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

NCT03632720 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 788

Last updated 2023-11-07

Study results available
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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.

Conditions

  • Healthy Volunteers (Meningococcal Infection)

Interventions

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

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
56 Days
Max Age
89 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-10-10
Primary Completion
2022-12-05
Completion
2022-12-05
FDA Drug
Yes

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03632720 on ClinicalTrials.gov