Trial record 18 of 53 for:
Open Studies | "Papilloma"
3-year Immunogenicity Evaluation of Quadrivalent HPV Vaccine in China
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Guangxi Center for Disease Control and Prevention.
Recruitment status was Not yet recruiting
Information provided by (Responsible Party):
Rongcheng Li, Guangxi Center for Disease Control and Prevention
First received: September 1, 2011
Last updated: NA
Last verified: September 2011
History: No changes posted
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.
Anogenital Human Papilloma Virus Infection
||Observational Model: Case-Only
Time Perspective: Prospective
||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:
| Study Start Date:
| Estimated Study Completion Date:
People that receive HPV vaccine in V501-030
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.
|Ages Eligible for Study:
||9 Years to 45 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Subjects who participated in V501-030 in Per-protocol population
- 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.
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01427777
|Liuzhou, Guangxi, China, 530028 |
|Contact: Youping Liu |
Guangxi Center for Disease Control and Prevention
||Rongcheng Li, MD
No publications provided
||Rongcheng Li, Director of Vaccine Research Center, Guangxi Center for Disease Control and Prevention
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 1, 2011
||September 1, 2011
||China: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 03, 2015
DNA Virus Infections
Tumor Virus Infections