Ignite Creation Date:
2024-05-05 @ 5:10 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00401531
Status:
COMPLETED
Last Update Posted:
2014-04-01
First Post:
2006-11-16
Brief Title:
Comparison of a DTaP-IPV-HB-PRPT Combined Vaccine to Infanrix-Hexa When Administered With Prevnar in Thai Infants
Sponsor:
Sanofi Pasteur a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
Immunogenicity Study of a DTaP IPV Hep B PRP T Combined Vaccine in Comparison to Infanrix Hexa Both Concomitantly Administered With Prevnar at 2 4 and 6 Months of Age in Thai Infants
Status:
COMPLETED
Status Verified Date:
2014-02
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 the study is to provide immunogenicity and safety data of the investigational hexavalent vaccine when it is given concomitantly the same day at separate injection sites with Prevnar according to the 2-4-6 month immunization schedule following one dose of HB vaccine at birth
Primary Objective
To demonstrate that the hexavalent DTaP-IPV-HB-PRPT combined vaccine induces an immune response that is at least as good as the response following Infanrix-Hexa in terms of seroprotection rates to HB and PRP one month after a 3 dose primary series 2 4 and 6 months when co-administered with Prevnar
Secondary Objectives
Immunogenicity
To describe in each group the immunogenicity parameters to each vaccine component for DTaP-IPV-HB-PRPT and Infanrix-Hexa one month after the third dose of the primary series
Safety
To describe the overall safety after each injection
Primary Objective
To demonstrate that the hexavalent DTaP-IPV-HB-PRPT combined vaccine induces an immune response that is at least as good as the response following Infanrix-Hexa in terms of seroprotection rates to HB and PRP one month after a 3 dose primary series 2 4 and 6 months when co-administered with Prevnar
Secondary Objectives
Immunogenicity
To describe in each group the immunogenicity parameters to each vaccine component for DTaP-IPV-HB-PRPT and Infanrix-Hexa one month after the third dose of the primary series
Safety
To describe the overall safety after each injection
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