Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06642558
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-11
Brief Title:
Safety and Immunogenicity of Recombinant RSV Vaccine CHO Cell in Healthy Subjects Aged 18 Years and Above
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase III Single Center Randomized Double-Blinded Placebo-Controlled Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant Respiratory Syncytial Virus Vaccine CHO Cell in Healthy Subjects Aged 18 Years and Above
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:
The purpose of this study is to assess the safety and immunogenicity of two dose levels of the single dose Recombinant RSV vaccineCHO cells when administered intramuscularly IM in healthy adults aged 18 years and older
Detailed Description:
A total of 522 subjects in the phase 12 study will be enrolled The study will be conducted in 2 parts phase 1 for dose escalation and phase 2 for expansion with first evaluation of safety of 2 two dose levels of Recombinant RSV vaccineCHO cells in healthy participants aged 18-59 and 60 in phase 1 before preceding with vaccination of the participants aged 50-59 and 60 in phase 2 To ensure the safety of the study participants phase 1 will follow a staggered enrolment with 3 steps All subjects in each age group in phase 1 will be randomly receive the investigational vaccinehalf or full dose and the placebo in a 21 ratio while all subjects in each age group in phase 2 will be randomly receive the half dose vaccine the full dose vaccine and the placebo in a 111 ratio
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