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
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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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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Dayton, Ohio 45419
Phone: 937-534-4201
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Downey, California 90241
Phone: 562-904-2123
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East Syracuse, New York 13057
Phone: 315-464-7209
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Erie, Pennsylvania 16506
Phone: 814-838-8724
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Hermitage, Pennsylvania 16148
Phone: 724-981-1219
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Houston, Texas 77087
Phone: 713-777-5343
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790 East Charing Cross Circle
Lake Mary, Florida 32746
Phone: 4078316200264
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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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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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Roy, Utah 84067
Phone: 801-644-8862
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San Diego, California 92102
Phone: 619-264-3107
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San Jose, California 94538
Phone: 510-267-7538
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Santa Clara, California 95051
Phone: 510-267-7538
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Sudbury, Ontario
Phone: 7055660005
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