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

NCT ID: NCT03890367

Last Updated: 2025-09-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 707 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-12
• Study Completion Date: 2020-10-14

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) .

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.

Conditions

Meningococcal Immunisation (Healthy Volunteers)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Group 1: MenACYW Conjugate Vaccine

Healthy, toddlers aged 12 to 23 months received a single dose of MenACYW Conjugate vaccine on Day 0.

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

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

Group 2: Nimenrix® Vaccine

Healthy, toddlers aged 12 to 23 months received a single dose of Nimenrix® vaccine on Day 0.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: BIOLOGICAL

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

Group 3: NeisVac-C® Vaccine

Healthy, toddlers aged 12 to 23 months received a single dose of NeisVac-C® vaccine on Day 0.

Group Type: ACTIVE_COMPARATOR

Meningococcal group C polysaccharide Conjugate vaccine adsorbed

Intervention Type: BIOLOGICAL

Pharmaceutical form: Suspension for injection Route of administration: Intramuscular

Interventions

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

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

Intervention Type: 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

Intervention Type: BIOLOGICAL

Meningococcal group C polysaccharide Conjugate vaccine adsorbed

Pharmaceutical form: Suspension for injection Route of administration: Intramuscular

Intervention Type: BIOLOGICAL

Other Intervention Names

MenACYW Conjugate vaccine; Nimenrix®; NeisVac-C®

Eligibility Criteria

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.

• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 23 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sanofi Pasteur, a Sanofi Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi Pasteur, a Sanofi Company

Locations

Investigational Site Number 2080001

Aarhus, , Denmark

Investigational Site Number 2080002

Hvidovre, , Denmark

Investigational Site Number 2080003

Odense, , Denmark

Investigational Site Number 2460006

Espoo, , Finland

Investigational Site Number 2460005

Helsinki, , Finland

Investigational Site Number 2460004

Järvenpää, , Finland

Investigational Site Number 2460008

Kokkola, , Finland

Investigational Site Number 2460007

Oulu, , Finland

Investigational Site Number 2460003

Pori, , Finland

Investigational Site Number 2460010

Seinäjoki, , Finland

Investigational Site Number 2460001

Tampere, , Finland

Investigational Site Number 2460002

Turku, , Finland

Investigational Site Number 2760015

Bönnigheim, , Germany

Investigational Site Number 2760004

Bramsche, , Germany

Investigational Site Number 2760019

Bretten, , Germany

Investigational Site Number 2760002

Erfurt, , Germany

Investigational Site Number 2760017

Hamburg, , Germany

Investigational Site Number 2760020

Herxheim, , Germany

Investigational Site Number 2760007

Hürth, , Germany

Investigational Site Number 2760013

Itzehoe, , Germany

Investigational Site Number 2760011

Mannheim, , Germany

Investigational Site Number 2760003

Mönchengladbach, , Germany

Investigational Site Number 2760005

Mönchengladbach, , Germany

Investigational Site Number 2760006

Schönau, , Germany

Investigational Site Number 2760008

Schwaigern, , Germany

Investigational Site Number 2760009

Schweigen, , Germany

Investigational Site Number 2760018

Tauberbischofsheim, , Germany

Investigational Site Number 2760010

Tuttlingen, , Germany

Investigational Site Number 2760012

Wolfsburg, , Germany

Countries

Denmark; Finland; Germany

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://www.trialsummaries.com/Study/StudyDetails?id=25309&tenant=MT_SNY_9011

MEQ00065 Plain Language Results Summary

Other Identifiers

2018-003790-10

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1217-2456

Identifier Type: OTHER

Identifier Source: secondary_id

MEQ00065

Identifier Type: -

Identifier Source: org_study_id