Trials / Completed
CompletedNCT03731182
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Children With Sickle Cell Disease (V114-023/PNEU-SICKLE)
A Phase 3, Multicenter, Randomized, Double-blind, Active Comparator Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Children With Sickle Cell Disease (PNEU-SICKLE)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 104 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 5 Years – 17 Years
- Healthy volunteers
- Not accepted
Summary
This study is designed to describe the safety, tolerability, and immunogenicity of V114 in children with sickle cell disease.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | V114 | V114 pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), and serotype 6B (4 mcg) in each 0.5 mL dose |
| BIOLOGICAL | Prevnar 13™ | Prevnar 13™ pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg) and 6B (4.4 mcg) in each 0.5 ml dose |
Timeline
- Start date
- 2019-01-23
- Primary completion
- 2020-06-08
- Completion
- 2020-06-08
- First posted
- 2018-11-06
- Last updated
- 2021-06-16
- Results posted
- 2021-06-16
Locations
19 sites across 7 countries: United States, Brazil, Colombia, Dominican Republic, Greece, Italy, Panama
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03731182. Inclusion in this directory is not an endorsement.