| Primary | Geometric Mean of Hemagglutination Inhibition (HAI) Antibody (Ab) Titer at Day 22 | The HAI antibody was measured by hemagglutination inhibition using horse red blood cells (HIH) measurement method. The 95% confidence interval (CI) was based on the Student t-distribution of log10-transformed values. | The Full analysis set (FAS) included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Day 22 are reported. | Posted | | Geometric Mean | 95% Confidence Interval | titer | | Day 22 | | | | ID | Title | Description |
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| OG000 | Group 1: Panblok H7 (7.5 mcg) + MF59 | Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22. | | OG001 | Group 2: Panblok H7 (15 mcg) + MF59 | Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22. | | OG002 | Group 3: Panblok H7 (45 mcg) Unadjuvanted | Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG0005.74(5.44 to 6.06)
- OG0015.61(5.34 to 5.90)
- OG0025.28(5.10 to 5.47)
|
|
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| Primary | Geometric Mean of Hemagglutination Inhibition Antibody Titer at Day 43 | The HAI antibody was measured by HIH measurement method. The 95% CI was based on the Student t-distribution of log10-transformed values. | The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Day 43 are reported. | Posted | | Geometric Mean | 95% Confidence Interval | titer | | Day 43 | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Panblok H7 (7.5 mcg) + MF59 | Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22. | | OG001 | Group 2: Panblok H7 (15 mcg) + MF59 | Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22. | | OG002 | Group 3: Panblok H7 (45 mcg) Unadjuvanted | Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22. |
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| Primary | Geometric Mean Ratio of Hemagglutination Inhibition Antibody Titer at Day 22 | The HAI antibody was measured by HIH measurement method. The geometric mean ratio of antibody titer at post-vaccination over pre-vaccination is reported. The 95% CI was based on the Student t-distribution of log10-transformed values. | The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Days 1 and 22 are reported. | Posted | | Geometric Mean | 95% Confidence Interval | ratio | | Days 1 and 22 | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Panblok H7 (7.5 mcg) + MF59 | Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22. | | OG001 | Group 2: Panblok H7 (15 mcg) + MF59 | Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22. | | OG002 | Group 3: Panblok H7 (45 mcg) Unadjuvanted | Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22. |
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| Primary | Geometric Mean Ratio of Hemagglutination Inhibition Antibody Titer at Day 43 | The HAI antibody was measured by HIH measurement method. The geometric mean ratio of antibody titer at post-vaccination over pre-vaccination is reported. The 95% CI was based on the Student t-distribution of log10-transformed values. | The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Days 1 and 43 are reported. | Posted | | Geometric Mean | 95% Confidence Interval | ratio | | Days 1 and 43 | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Panblok H7 (7.5 mcg) + MF59 | Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22. | | OG001 | Group 2: Panblok H7 (15 mcg) + MF59 | Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22. | | OG002 | Group 3: Panblok H7 (45 mcg) Unadjuvanted | Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22. |
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| Primary | Geometric Mean Ratio of Hemagglutination Inhibition Antibody Titer at Day 202 | The HAI antibody was measured by HIH measurement method. The geometric mean ratio of antibody titer at post-vaccination over pre-vaccination is reported. The 95% CI was based on the Student t-distribution of log10-transformed values. | The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Days 1 and 202 are reported. | Posted | | Geometric Mean | 95% Confidence Interval | ratio | | Days 1 and 202 | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Panblok H7 (7.5 mcg) + MF59 | Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22. | | OG001 | Group 2: Panblok H7 (15 mcg) + MF59 | Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22. | | OG002 | Group 3: Panblok H7 (45 mcg) Unadjuvanted | Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22. |
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| Primary | Geometric Mean Ratio of Hemagglutination Inhibition Antibody Titer at Day 387 | The HAI antibody was measured by HIH measurement method. The geometric mean ratio of antibody titer at post-vaccination over pre-vaccination is reported. The 95% CI was based on the Student t-distribution of log10-transformed values. | The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Days 1 and 387 are reported. | Posted | | Geometric Mean | 95% Confidence Interval | ratio | | Days 1 and 387 | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Panblok H7 (7.5 mcg) + MF59 | Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22. | | OG001 | Group 2: Panblok H7 (15 mcg) + MF59 | Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22. | | OG002 | Group 3: Panblok H7 (45 mcg) Unadjuvanted | Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22. |
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| Primary | Percentage of Participants With Seroconversion of Hemagglutination Inhibition Antibody Titer at Day 22 | The seroconversion was defined as titer <10 on Day 1 and post-injection titer >=40 on Day 22 or Day 43; or defined as titer >=10 on Day 1 and a >=4-fold increase in titer on Day 22 or Day 43. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place. | The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Day 22 are reported. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Day 22 | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Panblok H7 (7.5 mcg) + MF59 | Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22. | | OG001 | Group 2: Panblok H7 (15 mcg) + MF59 | Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22. | | OG002 | Group 3: Panblok H7 (45 mcg) Unadjuvanted | Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22. |
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| Primary | Percentage of Participants With Seroconversion of Hemagglutination Inhibition Antibody Titer at Day 43 | The seroconversion was defined as titer <10 on Day 1 and post-injection titer >=40 on Day 22 or Day 43; or defined as titer >=10 on Day 1 and a >=4-fold increase in titer on Day 22 or Day 43. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place. | The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Day 43 are reported. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Day 43 | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Panblok H7 (7.5 mcg) + MF59 | Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22. | | OG001 | Group 2: Panblok H7 (15 mcg) + MF59 | Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22. | | OG002 | Group 3: Panblok H7 (45 mcg) Unadjuvanted | Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22. |
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| Primary | Percentage of Participants With Hemagglutination Inhibition Antibody Titer >=1:40 at Day 1 | The HAI antibody was measured by HIH measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place. | The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Day 1 are reported. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Panblok H7 (7.5 mcg) + MF59 | Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22. | | OG001 | Group 2: Panblok H7 (15 mcg) + MF59 | Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22. | | OG002 | Group 3: Panblok H7 (45 mcg) Unadjuvanted | Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22. |
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| Primary | Percentage of Participants With Hemagglutination Inhibition Antibody Titer >=1:40 at Day 22 | The HAI antibody was measured by HIH measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place. | The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Day 22 are reported. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Day 22 | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Panblok H7 (7.5 mcg) + MF59 | Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22. | | OG001 | Group 2: Panblok H7 (15 mcg) + MF59 | Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22. | | OG002 | Group 3: Panblok H7 (45 mcg) Unadjuvanted | Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22. |
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| Primary | Percentage of Participants With Hemagglutination Inhibition Antibody Titer >=1:40 at Day 43 | The HAI antibody was measured by HIH measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place. | The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Day 43 are reported. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Day 43 | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Panblok H7 (7.5 mcg) + MF59 | Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22. | | OG001 | Group 2: Panblok H7 (15 mcg) + MF59 | Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22. | | OG002 | Group 3: Panblok H7 (45 mcg) Unadjuvanted | Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22. |
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| Primary | Percentage of Participants With Hemagglutination Inhibition Antibody Titer >=1:40 at Day 202 | The HAI antibody was measured by HIH measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place. | The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Day 202 are reported. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Day 202 | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Panblok H7 (7.5 mcg) + MF59 | Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22. | | OG001 | Group 2: Panblok H7 (15 mcg) + MF59 | Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22. | | OG002 | Group 3: Panblok H7 (45 mcg) Unadjuvanted | Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22. |
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| Primary | Percentage of Participants With Hemagglutination Inhibition Antibody Titer >=1:40 at Day 387 | The HAI antibody was measured by HIH measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place. | The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Day 387 are reported. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Day 387 | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Panblok H7 (7.5 mcg) + MF59 | Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22. | | OG001 | Group 2: Panblok H7 (15 mcg) + MF59 | Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22. | | OG002 | Group 3: Panblok H7 (45 mcg) Unadjuvanted | Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22. |
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| Primary | Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 1 | The HAI antibody was measured by HIH measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place. | The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Day 1 are reported. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Panblok H7 (7.5 mcg) + MF59 | Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22. | | OG001 | Group 2: Panblok H7 (15 mcg) + MF59 | Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22. | | OG002 | Group 3: Panblok H7 (45 mcg) Unadjuvanted | Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22. |
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| Primary | Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 22 | The HAI antibody was measured by HIH measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place. | The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Day 22 are reported. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Day 22 | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Panblok H7 (7.5 mcg) + MF59 | Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22. | | OG001 | Group 2: Panblok H7 (15 mcg) + MF59 | Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22. | | OG002 | Group 3: Panblok H7 (45 mcg) Unadjuvanted | Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22. |
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| Primary | Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 43 | The HAI antibody was measured by HIH measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place. | The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Day 43 are reported. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Day 43 | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Panblok H7 (7.5 mcg) + MF59 | Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22. | | OG001 | Group 2: Panblok H7 (15 mcg) + MF59 | Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22. | | OG002 | Group 3: Panblok H7 (45 mcg) Unadjuvanted | Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22. |
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| Primary | Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 202 | The HAI antibody was measured by HIH measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place. | The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Day 202 are reported. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Day 202 | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Panblok H7 (7.5 mcg) + MF59 | Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22. | | OG001 | Group 2: Panblok H7 (15 mcg) + MF59 | Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22. | | OG002 | Group 3: Panblok H7 (45 mcg) Unadjuvanted | Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22. |
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| Primary | Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 387 | The HAI antibody was measured by HIH measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place. | The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Day 387 are reported. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Day 387 | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Panblok H7 (7.5 mcg) + MF59 | Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22. | | OG001 | Group 2: Panblok H7 (15 mcg) + MF59 | Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22. | | OG002 | Group 3: Panblok H7 (45 mcg) Unadjuvanted | Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22. |
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| Primary | Geometric Mean of Neutralization Test (NT) Antibody Titer at Day 22 | The NT antibody was measured by seroneutralization (SN) measurement method. The 95% CI was based on the Student t-distribution of log10-transformed values. | The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Day 22 are reported. | Posted | | Geometric Mean | 95% Confidence Interval | titer | | Day 22 | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Panblok H7 (7.5 mcg) + MF59 | Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22. | | OG001 | Group 2: Panblok H7 (15 mcg) + MF59 | Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22. | | OG002 | Group 3: Panblok H7 (45 mcg) Unadjuvanted | Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22. |
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| Primary | Geometric Mean of Neutralization Test Antibody Titer at Day 43 | The NT antibody was measured by SN measurement method. The 95% CI was based on the Student t-distribution of log10-transformed values. | The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Day 43 are reported. | Posted | | Geometric Mean | 95% Confidence Interval | titer | | Day 43 | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Panblok H7 (7.5 mcg) + MF59 | Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22. | | OG001 | Group 2: Panblok H7 (15 mcg) + MF59 | Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22. | | OG002 | Group 3: Panblok H7 (45 mcg) Unadjuvanted | Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22. |
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| Primary | Geometric Mean Ratio of Neutralization Test Antibody Titer at Day 22 | The NT antibody was measured by SN measurement method. The geometric mean ratio of antibody titer at post-vaccination over pre-vaccination is reported. The 95% CI was based on the Student t-distribution of log10-transformed values. | The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Days 1 and 22 are reported. | Posted | | Geometric Mean | 95% Confidence Interval | ratio | | Days 1 and 22 | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Panblok H7 (7.5 mcg) + MF59 | Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22. | | OG001 | Group 2: Panblok H7 (15 mcg) + MF59 | Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22. | | OG002 | Group 3: Panblok H7 (45 mcg) Unadjuvanted | Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22. |
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| Primary | Geometric Mean Ratio of Neutralization Test Antibody Titer at Day 43 | The NT antibody was measured by SN measurement method. The geometric mean ratio of antibody titer at post-vaccination over pre-vaccination is reported. The 95% CI was based on the Student t-distribution of log10-transformed values. | The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Days 1 and 43 are reported. | Posted | | Geometric Mean | 95% Confidence Interval | ratio | | Days 1 and 43 | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Panblok H7 (7.5 mcg) + MF59 | Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22. | | OG001 | Group 2: Panblok H7 (15 mcg) + MF59 | Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22. | | OG002 | Group 3: Panblok H7 (45 mcg) Unadjuvanted | Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22. |
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| Primary | Geometric Mean Ratio of Neutralization Test Antibody Titer at Day 202 | The NT antibody was measured by SN measurement method. The geometric mean ratio of antibody titer at post-vaccination over pre-vaccination is reported. The 95% CI was based on the Student t-distribution of log10-transformed values. | The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Days 1 and 202 are reported. | Posted | | Geometric Mean | 95% Confidence Interval | ratio | | Days 1 and 202 | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Panblok H7 (7.5 mcg) + MF59 | Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22. | | OG001 | Group 2: Panblok H7 (15 mcg) + MF59 | Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22. | | OG002 | Group 3: Panblok H7 (45 mcg) Unadjuvanted | Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22. |
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| Primary | Geometric Mean Ratio of Neutralization Test Antibody Titer at Day 387 | The NT antibody was measured by SN measurement method. The geometric mean ratio of antibody titer at post-vaccination over pre-vaccination is reported. The 95% CI was based on the Student t-distribution of log10-transformed values. | The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Days 1 and 387 are reported. | Posted | | Geometric Mean | 95% Confidence Interval | ratio | | Days 1 and 387 | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Panblok H7 (7.5 mcg) + MF59 | Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22. | | OG001 | Group 2: Panblok H7 (15 mcg) + MF59 | Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22. | | OG002 | Group 3: Panblok H7 (45 mcg) Unadjuvanted | Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22. |
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| Primary | Percentage of Participants With Neutralization Test Antibody Titer >=1:20, >=1:40, and >=1:80 at Day 22 | The NT antibody was measured by SN measurement method. The 95% CI was the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place. | The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Day 22 are reported. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Day 22 | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Panblok H7 (7.5 mcg) + MF59 | Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22. | | OG001 | Group 2: Panblok H7 (15 mcg) + MF59 | Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22. | | OG002 | Group 3: Panblok H7 (45 mcg) Unadjuvanted | Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22. |
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| Primary | Percentage of Participants With Neutralization Test Antibody Titer >=1:20, >=1:40, and >=1:80 at Day 43 | The NT antibody was measured by SN measurement method. The 95% CI was the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place. | The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Day 43 are reported. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Day 43 | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Panblok H7 (7.5 mcg) + MF59 | Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22. | | OG001 | Group 2: Panblok H7 (15 mcg) + MF59 | Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22. | | OG002 | Group 3: Panblok H7 (45 mcg) Unadjuvanted | Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22. |
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| Primary | Percentage of Participants With >=2 and >=4 Fold Increase in Neutralization Test Antibody Titer at Day 22 | The NT antibody was measured by SN measurement method. The 95% CI was the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place. | The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Day 22 are reported. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Day 22 | | | | ID | Title | Description |
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| OG000 | Group 1: Panblok H7 (7.5 mcg) + MF59 | Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22. | | OG001 | Group 2: Panblok H7 (15 mcg) + MF59 | Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22. | | OG002 | Group 3: Panblok H7 (45 mcg) Unadjuvanted | Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22. |
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| Primary | Percentage of Participants With >=2 and >=4 Fold Increase in Neutralization Test Antibody Titer at Day 43 | The NT antibody was measured by SN measurement method. The 95% CI was the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place. | The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Day 43 are reported. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Day 43 | | | | ID | Title | Description |
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| OG000 | Group 1: Panblok H7 (7.5 mcg) + MF59 | Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22. | | OG001 | Group 2: Panblok H7 (15 mcg) + MF59 | Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22. | | OG002 | Group 3: Panblok H7 (45 mcg) Unadjuvanted | Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22. |
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| Primary | Percentage of Participants With Detectable Neutralization Test Antibody Titer >=1:10 at Day 1 | The NT antibody was measured by SN measurement method. The 95% CI was the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place. | The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Day 1 are reported. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Day 1 | | | | ID | Title | Description |
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| OG000 | Group 1: Panblok H7 (7.5 mcg) + MF59 | Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22. | | OG001 | Group 2: Panblok H7 (15 mcg) + MF59 | Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22. | | OG002 | Group 3: Panblok H7 (45 mcg) Unadjuvanted | Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22. |
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| Primary | Percentage of Participants With Detectable Neutralization Test Antibody Titer >=1:10 at Day 22 | The NT antibody was measured by SN measurement method. The 95% CI was the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place. | The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Day 22 are reported. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Day 22 | | | | ID | Title | Description |
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| OG000 | Group 1: Panblok H7 (7.5 mcg) + MF59 | Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22. | | OG001 | Group 2: Panblok H7 (15 mcg) + MF59 | Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22. | | OG002 | Group 3: Panblok H7 (45 mcg) Unadjuvanted | Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22. |
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| Primary | Percentage of Participants With Detectable Neutralization Test Antibody Titer >=1:10 at Day 43 | The NT antibody was measured by SN measurement method. The 95% CI was the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place. | The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Day 43 are reported. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Day 43 | | | | ID | Title | Description |
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| OG000 | Group 1: Panblok H7 (7.5 mcg) + MF59 | Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22. | | OG001 | Group 2: Panblok H7 (15 mcg) + MF59 | Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22. | | OG002 | Group 3: Panblok H7 (45 mcg) Unadjuvanted | Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22. |
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| Primary | Percentage of Participants With Detectable Neutralization Test Antibody Titer >=1:10 at Day 202 | The NT antibody was measured by SN measurement method. The 95% CI was the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place. | The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Day 202 are reported. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Day 202 | | | | ID | Title | Description |
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| OG000 | Group 1: Panblok H7 (7.5 mcg) + MF59 | Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22. | | OG001 | Group 2: Panblok H7 (15 mcg) + MF59 | Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22. | | OG002 | Group 3: Panblok H7 (45 mcg) Unadjuvanted | Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22. |
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| Primary | Percentage of Participants With Detectable Neutralization Test Antibody Titer >=1:10 at Day 387 | The NT antibody was measured by SN measurement method. The 95% CI was the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place. | The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Day 387 are reported. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Day 387 | | | | ID | Title | Description |
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| OG000 | Group 1: Panblok H7 (7.5 mcg) + MF59 | Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22. | | OG001 | Group 2: Panblok H7 (15 mcg) + MF59 | Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22. | | OG002 | Group 3: Panblok H7 (45 mcg) Unadjuvanted | Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22. |
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| Secondary | Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study vaccine, whether or not considered related to the study vaccine. An unsolicited AE is an observed AE that does not fulfill the conditions of solicited reactions, that is, pre-listed in the case report form in terms of diagnosis and onset window post-vaccination. Systemic AEs are all AEs that were not injection or administration site reactions. Immediate events are recorded to capture medically relevant unsolicited systemic AEs which occur within the first 30 minutes after vaccination. | The Safety analysis set included all participants who had received at least 1 study vaccine. | Posted | | Count of Participants | | Participants | | Up to 30 minutes after each vaccination | | | | ID | Title | Description |
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| OG000 | Group 1: Panblok H7 (7.5 mcg) + MF59 | Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22. | | OG001 | Group 2: Panblok H7 (15 mcg) + MF59 | Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22. | | OG002 | Group 3: Panblok H7 (45 mcg) Unadjuvanted | |
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| Secondary | Number of Participants With Solicited Injection Site Reactions and Systemic Reactions | An adverse reaction (AR) is any noxious and unintended response to a study vaccine related to any dose. A solicited reaction is an "expected" AR (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and case report form. An injection/administration site reaction is an AR at and around the injection/administration site of the investigational medical product. Systemic ARs are all ARs that are not injection or administration site reactions. | The Safety analysis set included all participants who had received at least 1 study vaccine. Only participants analyzed for specific parameter are reported. | Posted | | Count of Participants | | Participants | | Up to 7 days after each vaccination | | | | ID | Title | Description |
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| OG000 | Group 1: Panblok H7 (7.5 mcg) + MF59 | Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22. | | OG001 | Group 2: Panblok H7 (15 mcg) + MF59 | Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22. | | OG002 | Group 3: Panblok H7 (45 mcg) Unadjuvanted | Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22. |
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| Secondary | Number of Participants With Unsolicited AEs | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study vaccine, whether or not considered related to the study vaccine. An unsolicited AE is an observed AE that does not fulfill the conditions of solicited reactions, that is, pre-listed in the case report form in terms of diagnosis and onset window post-vaccination. | The Safety analysis set included all participants who had received at least 1 study vaccine. | Posted | | Count of Participants | | Participants | | Up to 21 days after each vaccination | | | | ID | Title | Description |
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| OG000 | Group 1: Panblok H7 (7.5 mcg) + MF59 | Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22. | | OG001 | Group 2: Panblok H7 (15 mcg) + MF59 | Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22. | | OG002 | Group 3: Panblok H7 (45 mcg) Unadjuvanted | Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22. |
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| Secondary | Number of Participants With Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESIs) and Medically Attended Adverse Events (MAAEs) | An SAE is any untoward medical occurrence that at any dose results in death or is life-threatening or requires inpatient hospitalization or prolongation of existing hospitalization or results in persistent or significant disability/incapacity or is a congenital anomaly/birth defect or is an important medical event. An AESI (serious or non-serious) is one of scientific and medical concern specific to the Sponsor's study vaccine or program, for which ongoing monitoring and rapid communication by the investigator to the Sponsor can be appropriate. An MAAE is a new onset or a worsening of a condition that prompts the participant to seek unplanned medical advice at a physician's office or Emergency Department. | The Safety analysis set included all participants who had received at least 1 study vaccine. | Posted | | Count of Participants | | Participants | | From first dose vaccine administration (Day 1) until 12 months after the last dose administration, 387 days | | | | ID | Title | Description |
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| OG000 | Group 1: Panblok H7 (7.5 mcg) + MF59 | Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22. | | OG001 | Group 2: Panblok H7 (15 mcg) + MF59 | Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22. |
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