Safety and Immunogenicity of V116 in Adults With Increased Risk for Pneumococcal Disease (V116-008) (STRIDE-8)
Pneumococcal Infection
About this trial
This is an interventional prevention trial for Pneumococcal Infection
Eligibility Criteria
Inclusion Criteria: Has documented result(s) of ≥1 of the following risk conditions for pneumococcal disease: diabetes mellitus, receiving treatment with ≥1 approved antidiabetic medication, with all Hemoglobin A1c (HbA1c) measurements ≤9% within 6 months before first study vaccination; compensated chronic liver disease; diagnosis of chronic obstructive pulmonary disease (COPD) managed per local guidelines; diagnosis of mild or moderate persistent asthma managed per local guidelines; confirmed diagnosis of chronic heart disease managed per local guidelines; confirmed diagnosis of chronic kidney disease (>3 months duration). Is receiving stable medical management for the listed risk conditions for ≥3 months with no anticipated major change in treatment expected for the duration of the study and with ≤1 hospitalization directly related to the risk condition. Female Is not a participant of childbearing potential (POCBP); or if a POCBP Uses an acceptable contraceptive method or is abstinent from penile-vaginal intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis); their medical history, menstrual history, and recent sexual activity has been reviewed by the investigator. Exclusion Criteria: Has a history of active hepatitis. Has a history of diabetic ketoacidosis or 2 or more episodes of severe, symptomatic hypoglycemia within 3 months before first study vaccination (Day 1). Has a history of myocardial infarction, acute coronary syndrome, transient ischemic attack, or ischemic or hemorrhagic stroke within 3 months before first study vaccination (Day 1). Has a history of severe pulmonary hypertension with World Health Organization (WHO) functional class ≥3 or history of Eisenmenger syndrome Has a history of autoimmune related chronic kidney disease, chronic kidney failure, a reversible cause of kidney disease, nephrotic syndrome, or any ineligible Kidney Disease: Improving Global Outcomes (KDIGO)-recommended stage of glomerular filtration rate (GFR) and Albuminuria Has a history of invasive pneumococcal disease (IPD) (positive blood culture, positive cerebrospinal fluid culture, or positive culture at another sterile site) or known history of other culture-positive pneumococcal disease within 3 years before first study vaccination (Day 1). Has a known hypersensitivity to any component of V116, PCV15, or PPSV23, including diphtheria toxoid. Has a known or suspected impairment of immunological function including, but not limited to, congenital or acquired immunodeficiency, documented human immunodeficiency virus (HIV) infection, functional or anatomic asplenia, or autoimmune disease. Has a coagulation disorder contraindicating intramuscular (IM) vaccination. Had a recent febrile illness or received antibiotic therapy for any acute illness occurring within 72 hours before receipt of any study vaccine. Has a known malignancy that is progressing or has required active treatment <3 years before randomization. Has planned organ transplantation (heart, liver, lung, kidney, or pancreas) or other planned major surgical procedure during the duration of this study. Has expected survival for <1 year. Has received any prior pneumococcal vaccine or is expected to receive any pneumococcal vaccine during the study outside the protocol. Has received systemic corticosteroids (prednisone equivalent of ≥20 mg/day) for ≥14 consecutive days and has not completed intervention ≥14 days before receipt of study vaccine at Visit 2 (Day 1). Is currently receiving systemic immunosuppressive therapy, including chemotherapeutic agents or other immunotherapies/immunomodulators used to treat cancer or other conditions, and interventions associated with organ or bone marrow transplantation, or autoimmune disease. Has received any non-live vaccine ≤14 days before receipt of any study vaccine or is scheduled to receive any non-live vaccine ≤30 days after receipt of any study vaccine. Has received any live virus vaccine (including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) live virus vaccines) ≤30 days before receipt of any study vaccine or is scheduled to receive any live virus vaccine ≤30 days after receipt of any study vaccine Has received a blood transfusion or blood products, including immunoglobulin ≤6 months before receipt of any study vaccine or is scheduled to receive a blood transfusion or blood product ≤30 days after receipt of any study vaccine. Is receiving chronic home oxygen therapy.
Sites / Locations
- Aventiv Research ( Site 0022)
- Indago Research & Health Center, Inc ( Site 0002)
- Triple O Research Institute, P.A ( Site 0011)
- SKY Integrative Medical Center/SKYCRNG ( Site 0012)
- Mid Hudson Medical Research ( Site 0008)
- Holston Medical Group ( Site 0010)
- EmVenio Research ( Site 0018)
- Wenatchee Valley Hospital ( Site 0019)
- Holdsworth House Medical Practice ( Site 0402)
- Royal Brisbane and Women's Hospital ( Site 0400)
- G A Research Associates ( Site 0100)
- Hamilton Medical Research Group ( Site 0107)
- Milestone Research Inc. ( Site 0106)
- Manna Research Mirabel ( Site 0105)
- Clinique de médecine Urbaine du Quartier Latin ( Site 0111)
- Diex Recherche Trois-Rivieres ( Site 0110)
- Diex Recherche Victoriavile Inc. ( Site 0102)
- Hospital Dr. Hernán Henríquez Aravena ( Site 1001)
- Centro de Investigación del Maule-Centro de Investigación 2 ( Site 1010)
- Universidad San Sebastian - Providencia ( Site 1003)
- Centro de Investigaciones Medicas Respiratorias (CIMER) ( Site 1008)
- Centro de Investigacion Clinicadela Universidad Catolica ( Site 1004)
- Universidad de Chile - Hospital Clínico Universidad de Chile-Cardiology ( Site 1006)
- CESFAM Esmeralda ( Site 1009)
- Medical corporation Applied Bio-Pharmatech Kurume Clinical Pharmacology Clinic ( Site 0200)
- Shimonoseki Medical Center ( Site 0201)
- Hallym University Sacred Heart Hospital ( Site 0303)
- Korea University Anam Hospital ( Site 0305)
- Seoul National University Hospital ( Site 0300)
- Konkuk University Medical Center ( Site 0302)
- Hallym University Kangdong Sacred Heart Hospital ( Site 0301)
- Pacific Clinical Research Network - Rotorua ( Site 0500)
- P3 Research - Tauranga ( Site 0507)
- CGM Research Trust ( Site 0505)
- Pacific Clinical Research Network - Forte ( Site 0501)
- P3 Research - Lower Hutt ( Site 0508)
- P3 Research - Wellington ( Site 0503)
- IN VIVO ( Site 0601)
- Centrum Medyczne Pratia Bydgoszcz-Centrum Medyczne Pratia Bydgoszcz ( Site 0607)
- MICS Centrum Medyczne Torun ( Site 0606)
- Clinmedica Research Sp. z. o. o. ( Site 0603)
- Centrum Medyczne Medyk ( Site 0602)
- Centrum Medyczne Pratia Katowice ( Site 0604)
- Clinical Medical Research ( Site 0605)
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
V116
PCV15 + PPSV23
Participants will receive a single intramuscular (IM) dose of V116 on Day 1, and single IM dose of placebo for PCV15 + PPSV23 on Week 8
Participants will receive a single IM dose of PCV15 on Day 1, and a single IM dose of PPSV23 on Week 8.