Ignite Creation Date:
2024-05-05 @ 5:06 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00384397
Status:
COMPLETED
Last Update Posted:
2016-04-14
First Post:
2006-10-05
Brief Title:
A Study of 2 Doses of Menactra a Meningococcal Conjugate Vaccine in Healthy Toddlers
Sponsor:
Sanofi Pasteur a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
An Immunogenicity and Safety Evaluation of Two Doses of Menactra Meningococcal Groups A C Y and W-135 Polysaccharide Diphtheria Toxoid Conjugate Vaccine Given to Healthy Subjects at 9 and 12 Months of Age
Status:
COMPLETED
Status Verified Date:
2016-04
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 is a Phase III modified single-blind randomized parallel-group multicenter comparative trial in the United States designed to evaluate the immunogenicity and safety of two doses of Menactra vaccine administered alone and concomitantly with other routine pediatric vaccines typically administered between 12 and 15 months of age
Primary Objective
To evaluate the antibody responses to meningococcal serogroups A C Y and W-135
Secondary Objectives
Immunogenicity
To evaluate the antibody responses to meningococcal serogroups A C Y and W-135 when Menactra vaccine is administered alone or concomitantly with Hib and MMRV vaccines
To evaluate the antibody responses to meningococcal serogroups A C Y and W-135 when Menactra vaccine is administered alone or concomitantly with PCV vaccine
Safety
- To describe the safety profile within 7 and 30 days of each vaccination and serious adverse events SAEs throughout the course of the study
Primary Objective
To evaluate the antibody responses to meningococcal serogroups A C Y and W-135
Secondary Objectives
Immunogenicity
To evaluate the antibody responses to meningococcal serogroups A C Y and W-135 when Menactra vaccine is administered alone or concomitantly with Hib and MMRV vaccines
To evaluate the antibody responses to meningococcal serogroups A C Y and W-135 when Menactra vaccine is administered alone or concomitantly with PCV vaccine
Safety
- To describe the safety profile within 7 and 30 days of each vaccination and serious adverse events SAEs throughout the course of the study
Detailed Description:
None
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