Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00148941
Status:
COMPLETED
Last Update Posted:
2020-02-05
First Post:
2005-09-07
Brief Title:
Immune Response and Safety Comparison of 3 Lots of GSK Biologicals DTaP-IPV Candidate Vaccine to DTaP IPV Vaccines
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Safety Immunogenicity and Consistency of 3 Manufacturing Lots of DTaP-IPV Vaccine Versus Separate Injections of GSK Biologicals DTaP Aventis Pasteurs IPV Administered as Booster Doses to Healthy Children 4-6 Years Each Co-administered With Mercks MMR Vaccine
Status:
COMPLETED
Status Verified Date:
2020-01
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 trial are to demonstrate the consistency of three manufacturing lots of GSK Biologicals DTaP-IPV candidate vaccine in terms of immunogenicity and to evaluate the non-inferiority of GSK Biologicals DTaP-IPV vaccine with respect to immunogenicity and safety compared to the control vaccines separate injections of GSK Biologicals DTaP vaccine Infanrix and Aventis Pasteurs IPV vaccine IPOL when administered as a 5th dose of DTaP and a 4th dose of inactivated poliovirus vaccine in subjects 4 to 6 years of age Vaccines will be co-administered with the second dose of M-M-RII which is recommended at this age Concomitant administration of a US-licensed influenza vaccine will be allowed according to seasonal availability of vaccine and at the discretion of the investigator
Detailed Description:
Investigational groups 3 each receive one of 3 lots of DTaP-IPV vaccine
Control US-licensed DTaP Infanrix US-licensed IPV IPOL vaccines administered in separate injections
Two study visits one month apart for a subset of subjects Safety and Immunogenicity subset with a blood draw at each visit All other subjects will have one visit
A telephone contact 4-6 days after vaccination for all subjects a telephone contact 31-38 days after vaccination for the Safety only subset and a telephone contact for all subjects during the extended safety follow-up phase 5 months following the active phase
Control US-licensed DTaP Infanrix US-licensed IPV IPOL vaccines administered in separate injections
Two study visits one month apart for a subset of subjects Safety and Immunogenicity subset with a blood draw at each visit All other subjects will have one visit
A telephone contact 4-6 days after vaccination for all subjects a telephone contact 31-38 days after vaccination for the Safety only subset and a telephone contact for all subjects during the extended safety follow-up phase 5 months following the active phase
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