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| Name | Class |
|---|---|
| Xiamen Innovax Biotech Co., Ltd | INDUSTRY |
| Beijing Wantai Biological Pharmacy Enterprise Co., Ltd. | INDUSTRY |
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The primary objective of this study is to evaluate the durability of protection of Recombinant Human Papillomavirus Bivalent (Types 16,18) Vaccine administered in females aged 18-45 years.
This is a follow-up study that is based on phase III clinical study of a recombinant human papillomavirus 16/18 bivalent vaccine in females aged 18-45 years (Unique Protocol ID: HPV-PRO-003, Identifiers: NCT01735006). The investigators will recruit people who have participated in phase III clinical study on Hebei Province before and to evaluate the durability of protection of the bivalent HPV vaccine on 90m and 114m after dose 1.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vaccine group | Participants in this arm have received 3 doses of HPV 16/18 bivalent vaccine that contains 40μg HPV 16 virus-like particle antigen and 20μg HPV 18 virus-like particle antigen adsorbed in alum-adjuvant. |
| |
| Control group | Participants in this arm have received 3 doses of HEV vaccine that contains 30μg HEV virus-like particle antigen adsorbed in alum-adjuvant. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli) | Biological | The bivalent HPV-16/18 vaccine was a mixture of two aluminum hydroxide adjuvant-absorbed recombinant L1 VLPs of HPV-16 and HPV-18 expressed in E. coli. A 0.5 ml dose of the bivalent HPV test vaccine comprised 40 μg of HPV-16 and 20 μg of HPV-18 L1 VLPs absorbed with 208 μg of aluminum adjuvant |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With CIN2+ and/or VIN2+ and/or VaIN2+ Associated With HPV-16 and/or -18 Cervical Infection on 90m and 114m after dose 1 | To observe the number of Subjects With Histopathologically-confirmed CIN2+ and/or VIN2+ and/or VaIN2+ Associated With HPV-16 and/or -18 Cervical Infection on 90m and 114m after dose 1 | expected 2-3 years |
| Number of Subjects With HPV-16 and/or -18 persistent cervical infection(6-month+ definition) on 90m and 114m after dose 1 | To detect the HPV16 and HPV18 DNA on the gynecological specimens ( Cervical exfoliated cell specimens and biopsy specimens) collected from the subjects | expected 2-3 years |
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Inclusion Criteria:
Exclusion Criteria:
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In Hebei Province, participants who participated in the Phase III clinical study of a recombinant human papillomavirus 16/18 bivalent vaccine in females (Unique Protocol ID: HPV-PRO-003, Identifiers: NCT01735006) and received at least one dose
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chao Zhao, Doctor | Contact | +86-010-88324354 | zhaochaocjr@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Ting Wu, Ph. D. | Xiamen University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Recruiting | Beijing | Beijing Municipality | 100044 | China |
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|
|
| ID | Term |
|---|---|
| D002578 | Uterine Cervical Dysplasia |
| D002583 | Uterine Cervical Neoplasms |
| D000088562 | Persistent Infection |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| 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 |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D007239 | Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D014612 | Vaccines |
| ID | Term |
|---|---|
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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