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
Fort Worth, Texas 76104
Phone: 817-348-0228
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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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Galveston, TX
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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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851 Middle Street
Fall River, Massachusetts 02724
Phone: 5083246800ext380
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Fall River, MA
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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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