The mRNA-1273 vaccine is being developed to prevent COVID-19, the disease resulting from Severe Acute Respiratory Syndrome coronavirus (SARS-CoV-2) infection. The study is designed to primarily evaluate the safety, reactogenicity, and effectiveness of mRNA-1273 vaccine administered as primary series and a booster dose (BD) to an adolescent population. The study will also evaluate the safety and immunogenicity of an mRNA-1273.222 vaccine against the SARS-CoV- 2 omicron variant as a primary series.
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Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)
Timeframe: 7 days post-vaccination
Number of Participants With Unsolicited AEs
Timeframe: Up to 28 days post-vaccination
Part 1A Geometric Mean Value of Serum Pseudovirus Neutralizing Antibody (nAb) ID50 Titers From Study P203 Vaccine Recipients at Day 57 Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in Study P301
Timeframe: Day 57 Study P203/Day 57 Study P301
Part 1A Seroresponse Rate (SRR) for Serum Pseudovirus nAb ID50 in Study P203 Vaccine Recipients at Day 57 Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in Study P301
Timeframe: Day 57 Study P203/Day 57 Study P301
Part 1C-1 Geometric Mean Concentration (GMC) of Serum Pseudovirus nAb Against the Original Strain After the BD in Study P203 at BD Day 29 Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in Study P301
Timeframe: BD Day 29 Study P203/Day 57 Study P301
Part 1C-1 SRR of Serum Pseudovirus nAb Against the Original Strain After the BD in Study P203 at BD Day 29 Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in Study P301
Timeframe: BD Day 29 Study P203/Day 57 Study P301
Part 3 GMC of nAb Post Dose 1 mRNA 1273.222 Against Omicron BA.4/BA.5 Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in Study P301
Timeframe: Day 29 Study P203/Day 57 Study P301
Part 1C-2 GMC of Post-booster Pseudovirus nAb Against Ancestral Strain at BD Day 29
Timeframe: BD Day 29
Part 2 GMC of the Pseudovirus nAb Against Ancestral Strain at Day 57
Timeframe: Day 57
Part 3 GMC of nAb Post Dose 1 mRNA 1273.222 Against SARS-CoV-2 Ancestral Strain Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in Study P301
Timeframe: Day 29 Study P203/Day 57 Study P301
Part 2 SRR of Pseudovirus nAb Against Ancestral Strain
Timeframe: Day 57
Number of Participants With SAEs, AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Study Discontinuation
Timeframe: Day 1 up to Day 751