Recent Updates
Recently added Catalysts

DTPa-HBV-IPV/Hib vaccine

Phase 3

Diphtheria | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: Oct 12, 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 Trials2
Total Enrollment639
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00320463Compare Immunogenicity & Safety of 2 Formulations of GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine Given in Healthy InfantsPHASE3 COMPLETED 415 — — Apr 1, 2006Jan 1, 2007Oct 12, 20164 Russia
NCT00316147Immunogenicity & Safety of GSK's Combined DTPa-HBV-IPV/Hib Vaccine in Indian Infants at 2 Diff Vaccination SchedulesPHASE3 COMPLETED 224 — — Dec 1, 2005Aug 1, 2006Sep 28, 20164 India
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
One month after vaccination, measurement of antibodies against all vaccine antigens.
1M post-dose 3, vaccine response for pertussis and anti-poliovirus types 1, 2, and 3 titers
Secondary Endpoints
Immunogenicity: One month after vaccination, vaccine response for the pertussis antigens.
Reactogenicity & safety: After each dose, solicited (day 0-3, local & general) & unsolicited (day 0-30) symptoms. Over the full course of the study: serious adverse events (SAEs)."
1M post-dose 3, antibody levels against all antigens
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION
Interventions
NameTypeDescription
DTPa-HBV-IPV/Hib vaccineBIOLOGICAL -
Unlock Study Design Details
Eligibility Criteria
Age Range11 Weeks — 17 Weeks
SexALL
Healthy VolunteersYes
Study Sites4

"Inclusion criteria: * A healthy male or female infant between, and including, 11 and 17 weeks of age at the time of the first vaccination. * Infant born to known hepatitis B surface antigen (HBsAg) seronegative mother (documented laboratory result of HBsAg assay from the maternal blood sample is a...

Countries:RussiaIndia
Unlock Eligibility Criteria