Ignite Creation Date:
2024-05-05 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00500357
Status:
COMPLETED
Last Update Posted:
2011-04-19
First Post:
2007-07-10
Brief Title:
Study Evaluating a 13-valent Pneumococcal Conjugate Vaccine in Elderly Subjects
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Organization:
Wyeth is now a wholly owned subsidiary of Pfizer
Study Overview
Official Title:
A Phase 3 Open-Label Single-Arm Trial Evaluating the Safety Tolerability and Immunogenicity of a Subsequent Dose of 13-valent Pneumococcal Conjugate Vaccine Administered to One Group of Individuals Who Participated in Study 6115A1-500
Status:
COMPLETED
Status Verified Date:
2011-04
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:
This is a follow-up study to the core study NCT00269672 6115A1-500 This study will further evaluate the safety tolerability and immunogenicity of 13-valent pneumococcal conjugate vaccine 13vPnC when administered to subjects who have already received one dose of 13vPnC and one dose of 23-valent pneumococcal polysaccharide vaccine 23vPS one year later This study will determine if a subsequent dose of 13vPnC one year later results in similar or greater immune response bodys ability to protect against disease than that measured after the initial dose of 13vPnC
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