Meningococcal ImmunizationPhase 3MET55NCT04143061

Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Healthy Adults, Adolescents, Children, and Toddlers in India and Healthy Adolescents and Children in the Republic of South Africa

A Phase 3 study testing Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid conjugate vaccine, Meningococcal polysaccharide (serogroups A,C,Y and W-135) diphtheria toxoid conjugate vaccine and Meningococcal polysaccharide (serogroups A, C, Y and W-135) vaccine in people with Meningococcal Immunization and Healthy Volunteers, run by Sanofi Pasteur, a Sanofi Company at 17 sites in 2 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

Who is it for?: Ages 12 months and olderHealthy volunteers can take part
Conditions the study is for: Meningococcal Immunization, Healthy Volunteers
What is being tested?: Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid conjugate vaccine, Meningococcal polysaccharide (serogroups A,C,Y and W-135) diphtheria toxoid conjugate vaccine and Meningococcal polysaccharide (serogroups A, C, Y and W-135) vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,328 participants
Where: 17 sitesin 2 countries
Study dates: 30 Dec 2019to 28 Jan 2023
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 months and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

Age in the defined range on the day of inclusion: For Adults: Aged ≥ 18 years on the day of inclusion For Children and Adolescents: Aged 2 to 17 years on the day of inclusion For Toddlers: Aged 12 to 23 months† on the day of inclusion
Z-score of ≥ -2 standard deviations (SD) on the Weight-for-height table of the World Health Organization (WHO) Child Growth Standards: For toddlers and children: Toddlers aged 12 to 23 months and Children aged 2 to 5 years had a Z-score of ≥ -2 SD on the Weight-for-height table of the WHO Child Growth Standards
Informed consent obtained For adults: Informed consent form has been signed and dated by the subject and by an independent witness, if required by local regulations For toddlers, children, and adolescents: Assent form has been signed and dated by the subject (for subjects 7 to 17 years of age), and informed consent form has been signed and dated by the parent(s) or legally acceptable representative and by an independent witness, if required by local regulations
Were able to attend all scheduled visits and to comply with all trial procedures For adults: Were able to attend all scheduled visits and to comply with all trial procedures For toddlers, children, and adolescents: Participants and parent / legally acceptable representative were able to attend all scheduled visits and to comply with all trial procedures
For Toddlers: All toddlers were due to receive an age-recommended RPV on D0

Who cannot join

Participant was pregnant, or lactating, or of childbearing potential and was not using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination. To be considered of non-childbearing potential, a female must be pre-menarche, or post-menopausal for at least 1 year, or surgically sterile
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
Receipt of any vaccine in the 4 weeks (28 days) preceding the IMP or planned receipt of any vaccine in the 4 weeks following vaccination except for oral poliovirus vaccine (OPV) in India, received during national immunization days. In India, OPV might have been received with a gap of at least 2 weeks before the IMP. This exception included monovalent and bivalent OPV.
Previous vaccination against meningococcal disease with either the IMP or another vaccine (i.e., mono- or polyvalent, polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C, Y, or W; or meningococcal B serogroup containing vaccine)
Receipt of immune globulins, blood or blood-derived products in the past 3 months
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)

Show all 20Show fewer

History of meningococcal infection, confirmed either clinically, serologically, or microbiologically
At high risk for meningococcal infection during the trial (specifically, but not limited to, subjects with persistent complement deficiency, with anatomic or functional asplenia, or subjects traveling to countries with high endemic or epidemic disease)
Known systemic hypersensitivity to latex or to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances
Verbal report of thrombocytopenia, as reported by the subject or the subject's parent / legally acceptable representative, 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
Personal history of Guillain-Barré syndrome
Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine within 10 years of the proposed study vaccination
Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
Current alcohol abuse or drug addiction
Chronic illness that, in the opinion of the investigator, was at a stage where it might interfere with trial conduct or completion
Any condition which, in the opinion of the Investigator, might have interfered with the evaluation of the study objectives.
Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination, febrile illness (temperature ≥ 38.0°C), persistent diarrhea, vomiting. A prospective subject was not included in the study until the condition has been resolved or the febrile event has been subsided
Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw
Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study

Trial locations and contacts

17 sites in 2 countries.

Country

City, postcode or hospital

17 sites in 2 countries

India10 sites

Investigational Site Number : 3560002
Bangalore, 560054
Investigational Site Number : 3560016
Belagavi, 590002
Investigational Site Number : 3560007
Chennai, 603203
Investigational Site Number : 3560004
Hyderabad, 500018
Investigational Site Number : 3560011
Kolkata, 700017
Investigational Site Number : 3560012
Mysore, 570004
Investigational Site Number : 3560015
Odisha, 751003
Investigational Site Number : 3560003
Pune, 411011
Investigational Site Number : 3560008
Pune, 411043
Investigational Site Number : 3560010
Punjab, 141008

Other trials in India

South Africa7 sites

Investigational Site Number : 7100004
Bertsham, 2013
Investigational Site Number : 7100007
Bloemfontein, 9301
Investigational Site Number : 7100005
Cape Town, 7505
Investigational Site Number : 7100002
Cape Town, 7937
Investigational Site Number : 7100001
Middelburg, 1055
Investigational Site Number : 7100006
Pretoria, 0002
Investigational Site Number : 7100003
Soweto, 1818

Other trials in South Africa

About this study

This will be a Phase III, modified double-blind (open-label for toddlers in India), randomized, parallel-group, active-controlled, step-wise, multi-center study to compare and describe the immunogenicity and safety of MenACYW conjugate vaccine when administered as a single dose in healthy adults, adolescents, children, and toddlers in India and a modified double-blind, randomized, parallel-group, active-controlled, multi-center study to compare and describe the immunogenicity and safety of MenACYW conjugate vaccine when administered as a single dose in healthy adolescents and children in RSA.

Read the detailed description

Study duration per participant is approximately 31 to 45 days

Conditions: Meningococcal Immunization, Healthy Volunteers
Being tested: Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid conjugate vaccine, Meningococcal polysaccharide (serogroups A,C,Y and W-135) diphtheria toxoid conjugate vaccine, Meningococcal polysaccharide (serogroups A, C, Y and W-135) 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,Y and W) tetanus toxoid conjugate vaccineBiological
Also called MenACYW conjugate vaccine
Pharmaceutical form: solution for injection; Route of administration: intramuscular, 0.5 mL
Meningococcal polysaccharide (serogroups A,C,Y and W-135) diphtheria toxoid conjugate vaccineBiological
Also called Menactra®
Pharmaceutical form: sterile aqueous solution; Route of administration: intramuscular, 0.5 mL
Meningococcal polysaccharide (serogroups A, C, Y and W-135) vaccineBiological
Also called Quadri Meningo™
Pharmaceutical form: reconstituted solution for injection; Route of administration: intramuscular, 0.5 mL

Study groups in NCT04143061
Study group	Role	What they receive
Group 1	Experimental	MenACYW conjugate vaccine, 1 vaccination, adults in India aged 18 to 55 years Receives: Biological: Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid conjugate vaccine
Group 2	Active comparator	Menactra® conjugate vaccine, 1 vaccination, adults in India aged 18 to 55 years Receives: Biological: Meningococcal polysaccharide (serogroups A,C,Y and W-135) diphtheria toxoid conjugate vaccine
Group 3	Experimental	MenACYW conjugate vaccine, 1 vaccination, adults in India aged ≥ 56 years Receives: Biological: Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid conjugate vaccine
Group 4	Active comparator	Quadri Meningo™, 1 vaccination, adults in India aged ≥ 56 years Receives: Biological: Meningococcal polysaccharide (serogroups A, C, Y and W-135) vaccine
Group 5	Experimental	MenACYW conjugate vaccine, 1 vaccination, children and adolescents in India aged 2 to 17 years Receives: Biological: Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid conjugate vaccine
Group 6	Active comparator	Menactra®, 1 vaccination, children and adolescents in India aged 2 to 17 years Receives: Biological: Meningococcal polysaccharide (serogroups A,C,Y and W-135) diphtheria toxoid conjugate vaccine
Group 7	Experimental	MenACYW conjugate vaccine, 1 vaccination, children and adolescents in RSA aged 2 to 17 years Receives: Biological: Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid conjugate vaccine
Group 8	Active comparator	Menactra®, 1 vaccination, children and adolescents in RSA aged 2 to 17 years Receives: Biological: Meningococcal polysaccharide (serogroups A,C,Y and W-135) diphtheria toxoid conjugate vaccine

What is being measured

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

Group 5 + 7 and Group 6 + 8: Percentage of Participants Who Achieved Antibody Titers ≥1:8 Against Meningococcal Serogroups A, C, Y, and W
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured by serum bactericidal assay using human complement (hSBA). Percentages are rounded off to the tenth decimal place. As pre-specified in protocol, the endpoint was assessed in children and adolescents aged 2 to 17 years in India and RSA as combined groups: Group 5 + Group 7 and Group 6 + Group 8 as they received the same dose of MenACYW conjugate vaccine and Menactra® respectively.
Measured: Day 30 (30 days post-vaccination on Day 0)

Secondary outcomes (9)

Group 1 and Group 2: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured by hSBA and serum bactericidal assay using baby rabbit complement (rSBA).
Measured: Day 0 (pre-vaccination) and Day 30 (30 days post-vaccination on Day 0)
Group 1 and Group 2: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured by hSBA and rSBA. Percentages are rounded off to the tenth decimal place. Percentage of participants who achieved antibody titers ≥1:4 and ≥1:8 by hSBA and ≥1:8 and ≥1:128 by rSBA are reported.
Measured: Day 0 (pre-vaccination) and Day 30 (30 days post-vaccination on Day 0)
Group 3 and Group 4: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured by hSBA and rSBA.
Measured: Day 0 (pre-vaccination) and Day 30 (30 days post-vaccination on Day 0)
Group 3 and Group 4: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured by hSBA and rSBA. Percentages are rounded off to the tenth decimal place. Percentage of participants who achieved antibody titers ≥1:4 and ≥1:8 by hSBA and ≥1:8 and ≥1:128 by rSBA are reported.
Measured: Day 0 (pre-vaccination) and Day 30 (30 days post-vaccination on Day 0)
Group 5 + 7 and Group 6 + 8: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured by hSBA and rSBA. As pre-specified in protocol, the endpoint was assessed in children and adolescents aged 2 to 17 years in India and RSA as combined groups: Group 5 + Group 7 and Group 6 + Group 8 as they received the same dose of MenACYW conjugate vaccine and Menactra® respectively.
Measured: Day 0 (pre-vaccination) and Day 30 (30 days post-vaccination on Day 0)
Group 5 and Group 6: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured by hSBA and rSBA.
Measured: Day 0 (pre-vaccination) and Day 30 (30 days post-vaccination on Day 0)
Group 5 and Group 6: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured by hSBA and rSBA. Percentages are rounded off to the tenth decimal place. Percentage of participants who achieved antibody titers ≥1:4 and ≥1:8 by hSBA and ≥1:8 and ≥1:128 by rSBA are reported.
Measured: Day 0 (pre-vaccination) and Day 30 (30 days post-vaccination on Day 0)
Group 7 and Group 8: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured by hSBA and rSBA.
Measured: Day 0 (pre-vaccination) and Day 30 (30 days post-vaccination on Day 0)
Group 7 and Group 8: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured by hSBA and rSBA. Percentages are rounded off to the tenth decimal place. Percentage of participants who achieved antibody titers ≥1:4 and ≥1:8 by hSBA and ≥1:8 and ≥1:128 by rSBA are reported.
Measured: Day 0 (pre-vaccination) and Day 30 (30 days post-vaccination on Day 0)

Timeline

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

30 Dec 201928 Jan 2023

First posted29 Oct 2019
Study start30 Dec 2019
Primary completion28 Jan 2023
Study completion28 Jan 2023

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 ImmunizationStudies 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
Model description: Toddlers (open-label), children, adolescents and adults aged 12 months and above are enrolled in India, and children and adolescents aged 2 to 17 years are included in RSA. The older populations (adults) are recruited before initiating the study in children and adolescents younger than 17 years of age in India.
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 1,328 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04143061
Sponsor's protocol ID: MET55
Other IDs: U1111-1183-6581, MET55, 2020-004341-36
Acronym: MET55
Status last verified: Jan 2025
First submitted: 25 Oct 2019
Last updated: 3 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
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

Not yet recruitingPhase 4
Single-center, Open-label Study: Immunogenicity and Safety Observation After Vaccination With ACYW135 Meningococcal Polysaccharide Vaccine in Junior High School Students Aged 13-15 Years
Meningococcal Disease; Meningococcal Meningitis
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
Not yet recruitingObservational study
Metagenomic Analysis of the Pharynx in High Risk Partners
Gonorrhea, Neisseria Gonorrhea
RecruitingObservational study
Evaluation of the Antibody Persistence Beyond Five Years After Immunization With MenFiveTM (NmCV-5), a Pentavalent Meningococcal ACYWX Conjugate Vaccine
Meningoccocal Disease

All Meningococcal Immunization trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Feb 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 in Healthy Adults, Adolescents, Children, and Toddlers in India and Healthy Adolescents and Children in the Republic of South Africa
ClinicalTrials.gov ID: NCT04143061
Acronym / sponsor ID: MET55 / MET55
Conditions: Meningococcal Immunization, Healthy Volunteers
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,328 participants (actual)
Lead sponsor: Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
Study start: 30 Dec 2019 (actual)
Primary completion: 28 Jan 2023 (actual)
Study completion: 28 Jan 2023 (actual)
First posted: 29 Oct 2019 (actual)
Results: Posted 3 Feb 2025

Clinical summary

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

Detailed description

Study duration per participant is approximately 31 to 45 days

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 8
Model description: Toddlers (open-label), children, adolescents and adults aged 12 months and above are enrolled in India, and children and adolescents aged 2 to 17 years are included in RSA. The older populations (adults) are recruited before initiating the study in children and adolescents younger than 17 years of age in India.

Arm	Type	Receives
Group 1	Experimental	Biological: Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid conjugate vaccineMenACYW conjugate vaccine, 1 vaccination, adults in India aged 18 to 55 years
Group 2	Active comparator	Biological: Meningococcal polysaccharide (serogroups A,C,Y and W-135) diphtheria toxoid conjugate vaccineMenactra® conjugate vaccine, 1 vaccination, adults in India aged 18 to 55 years
Group 3	Experimental	Biological: Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid conjugate vaccineMenACYW conjugate vaccine, 1 vaccination, adults in India aged ≥ 56 years
Group 4	Active comparator	Biological: Meningococcal polysaccharide (serogroups A, C, Y and W-135) vaccineQuadri Meningo™, 1 vaccination, adults in India aged ≥ 56 years
Group 5	Experimental	Biological: Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid conjugate vaccineMenACYW conjugate vaccine, 1 vaccination, children and adolescents in India aged 2 to 17 years
Group 6	Active comparator	Biological: Meningococcal polysaccharide (serogroups A,C,Y and W-135) diphtheria toxoid conjugate vaccineMenactra®, 1 vaccination, children and adolescents in India aged 2 to 17 years
Group 7	Experimental	Biological: Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid conjugate vaccineMenACYW conjugate vaccine, 1 vaccination, children and adolescents in RSA aged 2 to 17 years
Group 8	Active comparator	Biological: Meningococcal polysaccharide (serogroups A,C,Y and W-135) diphtheria toxoid conjugate vaccineMenactra®, 1 vaccination, children and adolescents in RSA aged 2 to 17 years

Who may qualify

Ages: 12 months and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (5 listed)

Age in the defined range on the day of inclusion: For Adults: Aged ≥ 18 years on the day of inclusion For Children and Adolescents: Aged 2 to 17 years on the day of inclusion For Toddlers: Aged 12 to 23 months† on the day of inclusion
Z-score of ≥ -2 standard deviations (SD) on the Weight-for-height table of the World Health Organization (WHO) Child Growth Standards: For toddlers and children: Toddlers aged 12 to 23 months and Children aged 2 to 5 years had a Z-score of ≥ -2 SD on the Weight-for-height table of the WHO Child Growth Standards
Informed consent obtained For adults: Informed consent form has been signed and dated by the subject and by an independent witness, if required by local regulations For toddlers, children, and adolescents: Assent form has been signed and dated by the subject (for subjects 7 to 17 years of age), and informed consent form has been signed and dated by the parent(s) or legally acceptable representative and by an independent witness, if required by local regulations
Were able to attend all scheduled visits and to comply with all trial procedures For adults: Were able to attend all scheduled visits and to comply with all trial procedures For toddlers, children, and adolescents: Participants and parent / legally acceptable representative were able to attend all scheduled visits and to comply with all trial procedures
For Toddlers: All toddlers were due to receive an age-recommended RPV on D0

Key exclusion criteria (20 listed)

Participant was pregnant, or lactating, or of childbearing potential and was not using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination. To be considered of non-childbearing potential, a female must be pre-menarche, or post-menopausal for at least 1 year, or surgically sterile
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
Receipt of any vaccine in the 4 weeks (28 days) preceding the IMP or planned receipt of any vaccine in the 4 weeks following vaccination except for oral poliovirus vaccine (OPV) in India, received during national immunization days. In India, OPV might have been received with a gap of at least 2 weeks before the IMP. This exception included monovalent and bivalent OPV.
Previous vaccination against meningococcal disease with either the IMP or another vaccine (i.e., mono- or polyvalent, polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C, Y, or W; or meningococcal B serogroup containing vaccine)
Receipt of immune globulins, blood or blood-derived products in 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: solution for injection; Route of administration: intramuscular, 0.5 mL	Biological	Group 1, Group 3, Group 5, Group 7
Meningococcal polysaccharide (serogroups A,C,Y and W-135) diphtheria toxoid conjugate vaccineAlso: Menactra®Pharmaceutical form: sterile aqueous solution; Route of administration: intramuscular, 0.5 mL	Biological	Group 2, Group 6, Group 8
Meningococcal polysaccharide (serogroups A, C, Y and W-135) vaccineAlso: Quadri Meningo™Pharmaceutical form: reconstituted solution for injection; Route of administration: intramuscular, 0.5 mL	Biological	Group 4

Primary outcome

Group 5 + 7 and Group 6 + 8: Percentage of Participants Who Achieved Antibody Titers ≥1:8 Against Meningococcal Serogroups A, C, Y, and W
Time frame: Day 30 (30 days post-vaccination on Day 0)
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured by serum bactericidal assay using human complement (hSBA). Percentages are rounded off to the tenth decimal place. As pre-specified in protocol, the endpoint was assessed in children and adolescents aged 2 to 17 years in India and RSA as combined groups: Group 5 + Group 7 and Group 6 + Group 8 as they received the same dose of MenACYW conjugate vaccine and Menactra® respectively.

9 secondary outcomes

Group 1 and Group 2: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W
Time frame: Day 0 (pre-vaccination) and Day 30 (30 days post-vaccination on Day 0)
Group 1 and Group 2: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W
Time frame: Day 0 (pre-vaccination) and Day 30 (30 days post-vaccination on Day 0)
Group 3 and Group 4: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W
Time frame: Day 0 (pre-vaccination) and Day 30 (30 days post-vaccination on Day 0)
Group 3 and Group 4: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W
Time frame: Day 0 (pre-vaccination) and Day 30 (30 days post-vaccination on Day 0)
Group 5 + 7 and Group 6 + 8: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W
Time frame: Day 0 (pre-vaccination) and Day 30 (30 days post-vaccination on Day 0)
Group 5 and Group 6: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W
Time frame: Day 0 (pre-vaccination) and Day 30 (30 days post-vaccination on Day 0)
Group 5 and Group 6: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W
Time frame: Day 0 (pre-vaccination) and Day 30 (30 days post-vaccination on Day 0)
Group 7 and Group 8: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W
Time frame: Day 0 (pre-vaccination) and Day 30 (30 days post-vaccination on Day 0)
Group 7 and Group 8: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W
Time frame: Day 0 (pre-vaccination) and Day 30 (30 days post-vaccination on Day 0)

Results and safety

Results posted to the registry on 3 Feb 2025, 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	98	96
Group 2: Menactra®	100	100
Group 3: MenACYW Conjugate Vaccine	100	100
Group 4: Quadri Meningo™/Locally Available Licensed Meningococcal Vaccine	100	100
Group 5: MenACYW Conjugate Vaccine	232	224
Group 6: Menactra®	233	229
Group 7: MenACYW Conjugate Vaccine	233	226
Group 8: Menactra®	232	220

Primary outcome: Group 5 + 7 and Group 6 + 8: Percentage of Participants Who Achieved Antibody Titers ≥1:8 Against Meningococcal Serogroups A, C, Y, and W

Time frame: Day 30 (30 days post-vaccination on Day 0). Number (95% Confidence Interval). Unit: percentage of participants

Measure	Group 5 + Group 7: MenACYW Conjugate Vaccine n = 445	Group 6 + Group 8: Menactra® n = 445
Serogroup A	89.6 (86.4 to 92.3)	83.1 (79.2 to 86.4)
Serogroup C	99.3 (98.0 to 99.9)	77.7 (73.5 to 81.4)
Serogroup Y	96.6 (94.5 to 98.1)	85.6 (81.9 to 88.7)
Serogroup W	98.7 (97.1 to 99.5)	87.6 (84.2 to 90.6)

Group 5 + Group 7: MenACYW Conjugate Vaccine vs Group 6 + Group 8: Menactra®: Difference in percentage of participants: 6.55 (95% CI 2.03 to 11.08)
Group 5 + Group 7: MenACYW Conjugate Vaccine vs Group 6 + Group 8: Menactra®: Difference in percentage of participants: 21.67 (95% CI 17.82 to 25.80)
Group 5 + Group 7: MenACYW Conjugate Vaccine vs Group 6 + Group 8: Menactra®: Difference in percentage of participants: 11.08 (95% CI 7.43 to 14.89)

Population analysed: Analysis was performed on the per-protocol analysis set (PPAS) which was a subset of the full analysis set (FAS). The FAS was the subset of randomized participants who received at least 1 dose of the study vaccine and had a valid post-vaccination blood sample result. Only participants with data collected for each specific serogroup are reported.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the first study vaccine administration (Day 0) up to 30 days post-vaccination on Day 0, mean study subject duration was 33 days for Groups 1 to 4, 34 days for Groups 5 and 6, and 35 days for Groups 7 and 8.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1: MenACYW Conjugate Vaccine	1 of 98 (1%)	32 of 98 (32.7%)	0 of 98
Group 2: Menactra®	0 of 100 (0%)	26 of 100 (26%)	0 of 100
Group 3: MenACYW Conjugate Vaccine	0 of 100 (0%)	18 of 100 (18%)	0 of 100
Group 4: Quadri Meningo™/Locally Available Licensed Meningococcal Vaccine	0 of 100 (0%)	21 of 100 (21%)	0 of 100
Group 5: MenACYW Conjugate Vaccine	1 of 232 (0.4%)	81 of 232 (34.9%)	0 of 232
Group 6: Menactra®	0 of 232 (0%)	43 of 232 (18.5%)	0 of 232
Group 7: MenACYW Conjugate Vaccine	0 of 229 (0%)	115 of 229 (50.2%)	0 of 229
Group 8: Menactra®	0 of 227 (0%)	128 of 227 (56.4%)	0 of 227

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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

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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

17 sites in 2 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 5 inclusion and 20 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 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in India, South Africa. 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 3 Feb 2025). 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?

Group 5 + 7 and Group 6 + 8: Percentage of Participants Who Achieved Antibody Titers ≥1:8 Against Meningococcal Serogroups A, C, Y, and W (time frame: Day 30 (30 days post-vaccination on Day 0)). 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 NCT04143061.

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 3 Feb 2025.