CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 120 enrolled
Drug / intervention
Fluzone Quadrivalent Influenza Vaccinebiological
Likely dose
Not stated in 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/NCT03546192
NCT03546192Phase 4Completed
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Immunogenicity and Safety of Fluzone® Quadrivalent, Southern Hemisphere 2015 Formulation (Intramuscular Route)

Sanofi Pasteur, a Sanofi Company·interventional·Posted Jun 6, 2018·Updated Mar 29, 2022

In Brief

A Phase 4 clinical trial evaluating Fluzone Quadrivalent Influenza Vaccine for Influenza. Completed, enrolled 120 participants across 3 sites.

Detailed Summary

The aim of the study was to assess the immunogenicity and safety of Fluzone Quadrivalent influenza vaccine Southern Hemisphere (SH) 2015 formulation in participants aged 18 to 60 years as well as in participants 61 years or older. The objectives were: * To evaluate the compliance, in terms of immunogenicity, of the Fluzone Quadrivalent influenza vaccine SH 2015 formulation with the requirements of the European Medicines Agency (EMA) Note for guidance (NfG) CPMP/BWP/214/96 * To describe the immunogenicity of the Fluzone Quadrivalent influenza vaccine SH 2015 formulation * To describe the safety of the Fluzone Quadrivalent influenza vaccine SH 2015 formulation

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesPhilippines
Collaborators--

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 6, 2018
Enrollment StartJun 17, 2015
Primary CompletionJul 17, 2015
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 8.1 years ago

Interventions

Fluzone Quadrivalent Influenza Vaccinebiological

0.5-mL, Intramuscular, SH 2015 formulation