CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 33 enrolled
Drug / intervention
Influenza virus vaccine (Pediatric formulation)biological
Likely dose
Influenza virus vaccine (Pediatric 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/NCT00836953
NCT00836953Phase 4Completed

A Trial for the Collection of Sera in Healthy Children Receiving Influenza Virus Vaccine USP Trivalent Types A and B (Zonal Purified Subvirion) Fluzone® 2003/2004

Sanofi Pasteur, a Sanofi Company·interventional·Posted Feb 4, 2009·Updated Apr 14, 2016

In Brief

A Phase 4 clinical trial evaluating Influenza virus vaccine (Pediatric formulation) for Influenza. Completed, enrolled 33 participants across 1 site.

Detailed Summary

To describe the safety findings from Days 0 to 44 following injection of the 2003-2004 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 findings from Days 0 to 44 following injection of the 2003-2004 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 4, 2009
Enrollment StartSep 1, 2003
Primary CompletionJan 1, 2004
Study CompletionJul 1, 2004
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 17.4 years ago

Interventions

Influenza virus vaccine (Pediatric formulation)biological

0.25 mL, Intramuscular