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A Double-Blind, Randomized, Controlled Trial to Evaluate the Safety, Immunogenicity, and Efficacy of Standard Dose Quadrivalent Inactivated Influenza Vaccine, and Double Dose Quadrivalent Inactivated Influenza Vaccine in HIV-Infected and HIV-Uninfected Pregnant Women in a Malaria-Endemic Area of Rural Western Kenya

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Trial Profile

A Double-Blind, Randomized, Controlled Trial to Evaluate the Safety, Immunogenicity, and Efficacy of Standard Dose Quadrivalent Inactivated Influenza Vaccine, and Double Dose Quadrivalent Inactivated Influenza Vaccine in HIV-Infected and HIV-Uninfected Pregnant Women in a Malaria-Endemic Area of Rural Western Kenya

Status: Withdrawn prior to enrolment
Phase of Trial: Phase II/III

Latest Information Update: 12 Jun 2014

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At a glance

  • Drugs Influenza virus vaccine (Primary) ; Poliovirus vaccine inactivated; Poliovirus vaccine inactivated
  • Indications Influenza virus infections; Poliomyelitis
  • Focus Adverse reactions; Pharmacodynamics; Registrational
  • Most Recent Events

    • 08 Apr 2014 According to the ClinicalTrials.gov record, status changed from not yet recruiting to withdrawn prior to recruitment.
    • 30 Jan 2014 Planned number of patients changed from 960 to 720 as reported by ClinicalTrials.gov
    • 08 Jan 2014 Protocol has been amended with changes in official title, endpoints, treatment table, planned patient number.

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