A Study to Evaluate the Safety and Tolerability of V114 and Prevnar 13™ in Healthy Infants (V114-031/PNEU-LINK)
Purpose
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™.
Condition
- Pneumococcal Infections
Eligibility
- Eligible Ages
- Between 42 Days and 90 Days
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
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.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Care Provider, Investigator)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental V114 |
Participants will receive a single 0.5 mL intramuscular (IM) injection of V114 at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4). |
|
Active Comparator Prevnar 13™ |
Participants will receive a single 0.5 mL IM injection of Prevnar 13™ at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4). |
|
More Details
- Status
- Completed
- Sponsor
- Merck Sharp & Dohme LLC