A Phase III, Observer-Blind, Randomized, Multi-Center Study to Evaluate Safety, Tolerability and Immunogenicity of a Single Intramuscular Dose of a Trivalent Subunit Influenza Vaccine Produced in Mammalian Cell Culture and of a Trivalent Subunit Influenza Vaccine Produced in Embryonated Hen Eggs, in Healthy Adult and Elderly Subjects.

Trial Profile

A Phase III, Observer-Blind, Randomized, Multi-Center Study to Evaluate Safety, Tolerability and Immunogenicity of a Single Intramuscular Dose of a Trivalent Subunit Influenza Vaccine Produced in Mammalian Cell Culture and of a Trivalent Subunit Influenza Vaccine Produced in Embryonated Hen Eggs, in Healthy Adult and Elderly Subjects.

Completed
Phase of Trial: Phase III

Latest Information Update: 25 Jan 2016

At a glance

  • Drugs Influenza vaccine (Optaflu) (Primary) ; Influenza virus vaccine; Pneumococcal vaccine
  • Indications Influenza virus infections
  • Focus Adverse reactions; Pharmacodynamics; Registrational
  • Sponsors Novartis
  • Most Recent Events

    • 05 Mar 2012 Actual end date (Mar 2005) added as reported by ClinicalTrials.gov (Parent trial: NCT00492063).
    • 15 Sep 2009 Results published in the Journal of Infectious Diseases.
    • 24 Oct 2006 New trial record.
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