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Pneumococcal Vaccine, Polyvalent

Phase 3

Pneumococcal Infection | Monoclonal antibody | Other |Merck & Company, Inc.|Last Updated: Mar 14, 2017

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
UNCONTROLLED
Total Trials1
Total Enrollment133
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00496093Safety, Tolerability and Immunogenicity of Pneumovax 23 in Healthy Adults in India (V110-011)PHASE3 COMPLETED 133 — — Oct 1, 2005Jan 1, 2006Mar 14, 2017 - —
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Study Endpoints
Primary Endpoints
Percentage of subjects exhibiting a >= 2 fold increase in IGG antibody level from pre-vaccination to post-vaccination for both serotypes 1 and 6b
post-vaccination
Secondary Endpoints
Any AE within 15 days after vaccination, with particular attention to injection site AE and fever
15 days after vaccination
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Pneumococcal Vaccine, Polyvalent (23-valent)EXPERIMENTALParticipants received one 0.5 mL dose of Pneumococcal Vaccine, Polyvalent (23-valent) by intramuscular (deltoid) injection on Day 1.
Interventions
NameTypeDescription
Pneumococcal Vaccine, Polyvalent (23-valent)BIOLOGICAL -
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Eligibility Criteria
Age Range50 Years — N/A
SexALL
Healthy VolunteersYes

Inclusion Criteria: * Healthy indian adults of 50 years of age * In good health; any underlying chronic illness must be documented to be in stable condition * Signed and dated informed consent prior to receipt of the study vaccine Exclusion Criteria: * Functional or anatomic asplenia * History of...

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