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A phase II, observer-blind, randomised, active controlled study to compare the safety, immunogenicity, and induction of immunological memory of a meningococcal A conjugate vaccine [PsA-TT; meningococcal vaccine group A conjugate], a meningococcal ACYW polysaccharide vaccine [meningococcal vaccine groups A C Y W-135 polysaccharide] and a Hib conjugate vaccine [Hib vaccine conjugate; controls], administered in healthy toddlers 12-23 months of age.

Trial Profile

A phase II, observer-blind, randomised, active controlled study to compare the safety, immunogenicity, and induction of immunological memory of a meningococcal A conjugate vaccine [PsA-TT; meningococcal vaccine group A conjugate], a meningococcal ACYW polysaccharide vaccine [meningococcal vaccine groups A C Y W-135 polysaccharide] and a Hib conjugate vaccine [Hib vaccine conjugate; controls], administered in healthy toddlers 12-23 months of age.

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 vaccine conjugate; Meningococcal vaccine groups A C Y W-135 polysaccharide
  • Indications Bacterial meningitis; Meningococcal group A infections; Meningococcal infections
  • 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
    • 15 Nov 2015 Results published in the Clinical Infectious Diseases
    • 24 Jun 2011 Status changed from active, no longer recruiting to completed as reported by ISRCTN: Current Controlled Trials record.
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