Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06632912
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-08
Brief Title:
Phase IIIb Clinical Trial of Quadrivalent Recombinant Human Papillomavirus Vaccine Hansenulapolymorpha for AgeImmunization Schedule Bridging
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Open-label Non-inferiority Designed Phase IIIb Clinical Trial to Evaluate the Immunogenicity and Safety of Quadrivalent Recombinant Human Papillomavirus Vaccine Hansenulapolymorpha Between 2 Doses in Adolescent Females Aged 9-14 Years3 Doses in Adolescent Females Aged 9-17 Years and AgeImmunization Schedule Bridging in Females Aged 18-26 Year
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This vaccine was jointly developed by Chengdu Institute of Biological Products Co Ltd and National Vaccine and Serum Institute China is co-sponsoring this clinical trial
This trial plans to enroll 1800 female subjects aged 9-26 years 600 in each of the 18-26 years old 3-dose group 9-17 years old 3-dose group and 9-14 years old 2-dose group
All subjects in the 9-14 years old 2-dose group will be injected with 2 doses of the experimental vaccine in the deltoid muscle of the upper arm according to the 0-6 month immunization schedule Subjects in the non-immune persistence subgroup will need to complete 6 on-site visits V1-V3 V7-V9 and subjects in the immune persistence subgroup will need to complete 12 on-site visits V1-V3 V7-V15 All subjects in the 9-17 years old 3-dose group and the 18-26 years old 3-dose group will be injected with 3 doses of the experimental vaccine in the deltoid muscle of the upper arm according to the 0 2 and 6 month immunization schedule Subjects in the non-immune persistence subgroup will need to complete 9 on-site visits V1-V9 and subjects in the immune persistence subgroup will need to complete 15 on-site visits V1-V15
This trial plans to enroll 1800 female subjects aged 9-26 years 600 in each of the 18-26 years old 3-dose group 9-17 years old 3-dose group and 9-14 years old 2-dose group
All subjects in the 9-14 years old 2-dose group will be injected with 2 doses of the experimental vaccine in the deltoid muscle of the upper arm according to the 0-6 month immunization schedule Subjects in the non-immune persistence subgroup will need to complete 6 on-site visits V1-V3 V7-V9 and subjects in the immune persistence subgroup will need to complete 12 on-site visits V1-V3 V7-V15 All subjects in the 9-17 years old 3-dose group and the 18-26 years old 3-dose group will be injected with 3 doses of the experimental vaccine in the deltoid muscle of the upper arm according to the 0 2 and 6 month immunization schedule Subjects in the non-immune persistence subgroup will need to complete 9 on-site visits V1-V9 and subjects in the immune persistence subgroup will need to complete 15 on-site visits V1-V15
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None