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Live attenuated human rotavirus vaccine

Phase 3

Infections, Rotavirus | Monoclonal antibody | Other |GSK plc|Last Updated: May 30, 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-BlindUNCONTROLLEDBiomarker
Total Trials2
Total Enrollment510
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00289172Assess the Immunogenicity & Safety of 2 Doses of Oral Live Attenuated Human Rota(HRV)Vaccine in Healthy Infants in IndiaPHASE3 COMPLETED 360Feb 10, 2006Sep 8, 2006May 30, 20174 India
NCT00134732Study of 2 Doses of Oral Live Attenuated Human Rotavirus (HRV) Vaccine for the Prophylaxis of Rotavirus GastroenteritisPHASE3 COMPLETED 150Jul 1, 2005May 1, 2006Sep 23, 20166 South Korea
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Study Endpoints
Primary Endpoints
Percentage of seroconversion (anti-rota serum IgA) in children, after two doses of HRV vaccine versus two doses of placebo.
Percent who seroconverted (anti-rota serum IgA, 2 months post dose 2)
Secondary Endpoints
Fever, vomiting, diarrhea. Solicited symptoms. Unsolicited events. SAEs. Presence of rotavirus in GE stools.
Grade 2 and 3 fever, vomiting, diarrhea, solicited symptoms
Unsolicited events
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Study Design & Arms
AllocationRANDOMIZED
ModelPARALLEL
PurposePREVENTION
Interventions
NameTypeDescription
Live attenuated human rotavirus vaccineBIOLOGICAL -
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Eligibility Criteria
Age Range8 Weeks — 12 Weeks
SexALL
Healthy VolunteersYes
Study Sites4

"Inclusion criteria: * A male or female between, and including, 8 and 10 weeks of age at the time of the first vaccination. * Written informed consent obtained from the parent or guardian of the subject. * Free of obvious health problems as established by medical history and clinical examination be...

Countries:IndiaSouth Korea
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