Ignite Creation Date:
2024-05-06 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06243666
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-13
First Post:
2024-01-29
Brief Title:
Long-term Effectiveness and Immuno-persistence Study of a Recombinant HPV 1618 Bivalent Vaccine in Preadolescent Girls
Sponsor:
Xiamen University
Organization:
Xiamen University
Study Overview
Official Title:
Long-term Effectiveness and Immuno-persistence Study of a Recombinant Human Papillomavirus 1618 Bivalent Vaccine in Girls Aged 9-17 Years
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
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:
The primary objective of this study is to evaluate the protective efficacy against future infections of HPV types 1618 or related diseases and immuno-persistence type specific IgG antibody of the bivalent HPV vaccine in young female populations aged 9-17 years
Detailed Description:
This is a follow-up study that is based on the bridging study of a recombinant human papillomavirus 1618 bivalent vaccine in preadolescent girlsUnique Protocol IDHPV-PRO-006Identifiers NCT02562508 This study proposes to conduct a prospective cohort study based on the cohort population from the immunobridging clinical trial of the bivalent HPV vaccine Unique Protocol IDHPV-PRO-006Identifiers NCT02562508 By matching control groups according to factors such as age and education level and through long-term follow-up this research aims to elucidate the protective efficacy of the bivalent HPV vaccine against future infections of HPV types 1618313345 or related diseases in young female populations aged 9-17 years Additionally the study will evaluate the persistence of vaccine-induced antibodies investigate the potential for type replacementcompetition phenomena post-vaccination and assess oral HPV infections in the cohort population
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