Healthy Volunteers, Influenza
Conditions
Brief summary
VAM00001 is a Phase I/II, randomized, modified double-blind, multi-center study. The purpose of this study is to compare 2 dose levels of Panblok H7 (dose 1 and dose 2 of rHA) with a standard squalene dose of adjuvant MF59 to Panblok H7 (dose 3) unadjuvanted in approximately 700 adult participants in order to select one dose formulation to be used for further clinical development. The randomization ratio will be 3:3:1 for Panblok H7 (dose 1) + MF59, Panblok H7 (dose 2) + MF59, and Panblok H7 (dose 3) unadjuvanted, respectively. Each study group will be stratified into the age groups 18-64 years and ≥ 65 years of age. The study duration for each participant will be approximately 13 months.
Detailed description
The study duration for each participant will be approximately 13 months.
Interventions
BIOLOGICALPanblok + MF59 Dose 1
Pharmaceutical form: suspension for injection Route of administration: intramuscular
BIOLOGICALPanblok + MF59 Dose 2
Pharmaceutical form: suspension for injection Route of administration: intramuscular
BIOLOGICALUnadjuvanted Panblok Dose 3
Pharmaceutical form: liquid for injection Route of administration: intramuscular
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Modified double-blind: * Investigators and study staff who conduct the safety assessment, laboratory personnel who analyze the blood samples, Sponsor's personnel and study Team members, and the participant will not know which study dose is administered * Only the study staff who prepare and administer the study intervention and are not involved with the safety evaluation will know which study dose is administered
Intervention model description
Eligible participants (18-64 years of age and ≥65 years of age) will be randomized in a 3:3:1 ratio to receive 2 doses, 21 days apart, by intramuscular (IM) route of either Panblok H7+MF59 (dose 1), Panblok H7+MF59 (dose 2), or unadjuvanted Panblok H7 (dose 3) at D01.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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 following conditions applies: Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year, or surgically sterile. OR Is of childbearing potential and agrees to use a highly effective contraceptive method or abstinence from at least 4 weeks prior to each study intervention administration until at least 12 weeks after the last study intervention administration. * A female participant of childbearing potential must have a negative highly sensitive pregnancy test (urine or serum as required by local regulation) within 24 hours before the first dose of study intervention * Informed consent form has been signed and dated
Exclusion criteria
Participants are excluded from the study if any of the following criteria apply: * Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months) * Known systemic hypersensitivity to any of the study intervention components, or history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances * Thrombocytopenia or bleeding disorder contraindicating intramuscular injection based on investigator's judgement * Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion (1) (1) Chronic illness may include, but is not limited to, cardiac disorders, renal disorders, auto-immune disorders, diabetes, psychiatric disorders, or chronic infection * Neoplastic disease or any hematologic malignancy (except localized skin or prostate cancer that is stable at the time of study intervention administration in the absence of therapy, and participants who have a history of neoplastic disease and who have been disease-free for ≥ 5 years) * Moderate or severe acute illness/infection (according to investigator judgment) or febrile illness (temperature ≥ 100.4°F) on the day of study intervention administration. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided * Alcohol, prescription drug, or substance abuse that, in the opinion of the Investigator, might interfere with the study conduct or completion * Receipt of any vaccine in the 14 days preceding Visit 1 or planned receipt of any vaccine prior to Visit 3, except for seasonal flu vaccine, which may be received at least 2 weeks after Visit 2 * Previous vaccination against H7N9 with an investigational vaccine * Receipt of immune globulins, blood or blood-derived products in the past 3 months * Participation at the time of study enrollment (or in the 4 weeks preceding the first study intervention administration) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure * Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily * Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (ie, parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study * Personal or family history of Guillain-Barré syndrome * Self-reported seropositivity for Hepatitis B antigen or Hepatitis C The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Detectable Neutralization Test Antibody Titer >=1:10 at Day 387 | 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. |
| Percentage of Participants With Detectable Neutralization Test Antibody Titer >=1:10 at Day 1 | 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. |
| Percentage of Participants With Detectable Neutralization Test Antibody Titer >=1:10 at Day 22 | 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. |
| Percentage of Participants With Detectable Neutralization Test Antibody Titer >=1:10 at Day 43 | 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. |
| Percentage of Participants With Detectable Neutralization Test Antibody Titer >=1:10 at Day 202 | 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. |
| Geometric Mean of Hemagglutination Inhibition (HAI) Antibody (Ab) Titer at Day 22 | 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. |
| Geometric Mean of Hemagglutination Inhibition Antibody Titer at Day 43 | 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. |
| Geometric Mean Ratio of Hemagglutination Inhibition Antibody Titer at Day 22 | Days 1 and 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. |
| Geometric Mean Ratio of Hemagglutination Inhibition Antibody Titer at Day 43 | Days 1 and 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. |
| Geometric Mean Ratio of Hemagglutination Inhibition Antibody Titer at Day 202 | Days 1 and 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. |
| Geometric Mean Ratio of Hemagglutination Inhibition Antibody Titer at Day 387 | Days 1 and 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. |
| Percentage of Participants With Seroconversion of Hemagglutination Inhibition Antibody Titer at Day 22 | 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. |
| Percentage of Participants With Seroconversion of Hemagglutination Inhibition Antibody Titer at Day 43 | 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. |
| Percentage of Participants With Hemagglutination Inhibition Antibody Titer >=1:40 at Day 1 | 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. |
| Percentage of Participants With Hemagglutination Inhibition Antibody Titer >=1:40 at Day 22 | 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. |
| Percentage of Participants With Hemagglutination Inhibition Antibody Titer >=1:40 at Day 43 | 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. |
| Percentage of Participants With Hemagglutination Inhibition Antibody Titer >=1:40 at Day 202 | 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. |
| Percentage of Participants With Hemagglutination Inhibition Antibody Titer >=1:40 at Day 387 | 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. |
| Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 1 | 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. |
| Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 22 | 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. |
| Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 43 | 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. |
| Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 202 | 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. |
| Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 387 | 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. |
| Geometric Mean of Neutralization Test (NT) Antibody Titer at Day 22 | 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. |
| Geometric Mean of Neutralization Test Antibody Titer at Day 43 | 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. |
| Geometric Mean Ratio of Neutralization Test Antibody Titer at Day 22 | Days 1 and 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. |
| Geometric Mean Ratio of Neutralization Test Antibody Titer at Day 43 | Days 1 and 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. |
| Geometric Mean Ratio of Neutralization Test Antibody Titer at Day 202 | Days 1 and 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. |
| Geometric Mean Ratio of Neutralization Test Antibody Titer at Day 387 | Days 1 and 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. |
| Percentage of Participants With Neutralization Test Antibody Titer >=1:20, >=1:40, and >=1:80 at Day 22 | 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. |
| Percentage of Participants With Neutralization Test Antibody Titer >=1:20, >=1:40, and >=1:80 at Day 43 | 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. |
| Percentage of Participants With >=2 and >=4 Fold Increase in Neutralization Test Antibody Titer at Day 22 | 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. |
| Percentage of Participants With >=2 and >=4 Fold Increase in Neutralization Test Antibody Titer at Day 43 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Solicited Injection Site Reactions and Systemic Reactions | Up to 7 days after each vaccination | 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. |
| Number of Participants With Unsolicited AEs | Up to 21 days after each vaccination | 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. |
| Number of Participants With Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESIs) and Medically Attended Adverse Events (MAAEs) | From first dose vaccine administration (Day 1) until 12 months after the last dose administration, 387 days | 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. |
| Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs) | Up to 30 minutes after each vaccination | 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. |
Countries
United States
Participant flow
Recruitment details
The study was conducted at 16 centers in the United States between 03 November 2022 and 13 February 2024.
Pre-assignment details
A total of 581 participants were enrolled and randomized in the study.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 243 |
| Group 2: Panblok H7 (15 mcg) + MF59 Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22. | 246 |
| Group 3: Panblok H7 (45 mcg) Unadjuvanted Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22. | 84 |
| Total | 573 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 1 | 3 |
| Overall Study | Lost to Follow-up | 25 | 27 | 15 |
| Overall Study | Participants were not vaccinated or withdrew for other reasons | 6 | 7 | 0 |
| Overall Study | Protocol Violation | 2 | 3 | 0 |
| Overall Study | Withdrawal by Subject | 10 | 12 | 4 |
Baseline characteristics
| Characteristic | Group 1: Panblok H7 (7.5 mcg) + MF59 | Group 2: Panblok H7 (15 mcg) + MF59 | Group 3: Panblok H7 (45 mcg) Unadjuvanted | Total |
|---|---|---|---|---|
| Age, Continuous | 56.6 years STANDARD_DEVIATION 15.2 | 56.2 years STANDARD_DEVIATION 15.3 | 54.7 years STANDARD_DEVIATION 17.1 | 56.2 years STANDARD_DEVIATION 15.5 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 2 Participants | 1 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Black or African American | 67 Participants | 62 Participants | 17 Participants | 146 Participants |
| Race/Ethnicity, Customized Multiple origin | 0 Participants | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Not Reported | 4 Participants | 2 Participants | 0 Participants | 6 Participants |
| Race/Ethnicity, Customized Unknown | 1 Participants | 3 Participants | 0 Participants | 4 Participants |
| Race/Ethnicity, Customized White | 168 Participants | 173 Participants | 67 Participants | 408 Participants |
| Sex: Female, Male Female | 127 Participants | 125 Participants | 47 Participants | 299 Participants |
| Sex: Female, Male Male | 116 Participants | 121 Participants | 37 Participants | 274 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 243 | 1 / 246 | 0 / 84 |
| other Total, other adverse events | 82 / 243 | 82 / 246 | 23 / 84 |
| serious Total, serious adverse events | 11 / 243 | 12 / 246 | 6 / 84 |
Outcome results
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.
Time frame: Day 43
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1: Panblok H7 (7.5 mcg) + MF59 | Geometric Mean of Hemagglutination Inhibition Antibody Titer at Day 43 | 12.6 titer |
| Group 2: Panblok H7 (15 mcg) + MF59 | Geometric Mean of Hemagglutination Inhibition Antibody Titer at Day 43 | 13.4 titer |
| Group 3: Panblok H7 (45 mcg) Unadjuvanted | Geometric Mean of Hemagglutination Inhibition Antibody Titer at Day 43 | 5.80 titer |
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.
Time frame: Day 22
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1: Panblok H7 (7.5 mcg) + MF59 | Geometric Mean of Hemagglutination Inhibition (HAI) Antibody (Ab) Titer at Day 22 | 5.74 titer |
| Group 2: Panblok H7 (15 mcg) + MF59 | Geometric Mean of Hemagglutination Inhibition (HAI) Antibody (Ab) Titer at Day 22 | 5.61 titer |
| Group 3: Panblok H7 (45 mcg) Unadjuvanted | Geometric Mean of Hemagglutination Inhibition (HAI) Antibody (Ab) Titer at Day 22 | 5.28 titer |
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.
Time frame: Day 43
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1: Panblok H7 (7.5 mcg) + MF59 | Geometric Mean of Neutralization Test Antibody Titer at Day 43 | 26.8 titer |
| Group 2: Panblok H7 (15 mcg) + MF59 | Geometric Mean of Neutralization Test Antibody Titer at Day 43 | 25.8 titer |
| Group 3: Panblok H7 (45 mcg) Unadjuvanted | Geometric Mean of Neutralization Test Antibody Titer at Day 43 | 11.5 titer |
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.
Time frame: Day 22
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1: Panblok H7 (7.5 mcg) + MF59 | Geometric Mean of Neutralization Test (NT) Antibody Titer at Day 22 | 7.23 titer |
| Group 2: Panblok H7 (15 mcg) + MF59 | Geometric Mean of Neutralization Test (NT) Antibody Titer at Day 22 | 6.85 titer |
| Group 3: Panblok H7 (45 mcg) Unadjuvanted | Geometric Mean of Neutralization Test (NT) Antibody Titer at Day 22 | 6.88 titer |
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.
Time frame: Days 1 and 202
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1: Panblok H7 (7.5 mcg) + MF59 | Geometric Mean Ratio of Hemagglutination Inhibition Antibody Titer at Day 202 | 1.01 ratio |
| Group 2: Panblok H7 (15 mcg) + MF59 | Geometric Mean Ratio of Hemagglutination Inhibition Antibody Titer at Day 202 | 0.966 ratio |
| Group 3: Panblok H7 (45 mcg) Unadjuvanted | Geometric Mean Ratio of Hemagglutination Inhibition Antibody Titer at Day 202 | 0.990 ratio |
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.
Time frame: Days 1 and 22
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1: Panblok H7 (7.5 mcg) + MF59 | Geometric Mean Ratio of Hemagglutination Inhibition Antibody Titer at Day 22 | 1.09 ratio |
| Group 2: Panblok H7 (15 mcg) + MF59 | Geometric Mean Ratio of Hemagglutination Inhibition Antibody Titer at Day 22 | 1.05 ratio |
| Group 3: Panblok H7 (45 mcg) Unadjuvanted | Geometric Mean Ratio of Hemagglutination Inhibition Antibody Titer at Day 22 | 1.03 ratio |
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.
Time frame: Days 1 and 387
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1: Panblok H7 (7.5 mcg) + MF59 | Geometric Mean Ratio of Hemagglutination Inhibition Antibody Titer at Day 387 | 0.998 ratio |
| Group 2: Panblok H7 (15 mcg) + MF59 | Geometric Mean Ratio of Hemagglutination Inhibition Antibody Titer at Day 387 | 0.976 ratio |
| Group 3: Panblok H7 (45 mcg) Unadjuvanted | Geometric Mean Ratio of Hemagglutination Inhibition Antibody Titer at Day 387 | 0.978 ratio |
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.
Time frame: Days 1 and 43
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1: Panblok H7 (7.5 mcg) + MF59 | Geometric Mean Ratio of Hemagglutination Inhibition Antibody Titer at Day 43 | 2.39 ratio |
| Group 2: Panblok H7 (15 mcg) + MF59 | Geometric Mean Ratio of Hemagglutination Inhibition Antibody Titer at Day 43 | 2.52 ratio |
| Group 3: Panblok H7 (45 mcg) Unadjuvanted | Geometric Mean Ratio of Hemagglutination Inhibition Antibody Titer at Day 43 | 1.13 ratio |
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.
Time frame: Days 1 and 202
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1: Panblok H7 (7.5 mcg) + MF59 | Geometric Mean Ratio of Neutralization Test Antibody Titer at Day 202 | 1.20 ratio |
| Group 2: Panblok H7 (15 mcg) + MF59 | Geometric Mean Ratio of Neutralization Test Antibody Titer at Day 202 | 1.17 ratio |
| Group 3: Panblok H7 (45 mcg) Unadjuvanted | Geometric Mean Ratio of Neutralization Test Antibody Titer at Day 202 | 0.856 ratio |
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.
Time frame: Days 1 and 22
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1: Panblok H7 (7.5 mcg) + MF59 | Geometric Mean Ratio of Neutralization Test Antibody Titer at Day 22 | 1.21 ratio |
| Group 2: Panblok H7 (15 mcg) + MF59 | Geometric Mean Ratio of Neutralization Test Antibody Titer at Day 22 | 1.14 ratio |
| Group 3: Panblok H7 (45 mcg) Unadjuvanted | Geometric Mean Ratio of Neutralization Test Antibody Titer at Day 22 | 1.09 ratio |
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.
Time frame: Days 1 and 387
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1: Panblok H7 (7.5 mcg) + MF59 | Geometric Mean Ratio of Neutralization Test Antibody Titer at Day 387 | 1.20 ratio |
| Group 2: Panblok H7 (15 mcg) + MF59 | Geometric Mean Ratio of Neutralization Test Antibody Titer at Day 387 | 1.18 ratio |
| Group 3: Panblok H7 (45 mcg) Unadjuvanted | Geometric Mean Ratio of Neutralization Test Antibody Titer at Day 387 | 0.909 ratio |
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.
Time frame: Days 1 and 43
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1: Panblok H7 (7.5 mcg) + MF59 | Geometric Mean Ratio of Neutralization Test Antibody Titer at Day 43 | 4.51 ratio |
| Group 2: Panblok H7 (15 mcg) + MF59 | Geometric Mean Ratio of Neutralization Test Antibody Titer at Day 43 | 4.29 ratio |
| Group 3: Panblok H7 (45 mcg) Unadjuvanted | Geometric Mean Ratio of Neutralization Test Antibody Titer at Day 43 | 1.86 ratio |
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.
Time frame: Day 22
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Panblok H7 (7.5 mcg) + MF59 | Percentage of Participants With >=2 and >=4 Fold Increase in Neutralization Test Antibody Titer at Day 22 | >=2 fold increase | 22.2 percentage of participants |
| Group 1: Panblok H7 (7.5 mcg) + MF59 | Percentage of Participants With >=2 and >=4 Fold Increase in Neutralization Test Antibody Titer at Day 22 | >=4 fold increase | 7.8 percentage of participants |
| Group 2: Panblok H7 (15 mcg) + MF59 | Percentage of Participants With >=2 and >=4 Fold Increase in Neutralization Test Antibody Titer at Day 22 | >=2 fold increase | 17.2 percentage of participants |
| Group 2: Panblok H7 (15 mcg) + MF59 | Percentage of Participants With >=2 and >=4 Fold Increase in Neutralization Test Antibody Titer at Day 22 | >=4 fold increase | 6.0 percentage of participants |
| Group 3: Panblok H7 (45 mcg) Unadjuvanted | Percentage of Participants With >=2 and >=4 Fold Increase in Neutralization Test Antibody Titer at Day 22 | >=2 fold increase | 18.4 percentage of participants |
| Group 3: Panblok H7 (45 mcg) Unadjuvanted | Percentage of Participants With >=2 and >=4 Fold Increase in Neutralization Test Antibody Titer at Day 22 | >=4 fold increase | 5.3 percentage of participants |
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.
Time frame: Day 43
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Panblok H7 (7.5 mcg) + MF59 | Percentage of Participants With >=2 and >=4 Fold Increase in Neutralization Test Antibody Titer at Day 43 | >=2 fold increase | 64.6 percentage of participants |
| Group 1: Panblok H7 (7.5 mcg) + MF59 | Percentage of Participants With >=2 and >=4 Fold Increase in Neutralization Test Antibody Titer at Day 43 | >=4 fold increase | 51.1 percentage of participants |
| Group 2: Panblok H7 (15 mcg) + MF59 | Percentage of Participants With >=2 and >=4 Fold Increase in Neutralization Test Antibody Titer at Day 43 | >=2 fold increase | 71.4 percentage of participants |
| Group 2: Panblok H7 (15 mcg) + MF59 | Percentage of Participants With >=2 and >=4 Fold Increase in Neutralization Test Antibody Titer at Day 43 | >=4 fold increase | 51.9 percentage of participants |
| Group 3: Panblok H7 (45 mcg) Unadjuvanted | Percentage of Participants With >=2 and >=4 Fold Increase in Neutralization Test Antibody Titer at Day 43 | >=2 fold increase | 48.6 percentage of participants |
| Group 3: Panblok H7 (45 mcg) Unadjuvanted | Percentage of Participants With >=2 and >=4 Fold Increase in Neutralization Test Antibody Titer at Day 43 | >=4 fold increase | 26.4 percentage of participants |
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.
Time frame: Day 1
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: Panblok H7 (7.5 mcg) + MF59 | Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 1 | 3.4 percentage of participants |
| Group 2: Panblok H7 (15 mcg) + MF59 | Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 1 | 3.4 percentage of participants |
| Group 3: Panblok H7 (45 mcg) Unadjuvanted | Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 1 | 1.3 percentage of participants |
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.
Time frame: Day 202
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: Panblok H7 (7.5 mcg) + MF59 | Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 202 | 3.3 percentage of participants |
| Group 2: Panblok H7 (15 mcg) + MF59 | Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 202 | 2.4 percentage of participants |
| Group 3: Panblok H7 (45 mcg) Unadjuvanted | Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 202 | 1.5 percentage of participants |
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.
Time frame: Day 22
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: Panblok H7 (7.5 mcg) + MF59 | Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 22 | 6.9 percentage of participants |
| Group 2: Panblok H7 (15 mcg) + MF59 | Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 22 | 6.5 percentage of participants |
| Group 3: Panblok H7 (45 mcg) Unadjuvanted | Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 22 | 2.6 percentage of participants |
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.
Time frame: Day 387
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: Panblok H7 (7.5 mcg) + MF59 | Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 387 | 3.0 percentage of participants |
| Group 2: Panblok H7 (15 mcg) + MF59 | Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 387 | 2.5 percentage of participants |
| Group 3: Panblok H7 (45 mcg) Unadjuvanted | Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 387 | 0.0 percentage of participants |
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.
Time frame: Day 43
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: Panblok H7 (7.5 mcg) + MF59 | Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 43 | 46.9 percentage of participants |
| Group 2: Panblok H7 (15 mcg) + MF59 | Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 43 | 52.4 percentage of participants |
| Group 3: Panblok H7 (45 mcg) Unadjuvanted | Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 43 | 9.7 percentage of participants |
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.
Time frame: Day 1
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: Panblok H7 (7.5 mcg) + MF59 | Percentage of Participants With Detectable Neutralization Test Antibody Titer >=1:10 at Day 1 | 14.2 percentage of participants |
| Group 2: Panblok H7 (15 mcg) + MF59 | Percentage of Participants With Detectable Neutralization Test Antibody Titer >=1:10 at Day 1 | 15.5 percentage of participants |
| Group 3: Panblok H7 (45 mcg) Unadjuvanted | Percentage of Participants With Detectable Neutralization Test Antibody Titer >=1:10 at Day 1 | 18.4 percentage of participants |
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.
Time frame: Day 202
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: Panblok H7 (7.5 mcg) + MF59 | Percentage of Participants With Detectable Neutralization Test Antibody Titer >=1:10 at Day 202 | 25.7 percentage of participants |
| Group 2: Panblok H7 (15 mcg) + MF59 | Percentage of Participants With Detectable Neutralization Test Antibody Titer >=1:10 at Day 202 | 25.0 percentage of participants |
| Group 3: Panblok H7 (45 mcg) Unadjuvanted | Percentage of Participants With Detectable Neutralization Test Antibody Titer >=1:10 at Day 202 | 6.1 percentage of participants |
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.
Time frame: Day 22
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: Panblok H7 (7.5 mcg) + MF59 | Percentage of Participants With Detectable Neutralization Test Antibody Titer >=1:10 at Day 22 | 26.8 percentage of participants |
| Group 2: Panblok H7 (15 mcg) + MF59 | Percentage of Participants With Detectable Neutralization Test Antibody Titer >=1:10 at Day 22 | 24.1 percentage of participants |
| Group 3: Panblok H7 (45 mcg) Unadjuvanted | Percentage of Participants With Detectable Neutralization Test Antibody Titer >=1:10 at Day 22 | 26.3 percentage of participants |
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.
Time frame: Day 387
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: Panblok H7 (7.5 mcg) + MF59 | Percentage of Participants With Detectable Neutralization Test Antibody Titer >=1:10 at Day 387 | 24.1 percentage of participants |
| Group 2: Panblok H7 (15 mcg) + MF59 | Percentage of Participants With Detectable Neutralization Test Antibody Titer >=1:10 at Day 387 | 26.3 percentage of participants |
| Group 3: Panblok H7 (45 mcg) Unadjuvanted | Percentage of Participants With Detectable Neutralization Test Antibody Titer >=1:10 at Day 387 | 8.2 percentage of participants |
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.
Time frame: Day 43
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: Panblok H7 (7.5 mcg) + MF59 | Percentage of Participants With Detectable Neutralization Test Antibody Titer >=1:10 at Day 43 | 69.6 percentage of participants |
| Group 2: Panblok H7 (15 mcg) + MF59 | Percentage of Participants With Detectable Neutralization Test Antibody Titer >=1:10 at Day 43 | 76.2 percentage of participants |
| Group 3: Panblok H7 (45 mcg) Unadjuvanted | Percentage of Participants With Detectable Neutralization Test Antibody Titer >=1:10 at Day 43 | 54.2 percentage of participants |
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.
Time frame: Day 1
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: Panblok H7 (7.5 mcg) + MF59 | Percentage of Participants With Hemagglutination Inhibition Antibody Titer >=1:40 at Day 1 | 0.0 percentage of participants |
| Group 2: Panblok H7 (15 mcg) + MF59 | Percentage of Participants With Hemagglutination Inhibition Antibody Titer >=1:40 at Day 1 | 0.9 percentage of participants |
| Group 3: Panblok H7 (45 mcg) Unadjuvanted | Percentage of Participants With Hemagglutination Inhibition Antibody Titer >=1:40 at Day 1 | 0.0 percentage of participants |
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.
Time frame: Day 202
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: Panblok H7 (7.5 mcg) + MF59 | Percentage of Participants With Hemagglutination Inhibition Antibody Titer >=1:40 at Day 202 | 0.5 percentage of participants |
| Group 2: Panblok H7 (15 mcg) + MF59 | Percentage of Participants With Hemagglutination Inhibition Antibody Titer >=1:40 at Day 202 | 0.0 percentage of participants |
| Group 3: Panblok H7 (45 mcg) Unadjuvanted | Percentage of Participants With Hemagglutination Inhibition Antibody Titer >=1:40 at Day 202 | 0.0 percentage of participants |
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.
Time frame: Day 22
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: Panblok H7 (7.5 mcg) + MF59 | Percentage of Participants With Hemagglutination Inhibition Antibody Titer >=1:40 at Day 22 | 2.2 percentage of participants |
| Group 2: Panblok H7 (15 mcg) + MF59 | Percentage of Participants With Hemagglutination Inhibition Antibody Titer >=1:40 at Day 22 | 0.9 percentage of participants |
| Group 3: Panblok H7 (45 mcg) Unadjuvanted | Percentage of Participants With Hemagglutination Inhibition Antibody Titer >=1:40 at Day 22 | 0.0 percentage of participants |
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.
Time frame: Day 387
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: Panblok H7 (7.5 mcg) + MF59 | Percentage of Participants With Hemagglutination Inhibition Antibody Titer >=1:40 at Day 387 | 0.0 percentage of participants |
| Group 2: Panblok H7 (15 mcg) + MF59 | Percentage of Participants With Hemagglutination Inhibition Antibody Titer >=1:40 at Day 387 | 0.0 percentage of participants |
| Group 3: Panblok H7 (45 mcg) Unadjuvanted | Percentage of Participants With Hemagglutination Inhibition Antibody Titer >=1:40 at Day 387 | 0.0 percentage of participants |
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.
Time frame: Day 43
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: Panblok H7 (7.5 mcg) + MF59 | Percentage of Participants With Hemagglutination Inhibition Antibody Titer >=1:40 at Day 43 | 23.2 percentage of participants |
| Group 2: Panblok H7 (15 mcg) + MF59 | Percentage of Participants With Hemagglutination Inhibition Antibody Titer >=1:40 at Day 43 | 23.4 percentage of participants |
| Group 3: Panblok H7 (45 mcg) Unadjuvanted | Percentage of Participants With Hemagglutination Inhibition Antibody Titer >=1:40 at Day 43 | 1.4 percentage of participants |
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.
Time frame: Day 22
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Panblok H7 (7.5 mcg) + MF59 | Percentage of Participants With Neutralization Test Antibody Titer >=1:20, >=1:40, and >=1:80 at Day 22 | Antibody Titer >=1:40 | 2.2 percentage of participants |
| Group 1: Panblok H7 (7.5 mcg) + MF59 | Percentage of Participants With Neutralization Test Antibody Titer >=1:20, >=1:40, and >=1:80 at Day 22 | Antibody Titer >=1:20 | 10.0 percentage of participants |
| Group 1: Panblok H7 (7.5 mcg) + MF59 | Percentage of Participants With Neutralization Test Antibody Titer >=1:20, >=1:40, and >=1:80 at Day 22 | Antibody Titer >=1:80 | 1.3 percentage of participants |
| Group 2: Panblok H7 (15 mcg) + MF59 | Percentage of Participants With Neutralization Test Antibody Titer >=1:20, >=1:40, and >=1:80 at Day 22 | Antibody Titer >=1:40 | 2.2 percentage of participants |
| Group 2: Panblok H7 (15 mcg) + MF59 | Percentage of Participants With Neutralization Test Antibody Titer >=1:20, >=1:40, and >=1:80 at Day 22 | Antibody Titer >=1:20 | 7.3 percentage of participants |
| Group 2: Panblok H7 (15 mcg) + MF59 | Percentage of Participants With Neutralization Test Antibody Titer >=1:20, >=1:40, and >=1:80 at Day 22 | Antibody Titer >=1:80 | 0.9 percentage of participants |
| Group 3: Panblok H7 (45 mcg) Unadjuvanted | Percentage of Participants With Neutralization Test Antibody Titer >=1:20, >=1:40, and >=1:80 at Day 22 | Antibody Titer >=1:20 | 7.9 percentage of participants |
| Group 3: Panblok H7 (45 mcg) Unadjuvanted | Percentage of Participants With Neutralization Test Antibody Titer >=1:20, >=1:40, and >=1:80 at Day 22 | Antibody Titer >=1:80 | 0.0 percentage of participants |
| Group 3: Panblok H7 (45 mcg) Unadjuvanted | Percentage of Participants With Neutralization Test Antibody Titer >=1:20, >=1:40, and >=1:80 at Day 22 | Antibody Titer >=1:40 | 0.0 percentage of participants |
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.
Time frame: Day 43
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Panblok H7 (7.5 mcg) + MF59 | Percentage of Participants With Neutralization Test Antibody Titer >=1:20, >=1:40, and >=1:80 at Day 43 | Antibody Titer >=1:40 | 35.7 percentage of participants |
| Group 1: Panblok H7 (7.5 mcg) + MF59 | Percentage of Participants With Neutralization Test Antibody Titer >=1:20, >=1:40, and >=1:80 at Day 43 | Antibody Titer >=1:20 | 54.9 percentage of participants |
| Group 1: Panblok H7 (7.5 mcg) + MF59 | Percentage of Participants With Neutralization Test Antibody Titer >=1:20, >=1:40, and >=1:80 at Day 43 | Antibody Titer >=1:80 | 22.3 percentage of participants |
| Group 2: Panblok H7 (15 mcg) + MF59 | Percentage of Participants With Neutralization Test Antibody Titer >=1:20, >=1:40, and >=1:80 at Day 43 | Antibody Titer >=1:40 | 35.1 percentage of participants |
| Group 2: Panblok H7 (15 mcg) + MF59 | Percentage of Participants With Neutralization Test Antibody Titer >=1:20, >=1:40, and >=1:80 at Day 43 | Antibody Titer >=1:20 | 55.8 percentage of participants |
| Group 2: Panblok H7 (15 mcg) + MF59 | Percentage of Participants With Neutralization Test Antibody Titer >=1:20, >=1:40, and >=1:80 at Day 43 | Antibody Titer >=1:80 | 16.0 percentage of participants |
| Group 3: Panblok H7 (45 mcg) Unadjuvanted | Percentage of Participants With Neutralization Test Antibody Titer >=1:20, >=1:40, and >=1:80 at Day 43 | Antibody Titer >=1:20 | 29.2 percentage of participants |
| Group 3: Panblok H7 (45 mcg) Unadjuvanted | Percentage of Participants With Neutralization Test Antibody Titer >=1:20, >=1:40, and >=1:80 at Day 43 | Antibody Titer >=1:80 | 2.8 percentage of participants |
| Group 3: Panblok H7 (45 mcg) Unadjuvanted | Percentage of Participants With Neutralization Test Antibody Titer >=1:20, >=1:40, and >=1:80 at Day 43 | Antibody Titer >=1:40 | 11.1 percentage of participants |
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.
Time frame: Day 22
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: Panblok H7 (7.5 mcg) + MF59 | Percentage of Participants With Seroconversion of Hemagglutination Inhibition Antibody Titer at Day 22 | 2.2 percentage of participants |
| Group 2: Panblok H7 (15 mcg) + MF59 | Percentage of Participants With Seroconversion of Hemagglutination Inhibition Antibody Titer at Day 22 | 0.4 percentage of participants |
| Group 3: Panblok H7 (45 mcg) Unadjuvanted | Percentage of Participants With Seroconversion of Hemagglutination Inhibition Antibody Titer at Day 22 | 0.0 percentage of participants |
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.
Time frame: Day 43
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: Panblok H7 (7.5 mcg) + MF59 | Percentage of Participants With Seroconversion of Hemagglutination Inhibition Antibody Titer at Day 43 | 22.9 percentage of participants |
| Group 2: Panblok H7 (15 mcg) + MF59 | Percentage of Participants With Seroconversion of Hemagglutination Inhibition Antibody Titer at Day 43 | 22.9 percentage of participants |
| Group 3: Panblok H7 (45 mcg) Unadjuvanted | Percentage of Participants With Seroconversion of Hemagglutination Inhibition Antibody Titer at Day 43 | 1.4 percentage of participants |
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.
Time frame: Up to 30 minutes after each vaccination
Population: The Safety analysis set included all participants who had received at least 1 study vaccine.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Panblok H7 (7.5 mcg) + MF59 | Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs) | 1 Participants |
| Group 2: Panblok H7 (15 mcg) + MF59 | Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs) | 0 Participants |
| Group 3: Panblok H7 (45 mcg) Unadjuvanted | Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs) | 0 Participants |
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.
Time frame: From first dose vaccine administration (Day 1) until 12 months after the last dose administration, 387 days
Population: The Safety analysis set included all participants who had received at least 1 study vaccine.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Panblok H7 (7.5 mcg) + MF59 | Number of Participants With Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESIs) and Medically Attended Adverse Events (MAAEs) | Any AESI | 1 Participants |
| Group 1: Panblok H7 (7.5 mcg) + MF59 | Number of Participants With Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESIs) and Medically Attended Adverse Events (MAAEs) | Any SAE | 11 Participants |
| Group 1: Panblok H7 (7.5 mcg) + MF59 | Number of Participants With Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESIs) and Medically Attended Adverse Events (MAAEs) | Any MAAE | 41 Participants |
| Group 2: Panblok H7 (15 mcg) + MF59 | Number of Participants With Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESIs) and Medically Attended Adverse Events (MAAEs) | Any AESI | 1 Participants |
| Group 2: Panblok H7 (15 mcg) + MF59 | Number of Participants With Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESIs) and Medically Attended Adverse Events (MAAEs) | Any SAE | 12 Participants |
| Group 2: Panblok H7 (15 mcg) + MF59 | Number of Participants With Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESIs) and Medically Attended Adverse Events (MAAEs) | Any MAAE | 42 Participants |
| Group 3: Panblok H7 (45 mcg) Unadjuvanted | Number of Participants With Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESIs) and Medically Attended Adverse Events (MAAEs) | Any SAE | 6 Participants |
| Group 3: Panblok H7 (45 mcg) Unadjuvanted | Number of Participants With Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESIs) and Medically Attended Adverse Events (MAAEs) | Any MAAE | 10 Participants |
| Group 3: Panblok H7 (45 mcg) Unadjuvanted | Number of Participants With Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESIs) and Medically Attended Adverse Events (MAAEs) | Any AESI | 0 Participants |
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.
Time frame: Up to 7 days after each vaccination
Population: The Safety analysis set included all participants who had received at least 1 study vaccine. Only participants analyzed for specific parameter are reported.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Panblok H7 (7.5 mcg) + MF59 | Number of Participants With Solicited Injection Site Reactions and Systemic Reactions | Solicited injection site reaction | 53 Participants |
| Group 1: Panblok H7 (7.5 mcg) + MF59 | Number of Participants With Solicited Injection Site Reactions and Systemic Reactions | Solicited systemic reaction | 57 Participants |
| Group 2: Panblok H7 (15 mcg) + MF59 | Number of Participants With Solicited Injection Site Reactions and Systemic Reactions | Solicited injection site reaction | 57 Participants |
| Group 2: Panblok H7 (15 mcg) + MF59 | Number of Participants With Solicited Injection Site Reactions and Systemic Reactions | Solicited systemic reaction | 56 Participants |
| Group 3: Panblok H7 (45 mcg) Unadjuvanted | Number of Participants With Solicited Injection Site Reactions and Systemic Reactions | Solicited injection site reaction | 8 Participants |
| Group 3: Panblok H7 (45 mcg) Unadjuvanted | Number of Participants With Solicited Injection Site Reactions and Systemic Reactions | Solicited systemic reaction | 20 Participants |
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.
Time frame: Up to 21 days after each vaccination
Population: The Safety analysis set included all participants who had received at least 1 study vaccine.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Panblok H7 (7.5 mcg) + MF59 | Number of Participants With Unsolicited AEs | 32 Participants |
| Group 2: Panblok H7 (15 mcg) + MF59 | Number of Participants With Unsolicited AEs | 39 Participants |
| Group 3: Panblok H7 (45 mcg) Unadjuvanted | Number of Participants With Unsolicited AEs | 9 Participants |