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De klinische studie NCT06137352 voor HPV-infectie, HPV-vaccin, Preventie van baarmoederhalskanker is nog niet rekruterend. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag. | ||
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Kaartweergave
Two Domestic HPV Vaccines and Imported HPV Vaccines in Women Aged 13-14 Years Study on Immunogenicity 3.000 Vaccin Multicenter Adolescenten
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De klinische studie NCT06137352 is een observationeel studie bij HPV-infectie, HPV-vaccin, Preventie van baarmoederhalskanker met de status nog niet rekruterend. De inclusie van 3.000 deelnemers start op 15 december 2023. De studie wordt geleid door Fujian Maternity and Child Health Hospital en de voltooiing is gepland op 31 december 2026. Laatste update op ClinicalTrials.gov: 18 november 2023.
Beknopte samenvatting
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...Toon meer
Uitgebreide beschrijving
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 years old; 2) Evaluate the immune persistence of two different domestically produced bivalent HPV vaccines (Wozehui ® and Cecolin ®) versus imported HPV vaccines in adolescent females aged 13-14 years old. This study is a...Toon meer
Officiële titel
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
Aandoeningen
HPV-infectieHPV-vaccinPreventie van baarmoederhalskankerAndere studie-ID's
- HVAC2303
NCT-ID
Startdatum (Werkelijk)
2023-12-15
Laatste update geplaatst
2023-11-18
Verwachte einddatum
2026-12-31
Inschrijving (Geschat)
3.000
Studietype
Observationeel
Status
Nog niet rekruterend
Armen / Interventies
| Deelnemersgroep/Studiearm | Interventie/Behandeling |
|---|---|
Adolescent females who received their first dose of HPV vaccine at 13-14 years Adolescent females who completed their last dose of domestic bivalent HPV vaccine or imported HPV vaccine and were between 13 and 14 years of age at the time of the first dose. Two follow-up visits were conducted 12 months (window period ± 1 month) and 36 months (window period ± 1 month) after the last dose of vaccination. | Follow-up Each subject was recruited in 30-60 days after the last dose of domestic bivalent HPV vaccine or imported HPV vaccine, and followed up at 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, with a total of two follow-up visits. At enrollment and both follow-up visits, subjects were required to collect 2 tubes of peri...Toon meer |
Primaire uitkomst
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
The neutralization antibody GMT and antibody positivity testing at baseline | The neutralization antibody GMT and antibody positivity for HPV types 16 and 18 were tested | Baseline |
The neutralization antibody GMT and antibody positivity testing at 12-mouth follow-up | The neutralization antibody GMT and antibody positivity for HPV types 16 and 18 were tested 12 mouths after the last dose of domestic bivalent HPV vaccine or imported HPV vaccine. | 12-month follow-up |
The neutralization antibody GMT and antibody positivity testing at baseline 36-mouth follow-up | The neutralization antibody GMT and antibody positivity for HPV types 16 and 18 were tested 36 mouths after the last dose of domestic bivalent HPV vaccine or imported HPV vaccine. | 36-month follow-up |
Deelname-assistent
Geschiktheidscriteria
Leeftijd van deelnemers
Kind
Minimumleeftijd
13 Years
Geslachten die in aanmerking komen voor de studie
Vrouw
Accepteert gezonde vrijwilligers
Ja
- 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.
- 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.
Fujian Maternity and Child Health HospitalCentraal Contactpersoon
Contact: Binhua Dong, +86-591-87558732, [email protected]
Contact: Pengming Sun, +86-591-87558732, [email protected]
1 Studielocaties in 1 landen
Fujian
Fujian Maternity and Child Health Hospital, Fuzhou, Fujian, 350001, China