Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-26 @ 3:28 AM
Study NCT ID:
NCT06678620
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-17
First Post:
2024-11-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase II Clinical Trial of 24-valent Pneumococcal Polysaccharide Conjugate Vaccine
Sponsor:
Shanghai Reinovax Biologics Co.,LTD
Organization:
Study Overview
Official Title:
A Phase II Clinical Trial to Evaluate the Safety and Immunogenicity of a 24-valent Pneumococcal Polysaccharide Conjugate Vaccine in People Aged 18 Years and Older
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-12
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:
A phase II clinical trial of a 24-valent pneumococcal conjugate vaccine (PCV24) developed by Shanghai Reinovax Biologics Co., LTD will be conducted in Chinese adults aged 18 years and older. The study's objective is to evaluate the safety and immunogenicity of PCV24. The trial is a single-center, randomized, blinded, parallel-controlled, non-inferiority design II clinical trial.
Detailed Description:
Phase II clinical trial of the 24-valent pneumococcal conjugate vaccine (PCV24) developed by Shanghai Reinovax Biologics Co., LTD will be conducted in Chinese adults aged 18 years and older. The study's objective is to evaluate the safety and immunogenicity of PCV24. The active control vaccine is a 23-valent pneumococcal polysaccharide vaccine (23-valent pneumococcal polysaccharide vaccine, PPSV23) produced by the Chengdu Institute of Biological Products.
At least 992 participants will be enrolled, including 496 adults aged 18-60 and 496 elderly people aged ≥61. Participants will be randomized 1:1:1:1 to receive one dose of PCV24 formulation 1, PCV24 formulation 2, PCV24 formulation 3,or PPSV23.
At least 992 participants will be enrolled, including 496 adults aged 18-60 and 496 elderly people aged ≥61. Participants will be randomized 1:1:1:1 to receive one dose of PCV24 formulation 1, PCV24 formulation 2, PCV24 formulation 3,or PPSV23.
Study Oversight
Has Oversight DMC:
False
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?: