Study Code: PSK00026
Study Title A Phase 3, randomized, modified double-blind, active controlled, parallel-group, 2-arm study to investigate the safety and immunogenicity of a single dose of a 21-valent pneumococcal conjugate vaccine in children and adolescents with sickle cell disease
Condition: Sickle Cell Disease
Age: 2-17
Phase: 3
Trial sites: Atlanta, GA; Birmingham, AL; Houston, TX; New Brunswick, NJ; Omaha, NE; and Washington, D.C., with additional locations expected soon.
Summary: this study is testing a new vaccine that protects against 21 types of pneumococcal bacteria. The study involves children and teenagers with sickle cell disease. 2 Out of 3 of the participants will receive the new vaccine, and 1 of 3 participants will receive an existing, standard pneumococcal vaccine (the 'active control'). Participants are randomly assigned to groups. Researchers will compare how safe the new vaccine is and how well it helps the body’s immune system fight disease. Each person gets 1 dose of the vaccine, and the study is designed so that neither the participants nor most of the researchers know who got which vaccine until the study is complete—this helps ensure fair, unbiased results.
