- Percentage of participants in Phase 1 reporting local reactions [ Time Frame: For 7 days after dose 1 and dose 2 ]
Pain at the injection site, redness, and swelling as self-reported on electronic diaries.
- Percentage of participants in Phase 1 reporting systemic events [ Time Frame: For 7 days after dose 1 and dose 2 ]
Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries.
- Percentage of participants in Phase 1 reporting adverse events [ Time Frame: From dose 1 through 1 month after the last dose ]
As elicited by investigational site staff
- Percentage of participants in Phase 1 reporting serious adverse events [ Time Frame: From dose 1 through 6 months after the last dose ]
As elicited by investigational site staff
- Percentage of Phase 1 participants with abnormal hematology and chemistry laboratory values [ Time Frame: 1 day after dose 1 ]
As measured at the central laboratory
- Percentage of Phase 1 participants with abnormal hematology and chemistry laboratory values [ Time Frame: 7 days after dose 1 ]
As measured at the central laboratory
- Percentage of Phase 1 participants with abnormal hematology and chemistry laboratory values [ Time Frame: 7 days after dose 2 ]
As measured at the central laboratory
- Percentage of Phase 1 participants with grading shifts in hematology and chemistry laboratory assessments [ Time Frame: Between baseline and 1 day after dose 1 ]
As measured at the central laboratory
- Percentage of Phase 1 participants with grading shifts in hematology and chemistry laboratory assessments [ Time Frame: Between baseline and 7 days after dose 1 ]
As measured at the central laboratory
- Percentage of Phase 1 participants with grading shifts in hematology and chemistry laboratory assessments [ Time Frame: Between before dose 2 and 7 days after dose 2 ]
As measured at the central laboratory
- In the first 360 participants randomized into Phase 2/3, percentage of participants reporting local reactions [ Time Frame: For 7 days after dose 1 and dose 2 ]
Pain at the injection site, redness, and swelling as self-reported on electronic diaries.
- In the first 360 participants randomized into Phase 2/3, percentage of participants reporting systemic events [ Time Frame: For 7 days after dose 1 and dose 2 ]
Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries.
- In the first 360 participants randomized into Phase 2/3, percentage of participants reporting adverse events [ Time Frame: From dose 1 through 1 month after the last dose ]
As elicited by investigational site staff
- In the first 360 participants randomized into Phase 2/3, percentage of participants reporting serious adverse events [ Time Frame: From dose 1 through 6 months after the last dose ]
As elicited by investigational site staff
- In a subset of at least 6000 participants randomized in Phase 2/3, percentage of participants reporting local reactions [ Time Frame: For 7 days after dose 1 and dose 2 ]
Pain at the injection site, redness, and swelling as self-reported on electronic diaries.
- In a subset of at least 6000 participants randomized in Phase 2/3, percentage of participants reporting systemic events [ Time Frame: For 7 days after dose 1 and dose 2 ]
Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries.
- Percentage of participants in Phase 2/3 reporting adverse events [ Time Frame: From dose 1 through 1 month after the last dose ]
As elicited by investigational site staff
- Percentage of participants in Phase 2/3 reporting serious adverse events [ Time Frame: From dose 1 through 6 months after the last dose ]
As elicited by investigational site staff
- Confirmed COVID-19 in Phase 2/3 participants without evidence of infection before vaccination [ Time Frame: From 7 days after the second dose of study intervention to the end of the study, up to 2 years ]
Per 1000 person-years of follow-up
- Confirmed COVID-19 in Phase 2/3 participants with and without evidence of infection before vaccination [ Time Frame: From 7 days after the second dose of study intervention to the end of the study, up to 2 years ]
Per 1000 person-years of follow-up
- Percentage of participants 12-15 years of age in Phase 3 reporting adverse events [ Time Frame: From dose 1 through 1 month after the last dose ]
As elicited by investigational site staff
- Percentage of participants 12-15 years of age in Phase 3 reporting adverse events [ Time Frame: From dose 1 through 6 months after the last dose ]
As elicited by investigational site staff
- In participants 12-15 years of age randomized in Phase 3, percentage of participants reporting local reactions [ Time Frame: For 7 days after dose 1 and dose 2 ]
Pain at the injection site, redness, and swelling as self-reported on electronic diaries.
- In participants 12-15 years of age randomized in Phase 3, percentage of participants reporting systemic events [ Time Frame: For 7 days after dose 1 and dose 2 ]
Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries.
