Ignite Creation Date:
2024-05-05 @ 5:21 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00436007
Status:
COMPLETED
Last Update Posted:
2018-08-16
First Post:
2007-02-15
Brief Title:
Safety and Immunogenicity Study of GSK Biologicals Malaria Vaccine 257049 When Incorporated Into an EPI Regimen
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Safety and Immunogenicity Study of GSK Biologicals Investigational Vaccination Regimen Malaria Vaccine 257049 When Incorporated Into an Expanded Program on Immunization EPI Regimen That Includes Tritanrix HepBHib OPV Measles and Yellow Fever Vaccination in Infants
Status:
COMPLETED
Status Verified Date:
2017-04
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:
This study is being done to assess the possibility of the potential integration of malaria vaccine into the EPI regimen It will evaluate whether the malaria vaccine is safe and immunogenic in infants aged 6 to 10 weeks at first dose when co-administered with other EPI vaccine antigens The Protocol Posting has been updated in order to comply with the FDA Amendment Act Sep 2007
Detailed Description:
Two vaccination schedules will be studied which constitutes the two alternative three dose regimens for the malaria candidate vaccine 257049 integration into EPI The co-administered EPI vaccines include GSK Biologicals Tritanrix-HepBHiberix a measles vaccine depending on the supply availability Aventis Pasteurs Yellow Fever vaccine Stamaril and GSK Biologicals Oral Polio vaccine Polio Sabin Tuberculosis vaccine Bacillus of Calmette and Guerin BCG will be administered according to national medical practice and will not be administered as part of this protocol but will be documented
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