Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-26 @ 1:02 AM
Study NCT ID:
NCT07272434
Status:
RECRUITING
Last Update Posted:
2025-12-09
First Post:
2025-11-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase III Clinical Trial of the Recombinant Respiratory Syncytial Virus Vaccine ( CHO Cell)
Sponsor:
MAXVAX Biotechnology Limited Liability Company
Organization:
Study Overview
Official Title:
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy, Immunogenicity, and Safety of a Recombinant Respiratory Syncytial Virus Vaccine (CHO Cell) in Adults Aged 60 Aears and Above
Status:
RECRUITING
Status Verified Date:
2025-11
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 will evaluate the efficacy of the Recombinant RSV vaccine(CHO cell) vaccine in preventing lower respiratory tract diseases(LRTD) caused by RSV in adults≥ 60 years of following a single dose of the RSV vaccine(CHO cell) vaccine .This study will also assess if the vaccine is safe and induces an immune response.
Detailed Description:
A total of 25000 adults aged 60 years and above will be enrolled, stratified into 60-69 and ≥70 years of age. All Participants will randomly receive investigational vaccine or placebo at a ratio of 1:1. Efficacy and safety will be assessed in all Participants, while immunogenicity will be assessed in a subset of 1200 Participants in a selected trial site.
Study Oversight
Has Oversight DMC:
True
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?: