Study of mRNA Vaccine Formulation Against COVID-19 in Healthy Adults 18 Years of Age and Older

Summary

The primary objectives of the study are: * To describe the safety profile of all participants in each age group and each study intervention group up to 12 months post-last dose. * To describe the neutralizing antibody profile at Day 1, Day 22, and Day 36 of each study intervention group. The secondary objectives of the study are: * To describe binding antibody profile from Day 1 to Day 387 of each study intervention group. * To describe the neutralizing antibody profile from Day 91 to Day 387 of each study intervention group. * To describe the occurrence of virologically-confirmed coronavirus disease-2019 (COVID-19)-like illness and serologically-confirmed SARS-CoV-2 infection. * To evaluate the correlation/association between antibody responses to SARS-CoV-2 messenger RNA (mRNA) vaccine and the risk of virologically-confirmed COVID-19-like illness and/or serologically-confirmed severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection.

Timeline

Start

2021-03-12

Primary completion

2022-06-27

Completion

2022-06-27

Outcome

Outcome not reported

Stopped: “Sponsor's decision not to pursue further development of this product given the wide availability of authorized/approved mRNA COVID-19 vaccines”

Drugs

Indications