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A phase II, double-blind, randomised, controlled, dose ranging study to evaluate the safety, immunogenicity, dose response and schedule response of a meningococcal A conjugate vaccine administered concomitantly with local expanded program on immunisation (EPI) vaccines in healthy infants

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A phase II, double-blind, randomised, controlled, dose ranging study to evaluate the safety, immunogenicity, dose response and schedule response of a meningococcal A conjugate vaccine administered concomitantly with local expanded program on immunisation (EPI) vaccines in healthy infants

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 30 Nov 2020

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At a glance

  • Drugs Meningococcal vaccine group A conjugate (Primary) ; Hib-DTP-hepatitis B vaccine; Measles virus vaccine live; Poliovirus vaccine inactivated; Yellow fever vaccine
  • Indications Diphtheria; Haemophilus infections; Hepatitis B; Measles; Meningococcal group A infections; Pertussis; Poliomyelitis; Tetanus; Yellow fever
  • Focus Pharmacodynamics
  • Sponsors Serum Institute of India

    • Most Recent Events

    • 19 Nov 2020 Results of secondary analysis from four clinical studies: PsATT-002, PsATT-003, PsATT-004 and PsATT-007 assessing safety and efficacy in children in African meningitis belt published in the Vaccine
    • 29 Oct 2015 Status changed from recruiting to completed as reported by ISRCTN: Current Controlled Trials.
    • 21 Sep 2015 Planned End Date changed from 31 Dec 2012 to 31 Dec 2017 as reported by ISRCTN: Current Controlled Trials.

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