Clinical Trial: A Study Evaluating Safety And Immunogenicity Of Meningococcal B Rlp2086 Vaccine In Adolescents

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

Official Title: A Randomized, Single-blind, Placebo-controlled, Phase 2 Trial Of The Safety, Immunogenicity, And Tolerability Of Meningococcal Serogroup B (Mnb) Rlp2086 Vaccine At Doses Of 60 Mug, 120 Mug, And 200 Mu

Brief Summary: The purpose of this study is to evaluate the safety and immunogenicity of an investigational meningococcal B rLP2086 vaccine in adolescents aged 11 to 18 years old.

Detailed Summary:
Sponsor: Pfizer

Current Primary Outcome:

  • Percentage of Participants With at Least 4-fold Rise in Recombinant Lipoprotein 2086 (rLP2086) Specific Serum Bactericidal Assay Using Human Complement (hSBA) Titer: Before Vaccination 1 up to 1 Month After Vaccination 2 [ Time Frame: Before vaccination 1 up to 1 month after vaccination 2 ]
  • Percentage of Participants With at Least 4-fold Rise in Recombinant Lipoprotein 2086 (rLP2086) Specific Serum Bactericidal Assay Using Human Complement (hSBA) Titer: Before Vaccination 1 up to 1 Month After Vaccination 3 [ Time Frame: Before vaccination 1 up to 1 month after vaccination 3 ]
  • Percentage of Participants With Atleast One Adverse Event (AE): Stage 1 [ Time Frame: Vaccination 1 upto 1 Month after vaccination 3 ]
  • Percentage of Participants With Atleast One Adverse Event (AE): Stage 2 [ Time Frame: 6 month after vaccination 3 up to 48 months ]


Original Primary Outcome: Adverse events will be monitored throughout the study to evaluate the safety and tolerability of rLP2086. The Serum Bactericidal Assay (SBA) will be used to measure the primary immunogenicity objective. [ Time Frame: SBA assay results are expected throughout the study period. The first SBA results are expected for June 2009. ]

Current Secondary Outcome: Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level [ Time Frame: 1 month before vaccination 1, 1 month after vaccination 2, 3 ]

Original Secondary Outcome:

Information By: Pfizer

Dates:
Date Received: December 12, 2008
Date Started: February 2009
Date Completion:
Last Updated: March 27, 2015
Last Verified: March 2015