A Pivotal Randomized, Single-Blind, Dose-Finding Study to Evaluate Immunogenicity, Safety and Tolerability of Different Formulations of an Adjuvanted and Non-Adjuvanted Egg-Derived, Inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Adult Subjects 18 or More Years of Age.

Trial Profile

A Pivotal Randomized, Single-Blind, Dose-Finding Study to Evaluate Immunogenicity, Safety and Tolerability of Different Formulations of an Adjuvanted and Non-Adjuvanted Egg-Derived, Inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Adult Subjects 18 or More Years of Age.

Completed
Phase of Trial: Phase II/III

Latest Information Update: 07 Dec 2011

At a glance

  • Drugs Influenza A virus vaccine-H1N1 (Primary)
  • Indications Influenza A virus H1N1 subtype
  • Focus Adverse reactions; Pharmacodynamics; Registrational
  • Sponsors Novartis
  • Most Recent Events

    • 24 May 2011 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
    • 24 May 2011 Actual end date (December 2010) added as reported by ClinicalTrials.gov.
    • 17 Nov 2009 Interim results reported in a Novartis media release.
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