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A PHASE 3, RANDOMIZED, ACTIVE-CONTROLLED, OBSERVER-BLINDED STUDY TO ASSESS THE IMMUNOGENICITY, SAFETY, AND TOLERABILITY OF BIVALENT RLP2086 WHEN ADMINISTERED AS A 2-DOSE REGIMEN AND A FIRST-IN-HUMAN STUDY TO DESCRIBE THE IMMUNOGENICITY, SAFETY, AND TOLERABILITY OF A BIVALENT RLP2086-CONTAINING PENTAVALENT VACCINE (MENABCWY) IN HEALTHY SUBJECTS≥10 TO <26 YEARS OF AGE

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Trial Profile

A PHASE 3, RANDOMIZED, ACTIVE-CONTROLLED, OBSERVER-BLINDED STUDY TO ASSESS THE IMMUNOGENICITY, SAFETY, AND TOLERABILITY OF BIVALENT RLP2086 WHEN ADMINISTERED AS A 2-DOSE REGIMEN AND A FIRST-IN-HUMAN STUDY TO DESCRIBE THE IMMUNOGENICITY, SAFETY, AND TOLERABILITY OF A BIVALENT RLP2086-CONTAINING PENTAVALENT VACCINE (MENABCWY) IN HEALTHY SUBJECTS≥10 TO <26 YEARS OF AGE

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 15 Dec 2023

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At a glance

  • Drugs Meningococcal vaccine group B (Primary) ; Meningococcal vaccine groups A B C Y W-135 conjugate (Primary) ; Meningococcal vaccine groups A C Y W-135 conjugate (Primary)
  • Indications Meningococcal group A infections; Meningococcal group B infections; Meningococcal group C infections; Meningococcal group W-135 infections; Meningococcal group Y infections
  • Focus Adverse reactions; First in man; Pharmacodynamics; Proof of concept; Registrational
  • Sponsors Pfizer

Most Recent Events

  • 01 Dec 2023 Results assessing Immunogenicity and safety of a pentavalent meningococcal ABCWY vaccine in adolescents and young adults published in The Lancet Infectious Diseases
  • 02 Feb 2023 This trial has been completed in Poland, according to European Clinical Trials Database record.
  • 08 Nov 2022 Status changed from active, no longer recruiting to completed.

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