Brief Title
Immuno-persistence Study of a Recombinant Human Papillomavirus 16/18 Bivalent Vaccine in Preadolescent Girls (54m)
Official Title
Immuno-persistence Study of A Bivalent Human Papillomavirus (Type 16, 18) Recombinant Vaccine (E.Coli) in Healthy Female Subjects Aged 9 to 17 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 18-26 years who received the standard 3-dose schedule (0,1,6 months).
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: NCT02562508) .The investigators will recruit people who have
participated in bridging study before and collect their serum samples to test the
seroprevalence and geometric mean concentrations of anti-HPV16 and anti-HPV18 antibody on 54
months after dose 1
Study Type
Observational
Primary Outcome
Anti-HPV16 and anti-HPV18 seroprevalence and geometric mean concentrations at Month 54 (type-specific IgG antibody)
Secondary Outcome
Anti-HPV16 and anti-HPV18 seroprevalence and geometric mean concentrations at Month 54 (type specific neutralizing antibody)
Condition
Cervical Intraepithelial Neoplasia
Intervention
Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli)
Study Arms / Comparison Groups
9-17y (0,1,6m)
Description: Participants in this arm have received 60μg of HPV 16/18 bivalent vaccine according to 3 doses of HPV 16/18 bivalent vaccine
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
979
Start Date
February 6, 2021
Completion Date
December 2022
Primary Completion Date
April 1, 2021
Eligibility Criteria
Inclusion Criteria:
1. 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;
2. Participants or participants and their legal guardians can fully understand the study
content and sign an informed consent form；
3. Able to comply with the requests of the study;
Exclusion Criteria:
1. 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 ;
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;
3. Abnormal blood clotting function or coagulopathy
Gender
Female
Ages
14 Years - 32 Years
Contacts
Ting Wu, Ph. D., ,
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT04704908
Organization ID
HPV-PRO-006-3
Responsible Party
Sponsor-Investigator
Study Sponsor
Jun Zhang
Collaborators
Xiamen Innovax Biotech Co., Ltd
Study Sponsor
Ting Wu, Ph. D., Study Chair, Xiamen University
Verification Date
July 2021