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 |
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™.
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
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790 East Charing Cross Circle
Lake Mary, Florida 32746
Lake Mary, Florida 32746
Phone: 4078316200264
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Madison, Wisconsin 53705
Phone: 608-263-8558
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1168 Goodlette-Frank Road
Naples, Florida 34102
Naples, Florida 34102
Phone: 239-230-2021
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1020 Walnut St
Philadelphia, Pennsylvania 19107
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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