Study of a Single Dose of a 21-valent Pneumococcal Conjugate Vaccine in Children and Adolescents With Sickle Cell Disease
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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 2 Years to 17 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 6 months
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "The study duration per participant will be up to 6 months."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests one dose of PCV21, an experimental vaccine against pneumococcal bacteria, in children ages 2 to 17 with sickle cell disease. It compares PCV21 with the approved vaccine 20vPCV to check safety and see how well the body makes antibodies, which help fight germs.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be 2 to 17 years old when joining the study.
- Have sickle cell disease listed in your medical record.
- Not be pregnant or breastfeeding.
- If able to become pregnant, use effective birth control or avoid sex from at least 4 weeks before until at least 4 weeks after the study shot. A pregnancy test within 25 hours before the shot must be negative.
- Sign the study agreement as required by local rules. A parent or legal guardian must also give permission when required.
- You and your parent or legal guardian must be able to attend all visits and follow study instructions.
Who can't join
- Have a known or suspected weak immune system, have had treatment that weakens it within the past 6 months, or take long-term steroids that affect the whole body.
- Have had a lab-confirmed pneumococcal infection, seizures, a serious nervous system disorder, or a severe allergy to a study vaccine or its ingredients.
- Have low platelets (blood cells that help stop bleeding), a bleeding disorder, or recent blood thinner use that makes a shot into muscle unsafe. A long-term illness that could affect study completion also rules out joining.
- Have a moderate or severe illness or a fever of 100.4°F (38°C) or higher on shot day; joining must wait until it clears. For ages 6 to 17, alcohol or drug misuse that could affect the study also rules out joining.
- Have ever received 20vPCV. Children under 6 cannot join if they have had fewer than 3 pneumococcal conjugate vaccine doses or any PPSV23 dose. Those ages 6 to 17 cannot join if they had PPSV23 within 5 years or their last pneumococcal conjugate vaccine within 8 weeks before the study shot.
- Have another vaccine within 4 weeks before or after the study shot, except a US-approved flu vaccine at least 2 weeks before or after. Other limits include blood products or immune globulins (antibody treatments) within 3 months, or oral or injected antibiotics for an acute illness within 72 hours before the first blood draw.
- Be in another study testing a vaccine, drug, device, or procedure now, within 6 weeks before the study shot, or during this study.
- Be in emergency care or have certain close family or work ties to staff directly involved in the study. For ages 6 to 17, being held by court or government order or hospitalized against your will also rules out joining.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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 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. INFORMED CONSENT * Assent form has been signed and dated by the participant (based on local regulations), and, if applicable, informed consent form has been signed and dated by the parent(s) or another legally acceptable representative (LAR) and by an independent witness, if required by local regulations. OTHER INCLUSIONS * Participant and parent(s)/LAR are able to attend all scheduled visits and to comply with all study procedures. Exclusion Criteria: 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. * Moderate or severe acute illness/infection (according to investigator judgment) or febrile illness (temperature ≥ 38.0°C \[≥ 100.4°F\]) on the day of study intervention administration. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided. For children/adolescents (6 to 17 YoA) only * Alcohol, prescription drug, or substance abuse that, in the opinion of the Investigator, might interfere with the study conduct or completion. PRIOR/CONCOMITANT THERAPY * Receipt of at least one dose of 20vPCV. * For children aged \< 6 years: receipt of \< 3 doses of pneumococcal conjugate vaccine or any dose of 23-valent pneumococcal polysaccharide vaccine (PPSV23). * For children and adolescents aged ≥ 6 years: receipt of PPSV23 \< 5 years before study vaccination or last PCV dose \< 8 weeks before study vaccination. * Receipt of any vaccine in the 4 weeks preceding the study intervention administration or planned receipt of any vaccine in the 4 weeks following the study intervention administration, except for US licensed influenza vaccination, which may be received at least 2 weeks before or 2 weeks after study vaccination. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines, as applicable per local recommendations. * Receipt of immune globulins, blood or blood-derived products in the past 3 months. * Receipt of an oral or injectable antibiotic therapy for any acute illness within 72 hours prior to the first blood draw. PRIOR/CONCURRENT CLINICAL STUDY EXPERIENCE * Participation at the time of study enrollment (or in the 6 weeks preceding the first study intervention administration) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure. OTHER EXCLUSIONS For children (2 to 5 YoA) only * Being in an emergency setting. * Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study. For children/adolescents (6 to 17 YoA) only * Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily. * Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (ie, parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Study sites (5)
GA
- Site # 8400006 · Atlanta, GA 30310More trials in Atlanta
- Site # 8400002 · Atlanta, GA 30322More trials in Atlanta
NE
- Site # 8400003 · Omaha, NE 68114More trials in Omaha
NJ
- Site # 8400001 · New Brunswick, NJ 08901More trials in New Brunswick
TX
- Site # 8400004 · Houston, TX 77030More trials in Houston