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Rotavirus

Phase 3

Infections, Rotavirus | Monoclonal antibody | Other |GSK plc|Last Updated: Dec 30, 2019

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 Trials4
Total Enrollment78,229
FDA Designations
No designations recorded
Clinical Trials (4)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00140686To Test 2 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Healthy Infants in Co-administration With Specific Childhood VaccinesPHASE3 COMPLETED 3,994 — — Sep 1, 2004Aug 1, 2006Mar 23, 2017101 Czechia, Finland +4
NCT00197210A Study to Test 2 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Healthy InfantsPHASE3 COMPLETED 10,708 — — Dec 1, 2003Jul 1, 2007Nov 4, 20164 Singapore
NCT00140673A Study to Test 2 Doses of the HRV Vaccine in Healthy Infants.PHASE3 COMPLETED 63,227 — — Aug 5, 2003Oct 20, 2005Dec 30, 201917 Argentina, Brazil +10
NCT00139334A Study to Test 2 Doses of the HRV Vaccine Given With or Without OPV in Healthy Infants in BangladeshPHASE2 COMPLETED 300 — — Jun 1, 2005Jan 1, 2006Sep 21, 20161 Bangladesh
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Study Endpoints
Primary Endpoints
Occurrence of any RV GE caused by the circulating wild-type RV strains during the first efficacy follow-up period.
Occurrence of severe RV GE caused by the wild RV strains from 2 weeks after Dose 2 until two years of age. Occurrence of definite IS cases within 31 days (Day 0 -Day 30) after each HRV vaccination dose.
1. Occurrence of severe RV GE caused by the wild RV strains during the period starting from 2 weeks after Dose 2 until one year of age. 2. Occurrence of definite IS cases within 31 days (Day 0 -Day 30) after each HRV vaccination dose.
Endpoints : Safety/immunogenicity.Immunogenicity of GSK Biologicals' HRV vaccine in terms of anti-rotavirus IgA antibody seroconversion at Visit 6 in the group receiving of HRV vaccine concomitantly with OPV versus placebo group.
Secondary Endpoints
Occurrence of severe RV GE caused by the circulating wild-type RV strains during the each efficacy follow-up period.
Occurrence of any and severe RV GE caused by the circulating wild-type RV strains of G1 serotype during each efficacy follow-up period.
Occurrence of any and severe RV GE caused by the circulating wild-type RV strains of non-G1 serotypes during each efficacy follow-up period.
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION
Interventions
NameTypeDescription
Rotavirus (vaccine)BIOLOGICAL -
RotavirusBIOLOGICAL -
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Eligibility Criteria
Age Range6 Weeks — 14 Weeks
SexALL
Healthy VolunteersYes
Study Sites101

Inclusion criteria: * Healthy infants 6 -14 weeks of age at the time of the first study vaccination with birth weight \> 2000g whose parent/guardian sign a written informed consent and whose parents/guardians can and will comply with the requirements of the protocol (e.g., completion of the diary c...

Countries:CzechiaFinlandFranceGermanyItalySpainSingaporeArgentinaBrazilChileColombiaDominican RepublicHondurasMexicoNicaraguaPanamaPeruVenezuelaBangladesh
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