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
Sanofi
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.
Description
The study duration per participant will be up to 6 months.
Eligibility
- Age range
- 2–17 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: AGE * Aged 2 to 17 years on the day of inclusion. TYPE OF PARTICIPANT AND DISEASE CHARACTERISTICS * Participants who have a documented diagnosis of sickle cell disease (SCD) in their medical record. SEX, CONTRACEPTIVE/BARRIER METHOD AND PREGNANCY TESTING REQUIREMENTS * A participant is eligible to participate if the participant is not pregnant or breastfeeding and one of the following conditions applies: * Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be pre-menarchal or surgically sterile. OR * Is of childbearing…
Interventions
- BiologicalPCV21
Investigational pneumococcal conjugate vaccine
- Biological20vPCV
20-valent pneumococcal conjugate vaccine
Locations (7)
- Site # 8400006Atlanta, Georgia
- Site # 8400002Atlanta, Georgia
- Site # 8400003Omaha, Nebraska
- Site # 8400001New Brunswick, New Jersey
- Site # 8400004Houston, Texas
- Site # 2140001Santo Domingo