Clinical Trial: Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Toddlers
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Toddlers 12 to 23 Months of Age.
Brief Summary:
The purpose of the study is to evaluate the quadrivalent meningococcal conjugate vaccine when used as a single-dose toddler vaccine in individuals who are either meningococcal vaccine naïve or have received one or more doses of monovalent meningococcal C (MenC) vaccines during infancy.
Primary Objectives:
- To demonstrate the non-inferiority of the antibody response to meningococcal serogroups A, C, Y, and W after a single dose of MenACYW conjugate vaccine or Nimenrix® in toddlers who either are meningococcal vaccine naïve or have received monovalent MenC vaccination during infancy
- To demonstrate the non-inferiority of the antibody response to meningococcal serogroups A, C, Y, and W after a single dose of MenACYW conjugate vaccine or Nimenrix® in meningococcal vaccine naïve toddlers
Secondary Objectives:
- To compare the antibody responses (geometric mean titers [GMTs]) to meningococcal serogroups A, C, Y, and W after a dose of MenACYW conjugate vaccine or Nimenrix® as measured by hSBA in toddlers who either are meningococcal vaccine naïve or have received monovalent MenC vaccination during infancy
- To compare the antibody responses (GMTs) to meningococcal serogroups A, C, Y, and W after a dose of MenACYW conjugate vaccine or Nimenrix® as measured by hSBA in meningococcal vaccine naïve toddlers
- To compare the antibody responses (GMTs) to meningococcal serogroups A, C, Y, and W after a dose of MenACYW conjugate vaccine or Nimenrix® as measured by hSBA in toddlers who received monovalent MenC vaccination durin
Detailed Summary: Healthy toddlers aged 12 to 23 months will be enrolled and randomized depending on the meningococcal background to receive either MenACYW conjugate vaccine or Nimenrix®. They will be assessed for immunogenicity assessment at baseline (pre-vaccination) and post-vaccination. Safety information will be collected post-vaccination and through the entire study.
Sponsor: Sanofi Pasteur, a Sanofi Company
Current Primary Outcome:
- Percentage of participants with antibody titers ≥ 1:8 against meningococcal serogroups A, C, Y, and W post-vaccination with either MenACYW conjugate vaccine or Nimenrix® vaccine. [ Time Frame: Day 30 Post-vaccination ]Antibody titers against meningococcal serogroups A, C, Y, and W post-vaccination will be measured using serum bactericidal assay using human complement (hSBA)
- Percentage of participants with antibody titers.≥ 1:8 against meningococcal serogroups A, C, Y, and W post vaccination with MenACYW conjugate vaccine or Nimenrix® in meningococcal vaccine naïve toddlers [ Time Frame: Day 30 Post-vaccination ]Antibody titers against meningococcal serogroups A, C, Y, and W post-vaccination will be measured using serum bactericidal assay using human complement
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Geometric Mean Titers against meningococcal serogroups A, C, Y, and W before and after vaccination with MenACYW conjugate vaccine or Nimenrix® in toddlers who are meningococcal vaccine naïve or have received monovalent MenC vaccination during infancy [ Time Frame: Day 0 (pre-vaccination) and Day 30 Post-vaccination ]Antibody titers against meningococcal serogroups A, C, Y, and W post-vaccination will be measured using serum bactericidal assay using human complement
- Geometric Mean Titers against meningococcal serogroups A, C, Y, and W before and after vaccination with MenACYW conjugate vaccine or Nimenrix® in meningococcal vaccine naïve toddlers [ Time Frame: Day 0 (pre-vaccination) and Day 30 Post-vaccination ]Antibody titers against meningococcal serogroups A, C, Y, and W post-vaccination will be measured using serum bactericidal assay using human complement
- Geometric Mean Titers against meningococcal serogroups A, C, Y, and W before and after vaccination with MenACYW conjugate vaccine or Nimenrix® in toddlers who received monovalent MenC vaccination during infancy [ Time Frame: Day 0 (pre vaccination) and Day 30 Post vaccination ]Antibody titers against meningococcal serogroups A, C, Y, and W post-vaccination will be measured using serum bactericidal assay using human complement
- Number of Participants with Solicited Reactions, Unsolicited Adverse Events and Serious Adverse Events Following Vaccination with Either MenACYW Conjugate Vaccine or Nimenrix® Vaccine [ Time Frame: Day 0 up to Day 45 post-vaccination ]Solicited injection-site and systemic reactions (Day 0 to Day 7 post-vaccination); unsolicited adverse events, including serious adverse events throughout the study
Original Secondary Outcome: Same as current
Information By: Sanofi
Dates:
Date Received: November 3, 2016
Date Started: February 24, 2017
Date Completion: April 2018
Last Updated: April 19, 2017
Last Verified: April 2017
- Percentage of participants with antibody titers ≥ 1:8 against meningococcal serogroups A, C, Y, and W post-vaccination with either MenACYW conjugate vaccine or Nimenrix® vaccine. [ Time Frame: Day 30 Post-vaccination ]
