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13-valent pneumococcal conjugate vaccine

Phase 3

Pneumonia | Monoclonal antibody | Infectious Disease |Co-Diagnostics, Inc.|Last Updated: May 13, 2020

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 Enrollment1,200
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02494999A Phase III Clinical Trial of a 13-valent Pneumococcal Conjugate Vaccine in Healthy InfantsPHASE3 COMPLETED 1,200Jun 1, 2016Oct 1, 2019May 13, 20204 China
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Study Endpoints
Primary Endpoints
Proportion of subjects with serotype-specific pneumococcal IgG antibody concentration ≥ 0.35 ug/mL 30 days after primary vaccination
30 days after primary vaccination
Geometric mean concentration (GMC) of serotype-specific pneumococcal IgG antibody 30 days after primary vaccination
30 days after primary vaccination
Secondary Endpoints
Proportion of subjects with serotype-specific pneumococcal IgG antibody concentration ≥ 1.0 ug/mL 30 days after primary vaccination
30 days after primary vaccination
Geometric mean fold increase (GMI) of serotype-specific pneumococcal IgG antibody 30 days after primary vaccination
30 days after primary vaccination
Proportion of subjects with serotype-specific geometric mean titer measured by OPA ≥1:8 30 days after primary vaccination
30 days after primary vaccination
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
13-valent pneumococcal conjugate vaccineEXPERIMENTALSingle 0.5 ml dose will be given via intramuscular injection in Month 0,2,4 and 10
Prevnar 13ACTIVE_COMPARATORSingle 0.5 ml dose will be given via intramuscular injection in Month 0,2,4 and 10
Interventions
NameTypeDescription
13-valent pneumococcal conjugate vaccineBIOLOGICAL0.5ml vaccine produced by Beijing Minhai Biotechnology Co., Ltd.,three doses with 2 month interval, a booster dose 10 months after the first dose
Prevnar 13BIOLOGICAL0.5ml vaccine produced by Wyeth,three doses with 2 month interval, a booster dose 10 months after the first dose
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Eligibility Criteria
Age Range42 Days — 77 Days
SexALL
Healthy VolunteersYes
Study Sites4

Inclusion Criteria: * Aged 42-77 days old on the day of inclusion * Subjects' legal guardians are able to understand and sign the informed consent * Subjects' legal guardians can and will comply with the requirements of the protocol * Subjects with temperature \<=37.0°C on axillary setting Exclusi...

Countries:China
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