3-year Immunogenicity Evaluation of Quadrivalent HPV Vaccine in China
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Purpose
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.
| Condition |
|---|
|
Anogenital Human Papilloma Virus Infection |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | 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 |
| Estimated Enrollment: | 300 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | June 2012 |
| Groups/Cohorts |
|---|
|
HPV Vaccine
People that receive HPV vaccine in V501-030
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 9 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Subjects who participated in V501-030 in Per-protocol population
Inclusion Criteria:
- Healthy Chinese subject who participated in V501-030 in Per-protocol population.
- Subject agrees to provide study personnel with a primary telephone number as well as an alternate telephone number for follow-up purposes.
- Subject is willing to give consent/assent.
Exclusion Criteria:
- Subject is concurrently enrolled in clinical studies of investigational agents which may interfere with the evaluation of the study objectives.
- Subject has any condition which in the opinion of the investigator might interfere with the evaluation of the study objectives
- Subject has a history of known prior vaccination with a HPV vaccine, either active agent or placebo after receiving the vaccination during V501-030
Contacts and Locations| Contact: Rongcheng Li, MD | 86 0771 2518986 | lrch2001@163.com |
| China, Guangxi | |
| Liuzhou CDC | Not yet recruiting |
| Liuzhou, Guangxi, China, 530028 | |
| Contact: Youping Liu | |
| Principal Investigator: | Rongcheng Li, MD | Guangxi CDC |
More Information
No publications provided
| Responsible Party: | Rongcheng Li, Director of Vaccine Research Center, Guangxi Center for Disease Control and Prevention |
| ClinicalTrials.gov Identifier: | NCT01427777 History of Changes |
| Other Study ID Numbers: | V501-030-1 |
| Study First Received: | September 1, 2011 |
| Last Updated: | September 1, 2011 |
| Health Authority: | China: Food and Drug Administration |
Additional relevant MeSH terms:
|
Papilloma Virus Diseases Warts Papillomavirus Infections Neoplasms, Squamous Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
Neoplasms DNA Virus Infections Skin Diseases, Viral Tumor Virus Infections Skin Diseases, Infectious Skin Diseases |
ClinicalTrials.gov processed this record on May 19, 2013