Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00362336
Status:
COMPLETED
Last Update Posted:
2014-05-02
First Post:
2006-08-08
Brief Title:
Comparison of DTaP-IPV-Hep B-PRPT Combined Vaccine to CombAct-HIB Concomitantly Given With Engerix B Paediatric and OPV
Sponsor:
Sanofi Pasteur a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
Immunogenicity Study of a DTaP-IPV-Hep B-PRPT Combined Vaccine in Comparison to CombAct-HIB Concomitantly Administered With Engerix B Paediatric and OPV at 6 10 and 14 Weeks of Age in South African Infants
Status:
COMPLETED
Status Verified Date:
2014-04
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:
The purpose of this study is to document the immunological response to the investigational hexavalent vaccine at the 6 10 and 14 weeks schedule
The primary objective is to demonstrate that the hexavalent DTaP-IPV-HB-PRPT combined vaccine does not induce lower immune responses than CombAct-HIB with Engerix B Paediatric and OPV in terms of seroprotection rates to Diphtheria D Tetanus T polio Hepatitis B HB and Polyribosyl ribitol phosphate PRP one month after a 3-dose primary series 6 10 and 14 weeks with no HB vaccination at birth
The secondary Objectives are
To describe the safety in terms of any adverse events in the first 28 days after each injection and any serious adverse events during the entire trial
To describe Immunogenicity after the primary series and prior to and after a booster vaccination
The primary objective is to demonstrate that the hexavalent DTaP-IPV-HB-PRPT combined vaccine does not induce lower immune responses than CombAct-HIB with Engerix B Paediatric and OPV in terms of seroprotection rates to Diphtheria D Tetanus T polio Hepatitis B HB and Polyribosyl ribitol phosphate PRP one month after a 3-dose primary series 6 10 and 14 weeks with no HB vaccination at birth
The secondary Objectives are
To describe the safety in terms of any adverse events in the first 28 days after each injection and any serious adverse events during the entire trial
To describe Immunogenicity after the primary series and prior to and after a booster vaccination
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