Meningococcal ImmunisationPhase 3NCT04936685
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
A Phase 3 study testing Meningococcal Polysaccharide (Serogroups A, C, W, and Y) Tetanus Toxoid Conjugate Vaccine in people with Meningococcal Immunisation and Healthy Volunteers, run by Sanofi Pasteur, a Sanofi Company at 27 sites in 4 countries.
Trial summary
The purpose of the MEQ00073 study is to describe the immunogenicity and safety of a booster dose and persistence of a priming dose of MenACYW conjugate vaccine (MenQuadfi®) in adolescents who had been vaccinated approximately 10 years earlier as toddlers as part of the MET51 study and to describe the immunogenicity… Read more about this study
- Who is it for?
- Ages 6 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Meningococcal Immunisation, Healthy Volunteers
- What is being tested?
- Meningococcal Polysaccharide (Serogroups A, C, W, and Y) Tetanus Toxoid Conjugate Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 209 participants
- Where
- 27 sitesin 4 countries
- Study dates
- 23 Aug 2022to 26 Dec 2027
- 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 6 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Received MenACYW vaccine in MET51 study (Groups 1 and 3) and completed the study (attended Visit 2)
- Participant and parent/ legally acceptable representative (LAR) are able to attend all scheduled visits and to comply with all trial procedures
- Covered by health insurance, if required by local regulations
Who cannot join
- 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 traveling to countries with high endemic or epidemic disease)
- Personal history of Guillain-Barré syndrome (GBS)
- Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid containing vaccine
- Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances
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- Verbal report by parent or LAR of thrombocytopenia or suspected thrombocytopenia, contraindicating intramuscular (IM) vaccination
- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination
- Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine (ie, mono- or polyvalent, polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C, W, or Y) with the exception of licensed MenC vaccination received during infancy (MET51 Group 3), of the single dose of meningococcal vaccine administered as part of study MET51 (Group 1 and 3) and of Meningococcal B vaccine
- Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine in the 4 weeks following trial vaccination except for influenza vaccination, which may be received at least 2 weeks before or after study vaccines. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines
- Receipt of immune globulins, blood or blood-derived products in the past 3 months
- Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw Participation at the time of study enrollment (or in the 4 weeks preceding the trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure Chronic illness that, in the opinion of the Investigator, is 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°C). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
- Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
27 sites in 4 countries.
27 sites in 4 countries
Germany10 sites
Investigational Site Number : 2760011
Bönnigheim, 74357
Investigational Site Number : 2760001
Bramsche, 49565
Investigational Site Number : 2760007
Bretten, 75015
Investigational Site Number : 2760004
Erfurt, 99086
Investigational Site Number : 2760009
Goch, 47574
Investigational Site Number : 2760015
Hamburg, 22415
Investigational Site Number : 2760002
Mönchengladbach, 41236
Investigational Site Number : 2760008
Mönchengladbach, 41236
Investigational Site Number : 2760006
Schönau am Königssee, 83471
Investigational Site Number : 2760003
Tauberbischofsheim, 97941
Finland9 sites
Investigational Site Number : 2460009
Espoo, 02230
Investigational Site Number : 2460001
Helsinki, 00100
Investigational Site Number : 2460006
Helsinki, 00930
Investigational Site Number : 2460002
Jarvenpaa, 04400
Investigational Site Number : 2460004
Kokkola, 67100
Investigational Site Number : 2460007
Oulu, 90220
Investigational Site Number : 2460003
Pori, 28100
Investigational Site Number : 2460008
Tampere, 33100
Investigational Site Number : 2460010
Turku, 20520
Hungary4 sites
Investigational Site Number : 3480002
Budapest, 1042
Investigational Site Number : 3480001
Budapest, 1188
Investigational Site Number : 3480005
Miskolc, 3527
Investigational Site Number : 3480006
Székesfehérvár, 8000
Spain4 sites
Investigational Site Number : 7240001
Madrid, Madrid, Comunidad de, 28046
Investigational Site Number : 7240002
Madrid, 28007
Investigational Site Number : 7240006
Santiago de Compostela, Galicia [Galicia], 15706
Investigational Site Number : 7240003
Seville, 41014
About this study
Official title: A Phase IIIb, Open-label, Multi-center Study to Evaluate the Immunogenicity and Safety of a Booster Dose and Describe the Immune Persistence of MenACYW Conjugate Vaccine With 5- and/or 10-year Booster Doses in Children and Adolescents Who Had Been Primed With MenACYW Conjugate Vaccine as Toddlers.
The purpose of the MEQ00073 study is to describe the immunogenicity and safety of a booster dose and persistence of a priming dose of MenACYW conjugate vaccine (MenQuadfi®) in adolescents who had been vaccinated approximately 10 years earlier as toddlers as part of the MET51 study and to describe the immunogenicity and safety of a second booster dose (as adolescents approximately 5 years after the first booster dose) and the persistence of a first booster dose of MenACYW in adolescents who had been primed with MenACYW conjugate vaccine as toddlers as part of the MET51 study and had received a first booster dose as children approximately 5 years after the priming dose.
Read the detailed description
The duration of each participant's participation will be approximately 5.5 years
- Conditions
- Meningococcal Immunisation, Healthy Volunteers
- Being tested
- Meningococcal Polysaccharide (Serogroups A, C, W, and Y) Tetanus Toxoid Conjugate Vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meningococcal Polysaccharide (Serogroups A, C, W, and Y) Tetanus Toxoid Conjugate VaccineBiological
Also called MenACYW conjugate vaccine MenQuadfi®
Liquid solution for injection Intramuscular
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Participants will receive a first booster dose of MenACYW conjugate vaccine at Day 1 and a second booster dose at year 5 of study MEQ00073 Receives: Biological: Meningococcal Polysaccharide (Serogroups A, C, W, and Y) Tetanus Toxoid Conjugate Vaccine |
| Group 2 | Experimental | Participants will receive a single booster dose of MenACYW conjugate vaccine at year 5 of study MEQ00073 Receives: Biological: Meningococcal Polysaccharide (Serogroups A, C, W, and Y) Tetanus Toxoid Conjugate Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Group 1: Percentage of Participants With Sufficiency of Serum Bactericidal Assay Using Human Complement (hSBA) Vaccine Seroresponse at 30 Days Post Booster Dose
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. hSBA vaccine seroresponse for serogroups A, C, W, and Y is defined as: percentage of participants with a pre-vaccination titer < 1:8, who had achieved a post-vaccination titer >= 1:16 or participants with a pre-vaccination titer >= 1:8, who had achieved a post-vaccination titer at least 4-fold greater than the pre-vaccination titer. The seroresponse sufficiency was demonstrated if the lower limit of 1-sided 97.5% confidence interval (CI) is > 75%.
Measured: Baseline (Day 1) and 30 days after the MenACYW conjugate vaccine 5-year booster dose
Secondary outcomes (19)
Antibody Persistence of Meningococcal (Groups 1 and 2): Percentage of Participants Achieving Titer (Seroprotection) >=1:8 hSBA and Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Titer >=1:8 Approximately 5 Years After the Primary Vaccination
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA and the rSBA and the results were expressed as vaccine seroprotection. Seroprotection rate is defined as percentage of participants with hSBA titer and rSBA titer >=1.8 who received MenACYW conjugate vaccine 5 years earlier. Antibody persistence of meningococcal serogroups A, C, W, and Y in children at 5 years (Groups 1 and 2).
Measured: At Day 1 (approximately 5 year after the administration of a priming dose as toddlers in study MET51)
Group 1: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA and the rSBA and the results were expressed as geometric mean titers.
Measured: Baseline (Day 1) and Day 31 after the administration of a 5-year booster dose
Group 2: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA and the rSBA and the results were expressed as geometric mean titers.
Measured: From Baseline (Day 1) until end of the study (approximately 5.5 years)
Group 1: Percentage of Participants With hSBA Titer >= 1:4 and >= 1:8
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. hSBA vaccine seroresponse is defined as a post-vaccination titer >= 1:16 for participants with pre-vaccination hSBA titer < 1:8, or a post-vaccination titer >= 4-fold increase at post baseline for participants with pre-vaccination hSBA titer >= 1:8.
Measured: Baseline (Day 1) and Day 31 after the administration of a 5-year booster dose
Group 2: Percentage of Participants With hSBA Titer >= 1:4 and >= 1:8
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. hSBA vaccine seroresponse is defined as a post-vaccination titer >= 1:16 for participants with pre-vaccination hSBA titer < 1:8, or a post-vaccination titer >= 4-fold increase at post baseline for participants with pre-vaccination hSBA titer >= 1:8.
Measured: From Baseline (Day 1) until end of the study (approximately 5.5 years)
Group 1: Percentage of Participants With rSBA Titer >= 1:8 and >= 1:128
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the rSBA. rSBA vaccine seroresponse is defined as a post-vaccination titer >= 1:32 for participants with pre-vaccination rSBA titer < 1:8, or a post-vaccination titer >= 4-fold increase at post baseline for participants with pre-vaccination rSBA titer >= 1:8.
Measured: Baseline (Day 1) and Day 31 after the administration of a 5-year booster dose
Group 2: Percentage of Participants With rSBA Titer >= 1:8 and >= 1:128
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the rSBA. rSBA vaccine seroresponse is defined as a post-vaccination titer >= 1:32 for participants with pre-vaccination rSBA titer < 1:8, or a post-vaccination titer >= 4-fold increase at post baseline for participants with pre-vaccination rSBA titer >= 1:8.
Measured: From Baseline (Day 1) until end of the study (approximately 5.5 years)
Group 1: Percentage of Participants With hSBA Titer >=4-Fold Rise From Pre-Vaccination to Post-Vaccination
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. hSBA vaccine seroresponse is defined as a post-vaccination titer >= 1:16 for participants with pre-vaccination hSBA titer < 1:8, or a post-vaccination titer >= 4-fold increase at post baseline for participants with pre-vaccination hSBA titer >= 1:8.
Measured: Baseline (Day 1) and Day 31 after the administration of a 5-year booster dose
Group 2: Percentage of Participants With hSBA Titer >=4-Fold Rise From Pre-Vaccination to Post-Vaccination
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. hSBA vaccine seroresponse is defined as a post-vaccination titer >= 1:16 for participants with pre-vaccination hSBA titer < 1:8, or a post-vaccination titer >= 4-fold increase at post baseline for participants with pre-vaccination hSBA titer >= 1:8.
Measured: From Baseline (Day 1) until end of the study (approximately 5.5 years)
Group 1: Percentage of Participants With rSBA Titer >=4-Fold Rise From Pre-Vaccination to Post-Vaccination
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the rSBA. rSBA vaccine seroresponse is defined as a post-vaccination titer >= 1:32 for participants with pre-vaccination rSBA titer < 1:8, or a post-vaccination titer >= 4-fold increase at post baseline for participants with pre-vaccination rSBA titer >= 1:8.
Measured: Baseline (Day 1) and Day 31 after the administration of a 5-year booster dose
Group 2: Percentage of Participants With rSBA Titer >=4-Fold Rise From Pre-Vaccination to Post-Vaccination
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the rSBA. rSBA vaccine seroresponse is defined as a post-vaccination titer >= 1:32 for participants with pre-vaccination rSBA titer < 1:8, or a post-vaccination titer >= 4-fold increase at post baseline for participants with pre-vaccination rSBA titer >= 1:8.
Measured: From Baseline (Day 1) until end of the study (approximately 5.5 years)
Group 1: Percentage of Participants With >=0.01 International Units (IU)/mL and >=0.1 IU/mL Anti-Tetanus Antibody Concentration
Anti-tetanus antibodies were measured by diphtheria, tetanus, pertussis multiplexed electrochemiluminescent (DTP-ECL) assay, a multiplexed serological assay that allowed for the simultaneous quantification of human antibodies to 6 specific antigens including diphtheria toxoid, tetanus toxoid, and 4 pertussis antigens: pertussis toxin, filamentous hemagglutinin, fimbriae and pertactin. The captured antibodies were then detected using a sulfotag-conjugated anti-human immunoglobulin (Ig)G conjugate.
Measured: Baseline (Day 1) and Day 31 after the administration of a 5-year booster dose
Group 2: Percentage of Participants With >=0.01 International Units (IU)/mL and >=0.1 IU/mL Anti-Tetanus Antibody Concentration
Anti-tetanus antibodies were measured by diphtheria, tetanus, pertussis multiplexed electrochemiluminescent (DTP-ECL) assay, a multiplexed serological assay that allowed for the simultaneous quantification of human antibodies to 6 specific antigens including diphtheria toxoid, tetanus toxoid, and 4 pertussis antigens: pertussis toxin, filamentous hemagglutinin, fimbriae and pertactin. The captured antibodies were then detected using a sulfotag-conjugated anti-human immunoglobulin (Ig)G conjugate.
Measured: From Baseline (Day 1) until end of the study (approximately 5.5 years)
Group 1: Geometric Mean Concentrations of Anti-Tetanus Antibody Concentration
Anti-tetanus antibodies were measured by DTP-ECL assay, a multiplexed serological assay that allowed for the simultaneous quantification of human antibodies to 6 specific antigens including diphtheria toxoid, tetanus toxoid, and 4 pertussis antigens: pertussis toxin, filamentous haemagglutinin, fimbriae and pertactin. The captured antibodies were then detected using a sulfotag-conjugated anti-human Ig G conjugate.
Measured: Baseline (Day 1) and Day 31 after the administration of a 5-year booster dose
Group 2: Geometric Mean Concentrations of Anti-Tetanus Antibody Concentration
Anti-tetanus antibodies were measured by DTP-ECL assay, a multiplexed serological assay that allowed for the simultaneous quantification of human antibodies to 6 specific antigens including diphtheria toxoid, tetanus toxoid, and 4 pertussis antigens: pertussis toxin, filamentous haemagglutinin, fimbriae and pertactin. The captured antibodies were then detected using a sulfotag-conjugated anti-human Ig G conjugate.
Measured: From Baseline (Day 1) until end of the study (approximately 5.5 years)
Group 1: Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs)
An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study vaccine, whether or not considered related to the study vaccine. An unsolicited AE is an observed AE that does not fulfill the conditions of solicited reactions (i.e.pre-listed in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination).
Measured: Within 30 minutes after vaccination
Group 1: Number of Participants With Solicited Injection Site Reactions and Systemic Reactions
All noxious and unintended responses to a study vaccine related to any dose was considered adverse reactions (AR). A solicited reaction is an "expected" AR (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRB. An injection/administration site reaction is an AR at and around the injection/administration site. Injection/administration site reactions are commonly inflammatory reactions. They were considered to be related to the study vaccine administered. Systemic reactions were all ARs that were not injection or administration site reactions and included systemic manifestations such as headache, fever, as well as localized or topical manifestations that are not associated with the vaccination or administration site.
Measured: 7 days after vaccination
Group 1: Number of Participants With Unsolicited AEs
An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study vaccine, whether or not considered related to the study vaccine. An unsolicited AE is an observed AE that does not fulfill the conditions of solicited reactions (i.e. pre-listed in the CRB in terms of diagnosis and/or onset window post-vaccination). Unsolicited AEs included both serious and non-serious unsolicited AEs.
Measured: Within 30 days after vaccination
Group 1: Number of Participants With Serious AEs (SAEs) and Adverse Event of Special Interest (AESI)
A SAEs is defined as any untoward medical occurrence, at any dose that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, was a congenital anomaly/birth defect, or other important medical event. An AESI (serious or non-serious) is defined as one of scientific and medical concern specific to the Sponsor's study vaccination or program, for which ongoing monitoring and rapid communication by the Investigator to the Sponsor was appropriate.
Measured: From the first study vaccine administration up to primary completion date of 09 March 2023, approximately 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start23 Aug 2022
- Primary completion9 Mar 2023
- Study completion26 Dec 2027 (estimated)
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Meningococcal ImmunisationStudies 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
- None (open label)
- Enrolment
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04936685
- Sponsor's protocol ID
- MEQ00073
- Other IDs
- U1111-1255-4941, 2023-510145-25-00, 2021-000104-38, 2023
- Status last verified
- Aug 2026
- First submitted
- 18 Jun 2021
- Last updated
- 28 Aug 2026
- 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
Publications
Martinon-Torres F, Simko R, Ebert R, Ramet M, Zocchetti C, Syrkina O, Bchir S, Bertrand-Gerentes I. Five-Year Immune Persistence of a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW-TT) and Immunogenicity and Safety of a Booster Dose in Children. Infect Dis Ther. 2025 May;14(5):991-1010. doi: 10.1007/s40121-025-01121-6. Epub 2025 Apr 1.
PubMed 40169489