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

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Sanofi
Study ID
NCT07247188
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
2 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • PCV21 — BIOLOGICAL
    Investigational pneumococcal conjugate vaccine
  • 20vPCV — BIOLOGICAL
    20-valent pneumococcal conjugate vaccine

Study Details

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.

Key Dates

Start date
Jan 20, 2026
Status verified
Apr 2026
Primary completion
Jan 7, 2027
Completion
Jan 7, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Investigated Vaccine: PCV21
    Participants will receive 1 intramuscular injection of the pneumococcal vaccine
  • Active Comparator: Comparator Vaccine: 20vPCV
    Participants will receive 1 intramuscular injection of the pneumococcal vaccine

Primary Outcome Measure

Number of participants reporting immediate adverse events (AEs) [ Time Frame: Within 30 minutes post-vaccination ]

Central Contacts

  • Trial Transparency email recommended (Toll free number for US & Canada)
    800-633-1610
    [email protected]

Locations (5)

FacilityCityStateZIPSite coordinators
Site # 8400002AtlantaGeorgia30322-
Site # 8400006AtlantaGeorgia30310-
Site # 8400003OmahaNebraska68114-
Site # 8400001New BrunswickNew Jersey08901-
Site # 8400004HoustonTexas77030-

Find similar trials in Atlanta, GA

By condition
Sickle cell disease
By research site
Site # 8400002· Atlanta, GASite # 8400006· Atlanta, GASite # 8400003· Omaha, NESite # 8400001· New Brunswick, NJSite # 8400004· Houston, TX

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