NCT03632720

Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine in Infants and Toddlers When Administered Concomitantly With Routine Pediatric Vaccines in the United Kingdom

Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Infants and Toddlers When Administered Using a 1+1 Schedule in a National Immunization Schedule Having a Meningococcal Group B Vaccine as Standard of Care

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 788 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 56 Days – 89 Days
• Healthy volunteers: Accepted

Summary

The primary objective of the study was to demonstrate the non-inferiority of the antibody responses to meningococcal serogroups A, C, W, and Y (MenACYW) in terms of serum bactericidal assay using human complement (hSBA) vaccine seroprotection (antibody titer greater than or equal to \[\>=\] 1:8) when MenACYW Conjugate vaccine was administered concomitantly with Bexsero® in the second year of life compared to when MenACYW Conjugate vaccine was given alone. The secondary objectives were to compare the hSBA antibody response in terms of geometric mean titers (GMTs) against meningococcal serogroups A, C, W, and Y when MenACYW Conjugate vaccine was administered concomitantly with Bexsero® or when MenACYW Conjugate vaccine was given alone in the second year of life; to describe the hSBA and serum bactericidal assay using baby rabbit complement (rSBA) antibody responses against meningococcal serogroups A, C, W, and Y before and after the 1st dose of MenACYW Conjugate vaccine administered at 3 months of age, before and after the 2nd dose of MenACYW Conjugate vaccine administered at 12 to 13 months of age for Group 1 and Group 2; to describe the hSBA and rSBA antibody persistence against meningococcal serogroups A, C, W, and Y after the 1st dose of MenACYW Conjugate vaccine administered at 3 months of age for Group 1 and Group 2.

Detailed description

Study duration per participant was approximately 11 to 12 months.

Conditions

• Healthy Volunteers (Meningococcal Infection)

Interventions

Type	Name	Description
BIOLOGICAL	Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid Conjugate vaccine	Pharmaceutical form: solution for injection; route of administration: intramuscular, 0.5 mL
BIOLOGICAL	Meningococcal group B vaccine	Pharmaceutical form: suspension for injection; route of administration: deep intramuscular, 0.5 mL
BIOLOGICAL	Diphtheria, tetanus, pertussis (acellular component), hepatitis B, poliomyelitis (inactivated) vaccine	Pharmaceutical form: powder and suspension for suspension injection; route of administration: deep intramuscular, 0.5 mL
BIOLOGICAL	Human rotavirus RIX4414 strain vaccine	Pharmaceutical form: oral suspension; route of administration: oral, 1.5 mL
BIOLOGICAL	Pneumococcal 13-valent polysaccharide conjugate vaccine	Pharmaceutical form: suspension for injection; route of administration: intramuscular, 0.5 mL

Timeline

• Start date: 2018-10-10
• Primary completion: 2022-12-05
• Completion: 2022-12-05
• First posted: 2018-08-15
• Last updated: 2023-11-07
• Results posted: 2023-11-07

Locations

13 sites across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study