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| ID | Type | Description | Link |
|---|---|---|---|
| 2007_566 |
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The purpose of this study is to evaluate vaccine immunogenicity and how well the body tolerates V504 when given with Gardasil.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | V504 + Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine |
|
| 2 | Placebo Comparator | Placebo + Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| V504 | Biological | V504 0.5 ml injection in 3 dose regimen for 6 month treatment period. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric mean titers (GMTs) to HPV types contained in the administered vaccines | 4 weeks post dose 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Seroconversion percentages to HPV types contained in the administered vaccines | 4 weeks post dose 3 |
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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: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine |
| Biological |
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine 0.5 ml injection in 3 dose regimen for 6 month treatment period. |
|
| Comparator: Placebo (unspecified) | Biological | V504 Placebo in 3 dose regimen for 6 month treatment period. |
|
| 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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| ID | Term |
|---|---|
| D014614 | Vaccines, Synthetic |
| ID | Term |
|---|---|
| D011994 | Recombinant Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D000941 | Antigens |
| D001685 | Biological Factors |
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