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GSK Biologicals' HPV vaccine

Phase 1

Infections, Papillomavirus | Monoclonal antibody | Other |GSK plc|Last Updated: May 10, 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
RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment540
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00478621Human Papillomavirus Vaccine Safety & Immunogenicity Trial in Healthy Young Adult Women With HPV Vaccine (GSK1674330A)PHASE1 COMPLETED 540 — — May 25, 2007Oct 13, 2008May 10, 20173 Belgium
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Study Endpoints
Primary Endpoints
Occurrence, intensity and relationship to vaccination of any solicited local or general symptoms
Within 7 days after each vaccine dose
Secondary Endpoints
Occurrence of serious adverse events
Up to one month after the last dose of vaccine
Occurrence, intensity and relationship to vaccination of any unsolicited symptom
Within 30 days after each vaccine dose
Occurrence of clinically relevant abnormalities in biochemical and hematological parameters
Assessed at Month 0, one month and six months after the last dose of vaccine
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Group AEXPERIMENTAL -
Group BEXPERIMENTAL -
Group CEXPERIMENTAL -
Group DEXPERIMENTAL -
Group EEXPERIMENTAL -
Group FACTIVE_COMPARATOR -
Interventions
NameTypeDescription
GSK Biologicals' HPV vaccine (GSK1674330A)BIOLOGICALIntramuscular administration, 5 different formulations
Cervarix TMBIOLOGICALIntramuscular administration
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Eligibility Criteria
Age Range18 Years — 25 Years
SexFEMALE
Healthy VolunteersYes
Study Sites3

Inclusion Criteria: * A woman whom the investigator believes can and will comply with the requirements of the protocol. * A woman between, and including, 18 and 25 years of age at the time of the first vaccination. * Written informed consent must be obtained from the subject prior to enrolment. * H...

Countries:Belgium
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