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Prevnar 13

Phase 1

Pneumococcal Infections | Monoclonal antibody | Other |Pfizer, Inc.|Last Updated: Jun 12, 2019

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_CONTROLLED
Total Trials1
Total Enrollment104
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03642847Trial to Evaluate the Safety and Immunogenicity of Multivalent Pneumococcal Vaccines in Japanese Adults 18 to 49 Years of AgePHASE1 COMPLETED 104 — — Aug 29, 2018Mar 29, 2019Jun 12, 20194 United States
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Study Endpoints
Primary Endpoints
Subjects reporting prompted local reactions within 14 days after vaccination (redness, swelling, and pain at the injection site).
14 days after vaccination
Subjects reporting prompted systemic events within 14 days after vaccination (fever, headache, fatigue, muscle pain, and joint pain).
14 days after vaccination
Subjects reporting adverse events (AEs) within 1 month after vaccination.
1 month after vaccination
Subjects reporting serious adverse events (SAEs) within 6 months after vaccination.
6 months after vaccination
Subjects reporting newly diagnosed chronic medical conditions (NDCMCs) within 6 months after vaccination.
6 months after vaccination
Secondary Endpoints
Immunogenicity
1 month after vaccination
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Prevnar 13ACTIVE_COMPARATOR13 valent Pneumococcal Conjugate
multivalent pneumococcal conjugate formulation 1EXPERIMENTALmultivalent pneumococcal conjugate formulation 1
multivalent pneumococcal conjugate formulation 2EXPERIMENTALmultivalent pneumococcal conjugate formulation 2
Interventions
NameTypeDescription
Prevnar 13BIOLOGICAL13 valent Pneumococcal Conjugate
multivalent pneumococcal conjugate formulation 1BIOLOGICALmultivalent pneumococcal conjugate formulation 1
multivalent pneumococcal conjugate formulation 2BIOLOGICALmultivalent pneumococcal conjugate formulation 2
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Eligibility Criteria
Age Range18 Years — 49 Years
SexALL
Healthy VolunteersYes
Study Sites4

Inclusion Criteria: * Male or female Japanese subjects 18 to 49 years of age, defined as Japanese born in Japan, with both parents and 4 grandparents who wer born in Japan (family tree by history), and who have not lived outside of Japan for more than 5 years total (confirmed by passport or intervi...

Countries:United States
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