This study will evaluate the safety and immunogenicity of the mRNA-1273.214 vaccine for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variant of concerns (VOCs) in participants aged 6 months to \<6 years, when administered as a primary series in SARS-CoV-2 vaccine-naïve participants (Part 1) and a single booster dose (BD) given to participants who previously received 2 doses of the mRNA-1273 vaccine as a primary series (Part 2); and will evaluate the safety and immunogenicity of the mRNA-1273.815 vaccine, when administered as a BD in participants aged 6 months to \<6 years (Part 3) and when administered to SARS-CoV-2 vaccine-naïve participants aged 2 years to \<5 years of age (Part 4).
SARS-CoV-2
This study will evaluate the safety and immunogenicity of the mRNA-1273.214 vaccine for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variant of concerns (VOCs) in participants aged 6 months to \<6 years, when administered as a primary series in SARS-CoV-2 vaccine-naïve participants (Part 1) and a single booster dose (BD) given to participants who previously received 2 doses of the mRNA-1273 vaccine as a primary series (Part 2); and will evaluate the safety and immunogenicity of the mRNA-1273.815 vaccine, when administered as a BD in participants aged 6 months to \<6 years (Part 3) and when administered to SARS-CoV-2 vaccine-naïve participants aged 2 years to \<5 years of age (Part 4).
A Study to Evaluate the Safety and Immunogenicity of the mRNA COVID-19 Vaccines in Healthy Children Between 6 Months to Less Than 6 Years of Age
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Trinity Clinical Research, LLC, Bessemer, Alabama, United States, 34020
Velcocity Clinical Research, Banning, California, United States, 92220
Sera Collection Research Services, Montebello, California, United States, 90640
Center For Clinical Trials LLC -Paramount, Paramount, California, United States, 90723
University of Colorado, Aurora, Colorado, United States, 80045
Meridian Clinical Research, Washington, District of Columbia, United States, 20016
Prohealth Research Center, Doral, Florida, United States, 33166
University of Florida Jacksonville, Jacksonville, Florida, United States, 32209
Kissimmee Clinical Research, Kissimmee, Florida, United States, 34741
Med-Care Research, Miami, Florida, United States, 33125
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
6 Months to 5 Years
ALL
Yes
ModernaTX, Inc.,
2025-10-27