Streptococcus pneumoniae type 1 capsular polysaccharide diphtheria CRM197 protein conjugate antigen
- Generic Name
- Streptococcus pneumoniae type 1 capsular polysaccharide diphtheria CRM197 protein conjugate antigen
- Brand Names
- Prevnar 13, Prevnar 20, Vaxneuvance
- Drug Type
- Biotech
- Unique Ingredient Identifier
- 54EC0SE5PZ
Overview
Streptococcus pneumoniae type 1 capsular polysaccharide diphtheria CRM197 protein conjugate antigen is a sterile vaccine that contains saccharides of the capsular antigens of Streptococcus pneumoniae serotype 1 individually conjugated to the CRM197 protein, a nontoxic variant of diphtheria toxin isolated from cultures of Corynebacterium diphtheriae strain C7 (β197). The saccharides in the vaccine are prepared from purified polysaccharides that are chemically activated then conjugated to the protein carrier CRM197 to form the glycoconjugate.
Background
Streptococcus pneumoniae type 1 capsular polysaccharide diphtheria CRM197 protein conjugate antigen is a sterile vaccine that contains saccharides of the capsular antigens of Streptococcus pneumoniae serotype 1 individually conjugated to the CRM197 protein, a nontoxic variant of diphtheria toxin isolated from cultures of Corynebacterium diphtheriae strain C7 (β197). The saccharides in the vaccine are prepared from purified polysaccharides that are chemically activated then conjugated to the protein carrier CRM197 to form the glycoconjugate.
Indication
No indication information available.
Associated Conditions
- Invasive Streptococcal Infection
- Otitis Media (OM) caused by Streptococcus Pneumoniae
- Invasive Infection caused by Streptococcus pneumoniae serotype 1
- Pneumonia caused by Streptococcus Pneumoniae
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
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No clinical trials found
No clinical trials found for this drug
FDA Approved Products
Product Name | Manufacturer | Route | Strength | Approved | NDC Code |
|---|---|---|---|---|---|
Wyeth Pharmaceutical Division of Wyeth Holdings LLC | INTRAMUSCULAR | 2.2 ug in 0.5 mL | 2025/04/18 | 0005-2000 | |
INTRAMUSCULAR | 2.2 ug in 0.5 mL | 2017/08/29 | 50090-1944 |
EMA Approved Products
Medicine Name | EMA Number | Auth. Holder | Country | Drug Type | Status | Issued | Opinion | Revision |
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No EMA products found
No EMA products found for this drug
HSA Approved Products
Product Name | Manufacturer | Dosage Form | Strength | Approved | Approval No. |
|---|---|---|---|---|---|
INJECTION, SUSPENSION | 1 μg PS1; 1.11-1.67 μg PD/dose | 2010/03/19 | SIN13775P |
NMPA Approved Products
Product Name | Approval No. | Manufacturer | Dosage Form | Trade Name | Strength | Type | Status | Date | Import |
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No NMPA products found
No NMPA products found for this drug
PPB Approved Products
Product Name | Registration Code | Company | Category | Sale Type | Reg. Date |
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No PPB products found
No PPB products found for this drug
TGA Approved Products
Product Name | ARTG ID | Sponsor | Status | Reg. Date | Ingredient |
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No TGA products found
No TGA products found for this drug