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

NCT03890367 | Completed Phase 3 Results FDA Drug

• 3 other identifiers: MEQ000652018-003790-10U1111-1217-2456
• Study Type: interventional
• Target: 707
• Locations: 3 countries
• Sites: 29

Brief Summary

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) .

Conditions

Meningococcal Immunisation (Healthy Volunteers)

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (6)

• 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)

  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)

  Day 30 (post-vaccination)

• GMTs of Antibodies Against Meningococcal Serogroup C Measured by rSBA Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® (Superiority Analysis)

  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)

  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)

  Day 30 (post-vaccination)

Study Arms (3)

Group 1: MenACYW Conjugate Vaccine

EXPERIMENTAL

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

Group 2: Nimenrix® Vaccine

ACTIVE COMPARATOR

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

Group 3: NeisVac-C® Vaccine

ACTIVE COMPARATOR

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

Interventions

Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid Conjugate vaccine BIOLOGICAL

Pharmaceutical form: Liquid solution for injection Route of administration: Intramuscular

Also known as: MenACYW Conjugate vaccine

Group 1: MenACYW Conjugate Vaccine

Meningococcal polysaccharide group A, C, W-135 and Y Conjugate vaccine BIOLOGICAL

Pharmaceutical form: Powder and solvent for suspension for injection Route of administration: Intramuscular

Also known as: Nimenrix®

Group 2: Nimenrix® Vaccine

Meningococcal group C polysaccharide Conjugate vaccine adsorbed BIOLOGICAL

Pharmaceutical form: Suspension for injection Route of administration: Intramuscular

Also known as: NeisVac-C®

Group 3: NeisVac-C® Vaccine

Eligibility Criteria

• Age: 12 Months - 23 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (29)

Investigational Site Number 2080001

Aarhus, 8200, Denmark

Location

Investigational Site Number 2080002

Hvidovre, 2650, Denmark

Location

Investigational Site Number 2080003

Odense, 5000, Denmark

Location

Investigational Site Number 2460006

Espoo, 02230, Finland

Location

Investigational Site Number 2460005

Helsinki, 00100, Finland

Location

Investigational Site Number 2460004

Jarvenpaa, 04400, Finland

Location

Investigational Site Number 2460008

Kokkola, 67100, Finland

Location

Investigational Site Number 2460007

Oulu, 90220, Finland

Location

Investigational Site Number 2460003

Pori, 28100, Finland

Location

Investigational Site Number 2460010

Seinäjoki, 60100, Finland

Location

Investigational Site Number 2460001

Tampere, 33100, Finland

Location

Investigational Site Number 2460002

Turku, 20520, Finland

Location

Investigational Site Number 2760015

Bönnigheim, 74357, Germany

Location

Investigational Site Number 2760004

Bramsche, 49565, Germany

Location

Investigational Site Number 2760019

Bretten, 75015, Germany

Location

Investigational Site Number 2760002

Erfurt, 99086, Germany

Location

Investigational Site Number 2760017

Hamburg, 22415, Germany

Location

Investigational Site Number 2760020

Herxheim, 76863, Germany

Location

Investigational Site Number 2760007

Hürth, 50354, Germany

Location

Investigational Site Number 2760013

Itzehoe, 25524, Germany

Location

Investigational Site Number 2760011

Mannheim, 68161, Germany

Location

Investigational Site Number 2760003

Mönchengladbach, 41236, Germany

Location

Investigational Site Number 2760005

Mönchengladbach, 41236, Germany

Location

Investigational Site Number 2760006

Schönau, 83471, Germany

Location

Investigational Site Number 2760008

Schwaigern, 74193, Germany

Location

Investigational Site Number 2760009

Schweigen, 76889, Germany

Location

Investigational Site Number 2760018

Tauberbischofsheim, 97941, Germany

Location

Investigational Site Number 2760010

Tuttlingen, 78532, Germany

Location

Investigational Site Number 2760012

Wolfsburg, 38448, Germany

Location

Related Links

• MEQ00065 Plain Language Results Summary

MeSH Terms

Interventions

meningococcal group A polysaccharide

Results Point of Contact

• Title: Trial Transparency Team
• Organization: Sanofi Pasteur

Contact-US@sanofi.com

800-633-1610

Study Officials

• Clinical Sciences & Operations

  Sanofi Pasteur, a Sanofi Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Modified double-blind: the participant (or legally acceptable representative), and the Investigator remained unaware of the treatment assignments throughout the study. An unblinded vaccine administrator administered the appropriate vaccine but was not involved in safety data collection.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2019
• First Posted: March 26, 2019
• Study Start: September 12, 2019
• Primary Completion: October 14, 2020
• Study Completion: October 14, 2020
• Last Updated: September 15, 2025
• Results First Posted: October 6, 2021

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

DK (3); FI (9); DE (17)