The purpose of this study is to measure whether PCV21 vaccine (investigational pneumococcal vaccine) is safe and can help the body to develop germ-fighting agents called "antibodies" (immunogenicity) compared with 20vPCV (licensed pneumococcal vaccine) when given as a single dose to children aged 2 to 17 years with sickle cell disease who had received or not a previous vaccination with pneumococcal conjugate or pneumococcal polysaccharide vaccine.
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Number of participants reporting immediate adverse events (AEs)
Timeframe: Within 30 minutes post-vaccination
Number of participants reporting solicited injection site and solicited systemic reactions
Timeframe: Up to Day 7 post-vaccination
Number of participants reporting unsolicited (spontaneously reported) injection site reactions and unsolicited systemic AEs after injection of a pneumococcal vaccine
Timeframe: Within 30 days post-vaccination
Number of participants reporting serious adverse events (SAEs) and adverse events of special interest (AESIs)
Timeframe: From day 0 to day 181
Number of participants with serotype-specific immunoglobulin G (IgG) concentrations for all serotypes included in PCV21
Timeframe: On day 30 post-vaccination
Trial Transparency email recommended (Toll free number for US & Canada)