A Study to Evaluate the Interchangeability of V114 and Prevnar 13™ in Healthy Infants (V114-027/PNEU-DIRECTION)
Purpose
This study is designed to evaluate the safety, tolerability, and immunogenicity of V114 and Prevnar 13™ in healthy infants switched from Prevnar 13™ to V114 during the Pneumococcal Conjugate Vaccine (PCV) immunization schedule.
Condition
- Pneumococcal Infections
Eligibility
- Eligible Ages
- Between 42 Days and 90 Days
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- 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
- 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
- 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
- Any contraindication to the concomitant study vaccines being administered in the study
- 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
- Has or his/her mother has a documented hepatitis B surface antigen - positive test
- 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 >1 dose of monovalent hepatitis B vaccine or hepatitis B based combination vaccine prior to study entry
- Received a dose of rotavirus vaccine prior to study entry
- Received a blood transfusion or blood products, including immunoglobulins
- 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.
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 |
---|---|---|
Active Comparator Group 1: Prevnar 13™ |
Participants will receive a single 0.5 mL intramuscular (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). Other licensed pediatric vaccines will be administered open-label concomitantly with the study vaccines according to the recommended schedule: RotaTeq™, Pentacel™, and Recombivax HB™ at approximately 2, 4, and 6 months of age (Study Day 1, Month 2, and Month 4), and Hiberix™, M-M-R™ II, and Varivax™ at approximately 12-15 months of age (Study Month 10-13). |
|
Experimental Group 2: Prevnar 13™ Switch to V114 at Dose 4 |
Participants will receive a single 0.5 mL IM injection of double-blind Prevnar 13™ at approximately 2, 4, and 6 months of age (Study Day 1, Month 2, and Month 4) and double-blind V114 at approximately 12-15 months of age (Study Month 10-13). Other licensed pediatric vaccines will be administered open-label concomitantly with the study vaccines according to the recommended schedule: RotaTeq™, Pentacel™, and Recombivax HB™ at approximately 2, 4, and 6 months of age (Study Day 1, Month 2, and Month 4), and Hiberix™, M-M-R™ II, and Varivax™ at approximately 12-15 months of age (Study Month 10-13). |
|
Experimental Group 3: Prevnar 13™ Switch to V114 at Dose 3 |
Participants will receive a single 0.5 mL IM injection of double-blind Prevnar 13™ at approximately 2 and 4 months of age (Study Day 1 and Month 2) and double-blind V114 at approximately 6 and 12-15 months of age (Study Month 4 and 10-13). Other licensed pediatric vaccines will be administered open-label concomitantly with the study vaccines according to the recommended schedule: RotaTeq™, Pentacel™, and Recombivax HB™ at approximately 2, 4, and 6 months of age (Study Day 1, Month 2, and Month 4), and Hiberix™, M-M-R™ II, and Varivax™ at approximately 12-15 months of age (Study Month 10-13). |
|
Experimental Group 4: Prevnar 13™ Switch to V114 at Dose 2 |
Participants will receive a single 0.5 mL IM injection of double-blind Prevnar 13™ at approximately 2 months of age (Study Day 1) and double-blind V114 at approximately 4, 6 and 12-15 months of age (Study Month 2, 4 and 10-13). Other licensed pediatric vaccines will be administered open-label concomitantly with the study vaccines according to the recommended schedule: RotaTeq™, Pentacel™, and Recombivax HB™ at approximately 2, 4, and 6 months of age (Study Day 1, Month 2, and Month 4), and Hiberix™, M-M-R™ II, and Varivax™ at approximately 12-15 months of age (Study Month 10-13). |
|
Experimental Group 5: V114 |
Participants will receive a single 0.5 mL 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). Other licensed pediatric vaccines will be administered open-label concomitantly with the study vaccines according to the recommended schedule: RotaTeq™, Pentacel™, and Recombivax HB™ at approximately 2, 4, and 6 months of age (Study Day 1, Month 2, and Month 4), and Hiberix™, M-M-R™ II, and Varivax™ at approximately 12-15 months of age (Study Month 10-13). |
|
Recruiting Locations
University of Texas Medical Branch ( Site 0023)
Galveston, Texas 77555
Galveston, Texas 77555
Contact:
Study Coordinator
409-795-8874
Study Coordinator
409-795-8874
More Details
- NCT ID
- NCT03620162
- Status
- Recruiting
- Sponsor
- Merck Sharp & Dohme Corp.