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NCT02563093 · ClinicalTrials.gov registry record · Phase 4

Study of Fluzone® Quadrivalent, Fluzone® Intradermal Quadrivalent, and Fluzone® High-Dose, Influenza Vaccines in Adults

A Phase 4 study of Influenza, sponsored by Sanofi Pasteur, a Sanofi Company.

Completed
Registry status
Phase 4
Development phase
208
Enrollment target
4
Study locations

NCT02563093: Completed Phase 4 study of Influenza, sponsored by Sanofi Pasteur, a Sanofi Company.

NCT02563093 is a Phase 4 study of Influenza that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 208 participants, below the 36,803-participant average among 156 other Influenza trials with a reported enrollment target (99% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02563093, a Phase 4 study of Influenza, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.

COMPLETED
Registry status
Phase 4
Development phase
208 participants
Enrollment target
4
Study locations

Study 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.

Primary Outcome

Solicited injection-site reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Shivering. Grade 3 solicited injection-site reactions: Pain, Significant; prevents daily activity. Erythema, Swelling, Induration, and Ecchymosis \>100 mm. Grade 3 solicited systemic reactions: Fever, ≥ 39.0°C or ≥ 102.1°F; Headache, Malaise, Myalgia, and Shivering, Significant; prevents daily activity. A participant (18 to \< 65 Years) w

Conditions Studied

Influenza

Interventions

  • BIOLOGICAL Fluzone Quadrivalent vaccine, 2015-2016 formulation, No Preservative
  • BIOLOGICAL Fluzone Intradermal Quadrivalent vaccine, 2015-2016 formulation
  • BIOLOGICAL Fluzone High-Dose vaccine, 2015-2016 formulation

Study Locations (4)

California

  • - Santa Rosa

Iowa

  • - Council Bluffs

Louisiana

  • - Metairie

Ohio

  • - Cincinnati

Trial Details

FieldValue
Enrollment Target 208 participants
Start Date 2015-09
Est. Completion 2016-07
Phase Phase 4
Sanofi Pasteur, a Sanofi Company

153 total trials

What the finished NCT02563093 record still lists

NCT02563093 is an interventional study that assigns participants to a tested intervention. The registered 208 participants enrollment target is mid-sized for trials with a published cap, below the 36,803-participant average among 156 other Influenza trials with a reported enrollment target (99% lower).

The record links to 1 condition, with Influenza appearing as the primary indexed condition, and to 3 interventions - of which Fluzone Quadrivalent vaccine, 2015-2016 formulation, No Preservative is the first listed.

NCT02563093 reports a single indexed study location in California, Iowa, Louisiana.

Frequently Asked Questions

What is clinical trial NCT02563093 about?

NCT02563093 is a clinical study titled "Study of Fluzone® Quadrivalent, Fluzone® Intradermal Quadrivalent, and Fluzone® High-Dose, Influenza Vaccines in Adults". 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...

What is the current status of trial NCT02563093?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 208 participants. The study started on 2015-09. Estimated completion is 2016-07.

What conditions does trial NCT02563093 study?

This clinical trial studies the following conditions: Influenza.

What interventions are being tested in trial NCT02563093?

The interventions under investigation include: Fluzone Quadrivalent vaccine, 2015-2016 formulation, No Preservative (BIOLOGICAL), Fluzone Intradermal Quadrivalent vaccine, 2015-2016 formulation (BIOLOGICAL), Fluzone High-Dose vaccine, 2015-2016 formulation (BIOLOGICAL).

Who is sponsoring clinical trial NCT02563093?

This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02563093 being conducted?

This trial has 4 study locations across California, Iowa, Louisiana, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Influenza

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT02563093's enrollment target sits among peer trials

208 81st of 156 higher than 76 of 156 other Influenza trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Influenza trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT02563093, the US trial registry maintained by the National Library of Medicine. NCT02563093 (mid enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.