A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by PNEUMOVAX™23 in Healthy Adults 50 Years of Age or Older (V114-016/PNEU-PATH)



Status:Active, not recruiting
Conditions:Pneumonia, Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:50 - Any
Updated:12/2/2018
Start Date:June 22, 2018
End Date:December 30, 2019

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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 One Year Later in Healthy Adults 50 Years of Age or Older (PNEU-PATH)

This study is designed 1) to evaluate the safety, tolerability, and immunogenicity of V114
and Prevnar 13™ in healthy adults 50 years of age or older, 2) to describe the safety of
sequential administration of V114 or Prevnar 13™ followed by PNEUMOVAX™23, and 3) to evaluate
the immune responses to the 15 serotypes contained in V114 when PNEUMOVAX™23 is given
approximately 12 months after receipt of either V114 or Prevnar 13™.


Inclusion Criteria:

- Male or female in good health

- 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 administration of study vaccine.

Exclusion Criteria:

- History of invasive pneumococcal disease

- Known hypersensitivity to any vaccine component

- Known or suspected impairment of immune function

- Coagulation disorder contraindicating intramuscular vaccination

- History of malignancy ≤5 years before enrollment, except for adequately treated basal
cell or squamous cell skin cancer or in situ cervical cancer

- Female participant: positive urine or serum pregnancy test

- Prior administration of any pneumococcal vaccine

- Received systemic corticosteroids for ≥14 consecutive days and have not completed
within 30 days of enrollment

- Received immunosuppressive therapy

- Received a blood transfusion or blood products within 6 months of enrollment

- Participated in another clinical study of an investigational product within 2 months
of enrollment

- Current user of recreational or illicit drugs or history of drug or alcohol abuse or
dependence.
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16
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Walnut creek, California 94598
Phone: 925-930-7267
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4410 Medical Drive
San Antonio, Texas 78229
210-692-7157
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1709 S Rock Rd
Wichita, Kansas 67207
316-689-6629
Phone: 316-689-6635
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Chandler, Arizona 85224
Phone: 480-782-5552
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Cleveland, Ohio 44122
Phone: 216-682-0320
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801 Monterey Street
Coral Gables, Florida 33134
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Elkridge, Maryland
Phone: 4107303399119
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Galveston, Texas
Phone: 409-772-5278
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Houston, Texas
Phone: 713-838-2022
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Newport News, Virginia 23606
Phone: 757-591-8100
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Phoenix, Arizona 85020
Phone: 602-200-3814
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Salt Lake City, Utah 84109
Phone: 801-554-0158
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Seoul,
Phone: +82220722945
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South Jordan, Utah 84095
Phone: 801-554-0158
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6141 Sunset Drive
South Miami, Florida 33143
Phone: 305-598-3125
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Spring Valley, California 91978
Phone: 619-660-9068
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