Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00135486
Status:
COMPLETED
Last Update Posted:
2016-09-16
First Post:
2005-08-25
Brief Title:
Study to Evaluate GlaxoSmithKline GSK Biologicals MenC-TT Vaccine and Hib-MenC-TT Vaccine in Infants
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Evaluate Immunogenicity Reactogenicity Safety of GSK Biologicals MenC-TT Vaccine 2 Formulations Given With Infanrix Hexa GSK Biologicals Hib MenC-TT Vaccine 2 Formulations Given With Infanrix Penta to Infants in Mths 345 of Life
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 purpose of this primary vaccination study is to evaluate the immunogenicity safety and reactogenicity of three doses of GSK Biologicals MenC-TT Neisseria meningitidis group C polysaccharide-tetanus toxoid vaccine 2 different formulations and of three doses of GSK Biologicals Hib-MenC-TT Haemophilus influenzae type b-MenC-TT vaccine 2 different formulations when given to infants in their 3rd 4th and 5th months of life Concomitant vaccines were given to all children to complete the vaccination agenda
Detailed Description:
Five parallel treatment groups receiving a 3-dose primary vaccination course MenC-TT vaccine 2 formulations double-blind Infanrix hexa OR Hib-MenC-TT 2 formulations double-blind Infanrix penta OR Meningitec Infanrix hexa control Three blood samples taken before dose 1 and one month after dose 2 and dose 3
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