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)
NCT ID: NCT03547167
Last Updated: 2021-01-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1515 participants
INTERVENTIONAL
2018-07-16
2020-01-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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V114
Participants will receive a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2)
V114
15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg) and Merck Aluminum Phosphate Adjuvant (125 mcg) in each 0.5 mL dose
PNEUMOVAX™23
23-valent pneumococcal polysaccharide vaccine with serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, 33F (25 mcg each) in each 0.5 mL dose
Prevnar 13™
Participants will receive a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2)
Prevnar 13™
13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg) and 6B (4.4 mcg), and aluminum phosphate adjuvant (125 mcg aluminum) in each 0.5 ml dose
PNEUMOVAX™23
23-valent pneumococcal polysaccharide vaccine with serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, 33F (25 mcg each) in each 0.5 mL dose
Interventions
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V114
15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg) and Merck Aluminum Phosphate Adjuvant (125 mcg) in each 0.5 mL dose
Prevnar 13™
13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg) and 6B (4.4 mcg), and aluminum phosphate adjuvant (125 mcg aluminum) in each 0.5 ml dose
PNEUMOVAX™23
23-valent pneumococcal polysaccharide vaccine with serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, 33F (25 mcg each) in each 0.5 mL dose
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Diabetes mellitus Type 1 or Type 2 and with hemoglobin A1c (HgA1c) \<10%
2. Chronic liver disease with documented history of compensated cirrhosis (Child-Pugh Score A)
3. Confirmed diagnosis of Chronic Obstructive Pulmonary Disease (COPD) with spirometric Global Initiative for Chronic Obstructive Lung Disease Stage 1 to 3
4. Confirmed diagnosis of mild or moderate persistent asthma receiving guideline directed therapy
5. 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.
6. 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.
Exclusion Criteria
* 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
* Diabetes mellitus with HgA1c ≥10%
* Chronic liver disease with Child-Pugh Class B or C cirrhosis
* Chronic lung disease with Chronic Obstructive Pulmonary Disease (COPD) GOLD Stage 4 or severe persistent asthma
* Chronic heart disease with NYHA heart failure Class 4.
18 Years
49 Years
ALL
Yes
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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Chinle Comprehensive Health Care Facility ( Site 0001)
Chinle, Arizona, United States
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
Mountain View Clinical Research ( Site 0007)
Greer, South Carolina, United States
Holston Medical Group ( Site 0025)
Kingsport, Tennessee, United States
AIM Trials ( Site 0060)
Fort Worth, Texas, United States
University of Texas Medical Branch at Galveston ( Site 0034)
Galveston, Texas, United States
Private Practice Leadership, LLC ( Site 0051)
Houston, Texas, United States
Texas Center For Drug Development ( Site 0041)
Houston, Texas, United States
Texas Institute Of Cardiology ( Site 0048)
McKinney, Texas, United States
Village Health Partners ( Site 0006)
Plano, Texas, United States
Copperview Medical Center ( Site 0038)
South Jordan, Utah, United States
Timber Lane Allergy & Asthma Research, LLC ( Site 0044)
South Burlington, Vermont, United States
Pulmonary & Sleep Research ( Site 0046)
Spokane Valley, Washington, United States
Gundersen Health System ( Site 0021)
La Crosse, Wisconsin, United States
Marshfield Clinic ( Site 0013)
Marshfield, Wisconsin, United States
Paratus Clinical Pty Ltd - Blacktown Clinic ( Site 0174)
Blacktown, New South Wales, Australia
Holdsworth House Medical Practice ( Site 0170)
Sydney, New South Wales, Australia
Core Research Group Pty limited ( Site 0175)
Brisbane, Queensland, Australia
Emeritus Research Pty Ltd ( Site 0173)
Camberwell, Victoria, Australia
Paratus Clinical Kanwal ( Site 0172)
Kanwal, , Australia
Nepean Hospital ( Site 0176)
Kingswood, , Australia
The Liver and Intestinal Research Centre (LAIR) ( Site 0302)
Vancouver, British Columbia, Canada
GA Research Associates, Ltd/Ltee ( Site 0303)
Moncton, New Brunswick, Canada
Colchester Research Group ( Site 0094)
Truro, Nova Scotia, Canada
Hamilton Medical Research Group ( Site 0092)
Hamilton, Ontario, Canada
SKDS Research Inc. ( Site 0099)
Newmarket, Ontario, Canada
Omnispec Recherche Clinique Inc ( Site 0093)
Mirabel, Quebec, Canada
Dynamik Research ( Site 0095)
Pointe-Claire, Quebec, Canada
Diex Recherche Quebec Inc ( Site 0091)
Québec, Quebec, Canada
Q & T Research Sherbrooke Inc. ( Site 0097)
Sherbrooke, Quebec, Canada
Clinica Arauco Salud ( Site 0100)
Santiago, RM, Chile
Centro de Investigacion Clinica UC CICUC ( Site 0104)
Santiago, , Chile
CECIM ( Site 0101)
Santiago, , Chile
CESFAM Esmeralda ( Site 0102)
Santiago, , Chile
Hospital Dr. Hernan Henriquez Aravena ( Site 0105)
Temuco, , Chile
Southern Clinical Trials - Waitemata ( Site 0183)
Auckland, , New Zealand
Auckland Clinical Studies Limited ( Site 0189)
Auckland, , New Zealand
Optimal Clinical Trials ( Site 0182)
Auckland, , New Zealand
Christchurch Heart Institute ( Site 0280)
Christchurch, , New Zealand
Southern Clinical Trials Ltd ( Site 0180)
Christchurch, , New Zealand
Lakeland Clinical Trials ( Site 0181)
Rotorua, , New Zealand
Bay of Plenty Clinical School ( Site 0186)
Tauranga, , New Zealand
P3 Research Ltd - Wellington ( Site 0184)
Wellington, , New Zealand
WSOZ im.T.Browicza w Bydgoszczy ( Site 0317)
Bydgoszcz, , Poland
Centrum Medyczne Pratia Bydgoszcz ( Site 0139)
Bydgoszcz, , Poland
Synexus Polska Sp. z o.o. ( Site 0238)
Gdansk, , Poland
Specjalistyczny osrodek .All-Med. Grazyna Pulka ( Site 0233)
Krakow, , Poland
ID Clinic ( Site 0235)
Mysłowice, , Poland
Centrum Medyczne Ogrodowa Sp. Z o.o. ( Site 0319)
Skierniewice, , Poland
Niepubliczny Zaklad Opieki Zdrowotnej ( Site 0314)
Sopot, , Poland
Wroclawskie Centrum Zdrowia SP ZOZ ( Site 0236)
Wroclaw, , Poland
Synexus Polska Sp. z o.o. oddział we Wrocławiu ( Site 0234)
Wroclaw, , Poland
Republican Clinical Hospital of Infectious Diseases n. a. A.F.Agafonov ( Site 0249)
Kazan', , Russia
Saratov State Medical University n.a. V.I.Razumovskiy ( Site 0144)
Saratov, , Russia
Smolensk State Medical University ( Site 0246)
Smolensk, , Russia
Countries
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References
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Hammitt LL, Quinn D, Janczewska E, Pasquel FJ, Tytus R, Rajender Reddy K, Abarca K, Khaertynova IM, Dagan R, McCauley J, Cheon K, Pedley A, Sterling T, Tamms G, Musey L, Buchwald UK. Immunogenicity, Safety, and Tolerability of V114, a 15-Valent Pneumococcal Conjugate Vaccine, in Immunocompetent Adults Aged 18-49 Years With or Without Risk Factors for Pneumococcal Disease: A Randomized Phase 3 Trial (PNEU-DAY). Open Forum Infect Dis. 2021 Dec 18;9(3):ofab605. doi: 10.1093/ofid/ofab605. eCollection 2022 Mar.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2017-004915-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
V114-017
Identifier Type: OTHER
Identifier Source: secondary_id
V114-017
Identifier Type: -
Identifier Source: org_study_id
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