RecruitingPhase 3NCT07247188

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


Sponsor

Sanofi

Enrollment

100 participants

Start Date

Jan 20, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 2 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called 20vPCV and a biological treatment called PCV21 for people with sickle cell disease. The study is currently recruiting participants at 7 locations. People eligible for this study include aged 2 Years to 17 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALPCV21

Investigational pneumococcal conjugate vaccine

BIOLOGICAL20vPCV

20-valent pneumococcal conjugate vaccine


Locations(7)

Site # 8400006

Atlanta, Georgia, United States

Site # 8400002

Atlanta, Georgia, United States

Site # 8400003

Omaha, Nebraska, United States

Site # 8400001

New Brunswick, New Jersey, United States

Site # 8400004

Houston, Texas, United States

Site # 2140001

Santo Domingo, Dominican Republic

Site # 2140003

Santo Domingo, Dominican Republic

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NCT07247188


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