A Phase 3, Randomized, Placebo-controlled, Observer-blinded, Trial to Assess the Safety, Tolerability, and Immunogenicity of Bivalent rLP2086 Vaccine When Administered As a 3-dose Regimen in Healthy Young Adults Aged ≥18 to <26 Years

Trial Profile

A Phase 3, Randomized, Placebo-controlled, Observer-blinded, Trial to Assess the Safety, Tolerability, and Immunogenicity of Bivalent rLP2086 Vaccine When Administered As a 3-dose Regimen in Healthy Young Adults Aged ≥18 to <26 Years

Completed
Phase of Trial: Phase III

Latest Information Update: 30 May 2017

At a glance

  • Drugs PF 5212366 (Primary)
  • Indications Meningococcal group B infections
  • Focus Adverse reactions; Pharmacodynamics; Registrational
  • Sponsors Pfizer
  • Most Recent Events

    • 30 May 2017 According to a Pfizer media release, the European Commission (EC) has approved TRUMENBA (Meningococcal Group B Vaccine) for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B (MenB) in individuals 10 years of age and older. Results from this study supported the approval.
    • 13 May 2016 The results from this an another phase III trial (see CT profile 700208966) support additional upcoming global regulatory submissions and the planned US supplement to request the conversion of Accelerated Approval to Traditional Approval for TRUMENBA, according to a Pfizer media release.
    • 13 May 2016 Results from this trial were presented at the 34th Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID 2016), according to a Pfizer media release.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top