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RECRUITING
NCT07247188
PHASE3

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

Sponsor: Sanofi

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

2 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2026-01-20

Completion Date

2027-01-07

Last Updated

2026-01-28

Healthy Volunteers

No

Interventions

BIOLOGICAL

PCV21

Investigational pneumococcal conjugate vaccine

BIOLOGICAL

20vPCV

20-valent pneumococcal conjugate vaccine

Locations (1)

Site # 8400006

Atlanta, Georgia, United States