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Prevnar 13

Phase 1

Pneumococcal Infections | Monoclonal antibody | Infectious Disease |Pfizer, Inc.|Last Updated: Jun 12, 2019

Target and mechanism

ModalityMonoclonal antibody

Also known as Prevenar 20

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment104

FDA Designations

No designations recorded

Clinical trial landscape

Prevnar 13 · 1 trial · 1 indication

Phase 1 1
NCT03642847Trial to Evaluate the Safety and Immunogenicity of Multivalent Pneumococcal Vaccines in Japanese Adults 18 to 49 Years of AgePneumococcal Infections
COMPLETED104 Analytics
PHASE1COMPLETED
Trial to Evaluate the Safety and Immunogenicity of Multivalent Pneumococcal Vaccines in Japanese Adults 18 to 49 Years of Age
Pneumococcal Infections
NCT03642847104
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Study Endpoints

Primary Endpoints

Subjects reporting prompted local reactions within 14 days after vaccination (redness, swelling, and pain at the injection site).
14 days after vaccination
Subjects reporting prompted systemic events within 14 days after vaccination (fever, headache, fatigue, muscle pain, and joint pain).
14 days after vaccination
Subjects reporting adverse events (AEs) within 1 month after vaccination.
1 month after vaccination
Subjects reporting serious adverse events (SAEs) within 6 months after vaccination.
6 months after vaccination
Subjects reporting newly diagnosed chronic medical conditions (NDCMCs) within 6 months after vaccination.
6 months after vaccination

Secondary Endpoints

Immunogenicity
1 month after vaccination
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Prevnar 13ACTIVE_COMPARATOR13 valent Pneumococcal Conjugate
multivalent pneumococcal conjugate formulation 1EXPERIMENTALmultivalent pneumococcal conjugate formulation 1
multivalent pneumococcal conjugate formulation 2EXPERIMENTALmultivalent pneumococcal conjugate formulation 2

Interventions

NameTypeDescription
Prevnar 13BIOLOGICAL13 valent Pneumococcal Conjugate
multivalent pneumococcal conjugate formulation 1BIOLOGICALmultivalent pneumococcal conjugate formulation 1
multivalent pneumococcal conjugate formulation 2BIOLOGICALmultivalent pneumococcal conjugate formulation 2
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Eligibility Criteria

Age Range18 Years to 49 Years
SexALL
Healthy VolunteersYes
Study Sites4

Inclusion Criteria: * Male or female Japanese subjects 18 to 49 years of age, defined as Japanese born in Japan, with both parents and 4 grandparents who wer born in Japan (family tree by history), and who have not lived outside of Japan for more than 5 years total (confirmed by passport or intervi...

Countries:United States
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Frequently asked questions about Prevnar 13

What is Prevnar 13 used for?

Prevnar 13 is a pneumococcal vaccine being studied for the prevention of pneumococcal infections. It is currently in Phase 1 clinical development and is being evaluated for its safety and immunogenicity in adults. The drug is intended to protect against diseases caused by Streptococcus pneumoniae bacteria.

What does Prevnar 13 target?

Prevnar 13 targets Streptococcus pneumoniae, the bacterium responsible for pneumococcal infections. As a pneumococcal vaccine, it works by stimulating the immune system to produce antibodies against the bacteria, thereby providing protection against pneumococcal disease. The vaccine is designed to cover multiple serotypes of the bacterium.

Who makes Prevnar 13?

Prevnar 13 is developed by Pfizer, Inc., a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol PFE. Pfizer is responsible for the research, clinical development, and potential commercialization of this pneumococcal vaccine candidate.

What phase is Prevnar 13 in?

Prevnar 13 is in Phase 1 clinical development. It is an investigational vaccine and has not yet been approved by regulatory authorities. The drug is currently being studied in early-stage clinical trials to evaluate its safety and immunogenicity in healthy adult participants.

What clinical trials is Prevnar 13 in?

Prevnar 13 has been studied in one completed Phase 1 clinical trial, identified as NCT03642847. This trial evaluated the safety and immunogenicity of multivalent pneumococcal vaccines in Japanese adults aged 18 to 49 years. The study enrolled 104 participants and was conducted in the United States.

Is Prevnar 13 the same as Prevenar 20?

Yes, Prevnar 13 is also known as Prevenar 20. Both names refer to the same pneumococcal vaccine candidate developed by Pfizer. The alternative name Prevenar 20 may be used in different contexts or regions, but it represents the same drug product.