Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00169507
Status:
COMPLETED
Last Update Posted:
2017-05-30
First Post:
2005-09-12
Brief Title:
Study of Immunological Memory Induced in Children by a Full 4 Dose Vaccination Schedule of 11 Valent Pneumococcal Conjugate Vaccine by Giving 1 Dose of Aventis Pasteurs 23-valent Pneumococcal Polysaccharide Vaccine Pneumo 23
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Phase III Multicentric Open Study to Evaluate Immunological Memory Induced by 3-dose Primary Vaccination Followed by Booster Dose of GSK Biologicals 11-valent Conjugate Pneumococcal Vaccine Compared to Unprimed Subjects by Giving 1 Dose of Aventis Pasteurs Pneumo 23
Status:
COMPLETED
Status Verified Date:
2017-05
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:
Evaluate the immunological memory induced by 4 doses of GSK Biologicals 11valent pneumococcal vaccine study antibody persistence 30 months after the 4 dose vaccination with GSK Biologicals 11-valent pneumococcal vaccine in Undeca-Pn-010 study
Detailed Description:
Primed group 50 subjects who previously received 4 doses of GSK Biologicals 11Pn-PD vaccine will receive 1 dose of Pneumo 23 Unprimed group Control 50 subjects who received GSK Biologicals Havrix vaccine will receive 1 dose of Pneumo 23
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