Assessing immune response after HPV vaccination in women

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study evaluates the immune persistence in Chinese women aged 9-45 years who have completed the full vaccination schedule of the quadrivalent HPV vaccine. Participants will have received their vaccinations at 0, 2, and 6 months, and will provide blood samples to assess their immune response at the 7-month mark. The study aims to gather data on how long the immune protection lasts following vaccination against HPV-related conditions such as cervical cancer and genital warts.

Why it matters

Who can join: the full rules

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.

Where it's running

• Yangchun Center For Disease Prevention And Control
  Yangchun, Guangdong, China Recruiting
• Center for Disease Control and Prevention
  Mianyang, Sichuan, China Recruiting

Study contacts

• Study coordinator: Jikai Zhang
• Email: 56061237@qq.com
• Phone: 020-89020236

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.