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Study of Immunogenicity and Safety of MenQuadfi® as a Booster Vaccine in Toddlers 12 to 23 Months, Regardless of the Quadrivalent Meningococcal Conjugate Vaccine Used for Priming in Infancy

NCT05929651 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2025-09-22

Study results available
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Summary

This study evaluated the immunogenicity and safety of a single dose of MenQuadfi® administered as a booster vaccine in toddlers 12 - 23 months of age in Argentina who had been primed with at least 1 dose of the quadrivalent meningococcal conjugate vaccines Nimenrix® or Menveo® during infancy to protect against invasive meningococcal disease (IMD).

Participants received a single dose of MenQuadfi® at Visit 1. Participants provided 2 blood samples, one at D01 (Visit 1) pre-vaccination and another at D31 (Visit 2) post-vaccination for the immunogenicity assessments.

Study included 2 visits at D01 (Visit 1) and at D31 (Visit 2), and 1 Telephone call (TC) for safety follow-up at D09 post-study vaccination.

Conditions

  • Meningococcal Immunisation
  • Healthy Volunteers

Interventions

BIOLOGICAL

MenACYW conjugate vaccine

Pharmaceutical form: Liquid solution Route of administration: Intramuscular (IM) injection

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Clinical Sciences & Operations · Sanofi Pasteur, a Sanofi Company

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2023-09-07
Primary Completion
2024-09-09
Completion
2024-09-09
FDA Drug
Yes

Countries

  • Argentina

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 NCT05929651 on ClinicalTrials.gov