, if any consistency of production batches. This procedure is performed in the 2nd serology after vaccination.

Safety
Thirty days after MMR vaccine

Parents or guardians will take home the diary for recording adverse events. They will receive training on how to complete the diary of adverse events in health facilities where children are vaccinated after the first dose of MMR. They will receive a ruler and a mercury thermometer to check for adverse events and a pen for note. The diary of adverse events should be completed during the 10 days after vaccination •Adverse events will be compared for each of vaccines (TV1, TV2, TV3 and reference vaccine) and for each dose. Will determine the percentage of subjects with a report of any symptoms (solicited or unsolicited) during the 30 days of follow-up after vaccination. Are tabulated the percentages of subjects with adverse events (for the overall incidence of any symptom, for the incidence of any local symptoms and the incidence of any general symptoms). The comparison between groups will be made by the chi-square test with a significance level of 0.05.

Determine the consistency of production
Thirty days after MMR vaccine

Difference seroprotection for each of the antigens in the vaccines under test and reference vaccines or greater - 10%, one-tailed analysis. More precisely, the lower limit of 95% of the difference between the seroprotection rates in the vaccine test and reference vaccine should be greater than 10% (e.g. 4%, -3%, etc. .) evaluate the immunogenicity• Ratio of the geometric mean titers for each of the antigens ≥ 0.5 (for Bio-Manguinhos vaccine and reference vaccine). The analysis of non-inferiority will take into account three batches of vaccines TV1, TV2, TV3 and that will be compared together with the reference vaccine, if any consistency of production batches. This procedure is performed in the 2nd serology after vaccination.

Secondary Endpoints
Adverse events after tetraviral
Three months after MMR vaccine
Seroconversion after vaccine tetraviral( measles, mumps,rubella and varicela)
Four months after MMM vaccine
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeHEALTH_SERVICES_RESEARCH
Treatment Arms
ArmTypeDescription
MMR Bio-ManguinhosEXPERIMENTALArm 1:1170 children will receive MMR Bio-Manguinhos, 3 diferents lots
MMR GlaxoSmithKlineACTIVE_COMPARATORArm 2:390 children will receive MMR GlaxoSmithKline
Interventions
NameTypeDescription
MMR Bio-ManguinhosBIOLOGICAL1170 children will receive 100% produced by Bio-Manguinhos, 3 diferents lots. Application of a 0.5 ml dose, subcutaneous 390 children will receive 0,5 ml, subcutaneous, MMR GlaxoSmithKline
MMR GlaxoSmithKlineBIOLOGICAL390 children will receive 0,5 ml MMR GlaxoSmithKline
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Eligibility Criteria
Age Range12 Months — 18 Months
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Children of both sexes * Age between 12 to 15 months . * Child in good health , without significant past medical history personal , such as genetic syndromes , epilepsy , diabetes , severe infections and immune dysfunctions . * Consent of father or mother , or legal guardian o...

Countries:Brazil
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