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| ID | Type | Description | Link |
|---|---|---|---|
| 2007_567 |
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The purpose of this study is to evaluate the safety and immunogenicity of V505 in comparison to GARDASIL (TM)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Arm 1: 0.5 ml injection of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine as 3 dose regimen. |
|
| 2 | Experimental | Arm 2: 0.5 ml injection of V505 formulation 1 as 3 dose regimen. |
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| 3 | Experimental | Arm 3: 0.5 ml injection of V505 formulation 2 as 3 dose regimen |
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| 4 | Experimental | Arm 4: 0.5 ml injection of V505 formulation 2 as 2 dose regimen and 1 Pbo injection |
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| 5 | Experimental | Arm 5: 0.5 ml injection of V505 formulation 3 as 2 dose regimen and 1 Pbo injection |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comparator: V505 formulation 1 | Biological | 0.5 ml injection of V505 formulation 1 as 3 dose regimen at Day 1, Month 2 and Month 6. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Geometric mean titers (GMTs) to HPV types contained in the vaccines administered in a 3-dose regimen | 4 weeks post dose 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric mean titers (GMTs) to HPV types contained in the vaccines administered in a 2-dose regimen | 4 weeks post dose 2 |
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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 |
|---|---|---|---|
| 41276263 | Derived | Bergman H, Henschke N, Arevalo-Rodriguez I, Buckley BS, Crosbie EJ, Davies JC, Dwan K, Golder SP, Loke YK, Probyn K, Petkovic J, Villanueva G, Morrison J. Human papillomavirus (HPV) vaccination for the prevention of cervical cancer and other HPV-related diseases: a network meta-analysis. Cochrane Database Syst Rev. 2025 Nov 24;11(11):CD015364. doi: 10.1002/14651858.CD015364.pub2. |
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| Comparator: V505 formulation 2 | Drug | 0.5 ml injection of V505 formulation 2 as 3 dose regimen at Day 1, Month 2 and Month 6. |
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| Comparator: V505 formulation 2 | Drug | 0.5 ml injection of V505 formulation 2 as 2 dose regimen at Day 1 and Month 6. |
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| Comparator: V505 formulation 3 | Biological | 0.5 ml injection of V505 formulation 3 as 2 dose regimen at Day 1 and Month 6. |
|
| Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant | Biological | 0.5 ml injection of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine as 3 dose regimen at Day 1, Month 2 and Month 6. |
|
| Comparator: Placebo (unspecified) | Biological | 0.5 ml injection of placebo to V505 as a 1 dose regimen at Month 2. |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D014846 | Vulvar Neoplasms |
| D014625 | Vaginal Neoplasms |
| D003218 | Condylomata Acuminata |
| D030361 | Papillomavirus Infections |
| 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 |
| D014845 | Vulvar Diseases |
| D014623 | Vaginal Diseases |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014860 | Warts |
| D017193 | Skin Diseases, Viral |
| D014412 | Tumor Virus Infections |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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