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NCT03547167 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by PNEUMOVAX™23 in Adults at Increased Risk for Pneumococcal Disease (V114-017/PNEU-DAY)
A Phase 3 study of Pneumococcal Infections, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,515
- Enrollment target
- 20
- Study locations
NCT03547167 is a Phase 3 study of Pneumococcal Infections that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 1,515 participants, above the 753-participant average among 10 other Pneumococcal Infections trials with a reported enrollment target (101% higher). The trial reports 20 study locations across 11 states.
The verdict
NCT03547167, a Phase 3 study of Pneumococcal Infections, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,515 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study is designed to 1) describe the safety, tolerability, and immunogenicity of V114 and Prevnar 13™ in pneumococcal vaccine-naïve adults at increased risk for pneumococcal disease and to 2) describe the safety, tolerability, and immunogenicity of PNEUMOVAX™23 when administered 6 months after receipt of either V114 or Prevnar 13™. Increased risk for pneumococcal disease is defined as 1) an underlying medical condition, 2) behavioral habits such as smoking or alcohol use, or 3) living in a community/environment with increased risk of disease transmission.
Conditions Studied
Interventions
- BIOLOGICAL V114
- BIOLOGICAL Prevnar 13™
- BIOLOGICAL PNEUMOVAX™23
Study Locations (20)
Arizona
- Chinle Comprehensive Health Care Facility ( Site 0001) - Chinle
- Fort Defiance Center for American Indian Health ( Site 0002) - Fort Defiance
- Pulmonary Associates, PA ( Site 0043) - Glendale
- Central Phoenix Medical Clinic, LLC ( Site 0031) - Phoenix
- Whiteriver Center for American Indian Health ( Site 0005) - Whiteriver
Florida
- Top Medical Research, Inc ( Site 0033) - Cutler Bay
- Indago Research & Health Center, Inc ( Site 0054) - Hialeah
- Renstar Medical Research ( Site 0008) - Ocala
- Triple O Research Institute, P.A. ( Site 0026) - West Palm Beach
Illinois
- Evanston Premier Healthcare & Research, LLC. ( Site 0012) - Evanston
- Pharmakon Inc ( Site 0049) - Evergreen Park
New Mexico
- Gallup Center for American Indian Health ( Site 0003) - Gallup
- Shiprock Center for American Indian Health ( Site 0004) - Shiprock
California
- Inland Empire Clinical Trials, LLC ( Site 0052) - Rialto
Georgia
- Emory University School of Medicine at Grady Hospital ( Site 0027) - Atlanta
Idaho
- Kootenai Health ( Site 0042) - Coeur d'Alene
Indiana
- Reid Physician Associates ( Site 0055) - Richmond
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,515 participants |
| Start Date | 2018-07-16 |
| Est. Completion | 2020-01-20 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03547167
The ClinicalTrials.gov registry entry for NCT03547167 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,515 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 753-participant average among 10 other Pneumococcal Infections trials with a reported enrollment target (101% higher). 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.
NCT03547167 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Arizona, Florida, Illinois.
Frequently Asked Questions
What is clinical trial NCT03547167 about?
NCT03547167 is a clinical study titled "A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by PNEUMOVAX™23 in Adults at Increased Risk for Pneumococcal Disease (V114-017/PNEU-DAY)". This study is designed to 1) describe the safety, tolerability, and immunogenicity of V114 and Prevnar 13™ in pneumococcal vaccine-naïve adults at increased risk for pneumococcal disease and to 2) describe the safety, tolerability, and immunogenicity of PNEUMOVAX™23 when administered 6 months after ...
What is the current status of trial NCT03547167?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,515 participants. The study started on 2018-07-16. Estimated completion is 2020-01-20.
What conditions does trial NCT03547167 study?
This clinical trial studies the following conditions: Pneumococcal Infections.
What interventions are being tested in trial NCT03547167?
The interventions under investigation include: V114 (BIOLOGICAL), Prevnar 13™ (BIOLOGICAL), PNEUMOVAX™23 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03547167?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03547167 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Georgia, Idaho. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Read our methodology - how this data is sourced, computed, and verified.
Related
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