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Study details
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Study of a Single Dose of a 21-valent Pneumococcal Conjugate Vaccine in Children and Adolescents With Sickle Cell Disease

Sanofi
NCT IDNCT07247188ClinicalTrials.gov data as of Apr 2026
Phase

Phase 3

Target enrollment

100

Study length

about 12 months

Ages

2–17

Locations

5 sites in GA, NE, NJ +1

About this study

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.

Based on ClinicalTrials.gov records.

What participants do

  • 1.Receive 20vPCV
  • 2.Receive PCV21
PhasePhase 3
Primary goalNumber of participants reporting immediate adverse events (AEs)

Participation effort

Estimated from trial records. Details can vary by site.

Time + visits
Low14%
Logistics
Moderate50%

Logistics difficulty varies by site location and availability.

Trial highlights

Treatment details

Auto-extracted from trial records to preview treatments and outcomes.

Endpoints

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