A phase II, randomized, observer blind study to evaluate the safety and immunogenicity of three different vaccination schedules employing two formulations of the monovalent A/California/7/2009 (H1N1)v-like candidate vaccine adjuvanted with AS03 and the monovalent A/California/7/2009 (H1N1)v-like candidate vaccine formulated without adjuvant in subjects aged 10 to less than 18 years.

Trial Profile

A phase II, randomized, observer blind study to evaluate the safety and immunogenicity of three different vaccination schedules employing two formulations of the monovalent A/California/7/2009 (H1N1)v-like candidate vaccine adjuvanted with AS03 and the monovalent A/California/7/2009 (H1N1)v-like candidate vaccine formulated without adjuvant in subjects aged 10 to less than 18 years.

Completed
Phase of Trial: Phase II

Latest Information Update: 02 Feb 2017

At a glance

  • Drugs Influenza A virus vaccine-H1N1 (Primary) ; AS03A; AS03B
  • Indications Influenza A virus H1N1 subtype
  • Focus Pharmacodynamics
  • Sponsors GlaxoSmithKline; GlaxoSmithKline Biologicals
  • Most Recent Events

    • 16 Nov 2013 Results published in Vaccine.
    • 17 Mar 2012 Official title amended as reported by European Clinical Trials Database.
    • 17 Mar 2012 Actual end date (Dec 2010) added as reported by European Clinical Trials Database.
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