Study of the Safety of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age

Inclusion Criteria:

• Aged 42 to 89 days on the day of inclusion

• Participants who are healthy as determined by medical evaluation including medicalhistory and physical examination

• Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg or bornafter a gestation period above 28 (> 28 weeks) through 36 weeks with a birth weight ≥ 1.5 kg, and in both cases medically stable as assessed by the investigator

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; orlong-term systemic corticosteroid therapy

• History of microbiologically confirmed Streptococcus pneumoniae infection or disease

• Any contraindication to the routine pediatric vaccine being administered in thestudy

• History of seizure or significant stable or progressive neurologic disorders such asinfantile spasms, inflammatory nervous system diseases, encephalopathy, cerebralpalsy

• Known systemic hypersensitivity to any of the study interventions components, orhistory of a life-threatening reaction to the study interventions used in the studyor to a product containing any of the same substances

• Laboratory-confirmed or known thrombocytopenia, as reported by the parent(s) / legalacceptable representative (LAR(s)), contraindicating intramuscular (IM) injection

• Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion,contraindicating IM injection

• Chronic illness that, in the opinion of the investigator, is at a stage where itmight interfere with study conduct or completion

• Moderate or severe acute illness/infection (according to investigator judgment) orfebrile illness (temperature ≥ 38.0°C [≥ 100.4°F]) on the day of study interventionadministration. A prospective participant should not be included in the study untilthe condition has resolved or the febrile event has subsided

• Receipt of any non-US Food and Drug Administration (FDA) approved vaccine in the 4weeks preceding the study intervention administration or planned receipt of anynon-US FDA approved vaccine in the 4 weeks following the study interventionadministration, including monovalent pandemic influenza vaccines and multivalentinfluenza vaccines, as applicable per local recommendations.

• Receipt of any Bacillus of Calmette and Guerin (BCG) vaccine within 4 weekspreceding the first study intervention administration or planned receipt any BCGvaccine within the study period

• Previous vaccination against S. pneumoniae

• Previous vaccination against the following antigens: diphtheria, tetanus, pertussis,H. influenzae type b, poliovirus

• Receipt of more than 1 dose of hepatitis B vaccine

• Receipt of immune globulins, blood or blood-derived products since birth

• Participation at the time of study enrollment (or in the 6 weeks preceding the firststudy intervention administration) or planned participation during the present studyperiod in another clinical study investigating a vaccine, drug, medical device, ormedical procedure

Note: The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.