Overview
Human papillomavirus type 11 L1 capsid protein antigen is contained in Gardasil, or a recombinant Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) vaccine for intramuscular injection. It is an immunization for young men and women 9-26 years of age for the prevention of diseases caused by Human Papillomavirus (HPV) types 6, 11, 16 and 18. The vaccine is prepared from the purified virus-like particles (VLPs) of the major capsid (L1) protein of HPV Types 6, 11, 16, and 18, which are produced by separate fermentations in recombinant Saccharomyces cerevisiae and self-assembled into VLPs.
Indication
No indication information available.
Associated Conditions
- Human Papillomavirus (HPV) Infections
- Infection caused by human papillomavirus type 11
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/12/30 | N/A | Completed | Liaquat University of Medical & Health Sciences | ||
2023/11/21 | Phase 2 | Withdrawn | |||
2023/09/25 | Phase 4 | Not yet recruiting | |||
2021/09/01 | Phase 4 | Active, not recruiting | |||
2021/07/29 | Phase 4 | Completed | |||
2021/06/10 | Phase 1 | UNKNOWN | |||
2020/08/11 | Phase 3 | Completed | PATH | ||
2020/07/07 | Phase 4 | Completed | Centre Hospitalier Universitaire de la Réunion | ||
2019/12/20 | Phase 4 | Active, not recruiting | |||
2019/06/26 | Phase 3 | Active, not recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| A-S Medication Solutions | 50090-4958 | INTRAMUSCULAR | 40 ug in 0.5 mL | 5/15/2025 | |
| Merck Sharp & Dohme LLC | 0006-4119 | INTRAMUSCULAR | 40 ug in 0.5 mL | 3/25/2025 | |
| Merck Sharp & Dohme LLC | 0006-4121 | INTRAMUSCULAR | 40 ug in 0.5 mL | 3/25/2025 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 9/20/2006 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| Gardasil™ Vaccine Syringe | SIN13228P | SOLUTION, STERILE | 40 mcg | 12/5/2006 | |
| Gardasil™ Vaccine Vial | SIN13227P | SOLUTION, STERILE | 40 mcg | 12/5/2006 | |
| GARDASIL 9 SUSPENSION FOR INJECTION | SIN15141P | INJECTION, SUSPENSION | 40 mcg | 12/16/2016 |
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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