A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Allogeneic Hematopoietic Stem Cell Transplant Recipients (V114-022/PNEU-STEM)
Public ClinicalTrials.gov record NCT03565900. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 \[GVHD\]).
Study identification
- NCT ID
- NCT03565900
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 277 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 3 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 12, 2018 (Actual)
- Primary completion
- Nov 4, 2021 (Actual)
- Completion
- Nov 4, 2021 (Actual)
- Last update posted
- Jul 28, 2023
2018 – 2021
United States locations
- U.S. sites
- 13
- U.S. states
- 12
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Stanford Health Care ( Site 0005) | Palo Alto | California | 94305 | — |
| Children's Hospital Colorado ( Site 0166) | Aurora | Colorado | 80045 | — |
| University of Florida ( Site 0011) | Gainesville | Florida | 32610 | — |
| University of Chicago ( Site 0016) | Chicago | Illinois | 60637 | — |
| Indiana Blood and Marrow Transplantation ( Site 0001) | Indianapolis | Indiana | 46237 | — |
| University of Kansas Medical Center ( Site 0007) | Kansas City | Kansas | 66160 | — |
| Johns Hopkins - University ( Site 0023) | Baltimore | Maryland | 21287 | — |
| Children's Mercy Hospital ( Site 0167) | Kansas City | Missouri | 64108 | — |
| Montefiore Einstein Center ( Site 0164) | The Bronx | New York | 10467 | — |
| Cincinnati Children's Hospital Medical Center ( Site 0010) | Cincinnati | Ohio | 45229 | — |
| Cleveland Clinic Foundation ( Site 0168) | Cleveland | Ohio | 44106 | — |
| Oregon Health & Science University ( Site 0018) | Portland | Oregon | 97239 | — |
| Baylor College of Medicine - Texas Children's Hospital ( Site 0165) | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 39 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03565900, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 28, 2023 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03565900 live on ClinicalTrials.gov.