Meningococcal InfectionPhase 3NCT07135986
Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered in Healthy Children and Adolescents in China
A Phase 3 study testing MenACYW conjugate vaccine, MenACYW135 polysaccharide vaccine and MenAC conjugate vaccine in people with Meningococcal Infection and Healthy Volunteers, run by Sanofi at 4 sites in China.
Trial summary
This is a Phase 3, modified double-blind, randomized, parallel-group, active-controlled, multicenter study with 2 arms and 4 groups to evaluate the immunogenicity and safety of MenACYW conjugate vaccine in children and adolescents versus control meningococcal vaccines licensed in China. Read more about this study
- Who is it for?
- Ages 2 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Meningococcal Infection, Healthy Volunteers
- What is being tested?
- MenACYW conjugate vaccine, MenACYW135 polysaccharide vaccine and MenAC conjugate vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,602 participants
- Where
- 4 sitesChina
- Study dates
- 26 Sep 2025to 24 Sep 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 2 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- For Cohort I: Aged 7 to 17 years on the day of inclusion ("7 to 17 years" means from the day of the 7th birthday to the day before the 18th birthday.). For Cohort II: Aged 2 to 6 years on the day of inclusion (2 to 6 years" means from the day of the 2nd birthday to the day before the 7th birthday.)
- Participants who are healthy as determined by medical evaluation including medical history and physical examination.
- A female participant is eligible to participate if she is not pregnant or breastfeeding
- 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; or long-term systemic corticosteroid therapy
- History of meningococcal infection
Show all 21Show fewer
- History of any neurologic disorders
- History of Guillain-Barré syndrome
- History of an Arthus-type hypersensitivity reaction after a previous dose of tetanus toxoid-containing vaccine
- At high risk for meningococcal infection during the trial
- Known systemic hypersensitivity to any of the vaccine components
- Self-reported thrombocytopenia, contraindicating intramuscular vaccination.
- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination.
- 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
- Alcohol, prescription drug, or substance abuse that, in the opinion of the Investigator, might interfere with the study conduct or completion.
- 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.
- The time since last vaccination of meningococcal vaccine was 2 years or less.
- 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.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Who cannot join
None listed.
Trial locations and contacts
4 sites in 1 country.
China4 sites
Investigational Site Number : 1561001
Jingxi, 533899
Investigational Site Number : 1561003
Liuzhou, 545100
Investigational Site Number : 1561000
Nanning, Guangxi, 530028
Investigational Site Number : 1561002
Tengzhou, 543399
About this study
Official title: A Phase 3, Modified Double-blind, Multi-center Study of the Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered in Healthy Children and Adolescents (2 to 17 Years of Age) in China
This is a Phase 3, modified double-blind, randomized, parallel-group, active-controlled, multicenter study with 2 arms and 4 groups to evaluate the immunogenicity and safety of MenACYW conjugate vaccine in children and adolescents versus control meningococcal vaccines licensed in China.
Study details include:
- The study duration will be approximately 180 days.
- The vaccination visit will be Visit 1.
- The visit frequency will be 2 on-site visits with a 30-day interval. A safety visit/telephone call is planned on the ninth day after the vaccination for all groups; a safety follow-up telephone call is planned for all groups 180 days post the last vaccination.
Read the detailed description
The duration of each participant's participation will be approximately 180 days.
- Conditions
- Meningococcal Infection, Healthy Volunteers
- Being tested
- MenACYW conjugate vaccine, MenACYW135 polysaccharide vaccine, MenAC conjugate vaccine
- Medical subject headings
- Meningococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MenACYW conjugate vaccineBiological
Also called MenQuadfi
Pharmaceutical form:Liquid solution-Route of administration:Intramuscular (IM) injection
MenACYW135 polysaccharide vaccineBiological
Pharmaceutical form: Lyophilized powder-Route of administration:IM injection
MenAC conjugate vaccineBiological
Pharmaceutical form:Lyophilized powder-Route of administration:IM injection
| Study group | Role | What they receive |
|---|---|---|
| Group 1 MenACYW1-dose schedule | Experimental | 1 dose of MenACYW conjugate vaccine to participants aged 7 through 17 years of age Receives: Biological: MenACYW conjugate vaccine |
| Group 2 MenACYW135 Ps 1-dose schedule | Active comparator | 1 dose of MenACYW135 polysaccharide vaccine to participants aged 7 through 17 years of age Receives: Biological: MenACYW135 polysaccharide vaccine |
| Group 3 MenACYW1-dose schedule | Experimental | 1 dose of MenACYW conjugate vaccine to participants aged 2 through 6 years of age Receives: Biological: MenACYW conjugate vaccine |
| Group 4 Royal MenAC1-dose schedule | Active comparator | 1 dose of Royal's MenAC conjugate vaccine to participants aged 2 through 6 years of age Receives: Biological: MenAC conjugate vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants 7 through 17 years of age (Cohort I): Vaccine seroresponse to meningococcal serogroups A, C, Y, and W
30 days postvaccination rSBA titer ≥1:8 for participants with prevaccination rSBA titer <1:8, or At least 4-fold increase in rSBA titer from pre- to 30 days postvaccination for participants with pre vaccination rSBA titer ≥1:8
Measured: Day 01 (pre-vaccination) and Day 31 (post- vaccination)
Participants 7 through 17 years of age (Cohort I): Geometric mean titers (GMTs) of antibodies against meningococcal serogroups A, C, Y, and W
Antibodies titers are expressed as geometric mean titers
Measured: Day 31 (post- vaccination)
Participants 7 through 17 years of age (Cohort I): Vaccine seroresponse to meningococcal serogroups W and Y will be assessed in participants receiving MenACYW conjugate vaccine
30 days postvaccination rSBA titer ≥1:8 for participants with prevaccination rSBA titer <1:8, or At least 4-fold increase in rSBA titer from pre- to 30 days post-vaccination for participants with pre vaccination rSBA titer ≥1:8
Measured: Day 01 (pre-vaccination) and Day 31 (post- vaccination)
Participants 2 through 6 years of age (Cohort II): Vaccine seroresponse to meningococcal serogroups A and C
30 days postvaccination rSBA titer ≥1:8 for participants with prevaccination rSBA titer <1:8, or At least 4-fold increase in rSBA titer from pre- to 30 days postvaccination for participants with pre vaccination rSBA titer ≥1:8
Measured: Day 01 (pre-vaccination) and Day 31 (post- vaccination)
Participants 2 through 6 years of age (Cohort II): Geometric mean titers (GMTs) of antibodies against meningococcal serogroups A and C
Antibody titers are expressed as geometric mean titers
Measured: Day 01 (pre-vaccination) and Day 31 (post- vaccination)
Participants 2 through 6 years of age (Cohort II): Vaccine seroresponse to meningococcal serogroups W and Y in participants receiving MenACYW conjugate vaccine
30 days post-vaccination rSBA titer ≥1:8 for participants with pre-vaccination rSBA titer <1:8, or At least 4-fold increase in rSBA titer from pre- to 30◦days post-vaccination for participants with pre vaccination rSBA titer ≥1:8
Measured: Day 01 (pre-vaccination) and Day 31 (post- vaccination)
Secondary outcomes (9)
Participants 7 through 17 years of age (Cohort I): Vaccine seroresponse to meningococcal serogroups A, C, Y, and W (Group 1)
30 days post vaccination rSBA titer ≥1:8 for participants with pre vaccination rSBA titer <1:8, or At least 4-fold increase in rSBA titer from pre- to 30 days post vaccination for participants with pre vaccination rSBA titer ≥1:8
Measured: Day 01 (pre-vaccination) and Day 31 (post- vaccination)
Number of participants with immediate adverse events (AEs)
Unsolicited systemic AEs that occur within 30 minutes after vaccination
Measured: Within 30 minutes post-vaccination
Presence of solicited injection site reactions
Solicited injection site reactions include injection site pain, erythema and swelling
Measured: Within 7 days post-vaccination
Presence of solicited systemic reactions
Solicited systemic reactions include fever, headache, malaise and myalgia
Measured: Within 7 days post-vaccination
Presence of unsolicited AEs
Measured: Within 30 days post-vaccination
Presence of SAEs
SAEs, including adverse events of special interest (AESIs), reported throughout the study
Measured: Up to Day 181 post-vaccination
Participants 7 through 17 years of age (Cohort I): Antibody titers against meningococcal serogroups A, C, Y, and W in Groups 1 and 2
Antibody titers measured by rSBA titer ≥1:8, ≥1:128
Measured: Day 01 (pre-vaccination) and Day 31 (post- vaccination)
Participants 2 through 6 years of age (Cohort II): Antibody titers against meningococcal serogroups A, C, Y, and W in Group 3 and against meningococcal serogroups A and C in Group 4
Antibody titers measured by rSBA titer ≥1:8, ≥1:128
Measured: Day 01 (pre-vaccination) and Day 31 (post- vaccination)
Participants 2 through 6 years of age (Cohort II): Antibody titers in terms of GMTs against meningococcal serogroups Y and W in Group 3
Antibodies titers are expressed as geometric mean titers
Measured: Day 01 (pre-vaccination) and Day 31 (post- vaccination)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start26 Sep 2025
- Primary completion1 May 2026
- Study completion24 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meningococcal InfectionStudies of the same condition, open and under way.
- More trials run by SanofiThe 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
- 1,602 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07135986
- Sponsor's protocol ID
- MEQ00076
- Other IDs
- U1111-1256-8979
- Status last verified
- Oct 2026
- First submitted
- 14 Aug 2025
- Last updated
- 19 Oct 2026
- Results posted
- No
- 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
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Modified Double-blind, Multi-center Study of the Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered in Healthy Children and Adolescents (2 to 17 Years of Age) in China
- ClinicalTrials.gov ID
- NCT07135986
- Acronym / sponsor ID
- MEQ00076
- Conditions
- Meningococcal Infection, Healthy Volunteers
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,602 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 26 Sep 2025 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 24 Sep 2026 (actual)
- First posted
- 22 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 3, modified double-blind, randomized, parallel-group, active-controlled, multicenter study with 2 arms and 4 groups to evaluate the immunogenicity and safety of MenACYW conjugate vaccine in children and adolescents versus control meningococcal vaccines licensed in China.
Study details include:
- The study duration will be approximately 180 days.
- The vaccination visit will be Visit 1.
- The visit frequency will be 2 on-site visits with a 30-day interval. A safety visit/telephone call is planned on the ninth day after the vaccination for all groups; a safety follow-up telephone call is planned for all groups 180 days post the last vaccination.
Detailed description
The duration of each participant's participation will be approximately 180 days.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 MenACYW1-dose schedule | Experimental | Biological: MenACYW conjugate vaccine1 dose of MenACYW conjugate vaccine to participants aged 7 through 17 years of age |
| Group 2 MenACYW135 Ps 1-dose schedule | Active comparator | Biological: MenACYW135 polysaccharide vaccine1 dose of MenACYW135 polysaccharide vaccine to participants aged 7 through 17 years of age |
| Group 3 MenACYW1-dose schedule | Experimental | Biological: MenACYW conjugate vaccine1 dose of MenACYW conjugate vaccine to participants aged 2 through 6 years of age |
| Group 4 Royal MenAC1-dose schedule | Active comparator | Biological: MenAC conjugate vaccine1 dose of Royal's MenAC conjugate vaccine to participants aged 2 through 6 years of age |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (21 listed)
- For Cohort I: Aged 7 to 17 years on the day of inclusion ("7 to 17 years" means from the day of the 7th birthday to the day before the 18th birthday.). For Cohort II: Aged 2 to 6 years on the day of inclusion (2 to 6 years" means from the day of the 2nd birthday to the day before the 7th birthday.)
- Participants who are healthy as determined by medical evaluation including medical history and physical examination.
- A female participant is eligible to participate if she is not pregnant or breastfeeding
- 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; or long-term systemic corticosteroid therapy
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| MenACYW conjugate vaccineAlso: MenQuadfiPharmaceutical form:Liquid solution-Route of administration:Intramuscular (IM) injection | Biological | Group 1 MenACYW1-dose schedule, Group 3 MenACYW1-dose schedule |
| MenACYW135 polysaccharide vaccinePharmaceutical form: Lyophilized powder-Route of administration:IM injection | Biological | Group 2 MenACYW135 Ps 1-dose schedule |
| MenAC conjugate vaccinePharmaceutical form:Lyophilized powder-Route of administration:IM injection | Biological | Group 4 Royal MenAC1-dose schedule |
Primary outcome
Participants 7 through 17 years of age (Cohort I): Vaccine seroresponse to meningococcal serogroups A, C, Y, and W
Time frame: Day 01 (pre-vaccination) and Day 31 (post- vaccination)
30 days postvaccination rSBA titer ≥1:8 for participants with prevaccination rSBA titer <1:8, or At least 4-fold increase in rSBA titer from pre- to 30 days postvaccination for participants with pre vaccination rSBA titer ≥1:8
Participants 7 through 17 years of age (Cohort I): Geometric mean titers (GMTs) of antibodies against meningococcal serogroups A, C, Y, and W
Time frame: Day 31 (post- vaccination)
Antibodies titers are expressed as geometric mean titers
Participants 7 through 17 years of age (Cohort I): Vaccine seroresponse to meningococcal serogroups W and Y will be assessed in participants receiving MenACYW conjugate vaccine
Time frame: Day 01 (pre-vaccination) and Day 31 (post- vaccination)
30 days postvaccination rSBA titer ≥1:8 for participants with prevaccination rSBA titer <1:8, or At least 4-fold increase in rSBA titer from pre- to 30 days post-vaccination for participants with pre vaccination rSBA titer ≥1:8
Participants 2 through 6 years of age (Cohort II): Vaccine seroresponse to meningococcal serogroups A and C
Time frame: Day 01 (pre-vaccination) and Day 31 (post- vaccination)
30 days postvaccination rSBA titer ≥1:8 for participants with prevaccination rSBA titer <1:8, or At least 4-fold increase in rSBA titer from pre- to 30 days postvaccination for participants with pre vaccination rSBA titer ≥1:8
Participants 2 through 6 years of age (Cohort II): Geometric mean titers (GMTs) of antibodies against meningococcal serogroups A and C
Time frame: Day 01 (pre-vaccination) and Day 31 (post- vaccination)
Antibody titers are expressed as geometric mean titers
Participants 2 through 6 years of age (Cohort II): Vaccine seroresponse to meningococcal serogroups W and Y in participants receiving MenACYW conjugate vaccine
Time frame: Day 01 (pre-vaccination) and Day 31 (post- vaccination)
30 days post-vaccination rSBA titer ≥1:8 for participants with pre-vaccination rSBA titer <1:8, or At least 4-fold increase in rSBA titer from pre- to 30◦days post-vaccination for participants with pre vaccination rSBA titer ≥1:8
9 secondary outcomes
Participants 7 through 17 years of age (Cohort I): Vaccine seroresponse to meningococcal serogroups A, C, Y, and W (Group 1)
Time frame: Day 01 (pre-vaccination) and Day 31 (post- vaccination)
Number of participants with immediate adverse events (AEs)
Time frame: Within 30 minutes post-vaccination
Presence of solicited injection site reactions
Time frame: Within 7 days post-vaccination
Presence of solicited systemic reactions
Time frame: Within 7 days post-vaccination
Presence of unsolicited AEs
Time frame: Within 30 days post-vaccination
Presence of SAEs
Time frame: Up to Day 181 post-vaccination
Participants 7 through 17 years of age (Cohort I): Antibody titers against meningococcal serogroups A, C, Y, and W in Groups 1 and 2
Time frame: Day 01 (pre-vaccination) and Day 31 (post- vaccination)
Participants 2 through 6 years of age (Cohort II): Antibody titers against meningococcal serogroups A, C, Y, and W in Group 3 and against meningococcal serogroups A and C in Group 4
Time frame: Day 01 (pre-vaccination) and Day 31 (post- vaccination)
Participants 2 through 6 years of age (Cohort II): Antibody titers in terms of GMTs against meningococcal serogroups Y and W in Group 3
Time frame: Day 01 (pre-vaccination) and Day 31 (post- vaccination)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- MEQ00076 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 Infection
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
RecruitingPhase 3
Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered in Healthy Infants and Toddlers in China
Meningococcal Infection, Healthy Volunteers
Active, not recruitingPhase 2
Safety, Tolerability, and Immunogenicity of MenABCWY Administered on Different Dosing Schedules in Healthy Adolescents
Meningitis, Meningococcal
RecruitingObservational study
A Study to Learn About the Safety of PENBRAYA During Pregnancy
Meningococcal Disease
RecruitingPhase 3
Phase Ⅲ Trial of Group ACYW135 Meningococcal Conjugate Vaccine in Children Aged 3-5 Months
Epidemic Meningitis, Meningococcal Vaccines
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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MenACYW conjugate vaccine, MenACYW135 polysaccharide vaccine and MenAC conjugate vaccine in people with Meningococcal Infection and Healthy Volunteers, run by Sanofi at 4 sites in China.
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 21 inclusion and 0 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 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Participants 7 through 17 years of age (Cohort I): Vaccine seroresponse to meningococcal serogroups A, C, Y, and W (time frame: Day 01 (pre-vaccination) and Day 31 (post- vaccination)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Oct 2026.