Immune Persistence After the Whole Vaccination Shcedule With Recombination Quadrivalent HPV Vaccine

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Brief Title

Immune Persistence After the Whole Vaccination Shcedule With Recombination Quadrivalent HPV Vaccine

Official Title

Evaluating the Immune Persistence of Recombination Quadrivalent HPV Vaccine (Type 6, 11, 16, 18) in Healthy Chinese Female Subjects Aged 9 to 45 Years: A Phase 3, Open-label, Non-randomized Clinical Trial

Brief Summary

      To access the immune persistence of Chinese women aged 9-45 years after receiving
      quadrivalent HPV vaccine with the immunization schedule of 0, 2 and 6 months.

Study Type

Observational

Primary Outcome

Seroconversion rate (SCR) for Each of the HPV Types Contained in the Vaccine

Condition

HPV Infections

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Estimated Enrollment

600

Start Date

May 2022

Completion Date

May 2027

Primary Completion Date

May 2027

Eligibility Criteria

        Inclusion Criteria:

          -  Subjects who participated in the phase III clinical trial of non inferior efficacy of
             HPV tetravalent vaccine of Yangchun Center for Disease Control and Prevention
             (protocol No.: 4-HPV-3001), completed three doses of HPV quadrivalent vaccine and
             provided blood sample at months 7; Or subjects who have participated in the bridging
             study of HPV quadrivalent vaccine of Mianyang Center for Disease Control and
             Prevention (scheme No.: 4-HPV-3002), completed the whole vaccine schedule at month
             0，2，6, and provided blood sample at months 7;

          -  The subjects aged 9 to 17 years old at Mianyang site and their legal guardian should
             provide legal indentification; the subjects aged over 18 years old should provide
             legal indentification;

          -  The subject voluntarily agrees to enroll in this study. If the subject is a minor,
             both the subject and subject's legal guardian should voluntarily agree to enroll in
             this study and sign an informed consent form;

          -  Be able to understand the study procedures and promise to participate in regular
             follow-ups under the requirements.

        Exclusion Criteria:

          -  Enrolling or plan to enroll in other clinical trials (drugs or vaccines) (except that
             the observational clinical study and the subjects at Mianyang site are still in the
             post exemption safety follow-up stage of the 4-HPV-3002 trial);

          -  Suffering from thrombocytopenia or any coagulation dysfunction that can be a
             contraindication to blood collection (such as coagulation factor deficiency,
             coagulation diseases, platelet abnormalities, etc.);

          -  According to the investigator's judgment, the subject has any condition may interfere
             with process of evaluation of immune persistence.

Gender

Female

Ages

9 Years - 45 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Jikai Zhang, 020-89020236, [email protected]

Administrative Informations

NCT ID

NCT05371353

Organization ID

4-HPV-3003

Responsible Party

Sponsor

Study Sponsor

Shanghai Bovax Biotechnology Co., Ltd.

Study Sponsor

Jikai Zhang, Study Director, Guangdong Center for Disease Prevention and Control

Verification Date

May 2022