Immune Persistence After the Whole Vaccination Shcedule With Recombination Quadrivalent HPV Vaccine
Recruiting
Observational Study
HPV InfectionsCervical Cancer Stage IIaVaginal CancerGenital WartCIN1CIN2CIN3
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
9 – 45
Sex
Female
Study type
Observational
Participants needed
600 (estimated)
Sponsor
Shanghai Bovax Biotechnology Co., Ltd. · Industry
Who this trial is looking for
This trial is looking for Chinese women aged 9 to 45 who have received the quadrivalent HPV vaccine. Participants will provide blood samples and follow up on their health over time.
Are You a Good Fit for This Trial?
You may be able to join if
I completed three doses of the quadrivalent HPV vaccine.
I am between 9 and 45 years old.
I can understand the study procedures.
I voluntarily agree to participate.
If I am a minor, my legal guardian agrees to participate.
You may not be able to join if
I am enrolled in another clinical trial.
I have a bleeding disorder or issues with blood clotting.
I have a condition that may interfere with the evaluation of immune persistence.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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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…
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.
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