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
Sponsor:
Information provided by (Responsible Party):
Rongcheng Li, Guangxi Center for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT01427777
First received: September 1, 2011
Last updated: NA
Last verified: September 2011
History: No changes posted
  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

Further study details as provided by Guangxi Center for Disease Control and Prevention:

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
Study Population

Subjects who participated in V501-030 in Per-protocol population

Criteria

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
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

Contacts
Contact: Rongcheng Li, MD 86 0771 2518986 lrch2001@163.com

Locations
China, Guangxi
Liuzhou CDC Not yet recruiting
Liuzhou, Guangxi, China, 530028
Contact: Youping Liu         
Sponsors and Collaborators
Guangxi Center for Disease Control and Prevention
Investigators
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 July 22, 2014