Overview
Streptococcus pneumoniae type 33F capsular polysaccharide diphtheria CRM197 protein conjugate antigen is a sterile vaccine that contains saccharides of the capsular antigens of Streptococcus pneumoniae serotype 33F individually conjugated to the CRM197 protein, a nontoxic variant of diphtheria toxin isolated from cultures of Corynebacterium diphtheriae strain C7 (β197). It is contained in the vaccine under the market name Prevnar that contains the saccharides for serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F for intramuscular injection. 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
No associated conditions information available.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/01/24 | Phase 2 | Active, not recruiting | |||
2022/06/09 | Phase 2 | Active, not recruiting | |||
2021/12/28 | Phase 4 | Recruiting | |||
2018/08/08 | Phase 3 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Wyeth Pharmaceutical Division of Wyeth Holdings LLC | 0005-2000 | INTRAMUSCULAR | 2.2 ug in 0.5 mL | 4/18/2025 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| APEXXNAR SUSPENSION FOR INJECTION IN SINGLE-DOSE PRE-FILLED SYRINGE 0.5ML | SIN16648P | INJECTION, SUSPENSION | 2.2 μg/0.5ml | 11/30/2022 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
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