A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-experienced Adults (V116-006, STRIDE-6)
Pneumonia, Pneumococcal
About this trial
This is an interventional prevention trial for Pneumonia, Pneumococcal
Eligibility Criteria
Inclusion Criteria:
- Has received pneumococcal vaccine >= 1 year before enrollment (PCV13, PCV15, PCV20, PPSV23, PCV13+PPSV23, PPSV23+PCV13, or PCV15+PPSV23).
Exclusion Criteria:
- Has a history of invasive pneumococcal disease (IPD).
- Has a known hypersensitivity to any component of V116, PCV15, PCV20, or PPSV23, including diphtheria toxoid.
- Has a known or suspected impairment of immunological function including, but not limited to, a history of congenital or acquired immunodeficiency, documented human immunodeficiency virus (HIV) infection, functional or anatomic asplenia, or history of autoimmune disease.
- Has a coagulation disorder contraindicating intramuscular vaccination.
- Has a known malignancy that is progressing or has required active treatment.
- Has received PPSV23 followed by either PCV15 or PCV20.
- Received systemic corticosteroids (prednisone equivalent of ≥20 mg/day).
- Is currently receiving 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 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 ≤30 days before receipt of study vaccine or is scheduled to receive any live virus vaccine ≤30 days after receipt of study vaccine.
- Has received a blood transfusion or blood products, including immunoglobulin ≤6 months before receipt of study vaccine or is scheduled to receive a blood transfusion or blood product until the Day 30 post-vaccination blood draw is complete.
Sites / Locations
- Central Research Associates ( Site 0024)
- Lenzmeier Family Medicine/CCT Research ( Site 0008)
- Fiel Family and Sports Medicine, PC/CCT Research ( Site 0006)
- Southland Clinical Research Center ( Site 0026)
- Diablo Clinical Research, Inc. ( Site 0019)
- Alliance for Multispecialty Research, LLC ( Site 0020)
- Indago Research & Health Center, Inc ( Site 0005)
- Advanced Medical Research Institute ( Site 0018)
- Solaris Clinical Research ( Site 0025)
- Centennial Medical Group ( Site 0002)
- Arcturus Healthcare , PLC, Troy Internal Medicine Research Division ( Site 0016)
- Meridian Clinical Research, LLC ( Site 0009)
- Advanced Medical Research ( Site 0001)
- University of Texas Medical Branch-Sealy Institute for Vaccine Sciences Clinical Trials Program ( Si
- Health Research of Hampton Roads, Inc. ( Site 0003)
- Hamilton Medical Research Group ( Site 0114)
- Milestone Research Inc. ( Site 0104)
- Manna Research Mirabel ( Site 0109)
- CHU de Québec-Université Laval-Équipe de recherche en vaccination ( Site 0120)
- Diex Recherche Sherbrooke Inc. ( Site 0101)
- CHU Bordeaux Haut-Leveque ( Site 0202)
- CHRU de Brest ( Site 0200)
- centre hospitalier lyon sud ( Site 0204)
- Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 0203)
- Rambam Health Care Campus ( Site 0303)
- Maccabi Health Services - Holon ( Site 0305)
- Maccabi Healthcare Services ( Site 0306)
- Hadassah Medical Center-Clinical Reaserch Unit ( Site 0300)
- Meir Medical Center ( Site 0301)
- Sheba Medical Center-Early Phase Clinical Trials Unit ( Site 0304)
- Clalit Health Services - Sakhnin Community Clinic-Research Unit ( Site 0302)
- Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico ( Site 0400)
- Ospedale San Raffaele ( Site 0403)
- A.O.U. Policlinico Paolo Giaccone ( Site 0402)
- Azienda Ospedaliero Universitaria Policlinico Riuniti di Foggia ( Site 0405)
- PS Clinic ( Site 0700)
- Nishikumamoto Hospital ( Site 0701)
- Gachon University Gil Medical Center ( Site 0755)
- Korea University Ansan Hospital ( Site 0751)
- The Catholic University of Korea, Eunpyeong St. Mary's Hospital ( Site 0752)
- The Catholic Univ. of Korea Seoul St. Mary's Hospital ( Site 0753)
- Hallym University Kangnam Sacred Heart Hospital-Internal Medicine ( Site 0754)
- Korea University Guro Hospital ( Site 0750)
- HOSPITAL CLÍNIC DE BARCELONA-Medicina Preventiva i Epidemiologia ( Site 0503)
- EBA CENTELLES ( Site 0500)
- Hospital Universitari de Bellvitge ( Site 0505)
- HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-Respiratory ( Site 0508)
- Hospital Internacional Xanit ( Site 0520)
- Hospital La Princesa ( Site 0515)
- National Cheng Kung University Hospital ( Site 0801)
- National Taiwan University Hospital ( Site 0800)
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Active Comparator
Experimental
Active Comparator
Experimental
Cohort 1: V116
Cohort 1: PCV15
Cohort 2: V116
Cohort 2: PPSV23
Cohort 3: V116
Participants will receive a single 0.5 mL intramuscular (IM) injection of V116 on Day 1. Participants in this arm received PPSV23 prior to the enrollment.
Participants will receive a single 0.5 mL IM injection of PCV15 on Day 1. Participants in this arm received PPSV23 prior to the enrollment.
Participants will receive a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV13 prior to the enrollment.
Participants will receive a single 0.5 mL IM injection of PPSV23 on Day 1. Participants in this arm received PCV13 prior to the enrollment.
Participants will receive a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV15, PCV20, PCV13+PPSV23, PCV15+PPSV23, or PPSV23+PCV13 prior to the enrollment.