Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered in Healthy Children and Adolescents in China

The duration of each participant's participation will be approximately 180 days.

• MenACYW conjugate vaccine (Biological), also known as MenQuadfi: Pharmaceutical form:Liquid solution-Route of administration:Intramuscular (IM) injection
• MenACYW135 polysaccharide vaccine (Biological): Pharmaceutical form: Lyophilized powder-Route of administration:IM injection
• MenAC conjugate vaccine (Biological): Pharmaceutical form:Lyophilized powder-Route of administration:IM injection

Primary outcomes

• Participants 7 through 17 years of age (Cohort I): Vaccine seroresponse to meningococcal serogroups A, C, Y, and W [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 [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 [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 [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 [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 [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

Secondary outcomes

• Participants 7 through 17 years of age (Cohort I): Vaccine seroresponse to meningococcal serogroups A, C, Y, and W (Group 1) [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
• Number of participants with immediate adverse events (AEs) [Within 30 minutes post-vaccination]: Unsolicited systemic AEs that occur within 30 minutes after vaccination
• Presence of solicited injection site reactions [Within 7 days post-vaccination]: Solicited injection site reactions include injection site pain, erythema and swelling
• Presence of solicited systemic reactions [Within 7 days post-vaccination]: Solicited systemic reactions include fever, headache, malaise and myalgia
• Presence of unsolicited AEs [Within 30 days post-vaccination]
• Presence of SAEs [Up to Day 181 post-vaccination]: SAEs, including adverse events of special interest (AESIs), reported throughout the study
• Participants 7 through 17 years of age (Cohort I): Antibody titers against meningococcal serogroups A, C, Y, and W in Groups 1 and 2 [Day 01 (pre-vaccination) and Day 31 (post- vaccination)]: Antibody titers measured by rSBA titer ≥1:8, ≥1:128
• 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 [Day 01 (pre-vaccination) and Day 31 (post- vaccination)]: Antibody titers measured by rSBA titer ≥1:8, ≥1:128
• Participants 2 through 6 years of age (Cohort II): Antibody titers in terms of GMTs against meningococcal serogroups Y and W in Group 3 [Day 01 (pre-vaccination) and Day 31 (post- vaccination)]: Antibodies titers are expressed as geometric mean titers

Sex: All, ages: 2 Years to 17 Years, accepts healthy volunteers

Inclusion Criteria:

* 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
* 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.