Status:
NOT_YET_RECRUITING
Two Domestic HPV Vaccines and Imported HPV Vaccines in Women Aged 13-14 Years Study on Immunogenicity
Lead Sponsor:
Fujian Maternity and Child Health Hospital
Conditions:
HPV Infection
HPV Vaccine
Eligibility:
FEMALE
13-14 years
Brief Summary
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 ...
Detailed Description
The study aims to: 1) Evaluate the immunogenicity of two different domestically produced bivalent HPV vaccines (Wozehui ® and Cecolin ®) versus imported HPV vaccines in adolescent females aged 13-14 y...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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 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;
- 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;
- Absence of spleen, functional absence of spleen, and subjects with any condition resulting in absence of spleen or splenectomy;
- Subjects with physician-diagnosed coagulation abnormalities (e.g., coagulation factor deficiencies, coagulopathies, platelet abnormalities) or significant bruising or coagulation disorders;
- Participants who, in the judgment of the investigator, have any other factors that make them unsuitable for participation in a clinical trials.
Key Trial Info
Start Date :
December 15 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
3000 Patients enrolled
Trial Details
Trial ID
NCT06137352
Start Date
December 15 2023
End Date
December 31 2026
Last Update
November 18 2023
Active Locations (1)
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1
Fujian Maternity and Child Health Hospital
Fuzhou, Fujian, China, 350001