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| Name | Class |
|---|---|
| Zhejiang Provincial Center for Disease Control and Prevention | OTHER_GOV |
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The purpose of this study is to evaluate the immunogenicity and safety of co-immunization with recombinant human papillomavirus bivalent (Types 16,18) vaccine (Escherichia coli) and Hepatitis E vaccine (Escherichia coli)
Cecolin is the first Chinese domestic human papillomavirus (HPV) vaccine. Cecolin is designed to protect against HPV types 16 and 18, the most common virus types that lead to cervical cancer. Hecolin is the first prophylactic vaccine against hepatitis E virus (HEV). The purpose of this study is to evaluate the immunogenicity and safety of co-immunization with Cecolin and Hecolin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Participants in this arm will be simultaneously administrated with HPV and HEV vaccine. The immunization schedule is 0,1,6 months. |
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| Group B | Active Comparator | Participants in this arm will be administrated with HPV vaccine. The immunization schedule is 0,1,6 months. |
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| Group C | Active Comparator | Participants in this arm will be administrated with HEV vaccine. The immunization schedule is 0,1,6 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cecolin | Biological | Bivalent HPV Vaccine |
| |
| Measure | Description | Time Frame |
|---|---|---|
| evaluate the concentration of IgG antibodies to HPV-16 | Detect the level of IgG antibodies to HPV-16 at 7 month to determine whether group A is non-inferior to group B | At 7 months after first dose |
| evaluate the concentration of IgG antibodies to HPV-18 | Detect the level of IgG antibodies to HPV-18 at 7 month to determine whether group A is non-inferior to group B | At 7 months after first dose |
| evaluate the concentration of IgG antibodies to HEV | detect the level of IgG antibodies to HEV at 7 month to determine whether group A is non-inferior to group C | At 7 months after first dose |
| Measure | Description | Time Frame |
|---|---|---|
| Local and systematic adverse events/reactions occurred within 7 days after each vaccination | Adverse reactions associated with vaccine will be observed in subjects after vaccination. To evaluate number of adverse events/reactions compared with non-simultane vaccination group. | During the 7-day period following each vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhenggang Jiang | Zhejiang Provincial Center for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Provincial Center for Disease Control and Prevention | Hanzhou | Zhejiang | 310000 | 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 |
|---|---|
| D016751 | Hepatitis E |
| ID | Term |
|---|---|
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| C577000 | hecolin |
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| Hecolin |
| Biological |
Hepatitis E vaccine |
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| Adverse events/reactions occurred within 30 days after each vaccination |
To evaluate number of adverse events/reactions compared with non-simultane vaccination group. |
| Within 30 days after any vaccination |
| Serious adverse events occurred throughout the study | Safety analysis. To evaluate number of SAEs compared with the non-simultane vaccination group | Up to 7 months |
| D006505 |
| Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |