drugset / Trial / NCT07247188

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

NCT07247188

Phase 3 Recruiting 100 enrolled Sanofi
RandomizedParallel-groupSingle-blindPrevention

Summary

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.

Timeline

Start
2026-01-20
Primary completion
2027-01-07
Completion
2027-01-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator 20vPCV Vaccine Intramuscular
Subject PCV21 Vaccine Intramuscular

Indications