Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00258895
Status:
COMPLETED
Last Update Posted:
2016-04-14
First Post:
2005-11-24
Brief Title:
Safety and Immunogenicity of DAPTACEL as 5th Dose in Children 4 to 6 Years Old After 4 Doses of Pentacel or DAPTACEL
Sponsor:
Sanofi Pasteur a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
Safety and Immunogenicity of DAPTACEL Administered as a 5th Dose in 4 to 6-Year-Old Children Previously Immunized With DAPTACEL or Pentacel
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:
Primary Objectives
1 To present the safety profile after a 5th dose of DAPTACEL in children 4 to 6 years of age who have previously received 4 doses of DAPTACEL or Pentacel
2 To present the pre-Dose 5 and post-Dose 5 antibody responses to the antigens in DAPTACEL in children 4 to 6 years of age who have previously received 4 doses of DAPTACEL or Pentacel
Observational Objectives
1 To compare under equivalence criteria the pre-Dose 5 and post-Dose 5 antibody responses to the antigens in DAPTACEL in children 4 to 6 years of age who have previously received 4 doses of DAPTACEL or Pentacel
2 To present the pre-vaccination anti-poliovirus GMTs and seroprotection rates
3 To present the post-vaccination anti-poliovirus GMTs and seroprotection rates among subjects receiving a 4th dose of IPV concurrently with the 5th dose of DAPTACEL and a 2nd dose of MMR
1 To present the safety profile after a 5th dose of DAPTACEL in children 4 to 6 years of age who have previously received 4 doses of DAPTACEL or Pentacel
2 To present the pre-Dose 5 and post-Dose 5 antibody responses to the antigens in DAPTACEL in children 4 to 6 years of age who have previously received 4 doses of DAPTACEL or Pentacel
Observational Objectives
1 To compare under equivalence criteria the pre-Dose 5 and post-Dose 5 antibody responses to the antigens in DAPTACEL in children 4 to 6 years of age who have previously received 4 doses of DAPTACEL or Pentacel
2 To present the pre-vaccination anti-poliovirus GMTs and seroprotection rates
3 To present the post-vaccination anti-poliovirus GMTs and seroprotection rates among subjects receiving a 4th dose of IPV concurrently with the 5th dose of DAPTACEL and a 2nd dose of MMR
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