Phase 3 Sickle Cell Disease Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• The child or teenager must be between 2 and 17 years old on the day they join the study.
• They must have an official diagnosis of sickle cell disease recorded in their medical records.
• If the participant could become pregnant, they must not currently be pregnant or breastfeeding, must agree to use effective birth control or abstain from sex for at least 4 weeks before and after receiving the study treatment, and must have a negative pregnancy test within 25 hours before receiving it.
• A parent, guardian, or legal representative must sign a consent form agreeing to the child's participation, and the child must also sign an assent form if required by local rules.
• The participant and their parent or guardian must be able to attend all scheduled appointments and follow all study procedures.

Who may not be able to join:

• Children who have a known or suspected immune system condition, have received chemotherapy or radiation in the past 6 months, or are on long-term steroid treatment.
• Children who have previously had a confirmed infection caused by the bacteria Streptococcus pneumoniae.
• Children who have a history of seizures or significant nervous system conditions, such as cerebral palsy or brain disease.
• Children who are known to be seriously allergic to any ingredient in the study treatment, or who have had a life-threatening reaction to a similar product.
• Children who have a confirmed or reported low platelet count that would make injections into the muscle unsafe.
• Children who have a bleeding disorder or have taken blood-thinning medication in the 3 weeks before joining the study.
• Children with a long-term illness that, in the study doctor's opinion, could interfere with the study.
• Children who are moderately or seriously ill, have an infection, or have a fever of 38.0°C (100.4°F) or higher on the day of the study treatment — they may be reconsidered once they have recovered.
• Children and teenagers aged 6 to 17 who have issues with alcohol, prescription drugs, or substance use that could interfere with the study (in the study doctor's opinion).
• Children who have already received at least one dose of the 20-valent pneumococcal conjugate vaccine (a specific type of pneumonia vaccine) (confirm with trial site).
• Children under 6 who have received fewer than 3 doses of pneumococcal conjugate vaccine, or any dose of a specific older pneumonia vaccine called PPSV23 (confirm with trial site).
• Children and teenagers aged 6 and over who received PPSV23 within the last 5 years, or received any pneumococcal conjugate vaccine within the last 8 weeks (confirm with trial site).
• Children who received any vaccine in the 4 weeks before or plan to receive any vaccine in the 4 weeks after the study treatment — with the exception of certain flu vaccines given at least 2 weeks before or after.
• Children who received immune globulins, blood, or blood-based products in the past 3 months.
• Children who took antibiotic medication by mouth or injection for any illness within 72 hours before their first blood draw.
• Children who are currently in, or have been in within the past 6 weeks, another clinical study involving a vaccine, drug, medical device, or medical procedure.
• Children aged 2 to 5 who are currently in an emergency medical situation.
• Children aged 2 to 5 who are the natural or adopted child of the study doctor or a study team member directly involved in the research.
• Teenagers aged 6 to 17 who are hospitalized against their will, in an emergency situation, or legally detained.
• Teenagers aged 6 to 17 who are themselves study staff, or are an immediate family member (parent, spouse, or child) of study staff directly involved in this research.

Important: Always verify eligibility with the trial site directly before applying.