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Live attenuated rotavirus vaccine

Phase 2

Infections, Rotavirus | Monoclonal antibody | Other |GSK plc|Last Updated: Sep 21, 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-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment250
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00137930Study of Immunogenicity & Safety of 2 Different Formulations of Human Rotavirus (HRV) Vaccine for the Prophylaxis of Rotavirus GastroenteritisPHASE2 COMPLETED 250Aug 1, 2005Nov 1, 2005Sep 21, 20165 Finland
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Study Endpoints
Primary Endpoints
Endpoint: immunogenicity and reactogenicity
Proportion of subjects with vaccine take
Secondary Endpoints
Proportion of seroconverters
RV-IgA concentration
Occurrence of solicited symptoms: loss of appetite, fussiness/irritability, fever, diarrhea, vomiting, cough/runny nose
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION
Interventions
NameTypeDescription
Live attenuated rotavirus vaccineBIOLOGICAL -
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Eligibility Criteria
Age Range6 Weeks — 12 Weeks
SexALL
Healthy VolunteersYes
Study Sites5

Inclusion Criteria: * Subjects with parents/guardians who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study. * Males or females between, and including, 6 and 12 weeks (42 - 90 days) of age at the time of the first vaccination. * Writ...

Countries:Finland
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