Dose-Ranging Study of Recombinant Human Papillomavirus Virus 16/18 Bivalent Vaccine
NCT ID: NCT01356823
Last Updated: 2016-01-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
1600 participants
INTERVENTIONAL
2011-03-31
2013-10-31
Brief Summary
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The primary purpose of this study is to evaluate which dosage of the HPV vaccine can induce higher antibody and at the same time caused less adverse events.
The secondary purpose of this study is to to evaluate the safety and immunopersistence of the study vaccine.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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30μg HPV
Participants in this arm would receive 30μg HPV vaccines which contains 20μg HPV 16 antigen and 10μg HPV 18 antigen
30μg HPV
Participants would intramuscularly receive 30μg of HPV 16/18 bivalent vaccine at 0, 1, 6 month for 3 doses.
60μg HPV
Participants in this arm would receive 60μg HPV vaccines which contains 40μg HPV 16 antigen and 20μg HPV 18 antigen
60μg HPV
Participants would intramuscularly receive 60μg of HPV 16/18 bivalent vaccine at 0, 1, 6 month for 3 doses.
90μg HPV
Participants in this arm would receive 90μg HPV vaccines which contains 60μg HPV 16 antigen and 30μg HPV 18 antigen
90μg HPV
Participants would receive 90μg HPV vaccines which contains 60μg HPV 16 antigen and 30μg HPV 18 antigen
hepatitis B vaccine
Participants in this arm would receive hepatitis B vaccine.
Hepatitis B vaccine
Participants would intramuscularly receive 10μg of hepatitis B vaccine at 0, 1, 6 month for 3 doses.
Interventions
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30μg HPV
Participants would intramuscularly receive 30μg of HPV 16/18 bivalent vaccine at 0, 1, 6 month for 3 doses.
60μg HPV
Participants would intramuscularly receive 60μg of HPV 16/18 bivalent vaccine at 0, 1, 6 month for 3 doses.
90μg HPV
Participants would receive 90μg HPV vaccines which contains 60μg HPV 16 antigen and 30μg HPV 18 antigen
Hepatitis B vaccine
Participants would intramuscularly receive 10μg of hepatitis B vaccine at 0, 1, 6 month for 3 doses.
Eligibility Criteria
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Inclusion Criteria
* Female between, and including, 18 and 25 years of age at the time of enrolment;
* Subjects must be free of obvious health problems;
* Not pregnant and having no plan for pregnancy;
Exclusion Criteria
* Previous vaccination against HPV;
* Having severe allergic history or other immunodeficiency;
* Chemotherapy and other immunosuppressive agents using;
18 Years
25 Years
FEMALE
Yes
Sponsors
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Xiamen Innovax Biotech Co., Ltd
INDUSTRY
Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
INDUSTRY
Xiamen University
OTHER
Responsible Party
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Jun Zhang
professor
Principal Investigators
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Jun Zhang, Master
Role: STUDY_CHAIR
Xiamen University
Yuemei Hu, Bachelor
Role: PRINCIPAL_INVESTIGATOR
Jiangsu Provincial Centre for Disease Control and Prevention
Ting Wu, Ph. D
Role: STUDY_DIRECTOR
Xiamen University
Locations
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Jiangsu Provincial Centre for Disease Control and Prevention
Nanjing, Jiangsu, China
Countries
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References
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Wu T, Hu YM, Li J, Chu K, Huang SJ, Zhao H, Wang ZZ, Yang CL, Jiang HM, Wang YJ, Lin ZJ, Pan HR, Sheng W, Wei FX, Li SW, Wang Y, Zhu FC, Li CG, Zhang J, Xia NS. Immunogenicity and safety of an E. coli-produced bivalent human papillomavirus (type 16 and 18) vaccine: A randomized controlled phase 2 clinical trial. Vaccine. 2015 Jul 31;33(32):3940-6. doi: 10.1016/j.vaccine.2015.06.052. Epub 2015 Jun 19.
Other Identifiers
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HPV-PRO-002
Identifier Type: -
Identifier Source: org_study_id
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