Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00135564
Status:
COMPLETED
Last Update Posted:
2016-09-16
First Post:
2005-08-25
Brief Title:
Study to Evaluate GlaxoSmithKline GSK Biologicals MenC-TT and Hib-MenC-TT or Meningitec in Healthy Toddlers
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Evaluate the Persistence and Immune Memory Induced by a Primary Vaccination Course With GSK Biologicals MenC-TT 1 Formulation GSK Biologicals Hib-MenC-TT 2 Formulations or Meningitec in Healthy Toddlers Aged 12-15 Months Primed in Study 711202001
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 booster vaccination study is to evaluate the persistence and immune memory induced by a three-dose primary vaccination course with GSK Biologicals MenC-TT Neisseria meningitidis group C polysaccharide-tetanus toxoid and GSK Biologicals Hib-MenC-TT Haemophilus influenzae type b-MenC-TT or Meningitec vaccines in healthy toddlers aged 12-15 months by giving them a 15th dose of Mencevax ACWY
Detailed Description:
The study is an extension of the primary vaccination study 711202001 MenC-TT-001 It comprises 5 groups 4 parallel groups of toddlers vaccinated in study 711202001 group vaccinated with Meningitec is control group 1 and 1 group of naive subjects no previous vaccination against MenC disease control group 2 All subjects receive 15th dose Mencevax ACWY and a concomitant dose of Infanrix hexa 2 blood samples prior to and 1 month after vaccination
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