Cervical Cancer Stage IIa, CIN1, CIN2, CIN3, Genital Wart, HPV Infections, Vaginal Cancer
Conditions
Keywords
Human papillomavirus, vaccine, Cervical Cancer
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.
Interventions
None listed
Sponsors
Shanghai Bovax Biotechnology Co., Ltd.
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
9 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Seroconversion rate (SCR) for Each of the HPV Types Contained in the Vaccine | Month 12 | The primary immue persistence outcome to evaluate respinses quadrivalent HPV vaccine was Year 5 seroconversion rate against HPV-types 6,11,16, and 18 |
| SCR for Each of the HPV Types Contained in the Vaccine | Month 24 | The primary immue persistence outcome to evaluate respinses quadrivalent HPV vaccine was Year 5 seroconversion rate against HPV-types 6,11,16, and 18 |
| Geometric Mean Titers (GMTs) for Each of the HPV Types Contained in the Vaccine | Month 12 | 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 |
| GMTs for Each of the HPV Types Contained in the Vaccine | Month 24 | 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 |
Countries
China
Contacts
Primary ContactJikai Zhang
Outcome results
None listed