A Multicentric, open label randomised controlled phase II/III study to evaluate the Safety and Immunogenicity of BES Inactivated JE vaccine in healthy greater than or equal to 1 TO 3 year old Indian children.

Trial Profile

A Multicentric, open label randomised controlled phase II/III study to evaluate the Safety and Immunogenicity of BES Inactivated JE vaccine in healthy greater than or equal to 1 TO 3 year old Indian children.

Completed
Phase of Trial: Phase II/III

Latest Information Update: 24 Aug 2016

At a glance

  • Drugs IC 51 (Primary) ; Japanese encephalitis vaccine
  • Indications Japanese encephalitis
  • Focus Adverse reactions; Pharmacodynamics; Registrational
  • Most Recent Events

    • 16 Sep 2011 The study met its primary endpoint, as reported in an Intercell and Biological E Limited media release.
    • 16 Sep 2011 Status changed from active, no longer recruiting to completed, as reported in an Intercell and Biological E Limited media release.
    • 16 Aug 2011 Biological E is moving towards submission for licensure in India, with a planned launch in 2012, according to an Intercell media release.
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