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L'essai clinique NCT06137352 pour Infection par le HPV, Vaccin contre le VPH, Prévention du cancer du col de l'utérus est pas encore en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici.
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Two Domestic HPV Vaccines and Imported HPV Vaccines in Women Aged 13-14 Years Study on Immunogenicity 3 000 Vaccin Multicentrique Adolescent

Pas encore en recrutement
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'étude' pour voir et discuter des informations sur l'étude dans la langue sélectionnée.
L'essai clinique NCT06137352 est une étude observationnel pour Infection par le HPV, Vaccin contre le VPH, Prévention du cancer du col de l'utérus. Son statut actuel est : pas encore en recrutement. Le recrutement est prévu pour commencer le 15 décembre 2023, avec un objectif de 3 000 participants. Dirigée par Fujian Maternity and Child Health Hospital, l'étude devrait être terminée d'ici le 31 décembre 2026. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 18 novembre 2023.
Résumé succinct
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...Afficher plus
Description détaillée
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...Afficher plus
Titre officiel

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

Pathologies
Infection par le HPVVaccin contre le VPHPrévention du cancer du col de l'utérus
Autres identifiants de l'étude
  • HVAC2303
Numéro NCT
NCT06137352
Date de début (réel)
2023-12-15
Dernière mise à jour publiée
2023-11-18
Date de fin (estimée)
2026-12-31
Inscription (estimée)
3 000
Type d'étude
Observationnel
Statut
Pas encore en recrutement
Bras / Interventions
Groupe de participants/BrasIntervention/Traitement
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.
Suivi
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...Afficher plus
Critère principal d'évaluation
Critères d'évaluationDescription de la mesurePériode
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
Assistant à la participation
Critères d'éligibilité

Âges éligibles
Enfant
Âge minimum
13 Years
Sexes éligibles
Femme
Accepte les volontaires en bonne santé
Oui
  • 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 Hospital logoFujian Maternity and Child Health Hospital
Contact central de l'étude
Contact: Binhua Dong, +86-591-87558732, [email protected]
Contact: Pengming Sun, +86-591-87558732, [email protected]
1 Centres de l'étude dans 1 pays

Fujian

Fujian Maternity and Child Health Hospital, Fuzhou, Fujian, 350001, China