CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 124 enrolled
Drug / intervention
Inactivated, Split-Virion Influenza Virusbiological
Likely dose
Inactivated, Split-Virion Influenza Virus 0.5 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/NCT00524940
NCT00524940Phase 2Completed

Immunogenicity and Safety of the Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2007-2008 Formulation (Intramuscular Route)

Sanofi Pasteur, a Sanofi Company·interventional·Posted Sep 5, 2007·Updated Apr 14, 2016

In Brief

A Phase 2 clinical trial evaluating Inactivated, Split-Virion Influenza Virus for Influenza. Completed, enrolled 124 participants across 1 site.

Detailed Summary

Objective 1:To describe the safety of the inactivated, split-virion influenza vaccine, Northern Hemisphere (NH) 2007-2008 formulation. Objective 2: To describe the immunogenicity, of Fluzone, inactivated, split virion influenza vaccine NH 2007-2008 formulation. Objective 3: Serum Collection - To submit remaining available sera to Center for Biologics Evaluation and research (CBER) for further analysis by the Food and Drug Administration (FDA), the Center for Disease Control and Prevention (CDC), and the World Health Organization (WHO) to support selection and recommendation of antigen strains for subsequent influenza vaccines.

Study Details

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

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 5, 2007
Enrollment StartAug 1, 2007
Primary CompletionSep 1, 2007
Study CompletionDec 1, 2007
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 18.8 years ago

Interventions

Inactivated, Split-Virion Influenza Virusbiological

0.5 mL, Intramuscular