A Study to Evaluate the Safety and Tolerability of V114 and Prevnar 13™ in Healthy Infants (V114-031/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™.
- Pneumococcal Infections
- Eligible Ages
- Between 42 Days and 90 Days
- Eligible Genders
- Accepts Healthy Volunteers
- 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.
- 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.
- Phase 3
- Study Type
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Triple (Participant, Care Provider, Investigator)
|Participants will receive a single 0.5 mL intramuscular (IM) injection of double-blind V114 at approximately 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13). Nonstudy pediatric vaccines are permitted and should be administered according to the local recommended schedule.||
|Participants will receive a single 0.5 mL IM injection of double-blind Prevnar 13™ at approximately 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13). Nonstudy pediatric vaccines are permitted and should be administered according to the local recommended schedule.||
- Active, not recruiting
- Merck Sharp & Dohme Corp.