NCT02842866

Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Adults 56 Years and Older

Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Adults Age 56 Years and Older

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 907 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 56 Years
• Healthy volunteers: Accepted

Summary

The aim of the study was to demonstrate non-inferiority of immunogenicity and evaluate the safety of a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid conjugate vaccine (MenACYW conjugate vaccine) compared to a single dose of Meningococcal Polysaccharide Vaccine Serogroups A, C, Y, and W-135 Combined (Menomune® - A/C/Y/W-135) in adults 56 years of age and older 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 those observed following the administration of a single dose of Menomune® - A/C/Y/W-135. Secondary objective: -To compare the serum bactericidal assay using human complement (hSBA) antibody geometric mean titers of meningococcal serogroups A, C, Y, and W following the administration of MenACYW conjugate vaccine to those observed following the administration of Menomune® - A/C/Y/W-135. Observational objectives: * To describe antibody titers against meningococcal serogroups A, C, Y, and W measured by hSBA at baseline (before vaccination) and 30 days after vaccination with MenACYW conjugate vaccine or Menomune® - A/C/Y/W-135 in a subset of 100 participants per treatment group. * To describe the safety profile of MenACYW conjugate vaccine compared to that of the licensed Menomune® - A/C/Y/W-135 after a single administration.

Detailed description

Participants were randomized in a 1:1 ratio to receive a single dose of MenACYW conjugate vaccine or Menomune® - A/C/Y/W-135 on Day 0 (Visit 1). Participants underwent immunogenicity assessment at baseline (pre-vaccination) and at 30 to 44 days post-vaccination and were also evaluated for safety up to Day 180 post-vaccination.

Conditions

• Meningitis
• Meningococcal Meningitis
• Meningococcal Infections

Interventions

Type	Name	Description
BIOLOGICAL	Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine	0.5 milliliter (mL), Intramuscular (IM), single dose on Day 0.
BIOLOGICAL	Meningococcal Polysaccharide Vaccine, Groups A, C, Y, and W-135 Combined	0.5 mL, Subcutaneous (SC), single dose on Day 0.

Timeline

• Start date: 2016-07-15
• Primary completion: 2017-02-13
• Completion: 2017-02-13
• First posted: 2016-07-25
• Last updated: 2022-04-05
• Results posted: 2020-02-18

Locations

36 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated drug study