Immuno-persistence Study of a Recombinant Human Papillomavirus 16/18 Bivalent Vaccine in Preadolescent Girls
NCT ID: NCT03206255
Last Updated: 2019-01-04
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
940 participants
OBSERVATIONAL
2017-07-01
2018-08-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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9-17y (0,1,6m)
Participants in this arm have received 60μg of HPV 16/18 bivalent vaccine according to 3 doses of HPV 16/18 bivalent vaccine
3 doses of HPV 16/18 bivalent vaccine
Participants have received 60μg of HPV 16/18 bivalent vaccine according to the standard 3-dose schedule (0,1,6 months)
9-14y (0,6m)
Participants in this arm have received 60μg of HPV 16/18 bivalent vaccine according to 2 doses of HPV 16/18 bivalent vaccine
2 doses of HPV 16/18 bivalent vaccine
Participants have received 60μg of HPV 16/18 bivalent vaccine according to an alternative 2-dose schedule (0,6 months)
18-26y (0,1,6m)
Participants in this arm have received 60μg of HPV 16/18 bivalent vaccine according to 3 doses of HPV 16/18 bivalent vaccine
3 doses of HPV 16/18 bivalent vaccine
Participants have received 60μg of HPV 16/18 bivalent vaccine according to the standard 3-dose schedule (0,1,6 months)
Interventions
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3 doses of HPV 16/18 bivalent vaccine
Participants have received 60μg of HPV 16/18 bivalent vaccine according to the standard 3-dose schedule (0,1,6 months)
2 doses of HPV 16/18 bivalent vaccine
Participants have received 60μg of HPV 16/18 bivalent vaccine according to an alternative 2-dose schedule (0,6 months)
Eligibility Criteria
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Inclusion Criteria
2. The legal guardian of participants under age 18 can provide identity certificate, or representative can provide authorization;
3. Participants under the age 18, able to sign or whose legal guardian agree to sign the written informed consent; or participants aged 18 and older agree to sign the written informed consent;
4. Able to comply with the requests of the study;
Exclusion Criteria
2. According to the investigator's judgment, there might be some medical, psychological, social or occupational factors which might impact on the individual to obey the protocol or sign the informed consent;
10 Years
28 Years
FEMALE
Yes
Sponsors
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Xiamen Innovax Biotech Co., Ltd
INDUSTRY
Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
INDUSTRY
Jun Zhang
OTHER
Responsible Party
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Jun Zhang
Professor
Principal Investigators
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Ting Wu, Ph. D.
Role: STUDY_CHAIR
Xiamen University
Yuemei Hu, Bachelor
Role: PRINCIPAL_INVESTIGATOR
Jiangsu Provincial Centre for Disease Control and Prevention
Locations
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Jiangsu Provincial Centre for Disease Control and Prevention
Nanjing, Jiangsu, China
Countries
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Other Identifiers
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HPV-PRO-006-2
Identifier Type: -
Identifier Source: org_study_id
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