A Phase 3, Multicenter, Randomized, Double-blind, Active Comparator-controlled Study to Evaluate the Safety and Tolerability of V114 in Healthy Infants (PNEU-LINK)

V114-031

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™.

2018-12-14

2021-03-26

2021-03-26

Completed

Early phase I

2409

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.

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2023-07-28