At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of the Concomitant Administration of Either 23-Valent Pneumococcal Polysaccharide Vaccine or 15-Valent Pneumococcal Conjugate Vaccine With a Booster Dose of SARS-CoV-2 mRNA Vaccine in Healthy Adults 50 Years of Age or Older.
In Brief
A Phase 3 clinical trial evaluating V110, V114, and 3 other interventions for Pneumococcal Infection. Completed, enrolled 850 participants across 46 sites in 2 countries.
Detailed Summary
The purpose of this study is to evaluate the concomitant and non-concomitant use of messenger ribonucleic acid (mRNA) mRNA-1273, the nucleoside-modified mRNA vaccine for active immunization to prevent coronavirus disease (COVID-19) caused by severe acute respiratory syndrome coronavirus (SARS-CoV-2), with a 23-valent pneumococcal polysaccharide vaccine (V110) for the prevention of pneumococcal disease, or a 15-valent pneumococcal conjugate vaccine (V114) indicated for the prevention of invasive pneumococcal disease.
Study Details
Timeline
Interventions
Single intramuscular (IM) dose of 0.5 mL V110, a pneumococcal polysaccharide vaccine (PCV), containing the 23 serotypes: 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F
Single IM dose of 0.5 mL V114 a 15-valent PCV containing the 15 serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F
Single IM dose of 50 μg/0.25 mL mRNA-1273
Single IM dose of 0.5 mL placebo for V110
Single IM dose of 0.5 mL placebo for V114