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Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Healthy Toddlers

NCT03205358 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 188

Last updated 2022-04-04

Study results available
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Summary

The purpose of the study was to evaluate the immunogenicity and safety profile of a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid (MenACYW) Conjugate vaccine when given alone compared to that of the licensed Meningococcal groups A, C, W 135 and Y (NIMENRIX®) Conjugate vaccine.

Observational objectives:

* To evaluate the antibody responses to the antigens (serogroups A, C, Y, and W) present in MenACYW Conjugate vaccine and NIMENRIX® measured by serum bactericidal assay using baby rabbit complement (rSBA) and by serum bactericidal assay using human complement (hSBA)
* To evaluate the antibody responses against tetanus in participants who received MenACYW Conjugate vaccine or NIMENRIX® vaccine
* To evaluate the safety profile of MenACYW Conjugate vaccine and NIMENRIX®

Conditions

  • Meningitis
  • Meningococcal Meningitis
  • Meningococcal Infections

Interventions

BIOLOGICAL

Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine

0.5 milliliter (mL), Intramuscular (IM)

BIOLOGICAL

Meningococcal Polysaccharide groups A, C, W-135 and Y Conjugate Vaccine

0.5 mL, IM

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Director · Sanofi Pasteur Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
23 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2015-08-19
Completion
2015-08-19
FDA Drug
Yes

Countries

  • Finland

Study Locations

More Related Trials

Entities

Diseases

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 NCT03205358 on ClinicalTrials.gov