At a glance
ClinicalIndex Comparison Record- ✓Has underlying chronic conditions but assessed to be stable as per investigator
- ✓Has ability to complete electronic Vaccine Report Card (eVRC) data collection without assistance as per investigator
- ✕History of invasive pneumococcal disease (IPD) or other culture-positive pneumococcal disease ≤3 years before Visit 1
- ✕Known or suspected congenital immunodeficiency, functional or anatomic asplenia, or history of autoimmune disease
- ✕Coagulation disorder contraindicating intramuscular vaccination
- ✕Recent illness with fever
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3 Randomized, Double-blind, Active Comparator-controlled, Lot-to-Lot Consistency Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Adults 18 to 49 Years of Age
In Brief
A Phase 3 clinical trial evaluating V116 and PPSV23 for Pneumococcal Disease. Completed, enrolled 2,162 participants across 72 sites in 8 countries.
Detailed Summary
This study will evaluate the safety, tolerability, and immunogenicity of a pneumococcal 21-valent conjugate vaccine (V116) in pneumococcal vaccine-naïve adults 18 to 49 years of age. The primary study hypothesis is that all 3 lots of V116 are equivalent as assessed by the serotype-specific opsonophagocytic activity (OPA) Geometric Mean Titers (GMTs) at 30 days postvaccination for all serotypes included in V116.
Study Details
Timeline
Interventions
Pneumococcal 21-valent conjugate vaccine with 4 μg of each of the following pneumococcal polysaccharides (PnPs) antigen: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B in each 0.5 mL sterile solution
Pneumococcal 23-valent conjugate vaccine with 25 μg of each of the following PnPs antigen: 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F in each 0.5 mL sterile solution