Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered in Healthy Children and Adolescents in China
NCT ID: NCT07135986
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
1602 participants
INTERVENTIONAL
2025-09-26
2026-06-29
Brief Summary
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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
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Group 1 MenACYW1-dose schedule
1 dose of MenACYW conjugate vaccine to participants aged 7 through 17 years of age
MenACYW conjugate vaccine
Pharmaceutical form:Liquid solution-Route of administration:Intramuscular (IM) injection
Group 2 MenACYW135 Ps 1-dose schedule
1 dose of MenACYW135 polysaccharide vaccine to participants aged 7 through 17 years of age
MenACYW135 polysaccharide vaccine
Pharmaceutical form: Lyophilized powder-Route of administration:IM injection
Group 3 MenACYW1-dose schedule
1 dose of MenACYW conjugate vaccine to participants aged 2 through 6 years of age
MenACYW conjugate vaccine
Pharmaceutical form:Liquid solution-Route of administration:Intramuscular (IM) injection
Group 4 Royal MenAC1-dose schedule
1 dose of Royal's MenAC conjugate vaccine to participants aged 2 through 6 years of age
MenAC conjugate vaccine
Pharmaceutical form:Lyophilized powder-Route of administration:IM injection
Interventions
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MenACYW conjugate vaccine
Pharmaceutical form:Liquid solution-Route of administration:Intramuscular (IM) injection
MenACYW135 polysaccharide vaccine
Pharmaceutical form: Lyophilized powder-Route of administration:IM injection
MenAC conjugate vaccine
Pharmaceutical form:Lyophilized powder-Route of administration:IM injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* History of meningococcal infection
* 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.
2 Years
17 Years
ALL
Yes
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Locations
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Investigational Site Number : 1561000
Nanning, Guangxi, China
Investigational Site Number : 1561003
Liuchow, , China
Countries
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Central Contacts
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Trial Transparency email recommended (Toll free for US & Canada)
Role: CONTACT
Phone: 800-633-1610
Email: [email protected]
Related Links
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MEQ00076 Plain Language Results Summary
Other Identifiers
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U1111-1256-8979
Identifier Type: REGISTRY
Identifier Source: secondary_id
MEQ00076
Identifier Type: -
Identifier Source: org_study_id