NCT05371353Recruiting
Immune Persistence After the Whole Vaccination Shcedule With Recombination Quadrivalent HPV Vaccine
Evaluating the Immune Persistence of Recombination Quadrivalent HPV Vaccine (Type 6, 11, 16, 18) in Healthy Chinese Female Subjects Aged 9 to 45 Years: A Phase 3, Open-label, Non-randomized Clinical Trial
Source: ClinicalTrials.gov · Last updated 17 Apr 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 600 (estimated)
- First submitted
- 4 May 2022
- Start date
- 14 May 2022
- Primary completion date
- May 2027
- Lead sponsor
- Shanghai Bovax Biotechnology Co., Ltd.
- Diseases
- Cervical cancer, Childhood cancers
- NCT number
- NCT05371353
What you commit to
- Study type: Observational
- Planned participants: 600
- From 14 May 2022 to the primary completion date, May 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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);
Other illness
- According to the investigator's judgment, the subject has any condition may interfere with process of evaluation of immune persistence.
Lab values
- 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.);
Who the study is looking for
- 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.
Age in the registry: 9 years to 45 years · Sex: Female · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Center for Disease Control and Prevention Coordinator of this site? Confirm its status | Mianyang | China | Recruiting |
| Yangchun Center For Disease Prevention And Control Coordinator of this site? Confirm its status | Yangchun | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.