Actively Recruiting
Study of a Single Dose of a 21-valent Pneumococcal Conjugate Vaccine in Children and Adolescents With Sickle Cell Disease
Led by Sanofi · Updated on 2026-04-15
100
Participants Needed
7
Research Sites
50 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of a Single Dose of a 21-valent Pneumococcal Conjugate Vaccine in Children and Adolescents With Sickle Cell Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 2 to 17 years on the day of inclusion.
- Documented diagnosis of sickle cell disease in medical records.
- Not pregnant or breastfeeding; if of childbearing potential, agrees to use effective contraception or abstinence from 4 weeks before until 4 weeks after vaccination and has a negative pregnancy test within 25 hours before vaccination.
- Assent form signed by participant and informed consent signed by parent(s) or legal representative as required.
- Participant and parent(s)/legal representative able to attend all visits and comply with study procedures.
You will not qualify if you...
- Known or suspected immunodeficiency or recent immunosuppressive therapy within 6 months.
- History of confirmed Streptococcus pneumoniae infection or disease.
- History of seizures or significant neurological disorders like encephalopathy or cerebral palsy.
- Known allergies to vaccine components or history of life-threatening reactions to similar products.
- Confirmed or reported thrombocytopenia contraindicating intramuscular injection.
- Bleeding disorders or recent use of anticoagulants contraindicating intramuscular injection.
- Chronic illness that may interfere with study participation.
- Moderate or severe acute illness or fever (temperature ≥ 38.0°C) on vaccination day.
- For ages 6 to 17 years: history of substance abuse that may interfere with study.
- Previous receipt of at least one dose of 20vPCV.
- For children under 6 years: fewer than 3 doses of pneumococcal conjugate vaccine or any dose of 23-valent pneumococcal polysaccharide vaccine.
- For children 6 years and older: receipt of 23-valent pneumococcal polysaccharide vaccine within 5 years or last pneumococcal conjugate vaccine dose within 8 weeks before vaccination.
- Vaccination with any vaccine other than licensed influenza vaccine within 4 weeks before or planned within 4 weeks after study vaccination.
- Receipt of immune globulins or blood products within 3 months.
- Use of antibiotics for acute illness within 72 hours before first blood draw.
- Participation in another clinical study involving vaccines, drugs, devices, or procedures within 6 weeks before study vaccination or planned during study.
- For children 2 to 5 years: being in emergency setting or related to investigator or staff.
- For children 6 to 17 years: deprived of freedom by court order, involuntary hospitalization, or related to investigator or staff as employee or immediate family member.
AI-Screening
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Trial Site Locations
Total: 7 locations
1
Site # 8400006
Atlanta, Georgia, United States, 30310
Actively Recruiting
2
Site # 8400002
Atlanta, Georgia, United States, 30322
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3
Site # 8400003
Omaha, Nebraska, United States, 68114
Actively Recruiting
4
Site # 8400001
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
5
Site # 8400004
Houston, Texas, United States, 77030
Actively Recruiting
6
Site # 2140001
Santo Domingo, Dominican Republic
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7
Site # 2140003
Santo Domingo, Dominican Republic
Actively Recruiting
Research Team
T
Trial Transparency email recommended (Toll free number for US & Canada)
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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