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
Conditions the study is for: Meningococcal Immunisation (Healthy Volunteers)
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
Type of treatment: Vaccines, Injection or infusion
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
Are there results?: Yes, posted in the registrySummary in the doctors' view

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.

Country

City, postcode or hospital

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:

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.

Conditions: Meningococcal Immunisation (Healthy Volunteers)
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 group	Role	What they receive
Group 1: MenACYW Conjugate Vaccine	Experimental	Healthy, 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® Vaccine	Active comparator	Healthy, 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® Vaccine	Active comparator	Healthy, 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.

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)
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)
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)
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)
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)
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)
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)

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)
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)
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)
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)
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)
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.

12 Sep 201914 Oct 2020

First posted26 Mar 2019
Study start12 Sep 2019
Primary completion14 Oct 2020
Study completion14 Oct 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Meningococcal Immunisation (Healthy Volunteers)Studies of the same condition, open and under way.
More trials run by Sanofi Pasteur, a Sanofi CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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
Results posted: Yes, on ClinicalTrials.gov
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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 3
Study on an Investigational Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Administered as a 5- and/or 10-year Booster Doses in Children and Adolescents Vaccinated 5 or 10 Years Earlier as Toddlers
Meningococcal Immunisation, Healthy Volunteers
RecruitingObservational study
Post Marketing Surveillance Study for MenQuadfi® [Meningococcal (Groups A, C, Y, W) Polysaccharide Tetanus Toxoid Conjugate Vaccine] Administered in Participants Aged 6 Weeks to 55 Years in Republic of Korea
Meningococcal Immunization, Healthy Volunteers
Active, not recruitingPhase 1/2
Safety and Immunogenicity of an Investigational Pentavalent Meningococcal ABCYW Vaccine Against Meningococcal Disease in Children, Toddlers, and Infants
Meningococcal Immunization, Healthy Volunteers

All Meningococcal Immunisation (Healthy Volunteers) trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03890367
Acronym / sponsor ID: MEQ00065
Conditions: Meningococcal Immunisation (Healthy Volunteers)
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 707 participants (actual)
Lead sponsor: Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
Study start: 12 Sep 2019 (actual)
Primary completion: 14 Oct 2020 (actual)
Study completion: 14 Oct 2020 (actual)
First posted: 26 Mar 2019 (actual)
Results: Posted 6 Oct 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Group 1: MenACYW Conjugate Vaccine	Experimental	Biological: Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid Conjugate vaccineHealthy, toddlers aged 12 to 23 months received a single dose of MenACYW Conjugate vaccine on Day 0.
Group 2: Nimenrix® Vaccine	Active comparator	Biological: Meningococcal polysaccharide group A, C, W-135 and Y Conjugate vaccineHealthy, toddlers aged 12 to 23 months received a single dose of Nimenrix® vaccine on Day 0.
Group 3: NeisVac-C® Vaccine	Active comparator	Biological: Meningococcal group C polysaccharide Conjugate vaccine adsorbedHealthy, toddlers aged 12 to 23 months received a single dose of NeisVac-C® vaccine on Day 0.

Who may qualify

Ages: 12 to 23 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (17 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid Conjugate vaccineAlso: MenACYW Conjugate vaccinePharmaceutical form: Liquid solution for injection Route of administration: Intramuscular	Biological	Group 1: MenACYW Conjugate Vaccine
Meningococcal polysaccharide group A, C, W-135 and Y Conjugate vaccineAlso: Nimenrix®Pharmaceutical form: Powder and solvent for suspension for injection Route of administration: Intramuscular	Biological	Group 2: Nimenrix® Vaccine
Meningococcal group C polysaccharide Conjugate vaccine adsorbedAlso: NeisVac-C®Pharmaceutical form: Suspension for injection Route of administration: Intramuscular	Biological	Group 3: NeisVac-C® Vaccine

Primary outcome

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)
Time frame: Day 30 (post-vaccination)
Antibody titers against Meningococcal Serogroup C were measured by hSBA.
Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroup C Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® (Non-inferiority Analysis)
Time frame: Day 30 (post-vaccination)
GMT titers against Meningococcal Serogroup C were measured by hSBA. Titers were expressed in terms of 1/dilution.
GMTs of Antibodies Against Meningococcal Serogroup C Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® (Superiority Analysis)
Time frame: Day 30 (post-vaccination)
GMT titers against Meningococcal Serogroup C were measured by hSBA. Titers were expressed in terms of 1/dilution.
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)
Time frame: Day 30 (post-vaccination)
Antibody titers against Meningococcal Serogroup C were measured by hSBA.
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)
Time frame: Day 30 (post-vaccination)
Antibody titers against Meningococcal Serogroup C were measured by rSBA.
GMTs of Antibodies Against Meningococcal Serogroup C Measured by rSBA Following Vaccination With MenACYW Conjugate Vaccine or NeisVac-C® (Non-inferiority Analysis)
Time frame: Day 30 (post-vaccination)
GMT titers against Meningococcal Serogroup C were measured by rSBA. Titers were expressed in terms of 1/dilution.
GMTs of Antibodies Against Meningococcal Serogroup C Measured by rSBA Following Vaccination With MenACYW Conjugate Vaccine or NeisVac-C® (Superiority Analysis)
Time frame: Day 30 (post-vaccination)
GMT titers against Meningococcal Serogroup C were measured by rSBA. Titers were expressed in terms of 1/dilution.

6 secondary outcomes

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)
Time frame: 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)
Time frame: Day 30 (post-vaccination)
GMTs of Antibodies Against Meningococcal Serogroup C Measured by rSBA Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® (Superiority Analysis)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Day 30 (post-vaccination)

Results and safety

Results posted to the registry on 6 Oct 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1: MenACYW Conjugate Vaccine	232	228
Group 2: Nimenrix® Vaccine	235	229
Group 3: NeisVac-C® Vaccine	240	239

Primary outcome: 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)

Time frame: Day 30 (post-vaccination). Number (95% Confidence Interval). Unit: percentage of participants

Measure	Group 1: MenACYW Conjugate Vaccine n = 214	Group 2: Nimenrix® Vaccine n = 211
Value	99.5 (97.4 to 100)	89.1 (84.1 to 93.0)

Group 1: MenACYW Conjugate Vaccine vs Group 2: Nimenrix® Vaccine: Difference in Percentage: 10.43 (97.5% CI 5.68 to 16.2)

Population analysed: Analysis was performed on hSBA per-protocol analysis set (PPAS) which was a subset that included all participants who received at least 1 dose of the study vaccine and had a valid post-vaccination serology result. The participants who presented protocol deviations were excluded from PPAS. Data for this outcome measure was planned to be collected and analyzed only for Group 1 and 2, and not for Group 3.

Primary outcome: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroup C Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® (Non-inferiority Analysis)

Time frame: Day 30 (post-vaccination). Geometric mean (95% Confidence Interval). Unit: titers

Measure	Group 1: MenACYW Conjugate Vaccine n = 214	Group 2: Nimenrix® Vaccine n = 211
Value	515 (450 to 591)	31.6 (26.5 to 37.6)

Group 1: MenACYW Conjugate Vaccine vs Group 2: Nimenrix® Vaccine: GMT Ratio: 16.3 (97.5% CI 12.7 to 21.0)

Population analysed: Analysis was performed on hSBA PPAS which was a subset that included all participants who received at least 1 dose of the study vaccine and had a valid post-vaccination serology result. The participants who presented protocol deviations were excluded from PPAS. Data for this outcome measure was planned to be collected and analyzed only for Group 1 and 2, and not for Group 3.

Primary outcome: GMTs of Antibodies Against Meningococcal Serogroup C Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® (Superiority Analysis)

Time frame: Day 30 (post-vaccination). Geometric mean (95% Confidence Interval). Unit: titers

Measure	Group 1: MenACYW Conjugate Vaccine n = 214	Group 2: Nimenrix® Vaccine n = 211
Value	515 (450 to 591)	31.6 (26.5 to 37.6)

Group 1: MenACYW Conjugate Vaccine vs Group 2: Nimenrix® Vaccine: GMT Ratio: 16.3 (97.5% CI 12.7 to 21.0)

Primary outcome: 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)

Time frame: Day 30 (post-vaccination). Number (95% Confidence Interval). Unit: percentage of participants

Measure	Group 1: MenACYW Conjugate Vaccine n = 214	Group 2: Nimenrix® Vaccine n = 211
Value	99.5 (97.4 to 100)	89.1 (84.1 to 93.0)

Group 1: MenACYW Conjugate Vaccine vs Group 2: Nimenrix® Vaccine: Difference in Percentage: 10.43 (97.5% CI 5.68 to 16.20)

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Unsolicited adverse events (AEs) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions were collected within 7 days post-vaccination. Serious AEs data were collected up to 30 days post-vaccination.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1: MenACYW Conjugate Vaccine	1 of 230 (0.4%)	197 of 230 (85.7%)	0 of 230
Group 2: Nimenrix® Vaccine	1 of 232 (0.4%)	192 of 232 (82.8%)	0 of 232
Group 3: NeisVac-C® Vaccine	2 of 239 (0.8%)	203 of 239 (84.9%)	0 of 239

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
MEQ00065 Plain Language Results SummaryLink provided by the sponsor.
Individual participant dataSharing planned: 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

Related trials for Meningococcal Immunisation (Healthy Volunteers)

Active, not recruitingPhase 3
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Meningococcal Immunisation, Healthy Volunteers
RecruitingObservational study
Post Marketing Surveillance Study for MenQuadfi® [Meningococcal (Groups A, C, Y, W) Polysaccharide Tetanus Toxoid Conjugate Vaccine] Administered in Participants Aged 6 Weeks to 55 Years in Republic of Korea
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Active, not recruitingPhase 1/2
Safety and Immunogenicity of an Investigational Pentavalent Meningococcal ABCYW Vaccine Against Meningococcal Disease in Children, Toddlers, and Infants
Meningococcal Immunization, Healthy Volunteers

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Sciences & Operations study director

Sanofi Pasteur, a Sanofi Company

29 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in Germany, Finland, Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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) (time frame: Day 30 (post-vaccination)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03890367.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.

Trial summary

Key requirements

Who may be able to join

Who cannot join

Trial locations and contacts

About this study

What participants receive

What is being measured

Timeline

Resources

More details

Study at a glance

Clinical summary

Study design

Who may qualify

Key inclusion criteria (3 listed)

Key exclusion criteria (17 listed)

Interventions

Primary outcome

Results and safety

Participant flow

Primary outcome: 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)

Primary outcome: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroup C Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® (Non-inferiority Analysis)

Primary outcome: GMTs of Antibodies Against Meningococcal Serogroup C Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® (Superiority Analysis)

Primary outcome: 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)

Adverse events

Research links

Related trials for Meningococcal Immunisation (Healthy Volunteers)

Study on an Investigational Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Administered as a 5- and/or 10-year Booster Doses in Children and Adolescents Vaccinated 5 or 10 Years Earlier as Toddlers

Post Marketing Surveillance Study for MenQuadfi® [Meningococcal (Groups A, C, Y, W) Polysaccharide Tetanus Toxoid Conjugate Vaccine] Administered in Participants Aged 6 Weeks to 55 Years in Republic of Korea

Safety and Immunogenicity of an Investigational Pentavalent Meningococcal ABCYW Vaccine Against Meningococcal Disease in Children, Toddlers, and Infants

Referral and contact

Questions about this trial

Participant flow

Primary outcome: 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)

Primary outcome: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroup C Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® (Non-inferiority Analysis)

Primary outcome: GMTs of Antibodies Against Meningococcal Serogroup C Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® (Superiority Analysis)

Primary outcome: 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)

Adverse events