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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 Pediatric Subjects 3 to < 9 Years of Age

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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 Pediatric Subjects 3 to < 9 Years of Age

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 14 Jan 2020

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At a glance

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

    • Most Recent Events

    • 14 Oct 2015 Treatment arms increased from 2 to 8, added a dosage of 15 micro-gram A/H1N1-SOIV.
    • 26 Jan 2011 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
    • 17 Nov 2009 Interim results reported in a Novartis media release.

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