Clinical Trial: Study Evaluating Safety, Tolerability, and Immunogenicity of Meningococcal B Vaccine in Healthy Infants
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: An Open Label, Randomized, Phase 1/2 Trial Of The Safety, Tolerability, And Immunogenicity Of Meningococcal Group B Rlp2086 Vaccine In Healthy Infants
Brief Summary: The primary purpose of this study is to evaluate the safety and immunogenicity of an investigational meningococcal B vaccine in healthy infants.
Detailed Summary:
Sponsor: Pfizer
Current Primary Outcome:
- Percentage of Participants Achieving at Least 1:4 rLP2086-specific Serum Bactericidal Assay (SBA) Titer to 1 Subfamily A Strain and 1 Subfamily B Strain [ Time Frame: 1 month after Dose 3 ]
- Percentage of Participants With at Least One Adverse Event (AE) [ Time Frame: From signing of informed consent form to completion of study (up to 2 years) ]
Original Primary Outcome: Immunogenicity as measured by serum bactericidal activity and total Ig levels to Meningococcal B vaccine.Safety and tolerability of the MnB vaccine as measured by frequency of solicited systemic events and local reactions and the occurence of AEs and SAE [ Time Frame: Approximately 7 months ]
Current Secondary Outcome:
- Serum Bactericidal Assay (SBA) Geometric Mean Titers (GMTs) for 1 Subfamily A Strain and 1 Subfamily B Strain [ Time Frame: 1 month after Dose 2, Dose 3; before Dose 4 ]
- Percentage of Participants Achieving at Least 1:4, 1:8, 1:16, 1:32, 1:64, 1:128 rLP2086-specific SBA Titer to 1 Subfamily A Strain and 1 Subfamily B Strain [ Time Frame: 1 month after Dose 2, Dose 3; before Dose 4 ]
Original Secondary Outcome: Immunogenicity as measured by serum bactericidal activity and total Ig levels to Meningococcal B vaccine one month after the toddler dose [ Time Frame: Approximately 12 months ]
Information By: Pfizer
Dates:
Date Received: November 25, 2008
Date Started: January 2009
Date Completion:
Last Updated: November 21, 2014
Last Verified: November 2014