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Pneumovax 23

Phase 3

Pneumococcal Disease | Monoclonal antibody | Other |Merck & Company, Inc.|Last Updated: Oct 30, 2018

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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment102
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01734239A Phase III Clinical Trial to Study the Safety and Immunogenicity of Pneumovax™ 23 (V110) in Participants From the Russian Population (V110-018)PHASE3 COMPLETED 102Jun 3, 2013Oct 22, 2013Oct 30, 2018 -
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Study Endpoints
Primary Endpoints
Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes Contained in the Vaccine
Prevaccination and Day 28 after vaccination

Serum antibodies to pneumococcal serotypes were measured by enzyme-linked immunosorbent assays

Percentage of Participants With >=2-fold Increase From Prevaccination to Postvaccination in Antibodies to Pneumococcal Serotypes Contained in the Vaccine
Day 28 postvaccination

Serum antibodies to pneumococcal serotypes were measured by enzyme-linked immunosorbent assays. A \>=2-fold increase in serum antibody is a marker for serologic response to pneumococcal vaccination in adults.

Number of Participants With Elevated Body Temperature (>=37.6 °C Axillary / >=38.0 °C Oral or Equivalent)
Up to 5 days postvaccination
Number of Participants Reporting an Injection-site or Systemic Adverse Experience That Was Reported by >=4 Participants
Up to Day 14 postvaccination

An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the sponsor's product, is also an AE. Injection-site or systemic AEs that occurred in \>=4 participants were reported for this endpoint.

Number of Participants Reporting Serious Adverse Experiences
Up to Day 28 postvaccination

A serious AE (SAE) is an AE that 1) results in death, 2) is life threatening, 3) results in a persistent or significant disability or incapacity, 4) results in or prolongs an existing inpatient hospitalization, 5) is a congenital anomaly or birth defect, 6) is a cancer, 7) is an overdose, or 8) is another important medical event which, based on appropriate medical judgment, may jeopardize the participant and may require medical or surgical intervention

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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Pneumovax™ 23: Participants Between 2 and 49 YearsEXPERIMENTALParticipants received a single, 0.5-mL intramuscular injection of Pneumovax™ 23 on Day 1
Pneumovax™ 23: Participants >=50 YearsEXPERIMENTALParticipants received a single, 0.5-mL intramuscular injection of Pneumovax™ 23 on Day 1
Interventions
NameTypeDescription
Pneumovax™ 23BIOLOGICALVaccine contains 25 µg of each of the 23 pneumococcal polysaccharides serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, and 33F
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Eligibility Criteria
Age Range2 Years — N/A
SexALL
Healthy VolunteersYes

Inclusion Criteria: * For participants 50 years of age or older: any underlying chronic illness must be in stable condition * For participants 2 to 49 years of age: participant has an increased risk for pneumococcal disease as a result of one of the following: chronic cardiovascular disease, chroni...

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