Study of a Single Dose of a 21-valent Pneumococcal Conjugate Vaccine in Children and Adolescents With Sickle Cell Disease

Exclusion Criteria

• •MEDICAL CONDITIONS
• •Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy.
• •History of microbiologically confirmed S. pneumoniae infection or disease.
• •History of seizure or significant stable or progressive neurological disorders such as inflammatory nervous system diseases, encephalopathy, and 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 substances.
• •Laboratory-confirmed thrombocytopenia, or known thrombocytopenia, as reported by the parent/LAR, 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. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided.
• •For children/adolescents (6 to 17 YoA) only
• •Alcohol, prescription drug, or substance abuse that, in the opinion of the Investigator, might interfere with the study conduct or completion.
• •PRIOR/CONCOMITANT THERAPY
• •Receipt of at least one dose of 20vPCV.
• •For children aged \< 6 years: receipt of \< 3 doses of pneumococcal conjugate vaccine or any dose of 23-valent pneumococcal polysaccharide vaccine (PPSV23).
• •For children and adolescents aged ≥ 6 years: receipt of PPSV23 \< 5 years before study vaccination or last PCV dose \< 8 weeks before study vaccination.
• •Receipt of any vaccine in the 4 weeks preceding the study intervention administration or planned receipt of any vaccine in the 4 weeks following the study intervention administration, except for US licensed influenza vaccination, which may be received at least 2 weeks before or 2 weeks after study vaccination. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines, as applicable per local recommendations.
• •Receipt of immune globulins, blood or blood-derived products in the past 3 months.
• •Receipt of an oral or injectable antibiotic therapy for any acute illness within 72 hours prior to the first blood draw.
• •PRIOR/CONCURRENT CLINICAL STUDY EXPERIENCE
• •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.
• •OTHER EXCLUSIONS For children (2 to 5 YoA) only
• •Being in an emergency setting.
• •Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study.
• •For children/adolescents (6 to 17 YoA) only
• •Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.
• •Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (ie, parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study.
• •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.