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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 immuno-persistence (type specific IgG antibody) of the tested vaccine administered in girls aged 9-17 years ,comparing to young healthy adults of 18-26 years who received the standard 3-dose schedule (0,1,6 months).
This is a follow-up study which is based on the bridging study of a recombinant human papillomavirus 16/18 bivalent vaccine in preadolescent girls(Unique Protocol ID:HPV-PRO-006,Identifiers: NCT02562508) .We will recruit people who have participated in bridging study before and collect their serum samples to test the seroprevalence and geometric mean concentrations of anti-HPV16 and anti-HPV18 antibody on 18 and 30 months after dose 1.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 9-17y (0,1,6m) | Participants in this arm have received 60μg of HPV 16/18 bivalent vaccine according to 3 doses of HPV 16/18 bivalent vaccine |
| |
| 9-14y (0,6m) | Participants in this arm have received 60μg of HPV 16/18 bivalent vaccine according to 2 doses of HPV 16/18 bivalent vaccine |
| |
| 18-26y (0,1,6m) | Participants in this arm have received 60μg of HPV 16/18 bivalent vaccine according to 3 doses of HPV 16/18 bivalent vaccine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3 doses of HPV 16/18 bivalent vaccine | Procedure | Participants have received 60μg of HPV 16/18 bivalent vaccine according to the standard 3-dose schedule (0,1,6 months) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Anti-HPV16 and anti-HPV18 seroprevalence and geometric mean concentrations at Months 18 and 30 (type specific IgG antibody) | To detect the anti-HPV 16 and anti-HPV 18 type specific IgG antibody level on 18 and 30 months after the dose 1 | Month 18 and 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-HPV16 and anti-HPV18 seroprevalence and geometric mean concentrations at Months 18 and 30 (type specific neutralizing antibody) | To detect the anti-HPV 16 and anti-HPV 18 type specific neutralizing antibody level on 18 and 30 months after the dose 1 | Month 18 and 30 |
| All the Serious Adverse Events(SAE) occurred during clinical trial time frame would be recorded |
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Inclusion Criteria:
Exclusion Criteria:
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Participants who participated in the bridging study (Unique Protocol ID:HPV-PRO-006-2, Identifiers: NCT02562508) and received at least one dose will be recruited.
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| Name | Affiliation | Role |
|---|---|---|
| Ting Wu, Ph. D. | Xiamen University | Study Chair |
| Yuemei Hu, Bachelor | Jiangsu Provincial Centre for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangsu Provincial Centre for Disease Control and Prevention | Nanjing | Jiangsu | 210009 | China |
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| 2 doses of HPV 16/18 bivalent vaccine | Procedure | Participants have received 60μg of HPV 16/18 bivalent vaccine according to an alternative 2-dose schedule (0,6 months) |
|
| between 7 months and 30months after the dose1 |
| 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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