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A Phase 2, Randomized, Controlled, Observer-Blinded Study to Describe the Immunogenicity, Safety, and Tolerability Of Neisseria Meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine (Bivalent rLP2086) in Healthy Subjects Aged ≥24 Months to <10 Years

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Trial Profile

A Phase 2, Randomized, Controlled, Observer-Blinded Study to Describe the Immunogenicity, Safety, and Tolerability Of Neisseria Meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine (Bivalent rLP2086) in Healthy Subjects Aged ≥24 Months to <10 Years

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 27 Apr 2018

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At a glance

  • Drugs Meningococcal vaccine group B (Primary) ; Hepatitis A vaccine inactivated
  • Indications Hepatitis A; Meningococcal group B infections
  • Focus Adverse reactions; Pharmacodynamics
  • Sponsors Pfizer

Most Recent Events

  • 23 Apr 2018 Pfizer received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for active immunization to prevent invasive disease caused by Neisseria meningitidis group B (MenB) in children ages 1 through 9 years, based on data from this study and other completed phase 2 studies in this investigational age group, according to Pfizer media release.
  • 06 Apr 2017 This trial has been completed in Finland (End date:2017-03-01) as per European Clinical Trials Database record.
  • 05 Apr 2017 Status changed from active, no longer recruiting to completed.

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