A Study to Evaluate the Interchangeability of V114 and Prevnar 13™ in Healthy Infants (V114-027/PNEU-DIRECTION)

Completed · Phase 3

Conditions studied: Pneumococcal Infections

In brief

The goal of this study is to evaluate the safety, tolerability, and immunogenicity of the Pneumococcal Conjugate Vaccines (PCVs) V114 and Prevnar 13™ in healthy infants switched from Prevnar 13™ to V114 during the four-dose PCV immunization schedule.

Key facts

Study ID

NCT03620162

Run by

Merck Sharp & Dohme LLC

People needed

900

Starts

2018-10-18

Expected to finish

2020-12-14

Last updated by the study team

2023-01-17

Who can join

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

You may qualify if…

• Is 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.

You may not qualify if…

• Has a 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
• Has a 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
• Has any contraindication to the concomitant study vaccines being administered in the study
• Has a known or suspected impairment of immunological function
• Has a 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
• Has known or history of functional or anatomic asplenia
• Has failure to thrive based on the clinical judgment of the investigator
• Has a known coagulation disorder contraindicating intramuscular vaccination
• Has a 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)
• Has a known neurologic or cognitive behavioral disorder, including encephalitis/myelitis, acute disseminating encephalomyelitis, pervasive development disorder, and related disorders
• Has received a dose of any pneumococcal vaccine prior to study entry
• Has received >1 dose of monovalent hepatitis B vaccine or hepatitis B based combination vaccine prior to study entry
• Has received a dose of rotavirus vaccine prior to study entry
• Has received a blood transfusion or blood products, including immunoglobulins
• Has 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.

Where it is running

• Alabama Clinical Therapeutics ( Site 0015) — Birmingham, Alabama, United States
• Southeastern Pediatric Associates, P.A. ( Site 0002) — Dothan, Alabama, United States
• Children's Clinic of Jonesboro, PA ( Site 0022) — Jonesboro, Arkansas, United States
• Davita Medical Group ( Site 0012) — Colorado Springs, Colorado, United States
• Suncoast Research Associates, LLC ( Site 0035) — Miami, Florida, United States
• Kentucky Pediatric/Adult Research Inc ( Site 0011) — Bardstown, Kentucky, United States
• Pediatric Associates of Fall River ( Site 0021) — Fall River, Massachusetts, United States
• Midwest Children's Health Research Institute, LLC ( Site 0024) — Lincoln, Nebraska, United States
• Midwest Children's Health Research Institute, LLC ( Site 0003) — Lincoln, Nebraska, United States
• Midwest Children's Health Research Institute, LLC ( Site 0004) — Lincoln, Nebraska, United States
• Midwest Children's Health Research Institute, LLC ( Site 0001) — Lincoln, Nebraska, United States
• Summerwood Pediatrics ( Site 0009) — Liverpool, New York, United States
• University of Rochester Medical Center ( Site 0029) — Rochester, New York, United States
• SUNY Upstate Medical University ( Site 0008) — Syracuse, New York, United States
• Piedmont Healthcare, PA ( Site 0025) — Statesville, North Carolina, United States
• Coastal Pediatric Research ( Site 0006) — Charleston, South Carolina, United States
• Parkside Pediatric ( Site 0007) — Greenville, South Carolina, United States
• Holston Medical Group ( Site 0018) — Kingsport, Tennessee, United States
• Ventavia Research Group LLC ( Site 0017) — Fort Worth, Texas, United States
• University of Texas Medical Branch ( Site 0023) — Galveston, Texas, United States
• Wasatch Pediatrics-Cottonwood Office ( Site 0014) — Murray, Utah, United States
• Multicare ( Site 0019) — Spokane, Washington, United States
• Cooperativa de Facultad Medica Sanacoop ( Site 0057) — Bayamón, Puerto Rico
• Clinical Research of Puerto Rico ( Site 0050) — Guayama, Puerto Rico
• CAIMED Center - Ponce School of Medicine ( Site 0053) — Ponce, Puerto Rico

Full record on ClinicalTrials.gov

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