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)
Completed · Phase 3
Conditions studied: Pneumococcal Infections
In brief
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.
Key facts
- Study ID
- NCT03547167
- Run by
- Merck Sharp & Dohme LLC
- People needed
- 1515
- Starts
- 2018-07-16
- Expected to finish
- 2020-01-20
- Last updated by the study team
- 2021-01-15
Who can join
Age: 18 and older, up to 49. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Native American participant enrolled from any of the clinical sites of the Johns Hopkins Center for American Indian Health (CAIH) without any of the pre-specified risk conditions for pneumococcal disease listed below, OR Native American participant enrolled from any of the CAIH sites or participant from a site other than CAIH with ≥1 of the following risk conditions for pneumococcal disease:
- Diabetes mellitus Type 1 or Type 2 and with hemoglobin A1c (HgA1c) <10%
- Chronic liver disease with documented history of compensated cirrhosis (Child-Pugh Score A)
- Confirmed diagnosis of Chronic Obstructive Pulmonary Disease (COPD) with spirometric Global Initiative for Chronic Obstructive Lung Disease Stage 1 to 3
- Confirmed diagnosis of mild or moderate persistent asthma receiving guideline directed therapy
- Confirmed diagnosis of chronic heart disease (New York Heart Association [NYHA] heart failure Class 1 to 3, receiving guideline-directed oral heart failure treatment) due to reduced or preserved ejection fraction or due to non-cyanotic congenital heart disease.
- Current smoker
- Female participant: not pregnant, not breastfeeding and 1) not of childbearing potential, or 2) of childbearing potential and agrees to practice contraception through 6 weeks after last administration of study vaccine.
You may not qualify if…
- History of active hepatitis within the prior 3 months
- History of diabetic ketoacidosis, or >1 episodes of severe, symptomatic hypoglycemia within the prior 3 months
- Myocardial infarction, acute coronary syndrome, transient ischemic attack, and ischemic or hemorrhagic stroke within the prior 3 months
- History of severe pulmonary hypertension or history of Eisenmenger syndrome
- History of invasive pneumococcal disease (IPD) or known history of other culture-positive pneumococcal disease within the prior 3 years
- Known hypersensitivity to any vaccine component, pneumococcal conjugate vaccine, or diphtheria toxoid-containing vaccine
- Known or suspected impairment of immunological function (including human immunodeficiency virus (HIV) infection or autoimmune disease)
- History of malignancy within the prior 5 years, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer
- History of Stage 4 or 5 Chronic Kidney Disease or nephrotic syndrome
- History of alcohol withdrawal or alcohol withdrawal seizure within the prior 12 months
- History of coagulation disorder contraindicating intramuscular vaccination
- History of hospitalization within the prior 3 months
- Planned organ transplantation (heart, liver, lung, kidney, or pancreas) or other planned major surgery during the duration of this study.
- Expected survival for less than 1 year according to the investigator's judgment.
- Female participant: positive urine or serum pregnancy test
- Prior administration of any pneumococcal vaccine
- Received systemic corticosteroids (prednisone equivalent of ≥20 mg/day) for ≥14 consecutive days and has not completed within the prior 30 days
- Received systemic corticosteroids exceeding physiologic replacement doses within 14 days before study vaccination
- Receiving immunosuppressive or immunomodulatory therapy with a biological agent
- Received any licensed, non-live vaccine within 14 days before receipt of study vaccine or is scheduled to receive any licensed, non-live vaccine within 30 days following receipt of study vaccine
- Received any live vaccine within 30 days before receipt of any study vaccine or is scheduled to receive any live vaccine within 30 days following receipt of any study vaccine
- Received a blood transfusion or blood products within the prior 6 months
- Receiving chronic home oxygen therapy
- Participated in another clinical study of an investigational product within the prior 2 months
- Current user of recreational or illicit drugs or history of drug abuse or dependence
Where it is running
- Fort Defiance Center for American Indian Health ( Site 0002) — Fort Defiance, Arizona, United States
- Pulmonary Associates, PA ( Site 0043) — Glendale, Arizona, United States
- Central Phoenix Medical Clinic, LLC ( Site 0031) — Phoenix, Arizona, United States
- Whiteriver Center for American Indian Health ( Site 0005) — Whiteriver, Arizona, United States
- Inland Empire Clinical Trials, LLC ( Site 0052) — Rialto, California, United States
- Top Medical Research, Inc ( Site 0033) — Cutler Bay, Florida, United States
- Indago Research & Health Center, Inc ( Site 0054) — Hialeah, Florida, United States
- Renstar Medical Research ( Site 0008) — Ocala, Florida, United States
- Triple O Research Institute, P.A. ( Site 0026) — West Palm Beach, Florida, United States
- Emory University School of Medicine at Grady Hospital ( Site 0027) — Atlanta, Georgia, United States
- Kootenai Health ( Site 0042) — Coeur d'Alene, Idaho, United States
- Evanston Premier Healthcare & Research, LLC. ( Site 0012) — Evanston, Illinois, United States
- Pharmakon Inc ( Site 0049) — Evergreen Park, Illinois, United States
- Reid Physician Associates ( Site 0055) — Richmond, Indiana, United States
- The Center for Pharmaceutical Research PC ( Site 0050) — Kansas City, Missouri, United States
- Clinical Research Consortium ( Site 0053) — Las Vegas, Nevada, United States
- Internal Medicine Associates [Bridgeton, NJ] ( Site 0015) — Bridgeton, New Jersey, United States
- Gallup Center for American Indian Health ( Site 0003) — Gallup, New Mexico, United States
- Shiprock Center for American Indian Health ( Site 0004) — Shiprock, New Mexico, United States
- Corning Center For Clinical Research ( Site 0036) — Corning, New York, United States
- Mid Hudson Medical Research ( Site 0022) — New Windsor, New York, United States
- Wake Research Associates, LLC ( Site 0016) — Raleigh, North Carolina, United States
- Lehigh Valley Health Network ( Site 0040) — Allentown, Pennsylvania, United States
- University of Pennsylvania ( Site 0030) — Philadelphia, Pennsylvania, United States
- Chinle Comprehensive Health Care Facility ( Site 0001) — Chinle, Arizona, United States
Full record on ClinicalTrials.gov
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