Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00343421
Status:
COMPLETED
Last Update Posted:
2016-06-03
First Post:
2006-06-21
Brief Title:
Study to Compare Pediacel to Infanrix-IPVHib When Both Are Co-Administered With Prevenar in Infants and Toddlers
Sponsor:
Sanofi Pasteur a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
Immunogenicity and Safety of PEDIACEL a Combined Diphtheria Tetanus Five Component Acellular Pertussis Inactivated Poliomyelitis and Haemophilus Influenzae Type b Conjugate Vaccine Adsorbed Compared to Infanrix-IPVHib When Both Vaccines Are Co-Administered With Prevenar to Infants and Toddlers at 2 3 4 and 12-18 Months of Age
Status:
COMPLETED
Status Verified Date:
2016-06
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 safety and immunogenicity of Pediacel in infants and toddlers when given at 234 and 12-18 months of age
Primary Objectives
To compare the post-dose 3 immunogenicity of Pediacel to Infanrix-IPVHib when both are co-administered with Prevenar
To describe the post-dose 3 pertussis antibody responses
Secondary Objectives
To compare the post-dose 4 immunogenicity of Pediacel to Infanrix-IPVHib when both are co-administered with Prevenar
To describe the safety after each vaccination following co-administration with Prevenar
Primary Objectives
To compare the post-dose 3 immunogenicity of Pediacel to Infanrix-IPVHib when both are co-administered with Prevenar
To describe the post-dose 3 pertussis antibody responses
Secondary Objectives
To compare the post-dose 4 immunogenicity of Pediacel to Infanrix-IPVHib when both are co-administered with Prevenar
To describe the safety after each vaccination following co-administration with Prevenar
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