Viewing Study NCT00311428



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Study NCT ID: NCT00311428
Status: COMPLETED
Last Update Posted: 2006-09-14
First Post: 2006-04-03

Brief Title: Safety and Immunogenicity of Three Commercially Available Influenza Vaccines in Children Aged 6 to 36 Months
Sponsor: Novartis
Organization: Novartis

Study Overview

Official Title: A Phase IV Observer-Blind Randomized Parallel Groups Single-Center Exploratory Clinical Study to Evaluate the Immunogenicity and Safety of Two 025 mL Intramuscular Doses of Three Commercially Available Influenza Vaccines in Healthy Subjects Aged 6 to 36 Months
Status: COMPLETED
Status Verified Date: 2006-09
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 phase IV protocol is designed to evaluate the safety clinical tolerability and immunogenicity of the 2005-2006 formulation of three widely used conventional influenza vaccines in children aged 6 to 35 months
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
Secondary IDs
Secondary ID Type Domain Link
EUDRACT 2004-001952-35 None None None