Trials / Completed
CompletedNCT03565900
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Allogeneic Hematopoietic Stem Cell Transplant Recipients (V114-022/PNEU-STEM)
A Phase 3, Randomized, Double-blind, Active Comparator-controlled, Multicenter Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Recipients of Allogeneic Hematopoietic Stem Cell Transplant (PNEU-STEM)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 277 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 3 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to 1) evaluate the safety and tolerability, and immunogenicity of blinded V114 and Prevnar 13™ within each vaccination group, and 2) evaluate the safety and tolerability, and immunogenicity of PNEUMOVAX™23 (administered as open label, 12 months after allogeneic hematopoietic stem cell transplant \[allo-HSCT\] in participants who do not develop chronic graft-versus-host disease \[GVHD\]).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | V114 | 15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg) and Merck Aluminum Phosphate Adjuvant (125 mcg) in each 0.5 mL dose. |
| BIOLOGICAL | Prevnar 13™ | 13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg) and 6B (4.4 mcg), and aluminum phosphate adjuvant (125 mcg aluminum) in each 0.5 ml dose |
| BIOLOGICAL | PNEUMOVAX™23 | 23-valent pneumococcal polysaccharide vaccine with serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, 33F (25 mcg each) in each 0.5 mL dose |
Timeline
- Start date
- 2018-09-12
- Primary completion
- 2021-11-04
- Completion
- 2021-11-04
- First posted
- 2018-06-21
- Last updated
- 2023-07-28
- Results posted
- 2022-10-20
Locations
52 sites across 10 countries: United States, Australia, Belgium, Brazil, Canada, Colombia, France, Germany, Mexico, Sweden
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03565900. Inclusion in this directory is not an endorsement.