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Research type
Research Study
Full title
A randomized, observer-blind, active-controlled Phase 3 study to investigate the safety, immunogenicity, and relative vaccine efficacy of mRNA-1283.222 administered as a booster dose compared with mRNA-1273.222 in participants aged 12 years and older for the prevention of COVID-19
IRAS ID
1007516
Contact name
Spyros Chalkias
Contact email
Sponsor organisation
ModernaTX, Inc.
Clinicaltrials.gov Identifier
Research summary
Coronaviruses are a large family of viruses that cause illness ranging from the common cold to more severe diseases, such as Middle East respiratory syndrome and severe acute respiratory syndrome. Coronaviruses are zoonotic, meaning they are transmitted between animals and people.
An outbreak of the coronavirus disease (COVID-19) caused by the 2019 novel coronavirus SARS-CoV-2 began in Wuhan, Hubei Province, China in December 2019 and has spread throughout China and to over 215 other countries, territories, and areas, including the United States.
ModernaTX, Inc. is using the same technology as the previously approved and authorized mRNA COVID-19 vaccines, to develop additional SARS-CoV-2 mRNA vaccines that may be as protective as the currently authorized vaccine but at a lower dose level. It is likely that mRNA-1283.222 (the study vaccine) may also be stored for a longer period at refrigerated temperatures than the approved mRNA-1273.222 vaccine.
Participants will be randomised in a 1:1 ratio to receive a single dose of mRNA-1283.222 at 10 micrograms or a single dose of the active comparator mRNA-1273.222 at 50 micrograms.
Participants will be in the study for approximately 13 months during which they will have to complete electronic questionnaires on a smartphone, have six in-clinic visits for safety check ups and have regular follow-up calls at scheduled timepoints.
About 8472 participants aged 12 years and older, will take part in this study. This study will be conducted across sites in United States, United Kingdom, and Canada.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
23/SC/0094
Date of REC Opinion
4 May 2023
REC opinion
Further Information Favourable Opinion