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Research Report
A Comprehensive Clinical and Immunological Review of the Pneumococcal 13-valent Conjugate Vaccine (PCV13, Pfizer)
Section 1: Vaccine Profile and Immunological Mechanism
The Pneumococcal 13-valent Conjugate Vaccine (PCV13), developed and manufactured by Pfizer under the brand name Prevnar 13®, represents a significant advancement in the prevention of diseases caused by Streptococcus pneumoniae. Its design, based on sophisticated conjugate technology, allows it to elicit a robust and durable immune response across a wide range of age groups, including those with immature or aging immune systems. This section details the vaccine's composition and the immunological principles that underpin its high degree of efficacy.
1.1 Composition and Formulation
Prevnar 13® is a sterile suspension for intramuscular injection. Its active components are purified capsular polysaccharides from 13 distinct serotypes of Streptococcus pneumoniae, which were strategically selected based on their global prevalence, association with severe disease, and potential for antibiotic resistance.[1]
Antigenic Components: The 13 serotypes included in the vaccine are 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F.[1] These include the seven serotypes from the original 7-valent vaccine (PCV7) plus six additional serotypes (1, 3, 5, 6A, 7F, and 19A) that were responsible for a growing proportion of invasive pneumococcal disease (IPD) following the widespread use of PCV7.[4]
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/12 | Phase 3 | Not yet recruiting | |||
2023/12/27 | Phase 1 | Active, not recruiting | |||
2022/06/09 | Phase 2 | Completed | |||
2021/12/28 | Phase 4 | Recruiting | |||
2021/07/27 | Phase 4 | UNKNOWN | Mark Loeb | ||
2019/01/28 | Phase 1 | Completed | |||
2018/11/21 | Phase 4 | Completed | |||
2018/08/08 | Phase 3 | Completed | |||
2017/12/18 | Phase 2 | Terminated | |||
2017/05/24 | Phase 4 | Completed |
FDA Drug Approvals
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| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
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| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
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| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
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| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
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| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
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| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
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| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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