CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 120 enrolled
Drug / intervention
Split, Inactivated, Trivalent Influenza vaccine (Fluzone®)biological
Likely dose
Split, Inactivated, Trivalent Influenza vaccine (Fluzone®) 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/NCT00743275
NCT00743275Phase 4Completed
CompareCT.gov

Immunogenicity and Safety Among Adults of the Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2008-2009 Formulation (Intramuscular Route)

Sanofi Pasteur, a Sanofi Company·interventional·Posted Aug 28, 2008·Updated May 16, 2016

In Brief

A Phase 4 clinical trial evaluating Split, Inactivated, Trivalent Influenza vaccine (Fluzone®) for Influenza. Completed, enrolled 120 participants across 1 site.

Detailed Summary

To describe the safety of the inactivated, split-virion influenza vaccine, 2008-2009 formulation. To evaluate the compliance, in terms of immunogenicity, of the inactivated, split-virion influenza vaccine 2008-2009 formulation with the requirements of the Committee for Human Medicinal Products (CHMP) Note for Guidance (NfG) CPMP/BWP/214/96.

Study Details

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

Timeline

Phase 4CompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 28, 2008
Enrollment StartAug 1, 2008
Primary CompletionNov 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 17.8 years ago

Interventions

Split, Inactivated, Trivalent Influenza vaccine (Fluzone®)biological

0.5 mL, intramuscular