Ignite Creation Date:
2024-05-05 @ 4:51 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00327522
Status:
COMPLETED
Last Update Posted:
2008-10-13
First Post:
2006-05-17
Brief Title:
Safety and Immune Response Study of an Investigational Pneumococcal Vaccine
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
An Open Phase III Study to Evaluate the Safety Reactogenicity and Immunogenicity of GSK Biologicals 11PCV Vaccine Given as a 2-Dose Vaccination in Adults Aged 18-40 Years Old
Status:
COMPLETED
Status Verified Date:
2008-10
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 evaluate the safety and immunogenicity of two doses of GSK Biologicals 11 PCV vaccine when given to healthy subjects aged 18 to 40 years
Detailed Description:
The study is open and subjects will receive two vaccine doses of GSK Biologicals 11 PCV vaccine Five blood samples will be taken prior to and one month after each vaccine dose and 2 weeks after dose 2
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