RecruitingSickle Cell Disease
Study of a Single Dose of a 21-valent Pneumococcal Conjugate Vaccine in Children and Adolescents With Sickle Cell Disease
Eligible age
2–17 yrs
Accepts
All genders
Locations
4 states
Healthy volunteers
No
See if you qualify for this study
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About this study
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.
Sponsor: Sanofi
You may qualify if…
- ✓ 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 potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to study intervention administration until at least 4 weeks after study intervention administration. A participant of childbearing potential must have a negative highly sensitive pregnancy test (urine or serum as required by local regulation) within 25 hours before the study intervention.
You may not qualify if…
- ✕ MEDICAL CONDITIONS
- ✕ Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy.
- ✕ History of microbiologically confirmed S. pneumoniae infection or disease.
- ✕ History of seizure or significant stable or progressive neurological disorders such as inflammatory nervous system diseases, encephalopathy, and cerebral palsy.
- ✕ Known systemic hypersensitivity to any of the study interventions components, or history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances.
- ✕ Laboratory-confirmed thrombocytopenia, or known thrombocytopenia, as reported by the parent/LAR, contraindicating intramuscular (IM) injection.
- ✕ Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM injection.
- ✕ Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion.
Where it's recruiting
Source: ClinicalTrials.gov · NCT07247188 · last updated 2026-04-15