| Primary | Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HI) Antibodies Against the H5N6 Strain | GMT pre-vaccination, 1 and 3 weeks post-vaccination 1, and 3 weeks post-vaccination 2 Note: The Overall Number of Participants Analyzed (N) represents the total number of participants in the per-protocol set (PPS); definitions are provided in the Statistical Analysis Plan (SAP). The Number Analyzed (n) at each timepoint corresponds to the number of participants with an available serum analysis result for the relevant strain at that timepoint. Instances where n\ | Per-protocol set defined as all subjects who correctly received the study vaccine, provided at least one evaluable serum sample at relevant timepoints, had no major protocol deviations leading to exclusion, and were not excluded due to other reasons prior to unblinding or analysis. | Posted | | Geometric Mean | 95% Confidence Interval | titer | | Day 1, Day 8, Day 22, Day 43 | | | | ID | Title | Description |
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| OG000 | Group 1 | Eligible subjects who received 2 doses of aH5N1c in the parent study V89_18 randomized to receive two aH5N6c vaccinations, 3 weeks apart on Day 1 and Day 22 | | OG001 | Group 2 | Eligible subjects who received 2 doses of aH5N1c in the parent study V89_18 randomized to receive an aH5N6c vaccination on Day 1 and saline placebo on Day 22 | | OG002 | Group 3 | Eligible subjects who received placebo in the parent study V89_18 planned to receive two aH5N6c vaccinations, 3 weeks apart on Day 1 and Day 22 |
| | | Title | Denominators | Categories |
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| Day 1 | - ParticipantsOG00072
- ParticipantsOG00166
- ParticipantsOG00292
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| Primary | Geometric Mean Fold Increase (GMFI) of HI Antibodies Against the H5N6 Strain | GMFI 1 and 3 weeks post-vaccination 1, and 3 weeks post-vaccination 2 compared to pre-vaccination (Day 1) Note: The Overall Number of Participants Analyzed (N) represents the total number of participants in the PPS; definitions are provided in the SAP. The Number Analyzed (n) at each timepoint corresponds to the number of participants with an available serum analysis result for the relevant strain at that timepoint. Instances where n\ | Per-protocol set defined as all subjects who correctly received the study vaccine, provided at least one evaluable serum sample at relevant timepoints, had no major protocol deviations leading to exclusion, and were not excluded due to other reasons prior to unblinding or analysis. | Posted | | Geometric Mean | 95% Confidence Interval | ratio | | Day 1, Day 8, Day 22, Day 43 | | | | ID | Title | Description |
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| OG000 | Group 1 | Eligible subjects who received 2 doses of aH5N1c in the parent study V89_18 randomized to receive two aH5N6c vaccinations, 3 weeks apart on Day 1 and Day 22 | | OG001 | Group 2 | Eligible subjects who received 2 doses of aH5N1c in the parent study V89_18 randomized to receive an aH5N6c vaccination on Day 1 and saline placebo on Day 22 |
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| Primary | Percentage of Subjects With HI Titers ≥1:40 Against the H5N6 Strain | Pre-vaccination, 1 and 3 weeks post-vaccination 1, and 3 weeks post-vaccination 2 Note: The Overall Number of Participants Analyzed (N) represents the total number of participants in the PPS; definitions are provided in the SAP. The Number Analyzed (n) at each timepoint corresponds to the number of participants with an available serum analysis result for the relevant strain at that timepoint. Instances where n\ | Per-protocol set defined as all subjects who correctly received the study vaccine, provided at least one evaluable serum sample at relevant timepoints, had no major protocol deviations leading to exclusion, and were not excluded due to other reasons prior to unblinding or analysis. | Posted | | Number | 95% Confidence Interval | % of participants | | Day 1, Day 8, Day 22, Day 43 | | | | ID | Title | Description |
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| OG000 | Group 1 | Eligible subjects who received 2 doses of aH5N1c in the parent study V89_18 randomized to receive two aH5N6c vaccinations, 3 weeks apart on Day 1 and Day 22 | | OG001 | Group 2 | Eligible subjects who received 2 doses of aH5N1c in the parent study V89_18 randomized to receive an aH5N6c vaccination on Day 1 and saline placebo on Day 22 |
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| Primary | Percentage of Subjects With Seroconversion Against the H5N6 Strain | Seroconversion 1 and 3 weeks post-vaccination 1, and 3 weeks post-vaccination 2, defined as a ≥4-fold increase in HI titer post-vaccination in those with pre-vaccination titer ≥1:10, or a post-vaccination HI titer ≥1:40 for subjects with baseline titer <1:10 Note: The Overall Number of Participants Analyzed (N) represents the total number of participants in the PPS; definitions are provided in the SAP. The Number Analyzed (n) at each timepoint corresponds to the number of participants with an available serum analysis result for the relevant strain at that timepoint. Instances where n\ | Per-protocol set defined as all subjects who correctly received the study vaccine, provided at least one evaluable serum sample at relevant timepoints, had no major protocol deviations leading to exclusion, and were not excluded due to other reasons prior to unblinding or analysis. | Posted | | Number | 95% Confidence Interval | % of participants | | Day 8, Day 22, Day 43 | | | | ID | Title | Description |
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| OG000 | Group 1 | Eligible subjects who received 2 doses of aH5N1c in the parent study V89_18 randomized to receive two aH5N6c vaccinations, 3 weeks apart on Day 1 and Day 22 | | OG001 | Group 2 | Eligible subjects who received 2 doses of aH5N1c in the parent study V89_18 randomized to receive an aH5N6c vaccination on Day 1 and saline placebo on Day 22 |
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| Secondary | GMT of HI Antibodies Against the H5N1 Strain | GMT pre-vaccination, 1 and 3 weeks post-vaccination 1, and 3 weeks and 6 months post-vaccination 2 Note: The Overall Number of Participants Analyzed (N) represents the total number of participants in the PPS; definitions are provided in the SAP. The Number Analyzed (n) at each timepoint corresponds to the number of participants with an available serum analysis result for the relevant strain at that timepoint. Instances where n\ | Per-protocol set defined as all subjects who correctly received the study vaccine, provided at least one evaluable serum sample at relevant timepoints, had no major protocol deviations leading to exclusion, and were not excluded due to other reasons prior to unblinding or analysis. | Posted | | Geometric Mean | 95% Confidence Interval | titer | | Day 1, Day 8, Day 22, Day 43, Day 202 | | | | ID | Title | Description |
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| OG000 | Group 1 | Eligible subjects who received 2 doses of aH5N1c in the parent study V89_18 randomized to receive two aH5N6c vaccinations, 3 weeks apart on Day 1 and Day 22 | | OG001 | Group 2 | Eligible subjects who received 2 doses of aH5N1c in the parent study V89_18 randomized to receive an aH5N6c vaccination on Day 1 and saline placebo on Day 22 |
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| Secondary | GMFI of HI Antibodies Against the H5N1 Strain | GMFI 1 and 3 weeks post-vaccination 1, and 3 weeks and 6 months post-vaccination 2 compared to pre-vaccination (Day 1) Note: The Overall Number of Participants Analyzed (N) represents the total number of participants in the PPS; definitions are provided in the SAP. The Number Analyzed (n) at each timepoint corresponds to the number of participants with an available serum analysis result for the relevant strain at that timepoint. Instances where n\ | Per-protocol set defined as all subjects who correctly received the study vaccine, provided at least one evaluable serum sample at relevant timepoints, had no major protocol deviations leading to exclusion, and were not excluded due to other reasons prior to unblinding or analysis. | Posted | | Geometric Mean | 95% Confidence Interval | ratio | | Day 1, Day 8, Day 22, Day 43, Day 202 | | | | ID | Title | Description |
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| OG000 | Group 1 | Eligible subjects who received 2 doses of aH5N1c in the parent study V89_18 randomized to receive two aH5N6c vaccinations, 3 weeks apart on Day 1 and Day 22 | | OG001 | Group 2 | Eligible subjects who received 2 doses of aH5N1c in the parent study V89_18 randomized to receive an aH5N6c vaccination on Day 1 and saline placebo on Day 22 |
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| Secondary | Percentage of Subjects With HI Titers ≥1:40 Against the H5N1 Strain | Pre-vaccination, 1 and 3 weeks post-vaccination 1, and 3 weeks and 6 months post-vaccination 2 Note: The Overall Number of Participants Analyzed (N) represents the total number of participants in the PPS; definitions are provided in the SAP. The Number Analyzed (n) at each timepoint corresponds to the number of participants with an available serum analysis result for the relevant strain at that timepoint. Instances where n\ | Per-protocol set defined as all subjects who correctly received the study vaccine, provided at least one evaluable serum sample at relevant timepoints, had no major protocol deviations leading to exclusion, and were not excluded due to other reasons prior to unblinding or analysis. | Posted | | Number | 95% Confidence Interval | % of participants | | Day 1, Day 8, Day 22, Day 43, Day 202 | | | | ID | Title | Description |
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| OG000 | Group 1 | Eligible subjects who received 2 doses of aH5N1c in the parent study V89_18 randomized to receive two aH5N6c vaccinations, 3 weeks apart on Day 1 and Day 22 | | OG001 | Group 2 | Eligible subjects who received 2 doses of aH5N1c in the parent study V89_18 randomized to receive an aH5N6c vaccination on Day 1 and saline placebo on Day 22 |
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| Secondary | Percentage of Subjects With Seroconversion Against the H5N1 Strain | Seroconversion 1 and 3 weeks post-vaccination 1, and 3 weeks and 6 months post-vaccination 2, defined as a ≥4-fold increase in HI titer post-vaccination in those with pre-vaccination titer ≥1:10, or a post-vaccination HI titer ≥1:40 for subjects with baseline titer <1:10 Note: The Overall Number of Participants Analyzed (N) represents the total number of participants in the PPS; definitions are provided in the SAP. The Number Analyzed (n) at each timepoint corresponds to the number of participants with an available serum analysis result for the relevant strain at that timepoint. Instances where n\ | Per-protocol set defined as all subjects who correctly received the study vaccine, provided at least one evaluable serum sample at relevant timepoints, had no major protocol deviations leading to exclusion, and were not excluded due to other reasons prior to unblinding or analysis. | Posted | | Number | 95% Confidence Interval | % of participants | | Day 8, Day 22, Day 43, Day 202 | | | | ID | Title | Description |
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| OG000 | Group 1 | Eligible subjects who received 2 doses of aH5N1c in the parent study V89_18 randomized to receive two aH5N6c vaccinations, 3 weeks apart on Day 1 and Day 22 | | OG001 | Group 2 | Eligible subjects who received 2 doses of aH5N1c in the parent study V89_18 randomized to receive an aH5N6c vaccination on Day 1 and saline placebo on Day 22 |
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| Secondary | GMT of HI Antibodies Against the H5N6 Strain | GMT 6 months post-vaccination 2 | Per-protocol set defined as all subjects who correctly received the study vaccine, provided at least one evaluable serum sample at relevant timepoints, had no major protocol deviations leading to exclusion, and were not excluded due to other reasons prior to unblinding or analysis. | Posted | | Geometric Mean | 95% Confidence Interval | titer | | Day 202 | | | | ID | Title | Description |
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| OG000 | Group 1 | Eligible subjects who received 2 doses of aH5N1c in the parent study V89_18 randomized to receive two aH5N6c vaccinations, 3 weeks apart on Day 1 and Day 22 | | OG001 | Group 2 | Eligible subjects who received 2 doses of aH5N1c in the parent study V89_18 randomized to receive an aH5N6c vaccination on Day 1 and saline placebo on Day 22 | | OG002 | Group 3 | Eligible subjects who received placebo in the parent study V89_18 planned to receive two aH5N6c vaccinations, 3 weeks apart on Day 1 and Day 22 |
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| Secondary | GMFI of HI Antibodies Against the H5N6 Strain | GMFI 6 months post-vaccination 2 compared to pre-vaccination (Day 1) | Per-protocol set defined as all subjects who correctly received the study vaccine, provided at least one evaluable serum sample at relevant timepoints, had no major protocol deviations leading to exclusion, and were not excluded due to other reasons prior to unblinding or analysis. | Posted | | Geometric Mean | 95% Confidence Interval | ratio | | Day 1, Day 202 | | | | ID | Title | Description |
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| OG000 | Group 1 | Eligible subjects who received 2 doses of aH5N1c in the parent study V89_18 randomized to receive two aH5N6c vaccinations, 3 weeks apart on Day 1 and Day 22 | | OG001 | Group 2 | Eligible subjects who received 2 doses of aH5N1c in the parent study V89_18 randomized to receive an aH5N6c vaccination on Day 1 and saline placebo on Day 22 | | OG002 | Group 3 | Eligible subjects who received placebo in the parent study V89_18 planned to receive two aH5N6c vaccinations, 3 weeks apart on Day 1 and Day 22 |
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| Secondary | Percentage of Subjects With HI Titers ≥1:40 Against the H5N6 Strain | 6 months post-vaccination 2 | Per-protocol set defined as all subjects who correctly received the study vaccine, provided at least one evaluable serum sample at relevant timepoints, had no major protocol deviations leading to exclusion, and were not excluded due to other reasons prior to unblinding or analysis. | Posted | | Number | 95% Confidence Interval | % of participants | | Day 202 | | | | ID | Title | Description |
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| OG000 | Group 1 | Eligible subjects who received 2 doses of aH5N1c in the parent study V89_18 randomized to receive two aH5N6c vaccinations, 3 weeks apart on Day 1 and Day 22 | | OG001 | Group 2 | Eligible subjects who received 2 doses of aH5N1c in the parent study V89_18 randomized to receive an aH5N6c vaccination on Day 1 and saline placebo on Day 22 | | OG002 | Group 3 | Eligible subjects who received placebo in the parent study V89_18 planned to receive two aH5N6c vaccinations, 3 weeks apart on Day 1 and Day 22 |
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| Secondary | Percentage of Subjects With Seroconversion Against the H5N6 Strain | Seroconversion 6 months post-vaccination 2, defined as a ≥4-fold increase in HI titer post-vaccination in those with pre-vaccination titer ≥1:10, or a post-vaccination HI titer ≥1:40 for subjects with baseline titer <1:10 | Per-protocol set defined as all subjects who correctly received the study vaccine, provided at least one evaluable serum sample at relevant timepoints, had no major protocol deviations leading to exclusion, and were not excluded due to other reasons prior to unblinding or analysis. | Posted | | Number | 95% Confidence Interval | % of participants | | Day 202 | | | | ID | Title | Description |
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| OG000 | Group 1 | Eligible subjects who received 2 doses of aH5N1c in the parent study V89_18 randomized to receive two aH5N6c vaccinations, 3 weeks apart on Day 1 and Day 22 | | OG001 | Group 2 | Eligible subjects who received 2 doses of aH5N1c in the parent study V89_18 randomized to receive an aH5N6c vaccination on Day 1 and saline placebo on Day 22 | | OG002 | Group 3 | Eligible subjects who received placebo in the parent study V89_18 planned to receive two aH5N6c vaccinations, 3 weeks apart on Day 1 and Day 22 |
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| Secondary | Frequency and Severity of Solicited Local and Systemic Adverse Events (AEs) | For 7 days following each vaccination | Solicited Safety Set defined as all subjects in the All Exposed Set with any solicited AE data and/or indicators of solicited AEs. | Posted | | Count of Participants | | Participants | | Day 1 through Day 7 and Day 22 through Day 28 | | | | ID | Title | Description |
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| OG000 | Group 1 | Eligible subjects who received 2 doses of aH5N1c in the parent study V89_18 randomized to receive two aH5N6c vaccinations, 3 weeks apart on Day 1 and Day 22 | | OG001 | Group 2 | Eligible subjects who received 2 doses of aH5N1c in the parent study V89_18 randomized to receive an aH5N6c vaccination on Day 1 and saline placebo on Day 22 | | OG002 | Group 3 | Eligible subjects who received placebo in the parent study V89_18 planned to receive two aH5N6c vaccinations, 3 weeks apart on Day 1 and Day 22 |
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| Secondary | Frequency and Severity of Unsolicited AEs | For 3 weeks following each vaccination | Unsolicited Safety Set defined as all subjects in the All Exposed Set with unsolicited AE data, including confirmation of absence of unsolicited AEs. | Posted | | Count of Participants | | Participants | | Day 1 through Day 43 | | | | ID | Title | Description |
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| OG000 | Group 1 | Eligible subjects who received 2 doses of aH5N1c in the parent study V89_18 randomized to receive two aH5N6c vaccinations, 3 weeks apart on Day 1 and Day 22 | | OG001 | Group 2 | Eligible subjects who received 2 doses of aH5N1c in the parent study V89_18 randomized to receive an aH5N6c vaccination on Day 1 and saline placebo on Day 22 | | OG002 | Group 3 | Eligible subjects who received placebo in the parent study V89_18 planned to receive two aH5N6c vaccinations, 3 weeks apart on Day 1 and Day 22 |
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| Secondary | Frequency of Serious AEs (SAEs), AEs Leading to Withdrawal, AEs of Special Interest (AESI) and Medically Attended AEs (MAAEs) | From vaccination until study completion | Unsolicited Safety Set defined a all subjects in the All Exposed Set with unsolicited AE data, including confirmation of absence of unsolicited AEs. | Posted | | Count of Participants | | Participants | | Day 1 through Day 202 | | | | ID | Title | Description |
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| OG000 | Group 1 | Eligible subjects who received 2 doses of aH5N1c in the parent study V89_18 randomized to receive two aH5N6c vaccinations, 3 weeks apart on Day 1 and Day 22 | | OG001 | Group 2 | Eligible subjects who received 2 doses of aH5N1c in the parent study V89_18 randomized to receive an aH5N6c vaccination on Day 1 and saline placebo on Day 22 | | OG002 | Group 3 | Eligible subjects who received placebo in the parent study V89_18 planned to receive two aH5N6c vaccinations, 3 weeks apart on Day 1 and Day 22 |
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