Mean Percentage of Perforin+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.
Mean Percentage of Cluster of Differentiation 107a Positive (CD107a+) CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.
Mean Percentage of Interleukin-2 Positive (IL-2+) CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.
Mean Percentage of Tumor Necrosis Factor Positive (TNF+) CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.
Mean Percentage of Interferon Gamma Positive (IFNg+) CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.
Mean Percentage of Perforin+CD107a+IL-2+TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.
Mean Percentage of Perforin+CD107a+IL-2+TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.
Mean Percentage of Perforin+CD107a+IL-2+TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.
Mean Percentage of Perforin+CD107a+IL-2+TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.
Mean Percentage of Perforin+CD107a+IL-2-TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.
Mean Percentage of Perforin+CD107a+IL-2- TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.
Mean Percentage of Perforin+CD107a+IL-2-TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.
Mean Percentage of Perforin+CD107a+IL-2-TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.
Mean Percentage of Perforin+CD107a- IL-2+TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.
Mean Percentage of Perforin+CD107a- IL-2+TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.
Mean Percentage of Perforin+CD107a- IL-2+TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.
Mean Percentage of Perforin+CD107a- IL-2+TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.
Mean Percentage of Perforin+CD107a- IL-2- TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.
Mean Percentage of Perforin+CD107a- IL-2- TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.
Mean Percentage of Perforin+CD107a- IL-2- TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.
Mean Percentage of Perforin+CD107a- IL-2- TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.
Mean Percentage of Perforin- CD107a+IL-2+TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.
Mean Percentage of Perforin- CD107a+IL-2+TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.
Mean Percentage of Perforin- CD107a+IL-2+TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.
Mean Percentage of Perforin- CD107a+IL-2+TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.
Mean Percentage of Perforin- CD107a+IL-2- TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.
Mean Percentage of Perforin- CD107a+IL-2- TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.
Mean Percentage of Perforin- CD107a+IL-2- TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.
Mean Percentage of Perforin- CD107a+IL-2- TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.
Mean Percentage of Perforin- CD107a- IL-2+TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.
Mean Percentage of Perforin- CD107a- IL-2+TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.
Mean Percentage of Perforin- CD107a- IL-2+TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.
Mean Percentage of Perforin- CD107a- IL-2+TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.
Mean Percentage of Perforin- CD107a- IL-2- TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.
Mean Percentage of Perforin- CD107a- IL-2- TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.
Mean Percentage of Perforin- CD107a- IL-2- TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.
Mean Percentage of Perforin- CD107a- IL-2- TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.
Number of Participants With Clinical Safety Laboratory Adverse Events After the First M-001 Vaccination
Blood was collected after first vaccination for assessment by a central clinical laboratory. Clinical safety laboratory adverse events included white blood cells (WBC) </=3900/uL or >/=10,600/uL; platelets </=139,000/uL or >/=416,000/uL; hemoglobin </=11.4 g/dL (female) or </=12.4 g/dL (male); alanine aminotransferase (ALT) >/=44 IU/L (female) or >/=61 IU/L (male); creatinine >/=1.1 mg/dL (female) or >/=1.4 (male); and total bilirubin >/=1.30 mg/dL.
Number of Participants With Clinical Safety Laboratory Adverse Events After Second M-001 Vaccination
Clinical safety laboratory adverse events included WBC less than or equal to 3900/uL or greater than or equal to 10,600/uL; platelets less than or equal to 139,000/uL or greater than or equal to 416,000/uL; hemoglobin less than or equal to 11.4 g/dL (female) or less than or equal to 12.4 g/dL (male); alanine aminotransferase (ALT) greater than or equal to 44 IU/L (female) or greater than or equal to 61 IU/L (male); creatinine greater than or equal to 1.1 mg/dL (female) or greater than or equal to 1.4 (male); and total bilirubin greater than or equal to 1.30 mg/dL.
Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the First M-001 Vaccination
Participants maintained a memory aid and thermometer to record daily oral temperatures and the occurrence of systemic reactions of feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea, as well as local injection site reactions of pain, tenderness, redness, and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities, with a severity grade of mild meaning no interference, moderate as some interference and severe as significant interference/prevented daily activity. Fever was defined as an oral temperature of 38 degree Celsius or higher. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days post vaccination.
Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the Second M-001 Vaccination
Participants maintained a memory aid and thermometer to record daily oral temperatures and the occurrence of systemic reactions of feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea, as well as local injection site reactions of pain, tenderness, redness, and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities, with a severity grade of mild meaning no interference, moderate as some interference and severe as significant interference/prevented daily activity. Fever was defined as an oral temperature of 38 degree Celsius or higher. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days post vaccination.
Number of Participants Reporting Vaccine-related Serious Adverse Events (SAEs) After M-001 Vaccination
SAEs included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required inpatient hospitalization or prolongation or a congenital anomaly/birth defect. Relationship (related or unrelated to the study product) was determined by a site principal investigator blinded to the study product received by the participant.
Number of Participants Reporting Serious Adverse Events (SAEs) After M-001 Vaccination
SAEs included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required inpatient hospitalization or prolongation or a congenital anomaly/birth defect. All events are included regardless of relationship to the study product.
Incidence of Unsolicited Non-serious Adverse Events (AEs) After M-001 Vaccination
Unsolicited adverse events were collected from the time of first vaccination and at each follow-up visit through Day 43. Adverse events were defined as any untoward medical occurrence regardless of its causal relationship to the study treatment. Events were coded with MedDRA and are reported by System Organ Class.
The Percentage of Subjects Achieving HAI Seroconversion to IIV4 Vaccine Virus From Day 172 to Day 200
Blood was collected from participants for testing in the HAI assay with the vaccine viruses as the assay antigens. Seroconversion was defined as a Day 172 titer less than 10 and Day 200 titer greater than or equal to 40, or for those with a Day 172 titer of 10 or greater, a minimum 4-fold rise in Day 200 antibody titer.
The Percentage of Subjects Achieving Neutralizing Antibody Seroconversion to IIV4 Vaccine Virus From Day 172 to Day 200
Blood was collected from participants for testing in the neutralizing antibody assay with the vaccine viruses as the assay antigens. Seroconversion was defined as a Day 172 titer less than 10 and Day 200 titer greater than or equal to 40, or for those with a Day 172 titer of 10 or greater, a minimum 4-fold rise in Day 200 antibody titer.
The Percentage of Participants With an HAI Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 1
Blood was collected from participants for testing in the HAI assay with the vaccine viruses as the assay antigens. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 40 or greater.
The Percentage of Participants With an HAI Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 43
Blood was collected from participants for testing in the HAI assay with the vaccine viruses as the assay antigens. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 40 or greater.
The Percentage of Participants With an HAI Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 172
Blood was collected from participants for testing in the HAI assay with the vaccine viruses as the assay antigens. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 40 or greater.
The Percentage of Participants With an HAI Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 200
Blood was collected from participants for testing in the HAI assay with the vaccine viruses as the assay antigens. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 40 or greater.
The Percentage of Participants With a Neutralizing Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 1
Blood was collected from participants for testing in the neutralizing antibody assay with the vaccine viruses as the assay antigens. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 40 or greater.
The Percentage of Participants With a Neutralizing Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 43
Blood was collected from participants for testing in the neutralizing antibody assay with the vaccine viruses as the assay antigens. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 40 or greater.
The Percentage of Participants With a Neutralizing Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 172
Blood was collected from participants for testing in the neutralizing antibody assay with the vaccine viruses as the assay antigens. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 40 or greater.
The Percentage of Participants With a Neutralizing Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 200
Blood was collected from participants for testing in the neutralizing antibody assay with the vaccine viruses as the assay antigens. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 40 or greater.