A Study to Evaluate the Interchangeability of V114 and Prevnar 13™ in Healthy Infants (V114-027/PNEU-DIRECTION)



Status:Recruiting
Conditions:Pneumonia, Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:Any
Updated:3/24/2019
Start Date:October 18, 2018
End Date:April 16, 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 Study to Evaluate the Interchangeability of V114 and Prevnar 13™ With Respect to Safety, Tolerability, and Immunogenicity in Healthy Infants (PNEU-DIRECTION)

This study is designed to evaluate the safety, tolerability, and immunogenicity of V114 and
Prevnar 13™ in healthy infants switched from Prevnar 13™ to V114 during the Pneumococcal
Conjugate Vaccine (PCV) immunization schedule.


Inclusion Criteria:

- Healthy, based on clinical judgment of the investigator

- Has a legally acceptable representative who understands the study procedures,
alternate treatments available, and risks involved with the study and voluntarily
agrees to participate by giving written informed consent.

Exclusion Criteria:

- History of invasive pneumococcal disease (positive blood culture, positive
cerebrospinal fluid culture, or other sterile site) or known history of other culture
positive pneumococcal disease

- Known hypersensitivity to any component of the pneumococcal conjugate vaccine (PCV),
any component of the licensed pediatric vaccines to be administered concomitantly in
the study, or any diphtheria toxoid-containing vaccine

- Any contraindication to the concomitant study vaccines being administered in the study

- Known or suspected impairment of immunological function

- History of congenital or acquired immunodeficiency

- Has or his/her mother has a documented human immunodeficiency virus (HIV) infection

- Has or his/her mother has a documented hepatitis B surface antigen - positive test

- Known or history of functional or anatomic asplenia

- Failure to thrive based on the clinical judgment of the investigator

- Known coagulation disorder contraindicating intramuscular vaccination

- History of autoimmune disease (including but not limited to systemic lupus
erythematosus, antiphospholipid syndrome, Behcet's disease, autoimmune thyroid
disease, polymyositis and dermatomyositis, scleroderma, type 1 diabetes mellitus, or
other autoimmune disorders)

- Known neurologic or cognitive behavioral disorder, including encephalitis/myelitis,
acute disseminating encephalomyelitis, pervasive development disorder, and related
disorders

- Received a dose of any pneumococcal vaccine prior to study entry

- Received >1 dose of monovalent hepatitis B vaccine or hepatitis B based combination
vaccine prior to study entry

- Received a dose of rotavirus vaccine prior to study entry

- Received a blood transfusion or blood products, including immunoglobulins

- Participated in another clinical study of an investigational product before the
beginning or anytime during the duration of the current clinical study

- Has any other reason that, in the opinion of the investigator, may interfere with the
evaluation required by the study

- Has an immediate family member (e.g., parent/legal guardian or sibling) who is
investigational site or Sponsor staff directly involved with this study.
We found this trial at
19
sites
851 Middle Street
Fall River, Massachusetts 02724
Phone: 5083246800ext380
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301 University Blvd
Galveston, Texas 77555
(409) 772-1011
Phone: 409-795-8874
University of Texas Medical Branch Established in 1891 as the University of Texas Medical Department,...
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601 Elmwood Avenue
Rochester, New York 14642
(585) 275-2100
Phone: 585-275-9613
Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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Rochester, NY
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Bardstown, Kentucky 40004
Phone: 502-349-1569
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Bayamon, 00961
Phone: 7877809196
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Bayamon,
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Birmingham, Alabama 35235
Phone: 205-933-8522
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Birmingham, AL
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Charleston, South Carolina 29414
Phone: 843-518-5642
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Charleston, SC
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Colorado Springs, Colorado 80922
Phone: 310-803-2737
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Dothan, Alabama 36305
Phone: 334-794-8656
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Dothan, AL
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Fort Worth, Texas 76104
Phone: 817-348-0228
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Fort Worth, TX
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525 Verdae Boulevard
Greenville, South Carolina 29607
Phone: 864-272-0388
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Greenville, SC
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Jonesboro, Arkansas 72401
Phone: 870-934-3133
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Jonesboro, AR
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Kingsport, Tennessee 37660
Phone: 423-230-2436
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Lincoln, Nebraska 68504
Phone: 402-327-6065
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Lincoln, NE
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Liverpool, New York 13088
Phone: 315-884-7717
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Murray, Utah 84107
Phone: 801-644-8862
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Murray, UT
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Spokane, Washington 99202
Phone: 509-838-2531
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Spokane, WA
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Statesville, North Carolina 28677
Phone: 704-924-2105
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Statesville, NC
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750 East Adams Street
Syracuse, New York 13210
Phone: 315-464-6331
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