| Primary | Groups 2a and 2b and ARCT-154-J01 Historical Control: Geometric Mean Titers (GMT) of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Neutralizing Antibody Titers Against Omicron XBB.1.5 Subvariant at Day 29 | | Study treatment arm: per protocol (PP) set for immunogenicity, participants in the Modified Intent-To-Treat Analysis Set (mITT) who correctly received all protocol-required doses of study vaccines at Day 1 and who at or prior to the specified timepoint (Day 29 or Day 181) had no evidence of SARS-CoV-2 infection and no protocol deviations impacting the analysis of immunogenicity data. As pre-specified, data for groups 2a & 2b were collected and are reported pooled as a combined group. | Posted | | Geometric Mean | 95% Confidence Interval | Titer | | Day 29 | | | | ID | Title | Description |
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| OG000 | Cohort A Group 2a: ARCT-2303 + Placebo + QIV and Cohort B Group 2b: ARCT-2303 + Placebo + aQIV | Cohort A Group 2a: Younger adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of QIV on Day 29. Cohort B Group 2b: Older adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of aQIV on Day 29. | | OG001 | ARCT-154-J01 (Historical Control) | Participants from study ARCT-154-J01 with available pre- and post-vaccination serum samples who were allocated in the ARCT-154 group. This group of participants was used as a historical control group. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000718(652 to 791)
- OG001263(236 to 293)
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| Primary | Groups 2a and 2b and ARCT-154-J01 Historical Control: Number of Participants With Seroconversion to SARS-CoV-2 Neutralizing Antibody Against Omicron XBB.1.5 Subvariant at Day 29 | Seroconversion was defined as either a pre-vaccination titer below the lower limit of quantitation (LLOQ) and a postvaccination titer ≥4xLLOQ; or a pre-vaccination titer ≥LLOQ and a ≥4-fold increase in post-vaccination titer. | Study treatment arm: PP set for immunogenicity, which included participants in the mITT who correctly received all protocol-required doses of study vaccines at Day 1 and who at or prior to the specified timepoint (Day 29) had no evidence of SARS-CoV-2 infection and no protocol deviations impacting the analysis of immunogenicity data. As pre-specified, data for groups 2a &2b were collected and are reported pooled as a combined group. | Posted | | Count of Participants | | Participants | | Day 29 | | | | ID | Title | Description |
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| OG000 | Cohort A Group 2a: ARCT-2303 + Placebo + QIV and Cohort B Group 2b: ARCT-2303 + Placebo + aQIV | Cohort A Group 2a: Younger adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of QIV on Day 29. Cohort B Group 2b: Older adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of aQIV on Day 29. | | OG001 | ARCT-154-J01 (Historical Control) | Participants from study ARCT-154-J01 with available pre- and post-vaccination serum samples who were allocated in the ARCT-154 group. This group of participants was used as a historical control group. |
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| Primary | Groups 1a and 3a: Adjusted Hemagglutination Inhibition (HI) GMTs Against Influenza Vaccine Strains at Day 29 | Influenza vaccine strains were A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. | PP set for immunogenicity, which included participants in the mITT who correctly received all protocol-required doses of study vaccines at Day 1 and who at or prior to the specified timepoint (Day 29) had no evidence of SARS-CoV-2 infection and no protocol deviations impacting the analysis of immunogenicity data. | Posted | | Geometric Mean | 95% Confidence Interval | titers | | Day 29 | | | | ID | Title | Description |
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| OG000 | Cohort A Group 1a: ARCT-2303+ QIV + Placebo | Younger adult participants received one dose of ARCT-2303 and one dose of QIV on Day 1, and one dose of placebo on Day 29. | | OG001 | Cohort A Group 3a: QIV + Placebo + ARCT-2303 | Younger adult participants received one dose of QIV and one dose of placebo on Day 1, and one dose of ARCT-2303 on Day 29. |
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| Primary | Groups 1a and 2a: Adjusted GMTs of SARS-CoV-2 Neutralizing Antibody Against Omicron XBB.1.5 Subvariant at Day 29 | | PP set for immunogenicity, which included participants in the mITT who correctly received all protocol-required doses of study vaccines at Day 1 and who at or prior to the specified timepoint (Day 29) had no evidence of SARS-CoV-2 infection and no protocol deviations impacting the analysis of immunogenicity data. | Posted | | Geometric Mean | 95% Confidence Interval | titers | | Day 29 | | | | ID | Title | Description |
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| OG000 | Cohort A Group 1a: ARCT-2303+ QIV + Placebo | Younger adult participants received one dose of ARCT-2303 and one dose of QIV on Day 1, and one dose of placebo on Day 29. | | OG001 | Cohort A Group 2a: ARCT-2303 + Placebo + QIV | Younger adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of QIV on Day 29. |
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| Secondary | Groups 1a and 2a: GMT of SARS-CoV-2 Neutralizing Antibodies Against Omicron XBB.1.5 Subvariant at Days 1, 29 and 181 | | PP set for immunogenicity, which included participants in the mITT who correctly received all protocol-required doses of study vaccines at Day 1 and who at or prior to the specified timepoint (Day 29 or Day 181) had no evidence of SARS-CoV-2 infection and no protocol deviations impacting the analysis of immunogenicity data. Overall number of participants analyzed = participants evaluable for this outcome measure. Number analyzed = participants evaluable at the specified timepoint. | Posted | | Geometric Mean | 95% Confidence Interval | titers | | Group 1a: Days 1 and 29; Group 2a: Days 1, 29, and 181 | | | | ID | Title | Description |
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| OG000 | Cohort A Group 1a: ARCT-2303+ QIV + Placebo | Younger adult participants received one dose of ARCT-2303 and one dose of QIV on Day 1, and one dose of placebo on Day 29. | | OG001 | Cohort A Group 2a: ARCT-2303 + Placebo + QIV | Younger adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of QIV on Day 29. |
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| Secondary | Groups 1a and 2a: Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Neutralizing Antibodies Against Omicron XBB.1.5 Subvariant at Days 29 and 181 | GMFR is reported as a ratio to Day 1. | PP set for immunogenicity, which included participants in the mITT who correctly received all protocol-required doses of study vaccines at Day 1 and who at or prior to the specified timepoint (Day 29 or Day 181) had no evidence of SARS-CoV-2 infection and no protocol deviations impacting the analysis of immunogenicity data. Overall number of participants analyzed = participants evaluable for this outcome measure. Number analyzed = participants evaluable at the specified timepoint. | Posted | | Geometric Mean | 95% Confidence Interval | ratio | | Group 1a: Day 29; Group 2a: Days 29 and 181 | | | | ID | Title | Description |
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| OG000 | Cohort A Group 1a: ARCT-2303+ QIV + Placebo | Younger adult participants received one dose of ARCT-2303 and one dose of QIV on Day 1, and one dose of placebo on Day 29. | | OG001 | Cohort A Group 2a: ARCT-2303 + Placebo + QIV | Younger adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of QIV on Day 29. |
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| Secondary | Groups 1a and 2a: Number of Participants With Seroconversion of SARS-CoV-2 Neutralizing Antibodies Against Omicron XBB.1.5 Subvariant at Day 29 | Seroconversion was defined as either a pre-vaccination titer below the LLOQ and a postvaccination titer ≥4xLLOQ; or a pre-vaccination titer ≥LLOQ and a ≥4-fold increase in post-vaccination titer. | PP set for immunogenicity, which included participants in the mITT who correctly received all protocol-required doses of study vaccines at Day 1 and who at or prior to the specified timepoint (Day 29) had no evidence of SARS-CoV-2 infection and no protocol deviations impacting the analysis of immunogenicity data. | Posted | | Count of Participants | | Participants | | Day 29 | | | | ID | Title | Description |
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| OG000 | Cohort A Group 1a: ARCT-2303+ QIV + Placebo | Younger adult participants received one dose of ARCT-2303 and one dose of QIV on Day 1, and one dose of placebo on Day 29. | | OG001 | Cohort A Group 2a: ARCT-2303 + Placebo + QIV | Younger adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of QIV on Day 29. |
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| Secondary | Groups 1a and 2a: Number of Participants With SARS-CoV-2 Neutralizing Antibody Against Omicron XBB.1.5 Subvariant Titer ≥ LLOQ at Days 1 and 29 | | PP set for immunogenicity, which included participants in the mITT who correctly received all protocol-required doses of study vaccines at Day 1 and who at or prior to the specified timepoint (Day 29) had no evidence of SARS-CoV-2 infection and no protocol deviations impacting the analysis of immunogenicity data. | Posted | | Count of Participants | | Participants | | Days 1 and 29 | | | | ID | Title | Description |
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| OG000 | Cohort A Group 1a: ARCT-2303+ QIV + Placebo | Younger adult participants received one dose of ARCT-2303 and one dose of QIV on Day 1, and one dose of placebo on Day 29. | | OG001 | Cohort A Group 2a: ARCT-2303 + Placebo + QIV | Younger adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of QIV on Day 29. |
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| Secondary | Groups 1a and 3a: GMTs of HI Assay Titers Against Influenza Vaccine Strains at Days 1 and 29 | Vaccine strains were A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. | PP set for immunogenicity, which included participants in the mITT who correctly received all protocol-required doses of study vaccines at Day 1 and who at or prior to the specified timepoint (Day 29) had no evidence of SARS-CoV-2 infection and no protocol deviations impacting the analysis of immunogenicity data. | Posted | | Geometric Mean | 95% Confidence Interval | titer | | Days 1 and 29 | | | | ID | Title | Description |
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| OG000 | Cohort A Group 1a: ARCT-2303+ QIV + Placebo | Younger adult participants received one dose of ARCT-2303 and one dose of QIV on Day 1, and one dose of placebo on Day 29. | | OG001 | Cohort A Group 3a: QIV + Placebo + ARCT-2303 | Younger adult participants received one dose of QIV and one dose of placebo on Day 1, and one dose of ARCT-2303 on Day 29. |
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| Secondary | Groups 1a and 3a: GMFR of HI Assay Titers Against Influenza Vaccine Strains at Day 29 | Vaccine strains were A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. GMFR is reported as a ratio to Day 1. | PP set for immunogenicity, which included participants in the mITT who correctly received all protocol-required doses of study vaccines at Day 1 and who at or prior to the specified timepoint (Day 29) had no evidence of SARS-CoV-2 infection and no protocol deviations impacting the analysis of immunogenicity data. | Posted | | Geometric Mean | 95% Confidence Interval | ratio | | Day 29 | | | | ID | Title | Description |
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| OG000 | Cohort A Group 1a: ARCT-2303+ QIV + Placebo | Younger adult participants received one dose of ARCT-2303 and one dose of QIV on Day 1, and one dose of placebo on Day 29. | | OG001 | Cohort A Group 3a: QIV + Placebo + ARCT-2303 | Younger adult participants received one dose of QIV and one dose of placebo on Day 1, and one dose of ARCT-2303 on Day 29. |
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| Secondary | Groups 1a and 3a: Number of Participants With Seroconversion of HI Assay Titers Against Influenza Vaccine Strains at Day 29 | Seroconversion was defined as either a pre-vaccination titer below the LLOQ and a postvaccination titer ≥4xLLOQ; or a pre-vaccination titer ≥LLOQ and a ≥4-fold increase in post-vaccination titer. Vaccine strains were A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. | PP set for immunogenicity, which included participants in the mITT who correctly received all protocol-required doses of study vaccines at Day 1 and who at or prior to the specified timepoint (Day 29) had no evidence of SARS-CoV-2 infection and no protocol deviations impacting the analysis of immunogenicity data. | Posted | | Count of Participants | | Participants | | Day 29 | | | | ID | Title | Description |
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| OG000 | Cohort A Group 1a: ARCT-2303+ QIV + Placebo | Younger adult participants received one dose of ARCT-2303 and one dose of QIV on Day 1, and one dose of placebo on Day 29. | | OG001 | Cohort A Group 3a: QIV + Placebo + ARCT-2303 | Younger adult participants received one dose of QIV and one dose of placebo on Day 1, and one dose of ARCT-2303 on Day 29. |
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| Secondary | Groups 1a and 3a: Number of Participants With HI Titer ≥1:40 at Days 1 and 29 | Vaccine strains were A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. | PP set for immunogenicity, which included participants in the mITT who correctly received all protocol-required doses of study vaccines at Day 1 and who at or prior to the specified timepoint (Day 29) had no evidence of SARS-CoV-2 infection and no protocol deviations impacting the analysis of immunogenicity data. | Posted | | Count of Participants | | Participants | | Days 1 and 29 | | | | ID | Title | Description |
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| OG000 | Cohort A Group 1a: ARCT-2303+ QIV + Placebo | Younger adult participants received one dose of ARCT-2303 and one dose of QIV on Day 1, and one dose of placebo on Day 29. | | OG001 | Cohort A Group 3a: QIV + Placebo + ARCT-2303 | Younger adult participants received one dose of QIV and one dose of placebo on Day 1, and one dose of ARCT-2303 on Day 29. |
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| Secondary | Groups 1b and 2b: GMTs of SARS-CoV-2 Neutralizing Antibodies Against Omicron XBB.1.5 Subvariant at Days 1, 29 and 181 | | PP set for immunogenicity, which included participants in the mITT who correctly received all protocol-required doses of study vaccines at Day 1 and who at or prior to the specified timepoint (Day 29 or Day 181) had no evidence of SARS-CoV-2 infection and no protocol deviations impacting the analysis of immunogenicity data. Overall number of participants analyzed = number evaluable for the outcome measure. Number analyzed = participants evaluable at the specified timepoint. | Posted | | Geometric Mean | 95% Confidence Interval | titer | | Group 1b: Days 1 and 29, Group 2b: Days 1, 29 and 181 | | | | ID | Title | Description |
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| OG000 | Cohort B Group 1b: ARCT-2303 + Adjuvanted QIV (aQIV) + Placebo | Older adult participants received one dose of ARCT-2303 and one dose of aQIV on Day 1, and one dose of placebo on Day 29. | | OG001 | Cohort B Group 2b: ARCT-2303 + Placebo + aQIV | Older adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of aQIV on Day 29. |
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| Secondary | Groups 1b and 2b: GMFRs of SARS-CoV-2 Neutralizing Antibodies Against Omicron XBB.1.5 Subvariant at Days 29 and 181 | GMFR is reported as a ratio to Day 1. | PP set for immunogenicity, which included participants in the mITT who correctly received all protocol-required doses of study vaccines at Day 1 and who at or prior to the specified timepoint (Day 29 or Day 181) had no evidence of SARS-CoV-2 infection and no protocol deviations impacting the analysis of immunogenicity data. Overall number of participants analyzed = number evaluable for the outcome measure. Number analyzed = participants evaluable at the specified timepoint. | Posted | | Geometric Mean | 95% Confidence Interval | ratio | | Group 1b: Day 29 and Group 2b: Days 29 and 181 | | | | ID | Title | Description |
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| OG000 | Cohort B Group 1b: ARCT-2303 + Adjuvanted QIV (aQIV) + Placebo | Older adult participants received one dose of ARCT-2303 and one dose of aQIV on Day 1, and one dose of placebo on Day 29. | | OG001 | Cohort B Group 2b: ARCT-2303 + Placebo + aQIV | Older adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of aQIV on Day 29. |
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| Secondary | Groups 1b and 2b: Number of Participants With Seroconversion of SARS-CoV-2 Neutralizing Antibodies Against Omicron XBB.1.5 Subvariant at Day 29 | Seroconversion was defined as either a pre-vaccination titer below the LLOQ and a postvaccination titer ≥4xLLOQ; or a pre-vaccination titer ≥LLOQ and a ≥4-fold increase in post-vaccination titer. | PP set for immunogenicity, which included participants in the mITT who correctly received all protocol-required doses of study vaccines at Day 1 and who at or prior to the specified timepoint (Day 29) had no evidence of SARS-CoV-2 infection and no protocol deviations impacting the analysis of immunogenicity data. | Posted | | Count of Participants | | Participants | | Day 29 | | | | ID | Title | Description |
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| OG000 | Cohort B Group 1b: ARCT-2303 + Adjuvanted QIV (aQIV) + Placebo | Older adult participants received one dose of ARCT-2303 and one dose of aQIV on Day 1, and one dose of placebo on Day 29. | | OG001 | Cohort B Group 2b: ARCT-2303 + Placebo + aQIV | Older adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of aQIV on Day 29. |
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| Secondary | Groups 1b and 2b: Number of Participants With SARS-CoV-2 Neutralizing Antibody Against Omicron XBB.1.5 Subvariant Titer ≥ LLOQ at Days 1 and 29 | | PP set for immunogenicity, which included participants in the mITT who correctly received all protocol-required doses of study vaccines at Day 1 and who at or prior to the specified timepoint (Day 29) had no evidence of SARS-CoV-2 infection and no protocol deviations impacting the analysis of immunogenicity data. | Posted | | Count of Participants | | Participants | | Days 1 and 29 | | | | ID | Title | Description |
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| OG000 | Cohort B Group 1b: ARCT-2303 + Adjuvanted QIV (aQIV) + Placebo | Older adult participants received one dose of ARCT-2303 and one dose of aQIV on Day 1, and one dose of placebo on Day 29. | | OG001 | Cohort B Group 2b: ARCT-2303 + Placebo + aQIV | Older adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of aQIV on Day 29. |
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| Secondary | Groups 1b and 3b: GMTs of HI Assay Titers Against Influenza Vaccine Strains at Days 1 and 29 | Vaccine strains were A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. | PP set for immunogenicity, which included participants in the mITT who correctly received all protocol-required doses of study vaccines at Day 1 and who at or prior to the specified timepoint (Day 29) had no evidence of SARS-CoV-2 infection and no protocol deviations impacting the analysis of immunogenicity data. | Posted | | Geometric Mean | 95% Confidence Interval | titers | | Days 1 and 29 | | | | ID | Title | Description |
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| OG000 | Cohort B Group 1b: ARCT-2303 + Adjuvanted QIV (aQIV) + Placebo | Older adult participants received one dose of ARCT-2303 and one dose of aQIV on Day 1, and one dose of placebo on Day 29. | | OG001 | Cohort B Group 3b: aQIV + Placebo + ARCT-2303 | Older adult participants received one dose of aQIV and one dose of placebo on Day 1, and one dose of ARCT-2303 on Day 29. |
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| Secondary | Groups 1b and 3b: GMFRs of of HI Assay Titers Against Influenza Vaccine Strains at Day 29 | Vaccine strains were A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. GMFR is reported as a ratio to Day 1. | PP set for immunogenicity, which included participants in the mITT who correctly received all protocol-required doses of study vaccines at Day 1 and who at or prior to the specified timepoint (Day 29) had no evidence of SARS-CoV-2 infection and no protocol deviations impacting the analysis of immunogenicity data. | Posted | | Geometric Mean | 95% Confidence Interval | ratio | | Day 29 | | | | ID | Title | Description |
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| OG000 | Cohort B Group 1b: ARCT-2303 + Adjuvanted QIV (aQIV) + Placebo | Older adult participants received one dose of ARCT-2303 and one dose of aQIV on Day 1, and one dose of placebo on Day 29. | | OG001 | Cohort B Group 3b: aQIV + Placebo + ARCT-2303 | Older adult participants received one dose of aQIV and one dose of placebo on Day 1, and one dose of ARCT-2303 on Day 29. |
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| Secondary | Groups 1b and 3b: Number of Participants With Seroconversion of HI Assay Titers Against Influenza Vaccine Strains at Day 29 | Seroconversion was defined as either a pre-vaccination titer below the LLOQ and a postvaccination titer ≥4xLLOQ; or a pre-vaccination titer ≥LLOQ and a ≥4-fold increase in post-vaccination titer. Vaccine strains were A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. | PP set for immunogenicity, which included participants in the mITT who correctly received all protocol-required doses of study vaccines at Day 1 and who at or prior to the specified timepoint (Day 29) had no evidence of SARS-CoV-2 infection and no protocol deviations impacting the analysis of immunogenicity data. | Posted | | Count of Participants | | Participants | | Day 29 | | | | ID | Title | Description |
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| OG000 | Cohort B Group 1b: ARCT-2303 + Adjuvanted QIV (aQIV) + Placebo | Older adult participants received one dose of ARCT-2303 and one dose of aQIV on Day 1, and one dose of placebo on Day 29. | | OG001 | Cohort B Group 3b: aQIV + Placebo + ARCT-2303 | Older adult participants received one dose of aQIV and one dose of placebo on Day 1, and one dose of ARCT-2303 on Day 29. |
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| Secondary | Groups 1b and 3b: Number of Participants With HI Titer ≥1:40 at Days 1 and 29 | Vaccine strains analyzed for this outcome measure were A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. | PP set for immunogenicity, which included participants in the mITT who correctly received all protocol-required doses of study vaccines at Day 1 and who at or prior to the specified timepoint (Day 29) had no evidence of SARS-CoV-2 infection and no protocol deviations impacting the analysis of immunogenicity data. | Posted | | Count of Participants | | Participants | | Days 1 and 29 | | | | ID | Title | Description |
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| OG000 | Cohort B Group 1b: ARCT-2303 + Adjuvanted QIV (aQIV) + Placebo | Older adult participants received one dose of ARCT-2303 and one dose of aQIV on Day 1, and one dose of placebo on Day 29. | | OG001 | Cohort B Group 3b: aQIV + Placebo + ARCT-2303 | Older adult participants received one dose of aQIV and one dose of placebo on Day 1, and one dose of ARCT-2303 on Day 29. |
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| Secondary | Number of Participants With Local and Systemic Adverse Events (AEs) | Systemic AEs: fatigue, headache, myalgia, arthralgia, nausea, dizziness, chills, and fever. Solicited local (injection site) AEs: injection site pain, erythema, and swelling. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. | Safety Analysis Set (SAF), which included all participants in the Exposed Set (participants who received at least one dose of a study vaccine) who provided any evaluable post-vaccination reactogenicity and/or safety data. Number analyzed = participants evaluable at the specified timepoint. | Posted | | Count of Participants | | Participants | | Day 8 and Day 36 (up to 7 days after each study vaccination) | | | | ID | Title | Description |
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| OG000 | Cohort A Group 1a: ARCT-2303+ QIV + Placebo | Younger adult participants received one dose of ARCT-2303 and one dose of QIV on Day 1, and one dose of placebo on Day 29. | | OG001 | Cohort A Group 2a: ARCT-2303 + Placebo + QIV | Younger adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of QIV on Day 29. | | OG002 | Cohort A Group 3a: QIV + Placebo + ARCT-2303 | |
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| Secondary | Number of Participants With Unsolicited AEs | An unsolicited AE was an AE that was not listed as 'solicited' and was defined as any spontaneously occurring AE (serious and non-serious). Potential unsolicited AEs may have been medically attended (defined as symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a healthcare provider) or were of concern to the participants. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. | Safety Analysis Set, which included all participants in the Exposed Set (participants who received at least one dose of a study vaccine) who provided any evaluable post-vaccination reactogenicity and/or safety data. Overall number of participants analyzed = participants evaluable for the outcome measure. Number analyzed = participants evaluable at the specified timepoint. | Posted | | Count of Participants | | Participants | | Up to Day 29 (Up to 28 days after first study vaccination) and up to Day 57 (28 days after second study vaccination) | | | | ID | Title | Description |
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| OG000 | Cohort A Group 1a: ARCT-2303+ QIV + Placebo | Younger adult participants received one dose of ARCT-2303 and one dose of QIV on Day 1, and one dose of placebo on Day 29. | | OG001 | Cohort A Group 2a: ARCT-2303 + Placebo + QIV | Younger adult participants received one dose of ARCT-2303 and one dose of placebo on Day 1, and one dose of QIV on Day 29. |
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| Secondary | Number of Participants With Serious Adverse Events (SAEs), AEs Leading to Early Termination From Study, Medically Attended Adverse Event (MAAEs), and Adverse Event of Special Interest (AESIs) | SAEs were defined as any event that resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, a congenital anomaly or birth defect, or was an important medical event. A MAAE was an AE that led to an unscheduled visit (including a telemedicine visit) to a healthcare practitioner. AESIs were defined as AEs potentially associated with Coronavirus Disease 2019 (COVID-19) and COVID-19 vaccines. Number of participants with AEs leading to early termination included AEs leading to death. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. | Safety Analysis Set, which included all participants in the Exposed Set (participants who received at least one dose of a study vaccine) who provided any evaluable post-vaccination reactogenicity and/or safety data. | Posted | | Count of Participants | | Participants | | Day 1 up to Day 181 | | | | ID | Title | Description |
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| OG000 | Cohort A Group 1a: ARCT-2303+ QIV + Placebo | Younger adult participants received one dose of ARCT-2303 and one dose of QIV on Day 1, and one dose of placebo on Day 29. | | OG001 | Cohort A Group 2a: ARCT-2303 + Placebo + QIV |
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