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MEDI-517 HPV-16/18 VLP AS04 vaccine

Phase 2

Infections, Papillomavirus | Monoclonal antibody | Other |GSK plc|Last Updated: Sep 16, 2016

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-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment60
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00693615Safety and Immunogenicity Study of MEDI-517 (GSK 580299) With or Without Adjuvant in Healthy Adult FemalesPHASE2 COMPLETED 60 — — Oct 1, 2000Jan 1, 2005Sep 16, 2016 - —
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Study Endpoints
Primary Endpoints
Solicited adverse event rates (including injection site and systemic reactions)
For 7 days after each injection
Solicited adverse event rates
For 30 days after each injection
Serious adverse event rates
From first injection through 6 months after last injection
Laboratory assessments (Chemistry and Hematology parameters)
Study Days 0, 30 and 210
Vital signs (temperature, blood pressure, pulse rate, respiratory rate)
At the time of each injection and 30 minutes after each injection
Serum ELISA titers against HPV-16 and HPV-18
30 days after the third injection
Secondary Endpoints
Serum ELISA titers against HPV-16 and HPV-18
Study Days 0, 7, 30, 60, 180, 210, and 360, and at 18, 24, 36, and 48 months
Neutralization titers against HPV-16 and HPV-18
Study Days 0, 60, 210 and 360
Inhibitory ELISAs
Study Days 0, 60, 210, and 360, and at 18, 24, 36, and 48 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Group AEXPERIMENTALFormulation 1 of the vaccine (MEDI-517 HPV-16/18 VLP AS04 vaccine)
Group BEXPERIMENTALFormulation 2 of the vaccine \[with Al(OH)3\]
Group CEXPERIMENTALFormulation 3 of the vaccine (without adjuvant)
Interventions
NameTypeDescription
MEDI-517 HPV-16/18 VLP AS04 vaccineBIOLOGICALIM injection
MEDI-517 HPV-16/18 VLP vaccine with Al(OH)3BIOLOGICALIM injection
MEDI-517 HPV-16/18 VLP vaccine without adjuvantBIOLOGICALIM injection
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Eligibility Criteria
Age Range18 Years — 30 Years
SexFEMALE
Healthy VolunteersYes

Inclusion Criteria: * Females 18 through 30 years of age (must not have reached the 31st birthday) * Written informed consent obtained from the volunteer * Unless previously surgically sterilized, agrees to use an effective method of birth control beginning 30 days before the first study injection ...

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