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The thirty-six-month immunogenicity evaluation of Quadrivalent HPV (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine in Chinese female subjects aged 9 to 45 years and male subjects aged 9 to 15 years.
All eligible subjects will be enrolled for one visit. A medical history and physical examination will be conducted on all subjects. A 10 mL blood specimen will be collected. All Sera should be shipped to PPD Vaccines and Biologics Laboratory in the US. The serum specimen will be tested at PPD Laboratory with competitive Luminex immunoassay (cLIA) and multiplexed HPV immunoassay. The purpose of the quadrivalent HPV cLIA and multiplex is to detect neutralizing antibody and total IgG to HPV virus-like particles (VLPs), serotypes 6, 11, 16, 18, respectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HPV Vaccine | People that receive HPV vaccine in V501-030 |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects who participated in V501-030 in Per-protocol population
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rongcheng Li, MD | Contact | 86 0771 2518986 | lrch2001@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Rongcheng Li, MD | Guangxi CDC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liuzhou CDC | Liuzhou | Guangxi | 530028 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29428178 | Derived | Huang T, Liu Y, Li Y, Liao Y, Shou Q, Zheng M, Liao X, Li R. Evaluation on the persistence of anti-HPV immune responses to the quadrivalent HPV vaccine in Chinese females and males: Up to 3.5 years of follow-up. Vaccine. 2018 Mar 7;36(11):1368-1374. doi: 10.1016/j.vaccine.2018.02.006. Epub 2018 Feb 7. |
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