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)



Status:Recruiting
Conditions:Pneumonia, Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 49
Updated:3/29/2019
Start Date:July 16, 2018
End Date:January 17, 2020
Contact:Toll Free Number
Email:Trialsites@merck.com
Phone:1-888-577-8839

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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)

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 3) living in a community/environment with increased risk of disease
transmission.


Inclusion Criteria: - 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:

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 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 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
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 - 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 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.
We found this trial at
38
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New Windsor, New York 12553
Phone: 844-337-8839
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104 SE 1st Avenue
Ocala, Florida 34471
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Allentown, Pennsylvania 18105
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Atlanta, Georgia 30303
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Blacktown, New South Wales
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Bridgeton, New Jersey 08302
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Chinle, Arizona 86503
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Coeur d'Alene, Idaho 83814
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Corning, New York 14830
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Cutler Bay, Florida 33189
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Evanston, Illinois 60201
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Evergreen Park, Illinois 60805
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Fort Defiance, Arizona 86504
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Gallup, New Mexico 87301
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Galveston, Texas
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Glendale, Arizona 85306
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Greer, South Carolina 29651
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Hialeah, Florida 33012
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Houston, Texas
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Houston, Texas 77094
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Kansas City, Missouri 64114
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Kingsport, Tennessee 37660
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1900 South Avenue
La Crosse, Wisconsin 54601
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Las Vegas, Nevada 89119
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Marshfield, Wisconsin 54449
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McKinney, Texas 75069
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Phone: 215-360-0836
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Phoenix, Arizona 85020
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Plano, Texas 75024
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3100 Duraleigh Rd
Raleigh, North Carolina 27612
(919) 781-2514
Phone: 919-781-2514
Wake Research Associates, LLC Wake Research is an Organization of Unified Investigational Sites working closely...
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Richmond, Indiana 47374
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Shiprock, New Mexico 87420
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53 Timber Lane
South Burlington, Vermont 05403
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South Jordan, Utah 84095
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