V116-010

To evaluate the safety and tolerability of V116 as assessed by the proportion of participants with adverse events (AEs)

To compare the serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) at 30 days postvaccination with V116 versus PPSV23

To compare the proportions of participants with a ≥4-fold rise in serotype-specific OPA responses from baseline to 30 days postvaccination with V116 versus PPSV23 for the unique serotypes in V116

To evaluate serotype-specific cross-reactive OPA responses from baseline to 30 days postvaccination with V116 for serotypes within a serogroup.

To evaluate the serotype-specific immunoglobulin G (IgG) geometric mean concentrations (GMCs) at 30 days postvaccination with V116 compared with PPSV23.

To evaluate the serotype-specific geometric mean fold rise (GMFR) and proportions of participants with a ≥4-fold rise in serotype-specific OPA and IgG responses from baseline to 30 days postvaccination with V116 and separately for PPSV23.

• The participant may have underlying chronic conditions if they are assessed to be stable as per the investigator’s judgment.
• Is an individual of any sex/gender, ≥50 years of age, at the time of informed consent.
• Female Participants
  • A participant assigned female sex at birth is eligible to participate if not pregnant or breastfeeding, and at least one of the following conditions applies:
    • Not a POCBP
  • OR
    • A POCBP and:
      • 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), for at least 6 weeks after the last dose of study intervention.
      • Has a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within 24 hours before the first dose of study intervention.
      • Medical history, menstrual history, and recent sexual activity has been reviewed by the investigator to decrease the risk for inclusion of a POCBP with an early undetected pregnancy.
• The participant has the ability to complete eVRC data collection without assistance based on judgment of the investigator.

• Has a history of 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 HIV infection, functional or anatomic asplenia, or history of autoimmune disease (including, but not limited to, the autoimmune conditions outlined in the Investigator Trial File Binder for this study).
• 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
• Has a known malignancy that is progressing or has required active treatment
• Received any 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. Note: Physiologic replacement doses (prednisone equivalent of approximately 5 mg/day), topical, ophthalmic, intraarticular or soft-tissue (eg, bursa, tendon steroid injections), and inhaled/nebulized steroids are permitted.
• 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. Exception: Inactivated influenza vaccine and SARS-CoV-2 mRNA or SARS-CoV-2 protein subunit vaccine may be administered but must be given ≥7 days before or ≥15 days after receipt of study vaccine.
• 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. Autologous blood transfusions are not considered an exclusion criterion.
• Is currently participating in or has participated in an interventional clinical study with an investigational compound or device within 2 months of participating in this current study.