Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00259337
Status:
COMPLETED
Last Update Posted:
2012-04-16
First Post:
2005-11-24
Brief Title:
Immunogenicity and Safety of Pentaxim in an Indian Population
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
Immunogenicity and Safety of the Sanofi Pasteur DTacP-IPVPRPT Combined Vaccine PENTAXIM Given as a Three-Dose Primary Vaccination at 6 10 and 14 Weeks of Age and Followed by a Booster Dose at 18-19 Months of Age in Healthy Infants in India
Status:
COMPLETED
Status Verified Date:
2012-04
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 present clinical study will assess the immunogenicity as the primary objective and the reactogenicity as the secondary objective of Aventis Pasteurs DTacP-IPV PRPT combined vaccine Pentavac or Pentaxim as a three-dose primary vaccination at 6 10 and 14 weeks of age followed by a booster dose during the second year of life
Safety
This study will describe the safety after each dose of the primary series of the studys combined vaccine Pentaxim
Safety
This study will describe the safety after each dose of the primary series of the studys combined vaccine Pentaxim
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