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)
Public ClinicalTrials.gov record NCT03547167. 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, Multicenter, Randomized, Double-blind, Active Comparator-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by Administration of PNEUMOVAX™23 Six Months Later in Immunocompetent Adults Between 18 and 49 Years of Age at Increased Risk for Pneumococcal Disease (PNEU - DAY)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03547167
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,515 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 49 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 16, 2018 (Actual)
- Primary completion
- Jan 20, 2020 (Actual)
- Completion
- Jan 20, 2020 (Actual)
- Last update posted
- Jan 15, 2021
2018 – 2020
United States locations
- U.S. sites
- 38
- U.S. states
- 21
- U.S. cities
- 37
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Chinle Comprehensive Health Care Facility ( Site 0001) | Chinle | Arizona | 86503 | — |
| Fort Defiance Center for American Indian Health ( Site 0002) | Fort Defiance | Arizona | 86504 | — |
| Pulmonary Associates, PA ( Site 0043) | Glendale | Arizona | 85306 | — |
| Central Phoenix Medical Clinic, LLC ( Site 0031) | Phoenix | Arizona | 85020 | — |
| Whiteriver Center for American Indian Health ( Site 0005) | Whiteriver | Arizona | 85941 | — |
| Inland Empire Clinical Trials, LLC ( Site 0052) | Rialto | California | 92377 | — |
| Top Medical Research, Inc ( Site 0033) | Cutler Bay | Florida | 33189 | — |
| Indago Research & Health Center, Inc ( Site 0054) | Hialeah | Florida | 33012 | — |
| Renstar Medical Research ( Site 0008) | Ocala | Florida | 34471 | — |
| Triple O Research Institute, P.A. ( Site 0026) | West Palm Beach | Florida | 33407 | — |
| Emory University School of Medicine at Grady Hospital ( Site 0027) | Atlanta | Georgia | 30303 | — |
| Kootenai Health ( Site 0042) | Coeur d'Alene | Idaho | 83814 | — |
| Evanston Premier Healthcare & Research, LLC. ( Site 0012) | Evanston | Illinois | 60201 | — |
| Pharmakon Inc ( Site 0049) | Evergreen Park | Illinois | 60805 | — |
| Reid Physician Associates ( Site 0055) | Richmond | Indiana | 47374 | — |
| The Center for Pharmaceutical Research PC ( Site 0050) | Kansas City | Missouri | 64114 | — |
| Clinical Research Consortium ( Site 0053) | Las Vegas | Nevada | 89119 | — |
| Internal Medicine Associates [Bridgeton, NJ] ( Site 0015) | Bridgeton | New Jersey | 08302 | — |
| Gallup Center for American Indian Health ( Site 0003) | Gallup | New Mexico | 87301 | — |
| Shiprock Center for American Indian Health ( Site 0004) | Shiprock | New Mexico | 87420 | — |
| Corning Center For Clinical Research ( Site 0036) | Corning | New York | 14830 | — |
| Mid Hudson Medical Research ( Site 0022) | New Windsor | New York | 12553 | — |
| Wake Research Associates, LLC ( Site 0016) | Raleigh | North Carolina | 27612 | — |
| Lehigh Valley Health Network ( Site 0040) | Allentown | Pennsylvania | 18102 | — |
| University of Pennsylvania ( Site 0030) | Philadelphia | Pennsylvania | 19104 | — |
| Mountain View Clinical Research ( Site 0007) | Greer | South Carolina | 29651 | — |
| Holston Medical Group ( Site 0025) | Kingsport | Tennessee | 37660 | — |
| AIM Trials ( Site 0060) | Fort Worth | Texas | 76104 | — |
| University of Texas Medical Branch at Galveston ( Site 0034) | Galveston | Texas | 77555-1115 | — |
| Private Practice Leadership, LLC ( Site 0051) | Houston | Texas | 77094 | — |
| Texas Center For Drug Development ( Site 0041) | Houston | Texas | 77801 | — |
| Texas Institute Of Cardiology ( Site 0048) | McKinney | Texas | 75071 | — |
| Village Health Partners ( Site 0006) | Plano | Texas | 75024 | — |
| Copperview Medical Center ( Site 0038) | South Jordan | Utah | 84095 | — |
| Timber Lane Allergy & Asthma Research, LLC ( Site 0044) | South Burlington | Vermont | 05403 | — |
| Pulmonary & Sleep Research ( Site 0046) | Spokane Valley | Washington | 99216 | — |
| Gundersen Health System ( Site 0021) | La Crosse | Wisconsin | 54601 | — |
| Marshfield Clinic ( Site 0013) | Marshfield | Wisconsin | 54449 | — |
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 40 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03547167, 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 Jan 15, 2021 · Synced Oct 23, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03547167 live on ClinicalTrials.gov.