Study on Immunogenicity and Safety of a Meningococcal ACYW Conjugate Vaccine in Healthy Infants and Toddlers

November 24, 2025 updated by: Sanofi Pasteur, a Sanofi Company

A Parallel-group, Prevention, Phase III, Modified Double-blind, 2-arm, Study to Investigate the Immunogenicity and Describe the Safety of a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Compared With Nimenrix® When Administered in a 1+1 Schedule in Healthy Infants and Toddlers at 6 and 12 Months of Age

This study is conducted to support a 2-dose series (1+1 vaccination schedule) for immunization of individuals from 6 months of age. The study is designed to evaluate the non-inferiority of the immunological response of MenACYW conjugate vaccine to Nimenrix® after the completion of the 2-dose series (1+1 vaccination schedule), with the first dose (priming dose) being given at 6-7 months of age to MenACWY- naïve healthy infants and the second dose (booster dose) given at 12-13 months of age. This study will also describe additional immunogenicity parameters and safety of MenACYW conjugate vaccine and Nimenrix® in the same population of participants.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study duration will be approximately 7 to 8.5 months (at least 7 months per participant).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
840

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Trial Transparency email recommended (Toll free for US & Canada)
  • Phone Number: option 6 800-633-1610
  • Email: Contact-US@sanofi.com

Study Locations

  • Czechia
      • Prague, Czechia
        • Investigational Site Number: 2030005
      • České Budějovice, Czechia, 370 06
        • Investigational Site Number : 2030002
      • České Budějovice, Czechia
        • Investigational Site Number: 2030001
  • Denmark
      • Aalborg, Denmark
        • Investigational Site Number: 2080007
      • Aarhus, Denmark
        • Investigational Site Number: 2080004
      • Herlev, Denmark
        • Investigational Site Number: 2080006
      • Hjørring, Denmark, 9800
        • Investigational Site Number : 2080005
      • Odense, Denmark
        • Investigational Site Number: 2080002
      • Zeeland, Denmark
        • Investigational Site Number: 2080001
  • Finland
      • Espoo, Finland
        • Investigational Site Number: 2460005
      • Helsinki, Finland
        • Investigational Site Number: 2460002
      • Helsinki, Finland
        • Investigational Site Number: 2460011
      • Jaarvenpa, Finland
        • Investigational Site Number: 2460006
      • Kokkola, Finland, 67100
        • Investigational Site Number : 2460003
      • Oulu, Finland
        • Investigational Site Number: 2460007
      • Tampere, Finland
        • Investigational Site Number: 2460004
      • Turku, Finland
        • Investigational Site Number: 2460012
  • Germany
      • Erfurt, Germany
        • Investigational Site Number: 2760007
      • Herxheim, Germany
        • Investigational Site Number: 2760004
      • Hürth, Germany
        • Investigational Site Number: 2760003
      • Mönchengladbach, Germany
        • Investigational Site Number: 2760001
      • Mönchengladbach, Germany
        • Investigational Site Number: 2760011
      • Schweigen-Rechtenbach, Germany
        • Investigational Site Number: 2760008
      • Schönau am Königssee, Germany
        • Investigational Site Number: 2760005
      • Wolfsburg, Germany
        • Investigational Site Number: 2760010
      • Worms, Germany, 67550
        • Investigational Site Number : 2760009
  • Poland
      • Bydgoszcz, Poland
        • Investigational Site Number: 6160003
      • Bydgoszcz, Poland
        • Investigational Site Number: 6160008
      • Bydgoszcz, Poland
        • Investigational Site Number: 6160017
      • Krakow, Poland
        • Investigational Site Number: 6160015
      • Krakow, Poland
        • Investigational Site Number: 6160021
      • Luboń, Poland
        • Investigational Site Number: 6160012
      • Siemianowice Śląskie, Poland
        • Investigational Site Number: 6160011
      • Torun, Poland
        • Investigational Site Number: 6160007
      • Trzebnica, Poland
        • Investigational Site Number: 6160014
      • Warsaw, Poland
        • Investigational Site Number: 6160022
      • Wroclav, Poland
        • Investigational Site Number: 6160010
      • Wroclaw, Poland
        • Investigational Site Number: 6160002
      • Łomianki, Poland
        • Investigational Site Number: 6160004
      • Łęczna, Poland
        • Investigational Site Number: 6160016
    • Kuyavian-Pomeranian Voivodeship
      • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-079
        • Investigational Site Number : 6160001
  • Romania
      • Bucharest, Romania, 011025
        • Investigational Site Number : 6420001
      • Bucharest, Romania, 021105
        • Investigational Site Number : 6420003
      • Bucharest, Romania
        • Investigational Site Number: 6420002
      • Călăraşi, Romania
        • Investigational Site Number: 6420005

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Aged 6 to 7 months on the day of inclusion
  • Participants who are healthy as determined by medical evaluation including medical history, physical examination and judgment of the Investigator

Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply:

  • 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 study (specifically but not limited to participants with persistent complement deficiency, with anatomic or functional asplenia, or participants traveling to countries with high endemic or epidemic disease)
  • Personal history of Guillain-Barré syndrome
  • Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine
  • Known systemic hypersensitivity to any of the study intervention components, or history of a life-threatening reaction to the study intervention(s) used in the study or to a product containing any of the same substances
  • Moderate or severe acute illness/infection (according to investigator judgment) or febrile illness (temperature ≥ 38.0°C [≥ 100.4°F]) on the day of study intervention administration. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided
  • Receipt of any vaccine (including COVID-19) and Meningococcal B vaccines) in the 4 weeks preceding the first and second study intervention administration or planned receipt of any vaccine (including COVID-19 and Meningococcal B vaccines) in the 4 weeks following any study intervention administration except for influenza vaccination, which may be received at least 2 weeks before or 2 weeks after the study interventions. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines.
  • Previous vaccination against meningococcal A, C, W, or Y disease with either the trial vaccine or another vaccine (i.e., mono- or quadrivalent meningococcal conjugate vaccine) containing serogroups A, C, Y, or W.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group 1: MenACYW conjugate vaccine
Participants will receive MenACYW Conjugate Vaccine (MenQuadfi®): 2-dose schedule (1+1); dose 1 (priming dose) at 6-7 months of age and dose 2 (booster dose) at 12-13 months of age (MenQuadfi®)
Biological: MenACYW conjugate vaccine
Pharmaceutical form:Solution for injection (in a single-dose vial)-Route of administration:Intramuscular (IM) injection
Other Names:
  • MenQuadfi®
Biological: MenACYW conjugate vaccine
Pharmaceutical form:Solution for injection (powder or cake in a single dose glass vial and a clear and colourless solvent in a pre filled syringe for reconstitution-Route of administration:Intramuscular (IM) injection
Other Names:
  • Nimenrix®
Active Comparator: Group 2: Nimenrix®
Participants will receive Nimenrix®: 2-dose schedule (1+1); dose 1 (priming dose) at 6-7 months of age and dose 2 (booster dose) at 12-13 months of age
Biological: MenACYW conjugate vaccine
Pharmaceutical form:Solution for injection (in a single-dose vial)-Route of administration:Intramuscular (IM) injection
Other Names:
  • MenQuadfi®
Biological: MenACYW conjugate vaccine
Pharmaceutical form:Solution for injection (powder or cake in a single dose glass vial and a clear and colourless solvent in a pre filled syringe for reconstitution-Route of administration:Intramuscular (IM) injection
Other Names:
  • Nimenrix®

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Geometric mean titers (GMTs) of Antibodies against meningococcal serogroups A, C, W and Y
Time Frame: 30 days after dose 2 (booster dose) (+14 days)
Geometric mean titers after a 2-dose serie measured by serum bactericidal assays using human complement (hSBA)
30 days after dose 2 (booster dose) (+14 days)
Vaccine Seroresponse to meningococcal serogroups A, C, W and Y assessed by hSBA
Time Frame: 30 days after dose 2 (booster dose) (+14 days)
Vaccine seroresponse after a 2-dose serie measured by hSBA
30 days after dose 2 (booster dose) (+14 days)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of participants with immediate adverse events (AEs)
Time Frame: Within 30 minutes after each vaccination
Unsolicited systemic AEs that occur within 30 minutes after vaccination
Within 30 minutes after each vaccination
Number of participants with solicited injection site reactions or systemic reactions
Time Frame: Within 7 days after each vaccination
Pre-defined solicited injection site reactions and systemic reactions that are pre-listed in the diary cards and CRF
Within 7 days after each vaccination
Rabbit complement (rSBA) antibody titers against meningococcal serogroups A, C, W, and Y
Time Frame: For infants 6-7 months old: Before and 30 days after dose 1 (priming dose) (+14 days) For toddlers12-13 months old: Before and 30 days after dose 2 (booster dose) (+14 days
For infants 6-7 months old: Before and 30 days after dose 1 (priming dose) (+14 days) For toddlers12-13 months old: Before and 30 days after dose 2 (booster dose) (+14 days
Percentage of Participants who achieved ≥4-fold rise in antibody titers over baseline measured by rSBA
Time Frame: For infants 6-7 months old: Before and 30 days after dose 1 (priming dose) (+14 days) For toddlers12-13 months old: Before and 30 days after dose 2 (booster dose) (+14 days
For infants 6-7 months old: Before and 30 days after dose 1 (priming dose) (+14 days) For toddlers12-13 months old: Before and 30 days after dose 2 (booster dose) (+14 days
Number of participants with unsolicited AEs
Time Frame: Up to 30 days after each vaccination
AEs other than solicited reactions
Up to 30 days after each vaccination
Number of participants with serious adverse events (SAEs)
Time Frame: From baseline to up to 7 months
SAEs (including adverse events of special interest [AESIs]) reported throughout the study
From baseline to up to 7 months
hSBA antibody titers ≥ 1:8 against meningococcal serogroups A, C, W and Y
Time Frame: 30 days after dose 1 (priming dose) (+14 days)
% of participants achieving antibody titers measured by hSBA ≥ predefined threshold of 1:8
30 days after dose 1 (priming dose) (+14 days)
hSBA antibody titers against meningococcal serogroups A, C, W and Y
Time Frame: For infants 6-7 months old: Before and 30 days after dose 1 (priming dose) (+14 days) For toddlers12-13 months old: Before and 30 days after dose 2 (booster dose) (+14 days)
Antibody titers are measured by hSBA and summarized as geometric mean titers (GMTs)
For infants 6-7 months old: Before and 30 days after dose 1 (priming dose) (+14 days) For toddlers12-13 months old: Before and 30 days after dose 2 (booster dose) (+14 days)
hSBA antibody titers ≥ several pre-defined thresholds against meningococcal serogroups A, C, W and Y
Time Frame: For infants 6-7 months old: Before and 30 days after dose 1 (priming dose) (+14 days) For toddlers12-13 months old: Before and 30 days after dose 2 (booster dose) (+14 days
Antibody titers are measured by hSBA and summarized as % of participants achieving antibody titers ≥ predefined thresholds
For infants 6-7 months old: Before and 30 days after dose 1 (priming dose) (+14 days) For toddlers12-13 months old: Before and 30 days after dose 2 (booster dose) (+14 days
Percentage of Participants who achieved ≥4-fold rise in antibody titers over baseline measured by hSBA
Time Frame: For infants 6-7 months old: Before and 30 days after dose 1 (priming dose) (+14 days) For toddlers 12-13 months old: Before and 30 days after dose 2 (booster dose) (+14 days
For infants 6-7 months old: Before and 30 days after dose 1 (priming dose) (+14 days) For toddlers 12-13 months old: Before and 30 days after dose 2 (booster dose) (+14 days
hSBA meningococcal serogroups A, C, W and Y vaccine seroresponse
Time Frame: For infants 6-7 months old: Before and 30 days after dose 1 (priming dose) (+14 days) For toddlers12-13 months old: Before and 30 days after dose 2 (booster dose) (+14 days
Vaccine seroresponse defined as follows: For a participant with a pre-vaccination titer < 1:8, a post vaccination titer ≥ 1:16 and for a participant with a pre-vaccination titer ≥ 1:8, a post vaccination titer at least 4-fold greater than the pre vaccination titer
For infants 6-7 months old: Before and 30 days after dose 1 (priming dose) (+14 days) For toddlers12-13 months old: Before and 30 days after dose 2 (booster dose) (+14 days
rSBA antibody titers ≥ several pre-defined thresholds against meningococcal serogroups A, C, W and Y
Time Frame: For infants 6-7 months old: Before and 30 days after dose 1 (priming dose) (+14 days) For toddlers 12-13 months old: Before and 30 days after dose 2 (booster dose) (+14 days
For infants 6-7 months old: Before and 30 days after dose 1 (priming dose) (+14 days) For toddlers 12-13 months old: Before and 30 days after dose 2 (booster dose) (+14 days
rSBA meningococcal serogroups A, C, W and Y vaccine seroresponse
Time Frame: For infants 6-7 months old: Before and 30 days after dose 1 (priming dose) (+14 days) For toddlers 12-13 months old: Before and 30 days after dose 2 (booster dose) (+14 days)
Vaccine seroresponse defined as follows: For a participant with a pre-vaccination titer < 1:8, a post vaccination titer ≥ 1:32 and for a participant with a pre-vaccination titer ≥ 1:8, a post vaccination titer at least 4-fold greater than the pre vaccination titer
For infants 6-7 months old: Before and 30 days after dose 1 (priming dose) (+14 days) For toddlers 12-13 months old: Before and 30 days after dose 2 (booster dose) (+14 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sanofi Pasteur, a Sanofi Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 19, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 14, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 14, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 22, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 29, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 2, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MEQ00089 (Sanofi Identifier)
  • 2023-508177-85 (Registry Identifier: CTIS)
  • U1111-1280-6981 (Registry Identifier: ICTRP)

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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