Safety and Immunogenicity of V116 in Adults 50 Years of Age or Older

Phase 1

• Conditions: Pneumococcal disease; MedDRA version: 20.0Level: LLTClassification code: 10035644Term: Pneumococcal infection NOS Class: 10021881; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: CTIS2022-503144-40-00
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-14
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1445

Inclusion Criteria

For females, is not pregnant or breastfeeding and is either not a woman of childbearing potential (WOCBP) or is a WOCBP and uses acceptable contraception/abstinence; 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), 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, 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified