NCT05929651

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

A Descriptive, Phase IV, Open-label, Single-arm Multi-center Study to Assess the Immunogenicity and Safety of MenQuadfi® as a Booster Vaccine in Healthy Toddlers 12 to 23 Months of Age Who Had Been Primed With at Least 1 Dose of Another Quadrivalent Meningococcal Conjugate Vaccine, ie, Nimenrix® (MCV4-TT) or Menveo® (MCV4-CRM), in Infancy.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 12 Months – 23 Months
• Healthy volunteers: Accepted

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.

Detailed description

Study duration was approximately 30 days (+14 days) per participant

Conditions

• Meningococcal Immunisation
• Healthy Volunteers

Interventions

Type	Name	Description
BIOLOGICAL	MenACYW conjugate vaccine	Pharmaceutical form: Liquid solution Route of administration: Intramuscular (IM) injection

Timeline

• Start date: 2023-09-07
• Primary completion: 2024-09-09
• Completion: 2024-09-09
• First posted: 2023-07-03
• Last updated: 2025-09-22
• Results posted: 2025-09-22

Locations

2 sites across 1 country: Argentina

Regulatory

• FDA-regulated drug study