Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2026-01-01 @ 2:02 PM
Study NCT ID:
NCT03869866
Status:
COMPLETED
Last Update Posted:
2025-03-17
First Post:
2019-03-08
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Assess the Safety and Immunogenicity of a Single Dose of a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) in Older Adults in Turkey and Lebanon
Sponsor:
Sanofi Pasteur, a Sanofi Company
Organization:
Study Overview
Official Title:
Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Potential Pilgrims Aged 56 Years and Older
Status:
COMPLETED
Status Verified Date:
2025-03
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:
MEQ00063
Brief Summary:
The primary objectives of this study are:
* To describe the antibody response to meningococcal serogroups A, C, W, and Y measured by serum bactericidal assay using baby rabbit complement (rSBA) before and after a single dose of MenACYW conjugate vaccine
* To describe the antibody response to meningococcal serogroups A, C, W, and Y measured by serum bactericidal assay using human complement (hSBA) before and after a single dose of MenACYW conjugate vaccine
* To describe the antibody responses against tetanus toxoid at baseline and after a single dose of MenACYW conjugate vaccine
* To describe the safety profile of a single dose of MenACYW conjugate vaccine
* To describe the antibody response to meningococcal serogroups A, C, W, and Y measured by serum bactericidal assay using baby rabbit complement (rSBA) before and after a single dose of MenACYW conjugate vaccine
* To describe the antibody response to meningococcal serogroups A, C, W, and Y measured by serum bactericidal assay using human complement (hSBA) before and after a single dose of MenACYW conjugate vaccine
* To describe the antibody responses against tetanus toxoid at baseline and after a single dose of MenACYW conjugate vaccine
* To describe the safety profile of a single dose of MenACYW conjugate vaccine
Detailed Description:
Study duration per participant is approximately 30 days including: 1 day of screening and vaccination, a phone call and a safety follow up/end of study visit at Day 8 and Day 30 after vaccine administration, respectively.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U1111-1183-6163 | REGISTRY | ICTRP | View |