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| ID | Type | Description | Link |
|---|---|---|---|
| 2005_086 |
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This dose-ranging study is to evaluate an investigational vaccine with the following objectives: (1) To demonstrate that the vaccine is well-tolerated in women (2) To evaluate immune responses in women who are between 16 and 23 years of age at enrollment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Gardasil |
|
| 2 | Experimental | HPV VLP vaccine -Dose regimen 1 |
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| 3 | Experimental | HPV VLP vaccine -Dose regimen 2 |
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| 4 | Experimental | HPV VLP vaccine -Dose regimen 3 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comparator: Gardasil | Biological | 0.5 mL intramuscular injection administered at Day 1, Month 2 and Month 6 |
|
| Measure | Description | Time Frame |
|---|---|---|
| The octavalent HPV VLP vaccine, when administered in a 3-dose regimen, induces acceptable responses for specific HPV types at 4 weeks Post dose 3. Immune responses measured by an HPV competitive Luminex immunoassay. | 4 weeks post dose 3 injection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25912208 | Background | Luxembourg A, Brown D, Bouchard C, Giuliano AR, Iversen OE, Joura EA, Penny ME, Restrepo JA, Romaguera J, Maansson R, Moeller E, Ritter M, Chen J. Phase II studies to select the formulation of a multivalent HPV L1 virus-like particle (VLP) vaccine. Hum Vaccin Immunother. 2015;11(6):1313-22. doi: 10.1080/21645515.2015.1012010. |
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| Comparator: octavalent HPV Vaccine - dose formulation 1 | Biological | 0.5 mL octavalent HPV vaccine - intramuscular injection administered at Day 1, Month 2 and Month 6 |
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| Comparator: octavalent HPV Vaccine - dose formulation 2 | Biological | 0.5 mL octavalent HPV vaccine - intramuscular injection administered at Day 1, Month 2 and Month 6 |
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| Comparator: octavalent HPV Vaccine - dose formulation 3 | Biological | 0.5 mL octavalent HPV vaccine - intramuscular injection administered at Day 1, Month 2 and Month 6 |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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