Safety and immunogenicity of V116 in vaccine-naive Japanese older adults

Phase 3

• Conditions: Pneumococcal infection prevention

• Registration Number: JPRN-jRCT2031220551
• Lead Sponsor: Tanaka Yoshiyuki

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-12-29
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 440

Inclusion Criteria

Is Japanese
- For females, is not pregnant or breastfeeding and iseither not a participant of childbearing potential (POCBP)or is a POCBP and uses acceptablecontraception/abstinence; has a negative highly sensitivepregnancy 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 activityhistory reviewed by the investigator to decrease thechance of inclusion of an early undetected pregnancy

Exclusion Criteria

- Has a history of invasive pneumococcal disease (IPD)[positive blood culture, positive cerebrospinal fluidculture, or positive culture at another sterile site] or known history of other culture-positive pneumococcaldisease 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 ofautoimmune disease
- Has a coagulation disorder contraindicating IMvaccination
- Had a recent febrile illness (defined as oral ortympanic temperature >=100.4 F [>=38.0 C] or axillary ortemporal temperature >=99.4 F [>=37.4 C]) or receivedantibiotic therapy for any acute illness occurring <72hours before receipt of study vaccine
- Has a known malignancy that is progressing or hasrequired active treatment <3 years before enrollment
- Received prior pneumococcal vaccine or is expectedto receive any pneumococcal vaccine during the studyoutside the protocol
- Received systemic corticosteroids (prednisoneequivalent of >=20 mg/day) for >=14 consecutive days andhas not completed intervention >=14 days before receiptof study vaccine
- Is currently receiving immunosuppressive therapy,including chemotherapeutic agents or otherimmunotherapies/immunomodulators used to treatcancer or other conditions, and interventions associatedwith organ or bone marrow transplantation, orautoimmune disease
- Received any nonlive vaccine <=14 days before receiptof study vaccine or is scheduled to receive any nonlivevaccine <=30 days after receipt of study vaccine(inactivated influenza and SARS-CoV2 vaccines may be acceptable)
- Received any live virus vaccine <=30 days beforereceipt of study vaccine or is scheduled to receive anylive virus vaccine <=30 days after receipt of study vaccine
- Received a blood transfusion or blood products,including immunoglobulin <=6 months before receipt ofstudy vaccine or is scheduled to receive a bloodtransfusion or blood product until the Day 30postvaccination blood draw is complete.

Study & Design

• Study Type: Interventional
• Study Design: Not specified