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Meningococcal Immunisation (Healthy Volunteers)Phase 3NCT03890367

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

A Phase 3 study testing Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid Conjugate vaccine, Meningococcal polysaccharide group A, C, W-135 and Y Conjugate vaccine and Meningococcal group C polysaccharide Conjugate vaccine adsorbed in people with Meningococcal Immunisation (Healthy Volunteers), run by Sanofi Pasteur, a Sanofi Company at 29 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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). Read more about this study

Who is it for?
Ages 12 to 23 monthsHealthy volunteers can take part
What is being tested?
Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid Conjugate vaccine, Meningococcal polysaccharide group A, C, W-135 and Y Conjugate vaccine and Meningococcal group C polysaccharide Conjugate vaccine adsorbed
Could I receive a placebo?
No, everyone receives an active treatment
How many people
707 participants
Where
29 sitesin 3 countries
Study dates
12 Sep 2019to 14 Oct 2020
Phase
Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 23 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 17Show fewer
  • 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.

Trial locations and contacts

29 sites in 3 countries.

29 sites in 3 countries

Germany17 sites

  • Investigational Site Number 2760015

    Bönnigheim, 74357

  • Investigational Site Number 2760004

    Bramsche, 49565

  • Investigational Site Number 2760019

    Bretten, 75015

  • Investigational Site Number 2760002

    Erfurt, 99086

  • Investigational Site Number 2760017

    Hamburg, 22415

  • Investigational Site Number 2760020

    Herxheim, 76863

  • Investigational Site Number 2760007

    Hürth, 50354

  • Investigational Site Number 2760013

    Itzehoe, 25524

  • Investigational Site Number 2760011

    Mannheim, 68161

  • Investigational Site Number 2760003

    Mönchengladbach, 41236

  • Investigational Site Number 2760005

    Mönchengladbach, 41236

  • Investigational Site Number 2760006

    Schönau, 83471

  • Investigational Site Number 2760008

    Schwaigern, 74193

  • Investigational Site Number 2760009

    Schweigen, 76889

  • Investigational Site Number 2760018

    Tauberbischofsheim, 97941

  • Investigational Site Number 2760010

    Tuttlingen, 78532

  • Investigational Site Number 2760012

    Wolfsburg, 38448

Other trials in Germany

Finland9 sites

  • Investigational Site Number 2460006

    Espoo, 02230

  • Investigational Site Number 2460005

    Helsinki, 00100

  • Investigational Site Number 2460004

    Jarvenpaa, 04400

  • Investigational Site Number 2460008

    Kokkola, 67100

  • Investigational Site Number 2460007

    Oulu, 90220

  • Investigational Site Number 2460003

    Pori, 28100

  • Investigational Site Number 2460010

    Seinäjoki, 60100

  • Investigational Site Number 2460001

    Tampere, 33100

  • Investigational Site Number 2460002

    Turku, 20520

Other trials in Finland

Denmark3 sites

  • Investigational Site Number 2080001

    Aarhus, 8200

  • Investigational Site Number 2080002

    Hvidovre, 2650

  • Investigational Site Number 2080003

    Odense, 5000

Other trials in Denmark

About this study

Official title: 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:

Read more
  • 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) .
Read the 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.

Being tested
Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid Conjugate vaccine, Meningococcal polysaccharide group A, C, W-135 and Y Conjugate vaccine, Meningococcal group C polysaccharide Conjugate vaccine adsorbed

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    Also called MenACYW Conjugate vaccine

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

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

    Also called Nimenrix®

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

  • Meningococcal group C polysaccharide Conjugate vaccine adsorbedBiological

    Also called NeisVac-C®

    Pharmaceutical form: Suspension for injection Route of administration: Intramuscular

Study groups in NCT03890367
Study groupRoleWhat they receive
Group 1: MenACYW Conjugate VaccineExperimentalHealthy, toddlers aged 12 to 23 months received a single dose of MenACYW Conjugate vaccine on Day 0.
Receives: Biological: Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid Conjugate vaccine
Group 2: Nimenrix® VaccineActive comparatorHealthy, toddlers aged 12 to 23 months received a single dose of Nimenrix® vaccine on Day 0.
Receives: Biological: Meningococcal polysaccharide group A, C, W-135 and Y Conjugate vaccine
Group 3: NeisVac-C® VaccineActive comparatorHealthy, toddlers aged 12 to 23 months received a single dose of NeisVac-C® vaccine on Day 0.
Receives: Biological: Meningococcal group C polysaccharide Conjugate vaccine adsorbed

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Day 30 (post-vaccination)

  2. 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.

    Measured: Day 30 (post-vaccination)

  3. 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.

    Measured: Day 30 (post-vaccination)

  4. 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.

    Measured: Day 30 (post-vaccination)

  5. 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.

    Measured: Day 30 (post-vaccination)

  6. 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.

    Measured: Day 30 (post-vaccination)

  7. 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.

    Measured: Day 30 (post-vaccination)

Secondary outcomes (6)

  1. 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.

    Measured: Day 30 (post-vaccination)

  2. 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.

    Measured: Day 30 (post-vaccination)

  3. 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.

    Measured: Day 30 (post-vaccination)

  4. 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.

    Measured: Day 30 (post-vaccination)

  5. 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.

    Measured: Day 30 (post-vaccination)

  6. 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.

    Measured: Day 30 (post-vaccination)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Mar 2019
  2. Study start12 Sep 2019
  3. Primary completion14 Oct 2020
  4. Study completion14 Oct 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
707 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03890367
Sponsor's protocol ID
MEQ00065
Other IDs
2018-003790-10, U1111-1217-2456, 2018
Status last verified
Sep 2025
First submitted
25 Mar 2019
Last updated
15 Sep 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

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