Ignite Creation Date:
2024-05-06 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06207175
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-23
First Post:
2024-01-02
Brief Title:
A Study to Evaluate the Immunogenicity and Safety of Nonavalent Human Papillomavirus HPV Vaccine
Sponsor:
Beijing Health Guard Biotechnology Inc
Organization:
Beijing Health Guard Biotechnology Inc
Study Overview
Official Title:
A Phase III Trial in Healthy Indonesian Women Ages 18-45 to Evaluate the Immunogenicity and Safety of Recombinant Nonavalent Types 61116183133455258 Human Papillomavirus HPV Vaccine Escherichia Coli
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-01
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 Study to Evaluate the Immunogenicity and Safety of Candidate Recombinant Nonavalent types 61116183133455258 Human Papillomavirus HPV Vaccine Escherichia coli Administered Intramuscularly in Healthy Female Participants Aged 18 to 45 Years
Detailed Description:
This is a randomized observer blinded active controlled multicenter clinical study
A total of approximately 1260 healthy female participants aged 18 to 45 years old who meet eligibility will be enrolled and be randomly assigned into 2 groups in a 11 ratio
Immunogenicity Blood samples 50 mL each time will be collected for all participants prior to the 1st dose of vaccination and on 1 6 12 18 months after full vaccination for anti-HPV type 61116183133455258 neutralizing antibodies and Immunoglobulin G antibodies testing
Safety evaluation for all participantsTo assess solicited local and systemic Adverse Event AEs within 7 days after each dose of vaccination unsolicited Adverse Event AEs within 30 days after each dose of vaccination and Serious Adverse Event SAEs from 1st dose to 18 months after full vaccination
Collection of pregnancy eventsTo assess the occurrence of pregnancy events in all participants from 1st dose to 18 months after full vaccination The subject will be followed to determine the outcome of the pregnancy
At the end of the pregnancy be it a full-term or premature birth information on the status of the newborns will be followed up during the first 12 months of life
A total of approximately 1260 healthy female participants aged 18 to 45 years old who meet eligibility will be enrolled and be randomly assigned into 2 groups in a 11 ratio
Immunogenicity Blood samples 50 mL each time will be collected for all participants prior to the 1st dose of vaccination and on 1 6 12 18 months after full vaccination for anti-HPV type 61116183133455258 neutralizing antibodies and Immunoglobulin G antibodies testing
Safety evaluation for all participantsTo assess solicited local and systemic Adverse Event AEs within 7 days after each dose of vaccination unsolicited Adverse Event AEs within 30 days after each dose of vaccination and Serious Adverse Event SAEs from 1st dose to 18 months after full vaccination
Collection of pregnancy eventsTo assess the occurrence of pregnancy events in all participants from 1st dose to 18 months after full vaccination The subject will be followed to determine the outcome of the pregnancy
At the end of the pregnancy be it a full-term or premature birth information on the status of the newborns will be followed up during the first 12 months of life
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