NCT06137352Not yet recruiting
Two Domestic HPV Vaccines and Imported HPV Vaccines in Women Aged 13-14 Years Study on Immunogenicity
Two Domestic HPV Vaccines (Wozehui ® and Cecolin ®) and Imported HPV Vaccines in Women Aged 13-14 Years Study on Immunogenicity：A Multi-center Cohort Study in China
Source: ClinicalTrials.gov · Last updated 18 Nov 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This is a multi-center, open, prospective cohort study that aims to investigate the immunogenicity and immune persistence of two different domestically produced bivalent HPV vaccines compared with an imported HPV vaccine in women aged 13-14 years. A total of 3,000 subjects who have completed 2 doses of the domestic bivalent HPV vaccine and 3 doses of the imported HPV vaccine will be recruited from Fujian Maternal and Child Health Hospital as the initiator of the study, and will be recruited from a number of healthcare institutions nationwide. Of these, 1,000 subjects were vaccinated with the domestic bivalent HPV vaccine (Wozehui), 1,000 subjects were vaccinated with the domestic bivalent HPV vaccine (Cecolin), and 1,000 subjects were vaccinated with the imported HPV vaccine. Each subject was enrolled within 30-60 days after the last dose of domestic bivalent HPV vaccine or imported HPV vaccine, and a total of two follow-up visits were conducted 12 months (window period ± 1 month) and 36 months (window period ± 1 month) after the last dose of domestic bivalent HPV vaccine or imported HPV vaccine. In response to the WHO Cervical Cancer Elimination Strategy, domestic bivalent HPV vaccine has been offered free of charge to adolescent females aged 13-14 years, but there is still a lack of evidence comparing the antibody titer levels of domestic HPV vaccine and imported HPV vaccine in younger females. Therefore, we conducted the present immunogenicity study to explore the immunogenicity and immune persistence after vaccination with domestic bivalent HPV vaccine versus imported HPV vaccine in this age group of females.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 3000 (estimated)
- First submitted
- 14 Nov 2023
- Start date
- 15 Dec 2023
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Fujian Maternity and Child Health Hospital
- Diseases
- Cervical cancer, Childhood cancers
- NCT number
- NCT06137352
What you commit to
- Study type: Observational
- Planned participants: 3000
- From 15 Dec 2023 to the primary completion date, 31 Dec 2026
- 1 site 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
- Participants who have received other marketed HPV vaccines, or who have participated in clinical studies of HPV vaccines, or who have participated in clinical studies of other vaccines within the last 6 months;
- Participants who are immune compromised or have been diagnosed with congenital or acquired immunodeficiency, Human Immunodeficiency Virus (HIV) infection, lymphoma, leukemia, Systemic Lupus Erythematosus (SLE), Rheumatoid - - Arthritis, Juvenile Rheumatoid Arthritis (JRA), Inflammatory Bowel Disease (IBD), or other autoimmune disease, subjects who have received immunosuppressive therapy within the past 6 months;
Other illness
- Participants with congenital malformations, developmental disorders, genetic defects, and severe malnutrition that are severe or cause damage to vital organs;
- Participants with a history of epilepsy, psychosis, and major depression requiring medication, convulsions or seizures or a family history of psychosis;
- Absence of spleen, functional absence of spleen, and subjects with any condition resulting in absence of spleen or splenectomy;
Lab values
- Subjects with physician-diagnosed coagulation abnormalities (e.g., coagulation factor deficiencies, coagulopathies, platelet abnormalities) or significant bruising or coagulation disorders;
Other
- Participants who, in the judgment of the investigator, have any other factors that make them unsuitable for participation in a clinical trials.
Who the study is looking for
- Participants who have completed all procedures of domestic bivalent HPV vaccine or imported HPV vaccine and are 30-60 days from the last dose of vaccination at the time of enrollment;
- The participants are between 13-14 years old at the time of the first dose of domestic or imported HPV vaccination;
- The participant himself/herself and his/her guardian are able to provide proof of legal identity;
- The participant and his/her guardian are capable of understanding and signing the informed consent form;
- Participants are willing to complete study-related follow-up visits and blood collection as required by the protocol.
Age in the registry: 13 years to 14 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fujian Maternity and Child Health Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.