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V114 Aluminum-adjuvanted

Phase 2

Pneumococcal Infections | Monoclonal antibody | Other |Merck & Company, Inc.|Last Updated: Apr 30, 2019

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 Enrollment1,152
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01215188A Study of Pneumococcal Conjugate Vaccine (V114) Compared to a Marketed Vaccine (V114-003)PHASE2 COMPLETED 1,152Oct 14, 2010Jul 31, 2012Apr 30, 2019 -
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Study Endpoints
Primary Endpoints
Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific ≥0.35 μg/mLThreshold Value for Postvaccination 3
One month postvaccination 3

Percentage of participants meeting the serotype-specific IgG reference level (an antibody concentration measured by the pneumococcal polysaccharide electrochemiluminescence \[Pn ECL\] assay corresponding to the World Health Organization enzyme-linked immunosorbent assay \[WHO ELISA\] ≥ 0.35 μg/mL) (post-dose 3) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®.

IgG Geometric Mean Concentrations (GMCs) for Postvaccination 3
One month postvaccination 3

The IgG GMCs were evaluated as measured in the Pn ECL assay, for recipients of adjuvanted V114, non-adjuvanted V114, and Prevnar 13® (post-dose 3) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®.

IgG GMCs for Postvaccination 4
One month postvaccination 4

The IgG GMCs were evaluated as measured in the Pn ECL assay, for recipients of adjuvanted V114, non-adjuvanted V114, and Prevnar 13® (post-dose 4) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®.

Number of Participants With an Adverse Event (AE)
Up to Day 14 postvaccination

An 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.

Number of Participants With an Injection-site AE
Up to Day 14 postvaccination

Injection-site AEs reported by \> 0% of participants in one or more vaccination groups were assessed.

Number of Participants With a Systemic AE
Up to Day 14 postvaccination

Systemic AEs reported by \> 0% of participants in one or more vaccination groups were assessed.

Number of Participants With a Serious Adverse Event (SAE)
Up to one month after last dose of study vaccine

An 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.

Number of Participants Who Discontinued the Study Due to an AE
Up to Day 14 postvaccination

An 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.

Secondary Endpoints
Percentage of Participants With Opsonophagocytic Killing Activity (OPA) Titer ≥ 8 as Measured by Fourfold Multiplexed Opsonization Assay (MOPA4) for Postvaccination 3
One month postvaccination 3
Percentage of Participants With OPA Titer ≥ 8 as Measured by MOPA4 for Postvaccination 4
One month postvaccination 4
OPA Geometric Mean Titers (GMTs) as Measured by MOPA4 for Postvaccination 3
One month postvaccination 3
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
V114 Aluminum-adjuvantedEXPERIMENTALFour intramuscular (IM) doses at 0.5 mL of aluminum-adjuvanted V114 pneumococcal conjugate vaccine at 2, 4, 6, and 12 to 15 months of age.
V114 Non-adjuvantedEXPERIMENTALFour IM doses at 0.5 mL of non-adjuvanted V114 pneumococcal conjugate vaccine at 2, 4, 6, and 12 to 15 months of age.
Prevnar 13®ACTIVE_COMPARATORFour IM doses at 0.5 mL of Prevnar 13® at 2, 4, 6, and 12 to 15 months of age.
Interventions
NameTypeDescription
V114 Aluminum-adjuvantedBIOLOGICAL15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2.2 mcg each), serotype 6B (4.4 mcg) and aluminum phosphate adjuvant (125 mcg) in each 0.5 mL dose.
V114 Non-adjuvantedBIOLOGICAL15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2 mcg each), and serotype 6B (4 mcg) 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 (2.2 mcg each), 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 Range6 Weeks — 12 Weeks
SexALL
Healthy VolunteersYes

Inclusion criteria: * Healthy infants ≥ 42 days to ≤ 89 days. * Participant's parent/legal guardian understands the study procedures, alternate treatments available and risks involved with the study, and voluntarily agrees to allow the child to participate by giving written informed consent. * Afeb...

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