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This study will assess the immunogenicity and safety of one dose of Cecolin and one dose of Gardasil
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Bivalent HPV Vaccine (Cecolin) |
|
| Group B | Active Comparator | Quadrivalent HPV vaccine (Gardasil) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HPV vaccine | Biological | Participants in the group A will be administrated with bivalent HPV vaccine Cecolin. The immunization schedule is 0, 6 months; Participants in the group B will be administrated with quadrivalent HPV vaccine Gardssil. The immunization schedule is 0, 2, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-HPV seropositivity | Seropositivity to HPV16 and HPV18 types of the neutralizing antibody in subjects will be assessed. | At 1 month after first dose |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-HPV Seropositivity | Seropositivity to HPV16 and HPV18 types of the neutralizing antibody in subjects will be assessed. | At 2 months after first dose |
| HPV Antibody Titers | Geometric mean titers (GMT) of HPV16 and HPV18 types at 1 and 2 months after the first dose of vaccine administration in the subjects will be assessed. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Provincial Center for Disease Control and Prevention | Fuzhou | Fujian | 350012 | China |
| 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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| ID | Term |
|---|---|
| D053918 | Papillomavirus Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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|
| At 1 and 2 months after first dose |
| Local and Systemic Reactions/Event | Soliciting local reactions/events; Soliciting systemic reactions/events; Non solicited adverse events; Serious adverse events | 7 and 30 days after each dose of vaccination; 0-7 months |