Study of a Single Dose of a 21-valent Pneumococcal Conjugate Vaccine in Children and Adolescents With Sickle Cell Disease
NCT07247188Phase 3Recruiting
- Lead sponsor
- Sanofi (Industry)
- Enrollment
- 100 (estimated)
- Start date
- 20 Jan 2026
- Primary completion
- 7 Jan 2027 (estimated)
- Study completion
- 7 Jan 2027
- Last update posted
- 15 Apr 2026
Design
- Study type
- Interventional
- Primary purpose
- Prevention
- Allocation
- Randomized
- Intervention model
- Parallel
- Masking
- Single
- Arms
- 2
Interventions
- PCV21 Biological
- 20vPCV Biological
Conditions and primary outcome
- Sickle Cell Disease
Primary outcome
Number of participants reporting immediate adverse events (AEs) (Within 30 minutes post-vaccination); Number of participants reporting solicited injection site and solicited systemic reactions (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 (Within 30 days post-vaccination); Number of participants reporting serious adverse events (SAEs) and adverse events of special interest (AESIs) (From day 0 to day 181); Number of participants with serotype-specific immunoglobulin G (IgG) concentrations for all serotypes included in PCV21 (On day 30 post-vaccination)
Posted results on ClinicalTrials.gov
Results posted on ClinicalTrials.gov: No
Results from company and journal sources
No editor-confirmed results are on record for this study.
Publications
No PubMed citation lists NCT07247188.
CT-VCA trial quality
About CT-VCALoading CT-VCA scores…
Data integrity
Compare what the registry, company releases, FDA documents and publications say about this study.
Drugs on HealthTrade
Source
- NCT07247188 on ClinicalTrials.gov (opens in a new tab) Licence: public-domain. Read
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.
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