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

JRCT ID: jRCT2031220551

Registered date:29/12/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Pneumococcal infection prevention
• Date of first enrollment: 10/01/2023
• Target sample size: 440
• Study type: Interventional
• Intervention(s): Pneumococcal 21-valent conjugate vaccine 0.5mL in V116 group or Pneumococcal Vaccine in PPSV23 group, Polyvalent (23-valent) 0.5 mL (PPSV23) will be administered as single IM injection.

Outcome(s)

• Primary Outcome: Serotype-specific OPA responses, Solicited AEs and vaccine related SAEs
• Secondary Outcome: Serotype-specific OPA and IgG responses

Key inclusion & exclusion criteria

• Age minimum: >= 65age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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.

Related Information

• Primary Sponsor: Tanaka Yoshiyuki
• Secondary ID(s): NCT05633992