NCT03547271

Immunogenicity and Safety Study of a Quadrivalent Meningococcal Conjugate Vaccine When Co-administered With Routine Pediatric Vaccines in Healthy Infants and Toddlers in Europe

Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in Europe

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,660 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 42 Days – 89 Days
• Healthy volunteers: Accepted

Summary

Primary objective: This study aimed to demonstrate the non-inferiority of the antibody response against meningococcal serogroups A, C, Y, and W following the administration of a 3-dose series of MenACYW conjugate vaccine compared to a 3-dose series of a licensed meningococcal vaccine when each vaccine was given concomitantly with routine pediatric vaccines (10-valent pneumococcal vaccine and diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b \[DTaP-IPV-HB-Hib vaccine\]) to infants and toddlers 6 weeks to 18 months old Secondary objectives: This study aimed to demonstrate the non-inferiority of the antibody (Ab) response against meningococcal serogroups A, C, Y, and W following the administration of 2 doses in infancy of MenACYW conjugate vaccine compared to 2 doses of a licensed meningococcal vaccine when each vaccine was given concomitantly with routine pediatric vaccines (10-valent pneumococcal vaccine and DTaP-IPV-HB-Hib vaccine) to infants and toddlers 6 weeks to 18 months old. \- This study aimed to describe the Ab responses against meningococcal groups A, C, Y, and W and the antigens of the routine pediatric vaccines administered in the study.

Conditions

• Meningococcal Infections

Interventions

Type	Name	Description
BIOLOGICAL	MenACYW conjugate vaccine	Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid conjugate vaccine, 0.5 mL, intramuscular
BIOLOGICAL	Meningococcal group A, C, W-135, and Y conjugate vaccine	Meningococcal group A, C, W-135, and Y conjugate vaccine, 0.5 mL, intramuscular
BIOLOGICAL	DTaP-IPV-HB-Hib vaccine	Diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b vaccine
BIOLOGICAL	Pneumococcal vaccine (13-valent)	Pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed)
BIOLOGICAL	Pneumococcal vaccine (10-valent)	Pneumococcal polysaccharide conjugate vaccine (10-valent, adsorbed)
BIOLOGICAL	MMR vaccine	Measles, mumps, and rubella vaccine

Timeline

• Start date: 2018-12-14
• Primary completion: 2023-05-17
• Completion: 2023-05-24
• First posted: 2018-06-06
• Last updated: 2025-03-03
• Results posted: 2025-01-22

Locations

33 sites across 7 countries: Czechia, Finland, Italy, Poland, Romania, Spain, Sweden

Regulatory

• FDA-regulated drug study