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Pneumococcal Conjugate Vaccine

Phase 2

Pneumococcal Infections | Monoclonal antibody | Other |Merck & Company, Inc.|Last Updated: Dec 13, 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
RandomizedDouble-BlindACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment692
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01513551The Safety, Tolerability, and Immunogenicity Profiles of a Single Dose of V114, PNEUMOVAX® 23, or PREVNAR 13® in Adults 50 Years of Age or Older (V114-002)PHASE2 COMPLETED 692Mar 13, 2012Feb 15, 2013Dec 13, 2018 -
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Study Endpoints
Primary Endpoints
Percentage of Participants With an Adverse Event
All AEs: up to 14 days after vaccination; Serious Adverse Events (SAEs): up to 6 months after vaccination

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 (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the Sponsor's product, is also an adverse experience.

Percentage of Participants With an Injection-site Adverse Event Reported With >=2% Incidence in One or More Vaccination Groups
Up to Day 14 postvaccination

Injection-site AEs reported by \>=2% of participants in one or more vaccination groups were assessed.

Percentage of Participants With a Systemic Adverse Event Reported With >=2% Incidence in One or More Vaccination Groups
Up to Day 14 postvaccination

Systemic AEs reported by \>=2% of participants in one or more vaccination groups were assessed.

Percentage of Participants With a Serious Adverse Event
Up to 6 months postvaccination

A serious adverse event (SAE) is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment.

Percentage of Participants With a Vaccine-related Serious Adverse Event
Up to 6 months postvaccination

A SAE is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. SAEs deemed by the investigator to be possibly, probably, or definitely related to study vaccine were reported.

Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies
One month postvaccination

Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence (ECL) assay.

Secondary Endpoints
Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibodies
One month postvaccination
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
V114EXPERIMENTALHealthy adult participants received a single 0.5 mL intramuscular injection of aluminum adjuvanted V114 on Day 1.
PNEUMOVAX® 23ACTIVE_COMPARATORHealthy adult participants received a single 0.5 mL intramuscular injection of PNEUMOVAX® 23 on Day 1.
PREVNAR 13®ACTIVE_COMPARATORHealthy adult participants received a single 0.5 mL intramuscular injection of PREVNAR 13® on Day 1.
Interventions
NameTypeDescription
Pneumococcal Conjugate Vaccine (V114)BIOLOGICAL15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg) and aluminum phosphate adjuvant (125 mcg) in each 0.5 mL dose.
PNEUMOVAX® 23BIOLOGICAL23-valent pneumococcal polysaccharide vaccine with serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, 33F (25 mcg each) in each 0.5 mL dose.
PREVNAR 13®BIOLOGICAL13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F, serotype 6B (4.4 mcg each) and aluminum phosphate adjuvant (125 mcg) in each 0.5. mL dose.
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Eligibility Criteria
Age Range50 Years — N/A
SexALL
Healthy VolunteersYes

Inclusion Criteria: -Without fever for 72 hours prior to vaccination Exclusion Criteria: * Prior receipt of any pneumococcal polysaccharide vaccine or any pneumococcal conjugate vaccine * Known or suspected to be immunocompromised * Functional or anatomic asplenia * History of autoimmune disease ...

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