CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 520 enrolled
Drug / intervention
Split, Inactivated, Trivalent Influenza Vaccine +3 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00391391
NCT00391391Phase 2Completed
CompareCT.gov

Immunogenicity and Safety of a Split, Inactivated, Trivalent Influenza Vaccine Administered by Intradermal Route in Comparison With Intramuscular Vaccination With Standard Fluzone® in Healthy Infants and Young Children.

Sanofi·interventional·Posted Oct 24, 2006·Updated Dec 1, 2011

In Brief

A Phase 2 clinical trial evaluating Split, Inactivated, Trivalent Influenza Vaccine and Split, Inactivated, Trivalent Influenza Vaccine ( Fluzone® 2006/2007 Formulation) for Orthomyxoviridae Infection and 2 related conditions. Completed, enrolled 520 participants across 19 sites.

Detailed Summary

Primary Objective: To evaluate for each influenza strain the non-inferiority of Investigational Fluzone vaccine to the standard Fluzone® vaccine in healthy subjects aged 6 to 35 months or 3 to 8 years. Secondary Objectives: * To describe the immunogenicity of of Investigational Fluzone vaccine to the standard Fluzone® vaccine in healthy subjects aged 6 to 35 months or 3 to 8 years. * To describe the safety of of Investigational Fluzone vaccine to the standard Fluzone® vaccine in healthy subjects aged 6 to 35 months or 3 to 8 years.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOrthomyxoviridae Infection, Influenza, Myxovirus Infection
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 24, 2006
Enrollment StartOct 1, 2006
Primary CompletionMar 1, 2007
Study CompletionOct 1, 2007
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 19.7 years ago

Interventions

Split, Inactivated, Trivalent Influenza Vaccinebiological

Vaccine (infant dose)

Split, Inactivated, Trivalent Influenza Vaccinebiological

Vaccine (children dose)

Split, Inactivated, Trivalent Influenza Vaccine ( Fluzone® 2006/2007 Formulation)biological

Vaccine (infant dose)

Split, Inactivated, Trivalent Influenza Vaccine ( Fluzone® 2006/2007 Formulation)biological

Vaccine (children dose)