NCT07247188

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

A Phase 3, Randomized, Modified Double-blind, Active-controlled, Parallel-group, 2-arm Study to Investigate the Safety and Immunogenicity of a Single Dose of a 21-valent Pneumococcal Conjugate Vaccine in Children and Adolescents With Sickle Cell Disease

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 2 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to measure 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.

Detailed description

The study duration per participant will be up to 6 months.

Conditions

• Sickle Cell Disease

Interventions

Type	Name	Description
BIOLOGICAL	PCV21	Investigational pneumococcal conjugate vaccine
BIOLOGICAL	20vPCV	20-valent pneumococcal conjugate vaccine

Timeline

• Start date: 2026-01-20
• Primary completion: 2027-01-07
• Completion: 2027-01-07
• First posted: 2025-11-25
• Last updated: 2026-04-15

Locations

7 sites across 2 countries: United States, Dominican Republic

Regulatory

• FDA-regulated drug study