Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00355121
Status:
COMPLETED
Last Update Posted:
2011-08-24
First Post:
2006-07-20
Brief Title:
Study of Menactra in Children Aged 4 to 6 Years When Administered Concomitantly With a Fifth Dose of DAPTACEL
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
Immunogenicity and Safety of Meningococcal Serogroups A C Y and W-135 Polysaccharide Diphtheria Toxoid Conjugate Vaccine Menactra in Children Aged 4 to 6 Years in the US When Administered Concomitantly With a Fifth Dose Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed
Status:
COMPLETED
Status Verified Date:
2011-08
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 evaluate the immunogenicity and safety of the concomitant administration of Menactra vaccine and DAPTACEL vaccine
The main objectives are
Immunogenicity
To evaluate the antibody responses to both vaccines when Menactra vaccine is given concomitantly with DAPTACEL compared to when either vaccine is given alone
Safety
To evaluate the rate of local and systemic reactions when DAPTACEL and Menactra vaccines are administered concomitantly compared to when each vaccine is given alone
The main objectives are
Immunogenicity
To evaluate the antibody responses to both vaccines when Menactra vaccine is given concomitantly with DAPTACEL compared to when either vaccine is given alone
Safety
To evaluate the rate of local and systemic reactions when DAPTACEL and Menactra vaccines are administered concomitantly compared to when each vaccine is given alone
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