Immune Persistence After the Whole Vaccination Shcedule With Recombination Quadrivalent HPV Vaccine
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age9-45
SponsorShanghai Bovax Biotechnology Co., Ltd.
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Subjects aged 9-45 years old have completed receiving three doses of quadrivalent HPV vaccine and provided blood sample at month 7
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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
Time frame
Month 122
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
Time frame
Month 243
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
Time frame
Month 364
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
Time frame
Month 48Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov