Participants who are healthy as determined by medical evaluation including medical history and physical examination
Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg or born after a gestation period above 28 (\> 28 weeks) through 36 weeks with a birth weight ≥ 1.5 kg, and in both cases medically stable
You may not be if
Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy; or long-term systemic corticosteroid therapy
History of microbiologically confirmed Streptococcus pneumoniae infection or disease
Any contraindication to the routine pediatric vaccine being administered in the study
History of seizure or significant stable or progressive neurologic disorders such as infantile spasms, inflammatory nervous system diseases, encephalopathy, cerebral palsy
Known systemic hypersensitivity to any of the study interventions components, or history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances3
Laboratory-confirmed or known thrombocytopenia, as reported by the parent(s) / legally acceptable 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 it might interfere with study conduct or completion
Moderate or severe acute illness/infection (according to investigator judgment) or febrile illness (temperature ≥ 38.0°C \[≥ 100.4°F\]) on the day of study intervention administration.
Receipt of any BCG vaccine within 4 weeks preceding the first study intervention administration or planned receipt any BCG vaccine within the study period
Previous vaccination against Streptococcus 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 first study intervention administration) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure
Note: The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Clareo Health | Lot-to-lot Consistency Study of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From 2 Months of Age
