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

Launched by SHANGHAI BOVAX BIOTECHNOLOGY CO., LTD. · May 7, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how long the immune protection lasts after receiving the quadrivalent HPV vaccine in Chinese women aged 9 to 45 years. The vaccine is given in three doses over six months, and the researchers want to see how well the immune system responds after the vaccination is complete. This study is important because it will help understand the long-term effects of the vaccine against HPV infections, which can lead to conditions like cervical cancer and genital warts.

To participate, women need to have completed the full vaccination schedule and provided a blood sample at a specific time after their shots. Participants can be as young as 9 years old with parental consent or adults over 18. They will need to be willing to follow up regularly with the study team. It's also important that participants are not involved in other clinical trials or have any health issues that might affect the study. If you or someone you know meets these criteria and is interested, this study could provide valuable insights into the effectiveness of the HPV vaccine.

Gender

FEMALE

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 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.