Recent Updates
Recently added Catalysts

Human rotavirus liquid vaccine

Phase 3

Infections, Rotavirus | Monoclonal antibody | Other |GSK plc|Last Updated: Oct 28, 2016

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment375
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00345956To Evaluate Immunogenicity, Reactogenicity & Safety of 2 Doses of GSK Bio HRV Liquid Vaccine Given to Infants (Vietnam)PHASE3 COMPLETED 375Sep 1, 2006Mar 1, 2007Oct 28, 20162 Vietnam
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Anti-RV IgA antibody SC at Month 2 • Safety: solicited & unsolicited adverse events and SAEs
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION
Interventions
NameTypeDescription
Human rotavirus liquid vaccineBIOLOGICAL -
Unlock Study Design Details
Eligibility Criteria
Age Range6 Weeks — 10 Weeks
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Healthy male or female infant between, and including, 6 and 10 weeks of age with a birth weight of \> 2000 grams. * Written informed consent obtained from the parent or guardian of the subject. Exclusion Criteria: * Use of any investigational or non-registered product (drug ...

Countries:Vietnam
Unlock Eligibility Criteria