Clinical Trial: A 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

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

Official Title: 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 (

Brief Summary: This study is looking at a new vaccine that might prevent meningococcal disease, and will study the immune response elicited by this vaccine when given to healthy young children. The study will also look at the safety of the new vaccine as well as how it is tolerated.

Detailed Summary:
Sponsor: Pfizer

Current Primary Outcome:

  • Proportion of subjects with antibody titers ≥lower limit of quantitation for each of the 4 primary Neisseria meningitidis serogroup B test strains 1 month after the third vaccination with bivalent rLP2086 [ Time Frame: Month 7 ]
  • Percentage of subjects reporting local reactions, systemic events and antipyretic use for 7 days after each vaccination visit [ Time Frame: Month 0 ]
  • Percentage of subjects reporting local reactions, systemic events and antipyretic use for 7 days after each vaccination visit [ Time Frame: Month 2 ]
  • Percentage of subjects reporting local reactions, systemic events and antipyretic use for 7 days after each vaccination visit [ Time Frame: Month 6 ]
  • Percentage of subjects with at least 1 SAE 30 days after each vaccination, 30 days after any vaccination, during the vaccination phase, during the follow-up phase, and throughout the study period [ Time Frame: Up to 12 months ]
  • Percentage of subjects with at least 1 medically attended adverse event 30 days after each vaccination, 30 days after any vaccination, during the vaccination phase, during the follow-up phase, and throughout the study period [ Time Frame: Up to 12 months ]
  • Percentage of subjects with at least 1 newly diagnosed chronic medical condition 30 days after each vaccination, 30 days after any vaccination, during the vaccination phase, during the follow-up phase, and throughout the study period [ Time Frame: Up to 12 months ]
  • Percentage of subjects with at least 1 adverse event 30 days after each vaccination, 30 days after any vaccinati

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Proportion of subjects with antibody titers ≥lower limit of quantitation for each of the 4 primary Neisseria meningitidis serogroup B test strains 1 month after the second vaccination and 1 and 6 months after the third vaccination with bivalent rLP2086 [ Time Frame: Up to 12 months ]
    • Proportion of subjects achieving fold rises in antibody titers for each of the 4 primary test strains at baseline, 1 month after the second vaccination, and 1 and 6 months after the third vaccination with bivalent rLP2086 [ Time Frame: Up to 12 months ]
    • Geometric mean antibody titers for each of the 4 primary test strains at baseline, 1 month after the second vaccination, and 1 and 6 months after the third vaccination with bivalent rLP2086 [ Time Frame: Up to 12 months ]


    Original Secondary Outcome: Same as current

    Information By: Pfizer

    Dates:
    Date Received: August 20, 2015
    Date Started: August 27, 2015
    Date Completion:
    Last Updated: April 5, 2017
    Last Verified: April 2017