Status:
UNKNOWN
Immuno-persistence Study of a Recombinant Human Papillomavirus 16/18 Bivalent Vaccine in Preadolescent Girls (54m)
Lead Sponsor:
Jun Zhang
Collaborating Sponsors:
Xiamen Innovax Biotech Co., Ltd
Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
Conditions:
Cervical Intraepithelial Neoplasia
Cervical Cancer
Eligibility:
FEMALE
14-32 years
Brief Summary
The primary objective of this study is to evaluate the immuno-persistence (type specific IgG antibody) of the tested vaccine administered in girls aged 9-17 years,comparing to young healthy adults of ...
Detailed Description
This is a follow-up study that is based on the bridging study of a recombinant human papillomavirus 16/18 bivalent vaccine in preadolescent girls(Unique Protocol ID:HPV-PRO-006,Identifiers: NCT0256250...
Eligibility Criteria
Inclusion
- Participants who participated in the bridging study of a recombinant human papillomavirus 16/18 bivalent vaccine in preadolescent girls (Unique Protocol ID: HPV-PRO-006, Identifiers: NCT02562508) and received at least one dose;
- Participants or participants and their legal guardians can fully understand the study content and sign an informed consent form；
- Able to comply with the requests of the study;
Exclusion
- Participants with coagulation dysfunction (such as coagulation factor deficiency, blood-clotting disorder, or platelet disorder) or coagulation disorders, as diagnosed by a physician after vaccination ;
- 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;
- Abnormal blood clotting function or coagulopathy
Key Trial Info
Start Date :
February 6 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
979 Patients enrolled
Trial Details
Trial ID
NCT04704908
Start Date
February 6 2021
End Date
December 1 2023
Last Update
January 26 2023
Active Locations (1)
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1
Jiangsu Provincial Centre for Disease Control and Prevention
Nanjing, Jiangsu, China, 210009