A Study to Evaluate the Safety and Tolerability of V114 and Prevnar 13™ in Healthy Infants (V114-031/PNEU-LINK)



Status:Recruiting
Conditions:Pneumonia, Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:Any
Updated:3/29/2019
Start Date:December 14, 2018
End Date:January 30, 2021
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 and Tolerability of V114 in Healthy Infants (PNEU -LINK)

This study is designed to evaluate the safety and tolerability of V114 and Prevnar 13™ in
healthy infants. This study will include both full-term infants (≥37 weeks gestational age)
and premature infants (<37 weeks gestational age). Premature infants will be included in a
Premature Infant Immunogenicity Substudy, which will assess immunogenicity and safety
following administration of V114 or Prevnar 13™.


Inclusion Criteria:

- Healthy (based on a review of medical history and physical examination) based on the
clinical judgment of the investigator

- Male or female approximately 2 months of age, from 42 days to 90 days inclusive, at
the time of obtaining the informed consent

- Have 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 (IPD) (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) or
any diphtheria toxoid containing vaccine

- 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

- 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 a blood transfusion or blood products, including immunoglobulins, before
receipt of first dose of study vaccine

- Participated in another clinical study of an investigational product before the
beginning or anytime during the duration of the current clinical study. Participants
enrolled in observational studies may be included.

- 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 who is investigational site or Sponsor staff directly
involved with this study.
We found this trial at
21
sites
San Diego, California 92102
Phone: 619-264-3107
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3800 Houma Blvd., Suite 335
Metairie, Louisiana 70006
Phone: 504-304-7197
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Charleston, South Carolina 29407
Phone: 843-766-5045
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Charleston, SC
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Dayton, Ohio 45419
Phone: 937-534-4201
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Downey, California 90241
Phone: 562-904-2123
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Downey, CA
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East Syracuse, New York 13057
Phone: 315-464-7209
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East Syracuse, NY
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Erie, Pennsylvania 16506
Phone: 814-838-8724
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Erie, PA
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Hermitage, Pennsylvania 16148
Phone: 724-981-1219
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Hermitage, PA
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Houston, Texas 77087
Phone: 713-777-5343
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Houston, TX
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790 East Charing Cross Circle
Lake Mary, Florida 32746
Phone: 4078316200264
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Lake Mary, FL
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Layton, Utah 84041
Phone: 801-644-8862
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Layton, Utah 84041
Phone: 801-773-4840
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League City, Texas 77573
Phone: 832-340-2311
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Madison, Wisconsin 53705
Phone: 608-263-8558
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Madison, WI
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1168 Goodlette-Frank Road
Naples, Florida 34102
Phone: 239-230-2021
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Overland Park, Kansas 66213
Phone: 816-943-0770
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1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Phone: 215-955-4720
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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Roy, Utah 84067
Phone: 801-644-8862
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Roy, UT
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San Jose, California 94538
Phone: 510-267-7538
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San Jose, CA
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Santa Clara, California 95051
Phone: 510-267-7538
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Sudbury, Ontario
Phone: 7055660005
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