Clinical Trial: Study Evaluating Safety And Tolerability Of Meningococcal B Rlp2086 Vaccine In Healthy Adults

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase 1 Randomized, Open-label, Parallel-group, Active- And Placebo-controlled Study To Assess Safety And Tolerability Of 60, 120, And 200 Mcg Meningococcal Group B Rlp2086 Vaccine In Healthy Adult

Brief Summary: The purpose of this study is to evaluate the safety and tolerability of an investigational meningococcal B rLP2086 vaccine in healthy adults.

Detailed Summary:
Sponsor: Pfizer

Current Primary Outcome:

  • Percentage of Participants With at Least One Adverse Event (AE) [ Time Frame: Baseline up to Month 7 ]
  • Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Alanine Aminotransferase [ALT]) [ Time Frame: Baseline up to Month 7 ]
  • Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Aspartate Aminotransferase [AST]) [ Time Frame: Baseline up to Month 7 ]
  • Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Total Protein) [ Time Frame: Baseline up to Month 7 ]
  • Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Albumin) [ Time Frame: Baseline up to Month 7 ]
  • Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Alkaline Phosphatase [ALP]) [ Time Frame: Baseline up to Month 7 ]
  • Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Total Bilirubin) [ Time Frame: Baseline up to Month 7 ]
  • Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Creatine Phosphokinase [CPK]) [ Time Frame: Baseline up to Month 7 ]
  • Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Prothrombin Time [PT]) [ Time Frame: Baseline up to Month 7 ]
  • Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Partial T

    Original Primary Outcome: Adverse Event collection and safety laboratory evaluation [ Time Frame: 1 month post third vaccination ]

    Current Secondary Outcome: Meningococcal Immunoglobulin G (IgG) Geometric Mean Titers (GMT) [ Time Frame: Before Dose 1, 1 month after Dose 2, before Dose 3, 1 month after Dose 3 ]

    Original Secondary Outcome: Ig binding assay [ Time Frame: 3 months post third vaccination. ]

    Information By: Pfizer

    Dates:
    Date Received: April 10, 2009
    Date Started: April 2009
    Date Completion:
    Last Updated: July 15, 2015
    Last Verified: July 2015