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.

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

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

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

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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

Other trials in China

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

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 groups in NCT07135986
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.

26 Sep 202524 Sep 2026

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)

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

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?

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