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A Phase II, Randomized, Observer-Blind, Multi-Center, Study to Evaluate Safety, Tolerability and Immunogenicity of an Adjuvanted Cell Culture-Derived H5N1 Subunit Influenza Virus Vaccine at Two Different Formulations in Healthy Elderly Subjects

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A Phase II, Randomized, Observer-Blind, Multi-Center, Study to Evaluate Safety, Tolerability and Immunogenicity of an Adjuvanted Cell Culture-Derived H5N1 Subunit Influenza Virus Vaccine at Two Different Formulations in Healthy Elderly Subjects

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 31 Jan 2019

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At a glance

  • Drugs Influenza A virus vaccine-H5N1 (Primary) ; Adjuvants
  • Indications Influenza A virus H5N1 subtype
  • Focus Adverse reactions; Pharmacodynamics
  • Sponsors Novartis Vaccines

    • Most Recent Events

    • 12 Aug 2015 Protocol has been amended in change of study design from single blind to double blind and change in time frames of primary endpoints
    • 22 Jul 2014 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov record.
    • 25 Jun 2013 Planned End Date changed from 1 Apr 2015 to 1 Jun 2014 as reported by ClinicalTrials.gov.

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