Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05608005 | Study on Two Adjuvanted Dose Levels of Panblok H7+MF59 Compared for Immunogenicity and Safety With an Unadjuvanted Dose of Panblok H7 in Participants 18 Years of Age and Older | PHASE1 | COMPLETED | 581 | — | — | Nov 3, 2022 | Feb 13, 2024 | Sep 24, 2025 | 16 | United States |
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 HAI antibody was measured by HIH measurement method. The 95% CI was based on the Student t-distribution of log10-transformed values.
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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 NT antibody was measured by seroneutralization (SN) measurement method. The 95% CI was based on the Student t-distribution of log10-transformed values.
The NT antibody was measured by SN measurement method. The 95% CI was based on the Student t-distribution of log10-transformed values.
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 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 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 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 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 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 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 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 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 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 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 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 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.
| Arm | Type | Description |
|---|---|---|
| Group 1 | EXPERIMENTAL | 2 doses, 21 days apart, of Panblok H7 dose 1 + MF59 |
| Group 2 | EXPERIMENTAL | 2 doses, 21 days apart, of Panblok H7 dose 2 + MF59 |
| Group 3 | ACTIVE_COMPARATOR | 2 doses, 21 days apart, of Panblok H7 dose 3 unadjuvanted |
| Name | Type | Description |
|---|---|---|
| Panblok + MF59 Dose 1 | BIOLOGICAL | Pharmaceutical form: suspension for injection Route of administration: intramuscular |
| Panblok + MF59 Dose 2 | BIOLOGICAL | Pharmaceutical form: suspension for injection Route of administration: intramuscular |
| Unadjuvanted Panblok Dose 3 | BIOLOGICAL | Pharmaceutical form: liquid for injection Route of administration: intramuscular |
Inclusion Criteria: * Aged 18 years or older on the day of inclusion * Participants who are healthy as determined by medical evaluation including medical history and physical examination * A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the followi...