Study of a Single Dose of a 21-valent Pneumococcal Conjugate Vaccine in Children and Adolescents With Sickle Cell Disease
← catalyst calendarNCT07247188 · readout in 141 d
Sponsored by Sanofi (industry) · SNY — their whole pipeline →.
Phase
Phase 3
Status
Recruiting
Study type
Interventional
Design
Randomized · Single · Prevention
Enrollment
100estimated
Sites
7
Countries
Dominican Republic, United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2026-01-20 | actual | When the study began enrolling |
| Primary completion | 2027-01-07 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-01-07 | estimated | The whole study's end, after follow-up |
| First posted | 2025-11-25 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-04-15 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Sickle Cell Disease
Interventions
- Biological: PCV21
- Biological: 20vPCV — also filed as Prevnar 20
Primary outcomes
what the primary-completion date above is the date OFNumber of participants reporting immediate adverse events (AEs)
measured Within 30 minutes post-vaccination
Number of participants reporting solicited injection site and solicited systemic reactions
measured Up to Day 7 post-vaccination
Number of participants reporting unsolicited (spontaneously reported) injection site reactions and unsolicited systemic AEs after injection of a pneumococcal vaccine
measured Within 30 days post-vaccination
Number of participants reporting serious adverse events (SAEs) and adverse events of special interest (AESIs)
measured From day 0 to day 181
Number of participants with serotype-specific immunoglobulin G (IgG) concentrations for all serotypes included in PCV21
measured On day 30 post-vaccination
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