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MEDI-517 HPV-16/18 VLP AS04 vaccine · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| Group A | EXPERIMENTAL | Formulation 1 of the vaccine (MEDI-517 HPV-16/18 VLP AS04 vaccine) |
| Group B | EXPERIMENTAL | Formulation 2 of the vaccine \[with Al(OH)3\] |
| Group C | EXPERIMENTAL | Formulation 3 of the vaccine (without adjuvant) |
| Group D | EXPERIMENTAL | Formulation 4 of the vaccine \[with Al(OH)3\] |
| Name | Type | Description |
|---|---|---|
| MEDI-517 HPV-16/18 VLP AS04 vaccine | BIOLOGICAL | IM injection |
| MEDI-517 HPV-16/18 VLP vaccine with Al(OH)3 | BIOLOGICAL | IM injection |
| MEDI-517 HPV-16/18 VLP vaccine without adjuvant | BIOLOGICAL | IM injection |
| MEDI-517 HPV-16/18 VLP AS04 vaccine (Formulation 1) | BIOLOGICAL | IM injection |
| MEDI-517 HPV-16/18 VLP AS04 vaccine (Formulation 2) | BIOLOGICAL | IM injection |
| MEDI-517 HPV-16/18 VLP AS04 vaccine (Formulation 3) | BIOLOGICAL | IM injection |
| MEDI-517 HPV-16/18 VLP with Al(OH)3 (Formulation 4) | BIOLOGICAL | IM injection |
Inclusion Criteria: * Females 18 through 30 years of age (must not have reached the 31st birthday) * Written informed consent obtained from the volunteer * Unless previously surgically sterilized, agrees to use an effective method of birth control beginning 30 days before the first study injection ...
MEDI-517 HPV-16/18 VLP AS04 vaccine is an investigational vaccine developed by GSK plc for infections and papillomavirus. It is a vaccine modality that combines HPV-16 and HPV-18 virus-like particles with the AS04 adjuvant system. It is in Phase 2 clinical development and has been studied in healthy adult females.
MEDI-517 HPV-16/18 VLP AS04 vaccine is being developed for infections and papillomavirus. Its clinical trials have enrolled healthy adult female volunteers aged 18 years and older. The vaccine is intended to prevent papillomavirus infections, though it remains investigational and has not been approved for use.
GSK plc, which trades under the ticker GSK, is the developer of MEDI-517 HPV-16/18 VLP AS04 vaccine. The vaccine is also referred to in trial documentation as GSK 580299. GSK conducted the Phase 2 studies evaluating the vaccine in healthy adult females.
MEDI-517 HPV-16/18 VLP AS04 vaccine is in Phase 2 clinical development. Two Phase 2 trials have been completed, and no active trials are ongoing. The vaccine is investigational and has not been approved by the FDA or any regulatory agency for commercial use.
MEDI-517 HPV-16/18 VLP AS04 vaccine has been evaluated in two completed Phase 2 trials. NCT00693966 was a dose-comparison study in 210 healthy adult females, and NCT00693615 was a safety and immunogenicity study with or without adjuvant in 60 healthy adult females. Both trials are completed.