Ignite Creation Date:
2024-05-05 @ 12:11 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00263692
Status:
COMPLETED
Last Update Posted:
2016-09-15
First Post:
2005-12-08
Brief Title:
Comparison of GSK Biologicals DTaP-IPV Candidate Vaccine to DTaP and IPV Separately Administered Vaccines in Terms of Immune Response and Safety
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Open Randomized Phase II Clinical Trial to Compare the Immunogenicity and Safety of a Booster Dose of GSK Biologicals DTaP-IPV Vaccine Infanrix-IPV Co-administered With a Booster Dose of Merck and Companys M-M-RII to That of Separate Injections of GSK Biologicals DTaP Vaccine Infanrix Aventis Pasteurs IPV IPOL and M-M-RII Administered as Booster Doses to Healthy Children 4 to 6 Years of Age
Status:
COMPLETED
Status Verified Date:
2016-09
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 aims of this study are to compare the immunogenicity and safety of the GSK Biologicals combined DTaP-IPV vaccine with separate administration of DTaP and IPV vaccines when administered as a fifth dose of acellular pertussis vaccine to children aged 4 to 6 years when co-administered with MMR vaccine in subjects who had previously received four doses of Infanrix three doses of poliovirus-containing vaccine and MMR 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