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13vPnC

Phase 3

Pneumococcal Disease | Monoclonal antibody | Other |Pfizer, Inc.|Last Updated: Apr 18, 2024

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
RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment1,269
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03835975Trial to Evaluate the Safety and Immunogenicity of a 20-Valent Pneumococcal Vaccine in Adults 65 Years of Age or Older With Prior Pneumococcal VaccinationPHASE3 COMPLETED 875Feb 12, 2019Feb 12, 2020Feb 21, 202142 United States, Sweden
NCT05489328Safety and Immunogenicity of Pneumococcal Conjugate Formulations in Healthy Adults 18 Through 49 Years of AgePHASE1 COMPLETED 394Aug 15, 2022Oct 7, 2022Apr 18, 202418 United States
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Study Endpoints
Primary Endpoints
Percentage of Participants With Local Reactions Within 10 Days After Vaccination
Within 10 days after vaccination

Local reactions were recorded using an electronic diary (e-diary). Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm). Redness and swelling were graded as mild (greater than \[\>\] 2.0 to 5.0 cm), moderate (\>5.0 to 10.0 cm) and severe (\>10.0 cm). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity).

Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Within 7 days after vaccination

Systemic events fever, fatigue, headache, muscle pain and joint pain were recorded by using an e-diary. Fever was defined as temperature \>=38.0 degree Celsius (C) and categorized to \>=38.0 to 38.4 degree C, \>38.4 to 38.9 degree C, \>38.9 to 40.0 degree C and \>40.0 degree C. Fatigue, headache, muscle pain and joint pain were graded as mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily routine activity).

Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination
Within 1 month after vaccination

An AE was any untoward medical occurrence in study participants who received study vaccine without regard to possibility of causal relationship with the treatment.

Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination
Within 6 months after vaccination

An SAE was any untoward medical occurrence at any dose that results in death; is life-threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); results in congenital anomaly/birth defect or that is considered to be an important medical event.

Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 6 Months After Vaccination
Within 6 months after vaccination

An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or was otherwise long-lasting in its effects.

Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination
1 month after vaccination

OPA GMTs were determined for serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F. OPA titer was expressed as reciprocal of the highest serum dilution.

Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention
Within 7 days after study intervention

Local reactions included redness, swelling and pain at the injection site collected in an electronic diary (e-diary) or case report form(CRF). Redness and swelling were measured and recorded in measuring device units. One measuring device unit=0.5 centimeter (cm). Redness and swelling reported in e-diary were graded as mild: greater than (\>) 2.0 cm to 5.0 cm, moderate: \>5.0 cm to 10.0 cm and severe \> 10 cm. Pain at injection site was graded as mild: did not interfere with activity; moderate: interfered with activity; and severe: prevented daily activity. Severity definition from CRF: mild (does not interfere)/moderate (interferes to some extent)/severe(interferes significantly) with the participant's usual function. Exact 2-sided 95% confidence interval (CI) was based on the Clopper and Pearson method.

Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention
Within 7 days after study intervention

Systemic events included fever, fatigue, headache, muscle pain and joint pain and were collected in an e-diary or CRF. Fever was defined as temperature greater than or equal to (\>=) 38.0 degrees Celsius (C) and categorized as \>=38.0 to 38.4 degrees C, \>38.4 to 38.9 degrees C, \>38.9 to 40.0 degrees C and \>40.0 degrees C. Fatigue, headache, muscle pain and joint pain were graded as mild: did not interfere with activity; moderate: some interference with activity and severe: prevented daily routine activities. Severity definition from the CRF: mild (does not interfere)/moderate(interferes to some extent)/severe(interferes significantly) with the participant's usual function. Exact 2-sided 95% CI was based on the Clopper and Pearson method.

Percentage of Participants With Adverse Events (AE) Within 1 Month After Administration of Study Intervention
Within 1 month after study intervention

An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Exact 2-sided 95% CI was based on the Clopper and Pearson method.

Percentage of Participants With Serious Adverse Events (SAE) Within 1 Month After Administration of Study Intervention
Within 1 month after study intervention

An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect and was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic and other important medical event. Exact 2-sided 95% CI was based on the Clopper and Pearson method.

Secondary Endpoints
Pneumococcal OPA Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination
From before vaccination to 1 month after vaccination
Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers From Before Vaccination to 1 Month After Vaccination
From before vaccination to 1 month after vaccination
Percentage of Participants With Pneumococcal OPA Titers >=Lower Limit of Quantitation (LLOQ) at 1 Month After Vaccination
1 month after vaccination
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
13vPnCACTIVE_COMPARATORPneumococcal conjugate vaccine
PPSV23ACTIVE_COMPARATORPneumococcal polysaccharide vaccine
20vPnCEXPERIMENTALPneumococcal conjugate vaccine
Candidate-1EXPERIMENTALParticipants to receive a single injection of Candidate-1.
Candidate-2EXPERIMENTALParticipants to receive a single injection of Candidate-2.
Candidate-3EXPERIMENTALParticipants to receive a single injection of Candidate-3.
Candidate-4EXPERIMENTALParticipants to receive a single injection of Candidate-4.
Candidate-5EXPERIMENTALParticipants to receive a single injection of Candidate-5.
Candidate-6EXPERIMENTALParticipants to receive a single injection of Candidate-6.
Candidate ControlACTIVE_COMPARATORParticipants to receive a single injection of Candidate Control.
13-valent pneumococcal conjugate vaccine (13vPnC)OTHERParticipants to receive a single injection of 13vPnC.
15-valent pneumococcal conjugate vaccine (PCV15)OTHERParticipants to receive a single injection of PCV15.
Interventions
NameTypeDescription
13vPnCBIOLOGICALPneumococcal conjugate vaccine
PPSV23BIOLOGICALPneumococcal polysaccharide vaccine
20vPnCBIOLOGICALPneumococcal conjugate vaccine
Candidate-1OTHERBiological
Candidate-2OTHERBiological
Candidate-3OTHERBiological
Candidate-4OTHERBiological
Candidate-5OTHERBiological
Candidate-6OTHERBiological
Candidate ControlOTHERBiological
PCV15BIOLOGICAL15-valent pneumococcal conjugate vaccine
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Eligibility Criteria
Age Range65 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites42

Inclusion Criteria 1. Male or female adults 65 years of age or greater. 2. Adults determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study, including adults with preexisting stable disease, defined as disease not requiring significant change i...

Countries:United StatesSweden
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