A Phase 3 Randomized, Double-blind, Placebo-Controlled Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 When Administered Concomitantly With Influenza Vaccine in Adults 50 Years of Age or Older

V116-005

This a study of V116 in adults ≥50 years of age who concomitantly received Influenza vaccine. The primary objectives of this study are to evaluate the safety, tolerability, and immunogenicity of V116 when administered concomitantly with Quadrivalent Influenza vaccine (QIV) compared with V116 administered sequentially with QIV. The primary hypotheses state that immune responses to V116 and to QIV are non-inferior when administered concomitantly as compared with sequential administration as measured by serotype-specific opsonophagocytic activity (OPA) and hemagglutination inhibition (HAI) geometric mean titers (GMTs) at 30 days postvaccination.

2022-09-23

2023-06-21

2023-06-21

Completed

Early phase I

1080

Inclusion Criteria: * Females: Not pregnant or a breast feeding and not a woman of childbearing potential (WOCBP) or a WOCBP agrees to use contraception or remain abstinent 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 * Has a known hypersensitivity to any component of V116 or any influenza vaccine, 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 intramuscular vaccination * Has a known malignancy that is progressing or has required active treatment \<3 years before enrollment * Is expected to receive any pneumococcal vaccine during the study outside of the protocol * Received any pneumococcal vaccine \<12 months prior to enrollment (including pneumococcal 13-valent conjugate vaccine \[PCV13\] followed by pneumococcal 23-valent polysaccharide vaccine \[PPSV23\] and PPSV23 followed by PCV13) * Had prior administration of PCV15 or PCV20 * Received any influenza vaccine \<6 months prior to enrollment or is expected to receive any influenza vaccine during the study outside of 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 * 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 before the Day 30 postvaccination blood draw is complete * 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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 1080, 'type': 'ACTUAL'}}

2023-06-27