At a glance

ClinicalIndex Comparison Record

Phase 4Completed· 30 enrolled

Drug / intervention

Influenza Vaccine 2004-2005 Paediatric Formulation +1 morebiological

Likely dose

Influenza Vaccine 2004-2005 Paediatric Formulation 0.25 mLfrom 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/NCT00831675

NCT00831675Phase 4Completed

Compare CT.gov

Annual Study for Serum Collection and Evaluation of Safety and Immunogenicity Among Healthy Children Receiving Influenza Virus Vaccine Fluzone® 2004-2005

Sanofi Pasteur, a Sanofi Company·interventional·Posted Jan 29, 2009·Updated Apr 14, 2016

In Brief

A Phase 4 clinical trial evaluating Influenza Vaccine 2004-2005 Paediatric Formulation for Influenza. Completed, enrolled 30 participants across 1 site.

Detailed Summary

To describe the safety of the 2004-2005 pediatric formulation of the inactivated, split-virion influenza vaccine Fluzone®, given in the two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to \< 36 months. To describe the immunogenicity of the 2004-2005 inactivated, split-virion influenza vaccine Fluzone®, administered in a two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to \< 36 months

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsInfluenza

CountriesUnited States

Collaborators--

Timeline

Phase 4CompletedFinished

20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartSep 2004

Primary CompletionApr 2006

First PostedJan 2009

TodayJul 2026

First PostedJan 29, 2009

Enrollment StartSep 1, 2004

Primary CompletionApr 1, 2006

TodayJul 2, 2026

Enrollment to primary: 1.6 yearsPosted 17.4 years ago

Interventions

Influenza Vaccine 2004-2005 Paediatric Formulationbiological

0.25 mL (Day 0 and Day 28), Intramuscular

Influenza Vaccine 2004-2005 Paediatric Formulationbiological

0.25 mL (Day 0 and Day 28), Intramuscular