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.
The study duration per participant will be up to 6 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
100
Site # 8400006
Atlanta, Georgia, United States
RECRUITINGSite # 8400002
Atlanta, Georgia, United States
RECRUITINGSite # 8400003
Omaha, Nebraska, United States
Number of participants reporting immediate adverse events (AEs)
Unsolicited (spontaneously reported) systemic AEs after injection of a pneumococcal vaccine
Time frame: Within 30 minutes post-vaccination
Number of participants reporting solicited injection site and solicited systemic reactions
Time frame: 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
Time frame: Within 30 days post-vaccination
Number of participants reporting serious adverse events (SAEs) and adverse events of special interest (AESIs)
SAEs and AESIs are collected throughout the study period
Time frame: From day 0 to day 181
Number of participants with serotype-specific immunoglobulin G (IgG) concentrations for all serotypes included in PCV21
Ab (antibody) concentrations for each pneumococcal serotype measured by electro-chemiluminescence (ECL) assay
Time frame: On day 30 post-vaccination
Number of participants with serotype-specific IgG concentrations for all serotypes included in PCV21
Ab concentrations for each pneumococcal serotype are measured by ECL assay
Time frame: Pre-vaccination and at 30 days post-vaccination
Number of participants with serotype specific opsonophagocytic activity (OPA) titers for all serotypes included in PCV21
Serotype specific OPA titers for each pneumococcal serotype are determined by multiplex opsonophagocytic killing assay (MOPA)
Trial Transparency email recommended (Toll free number for US & Canada)
CONTACT
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Site # 8400001
New Brunswick, New Jersey, United States
RECRUITINGSite # 8400004
Houston, Texas, United States
RECRUITINGSite # 2140001
Santo Domingo, Dominican Republic
RECRUITINGSite # 2140003
Santo Domingo, Dominican Republic
RECRUITINGTime frame: On day 30
Number of participants with serotype specific opsonophagocytic activity (OPA) titers for all serotypes included in PCV21
Serotype specific OPA titers for each pneumococcal serotype are determined by multiplex opsonophagocytic killing assay (MOPA)
Time frame: Pre-vaccination and at 30 days post-vaccination