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NCT03565900 · ClinicalTrials.gov registry record · Phase 3
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 study of Pneumococcal Infections, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 3
- Development phase
- 277
- Enrollment target
- 20
- Study locations
NCT03565900 is a Phase 3 study of Pneumococcal Infections that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 277 participants, below the 877-participant average among 10 other Pneumococcal Infections trials with a reported enrollment target (68% lower). The trial reports 20 study locations across 16 states.
The verdict
NCT03565900, a Phase 3 study of Pneumococcal Infections, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 277 participants
- Enrollment target
- 20
- Study locations
Study 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 Studied
Interventions
- BIOLOGICAL V114
- BIOLOGICAL Prevnar 13™
- BIOLOGICAL PNEUMOVAX™23
Study Locations (20)
Victoria
- Austin Health-Austin Hospital ( Site 0038) - Heidelberg
- The Alfred Hospital ( Site 0037) - Melbourne
- Royal Melbourne Hospital ( Site 0039) - Parkville
Ohio
- Cincinnati Children's Hospital Medical Center ( Site 0010) - Cincinnati
- Cleveland Clinic Foundation ( Site 0168) - Cleveland
New South Wales
- St. Vincent's Hospital ( Site 0041) - Sydney
- The Children s Hospital at Westmead ( Site 0191) - Westmead
California
- Stanford Health Care ( Site 0005) - Palo Alto
Colorado
- Children's Hospital Colorado ( Site 0166) - Aurora
Florida
- University of Florida ( Site 0011) - Gainesville
Illinois
- University of Chicago ( Site 0016) - Chicago
Indiana
- Indiana Blood and Marrow Transplantation ( Site 0001) - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 277 participants |
| Start Date | 2018-09-12 |
| Est. Completion | 2021-11-04 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03565900
The ClinicalTrials.gov registry entry for NCT03565900 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 277 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 877-participant average among 10 other Pneumococcal Infections trials with a reported enrollment target (68% lower). The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Pneumococcal Infections appearing as the primary indexed condition, and to 3 interventions - of which V114 is the first listed.
NCT03565900 reports 20 study locations spanning 16 distinct geographic areas - top geographies include Victoria, Ohio, New South Wales.
Frequently Asked Questions
What is clinical trial NCT03565900 about?
NCT03565900 is a clinical study titled "A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Allogeneic Hematopoietic Stem Cell Transplant Recipients (V114-022/PNEU-STEM)". 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 hematopoi...
What is the current status of trial NCT03565900?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 277 participants. The study started on 2018-09-12. Estimated completion is 2021-11-04.
What conditions does trial NCT03565900 study?
This clinical trial studies the following conditions: Pneumococcal Infections.
What interventions are being tested in trial NCT03565900?
The interventions under investigation include: V114 (BIOLOGICAL), Prevnar 13™ (BIOLOGICAL), PNEUMOVAX™23 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03565900?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03565900 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
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