Safety and Immunogenicity of V116 in Vaccine-naïve Japanese Older Adults (V116-009, STRIDE-9)
Pneumococcal Disease
About this trial
This is an interventional prevention trial for Pneumococcal Disease
Eligibility Criteria
Inclusion Criteria: Is Japanese For females, is not pregnant or breastfeeding and is either not a participant of childbearing potential (POCBP) or is a POCBP and uses acceptable contraception/abstinence; has a negative highly sensitive pregnancy test (urine or serum) within 24 (urine) or 72 (serum) hours before the first dose of study intervention; and has medical, menstrual, and recent sexual activity history reviewed by the investigator to decrease the chance of inclusion of an early undetected pregnancy Exclusion Criteria: 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 of Visit 1 (Day 1) Has a known hypersensitivity to any component of V116 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 IM vaccination Had a recent febrile illness (defined as oral or tympanic temperature ≥100.4°F [≥38.0°C] or axillary or temporal temperature ≥99.4°F [≥37.4°C]) or received antibiotic therapy for any acute illness occurring <72 hours before receipt of study vaccine Has a known malignancy that is progressing or has required active treatment <3 years before enrollment Received prior pneumococcal vaccine or is expected to receive any pneumococcal vaccine during the study outside the protocol 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 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 Received any nonlive vaccine ≤14 days before receipt of study vaccine or is scheduled to receive any nonlive vaccine ≤30 days after receipt of study vaccine (inactivated influenza and SARS-CoV2 vaccines may be acceptable) 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 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 postvaccination blood draw is complete
Sites / Locations
- Medical Corporation Heishinkai OPHAC Hospital ( Site 1008)
- Medical Corporation Heishinkai OCROM Clinic ( Site 1003)
- P-One Clinic ( Site 1001)
- Heishinkai Medical Group ToCROM Clinic ( Site 1004)
- Medical Corporation Shinanokai Shinanozaka Clinic ( Site 1006)
- Medical Corporation Houeikai Sekino Clinical Pharmacology Clinic ( Site 1005)
- PS Clinic ( Site 1002)
- Nishikumamoto Hospital ( Site 1007)
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
V116 Treatment
PPSV23 Treatment
Participants receive a single intramuscular (IM) injection of V116 on Day 1.
Participants receive a single IM injection of PPSV23 on Day 1.