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

Inclusion Criteria:

• Age in the defined range on the day of inclusion: For Adults: Aged ≥ 18 years on theday of inclusion For Children and Adolescents: Aged 2 to 17 years on the day ofinclusion 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 WorldHealth 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 ≥ -2SD on the Weight-for-height table of the WHO Child Growth Standards

• Informed consent obtained For adults: Informed consent form has been signed anddated by the subject and by an independent witness, if required by local regulationsFor toddlers, children, and adolescents: Assent form has been signed and dated bythe subject (for subjects 7 to 17 years of age), and informed consent form has beensigned and dated by the parent(s) or legally acceptable representative and by anindependent witness, if required by local regulations

• Were able to attend all scheduled visits and to comply with all trial procedures Foradults: Were able to attend all scheduled visits and to comply with all trialprocedures For toddlers, children, and adolescents: Participants and parent /legally acceptable representative were able to attend all scheduled visits and tocomply with all trial procedures

• For Toddlers: All toddlers were due to receive an age-recommended RPV on D0

Exclusion Criteria:

• Participant was pregnant, or lactating, or of childbearing potential and was notusing an effective method of contraception or abstinence from at least 4 weeks priorto vaccination until at least 4 weeks after vaccination. To be considered ofnon-childbearing potential, a female must be pre-menarche, or post-menopausal for atleast 1 year, or surgically sterile

• Participation at the time of study enrollment (or in the 4 weeks preceding the trialvaccination) or planned participation during the present trial period in anotherclinical 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 receiptof any vaccine in the 4 weeks following vaccination except for oral poliovirusvaccine (OPV) in India, received during national immunization days. In India, OPVmight have been received with a gap of at least 2 weeks before the IMP. Thisexception included monovalent and bivalent OPV.

• Previous vaccination against meningococcal disease with either the IMP or anothervaccine (i.e., mono- or polyvalent, polysaccharide, or conjugate meningococcalvaccine containing serogroups A, C, Y, or W; or meningococcal B serogroup containingvaccine)

• Receipt of immune globulins, blood or blood-derived products in the past 3 months

• Known or suspected congenital or acquired immunodeficiency; or receipt ofimmunosuppressive 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 3months)

• History of meningococcal infection, confirmed either clinically, serologically, ormicrobiologically

• At high risk for meningococcal infection during the trial (specifically, but notlimited to, subjects with persistent complement deficiency, with anatomic orfunctional asplenia, or subjects traveling to countries with high endemic orepidemic disease)

• Known systemic hypersensitivity to latex or to any of the vaccine components, orhistory of a life-threatening reaction to the vaccine(s) used in the trial or to avaccine containing any of the same substances

• Verbal report of thrombocytopenia, as reported by the subject or the subject'sparent / legally acceptable representative, contraindicating intramuscularvaccination 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 tetanustoxoid-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 itmight interfere with trial conduct or completion

• Any condition which, in the opinion of the Investigator, might have interfered withthe evaluation of the study objectives.

• Moderate or severe acute illness/infection (according to Investigator judgment) onthe day of vaccination, febrile illness (temperature ≥ 38.0°C), persistent diarrhea,vomiting. A prospective subject was not included in the study until the conditionhas been resolved or the febrile event has been subsided

• Receipt of oral or injectable antibiotic therapy within 72 hours prior to the firstblood draw

• Identified as an Investigator or employee of the Investigator or study center withdirect involvement in the proposed study, or identified as an immediate familymember (i.e., parent, spouse, natural or adopted child) of the Investigator oremployee with direct involvement in the proposed study