Study on a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Compared to Two Meningococcal Reference Vaccines in European Toddlers

Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Versus Nimenrix® or NeisVac-C® in Healthy Toddlers 12 to 23 Months of Age

Primary Objective:

To demonstrate:

• the non-inferiority of the seroprotection rate (antibody titers greater than or equal to [>=] 1:8) to meningococcal serogroup C following the administration of MenACYW Conjugate or Nimenrix® as measured by serum bactericidal assay using human complement (hSBA). If this non-inferiority was demonstrated, then
• the non-inferiority of the antibody response (geometric mean titers [GMT]). If this non-inferiority was demonstrated, then
• the superiority of the antibody response (GMT). If this superiority was demonstrated, then
• the superiority of the seroprotection rate.

Or to demonstrate:

• the non-inferiority of the seroprotection rate (antibody titers >= 1:8) to meningococcal serogroup C following the administration of MenACYW Conjugate or NeisVac-C® as measured by serum bactericidal assay using baby rabbit complement (rSBA). If this non-inferiority was demonstrated, then
• the non-inferiority of the antibody response (GMT). If this non-inferiority was demonstrated, then
• the superiority of the antibody response (GMT).

Secondary Objective:

To demonstrate:

• the non-inferiority of the seroprotection rate (antibody titers >= 1:8) to meningococcal serogroup C following the administration of MenACYW Conjugate vaccine or Nimenrix® as measured by rSBA. If this non-inferiority was demonstrated, then
• the non-inferiority of the antibody response (GMT). If this non-inferiority was demonstrated, then
• the superiority of the antibody response (GMT).

Or to demonstrate:

• the non-inferiority of the seroprotection rate (antibody titers >= 1:8) to meningococcal serogroup C following the administration of MenACYW Conjugate vaccine or NeisVac-C® as measured by hSBA. If this non-inferiority was demonstrated, then
• the non-inferiority of the antibody response (GMT). If this non-inferiority was demonstrated, then
• the superiority of the antibody response (GMT) .

Study Overview

• Status: Completed
• Conditions: Meningococcal Immunisation (Healthy Volunteers)
• Intervention / Treatment: Biological: Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid Conjugate vaccine; Biological: Meningococcal polysaccharide group A, C, W-135 and Y Conjugate vaccine; Biological: Meningococcal group C polysaccharide Conjugate vaccine adsorbed

Detailed Description

Study duration per participant was approximately 30 days including: 1 day of screening and vaccination, a phone call and a safety-follow up/end of study visit at Day 8 and Day 30 after vaccine administration, respectively.

Safety assessment included solicited reactions within 7 days after vaccination, unsolicited adverse events up to 30 days after vaccination, serious adverse events and adverse event of special interest throughout the study.

• Study Type: Interventional
• Enrollment (Actual): 707
• Phase: Phase 3

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark, 8200
    • Investigational Site Number 2080001
  • Hvidovre, Denmark, 2650
    • Investigational Site Number 2080002
  • Odense, Denmark, 5000
    • Investigational Site Number 2080003
• Finland
  • Espoo, Finland, 02230
    • Investigational Site Number 2460006
  • Helsinki, Finland, 00100
    • Investigational Site Number 2460005
  • Järvenpää, Finland, 04400
    • Investigational Site Number 2460004
  • Kokkola, Finland, 67100
    • Investigational Site Number 2460008
  • Oulu, Finland, 90220
    • Investigational Site Number 2460007
  • Pori, Finland, 28100
    • Investigational Site Number 2460003
  • Seinäjoki, Finland, 60100
    • Investigational Site Number 2460010
  • Tampere, Finland, 33100
    • Investigational Site Number 2460001
  • Turku, Finland, 20520
    • Investigational Site Number 2460002
• Germany
  • Bramsche, Germany, 49565
    • Investigational Site Number 2760004
  • Bretten, Germany, 75015
    • Investigational Site Number 2760019
  • Bönnigheim, Germany, 74357
    • Investigational Site Number 2760015
  • Erfurt, Germany, 99086
    • Investigational Site Number 2760002
  • Hamburg, Germany, 22415
    • Investigational Site Number 2760017
  • Herxheim, Germany, 76863
    • Investigational Site Number 2760020
  • Hürth, Germany, 50354
    • Investigational Site Number 2760007
  • Itzehoe, Germany, 25524
    • Investigational Site Number 2760013
  • Mannheim, Germany, 68161
    • Investigational Site Number 2760011
  • Mönchengladbach, Germany, 41236
    • Investigational Site Number 2760003
  • Mönchengladbach, Germany, 41236
    • Investigational Site Number 2760005
  • Schwaigern, Germany, 74193
    • Investigational Site Number 2760008
  • Schweigen, Germany, 76889
    • Investigational Site Number 2760009
  • Schönau, Germany, 83471
    • Investigational Site Number 2760006
  • Tauberbischofsheim, Germany, 97941
    • Investigational Site Number 2760018
  • Tuttlingen, Germany, 78532
    • Investigational Site Number 2760010
  • Wolfsburg, Germany, 38448
    • Investigational Site Number 2760012

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 1 year (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion criteria :

• Aged 12 to 23 months on the day of the first study visit ("12 to 23 months" means from the 12th month after birth to the day before the 24th month after birth).
• Informed consent form (ICF) had been signed and dated by the parent(s)/legally acceptable representative(s) and by an independent witness if required by local regulations.
• Participant and parent/legally acceptable representative were able to attend all scheduled visits and complied with all trial procedures.

Exclusion criteria:

• Participation in the 4 weeks (28 days) preceding the study vaccination or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure.
• Receipt of any vaccine in the 4 weeks (28 days) preceding the trial vaccination or planned receipt of any vaccine prior to Visit 2 except for influenza vaccination, which might be received at least 2 weeks before or after study vaccines. This exception included monovalent pandemic influenza vaccines and multivalent influenza vaccines.
• Receipt of immune globulins, blood or blood-derived products in the past 3 months.
• Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine (i.e., mono- or polyvalent, polysaccharide, or Conjugate meningococcal vaccine containing serogroups A, C, W, or Y; or meningococcal B vaccine).
• 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 trial (specifically, but not limited to, participants with persistent complement deficiency, with anatomic or functional asplenia, or participants travelling to countries with high endemic or epidemic disease).
• Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the study or to a vaccine containing any of the same substances .
• Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine.
• Personal history of Guillain-Barré syndrome.
• Thrombocytopenia, as reported by the parent/ legally acceptable representative or suspected thrombocytopenia contraindicating intramuscular vaccination in the Investigator's opinion.
• Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination in the Investigator's opinion.
• Chronic illness that, in the opinion of the Investigator, was at a stage where it might interfere with trial conduct or completion.
• Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature >= 38.0 degree Celsius). A prospective participant should not be included in the study until the condition had resolved or the febrile event had subsided.
• Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw.
• Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study.

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1: MenACYW Conjugate Vaccine; Healthy, toddlers aged 12 to 23 months received a single dose of MenACYW Conjugate vaccine on Day 0.	Biological: Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid Conjugate vaccine; Pharmaceutical form: Liquid solution for injection Route of administration: Intramuscular; Other Names: MenACYW Conjugate vaccine
Active Comparator: Group 2: Nimenrix® Vaccine; Healthy, toddlers aged 12 to 23 months received a single dose of Nimenrix® vaccine on Day 0.	Biological: Meningococcal polysaccharide group A, C, W-135 and Y Conjugate vaccine; Pharmaceutical form: Powder and solvent for suspension for injection Route of administration: Intramuscular; Other Names: Nimenrix®
Active Comparator: Group 3: NeisVac-C® Vaccine; Healthy, toddlers aged 12 to 23 months received a single dose of NeisVac-C® vaccine on Day 0.	Biological: Meningococcal group C polysaccharide Conjugate vaccine adsorbed; Pharmaceutical form: Suspension for injection Route of administration: Intramuscular; Other Names: NeisVac-C®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Antibody Titers >=1:8 Against Meningococcal Serogroup C Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® (Non-inferiority Analysis)	Antibody titers against Meningococcal Serogroup C were measured by hSBA.	Day 30 (post-vaccination)
Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroup C Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® (Non-inferiority Analysis)	GMT titers against Meningococcal Serogroup C were measured by hSBA. Titers were expressed in terms of 1/dilution.	Day 30 (post-vaccination)
GMTs of Antibodies Against Meningococcal Serogroup C Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® (Superiority Analysis)	GMT titers against Meningococcal Serogroup C were measured by hSBA. Titers were expressed in terms of 1/dilution.	Day 30 (post-vaccination)
Percentage of Participants With Antibody Titers >=1:8 Against Meningococcal Serogroup C Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® (Superiority Analysis)	Antibody titers against Meningococcal Serogroup C were measured by hSBA.	Day 30 (post-vaccination)
Percentage of Participants With Antibody Titers >=1:8 Against Meningococcal Serogroup C Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Following Vaccination With MenACYW Conjugate Vaccine or NeisVac-C® (Non-inferiority Analysis)	Antibody titers against Meningococcal Serogroup C were measured by rSBA.	Day 30 (post-vaccination)
GMTs of Antibodies Against Meningococcal Serogroup C Measured by rSBA Following Vaccination With MenACYW Conjugate Vaccine or NeisVac-C® (Non-inferiority Analysis)	GMT titers against Meningococcal Serogroup C were measured by rSBA. Titers were expressed in terms of 1/dilution.	Day 30 (post-vaccination)
GMTs of Antibodies Against Meningococcal Serogroup C Measured by rSBA Following Vaccination With MenACYW Conjugate Vaccine or NeisVac-C® (Superiority Analysis)	GMT titers against Meningococcal Serogroup C were measured by rSBA. Titers were expressed in terms of 1/dilution.	Day 30 (post-vaccination)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Antibody Titers >=1:8 Against Meningococcal Serogroup C Measured by rSBA Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® (Non-inferiority Analysis)	Antibody titers against Meningococcal Serogroup C were measured by rSBA.	Day 30 (post-vaccination)
GMTs of Antibodies Against Meningococcal Serogroup C Measured by rSBA Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® (Non-inferiority Analysis)	GMT titers against Meningococcal Serogroup C were measured by rSBA. Titers were expressed in terms of 1/dilution.	Day 30 (post-vaccination)
GMTs of Antibodies Against Meningococcal Serogroup C Measured by rSBA Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® (Superiority Analysis)	GMT titers against Meningococcal Serogroup C were measured by rSBA. Titers were expressed in terms of 1/dilution.	Day 30 (post-vaccination)
Percentage of Participants With Antibody Titers >=1:8 Against Meningococcal Serogroup C Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or NeisVac-C® (Non-inferiority Analysis)	Antibody titers against Meningococcal Serogroup C were measured by hSBA.	Day 30 (post-vaccination)
GMTs of Antibodies Against Meningococcal Serogroup C Measured by hSBA After Vaccination With MenACYW Conjugate Vaccine or NeisVac-C® (Non-inferiority Analysis)	GMT titers against Meningococcal Serogroup C were measured by hSBA. Titers were expressed in terms of 1/dilution.	Day 30 (post-vaccination)
GMTs of Antibodies Against Meningococcal Serogroup C Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or NeisVac-C® (Superiority Analysis)	GMT titers against Meningococcal Serogroup C were measured by hSBA. Titers were expressed in terms of 1/dilution.	Day 30 (post-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

• MEQ00065 Plain Language Results Summary

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2019
• Primary Completion (Actual): October 14, 2020
• Study Completion (Actual): October 14, 2020

Study Registration Dates

• First Submitted: March 25, 2019
• First Submitted That Met QC Criteria: March 25, 2019
• First Posted (Actual): March 26, 2019

Study Record Updates

• Last Update Posted (Estimated): September 15, 2025
• Last Update Submitted That Met QC Criteria: September 12, 2025
• Last Verified: September 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; Physiological Effects of Drugs; Immunologic Factors; meningococcal group A polysaccharide
• Other Study ID Numbers: MEQ00065; 2018-003790-10 (EudraCT Number); U1111-1217-2456 (Other Identifier: UTN)

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