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MEDI 517

Phase 1

Healthy | Monoclonal antibody | Other |AstraZeneca PLC|Last Updated: Jan 8, 2009

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-BlindACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment60
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00263744Study to Evaluate the Safety and Immunogenicity of MEDI-517P in Healthy Adult Female Volunteers Who Are HPV-16 or HPV-18 DNA PositivePHASE1 COMPLETED 60Nov 1, 1999Jun 1, 2001Jan 8, 2009 -
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Study Endpoints
Primary Endpoints
Evaluation of safety in terms of unsolicited adverse events and serious adverse events.
7 days after each injection
Secondary Endpoints
Determine the effect of MEDI-517 compared to aluminum hydroxide control on the proportion of volunteers who are positive for HPV DNA.
Swab taken on Study Day 210
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
1EXPERIMENTALMEDI517
2ACTIVE_COMPARATORAluminum hydroxide
Interventions
NameTypeDescription
MEDI 517BIOLOGICALVaccine is supplied in single use vials containing 0.75 mL of MEDI-517 at a concentration of 40 mg/0.5 mL formulated with SBAS4 adjuvant.
Aluminum hydroxideOTHERAluminum hydroxide supplied in single use vials containing 0.75 mL of aluminum hydroxide at a concentration of 0.5 mg of aluminum in the form of aluminum hydroxide per 0.5 mL.
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Eligibility Criteria
Age Range18 Years — 30 Years
SexFEMALE
Healthy VolunteersYes

Inclusion Criteria: * Female * 18 through 30 years of age (must not have reached the 31st birthday) * Unless previously surgically sterilized, agrees to use an effective method of birth control (e.g., abstinence, intrauterine contraceptive device, oral contraceptives, diaphragm or condom in combina...

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