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Comparator: Menactra

Phase 3

Neoplasms, Glandular and Epithelial | Monoclonal antibody | Oncology |Merck & Company, Inc.|Last Updated: Mar 12, 2015

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
RandomizedCONTROLLED
Total Trials1
Total Enrollment1,042
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00325130Concomitant Use of Gardasil (V501) (Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine) With Combined Diphtheria, Tetanus, Pertussis Vaccine and Meningococcal Conjugate Vaccine in Adolescents (V501-025)PHASE3 COMPLETED 1,042 — — Apr 1, 2006Apr 1, 2007Mar 12, 2015 - —
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Study Endpoints
Primary Endpoints
Number of Subjects Who Seroconverted for Human Papillomavirus (HPV) Type 6 (HPV 6 ≥ 20 mMU/mL) by Week 4 Postdose 3 (7 Months)
7 Months
Number of Subjects Who Seroconverted for HPV Type 11 (HPV 11 ≥ 16 mMU/mL) by Week 4 Postdose 3 (7 Months)
7 Months
Number of Subjects Who Seroconverted for HPV Type 16 (HPV 16 ≥ 20 mMU/mL) by Week 4 Postdose 3 (7 Months)
7 Months
Number of Subjects Who Seroconverted for HPV Type 18 (HPV 18≥ 24 mMU/mL) by Week 4 Postdose 3 (7 Months)
7 Months
Number of Subjects Who Achieved a Four-fold Rise in Titers to Meningococcal Serogroup A One Month Postvaccination (Week 4 Postdose 1) With Menactra™
7 Months
Number of Subjects Who Achieved a Four-fold Rise in Titers to Meningococcal Serogroup C One Month Postvaccination (Week 4 Postdose 1) With Menactra™
7 Months
Number of Subjects Who Achieved a Four-fold Rise in Titers to Meningococcal Serogroup W-135 One Month Postvaccination (Week 4 Postdose 1) With Menactra™
7 Months
Number of Subjects Who Achieved a Four-fold Rise in Titers to Meningococcal Serogroup Y One Month Postvaccination With Menactra™
7 Months
Number of Subjects Who Achieved Acceptable Levels of Titers (Diphtheria ≥ 0.1 IU/mL) to Diphtheria One Month Postvaccination (Week 4 Postdose 1) With ADACEL™
7 Months
Number of Subjects Who Achieved Acceptable Levels of Titers to Tetanus (Tetanus ≥ 0.1 IU/mL) One Month Postvaccination (Week 4 Postdose 1) With ADACEL™
7 Months
Geometric Mean Titers (GMTs) for Anti-HPV 6 at Week 4 Postdose 3 (7 Months) of GARDASIL™
7 Months
Geometric Mean Titers (GMTs) for Anti-HPV 11 at Week 4 Postdose 3 (7 Months) of GARDASIL™
7 Months
Geometric Mean Titers (GMTs) for Anti-HPV 16 at Week 4 Postdose 3 (7 Months) of GARDASIL™
7 Months
Geometric Mean Titers (GMTs) for Anti-HPV 18 at Week 4 Postdose 3 (7 Months) of GARDASIL™
7 Months
Geometric Mean Titers (GMTs) for Pertussis Anti-Pertussis Toxin (Anti-PT) One Month Postvaccination (Week 4 Postdose 1) With ADACEL™
7 Months
Geometric Mean Titers (GMTs) for Pertussis Anti-Filamentous Hemagglutinin) (Anti-FHA) One Month Postvaccination (Week 4 Postdose 1) With ADACEL™
7 Months
Geometric Mean Titers (GMTs) for Pertussis Anti Pertactin (Anti-PRN) One Month Postvaccination (Week 4 Postdose 1) With ADACEL™
7 Months
Geometric Mean Titers (GMTs) for Pertussis Anti-Fimbrial Agglutinogens 2/3 (Anti-FIM) One Month Postvaccination (Week 4 Postdose 1) With ADACEL™
7 Months
Secondary Endpoints
Acceptable Safety Profile
15 days post injection
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Group 1EXPERIMENTALConcomitant Administration
Group 2EXPERIMENTALNon-concomitant administration
Interventions
NameTypeDescription
Comparator: Quadrivalent Human Papillomavirus (HPV) vaccineBIOLOGICALQuadrivalent HPV vaccine was provided by the SPONSOR in single-dose vials containing a volume of 0.75 mL. The vaccine was administered as a 0.5-mL intramuscular dose at Day 1, Month 2, and Month 6.
Comparator: Menactra™ (Concomitant)BIOLOGICALA single administration of 0.5 mL intramuscular injection in a limb opposite that of quadrivalent HPV injection at Day 1
Comparator: Adacel™ (Concomitant)BIOLOGICALa single administration of 0.5 mL intramuscular injection administered in a limb opposite that of quadrivalent HPV injection at Day 1
Comparator: Menactra™ (Non-concomitant)BIOLOGICALA single administration of 0.5 mL intramuscular injection in a limb opposite that of quadrivalent HPV injection at Month 1
Comparator: Adacel™BIOLOGICALA single administration of 0.5 mL intramuscular injection in a limb opposite that of quadrivalent HPV injection at Month 1
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Eligibility Criteria
Age Range11 Years — 17 Years
SexALL
Healthy VolunteersYes

Inclusion Criteria: * Must be healthy boys or girls, 11-17 years of age * Must be a virgin with no intention of becoming sexually active during the study period * Must have been properly vaccinated against diphtheria, tetanus and pertussis Exclusion Criteria: * Must not have received a vaccine ag...

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