Study of a Single Dose of a 21-valent Pneumococcal Conjugate Vaccine in Children and Adolescents With Sickle Cell Disease
Phase 3
100
about 12 months
2–17
5 sites in GA, NE, NJ +1
What this study is about
This trial is testing 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.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Receive 20vPCV
- 2.Receive PCV21
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
You may get a placebo/standard care, and you won't know which.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
Primary: Number of participants reporting immediate adverse events (AEs), Number of participants reporting serious adverse events (SAEs) and adverse events of special interest (AESIs), Number of participants reporting unsolicited (spontaneously reported) injection site reactions and unsolicited systemic AEs after injection of a pneumococcal vaccine