Clinical Trial: Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered in Children Aged 2 to 9 Years

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered in Healthy Children 2 to 9 Years of Age

Brief Summary:

The aim of this trial is to evaluate the immunogenicity and describe the safety of MenACYW conjugate vaccine compared to MENVEO® in healthy children 2 to 9 years of age in the United States.

Primary objective:

- To demonstrate the non-inferiority of the vaccine seroresponse to meningococcal serogroups A, C, Y, and W following the administration of a single dose of MenACYW conjugate vaccine compared to that observed following the administration of a single dose of MENVEO® in children aged 2 to 9 years.

Secondary objectives:

  • To compare the hSBA antibody geometric mean titers (GMTs) of meningococcal serogroups A, C, Y, and W following the administration of MenACYW conjugate vaccine to those observed following the administration of MENVEO® in children 2 to 9 years of age
  • To evaluate the hSBA antibody GMTs of meningococcal serogroups A, C, Y, and W following the administration of MenACYW conjugate vaccine and those observed following the administration of MENVEO® in children 2 to 5 years of age, and in children 6 to 9 years of age, respectively.
  • To evaluate the hSBA vaccine seroresponse to meningococcal serogroups A, C, Y, and W before and 30 days (+14 days) post-vaccination in children 2 to 5 years of age, and in children 6 to 9 years of age, respectively.

Observational objective:

- To describe the safety profile of MenACYW conjugate vaccine and that of the licensed MENVEO®.


Detailed Summary:

Healthy participants will be enrolled, randomized, and will receive a single dose of either MenACYW conjugate vaccine or MENVEO®.

All participants will be assessed for immunogenicity at baseline (pre-vaccination) and at Visit 2 (post-vaccination). Safety information will be collected post each vaccination and throughout the entire study.


Sponsor: Sanofi Pasteur, a Sanofi Company

Current Primary Outcome: Antibody titers against meningococcal serogroups A, C, Y, and W at baseline and post-vaccination with either a single dose of MenACYW conjugate vaccine or MENVEO® [ Time Frame: Day 30 post vaccination ]

Meningococcal serogroups A, C, Y, and W antibodies will be measured by serum bactericidal assays using human complement (hSBA)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Geometric mean titers of antibodies against meningococcal serogroups A, C, Y, and W before and after vaccination with MenACYW conjugate vaccine or MENVEO® [ Time Frame: Day 30 post vaccination ]
    Meningococcal serogroups A, C, Y, and W antibodies will be measured by serum bactericidal assays using human complement (hSBA)
  • Number of participants with seroresponse against meningococcal serogroups A, C, Y, and W after vaccination with MenACYW conjugate vaccine or MENVEO® [ Time Frame: Day 30 post vaccination ]
    Meningococcal serogroups A, C, Y, and W antibodies will be measured by serum bactericidal assays using human complement (hSBA)
  • Number of participants reporting solicited reactions, unsolicited adverse events, serious adverse events, and adverse events of special interest following vaccination with MenACYW conjugate vaccine or MENVEO® [ Time Frame: Day 180 post vaccination ]
    Solicited injection site reactions and systemic reactions (Day 0 to Day 7 post each vaccination); unsolicited adverse events, including serious adverse events and adverse events of special interest will be collected throughout the study


Original Secondary Outcome: Same as current

Information By: Sanofi

Dates:
Date Received: March 8, 2017
Date Started: February 17, 2017
Date Completion: May 2018
Last Updated: April 25, 2017
Last Verified: April 2017