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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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HPV Infections, Cervical Cancer Stage IIa, Vaginal Cancer, Genital Wart, CIN1, CIN2, CIN3

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seroconversion rate (SCR) for Each of the HPV Types Contained in the Vaccine | The primary immue persistence outcome to evaluate respinses quadrivalent HPV vaccine was Year 5 seroconversion rate against HPV-types 6,11,16, and 18 | Month 12 | 
| SCR for Each of the HPV Types Contained in the Vaccine | The primary immue persistence outcome to evaluate respinses quadrivalent HPV vaccine was Year 5 seroconversion rate against HPV-types 6,11,16, and 18 | Month 24 | 
| SCR for Each of the HPV Types Contained in the Vaccine | The primary immue persistence outcome to evaluate respinses quadrivalent HPV vaccine was Year 5 seroconversion rate against HPV-types 6,11,16, and 18 | Month 36 | 
| SCR for Each of the HPV Types Contained in the Vaccine | The primary immue persistence outcome to evaluate respinses quadrivalent HPV vaccine was Year 5 seroconversion rate against HPV-types 6,11,16, and 18 | Month 48 | 
| SCR for Each of the HPV Types Contained in the Vaccine | The primary immue persistence outcome to evaluate respinses quadrivalent HPV vaccine was Year 5 seroconversion rate against HPV-types 6,11,16, and 18 | Month 60 | 
| Geometric Mean Titers (GMTs) for Each of the HPV Types Contained in the Vaccine | The primary immune persistence endpoint is anti-HPV type 6,11,16,and 18 antibody GMTs 5 years post dose 1 assessed among the subjects who were seropositive at Month 7 | Month 12 | 
| GMTs for Each of the HPV Types Contained in the Vaccine | The primary immune persistence endpoint is anti-HPV type 6,11,16,and 18 antibody GMTs 5 years post dose 1 assessed among the subjects who were seropositive at Month 7 | Month 24 | 
| GMTs for Each of the HPV Types Contained in the Vaccine | The primary immune persistence endpoint is anti-HPV type 6,11,16,and 18 antibody GMTs 5 years post dose 1 assessed among the subjects who were seropositive at Month 7 | Month 36 | 
| GMTs for Each of the HPV Types Contained in the Vaccine | The primary immune persistence endpoint is anti-HPV type 6,11,16,and 18 antibody GMTs 5 years post dose 1 assessed among the subjects who were seropositive at Month 7 | Month 48 | 
| GMTs for Each of the HPV Types Contained in the Vaccine | The primary immune persistence endpoint is anti-HPV type 6,11,16,and 18 antibody GMTs 5 years post dose 1 assessed among the subjects who were seropositive at Month 7 | Month 60 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Human papillomavirus, vaccine, Cervical Cancer