Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
The primary objective of this study is to describe the safety of 40 mg MEDI-517, with a control of aluminum hydroxide, when given to healthy adult women who have evidence of HPV-16 and/or HPV-18 DNA detected in cervical brushings.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | MEDI517 |
|
| 2 | Active Comparator | Aluminum hydroxide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MEDI 517 | Biological | Vaccine is supplied in single use vials containing 0.75 mL of MEDI-517 at a concentration of 40 mg/0.5 mL formulated with SBAS4 adjuvant. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of safety in terms of unsolicited adverse events and serious adverse events. | 7 days after each injection |
| Measure | Description | Time Frame |
|---|---|---|
| Determine the effect of MEDI-517 compared to aluminum hydroxide control on the proportion of volunteers who are positive for HPV DNA. | Swab taken on Study Day 210 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Genevieve Losonsky, M.D. | MedImmune LLC | Study Director |
Not provided
Not provided
| ID | Term |
|---|---|
| D000536 | Aluminum Hydroxide |
| ID | Term |
|---|---|
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D017607 | Aluminum Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Aluminum hydroxide | Other | Aluminum hydroxide supplied in single use vials containing 0.75 mL of aluminum hydroxide at a concentration of 0.5 mg of aluminum in the form of aluminum hydroxide per 0.5 mL. |
|
| D000838 |
| Anions |
| D007477 | Ions |
| D004573 | Electrolytes |