Pneumococcal disease MedDRA version: 20.0 Level: PT Classification code 10061353 Term: Pneumococcal infection System Organ Class: 10021881 - Infections and infestations
Conditions
Sponsors
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Is healthy (based on review of medical history and physical examination) based on the clinical judgement of the investigator. 2. Is male or female, approximately 3 months of age, from 70 days to 111 days inclusive, at the time of signing the informed consent. 3. 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. The legally acceptable representative may also provide consent for future biomedical research. However, the participant may participate in the main study without participating in future biomedical research. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Was born prior to 37 weeks of gestation. 2. Has a history of IPD (positive blood culture, positive cerebrospinal fluid culture, or other sterile site) or known history of other culture positive pneumococcal disease. 3. Has a known hypersensitivity to any component of the PCV, any component of the licensed pediatric vaccines to be administered concomitantly in the study, or any diphtheria toxoid containing vaccine. 4. Has any contraindication to the concomitant study vaccines being administered in the study (concomitant vaccine contraindication details provided in the Investigator Trial File Binder). 5. *Had a recent febrile illness (rectal temperature =38.1°C [=100.5°F] or axillary temperature =37.8°C [=100.0°F]) occurring within 72 hours prior to receipt of study vaccine. 6. Has a known or suspected impairment of immunological function. 7. Has a history of congenital or acquired immunodeficiency. 8. Has, or his/her mother has, a documented human immunodeficiency virus (HIV) infection. 9. Has, or his/her mother has, a documented hepatitis B surface antigen – positive test. 10. Has known or history of functional or anatomic asplenia. 11. Has failure to thrive based on the clinical judgement of the investigator. 12. Has a bleeding disorder contraindicating intramuscular vaccination. 13. 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). 14. Has a known neurologic or cognitive behavioral disorder, including encephalitis/myelitis, acute disseminating encephalomyelitis, pervasive development disorder, and related disorders. 15. Has received a dose of any pneumococcal vaccine prior to study entry. 16. Has received >1 dose of monovalent hepatitis B vaccine or hepatitis B-based combination vaccine prior to study entry. 17. Has received a dose of any acellular pertussis- or whole cell pertussis-based combination vaccines, Haemophilus influenzae type b conjugate vaccine, poliovirus vaccine, or any other combination thereof, prior to study entry. 18. *Meets one or more of the following systemic corticosteroid exclusion criteria: a. Has received systemic corticosteroids (equivalent of =2 mg/kg total daily dose of prednisone or =20 mg/day for persons weighing >10 kg) for =14 consecutive days and has not completed this course of treatment at least 30 days prior to the first dose of study vaccine at randomization. b. Has received or is expected to receive systemic corticosteroids within 14 days prior to any dose of study vaccine. c. Is expected to require systemic corticosteroids within 30 days after any study vaccination during conduct of the study. 19. *Has received other licensed non-live vaccines within 14 days before receipt of the first dose of study vaccines. 20. *Has received a licensed live vaccine within 30 days before receipt of the first dose of study vaccines. Exception: Rotavirus vaccine may be administered according to local guidelines. 21. Has received a blood transfusion or blood products, including immunoglobulins. 22. Has 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; these will be reviewed on a case-by-case basis for approval by the Sponsor. 2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To evaluate the safety and tolerability of V114 with respect to the proportion of participants with adverse events (AEs). 2. To compare the anti-pneumococcal polysaccharide (PnPs) serotype-specific immunoglobulin G (IgG) response rates (proportion of participants meeting serotype-specific IgG threshold value of =0.35 µg/mL) at 30 days following Dose 3 for participants administered V114 versus participants administered Prevenar 13™. 3. To compare anti-PnPs serotype-specific IgG geometric mean concentrations (GMCs) at 30 days following Dose 3 for participants administered V114 versus participants administered Prevenar 13™. ;Secondary Objective: 1. To compare the antigen-specific response rate to each antigen included in Vaxelis™ at 30 days following Dose 3 for participants administered V114 concomitantly with Vaxelis™ versus participants administered Prevenar 13™ concomitantly with Vaxelis™. 2. To evaluate the anti-PnPs serotype-specific IgG response rates and GMCs at 30 days following Dose 2 by each vaccination group. 3. To evaluate the anti-PnPs serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) and response rate at 30 days following Dose 3 by each vaccination group. ;Primary end point(s): 1. Percentage of Participants with a Solicited Injection-site Adverse Event 2. Percentage of Participants with a Solicited Systemic Adverse Event 3. Percentage of Participants with a Vaccine-related Serious Adverse Event 4. Percentage of Participants Meeting the Serotype specific Immunoglobulin (IgG) Threshold Value of =0.35 µg/mL for Each Serotype in V114 5. Geometric Mean Concentration (GMC) of Serotype-specific IgG for Each Serotype in V114 ;Timepoint(s) of evaluation of this end point: 1. Up to 14 days after any vaccination 2. Up to 14 days after any vaccination 3. Up to 6 months after Dose 3 (up to 194 days) 4. 30 days after Dose 3 5. 30 days after Dose 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Percentage of Participants Meeting the Antigen-specific Antibody Threshold Value for Each Antigen included in Vaxelis™ 2. Percentage of Participants Meeting the Serotype specific IgG Threshold Value of =0.35 µg/mL for Each Serotype in V114 3. GMC of Serotype-specific IgG for Each Serotype in V114 4. Percentage of Participants Meeting the Serotype-specific Opsonophagocytic Activity (OPA) Threshold Value for Each Serotype in V114 5. Geometric Mean Titer (GMT) of Serotype-specific OPA for Each Serotype in V114 ;Timepoint(s) of evaluation of this end point: 1. 30 days after Dose 3 2. 30 days after Dose 2 3. 30 days after Dose 2 4. 30 days after Dose 3 5. 30 days after Dose 3 | — |
Countries
Denmark, Finland, Italy, Norway, Sweden
Outcome results
None listed