A Phase 3, Multicenter, Randomized, Double-blind Study to Evaluate the Interchangeability of V114 and Prevnar 13™ With Respect to Safety, Tolerability, and Immunogenicity in Healthy Infants (PNEU-DIRECTION)

V114-027

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.

2018-10-18

2020-12-14

2020-12-14

Completed

Early phase I

900

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 900, 'type': 'ACTUAL'}}

2023-01-17