Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibody Response for Each Homologous Influenza Strain on Day 0
The GMTs in each treatment group were measured using an HI assay for the homologous influenza strains: A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage).
GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 28
The GMTs in each treatment group were measured using an HI assay for the homologous influenza strains: A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage).
Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 28
Seroconversion rate: the percentage of participants in a given treatment group with either a ≥4-fold increase in reciprocal HI titers between Day 0 and Day 28 or a rise of undetectable HI titer (i.e. < 10) pre-vaccination (Day 0) to an HI titer of ≥ 40 on Day 28 was measured using an HI assay for the homologous influenza strains A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage).
Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 28
Seroprotection rate: the percentage of participants in a given treatment group attaining a reciprocal HI titer of ≥40 on Day 28 (the percentage of vaccine recipients with a serum HI titer of at least 1:40 following vaccination) for the homologous influenza strains A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage).
Geometric Mean Fold Rise (GMFR) Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 28/Day 0)
GMFR, the geometric mean of the ratio of GMTs (Day 28/Day 0) in each treatment group was measured using an HI assay for the homologous strains: A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage).
Number of Participants With at Least One Immediate Adverse Event (AE)
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. Immediate AEs were defined as any solicited (local and systemic) and unsolicited AEs that started up to 30 minutes after vaccination. Solicited local AEs included erythema, swelling, and pain at the injection site. Solicited systemic AEs included fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in the axilla, and swelling in the neck.
Number of Participants With at Least One Immediate AE of Grade 1, 2, 3, or 4
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. Immediate AEs were defined as any solicited (local and systemic) and unsolicited AEs that started up to 30 minutes after vaccination. Solicited local AEs included erythema, swelling, and pain at the injection site. Solicited systemic AEs included fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in the axilla, and swelling in the neck. The intensity of the AEs was graded according to the United States Food and Drug Administration Toxicity Grading Scale: mild (Grade 1), moderate (Grade 2), severe (Grade 3), or potentially life threatening (Grade 4).
Number of Participants With at Least One Immediate AE Related to Vaccination
An AE is defined in OM #6. Immediate AEs were defined as any solicited (local and systemic) and unsolicited AEs that started up to 30 minutes after vaccination. Solicited local AEs included erythema, swelling and pain at the injection site. Solicited systemic AEs included fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in the axilla, and swelling in the neck. A related AE is an event where the investigator determined that the relationship to study vaccine was "Possibly Related", "Probably Related" or "Definitely Related". If a participant reported multiple occurrences of the same AE, only the most closely related occurrence was presented. The causal relationship of all solicited local and systemic AEs was considered related to vaccination. Participants with any related AE was reported.
Number of Participants With at Least One Solicited Local or Systemic AE From Day 0 up to Day 7
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. Solicited local AEs included erythema, swelling, and pain at the injection site. Solicited systemic AEs included fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in the axilla, and swelling in the neck.
Number of Participants With at Least One Solicited Local or Systemic AE of Grade 1, 2, 3, or 4 From Day 0 up to Day 7
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. Solicited local AEs included erythema, swelling and pain at the injection site. Solicited systemic AEs included fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in the axilla, and swelling in the neck. The intensity of the AEs was graded according to the FDA Toxicity Grading Scale: mild (Grade 1), moderate (Grade 2), severe (Grade 3), or potentially life threatening (Grade 4).
Number of Participants With at Least One Unsolicited AE From Day 0 up to Day 28
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product.
Number of Participants With at Least One Unsolicited AE of Grade 1, 2, 3, or 4 From Day 0 up to Day 28
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. The intensity of the AEs was graded according to the FDA Toxicity Grading Scale: mild (Grade 1), moderate (Grade 2), severe (Grade 3), or potentially life threatening (Grade 4).
Number of Participants With at Least One Unsolicited AE Related to Vaccination From Day 0 up to Day 28
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. A related AE was an event where the Investigator determined that the relationship to study vaccine was "Possibly Related", "Probably Related" or "Definitely Related". If a participant reported multiple occurrences of the same AE, only the most closely related occurrence was presented. Participants with any related AE were reported.
Number of Participants With at Least One Serious Adverse Events (SAE) From Day 1 up to Day 28
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. An SAE is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, or is another important medical event.
Number of Participants With at Least One AE Leading to Withdrawal From the Study From Day 1 up to Day 28
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product.
Number of Participants With at Least One Adverse Event of Special Interest (AESI) From Day 1 up to Day 28
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. AESIs included hypersensitivity reactions, narcolepsy, Potential Immune-Mediated Diseases (pIMDs), and other AESIs. Participants with any AESI were reported.
Number of Participants With at Least One Medically Attended AE (MAAE) From Day 1 up to Day 28
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. MAAEs are defined as symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a healthcare provider.
Number of Participants With at Least One New Onset Clinical Disease (NOCD) From Day 1 up to Day 28
All NOCDs that may plausibly have an allergic, autoimmune or inflammatory component were assessed and reported. Plausibility was interpreted broadly; the only clear exceptions were degenerative conditions such as osteoarthritis, age-related physiologic changes and life-style diseases. In this context, most cancers, cardiac conditions, and kidney diseases had to be reported.
Number of Participants With the Occurrence of Death From Day 1 up to Day 28
The number of participants in each treatment group with an occurrence of death was assessed.
Number of Participants With at Least One SAE From Day 29 up to Day 182
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. An SAE is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, or is another important medical event.
Number of Participants With at Least One AE Leading to Withdrawal From the Study From Day 29 up to Day 182
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. The number of participants with at least one AE leading to withdrawal was assessed.
Number of Participants With at Least One AESI From Day 29 up to Day 182
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. AESIs included hypersensitivity reactions, narcolepsy, pIMDs, and other AESIs. Participants with any AESI were reported.
Number of Participants With at Least One MAAE From Day 29 up to Day 182
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. MAAEs are defined as symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider.
Number of Participants With at Least One New NOCD From Day 29 up to Day 182
All NOCDs that may plausibly have an allergic, autoimmune or inflammatory component were assessed and reported. Plausibility was interpreted broadly; the only clear exceptions were degenerative conditions such as osteoarthritis, age-related physiologic changes and life-style diseases. In this context, most cancers, cardiac conditions, and kidney diseases were reported.
Number of Participants With an Occurrence of Death From Day 29 up to Day 182
The number of participants in each treatment group with an occurrence of death was assessed.
Number of Participants With at Least One SAE From Day 183 up to Day 365
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. An SAE is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, or is another important medical event.
Number of Participants With at Least One AE Leading to Withdrawal From the Study From Day 183 up to Day 365
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. The number of participants with at least one AE leading to withdrawal was assessed.
Number of Participants With at Least One AESI From Day 183 up to Day 365
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. AESIs included hypersensitivity reactions, narcolepsy, pIMDs, and other AESIs. Participants with any AESI were reported.
Number of Participants With at Least One MAAE From Day 183 up to Day 365
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. MAAEs were defined as symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider.
Number of Participants With at Least One NOCD From Day 183 up to Day 365
All NOCDs that may plausibly have an allergic, autoimmune or inflammatory component were assessed and reported. Plausibility should be interpreted broadly; the only clear exceptions are degenerative conditions such as osteoarthritis, age-related physiologic changes and life-style diseases. In this context, most cancers, cardiac conditions, and kidney diseases should be reported.
Number of Participants With an Occurrence of Death From Day 183 up to Day 365
The number of participants in each treatment group with an occurrence of death was assessed.
Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 0
Participants were monitored for any abnormal findings in urine parameters (urine color, glucose, occult blood, protein, specific gravity, specimen appearance, pH), hematological parameters (basophils, leukocytes, eosinophils, erythrocytes mean corpuscular hemoglobin, erythrocytes, hematocrit, hemoglobin, lymphocytes, mean platelet volume, monocytes, neutrophils, platelets), and blood chemistry parameters (alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, calcium, chloride, cholesterol, creatinine, gamma glutamyl transferase, glucose, HDL and LDL cholesterol, phosphate, potassium, protein, sodium, triglycerides, urea nitrogen). Any laboratory result outside of the testing laboratory's normal range was classified as "clinically significant" or "not clinically significant" by the site investigator, with appropriate documentation.
Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 3
Participants were monitored for any abnormal findings in urine parameters (urine color, glucose, occult blood, protein, specific gravity, specimen appearance, pH), hematological parameters (basophils, leukocytes, eosinophils, erythrocytes mean corpuscular hemoglobin, erythrocytes, hematocrit, hemoglobin, lymphocytes, mean platelet volume, monocytes, neutrophils, platelets), and blood chemistry parameters (alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, calcium, chloride, cholesterol, creatinine, gamma glutamyl transferase, glucose, HDL and LDL cholesterol, phosphate, potassium, protein, sodium, triglycerides, urea nitrogen). Any laboratory result outside of the testing laboratory's normal range was classified as "clinically significant" or "not clinically significant" by the site investigator, with appropriate documentation.
Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 28
Participants were monitored for any abnormal findings in urine parameters (urine color, glucose, occult blood, protein, specific gravity, specimen appearance, and pH), hematological parameters (basophils, leukocytes, eosinophils, erythrocytes mean corpuscular hemoglobin, erythrocytes, hematocrit, hemoglobin, lymphocytes, mean platelet volume, monocytes, neutrophils, and platelets), and blood chemistry parameters (alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, calcium, chloride, cholesterol, creatinine, gamma glutamyl transferase, glucose, cholesterol, phosphate, potassium, protein, sodium, triglycerides, and urea nitrogen). Any laboratory result outside of the testing laboratory's normal range was classified as "clinically significant" or "not clinically significant" by the site investigator, with appropriate documentation.
GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365
The GMTs in each treatment group were measured using an HI assay for the homologous influenza strains: A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage).
Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365
Seroconversion rate: the percentage of participants in a given treatment group with either a ≥4-fold increase in reciprocal HI titers between Day 0 and Day 182 and Day 0 and Day 365 or a rise of undetectable HI titer (i.e. <10) pre-vaccination (Day 0) to an HI titer of ≥40 on Day 182 and Day 365 was measured using an HI assay for the following homologous influenza strains: A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage).
Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365
Seroprotection rate: the percentage of participants in a given treatment group attaining a reciprocal HI titer of ≥40 on Day 182 and on Day 365 (the percentage of vaccine recipients with a serum HI titer of at least 1:40 following vaccination) for the homologous influenza strains A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage)
GMFR Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 182/Day 0 and Day 365/Day 0)
GMFR: the geometric mean of the ratio of GMTs (Day 182/Day 0 and Day 365/Day 0) measured using an HI assay for the homologous strains A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage).
GMTs of HI Antibody Response for Each Heterologous Influenza Strain
The GMTs in each treatment group were measured using an HI assay for the heterologous influenza strains: A/Brisbane/02/2018 (H1N1), A/Kansas/14/2017 (H3N2), and B/Maryland/15/2016 (B/Victoria lineage).
Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Heterologous Influenza Strain
Seroconversion rate: the percentage of participants in a given treatment group with either a ≥4-fold increase in reciprocal HI titers between Day 0 and Day 28 or a rise of undetectable HI titer (i.e. <10) pre-vaccination (Day 0) to an HI titer of ≥40 on Day 28 was measured using an HI assay for the heterologous influenza strains A/Brisbane/02/2018 (H1N1), A/Kansas/14/2017 (H3N2), and B/Maryland/15/2016 (B/Victoria lineage).
Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Heterologous Influenza Strain
Seroprotection rate: the percentage of participants in a given treatment group attaining a reciprocal HI titer of ≥40 on Day 28 (the percentage of vaccine recipients with a serum HI titer of at least 1:40 following vaccination) for the heterologous influenza strains A/Brisbane/02/2018 (H1N1), A/Kansas/14/2017 (H3N2), and B/Maryland/15/2016 (B/Victoria lineage)
GMFR Measured by HI Antibody Response for Each Heterologous Influenza Strain
GMFR: the geometric mean of the ratio of GMTs (Day 28/Day 0) measured using an HI assay for the heterologous strains A/Brisbane/02/2018 (H1N1), A/Kansas/14/2017 (H3N2), and B/Maryland/15/2016 (B/Victoria lineage).
GMTs of Microneutralization (MN) Antibody Response for Each Homologous Influenza Strain
The GMTs in each treatment group were measured using an MN assay for the homologous influenza strains: A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage).
Percentage of Participants With Seroconversion Measured by MN Antibody Response for Each Homologous Influenza Strain
Seroconversion rate: the percentage of participants in a given treatment group with either a ≥4-fold increase in reciprocal HI titers between Day 0 and Day 28 or a rise of undetectable MN titer (i.e. <10) pre-vaccination (Day 0) to an MN titer of ≥40 on Day 28 was measured using an MN assay for the homologous influenza strains A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage).
GMFR Measured by MN Antibody Response for Each Homologous Influenza Strain
GMFR: the geometric mean of the ratio of GMTs (Day 28/Day 0) measured using an MN assay for the homologous strains A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage).
GMTs of HI Antibody Response for Each Homologous Influenza Strain, Stratified by Prior Influenza Vaccination Status
The GMTs in each treatment group were measured using an HI assay for the homologous influenza strains: A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage). It was planned that the endpoint would be analyzed only if >25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain, Stratified by Prior Influenza Vaccination Status
Seroconversion rate: the percentage of participants in a given treatment group with either a ≥4-fold increase in reciprocal HI titers between Day 0 and Day 28 or a rise of undetectable HI titer (i.e. <10) pre-vaccination (Day 0) to an HI titer of ≥40 on Day 28 was measured using an HI assay for the homologous influenza strains A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage). It was planned that the endpoint would be analyzed only if >25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain, Stratified by Prior Influenza Vaccination Status
Seroprotection rate: the percentage of participants in a given treatment group attaining a reciprocal HI titer of ≥40 on Day 28 (the percentage of vaccine recipients with a serum HI titer of at least 1:40 following vaccination) for the homologous influenza strains A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage). It was planned that the endpoint would be analyzed only if >25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
GMFR Measured by HI Antibody Response for Each Homologous Influenza Strain, Stratified by Prior Influenza Vaccination Status
GMFR: the geometric mean of the ratio of GMTs (Day 28/Day 0) measured using an HI assay for the homologous strains A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage). It was planned that the endpoint would be analyzed only if >25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
GMTs of HI Antibody Response for Each Heterologous Influenza Strain, Stratified by Prior Influenza Vaccination Status
The GMTs in each treatment group were measured using an HI assay for the heterologous influenza strains: A/Brisbane/02/2018 (H1N1), A/Kansas/14/2017 (H3N2), and B/Maryland/15/2016 (B/Victoria lineage). It was planned that the endpoint would be analyzed only if >25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination. It was planned that the endpoint would be analyzed only if >25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Heterologous Influenza Strain, Stratified by Prior Influenza Vaccination Status
Seroconversion rate: the percentage of participants in a given treatment group with either a ≥4-fold increase in reciprocal HI titers between Day 0 and Day 28 or a rise of undetectable HI titer (i.e. <10) pre-vaccination (Day 0) to an HI titer of ≥40 on Day 28 was measured using an HI assay for the following heterologous influenza strains: A/Brisbane/02/2018 (H1N1), A/Kansas/14/2017 (H3N2), and B/Maryland/15/2016 (B/Victoria lineage). It was planned that the endpoint would be analyzed only if >25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Heterologous Influenza Strain, Stratified by Prior Influenza Vaccination Status
Seroprotection rate: the percentage of participants in a given treatment group attaining a reciprocal HI titer of ≥40 on Day 28 (the percentage of vaccine recipients with a serum HI titer of at least 1:40 following vaccination) for the following heterologous influenza strains: A/Brisbane/02/2018 (H1N1), A/Kansas/14/2017 (H3N2), and B/Maryland/15/2016 (B/Victoria lineage). It was planned that the endpoint would be analyzed only if >25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
GMFR Measured by HI Antibody Response for Each Heterologous Influenza Strain, Stratified by Prior Influenza Vaccination Status
GMFR: the geometric mean of the ratio of GMTs (Day 28/Day 0) measured using an HI assay for the heterologous strains A/Brisbane/02/2018 (H1N1), A/Kansas/14/2017 (H3N2), and B/Maryland/15/2016 (B/Victoria lineage). It was planned that the endpoint would be analyzed only if >25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
GMTs of MN Antibody Response for Each Homologous Influenza Strain, Stratified by Prior Influenza Vaccination Status
The GMTs in each treatment group were measured using an MN assay for the following homologous influenza strains: A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage). It was planned that the endpoint would be analyzed only if >25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
Percentage of Participants With Seroconversion Measured by MN Antibody Response for Each Homologous Influenza Strain, Stratified by Prior Influenza Vaccination Status
Seroconversion rate: the percentage of participants in a given treatment group with either a ≥4-fold increase in reciprocal HI titers between Day 0 and Day 28 or a rise of undetectable MN titer (i.e. <10) pre-vaccination (Day 0) to an MN titer of ≥40 on Day 28 was measured using an MN assay for the homologous influenza strains A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage). It was planned that the endpoint would be analyzed only if >25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
GMFR Measured by MN Antibody Response for Each Homologous Influenza Strain, Stratified by Prior Influenza Vaccination Status
GMFR: the geometric mean of the ratio of GMTs (Day 28/Day 0) measured using an MN assay for the strains A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage). It was planned that the endpoint would be analyzed only if >25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
Number of Participants With at Least One Immediate AE, Stratified by Prior Influenza Vaccination Status
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. Immediate AEs were defined as any solicited (local and systemic) and unsolicited AEs that started up to 30 minutes after vaccination. Solicited local AEs included erythema, swelling and pain at the injection site. Solicited systemic AEs included fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in the axilla, and swelling in the neck. It was planned that the endpoint would be analyzed only if >25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
Number of Participants With at Least One Immediate AE of Grade 1, 2, 3, or 4, Stratified by Prior Influenza Vaccination Status
An AE is defined in OM #6. Immediate AEs were defined as any solicited (local and systemic) and unsolicited AEs that started up to 30 minutes after vaccination. Solicited local AEs included erythema, swelling and pain at the injection site. Solicited systemic AEs included fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in the axilla, and swelling in the neck. The intensity of the AEs was graded according to the FDA Toxicity Grading Scale: mild (Grade 1), moderate (Grade 2), severe (Grade 3), or potentially life threatening (Grade 4). It was planned that the endpoint would be analyzed only if >25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
Number of Participants With at Least One Immediate AE Related to Vaccination, Stratified by Prior Influenza Vaccination Status
An AE is defined in OM #6. Immediate AEs were defined as any solicited (local and systemic) and unsolicited AEs that started up to 30 minutes after vaccination. Solicited local AEs included erythema, swelling and pain at the injection site. Solicited systemic AEs included fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in the axilla, and swelling in the neck. A related AE is an event where the investigator determined that the relationship to study vaccine was "Possibly Related", "Probably Related", or "Definitely Related". If a participant reported multiple occurrences of the same AE, only the most closely related occurrence was presented. It was planned that the endpoint would be analyzed only if >25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
Number of Participants With at Least One Solicited Local or Systemic AE, Stratified by Prior Influenza Vaccination Status
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. Solicited local AEs included erythema, swelling and pain at the injection site. Solicited systemic AEs included fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in the axilla, and swelling in the neck. It was planned that the endpoint would be analyzed only if >25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
Number of Participants With at Least One Solicited Local or Systemic AE of Grade 1, 2, 3, or 4, Stratified by Prior Influenza Vaccination Status
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. Solicited local AEs included erythema, swelling and pain at the injection site. Solicited systemic AEs included fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in the axilla, and swelling in the neck. The intensity of the AEs was graded according to the FDA Toxicity Grading Scale: mild (Grade 1), moderate (Grade 2), severe (Grade 3), or potentially life threatening (Grade 4). It was planned that the endpoint would be analyzed only if >25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
Number of Participants With at Least One Unsolicited AE, Stratified by Prior Influenza Vaccination Status
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. It was planned that the endpoint would be analyzed only if >25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
Number of Participants With at Least One Unsolicited AE of Grade 1, 2, 3, or 4, Stratified by Prior Influenza Vaccination Status
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. The intensity of the AEs was graded according to the FDA Toxicity Grading Scale: mild (Grade 1), moderate (Grade 2), severe (Grade 3), or potentially life threatening (Grade 4). It was planned that the endpoint would be analyzed only if >25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
Number of Participants With at Least One Unsolicited AE Related to Vaccination, Stratified by Prior Influenza Vaccination Status
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. A related AE was an event where the Investigator determined that the relationship to study vaccine was "Possibly Related", "Probably Related", or "Definitely Related". It was planned that the endpoint would be analyzed only if >25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
Number of Participants With at Least One SAE From Day 1 up to Day 28, Day 29 up to Day 182, and Day 183 up to Day 365, Stratified by Prior Influenza Vaccination Status
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. An SAE is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, or is another important medical event. It was planned that the endpoint would be analyzed only if >25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
Number of Participants With at Least One AE Leading to Withdrawal From the Study From Day 1 up to Day 28, Day 29 up to Day 182, and Day 183 up to Day 365, Stratified by Prior Influenza Vaccination Status
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. It was planned that the endpoint would be analyzed only if >25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
Number of Participants With at Least One AESI From Day 1 up to Day 28, Day 29 up to Day 182, and Day 183 up to Day 365, Stratified by Prior Influenza Vaccination Status
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. AESIs included hypersensitivity reactions, narcolepsy, pIMDs, and other AESIs. It was planned that the endpoint would be analyzed only if >25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
Number of Participants With at Least One MAAE From Day 1 up to Day 28, Day 29 up to Day 182, and Day 183 up to Day 365, Stratified by Prior Influenza Vaccination Status
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. MAAEs are defined as symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider. It was planned that the endpoint would be analyzed only if >25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
Number of Participants With at Least One NOCD From Day 1 up to Day 28, Day 29 up to Day 182, and Day 183 up to Day 365, Stratified by Prior Influenza Vaccination Status
All NOCDs that may plausibly have an allergic, autoimmune or inflammatory component were assessed and reported. Plausibility was interpreted broadly; the only clear exceptions were degenerative conditions such as osteoarthritis, age-related physiologic changes and life-style diseases. In this context, most cancers, cardiac conditions, and kidney diseases had to be reported. It was planned that the endpoint would be analyzed only if >25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
Number of Participants With the Occurrence of Death From Day 1 up to Day 28, From Day 29 to Day 182, and From Day 183 to Day 365, Stratified by Prior Influenza Vaccination Status
The number of participants in each treatment group with an occurrence of death was assessed. It was planned that the endpoint would be analyzed only if >25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 0, Stratified by Prior Influenza Vaccination Status
Participants were monitored for abnormal findings in urine parameters (urine color, glucose, occult blood, protein, specific gravity, specimen appearance, pH), hematological parameters (basophils, leukocytes, eosinophils, erythrocytes mean corpuscular hemoglobin, erythrocytes, hematocrit, hemoglobin, lymphocytes, mean platelet volume, monocytes, neutrophils, platelets), and blood chemistry parameters (alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, calcium, chloride, cholesterol, creatinine, gamma glutamyl transferase, glucose, HDL and LDL cholesterol, phosphate, potassium, protein, sodium, triglycerides, urea nitrogen). Any laboratory result outside of the normal range was classified as "clinically significant" or "not clinically significant" by the site investigator. It was planned that the endpoint would be analyzed if >25% of the participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 3, Stratified by Prior Influenza Vaccination Status
Participants were monitored for abnormal findings in urine parameters (urine color, glucose, occult blood, protein, specific gravity, specimen appearance, pH), hematological parameters (basophils, leukocytes, eosinophils, erythrocytes mean corpuscular hemoglobin, erythrocytes, hematocrit, hemoglobin, lymphocytes, mean platelet volume, monocytes, neutrophils, platelets), and blood chemistry parameters (alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, calcium, chloride, cholesterol, creatinine, gamma glutamyl transferase, glucose, HDL and LDL cholesterol, phosphate, potassium, protein, sodium, triglycerides, urea nitrogen). Any laboratory result outside of the normal range was classified as "clinically significant" or "not clinically significant" by the site investigator. It was planned that the endpoint would be analyzed if >25% of the participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 28, Stratified by Prior Influenza Vaccination Status
Participants were monitored for abnormal findings in urine parameters (urine color, glucose, occult blood, protein, specific gravity, specimen appearance, pH), hematological parameters (basophils, leukocytes, eosinophils, erythrocytes mean corpuscular hemoglobin, erythrocytes, hematocrit, hemoglobin, lymphocytes, mean platelet volume, monocytes, neutrophils, platelets), and blood chemistry parameters (alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, calcium, chloride, cholesterol, creatinine, gamma glutamyl transferase, glucose, HDL and LDL cholesterol, phosphate, potassium, protein, sodium, triglycerides, urea nitrogen). Any laboratory result outside of the normal range was classified as "clinically significant" or "not clinically significant" by the site investigator. It was planned that the endpoint would be analyzed if >25% of the participants had received a standard influenza vaccine during the 12 months prior to study vaccination.