Trial intelligence / Profile preview

Immunogenicity and Safety of Intradermal Influenza Vaccine (2009-2010)

NCT00945438Phase 2

Key facts

Status
Completed
Start
May 2009
Primary completion
Jun 2009
Countries
1
Sponsor
Sanofi
Modality
Recombinant Proteins and Enzymes, Vaccines & Immunotherapeutics
Drugs
IDflu
Conditions
influenza
01

Overview

Phase 2, open-label trial of IDflu in influenza (2 arms), sponsored by Sanofi. Primary endpoints: Immunogenicity of Intradermal Influenza vaccine and Safety of Intradermal Influenza vaccine. Started May 2009; status: completed.

02

Design

2 arms
Study design
Non-randomizedOpen-label
  • Group 1 (18-59 years)

    Participants aged 18 to 59 years receiving 0.1 mL Intradermal vaccine.

  • Group 2 (60+ years)

    Participants aged 60 years or older receiving 0.5 mL Intradermal vaccine.

03

Who it enrols

Adults 18 years and older, including elderly, without acute illness, immunodeficiency, bleeding disorders, or recent vaccination.

04

Endpoints

Primary

  • Immunogenicity of Intradermal Influenza vaccine

  • Safety of Intradermal Influenza vaccine

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