Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00161863
Status:
COMPLETED
Last Update Posted:
2015-05-21
First Post:
2005-09-08
Brief Title:
Safety Study of FSME-IMMUN NEW in Healthy Children and Adolescents Aged 1 to 15 Years
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
Open-label Safety Study of FSME-IMMUN NEW in Healthy Children and Adolescents Aged 1 to 15 Years
Status:
COMPLETED
Status Verified Date:
2015-05
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:
The purpose of this study is to investigate the safety of five consecutive lots of FSME-IMMUN NEW in healthy volunteers The main criterion for investigation is the fever rate after the first vaccination in three different age classes The immunogenicity of 025 ml FSME-IMMUN NEW has been demonstrated in previous clinical studies in children therefore in the present study immunogenicity was investigated in a subgroup only
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