Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06593587
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-09
Brief Title:
A Study to Assess the Safety Tolerability and Immunogenicity of RSVpreF in Older Adults in Korea
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A PHASE 3 STUDY TO EVALUATE THE SAFETY TOLERABILITY AND IMMUNOGENICITY OF RESPIRATORY SYNCYTIAL VIRUS RSV PREFUSION F SUBUNIT VACCINE IN OLDER ADULTS IN KOREA
Status:
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 goal of this clinical trial is to quantify the immune response in older Korean adults after a RSVpreF vaccination It will also learn about the safety and tolerability of RSVpreF vaccination The main questions it aims to answer are
What local reactions and systemic events do participants have after a RSVpreF vaccination What medical problems do participants have after a RSVpreF vaccination Researchers will compare RSVpreF to a placebo a look-alike substance that contains no RSVpreF to see if RSVpreF is safe and well tolerated It will also examine the change in antibody levels immune responses before and after vaccination
Participants will
Receive the RSVpreF vaccination or a placebo injection once at Visit 1 Visit the clinic a month later for a checkup and tests Receive a phone call 1 week after vaccination and 2 months after vaccination for health checks
Keep a diary of their symptoms for 7 days after vaccination
What local reactions and systemic events do participants have after a RSVpreF vaccination What medical problems do participants have after a RSVpreF vaccination Researchers will compare RSVpreF to a placebo a look-alike substance that contains no RSVpreF to see if RSVpreF is safe and well tolerated It will also examine the change in antibody levels immune responses before and after vaccination
Participants will
Receive the RSVpreF vaccination or a placebo injection once at Visit 1 Visit the clinic a month later for a checkup and tests Receive a phone call 1 week after vaccination and 2 months after vaccination for health checks
Keep a diary of their symptoms for 7 days after vaccination
Detailed Description:
This is a Phase 3 randomized double-blinded placebo-controlled multicenter trial to describe the safety tolerability and immunogenicity of bivalent RSVpreF in adults 60 years of age and older in Korea
The study duration is approximately 2 months 4 study visits are required and are comprised of 2 scheduled clinic visits and 2 scheduled telephone calls
Approximately 360 study-eligible participants will be randomized to receive either the 120-µg dose of RSVpreF or placebo in a 21 ratio
After screening and confirmation of eligibility a prevaccination blood sample will be collected for immunogenicity assessments and a single dose of study intervention RSVpreF or placebo will be administered
Participants will report daily reactogenicity data using an electronic device for 7-days or until resolution
Participants will return approximately 1 month later for a follow-up blood draw for immunogenicity assessments and collection of safety information
A telephone follow-up visit will be conducted approximately 1 week after vaccination to review reactogenicity and approximately 2 months after vaccination to collect safety information
For all participants adverse events AEs will be collected from informed consent through 1 month following study intervention administration Serious adverse events SAEs newly diagnosed chronic medical conditions NDCMCs and adverse events of special interest AESIs will be collected from informed consent throughout study participation
The study duration is approximately 2 months 4 study visits are required and are comprised of 2 scheduled clinic visits and 2 scheduled telephone calls
Approximately 360 study-eligible participants will be randomized to receive either the 120-µg dose of RSVpreF or placebo in a 21 ratio
After screening and confirmation of eligibility a prevaccination blood sample will be collected for immunogenicity assessments and a single dose of study intervention RSVpreF or placebo will be administered
Participants will report daily reactogenicity data using an electronic device for 7-days or until resolution
Participants will return approximately 1 month later for a follow-up blood draw for immunogenicity assessments and collection of safety information
A telephone follow-up visit will be conducted approximately 1 week after vaccination to review reactogenicity and approximately 2 months after vaccination to collect safety information
For all participants adverse events AEs will be collected from informed consent through 1 month following study intervention administration Serious adverse events SAEs newly diagnosed chronic medical conditions NDCMCs and adverse events of special interest AESIs will be collected from informed consent throughout study participation
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