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.

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers; Meningococcal Immunisation
• Intervention / Treatment: Biological: MenACYW conjugate vaccine

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Phase 4

Contacts and Locations

Study Locations

• Argentina
  • Ciudad Autonoma Buenos Aires, Argentina, C1425EFD
    • Investigational Site Number : 0320001
  • Buenos Aires F.D.
    • Buenos Aires, Buenos Aires F.D., Argentina, 1430
      • Investigational Site Number : 0320002

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Aged 12 to 23 months on the day of inclusion
• Participants who are healthy as determined by medical evaluation including medical history, physical examination, and judgement of the Investigator
• Received at least one priming dose of licensed Nimenrix® or Menveo® vaccine during infancy before 12 months of age with an interval of at least 2 months between the last vaccination with Nimenrix® or Menveo® and the MenQuadfi® booster dose

Exclusion Criteria:

• Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
• History of meningococcal infection, confirmed either clinically, serologically, or microbiologically
• At high risk for meningococcal infection during the study (specifically but not limited to participants with persistent complement deficiency, with anatomic or functional asplenia, or participants traveling to countries with high endemic or epidemic disease)
• Personal history of Guillain-Barré syndrome
• Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid containing vaccine
• Known systemic hypersensitivity to any of the study intervention components, or history of a life-threatening reaction to the study intervention used in the study or to a product containing any of the same substances
• Moderate or severe acute illness/infection (according to investigator judgment) or febrile illness (temperature ≥ 38.0°C [≥ 100.4°F]) on the day of study intervention administration. Prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided
• Receipt of any vaccine (including COVID-19 vaccines) in the 4 weeks preceding the study intervention administration or planned receipt of any vaccine (including COVID-19 vaccines) in the 4 weeks following the study intervention administration except for influenza vaccination, which may be received at least 2 weeks before or 2 weeks after the study intervention. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines.
• Previous vaccination with a Meningococcal C vaccine or Meningococcal B (MenB) vaccine
• Receipt of immunoglobulins, blood or blood-derived products in the past 3 months
• Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw

NOTE: The above information was not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MenACYW conjugate vaccine; participants received a single booster dose of the MenACYW conjugate vaccine with an interval of at least 2 months after the last vaccination with Nimenrix® or Menveo® received during infancy before 12 months of age	Biological: MenACYW conjugate vaccine; Pharmaceutical form: Liquid solution Route of administration: Intramuscular (IM) injection; Other Names: MenQuadfi®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:8 Against Meningococcal Serogroups A, C, Y, and W	Functional meningococcal antibody activity against serogroups A, C, Y, and W was measured in a serum bactericidal assay using human complement (hSBA). Percentages are rounded to the nearest tenth.	Day 1 (pre-vaccination) and Day 31 (30 days post-vaccination on Day 1)
Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, Y, and W as Measured by Serum Bactericidal Assay Using Human Complement	Functional meningococcal antibody activity against serogroups A, C, Y, and W was measured in a serum bactericidal assay using human complement (hSBA).	Day 1 (pre-vaccination) and Day 31 (30 days post-vaccination on Day 1)
Percentage of Participants With Serum Bactericidal Assay Using Human Complement Antibody Titers >=1:4 Against Meningococcal Serogroups A, C, Y, and W	Functional meningococcal antibody activity against serogroups A, C, Y, and W was measured in a serum bactericidal assay using human complement (hSBA). Percentages are rounded to the nearest tenth.	Day 1 (pre-vaccination) and Day 31 (30 days post-vaccination on Day 1)
Percentage of Participants With Serum Bactericidal Assay Using Human Complement Antibody Titers >=4-Fold Rise From Pre-vaccination to Post-Vaccination	Functional meningococcal antibody activity against serogroups A, C, Y, and W was measured in a serum bactericidal assay using human complement (hSBA). Percentages are rounded to the nearest tenth.	Day 1 (pre-vaccination) and Day 31 (30 days post-vaccination on Day 1)
Percentage of Participants With Vaccine Seroresponse by Serum Bactericidal Assay Using Human Complement	Functional meningococcal antibody activity against serogroups A, C, Y, and W was measured in a serum bactericidal assay using human complement (hSBA). hSBA vaccine seroresponse was defined for a participant with a pre-vaccination titer <1:8 as a post-vaccination titer of >=1:16 and for a participant with a pre-vaccination titer >=1:8 as a post-vaccination titer that is at least 4-fold greater than the pre-vaccination titer. Percentages are rounded to the nearest tenth.	Day 1 (pre-vaccination) and Day 31 (30 days post vaccination on Day 1)
Geometric Mean Titers Against Meningococcal Serogroups A, C, Y, and W as Measured by Serum Bactericidal Antibody Assay Using Baby Rabbit Complement (rSBA)	Functional meningococcal antibody activity against serogroups A, C, Y, and W was measured in a serum bactericidal assay using baby rabbit complement (rSBA).	Day 1 (pre-vaccination) and Day 31 (30 days post-vaccination on Day 1)
Percentage of Participants With Serum Bactericidal Antibody Assay Using Baby Rabbit Complement Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W	Functional meningococcal antibody activity against serogroups A, C, Y, and W was measured in a serum bactericidal assay using baby rabbit complement (rSBA). Percentages are rounded to the nearest tenth.	Day 1 (pre-vaccination) and Day 31 (30 days post-vaccination on Day 1)
Percentage of Participants With Serum Bactericidal Antibody Assay Using Baby Rabbit Complement Antibody Titers >=4-Fold Rise From Pre-vaccination to Post-Vaccination	Functional meningococcal antibody activity against serogroups A, C, Y, and W was measured in a serum bactericidal assay using baby rabbit complement (rSBA). Percentages are rounded to the nearest tenth.	Day 1 (pre-vaccination) and Day 31 (30 days post-vaccination on Day 1)
Percentage of Participants With Vaccine Seroresponse by Serum Bactericidal Antibody Assay Using Baby Rabbit Complement	Functional meningococcal antibody activity against serogroups A, C, Y, and W was measured in a serum bactericidal assay using baby rabbit complement (rSBA). rSBA vaccine seroresponse was defined for a participant with a pre-vaccination titer <1:8 as a post-vaccination titer of >=1:32 and for a participant with a pre-vaccination titer >=1:8 as a post-vaccination titer that is at least 4-fold greater than the pre-vaccination titer. Percentages are rounded to the nearest tenth.	Day 1 (pre-vaccination) and Day 31 (30 days post-vaccination on Day 1)
Geometric Mean Concentrations (GMCs) of Antibodies Against Tetanus Toxoid	Geometric Mean Concentrations (GMCs) of anti-tetanus toxoid antibodies was measured by diphtheria, tetanus, pertussis multiplexed electrochemiluminescent assay.	Day 1 (pre-vaccination) and Day 31 (30 days post-vaccination on Day 1)
Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs)	An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, i.e., pre-listed in the CRF in terms of diagnosis and onset window post-vaccination.	Up to 30 minutes post-vaccination on Day 1
Number of Participants With Solicited Injection Site Reactions and Systemic Reactions	A solicited reaction was an "expected" adverse reaction (AR) (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRF. An injection site reaction was an AR at and around the injection site. Solicited injection site reactions included injection site tenderness, injection site erythema and injection site swelling. Solicited systemic reactions included fever, vomiting, crying abnormal, drowsiness, appetite loss and irritability.	Up to 7 days post-vaccination on Day 1
Number of Participants With Unsolicited Adverse Events	An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, i.e., pre-listed in the CRF in terms of diagnosis and/or onset window post-vaccination.	Up to 30 days post-vaccination on Day 1
Number of Participants With Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)	An SAE was any AE that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. An AESI (serious or non-serious) was defined as one of scientific and medical concern specific to the Sponsor's study intervention or program, for which ongoing monitoring and rapid communication by the investigator to the Sponsor could be appropriate.	From vaccination (Day 1) up to 30 days post vaccination, 31 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rabbit complement (rSBA) antibody titers against meningococcal serogroups A, C, Y, and W		Day 01 and Day 31 (+14 days) after booster vaccination
rSBA antibody titers ≥ several pre-defined thresholds against meningococcal serogroups A, C, Y, and W		Day 01 and Day 31 (+14 days) after booster vaccination
Percentage of Participants who achieved ≥4-fold rise in antibody titers over baseline measured by rSBA		Day 01 and Day 31 (+14 days) after booster vaccination
rSBA meningococcal serogroups A, C, Y, and W vaccine seroresponse	Vaccine seroresponse defined as follows: For a participant with a pre-vaccination titer < 1:8, a post vaccination titer ≥ 1:32 and for a participant with a pre-vaccination titer ≥ 1:8, a post vaccination titer at least 4-fold greater that the pre vaccination titer	Day 01 and Day 31 (+14 days) after booster vaccination

Collaborators and Investigators

• Sponsor: Sanofi Pasteur, a Sanofi Company
• Investigators: Study Director: Clinical Sciences & Operations, Sanofi Pasteur, a Sanofi Company

Publications and helpful links

Helpful Links

• MEQ00086 Plain Language Results Summary

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2023
• Primary Completion (Actual): September 9, 2024
• Study Completion (Actual): September 9, 2024

Study Registration Dates

• First Submitted: June 12, 2023
• First Submitted That Met QC Criteria: June 28, 2023
• First Posted (Actual): July 3, 2023

Study Record Updates

• Last Update Posted (Actual): September 22, 2025
• Last Update Submitted That Met QC Criteria: August 29, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Neisseriaceae Infections; Meningococcal Infections
• Other Study ID Numbers: MEQ00086; U1111-1277-6838 (Registry Identifier: ICTRP); 2025-000002-42 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes