Ignite Creation Date:
2024-05-06 @ 7:47 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06137352
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-18
First Post:
2023-11-14
Brief Title:
Two Domestic HPV Vaccines and Imported HPV Vaccines in Women Aged 13-14 Years Study on Immunogenicity
Sponsor:
Fujian Maternity and Child Health Hospital
Organization:
Fujian Maternity and Child Health Hospital
Study Overview
Official Title:
Two Domestic HPV Vaccines Wozehui and Cecolin and Imported HPV Vaccines in Women Aged 13-14 Years Study on ImmunogenicityA Multi-center Cohort Study in China
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 imported HPV vaccine in women aged 13-14 years A total of 3000 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 1000 subjects were vaccinated with the domestic bivalent HPV vaccine Wozehui 1000 subjects were vaccinated with the domestic bivalent HPV vaccine Cecolin and 1000 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
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 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 multi-center open prospective cohort study with a total of 3000 subjects recruited According to the HPV vaccine that the participants received in the previous period they were divided into 1000 people in the domestic bivalent HPV vaccine group Wozehui 1000 people in the domestic bivalent HPV vaccine group Cecolin and 1000 people in the imported HPV vaccine group Three immuneogenic blood was collected in all subjects 30-60 days 12 months window period 1 month and 36 months window period 1 month after the last dose of either the domestic bivalent HPV vaccine or the imported HPV vaccine which was used to perform HPV type 16 and 18 neutralizing antibody testing The aim of this study was to evaluate the immunogenicity difference between two different domestically produced bivalent HPV vaccines and imported HPV vaccines in adolescent females aged 13-14 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None