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).
Part 1 will enroll participants aged 6 months to \<6 years who have not been previously vaccinated against SARS-CoV-2. Participants will receive 2 doses of the mRNA-1273.214 vaccine. Part 2 will enroll participants aged 6 months to \<6 years who have previously been vaccinated with a mRNA-1273 primary series in Study mRNA-1273-P204 (NCT04796896). Participants will receive a single BD of the mRNA-1273.214 vaccine, at least 4 months after completion of the mRNA-1273 primary series. Part 3 will enroll participants aged 6 months to \<6 years who have previously been vaccinated with an authorized/approved COVID-19 vaccine. Participants will receive a BD of the mRNA-1273.815 vaccine at least 4 months after the last receipt of a COVID-19 vaccine. Part 4 will evaluate mRNA-1273.815 vaccine administered as a single dose to SARS-CoV-2 vaccine-naïve participants aged 2 years to \<5 years of age enrolled in Cohort A (Part 4A), compared to 2 doses given to SARS-CoV-2 vaccine-naïve participants aged 6 months to \<2 years enrolled in Cohort B (Part 4B).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
1,807
Sterile liquid for injection
Sterile liquid for injection
Trinity Clinical Research, LLC
Bessemer, Alabama, United States
Velcocity Clinical Research
Banning, California, United States
Sera Collection Research Services
Montebello, California, United States
Center For Clinical Trials LLC -Paramount
Paramount, California, United States
University of Colorado
Aurora, Colorado, United States
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Time frame: Up to Day 8 (7 days post-vaccination)
Number of Participants with Unsolicited Adverse Events (AEs)
Time frame: Up to Day 29 (28 days after each injection)
Number of Participants with Medically-Attended AEs (MAAEs)
Time frame: Up to Day 394 (12 months after last dose)
Number of Participants with Serious AEs (SAEs)
Time frame: Up to Day 394 (12 months after last dose)
Number of Participants with Adverse Events of Special Interest (AESI)
Time frame: Up to Day 394 (12 months after last dose)
Number of Participants with AEs Leading to Withdrawal
Time frame: Up to Day 394 (12 months after last dose)
Geometric Mean (GM) of the Serum Antibody (Ab) Level against Omicron BA.1 and Ancestral SARS-CoV-2 after mRNA-1273.214 Administration at Day 57
Time frame: Day 57
GM of the Serum Ab Level against Omicron BA.1 and Ancestral SARS-CoV-2 after mRNA-1273.214 Administration at Day 29
Time frame: Day 29
Seroresponse Rate (SRR) against Omicron BA.1 and Ancestral SARS-CoV-2 after mRNA-1273.214 Administration
Time frame: Day 29
GM of the Serum Ab Level against Omicron XBB.1.5 after mRNA-1273.815 Administration
Time frame: Up to Day 57
SRR against Omicron BA.1 and Ancestral SARS-CoV-2 after mRNA-1273.214 Administration Regardless of prior SARS-CoV-2 Infection
Time frame: Day 57
GM of the Serum Ab Level against Omicron XBB.1.5 after mRNA-1273.815 Administration Regardless of prior SARS-CoV-2 Infection
Time frame: Up to Day 57
SRR against Omicron XBB.1.5 after mRNA-1273.815 Administration Regardless of prior SARS-CoV-2 Infection
Time frame: Up to Day 57
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Meridian Clinical Research
Washington D.C., District of Columbia, United States
Prohealth Research Center
Doral, Florida, United States
University of Florida Jacksonville
Jacksonville, Florida, United States
Kissimmee Clinical Research
Kissimmee, Florida, United States
Med-Care Research
Miami, Florida, United States
...and 64 more locations