CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 31 enrolled
Drug / intervention
Influenza Virus Vaccine (Fluzone®) +1 morebiological
Likely dose
Influenza Virus Vaccine (Fluzone®) 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/NCT00389857
NCT00389857Phase 4Completed

Annual Study for Serum Collection and Evaluation of Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Influenza Virus Vaccine (2006-2007 Formulation)

Sanofi Pasteur, a Sanofi Company·interventional·Posted Oct 19, 2006·Updated Apr 14, 2016

In Brief

A Phase 4 clinical trial evaluating Influenza Virus Vaccine (Fluzone®) for Influenza. Completed, enrolled 31 participants across 1 site.

Detailed Summary

To provide Centers for Biologics Evaluation and Research (CBER) with sera collected from healthy children receiving the 2006-2007 formulation of the inactivated, split-virion influenza vaccine Fluzone® for further study by the Food and Drug Administration (FDA), Center for Disease Control and Prevention (CDC) and World Health Organization (WHO).

Study Details

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

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 19, 2006
Enrollment StartOct 1, 2006
Primary CompletionSep 1, 2007
Study CompletionJul 1, 2008
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 19.7 years ago

Interventions

Influenza Virus Vaccine (Fluzone®)biological

0.25 mL, Intramuscular (infant/children dose)

Influenza Virus Vaccine (Fluzone®)biological

0.25 mL, Intramuscular (infant/children dose)