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Pneumo 23

Phase 3

Streptococcus Pneumoniae | Monoclonal antibody | Infectious Disease |Sanofi|Last Updated: Jun 18, 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
RandomizedDouble-BlindACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment339
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00594347Immunogenicity and Safety of a Booster Dose of Pneumo 23® in 12 to 18 Months-Old Children Primed With PrevnarPHASE3 COMPLETED 339Nov 1, 2007Apr 1, 2009Jun 18, 20152 Thailand
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Study Endpoints
Primary Endpoints
To provide information concerning the safety after booster administration of 23-valent polysaccharidic pneumococcal vaccine
30 days post-vaccination
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Group AEXPERIMENTALPneumo 23
Group BACTIVE_COMPARATORPrevnar
Interventions
NameTypeDescription
Pneumo 23BIOLOGICALVaccine (Pneumo 23)
PrevnarBIOLOGICALVaccine (Prevnar)
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Eligibility Criteria
Age Range12 Months — 18 Months
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Aged 12 to 18 months on the day of inclusion * Informed consent form signed by the parent/legally acceptable representative and by an independent witness if requested by local Ethics Committee regulation or/and if the parent/legally acceptable representative is illiterate * Ch...

Countries:Thailand
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