Ignite Creation Date:
2024-07-17 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06465914
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-06-14
Brief Title:
A Phase III Study to Evaluate the Efficacy Immunogenicity and Safety of the 9-valent HPV Vaccine in Chinese Males
Sponsor:
Shanghai Bovax Biotechnology Co Ltd
Organization:
Shanghai Bovax Biotechnology Co Ltd
Study Overview
Official Title:
A Randomized Double-blinded Multicenter and Placebo-controlled Phase III Study to Evaluate the Efficacy Immunogenicity and Safety of the 9-valent HPV Recombinant Vaccine Hansenula Polymorpha in Chinese Males Aged 18-45 Years
Status:
RECRUITING
Status Verified Date:
2024-06
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 is designed to evaluate the vaccine efficacy immunogenicity and safety of the 9-valent Types 6 11 16 18 31 33 45 52 and 58 Human Papillomavirus HPV Recombinant Vaccine Hansenula Polymorpha in Chinese male subjects aged 18-45 years The primary hypothesis in the study is the 9-valent HPV recombinant vaccine reduces the incidence of vaccine HPV types-related genital warts compared with placebo in Chinese men
Detailed Description:
The primary aim of this clinical trial is to evaluate the efficacy of the 9-valent HPV vaccine in men aged 18-45 years old It will also learn about the safety and immunogenicity of the 9-valent HPV vaccine
Participants will inoculate the 9-valent HPV vaccine or a placebo according to the 0 2 6 month immunization program
Visit the clinic on the 8th and 31st day after each dose of vaccination for the collection of safety information keeping a diary of their symptoms and medications
Participants will inoculate the 9-valent HPV vaccine or a placebo according to the 0 2 6 month immunization program
Visit the clinic on the 8th and 31st day after each dose of vaccination for the collection of safety information keeping a diary of their symptoms and medications
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