Study on Immunogenicity and Safety of a Meningococcal ACYW Conjugate Vaccine in Healthy Infants and Toddlers

A Parallel-group, Prevention, Phase III, Modified Double-blind, 2-arm, Study to Investigate the Immunogenicity and Describe the Safety of a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Compared With Nimenrix® When Administered in a 1+1 Schedule in Healthy Infants and Toddlers at 6 and 12 Months of Age

This study is conducted to support a 2-dose series (1+1 vaccination schedule) for immunization of individuals from 6 months of age. The study is designed to evaluate the non-inferiority of the immunological response of MenACYW conjugate vaccine to Nimenrix® after the completion of the 2-dose series (1+1 vaccination schedule), with the first dose (priming dose) being given at 6-7 months of age to MenACWY- naïve healthy infants and the second dose (booster dose) given at 12-13 months of age. This study will also describe additional immunogenicity parameters and safety of MenACYW conjugate vaccine and Nimenrix® in the same population of participants.

Study Overview

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

Detailed Description

The study duration will be approximately 7 to 8.5 months (at least 7 months per participant).

• Study Type: Interventional
• Enrollment (Actual): 840
• Phase: Phase 3

Contacts and Locations

Study Locations

• Czechia
  • Prague, Czechia
    • Investigational Site Number: 2030005
  • České Budějovice, Czechia, 370 06
    • Investigational Site Number : 2030002
  • České Budějovice, Czechia
    • Investigational Site Number: 2030001
• Denmark
  • Aalborg, Denmark
    • Investigational Site Number: 2080007
  • Aarhus, Denmark
    • Investigational Site Number: 2080004
  • Herlev, Denmark
    • Investigational Site Number: 2080006
  • Hjørring, Denmark, 9800
    • Investigational Site Number : 2080005
  • Odense, Denmark
    • Investigational Site Number: 2080002
  • Zeeland, Denmark
    • Investigational Site Number: 2080001
• Finland
  • Espoo, Finland
    • Investigational Site Number: 2460005
  • Helsinki, Finland
    • Investigational Site Number: 2460002
  • Helsinki, Finland
    • Investigational Site Number: 2460011
  • Jaarvenpa, Finland
    • Investigational Site Number: 2460006
  • Kokkola, Finland, 67100
    • Investigational Site Number : 2460003
  • Oulu, Finland
    • Investigational Site Number: 2460007
  • Tampere, Finland
    • Investigational Site Number: 2460004
  • Turku, Finland
    • Investigational Site Number: 2460012
• Germany
  • Erfurt, Germany
    • Investigational Site Number: 2760007
  • Herxheim, Germany
    • Investigational Site Number: 2760004
  • Hürth, Germany
    • Investigational Site Number: 2760003
  • Mönchengladbach, Germany
    • Investigational Site Number: 2760001
  • Mönchengladbach, Germany
    • Investigational Site Number: 2760011
  • Schweigen-Rechtenbach, Germany
    • Investigational Site Number: 2760008
  • Schönau am Königssee, Germany
    • Investigational Site Number: 2760005
  • Wolfsburg, Germany
    • Investigational Site Number: 2760010
  • Worms, Germany, 67550
    • Investigational Site Number : 2760009
• Poland
  • Bydgoszcz, Poland
    • Investigational Site Number: 6160003
  • Bydgoszcz, Poland
    • Investigational Site Number: 6160008
  • Bydgoszcz, Poland
    • Investigational Site Number: 6160017
  • Krakow, Poland
    • Investigational Site Number: 6160015
  • Krakow, Poland
    • Investigational Site Number: 6160021
  • Luboń, Poland
    • Investigational Site Number: 6160012
  • Siemianowice Śląskie, Poland
    • Investigational Site Number: 6160011
  • Torun, Poland
    • Investigational Site Number: 6160007
  • Trzebnica, Poland
    • Investigational Site Number: 6160014
  • Warsaw, Poland
    • Investigational Site Number: 6160022
  • Wroclav, Poland
    • Investigational Site Number: 6160010
  • Wroclaw, Poland
    • Investigational Site Number: 6160002
  • Łomianki, Poland
    • Investigational Site Number: 6160004
  • Łęczna, Poland
    • Investigational Site Number: 6160016
  • Kuyavian-Pomeranian Voivodeship
    • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-079
      • Investigational Site Number : 6160001
• Romania
  • Bucharest, Romania, 011025
    • Investigational Site Number : 6420001
  • Bucharest, Romania, 021105
    • Investigational Site Number : 6420003
  • Bucharest, Romania
    • Investigational Site Number: 6420002
  • Călăraşi, Romania
    • Investigational Site Number: 6420005

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Aged 6 to 7 months on the day of inclusion
• Participants who are healthy as determined by medical evaluation including medical history, physical examination and judgment of the Investigator

Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply:

• 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(s) 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. A 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) and Meningococcal B vaccines) in the 4 weeks preceding the first and second study intervention administration or planned receipt of any vaccine (including COVID-19 and Meningococcal B vaccines) in the 4 weeks following any study intervention administration except for influenza vaccination, which may be received at least 2 weeks before or 2 weeks after the study interventions. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines.
• Previous vaccination against meningococcal A, C, W, or Y disease with either the trial vaccine or another vaccine (i.e., mono- or quadrivalent meningococcal conjugate vaccine) containing serogroups A, C, Y, or W.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1: MenACYW conjugate vaccine; Participants will receive MenACYW Conjugate Vaccine (MenQuadfi®): 2-dose schedule (1+1); dose 1 (priming dose) at 6-7 months of age and dose 2 (booster dose) at 12-13 months of age (MenQuadfi®)	Biological: MenACYW conjugate vaccine; Pharmaceutical form:Solution for injection (in a single-dose vial)-Route of administration:Intramuscular (IM) injection; Other Names: MenQuadfi®; Biological: MenACYW conjugate vaccine; Pharmaceutical form:Solution for injection (powder or cake in a single dose glass vial and a clear and colourless solvent in a pre filled syringe for reconstitution-Route of administration:Intramuscular (IM) injection; Other Names: Nimenrix®
Active Comparator: Group 2: Nimenrix®; Participants will receive Nimenrix®: 2-dose schedule (1+1); dose 1 (priming dose) at 6-7 months of age and dose 2 (booster dose) at 12-13 months of age	Biological: MenACYW conjugate vaccine; Pharmaceutical form:Solution for injection (in a single-dose vial)-Route of administration:Intramuscular (IM) injection; Other Names: MenQuadfi®; Biological: MenACYW conjugate vaccine; Pharmaceutical form:Solution for injection (powder or cake in a single dose glass vial and a clear and colourless solvent in a pre filled syringe for reconstitution-Route of administration:Intramuscular (IM) injection; Other Names: Nimenrix®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Geometric mean titers (GMTs) of Antibodies against meningococcal serogroups A, C, W and Y	Geometric mean titers after a 2-dose serie measured by serum bactericidal assays using human complement (hSBA)	30 days after dose 2 (booster dose) (+14 days)
Vaccine Seroresponse to meningococcal serogroups A, C, W and Y assessed by hSBA	Vaccine seroresponse after a 2-dose serie measured by hSBA	30 days after dose 2 (booster dose) (+14 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with immediate adverse events (AEs)	Unsolicited systemic AEs that occur within 30 minutes after vaccination	Within 30 minutes after each vaccination
Number of participants with solicited injection site reactions or systemic reactions	Pre-defined solicited injection site reactions and systemic reactions that are pre-listed in the diary cards and CRF	Within 7 days after each vaccination
Rabbit complement (rSBA) antibody titers against meningococcal serogroups A, C, W, and Y		For infants 6-7 months old: Before and 30 days after dose 1 (priming dose) (+14 days) For toddlers12-13 months old: Before and 30 days after dose 2 (booster dose) (+14 days
Percentage of Participants who achieved ≥4-fold rise in antibody titers over baseline measured by rSBA		For infants 6-7 months old: Before and 30 days after dose 1 (priming dose) (+14 days) For toddlers12-13 months old: Before and 30 days after dose 2 (booster dose) (+14 days
Number of participants with unsolicited AEs	AEs other than solicited reactions	Up to 30 days after each vaccination
Number of participants with serious adverse events (SAEs)	SAEs (including adverse events of special interest [AESIs]) reported throughout the study	From baseline to up to 7 months
hSBA antibody titers ≥ 1:8 against meningococcal serogroups A, C, W and Y	% of participants achieving antibody titers measured by hSBA ≥ predefined threshold of 1:8	30 days after dose 1 (priming dose) (+14 days)
hSBA antibody titers against meningococcal serogroups A, C, W and Y	Antibody titers are measured by hSBA and summarized as geometric mean titers (GMTs)	For infants 6-7 months old: Before and 30 days after dose 1 (priming dose) (+14 days) For toddlers12-13 months old: Before and 30 days after dose 2 (booster dose) (+14 days)
hSBA antibody titers ≥ several pre-defined thresholds against meningococcal serogroups A, C, W and Y	Antibody titers are measured by hSBA and summarized as % of participants achieving antibody titers ≥ predefined thresholds	For infants 6-7 months old: Before and 30 days after dose 1 (priming dose) (+14 days) For toddlers12-13 months old: Before and 30 days after dose 2 (booster dose) (+14 days
Percentage of Participants who achieved ≥4-fold rise in antibody titers over baseline measured by hSBA		For infants 6-7 months old: Before and 30 days after dose 1 (priming dose) (+14 days) For toddlers 12-13 months old: Before and 30 days after dose 2 (booster dose) (+14 days
hSBA meningococcal serogroups A, C, W and Y vaccine seroresponse	Vaccine seroresponse defined as follows: For a participant with a pre-vaccination titer < 1:8, a post vaccination titer ≥ 1:16 and for a participant with a pre-vaccination titer ≥ 1:8, a post vaccination titer at least 4-fold greater than the pre vaccination titer	For infants 6-7 months old: Before and 30 days after dose 1 (priming dose) (+14 days) For toddlers12-13 months old: Before and 30 days after dose 2 (booster dose) (+14 days
rSBA antibody titers ≥ several pre-defined thresholds against meningococcal serogroups A, C, W and Y		For infants 6-7 months old: Before and 30 days after dose 1 (priming dose) (+14 days) For toddlers 12-13 months old: Before and 30 days after dose 2 (booster dose) (+14 days
rSBA meningococcal serogroups A, C, W and Y 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 than the pre vaccination titer	For infants 6-7 months old: Before and 30 days after dose 1 (priming dose) (+14 days) For toddlers 12-13 months old: Before and 30 days after dose 2 (booster dose) (+14 days)

Collaborators and Investigators

• Sponsor: Sanofi Pasteur, a Sanofi Company

Publications and helpful links

Helpful Links

• MEQ00089 Plain Language Results Summary

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2024
• Primary Completion (Actual): November 14, 2025
• Study Completion (Actual): November 14, 2025

Study Registration Dates

• First Submitted: February 22, 2024
• First Submitted That Met QC Criteria: February 22, 2024
• First Posted (Actual): February 29, 2024

Study Record Updates

• Last Update Posted (Actual): December 2, 2025
• Last Update Submitted That Met QC Criteria: November 24, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immunologic Factors; Physiological Effects of Drugs; Vaccines
• Other Study ID Numbers: MEQ00089 (Sanofi Identifier); 2023-508177-85 (Registry Identifier: CTIS); U1111-1280-6981 (Registry Identifier: ICTRP)

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