3-year Immunogenicity Evaluation of Quadrivalent HPV Vaccine in China
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
1 other identifier
observational
300
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2011
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 1, 2011
CompletedStudy Start
First participant enrolled
September 1, 2011
CompletedFirst Posted
Study publicly available on registry
September 2, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedSeptember 2, 2011
September 1, 2011
September 1, 2011
September 1, 2011
Conditions
Study Arms (1)
HPV Vaccine
People that receive HPV vaccine in V501-030
Eligibility Criteria
Subjects who participated in V501-030 in Per-protocol population
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Liuzhou CDC
Liuchow, Guangxi, 530028, China
Related Publications (1)
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.
PMID: 29428178DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Rongcheng Li, MD
Guangxi CDC
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Vaccine Research Center
Study Record Dates
First Submitted
September 1, 2011
First Posted
September 2, 2011
Study Start
September 1, 2011
Study Completion
June 1, 2012
Last Updated
September 2, 2011
Record last verified: 2011-09