NCT03890367

Study on a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Compared to Two Meningococcal Reference Vaccines in European Toddlers

Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Versus Nimenrix® or NeisVac-C® in Healthy Toddlers 12 to 23 Months of Age

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 707 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 12 Months – 23 Months
• Healthy volunteers: Accepted

Summary

Primary Objective: To demonstrate: * the non-inferiority of the seroprotection rate (antibody titers greater than or equal to \[\>=\] 1:8) to meningococcal serogroup C following the administration of MenACYW Conjugate or Nimenrix® as measured by serum bactericidal assay using human complement (hSBA). If this non-inferiority was demonstrated, then * the non-inferiority of the antibody response (geometric mean titers \[GMT\]). If this non-inferiority was demonstrated, then * the superiority of the antibody response (GMT). If this superiority was demonstrated, then * the superiority of the seroprotection rate. Or to demonstrate: * the non-inferiority of the seroprotection rate (antibody titers \>= 1:8) to meningococcal serogroup C following the administration of MenACYW Conjugate or NeisVac-C® as measured by serum bactericidal assay using baby rabbit complement (rSBA). If this non-inferiority was demonstrated, then * the non-inferiority of the antibody response (GMT). If this non-inferiority was demonstrated, then * the superiority of the antibody response (GMT). Secondary Objective: To demonstrate: * the non-inferiority of the seroprotection rate (antibody titers \>= 1:8) to meningococcal serogroup C following the administration of MenACYW Conjugate vaccine or Nimenrix® as measured by rSBA. If this non-inferiority was demonstrated, then * the non-inferiority of the antibody response (GMT). If this non-inferiority was demonstrated, then * the superiority of the antibody response (GMT). Or to demonstrate: * the non-inferiority of the seroprotection rate (antibody titers \>= 1:8) to meningococcal serogroup C following the administration of MenACYW Conjugate vaccine or NeisVac-C® as measured by hSBA. If this non-inferiority was demonstrated, then * the non-inferiority of the antibody response (GMT). If this non-inferiority was demonstrated, then * the superiority of the antibody response (GMT) .

Detailed description

Study duration per participant was approximately 30 days including: 1 day of screening and vaccination, a phone call and a safety-follow up/end of study visit at Day 8 and Day 30 after vaccine administration, respectively. Safety assessment included solicited reactions within 7 days after vaccination, unsolicited adverse events up to 30 days after vaccination, serious adverse events and adverse event of special interest throughout the study.

Conditions

• Meningococcal Immunisation (Healthy Volunteers)

Interventions

Type	Name	Description
BIOLOGICAL	Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid Conjugate vaccine	Pharmaceutical form: Liquid solution for injection Route of administration: Intramuscular
BIOLOGICAL	Meningococcal polysaccharide group A, C, W-135 and Y Conjugate vaccine	Pharmaceutical form: Powder and solvent for suspension for injection Route of administration: Intramuscular
BIOLOGICAL	Meningococcal group C polysaccharide Conjugate vaccine adsorbed	Pharmaceutical form: Suspension for injection Route of administration: Intramuscular

Timeline

• Start date: 2019-09-12
• Primary completion: 2020-10-14
• Completion: 2020-10-14
• First posted: 2019-03-26
• Last updated: 2025-09-15
• Results posted: 2021-10-06

Locations

29 sites across 3 countries: Denmark, Finland, Germany

Regulatory

• FDA-regulated drug study