Phase 3b4 Open-label Study on the Safety and Immune Response of mRNA COVID-19 Variant Vaccines including mRNA-1273.167, mRNA-1273.712, mRNA-1273.251, and mRNA-1273.261

What this Trial Is About

Researchers are evaluating the immune response and safety of different mRNA COVID-19 vaccines that include formulations targeting various virus variants, including newly emerged types of SARS-CoV-2. This study follows a flexible master protocol that allows testing of different vaccine versions and age groups, with specific details outlined in subprotocols for each variant formulation. Participants will receive one or more intramuscular injections of one of the mRNA-1273 variant-containing vaccines, including mRNA-1273.167, mRNA-1273.712, mRNA-1273.251, or mRNA-1273.261. Each vaccine formulation is studied separately under subprotocols, and doses are administered according to the study schedule. The study is open-label and designed to assess multiple vaccine variants within the same framework. During the study, participants will undergo assessments of their immune response by measuring neutralizing antibodies against COVID-19 variants up to 29 days after vaccination. Safety will be monitored through recording adverse events, including serious events and reactions, for up to 209 days following the last dose. Participants will have visits and evaluations to track immune response, side effects, and overall health throughout the study period. Total participation duration varies with each vaccine formulation and age group under study.

A Study to Investigate the Immunogenicity and Safety of mRNA COVID-19 Variant-containing Vaccine Formulations