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

Completed · Phase 3

Conditions studied: Pneumococcal Infections

In brief

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™.

Key facts

Study ID

NCT03692871

Run by

Merck Sharp & Dohme LLC

People needed

2409

Starts

2018-12-14

Expected to finish

2021-03-26

Last updated by the study team

2023-07-28

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Beach Pediatrics ( Site 0040) — Huntington Beach, California, United States
• Khruz Biotechnology Research Institute ( Site 0006) — San Diego, California, United States
• Kaiser Permanente - San Jose ( Site 0036) — San Jose, California, United States
• Kaiser Permanente - Santa Clara ( Site 0027) — Santa Clara, California, United States
• Children's Research, LLC ( Site 0025) — Lake Mary, Florida, United States
• Advanced Research For Health Improvement LLC ( Site 0030) — Naples, Florida, United States
• Pediatric Partners, P.A. ( Site 0010) — Overland Park, Kansas, United States
• Novak Center for Childrens Health ( Site 0033) — Louisville, Kentucky, United States
• Medpharmics, LLC ( Site 0037) — Metairie, Louisiana, United States
• Child Health Care Associates ( Site 0024) — East Syracuse, New York, United States
• Primedical Clinical Research ( Site 0035) — Dayton, Ohio, United States
• Allegheny Health & Wellness Pavilion West ( Site 0034) — Erie, Pennsylvania, United States
• CCP- Kid's Way ( Site 0008) — Hermitage, Pennsylvania, United States
• Thomas Jefferson University ( Site 0029) — Philadelphia, Pennsylvania, United States
• Medical Research South, LLC ( Site 0013) — Charleston, South Carolina, United States
• Pediatric Associates [Houston, TX] ( Site 0039) — Houston, Texas, United States
• University of Texas Medical Branch ( Site 0018) — League City, Texas, United States
• Tanner Clinic ( Site 0009) — Layton, Utah, United States
• Wee Care Pediatrics ( Site 0031) — Layton, Utah, United States
• Wee Care Pediatrics ( Site 0020) — Roy, Utah, United States
• University of Wisconsin American Family Children's Hospital ( Site 0023) — Madison, Wisconsin, United States
• Monash Children s Hospital ( Site 0093) — Clayton, Victoria, Australia
• Perth Children s Hospital ( Site 0092) — Nedlands, Australia
• Children, Youth and Woman's Health Service ( Site 0094) — North Adelaide, Australia
• Premier Health Research Center, LLC ( Site 0005) — Downey, California, United States

Full record on ClinicalTrials.gov

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