CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 208 enrolled
Drug / intervention
Fluzone Quadrivalent vaccine, 2015-2016 formulation, No Preservative +3 morebiological
Likely dose
Fluzone Quadrivalent vaccine, 2015-2016 formulation, No Preservative 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/NCT02563093
NCT02563093Phase 4Completed
CompareCT.gov

Safety and Immunogenicity Among Adults of Fluzone® Quadrivalent, Fluzone® Intradermal Quadrivalent, and Fluzone® High-Dose, Influenza Vaccines, 2015-2016 Formulations

Sanofi Pasteur, a Sanofi Company·interventional·Posted Sep 29, 2015·Updated Dec 12, 2016

In Brief

A Phase 4 clinical trial evaluating Fluzone Quadrivalent vaccine, 2015-2016 formulation, No Preservative, Fluzone Intradermal Quadrivalent vaccine, 2015-2016 formulation, and 1 other intervention for Influenza. Completed, enrolled 208 participants across 4 sites.

Detailed Summary

The aim of the study is to evaluate the safety and immunogenicity of the 2015-2016 formulations of Fluzone Quadrivalent and Fluzone Intradermal Quadrivalent vaccines in adults 18 to \< 65 years of age, and of the 2015-2016 formulations of Fluzone Quadrivalent and Fluzone High-Dose vaccines in adults ≥ 65 years of age. Primary Objective: \- To describe the safety of the 2015-2016 formulations of Fluzone Quadrivalent and Fluzone Intradermal Quadrivalent vaccines in adults 18 to \< 65 years of age and the safety of the 2015-2016 formulations of Fluzone Quadrivalent and Fluzone High-Dose vaccines in adults ≥ 65 years of age. Observational Objectives: * To describe the immunogenicity of the 2015-2016 formulations of Fluzone Quadrivalent and Fluzone Intradermal Quadrivalent vaccines in adults 18 to \< 65 years of age and the immunogenicity of the 2015-2016 formulations of Fluzone Quadrivalent and Fluzone High-Dose vaccines in adults ≥ 65 years of age. * To evaluate the compliance, in terms of immunogenicity, of each study vaccine (Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, and Fluzone High-Dose) in the applicable age group with the historical requirements of the Committee for Human Medicinal Products (CHMP) Note for Guidance (NfG) Committee for Propriety Medicinal Products (CPMP) - CHMP NfG CPMP/BWP/214/96.

Study Details

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

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 29, 2015
Enrollment StartSep 1, 2015
Primary CompletionDec 1, 2015
Study CompletionJul 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 10.8 years ago

Interventions

Fluzone Quadrivalent vaccine, 2015-2016 formulation, No Preservativebiological

0.5 mL, Intramuscular (IM)

Fluzone Intradermal Quadrivalent vaccine, 2015-2016 formulationbiological

0.1 mL, Intradermal

Fluzone Quadrivalent vaccine, 2015-2016 formulation, No Preservativebiological

0.5 mL, Intramuscular

Fluzone High-Dose vaccine, 2015-2016 formulationbiological

0.5 mL, Intramuscular