Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2025-12-25 @ 7:18 PM
Study NCT ID:
NCT01890759
Status:
COMPLETED
Last Update Posted:
2022-04-19
First Post:
2013-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Immunogenicity and Safety of Menactra® Vaccine in Subjects Aged 9 to 23 Months in India and in the Russian Federation
Sponsor:
Sanofi Pasteur, a Sanofi Company
Organization:
Study Overview
Official Title:
Immunogenicity and Safety of a Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®) in Subjects Aged 9 to 23 Months in India and in the Russian Federation
Status:
COMPLETED
Status Verified Date:
2022-03
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:
None
Brief Summary:
The purpose of this study is to assess the immunogenicity and safety of Menactra® vaccine given as a two-dose series in infants and toddlers.
Primary Objectives:
* To assess the seroprotection rate (percentage of subjects with a serum bactericidal assay using human complement \[SBA-HC\] titer ≥ 1:8) 28 days after the second of 2 doses of Menactra® administered 3 to 6 months apart.
Secondary Objectives:
* To assess the immune responses to meningococcal antigens (serogroups A, C, Y, and W-135) 28 days following the second vaccination with Menactra® using SBA-HC and SBA-BR titers.
* To assess the safety profile of Menactra® after each and any vaccination.
Primary Objectives:
* To assess the seroprotection rate (percentage of subjects with a serum bactericidal assay using human complement \[SBA-HC\] titer ≥ 1:8) 28 days after the second of 2 doses of Menactra® administered 3 to 6 months apart.
Secondary Objectives:
* To assess the immune responses to meningococcal antigens (serogroups A, C, Y, and W-135) 28 days following the second vaccination with Menactra® using SBA-HC and SBA-BR titers.
* To assess the safety profile of Menactra® after each and any vaccination.
Detailed Description:
Study participants will receive 2 doses on Menactra® vaccine at 3 to 6 months apart and will be monitored for safety and immunogenicity.
The planned duration of each subject's participation in the trial will be from 118 to 215 days.
The planned duration of each subject's participation in the trial will be from 118 to 215 days.
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?: