NCT05158140

Safety, Tolerability, and Immunogenicity of V110 or V114 Co-administered With a Booster Dose of mRNA-1273 in Healthy Adults (V110-911)

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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 850 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pneumococcal Infection

Interventions

Type	Name	Description
BIOLOGICAL	V110	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
BIOLOGICAL	V114	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
BIOLOGICAL	mRNA-1273	Single IM dose of 50 μg/0.25 mL mRNA-1273
BIOLOGICAL	Placebo for V110	Single IM dose of 0.5 mL placebo for V110
BIOLOGICAL	Placebo for V114	Single IM dose of 0.5 mL placebo for V114

Timeline

• Start date: 2022-01-12
• Primary completion: 2023-02-21
• Completion: 2023-02-21
• First posted: 2021-12-15
• Last updated: 2025-07-18
• Results posted: 2024-02-13

Locations

46 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated drug study