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GSK Biologicals' human rotavirus vaccine 444563

Phase 1

Infections, Rotavirus | Monoclonal antibody | Other |GSK plc|Last Updated: May 19, 2017

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-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment50
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01107587Study to Assess the Safety of GSK Biologicals' Liquid Human Rotavirus Vaccine in Healthy InfantsPHASE1 COMPLETED 50 — — Apr 13, 2010Jun 28, 2010May 19, 20171 China
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Study Endpoints
Primary Endpoints
Occurrence of grade 3 solicited adverse events.
Within the 8-day (Day 0 - 7) follow-up period after each vaccine dose.
Secondary Endpoints
Occurrence of each solicited adverse event.
Within the 8-day (Day 0 - 7) follow-up period after each vaccine dose.
Occurrence of unsolicited adverse events.
Within the 31-day (Day 0 - 30) follow-up period after any vaccine dose.
Occurrence of serious adverse events.
Throughout the study period (Day 0 to Month 2).
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
HRV groupEXPERIMENTALSubjects will receive GSK Biologicals' human rotavirus vaccine 444563.
Placebo GroupPLACEBO_COMPARATORSubjects will receive placebo.
Interventions
NameTypeDescription
GSK Biologicals' human rotavirus vaccine 444563BIOLOGICALOral, two doses.
PlaceboBIOLOGICALOral, two doses.
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Eligibility Criteria
Age Range6 Weeks — 16 Weeks
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol. * A male or female infant of Chinese origin between, and including, 6 and 16 weeks of age at the time of the first vaccin...

Countries:China
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