Study of a Single Dose of a 21-valent Pneumococcal Conjugate Vaccine in Children and Adolescents With Sickle Cell Disease
Recruiting
Phase 3
Interventional Study
Sickle Cell Disease
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 2 – 17
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 100 (estimated)
- Sponsor
- Sanofi · Industry
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About This Trial
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 pneumococca…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
AGE
* Aged 2 to 17 years on the day of inclusion.
TYPE OF PARTICIPANT AND DISEASE CHARACTERISTICS
* Participants who have a documented diagnosis of sickle cell disease (SCD) in their medical record.
SEX, CONTRACEPTIVE/BARRIER METHOD AND PREGNANCY TESTING REQUIREMENTS
* A pa…
Contacts
Trial Transparency email recommended (Toll free number for US & Canada)
800-633-1610
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