Prevention of 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.Be healthy (based on medical history and physical examination) male or female infant approximately 2 months of age (42 days to 90 days), inclusive 2.Have a parent/legal guardian who understands the trial procedures, alternate treatments available, and risks involved with the trial. 3.Have a parent/legal guardian who is able to read, understand, and complete the VRC and voluntarily agree to participate by giving written informed consent. 4.A parent/legal guardian also acknowledges that they: a) will attend all scheduled visits b) comply with the trial procedures, and c) have access to a telephone. Are the trial subjects under 18? yes Number of subjects for this age range: 1050 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: If the subject meets criteria marked with an asterisk (*), the Day 1 Visit may be rescheduled for a time when these criteria are not met. 1.Had prior administration of any pneumococcal vaccine 2.Has a known hypersensitivity to any component of the pneumococcal conjugate vaccine, or any diphtheria toxoid-containing vaccine 3.* 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 trial vaccine 4.Has a known or suspected impairment of immunological function 5. Has a history of congenital or acquired immunodeficiency (e.g. splenomegaly) 6.Has or his/her mother has a documented human immunodeficiency virus (HIV) infection 7.Has or his/her mother has a documented hepatitis B surface antigen – positive test 8.Has known or history of functional or anatomic asplenia 9.Has a history of failure to thrive 10.Has known or history of a coagulation disorder contraindicating intramuscular vaccination 11.Has a history of autoimmune disease including systemic lupus erythematosus, antiphospholipid syndrome, Behcet's disease, autoimmune thyroid disease, polymyositis and dermatomyositis, scleroderma, type 1 diabetes mellitus, and other autoimmune disorders 12.Has a known neurologic or cognitive behavioral disorder, including encephalitis/myelitis, acute disseminating encephalomyelitis, pervasive development disorder, and related disorders 13.*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/d for persons weighing > 10 kg) for = 14 consecutive days and has not completed this course of treatment at least 30 days prior to trial randomization b)Has received systemic corticosteroids within 14 days prior to the first dose of vaccine at randomization c) Is expected to require systemic corticosteroids within 30 days after each vaccination during conduct of the trial 14.*Has received other licensed non-live vaccines within the 14 days before receipt of first dose of trial vaccine 15.*Has received a licensed live virus vaccine within the 30 days prior to receipt of first dose of trial vaccine 16.Had prior receipt of a blood transfusion or blood products, including immunoglobulins 17.Has participated in another clinical trial of an investigational product before the beginning or anytime during the duration of the current clinical trial. Subjects enrolled in observational studies may be included; these will be reviewed on a caseby- case basis for approval by the SPONSOR 18.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 19.Cannot be adequately followed for safety according to the protocol plan 20.Has a parent/legal guardian who is unlikely to adhere to trial procedures, keep appointments, or is planning to relocate during the trial 21.Has any other reason that in the opinion of the investigator may interfere with the e
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To evaluate the serotype-specific IgG GMCs of V114-1, V114-2, and Prevnar 13™, and the IgG GMC ratios between each of the two V114 lots and Prevnar 13™ for all 15 serotypes included in V114 at pre-dose 4 and 1 month postdose 4 (PD4).;Timepoint(s) of evaluation of this end point: Approximately 1 month post dose 3, For purposes of analysis and reporting, the overall trial ends when the Sponsor receives the last serological results; Main Objective: In healthy infants receiving one of the 2 V114 lots or Prevnar 13™ at approximately 2, 4, 6, and 12-15 months of age: 1.To describe the safety and tolerability profiles of 2 different lots of V114 [Lot 1 (V114-1), Lot 2 (V114-2)], after each dose 2.To demonstrate that V114 (either V114-1 or V114-2) is non-inferior to Prevnar 13™ for the 13 shared serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F), based on the proportion of subjects meeting serotype-specific immunoglobulin G (IgG) threshold value of =0.35 µg/mL at 1 month post-dose 3 (PD3) 3.To evaluate the serotype-specific IgG geometric mean concentrations (GMCs) of V114-1, V114-2, and Prevnar 13™, and the IgG GMC ratios between each of the two V114 lots and Prevnar 13™ for all 15 serotypes included in V114 (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F) at 1 month PD3. ; Primary end point(s): 1. The proportion of subjects meeting serotype-specific IgG =0.35 µg/mL for the 13 serotypes shared with Prevnar 13™ measured by the Pn ECL assay at 1 month post-dose 3 2. The serotype-specific IgG GMC for all 15 serotypes included in V114 measured by the Pn ECL assay at 1 month post-dose 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The serotype-specific IgG GMC for all 15 serotypes included in V114 measured by the Pn ECL assay at pre-dose 4 and 1 month post-dose 4.;Timepoint(s) of evaluation of this end point: pre-dose 4, and approximately 1 month post-dose 4 | — |
Countries
Canada, Denmark, Finland, Israel, Spain, United States
Contacts
Public ContactGlobal Clinical Trials Operations
Merck Sharp & Dohme Corp., a subsidiary of Merck
Outcome results
None listed