Ignite Creation Date:
2024-05-05 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00119743
Status:
TERMINATED
Last Update Posted:
2017-03-23
First Post:
2005-07-06
Brief Title:
A Efficacy Against Otitis Media in Children With 11 Valent Pneumococcal Vaccine
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Assess in Young Children the Efficacy in Preventing Acute Otitis Media AOM of GSK Biologicals Undecavalent Pneumococcal-protein D Conjugate Vaccine When Administered as a Three Dose Primary Vaccination Course During the First Year of Life With a Booster Dose in the Second Year of Life
Status:
TERMINATED
Status Verified Date:
2017-03
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 study is to assess the efficacy in young children in preventing acute otitis media due to vaccine serotype pneumococcal or non typable Hemophilus influenza following immunization with an 11-valent pneumococcal vaccine according to a 3 dose primary vaccination in the first year of life with booster dose in the second year of life Prophylactic immunization with pneumococcal conjugate vaccine is compared to placebo hepatitis A vaccine
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