A Multi-center, Randomized, Single-blind, Dose-Ranging Study to Evaluate Immunogenicity, Safety and Tolerability of Different Doses of Adjuvanted Cell-Derived, Inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Japanese Pediatric Subjects.

Trial Profile

A Multi-center, Randomized, Single-blind, Dose-Ranging Study to Evaluate Immunogenicity, Safety and Tolerability of Different Doses of Adjuvanted Cell-Derived, Inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Japanese Pediatric Subjects.

Completed
Phase of Trial: Phase II/III

Latest Information Update: 31 May 2016

At a glance

  • Drugs Influenza A virus vaccine-H1N1; MF 59
  • Indications Influenza A virus H1N1 subtype
  • Focus Adverse reactions; Pharmacodynamics; Registrational
  • Most Recent Events

    • 31 May 2011 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
    • 25 Jun 2010 Primary endpoint 'Seroconversion rate' has been met.
    • 25 Jun 2010 Primary endpoint 'Geometric mean antibody titre' has been met.
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