Study of a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Given With Routine Pediatric Vaccines in Healthy Infants and Toddlers in India and the Republic of South Africa

Inclusion Criteria:

• Cohort I: 6 months of age (180 to 209 days of age) on the day of the first studyvisit

• Cohort II: 6-8 weeks of age (42 to 62 days of age) on the day of the first studyvisit

• Healthy infants as determined by medical history, physical examination, and judgmentof the Investigator

• Participant and parent/ legally acceptable representative (LAR) are able to attendall scheduled visits and to comply with all study procedures

• Cohort I: Z-score ≥ -2 SD on the Weight-for-age table of the WHO Child GrowthStandards.

• Cohort II: Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5kg.

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

• 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).

*Note: Participants with a history of HIV but without evident severeimmunosuppression can be included.

• Family history of congenital or hereditary immunodeficiency, until the immunecompetence of the potential vaccine recipient is demonstrated.

• Individuals with active tuberculosis.

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

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

• History of intussusception.

• History of any neurologic disorders, including any seizures and progressiveneurologic disorders.

• History of Guillain-Barré syndrome (GBS).

• Known systemic hypersensitivity to any of the vaccine components, or history of alife-threatening reaction to the vaccine(s) used in the study or to a vaccinecontaining any of the same substances, including neomycin, gelatin, and yeast.

• Verbal report of thrombocytopenia, as reported by the parent/LAR, contraindicatingIM vaccination in the Investigator's opinion.

• Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion,contraindicating IM vaccination in the Investigator's opinion.

• Chronic illness (including, but not limited to, cardiac disorders, congenital heartdisease, chronic lung disease, renal disorders, auto-immune disorders, diabetes,psychomotor diseases, and known congenital or genetic diseases) that, in the opinionof the Investigator, is at a stage where it might interfere with study conduct orcompletion.

• Moderate or severe acute illness/infection (according to Investigator judgment) onthe day of vaccination or febrile illness (temperature ≥ 38.0°C). A prospectiveparticipant should not be included in the study until the condition has resolved orthe febrile event has subsided.

• Receipt of any vaccine in the 4 weeks preceding the first study vaccination (exceptfor Bacille Calmette-Guérin [BCG], birth dose OPV and birth dose of HepB vaccine) orplanned receipt of any vaccine in the 4 weeks following each study vaccinationexcept for the following vaccinations, which may be received at least 2 weeks beforeor 2 weeks after any study vaccination. This exception includes monovalent pandemicinfluenza vaccines, multivalent influenza vaccines, any COVID-19 vaccines, andadministration of OPV on National Immunization Day in India.

• Previous vaccination against meningococcal disease with either the study vaccine oranother vaccine (ie, mono- or polyvalent, polysaccharide, or conjugate meningococcalvaccine containing serogroups A, C, Y, or W; or meningococcal B serogroup-containingvaccine).

• For Cohort II: Previous vaccination against diphtheria, tetanus, pertussis,poliomyelitis (other than birth dose of OPV), Hepatitis A, measles, mumps, rubella,varicella; and of Hib, Streptococcus pneumoniae, and/or RV infection or disease.

• For Cohort II: Previous vaccination with more than 1 dose of HepB vaccine.

• 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 firstblood draw.

• Participation at the time of study enrollment (or in the 4 weeks preceding the firststudy vaccination) or planned participation during the present study period inanother clinical study investigating a vaccine, drug, medical device, or medicalprocedure.

• Identified as a natural or adopted child of the Investigator or employee with directinvolvement in the proposed study.