Influenza, Influenza Immunisation
Conditions
Keywords
Immunogenicity, Influenza Vaccine, M-001 vaccine, Reactogenicity, Safety
Brief summary
This is a Phase II randomized, double-blind, placebo-controlled trial in 120 males and non-pregnant females, 18 to 49 years old, inclusive, who are in good health and meet all eligibility criteria. This clinical trial will be conducted at 3 United States sites and is designed to assess the safety, reactogenicity, and immunogenicity of two priming doses of M-001 followed by a seasonal quadrivalent inactivated influenza vaccine (IIV4). The duration of this trial for each subject will be approximately 7 months. The entire study duration will be approximately 24 months. The primary objectives are: 1) To assess the safety as measured by vaccine related adverse events, reactogenicity, and laboratory adverse events of two doses of M-001 vaccine, each dose administered approximately 21 days apart; and 2) To assess the T cell responses to M-001 component peptides following two doses of M-001.
Detailed description
This is a Phase II randomized, double-blind, placebo-controlled trial in 120 males and non-pregnant females, 18 to 49 years old, inclusive, who are in good health and meet all eligibility criteria. This clinical trial will be conducted at 3 United States sites and is designed to assess the safety, reactogenicity, and immunogenicity of two priming doses of M-001 followed by a seasonal quadrivalent inactivated influenza vaccine (IIV4). The duration of this trial for each subject will be approximately 7 months. The entire study duration will be approximately 24 months. The primary objectives are: 1) To assess the safety as measured by vaccine related adverse events, reactogenicity, and laboratory adverse events of two doses of M-001 vaccine, each dose administered approximately 21 days apart; and 2) To assess the T cell responses to M-001 component peptides following two doses of M-001. The secondary objectives are: 1) To assess all serious adverse events (SAEs) following receipt of each dose of M-001 vaccine or placebo, each dose separated by approximately 21 days, through the end of the study; 2) To assess all unsolicited non-serious AEs following receipt of each dose of M-001 or placebo, each dose separated by approximately 21 days, through 21 days after each dose of M-001 or placebo; and 3) To assess the serum HAI and Neut antibody responses to the 2018-2019 IIV4 vaccine viruses.
Interventions
BIOLOGICALInfluenza Multimeric-001 Vaccine
The M-001 vaccine consists of 3 repetitions of 9 conserved linear epitopes that are prepared as a single recombinant protein. The M-001 vaccine is expected to protect against existing as well as future seasonal and pandemic virus strains.
OTHERPlacebo
Placebo is saline injection
Quadrivalent Inactivated Influenza Vaccine (IIV4) for intramuscular injection is indicated for active immunization against influenza disease caused by influenza virus subtypes A and type B present in the vaccine.
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
1. Provide written informed consent prior to initiation of any study procedures. 2. Are able to understand and comply with planned study procedures and be available for all study visits. 3. Are males or non-pregnant females, 18 to 49 years old, inclusive. 4. Are in good health\*. \*As determined by medical history and targeted physical examination to evaluate acute or currently ongoing chronic medical diagnoses or conditions, defined as those that have been present for at least 90 days, which would affect the assessment of the safety of subjects or the immunogenicity of study vaccinations. Chronic medical diagnoses or conditions should be stable for the last 60 days prior to investigational vaccine study product administration. This includes no change in chronic prescription medication, dose, or frequency as a result of deterioration of the chronic medical diagnosis or condition in the 60 days prior to enrollment and investigational vaccine study product administration. Any prescription change that is due to change of health care provider, insurance company, etc., or that is done for financial reasons, as long as in the same class of medication, will not be considered a deviation of this inclusion criterion. Any change in prescription medication due to improvement of a disease outcome, as determined by the site principal investigator or appropriate sub-investigator, will not be considered a deviation of this inclusion criterion. Subjects may be on chronic or as needed (prn) medications if, in the opinion of the site principal investigator or appropriate sub-investigator, they pose no additional risk to subject safety or assessment of reactogenicity and immunogenicity and do not indicate a worsening of medical diagnosis or condition. Similarly, medication changes subsequent to enrollment and investigational study product vaccination are acceptable provided there was no deterioration in the subject's chronic medical condition that necessitated a medication change. All chronic medical condtions should pose no additional risk to the subject or interference with the evaluation of responses to study vaccination. Note: Topical, nasal, and inhaled medications (with the exception of inhaled corticosteroids as outlined in the Subject
Exclusion criteria
), herbals, vitamins, and supplements are permitted. 5. Oral temperature is less than 100.0 degrees F. 6. Pulse\*\* is 50 to 100 bpm, inclusive. \*\*Acceptable pulse range prior to IIV4 dose is 45 to 115 bpm, inclusive and no symptoms. 7. Systolic blood pressure\*\*\* is 85 to 150 mmHg, inclusive. \*\*\*Acceptable systolic blood pressure range prior to IIV4 dose is 80 to 155 mm Hg, inclusive and no symptoms. 8. Diastolic blood pressure\*\*\*\* is 55 to 95 mmHg, inclusive. \*\*\*\*Acceptable diastolic blood pressure range prior to IIV4 dose is 50 to 100 mm Hg, inclusive and no symptoms. 9. Women of childbearing potential\* must use an acceptable method of contraception\*\* from 30 days prior to vaccination until 60 days after the second of dose of M-001 or placebo. 10. Women of childbearing potential\*\*\*\*\* must use an acceptable method of contraception\*\*\*\*\*\* from 30 days prior to receipt of IIV vaccination, and must plan to use until 28 days after the IIV. \*\*\*\*\*Not sterilized via tubal ligation, bilateral oophorectomy, hysterectomy, or successful Essure(R) placement (permanent, non-surgical, non-hormonal sterilization with history of documented radiological confirmation test achieved or with use of another approved birth control method if confirmation test not confirmed) and still menstruating or \< 1 year of the last menses if menopausal). \*\*\*\*\*\*Includes, but is not limited to, non-male sexual relationships, abstinence from sexual intercourse with a male partner, monogamous relationship with a vasectomized partner, male condoms with the use of applied spermicide, intrauterine devices, NuvaRing(R), and licensed hormonal methods such as implants, injectables, contraceptive patches or oral contraceptives (the pill). Method of contraception will be captured on the appropriate data collection form. 11. Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 24 hours prior to study vaccination.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting Vaccine-related Serious Adverse Events (SAEs) After M-001 Vaccination | Day 1 through Day 200 | 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. |
| Mean Percentage of Perforin- CD107a- IL-2+TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Day 1 through Day 36 | 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 | Day 1 through Day 36 | 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 | Day 1 through Day 36 | 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 | Day 1 through Day 36 | 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 | Day 1 through Day 36 | 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 | Day 1 through Day 36 | 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 | Day 1 through Day 36 | 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 | Day 1 through Day 36 | 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 | Day 9 | 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 | Day 22 through Day 29 | 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 | Day 1 through Day 8 | 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 | Day 22 through Day 29 | 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. |
| Mean Percentage of Perforin+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Day 1 through Day 36 | 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 | Day 1 through Day 36 | 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 | Day 1 through Day 36 | 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 | Day 1 through Day 36 | 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 | Day 1 through Day 36 | 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 | Day 1 through Day 36 | 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 | Day 1 through Day 36 | 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 | Day 1 through Day 36 | 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 | Day 1 through Day 36 | 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 | Day 1 through Day 36 | 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 | Day 1 through Day 36 | 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 | Day 1 through Day 36 | 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 | Day 1 through Day 36 | 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 | Day 1 through Day 36 | 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 | Day 1 through Day 36 | 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 | Day 1 through Day 36 | 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 | Day 1 through Day 36 | 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 | Day 1 through Day 36 | 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 | Day 1 through Day 36 | 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 | Day 1 through Day 36 | 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 | Day 1 through Day 36 | 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 | Day 1 through Day 36 | 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 | Day 1 through Day 36 | 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 | Day 1 through Day 36 | 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 | Day 1 through Day 36 | 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 | Day 1 through Day 36 | 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 | Day 1 through Day 36 | 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 | Day 1 through Day 36 | 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 | Day 1 through Day 36 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Unsolicited Non-serious Adverse Events (AEs) After M-001 Vaccination | Day 1 through Day 43 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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. |
| Number of Participants Reporting Serious Adverse Events (SAEs) After M-001 Vaccination | Day 1 through Day 200 | 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. |
Countries
United States
Participant flow
Recruitment details
Participants were healthy adult males and non-pregnant females recruited from existing volunteer populations and from the communities at large around the clinical sites. Participants were enrolled between 09APR2018 and 28JUN2018.
Participants by arm
| Arm | Count |
|---|---|
| M-001 + IIV4 0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172 | 61 |
| Placebo + IIV4 0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172 | 59 |
| Total | 120 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | M-001 + IIV4 | Placebo + IIV4 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 61 Participants | 59 Participants | 120 Participants |
| Age, Continuous | 32.6 years STANDARD_DEVIATION 7.9 | 33.5 years STANDARD_DEVIATION 7.8 | 33.0 years STANDARD_DEVIATION 7.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 6 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 56 Participants | 53 Participants | 109 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 8 Participants | 5 Participants | 13 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 49 Participants | 50 Participants | 99 Participants |
| Region of Enrollment United States | 61 participants | 59 participants | 120 participants |
| Sex: Female, Male Female | 42 Participants | 33 Participants | 75 Participants |
| Sex: Female, Male Male | 19 Participants | 26 Participants | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 61 | 0 / 59 |
| other Total, other adverse events | 52 / 61 | 44 / 59 |
| serious Total, serious adverse events | 1 / 61 | 0 / 59 |
Outcome results
Primary
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.
Time frame: Day 1 through Day 36
Population: The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| M-001 + IIV4 | Mean Percentage of Cluster of Differentiation 107a Positive (CD107a+) CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | CD107a+ CD4+ at Day 1 | 0.255 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Cluster of Differentiation 107a Positive (CD107a+) CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | CD107a+ CD4+ Day 36 | 0.242 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Cluster of Differentiation 107a Positive (CD107a+) CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | CD107a+ CD8+ Day 1 | 0.348 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Cluster of Differentiation 107a Positive (CD107a+) CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | CD107a+ CD8+ Day 36 | 0.352 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Cluster of Differentiation 107a Positive (CD107a+) CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | CD107a+ CD8+ Day 36 | 0.384 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Cluster of Differentiation 107a Positive (CD107a+) CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | CD107a+ CD4+ at Day 1 | 0.264 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Cluster of Differentiation 107a Positive (CD107a+) CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | CD107a+ CD8+ Day 1 | 0.367 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Cluster of Differentiation 107a Positive (CD107a+) CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | CD107a+ CD4+ Day 36 | 0.257 percentage of cells |
Comparison: This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.p-value: 0.74Wilcoxon (Mann-Whitney)
Comparison: This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.p-value: 0.73Wilcoxon (Mann-Whitney)
Primary
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.
Time frame: Day 1 through Day 36
Population: The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| M-001 + IIV4 | Mean Percentage of Interferon Gamma Positive (IFNg+) CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | INFg+ CD4+ at Day 1 | 0.0418 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Interferon Gamma Positive (IFNg+) CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | INFg+ CD4+ Day 36 | 0.0512 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Interferon Gamma Positive (IFNg+) CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | INFg+ CD8+ Day 1 | 0.0558 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Interferon Gamma Positive (IFNg+) CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | INFg+ CD8+ Day 36 | 0.0529 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Interferon Gamma Positive (IFNg+) CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | INFg+ CD8+ Day 36 | 0.0476 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Interferon Gamma Positive (IFNg+) CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | INFg+ CD4+ at Day 1 | 0.0333 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Interferon Gamma Positive (IFNg+) CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | INFg+ CD8+ Day 1 | 0.0400 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Interferon Gamma Positive (IFNg+) CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | INFg+ CD4+ Day 36 | 0.0436 percentage of cells |
Comparison: This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.p-value: 0.0078Wilcoxon (Mann-Whitney)
Comparison: This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.p-value: 0.94Wilcoxon (Mann-Whitney)
Primary
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.
Time frame: Day 1 through Day 36
Population: The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| M-001 + IIV4 | Mean Percentage of Interleukin-2 Positive (IL-2+) CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | IL-2+ CD4+ at Day 1 | 0.0682 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Interleukin-2 Positive (IL-2+) CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | IL-2+ CD4+ Day 36 | 0.0749 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Interleukin-2 Positive (IL-2+) CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | IL-2+ CD8+ Day 1 | 0.1260 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Interleukin-2 Positive (IL-2+) CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | IL-2+ CD8+ Day 36 | 0.1010 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Interleukin-2 Positive (IL-2+) CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | IL-2+ CD8+ Day 36 | 0.1170 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Interleukin-2 Positive (IL-2+) CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | IL-2+ CD4+ at Day 1 | 0.0634 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Interleukin-2 Positive (IL-2+) CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | IL-2+ CD8+ Day 1 | 0.0939 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Interleukin-2 Positive (IL-2+) CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | IL-2+ CD4+ Day 36 | 0.0692 percentage of cells |
Comparison: This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.p-value: 0.66Wilcoxon (Mann-Whitney)
Comparison: This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.p-value: 0.48Wilcoxon (Mann-Whitney)
Primary
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.
Time frame: Day 1 through Day 36
Population: The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| M-001 + IIV4 | Mean Percentage of Perforin- CD107a- IL-2- TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a- IL-2- TNF- IFNg- CD4+ at Day 1 | 98.1 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin- CD107a- IL-2- TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a- IL-2- TNF- IFNg- CD4+ Day 36 | 98.2 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin- CD107a- IL-2- TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a- IL-2- TNF- IFNg- CD8+ Day 1 | 83.5 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin- CD107a- IL-2- TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a- IL-2- TNF- IFNg- CD8+ Day 36 | 83.2 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin- CD107a- IL-2- TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a- IL-2- TNF- IFNg- CD8+ Day 36 | 85.8 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin- CD107a- IL-2- TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a- IL-2- TNF- IFNg- CD4+ at Day 1 | 98.4 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin- CD107a- IL-2- TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a- IL-2- TNF- IFNg- CD8+ Day 1 | 87.2 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin- CD107a- IL-2- TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a- IL-2- TNF- IFNg- CD4+ Day 36 | 98.5 percentage of cells |
Comparison: This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.p-value: 0.86Wilcoxon (Mann-Whitney)
Comparison: This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.p-value: 0.53Wilcoxon (Mann-Whitney)
Primary
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.
Time frame: Day 1 through Day 36
Population: The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| M-001 + IIV4 | Mean Percentage of Perforin- CD107a- IL-2- TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a- IL-2- TNF- IFNg+ CD4+ at Day 1 | 0.0238 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin- CD107a- IL-2- TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a- IL-2- TNF- IFNg+ CD4+ Day 36 | 0.0199 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin- CD107a- IL-2- TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a- IL-2- TNF- IFNg+ CD8+ Day 1 | 0.0314 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin- CD107a- IL-2- TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a- IL-2- TNF- IFNg+ CD8+ Day 36 | 0.0318 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin- CD107a- IL-2- TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a- IL-2- TNF- IFNg+ CD8+ Day 36 | 0.0308 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin- CD107a- IL-2- TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a- IL-2- TNF- IFNg+ CD4+ at Day 1 | 0.0147 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin- CD107a- IL-2- TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a- IL-2- TNF- IFNg+ CD8+ Day 1 | 0.0209 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin- CD107a- IL-2- TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a- IL-2- TNF- IFNg+ CD4+ Day 36 | 0.0255 percentage of cells |
Comparison: This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.p-value: 0.35Wilcoxon (Mann-Whitney)
Comparison: This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.p-value: 0.66Wilcoxon (Mann-Whitney)
Primary
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.
Time frame: Day 1 through Day 36
Population: The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| M-001 + IIV4 | Mean Percentage of Perforin- CD107a- IL-2- TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a- IL-2- TNF+IFNg- CD4+ at Day 1 | 0.390 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin- CD107a- IL-2- TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a- IL-2- TNF+IFNg- CD4+ Day 36 | 0.389 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin- CD107a- IL-2- TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a- IL-2- TNF+IFNg- CD8+ Day 1 | 0.0388 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin- CD107a- IL-2- TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a- IL-2- TNF+IFNg- CD8+ Day 36 | 0.0341 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin- CD107a- IL-2- TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a- IL-2- TNF+IFNg- CD8+ Day 36 | 0.0348 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin- CD107a- IL-2- TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a- IL-2- TNF+IFNg- CD4+ at Day 1 | 0.483 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin- CD107a- IL-2- TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a- IL-2- TNF+IFNg- CD8+ Day 1 | 0.0415 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin- CD107a- IL-2- TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a- IL-2- TNF+IFNg- CD4+ Day 36 | 0.354 percentage of cells |
Comparison: This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.p-value: 0.65Wilcoxon (Mann-Whitney)
Comparison: This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.p-value: 0.53Wilcoxon (Mann-Whitney)
Primary
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.
Time frame: Day 1 through Day 36
Population: The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| M-001 + IIV4 | Mean Percentage of Perforin- CD107a- IL-2- TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a- IL-2- TNF+IFNg+ CD4+ at Day 1 | 0.00935 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin- CD107a- IL-2- TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a- IL-2- TNF+IFNg+ CD4+ Day 36 | 0.01520 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin- CD107a- IL-2- TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a- IL-2- TNF+IFNg+ CD8+ Day 1 | 0.00488 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin- CD107a- IL-2- TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a- IL-2- TNF+IFNg+CD8+ Day 36 | 0.00257 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin- CD107a- IL-2- TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a- IL-2- TNF+IFNg+CD8+ Day 36 | 0.00242 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin- CD107a- IL-2- TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a- IL-2- TNF+IFNg+ CD4+ at Day 1 | 0.00881 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin- CD107a- IL-2- TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a- IL-2- TNF+IFNg+ CD8+ Day 1 | 0.00460 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin- CD107a- IL-2- TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a- IL-2- TNF+IFNg+ CD4+ Day 36 | 0.00731 percentage of cells |
Comparison: This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.p-value: <0.001Wilcoxon (Mann-Whitney)
Comparison: This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.p-value: 0.96Wilcoxon (Mann-Whitney)
Primary
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.
Time frame: Day 1 through Day 36
Population: The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| M-001 + IIV4 | Mean Percentage of Perforin- CD107a- IL-2+TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a- IL-2+TNF- IFNg- CD4+ at Day 1 | 0.0445 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin- CD107a- IL-2+TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a- IL-2+TNF- IFNg- CD4+ Day 36 | 0.0395 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin- CD107a- IL-2+TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a- IL-2+TNF- IFNg- CD8+ Day 1 | 0.0468 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin- CD107a- IL-2+TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a- IL-2+TNF- IFNg- CD8+ Day 36 | 0.0417 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin- CD107a- IL-2+TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a- IL-2+TNF- IFNg- CD8+ Day 36 | 0.0522 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin- CD107a- IL-2+TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a- IL-2+TNF- IFNg- CD4+ at Day 1 | 0.0400 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin- CD107a- IL-2+TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a- IL-2+TNF- IFNg- CD8+ Day 1 | 0.0444 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin- CD107a- IL-2+TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a- IL-2+TNF- IFNg- CD4+ Day 36 | 0.0478 percentage of cells |
Comparison: This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.p-value: 0.44Wilcoxon (Mann-Whitney)
Comparison: This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.p-value: 0.014Wilcoxon (Mann-Whitney)
Primary
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.
Time frame: Day 1 through Day 36
Population: The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| M-001 + IIV4 | Mean Percentage of Perforin- CD107a- IL-2+TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a- IL-2+TNF- IFNg+ CD4+ at Day 1 | 0.000169 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin- CD107a- IL-2+TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a- IL-2+TNF- IFNg+ CD4+ Day 36 | 0.000434 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin- CD107a- IL-2+TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a- IL-2+TNF- IFNg+ CD8+ Day 1 | 0.000397 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin- CD107a- IL-2+TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a- IL-2+TNF- IFNg+ CD8+ Day 36 | 0.000487 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin- CD107a- IL-2+TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a- IL-2+TNF- IFNg+ CD8+ Day 36 | 0.000378 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin- CD107a- IL-2+TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a- IL-2+TNF- IFNg+ CD4+ at Day 1 | 0.000438 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin- CD107a- IL-2+TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a- IL-2+TNF- IFNg+ CD8+ Day 1 | 0.000339 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin- CD107a- IL-2+TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a- IL-2+TNF- IFNg+ CD4+ Day 36 | 0.000372 percentage of cells |
Comparison: This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.p-value: 0.54Wilcoxon (Mann-Whitney)
Comparison: This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.p-value: 0.43Wilcoxon (Mann-Whitney)
Primary
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.
Time frame: Day 1 through Day 36
Population: The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| M-001 + IIV4 | Mean Percentage of Perforin- CD107a- IL-2+TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a- IL-2+TNF+IFNg- CD4+ at Day 1 | 0.01170 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin- CD107a- IL-2+TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a- IL-2+TNF+IFNg- CD4+ Day 36 | 0.01640 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin- CD107a- IL-2+TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a- IL-2+TNF+IFNg- CD8+ Day 1 | 0.00161 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin- CD107a- IL-2+TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a- IL-2+TNF+IFNg- IFNg- CD8+ Day 36 | 0.00129 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin- CD107a- IL-2+TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a- IL-2+TNF+IFNg- IFNg- CD8+ Day 36 | 0.00102 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin- CD107a- IL-2+TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a- IL-2+TNF+IFNg- CD4+ at Day 1 | 0.01240 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin- CD107a- IL-2+TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a- IL-2+TNF+IFNg- CD8+ Day 1 | 0.00184 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin- CD107a- IL-2+TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a- IL-2+TNF+IFNg- CD4+ Day 36 | 0.01130 percentage of cells |
Comparison: This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.p-value: 0.0093Wilcoxon (Mann-Whitney)
Comparison: This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.p-value: 0.51Wilcoxon (Mann-Whitney)
Primary
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.
Time frame: Day 1 through Day 36
Population: The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| M-001 + IIV4 | Mean Percentage of Perforin- CD107a- IL-2+TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a- IL-2+TNF+IFNg+ CD4+ at Day 1 | 0.00328 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin- CD107a- IL-2+TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a- IL-2+TNF+IFNg+ CD4+ Day 36 | 0.00955 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin- CD107a- IL-2+TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a- IL-2+TNF+IFNg+ CD8+ Day 1 | 0.000238 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin- CD107a- IL-2+TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a- IL-2+TNF+IFNg+ IFNg- CD8+ Day 36 | 0.000288 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin- CD107a- IL-2+TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a- IL-2+TNF+IFNg+ IFNg- CD8+ Day 36 | 0.000486 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin- CD107a- IL-2+TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a- IL-2+TNF+IFNg+ CD4+ at Day 1 | 0.00365 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin- CD107a- IL-2+TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a- IL-2+TNF+IFNg+ CD8+ Day 1 | 0.000693 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin- CD107a- IL-2+TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a- IL-2+TNF+IFNg+ CD4+ Day 36 | 0.00289 percentage of cells |
Comparison: This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.p-value: <0.001Wilcoxon (Mann-Whitney)
Comparison: This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.p-value: 0.62Wilcoxon (Mann-Whitney)
Primary
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.
Time frame: Day 1 through Day 36
Population: The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| M-001 + IIV4 | Mean Percentage of Perforin- CD107a+IL-2- TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a+IL-2- TNF- IFNg- CD4+ at Day 1 | 0.231 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin- CD107a+IL-2- TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a+IL-2- TNF- IFNg- CD4+ Day 36 | 0.220 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin- CD107a+IL-2- TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a+IL-2- TNF- IFNg- CD8+ Day 1 | 0.294 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin- CD107a+IL-2- TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a+IL-2- TNF- IFNg- CD8+ Day 36 | 0.295 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin- CD107a+IL-2- TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a+IL-2- TNF- IFNg- CD8+ Day 36 | 0.341 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin- CD107a+IL-2- TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a+IL-2- TNF- IFNg- CD4+ at Day 1 | 0.240 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin- CD107a+IL-2- TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a+IL-2- TNF- IFNg- CD8+ Day 1 | 0.323 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin- CD107a+IL-2- TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a+IL-2- TNF- IFNg- CD4+ Day 36 | 0.236 percentage of cells |
Comparison: This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.p-value: 0.67Wilcoxon (Mann-Whitney)
Comparison: This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.p-value: 0.48Wilcoxon (Mann-Whitney)
Primary
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.
Time frame: Day 1 through Day 36
Population: The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| M-001 + IIV4 | Mean Percentage of Perforin- CD107a+IL-2- TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a+IL-2- TNF- IFNg+ CD4+ at Day 1 | 0.000511 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin- CD107a+IL-2- TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a+IL-2- TNF- IFNg+ CD4+ Day 36 | 0.000731 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin- CD107a+IL-2- TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a+IL-2- TNF- IFNg+ CD8+ Day 1 | 0.001580 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin- CD107a+IL-2- TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a+IL-2- TNF- IFNg+ CD8+ Day 36 | 0.001780 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin- CD107a+IL-2- TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a+IL-2- TNF- IFNg+ CD8+ Day 36 | 0.002240 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin- CD107a+IL-2- TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a+IL-2- TNF- IFNg+ CD4+ at Day 1 | 0.000694 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin- CD107a+IL-2- TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a+IL-2- TNF- IFNg+ CD8+ Day 1 | 0.002160 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin- CD107a+IL-2- TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a+IL-2- TNF- IFNg+ CD4+ Day 36 | 0.001910 percentage of cells |
Comparison: This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.p-value: 0.16Wilcoxon (Mann-Whitney)
Comparison: This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.p-value: 0.44Wilcoxon (Mann-Whitney)
Primary
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.
Time frame: Day 1 through Day 36
Population: The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| M-001 + IIV4 | Mean Percentage of Perforin- CD107a+IL-2- TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a+IL-2- TNF+IFNg- CD4+ at Day 1 | 0.0147 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin- CD107a+IL-2- TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a+IL-2- TNF+IFNg- CD4+ Day 36 | 0.0123 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin- CD107a+IL-2- TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a+IL-2- TNF+IFNg- CD8+ Day 1 | 0.00678 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin- CD107a+IL-2- TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a+IL-2- TNF+IFNg- CD8+ Day 36 | 0.00427 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin- CD107a+IL-2- TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a+IL-2- TNF+IFNg- CD8+ Day 36 | 0.00630 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin- CD107a+IL-2- TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a+IL-2- TNF+IFNg- CD4+ at Day 1 | 0.0160 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin- CD107a+IL-2- TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a+IL-2- TNF+IFNg- CD8+ Day 1 | 0.00725 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin- CD107a+IL-2- TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a+IL-2- TNF+IFNg- CD4+ Day 36 | 0.0127 percentage of cells |
Comparison: This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.p-value: 0.31Wilcoxon (Mann-Whitney)
Comparison: This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.p-value: 0.22Wilcoxon (Mann-Whitney)
Primary
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.
Time frame: Day 1 through Day 36
Population: The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| M-001 + IIV4 | Mean Percentage of Perforin- CD107a+IL-2- TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a+IL-2- TNF+IFNg+ CD4+ at Day 1 | 0.00269 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin- CD107a+IL-2- TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a+IL-2- TNF+IFNg+ CD4+ Day 36 | 0.00309 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin- CD107a+IL-2- TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a+IL-2- TNF+IFNg+ CD8+ Day 1 | 0.00513 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin- CD107a+IL-2- TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a+IL-2- TNF+IFNg+ CD8+ Day 36 | 0.00604 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin- CD107a+IL-2- TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a+IL-2- TNF+IFNg+ CD8+ Day 36 | 0.00374 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin- CD107a+IL-2- TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a+IL-2- TNF+IFNg+ CD4+ at Day 1 | 0.00248 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin- CD107a+IL-2- TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a+IL-2- TNF+IFNg+ CD8+ Day 1 | 0.00617 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin- CD107a+IL-2- TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a+IL-2- TNF+IFNg+ CD4+ Day 36 | 0.00262 percentage of cells |
Comparison: This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.p-value: 0.72Wilcoxon (Mann-Whitney)
Comparison: This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.p-value: 0.31Wilcoxon (Mann-Whitney)
Primary
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.
Time frame: Day 1 through Day 36
Population: The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| M-001 + IIV4 | Mean Percentage of Perforin- CD107a+IL-2+TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a+IL-2+TNF- IFNg- CD4+ at Day 1 | 0.000809 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin- CD107a+IL-2+TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a+IL-2+TNF- IFNg- CD4+ Day 36 | 0.000653 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin- CD107a+IL-2+TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a+IL-2+TNF- IFNg- CD8+ Day 1 | 0.000377 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin- CD107a+IL-2+TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a+IL-2+TNF- IFNg- CD8+ Day 36 | 0.000912 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin- CD107a+IL-2+TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a+IL-2+TNF- IFNg- CD8+ Day 36 | 0.000369 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin- CD107a+IL-2+TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a+IL-2+TNF- IFNg- CD4+ at Day 1 | 0.000263 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin- CD107a+IL-2+TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a+IL-2+TNF- IFNg- CD8+ Day 1 | 0.000840 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin- CD107a+IL-2+TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a+IL-2+TNF- IFNg- CD4+ Day 36 | 0.000223 percentage of cells |
Comparison: This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.p-value: 0.14Wilcoxon (Mann-Whitney)
Comparison: This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.p-value: 0.26Wilcoxon (Mann-Whitney)
Primary
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.
Time frame: Day 1 through Day 36
Population: The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| M-001 + IIV4 | Mean Percentage of Perforin- CD107a+IL-2+TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a+IL-2+TNF- IFNg+ CD4+ at Day 1 | 0 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin- CD107a+IL-2+TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a+IL-2+TNF- IFNg+ CD4+ Day 36 | 0.0000725 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin- CD107a+IL-2+TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a+IL-2+TNF- IFNg+ CD8+ Day 1 | 0 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin- CD107a+IL-2+TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a+IL-2+TNF- IFNg+ CD8+ Day 36 | 0 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin- CD107a+IL-2+TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a+IL-2+TNF- IFNg+ CD8+ Day 36 | 0 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin- CD107a+IL-2+TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a+IL-2+TNF- IFNg+ CD4+ at Day 1 | 0.000156 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin- CD107a+IL-2+TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a+IL-2+TNF- IFNg+ CD8+ Day 1 | 0 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin- CD107a+IL-2+TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a+IL-2+TNF- IFNg+ CD4+ Day 36 | 0.000078 percentage of cells |
Comparison: This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.p-value: 0.94Wilcoxon (Mann-Whitney)
Comparison: This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.
Primary
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.
Time frame: Day 1 through Day 36
Population: The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| M-001 + IIV4 | Mean Percentage of Perforin- CD107a+IL-2+TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a+IL-2+TNF+IFNg- CD4+ at Day 1 | 0.00230 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin- CD107a+IL-2+TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a+IL-2+TNF+IFNg- CD4+ Day 36 | 0.00212 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin- CD107a+IL-2+TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a+IL-2+TNF+IFNg- CD8+ Day 1 | 0.000197 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin- CD107a+IL-2+TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a+IL-2+TNF+IFNg- CD8+ Day 36 | 0.000346 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin- CD107a+IL-2+TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a+IL-2+TNF+IFNg- CD8+ Day 36 | 0.0000719 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin- CD107a+IL-2+TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a+IL-2+TNF+IFNg- CD4+ at Day 1 | 0.00200 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin- CD107a+IL-2+TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a+IL-2+TNF+IFNg- CD8+ Day 1 | 0.0005900 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin- CD107a+IL-2+TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a+IL-2+TNF+IFNg- CD4+ Day 36 | 0.00144 percentage of cells |
Comparison: This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.p-value: 0.15Wilcoxon (Mann-Whitney)
Comparison: This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.p-value: 0.18Wilcoxon (Mann-Whitney)
Primary
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.
Time frame: Day 1 through Day 36
Population: The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| M-001 + IIV4 | Mean Percentage of Perforin- CD107a+IL-2+TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a+IL-2+TNF+IFNg+ CD4+ at Day 1 | 0.00135 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin- CD107a+IL-2+TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a+IL-2+TNF+IFNg+ CD4+ Day 36 | 0.00156 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin- CD107a+IL-2+TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a+IL-2+TNF+IFNg+ CD8+ Day 1 | 0.001170 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin- CD107a+IL-2+TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a+IL-2+TNF+IFNg+ CD8+ Day 36 | 0.000742 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin- CD107a+IL-2+TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a+IL-2+TNF+IFNg+ CD8+ Day 36 | 0.000465 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin- CD107a+IL-2+TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a+IL-2+TNF+IFNg+ CD4+ at Day 1 | 0.00122 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin- CD107a+IL-2+TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a+IL-2+TNF+IFNg+ CD8+ Day 1 | 0.001000 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin- CD107a+IL-2+TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin- CD107a+IL-2+TNF+IFNg+ CD4+ Day 36 | 0.00138 percentage of cells |
Comparison: This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.p-value: 0.97Wilcoxon (Mann-Whitney)
Comparison: This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.p-value: 0.62Wilcoxon (Mann-Whitney)
Primary
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.
Time frame: Day 1 through Day 36
Population: The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| M-001 + IIV4 | Mean Percentage of Perforin+CD107a- IL-2- TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a- IL-2- TNF- IFNg- CD4+ at Day 1 | 1.180 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin+CD107a- IL-2- TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a- IL-2- TNF- IFNg- CD4+ Day 36 | 1.080 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin+CD107a- IL-2- TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a- IL-2- TNF- IFNg- CD8+ Day 1 | 16.0 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin+CD107a- IL-2- TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a- IL-2- TNF- IFNg- CD8+ Day 36 | 16.2 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin+CD107a- IL-2- TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a- IL-2- TNF- IFNg- CD8+ Day 36 | 13.7 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin+CD107a- IL-2- TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a- IL-2- TNF- IFNg- CD4+ at Day 1 | 0.775 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin+CD107a- IL-2- TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a- IL-2- TNF- IFNg- CD8+ Day 1 | 12.3 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin+CD107a- IL-2- TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a- IL-2- TNF- IFNg- CD4+ Day 36 | 0.772 percentage of cells |
Comparison: This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.p-value: 0.53Wilcoxon (Mann-Whitney)
Comparison: This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.p-value: 0.56Wilcoxon (Mann-Whitney)
Primary
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.
Time frame: Day 1 through Day 36
Population: The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| M-001 + IIV4 | Mean Percentage of Perforin+CD107a- IL-2- TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a- IL-2- TNF- IFNg+ CD4+ at Day 1 | 0.000421 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin+CD107a- IL-2- TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a- IL-2- TNF- IFNg+ CD4+ Day 36 | 0.00027 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin+CD107a- IL-2- TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a- IL-2- TNF- IFNg+ CD8+ Day 1 | 0.00654 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin+CD107a- IL-2- TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a- IL-2- TNF- IFNg+ CD8+ Day 36 | 0.00376 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin+CD107a- IL-2- TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a- IL-2- TNF- IFNg+ CD8+ Day 36 | 0.00370 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin+CD107a- IL-2- TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a- IL-2- TNF- IFNg+ CD4+ at Day 1 | 0.000436 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin+CD107a- IL-2- TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a- IL-2- TNF- IFNg+ CD8+ Day 1 | 0.00177 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin+CD107a- IL-2- TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a- IL-2- TNF- IFNg+ CD4+ Day 36 | 0.000438 percentage of cells |
Comparison: This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.p-value: 0.42Wilcoxon (Mann-Whitney)
Comparison: This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.p-value: 0.26Wilcoxon (Mann-Whitney)
Primary
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.
Time frame: Day 1 through Day 36
Population: The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| M-001 + IIV4 | Mean Percentage of Perforin+CD107a- IL-2- TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a- IL-2- TNF+IFNg- CD4+ at Day 1 | 0.001100 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin+CD107a- IL-2- TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a- IL-2- TNF+IFNg- CD4+ Day 36 | 0.000564 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin+CD107a- IL-2- TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a- IL-2- TNF+IFNg- CD8+ Day 1 | 0.00880 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin+CD107a- IL-2- TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a- IL-2- TNF+IFNg- CD8+ Day 36 | 0.00947 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin+CD107a- IL-2- TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a- IL-2- TNF+IFNg- CD8+ Day 36 | 0.00595 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin+CD107a- IL-2- TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a- IL-2- TNF+IFNg- CD4+ at Day 1 | 0.000199 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin+CD107a- IL-2- TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a- IL-2- TNF+IFNg- CD8+ Day 1 | 0.00426 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin+CD107a- IL-2- TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a- IL-2- TNF+IFNg- CD4+ Day 36 | 0.000454 percentage of cells |
Comparison: This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.p-value: 0.36Wilcoxon (Mann-Whitney)
Comparison: This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.p-value: 0.32Wilcoxon (Mann-Whitney)
Primary
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.
Time frame: Day 1 through Day 36
Population: The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| M-001 + IIV4 | Mean Percentage of Perforin+CD107a- IL-2- TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a- IL-2- TNF+IFNg+ CD4+ at Day 1 | 0.0000639 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin+CD107a- IL-2- TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a- IL-2- TNF+IFNg+ CD4+ Day 36 | 0 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin+CD107a- IL-2- TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a- IL-2- TNF+IFNg+ CD8+ Day 1 | 0.00122 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin+CD107a- IL-2- TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a- IL-2- TNF+IFNg+ CD8+ Day 36 | 0.00305 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin+CD107a- IL-2- TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a- IL-2- TNF+IFNg+ CD8+ Day 36 | 0.00168 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin+CD107a- IL-2- TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a- IL-2- TNF+IFNg+ CD4+ at Day 1 | 0.000372 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin+CD107a- IL-2- TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a- IL-2- TNF+IFNg+ CD8+ Day 1 | 0.00135 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin+CD107a- IL-2- TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a- IL-2- TNF+IFNg+ CD4+ Day 36 | 0.000485 percentage of cells |
Comparison: This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.p-value: 0.0061Wilcoxon (Mann-Whitney)
Comparison: This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.p-value: 0.28Wilcoxon (Mann-Whitney)
Primary
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.
Time frame: Day 1 through Day 36
Population: The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| M-001 + IIV4 | Mean Percentage of Perforin+CD107a- IL-2+TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a- IL-2+TNF- IFNg- CD4+ at Day 1 | 0.00399 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin+CD107a- IL-2+TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a- IL-2+TNF- IFNg- CD4+ Day 36 | 0.00458 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin+CD107a- IL-2+TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a- IL-2+TNF- IFNg- CD8+ Day 1 | 0.0742 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin+CD107a- IL-2+TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a- IL-2+TNF- IFNg- CD8+ Day 36 | 0.0546 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin+CD107a- IL-2+TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a- IL-2+TNF- IFNg- CD8+ Day 36 | 0.0612 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin+CD107a- IL-2+TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a- IL-2+TNF- IFNg- CD4+ at Day 1 | 0.00307 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin+CD107a- IL-2+TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a- IL-2+TNF- IFNg- CD8+ Day 1 | 0.0434 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin+CD107a- IL-2+TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a- IL-2+TNF- IFNg- CD4+ Day 36 | 0.00354 percentage of cells |
Comparison: This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.p-value: 0.81Wilcoxon (Mann-Whitney)
Comparison: This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.p-value: 0.47Wilcoxon (Mann-Whitney)
Primary
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.
Time frame: Day 1 through Day 36
Population: The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| M-001 + IIV4 | Mean Percentage of Perforin+CD107a- IL-2+TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a- IL-2+TNF- IFNg+ CD4+ at Day 1 | 0 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin+CD107a- IL-2+TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a- IL-2+TNF- IFNg+ CD4+ Day 36 | 0 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin+CD107a- IL-2+TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a- IL-2+TNF- IFNg+ CD8+ Day 1 | 0 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin+CD107a- IL-2+TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a- IL-2+TNF- IFNg+ CD8+ Day 36 | 0 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin+CD107a- IL-2+TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a- IL-2+TNF- IFNg+ CD8+ Day 36 | 0.0000966 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin+CD107a- IL-2+TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a- IL-2+TNF- IFNg+ CD4+ at Day 1 | 0.000101 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin+CD107a- IL-2+TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a- IL-2+TNF- IFNg+ CD8+ Day 1 | 0.0003780 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin+CD107a- IL-2+TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a- IL-2+TNF- IFNg+ CD4+ Day 36 | 0.000061 percentage of cells |
Comparison: This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.p-value: >0.99Wilcoxon (Mann-Whitney)
Comparison: This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.p-value: >0.99Wilcoxon (Mann-Whitney)
Primary
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.
Time frame: Day 1 through Day 36
Population: The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| M-001 + IIV4 | Mean Percentage of Perforin+CD107a- IL-2+TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a- IL-2+TNF+IFNg- CD4+ at Day 1 | 0.0000375 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin+CD107a- IL-2+TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a- IL-2+TNF+IFNg- CD4+ Day 36 | 0.0000327 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin+CD107a- IL-2+TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a- IL-2+TNF+IFNg- CD8+ Day 1 | 0.0005150 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin+CD107a- IL-2+TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a- IL-2+TNF+IFNg- CD8+ Day 36 | 0.0000524 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin+CD107a- IL-2+TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a- IL-2+TNF+IFNg- CD8+ Day 36 | 0 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin+CD107a- IL-2+TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a- IL-2+TNF+IFNg- CD4+ at Day 1 | 0 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin+CD107a- IL-2+TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a- IL-2+TNF+IFNg- CD8+ Day 1 | 0.000322 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin+CD107a- IL-2+TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a- IL-2+TNF+IFNg- CD4+ Day 36 | 0 percentage of cells |
Comparison: This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.p-value: 0.5Wilcoxon (Mann-Whitney)
Comparison: This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.p-value: 0.5Wilcoxon (Mann-Whitney)
Primary
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.
Time frame: Day 1 through Day 36
Population: The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| M-001 + IIV4 | Mean Percentage of Perforin+CD107a- IL-2+TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a- IL-2+TNF+IFNg+ CD4+ at Day 1 | 0.0000621 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin+CD107a- IL-2+TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a- IL-2+TNF+IFNg+ CD4+ Day 36 | 0.0000888 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin+CD107a- IL-2+TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a- IL-2+TNF+IFNg+ CD8+ Day 1 | 0.000123 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin+CD107a- IL-2+TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a- IL-2+TNF+IFNg+ CD8+ Day 36 | 0.000184 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin+CD107a- IL-2+TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a- IL-2+TNF+IFNg+ CD8+ Day 36 | 0.000128 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin+CD107a- IL-2+TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a- IL-2+TNF+IFNg+ CD4+ at Day 1 | 0.0000457 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin+CD107a- IL-2+TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a- IL-2+TNF+IFNg+ CD8+ Day 1 | 0 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin+CD107a- IL-2+TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a- IL-2+TNF+IFNg+ CD4+ Day 36 | 0.0001010 percentage of cells |
Comparison: This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.p-value: >0.99Wilcoxon (Mann-Whitney)
Comparison: This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.p-value: 0.75Wilcoxon (Mann-Whitney)
Primary
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.
Time frame: Day 1 through Day 36
Population: The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| M-001 + IIV4 | Mean Percentage of Perforin+CD107a+IL-2- TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a+IL-2-TNF+IFNg- CD4+ at Day 1 | 0.000036 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin+CD107a+IL-2- TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a+IL-2-TNF+IFNg- CD4+ Day 36 | 0 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin+CD107a+IL-2- TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a+IL-2-TNF+IFNg- CD8+ Day 1 | 0.00288 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin+CD107a+IL-2- TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a+IL-2-TNF+IFNg- CD8+ Day 36 | 0.00326 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin+CD107a+IL-2- TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a+IL-2-TNF+IFNg- CD8+ Day 36 | 0.00134 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin+CD107a+IL-2- TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a+IL-2-TNF+IFNg- CD4+ at Day 1 | 0 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin+CD107a+IL-2- TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a+IL-2-TNF+IFNg- CD8+ Day 1 | 0.00172 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin+CD107a+IL-2- TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a+IL-2-TNF+IFNg- CD4+ Day 36 | 0.000161 percentage of cells |
Comparison: This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.p-value: 0.5Wilcoxon (Mann-Whitney)
Comparison: This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.p-value: 0.9Wilcoxon (Mann-Whitney)
Primary
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.
Time frame: Day 1 through Day 36
Population: The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| M-001 + IIV4 | Mean Percentage of Perforin+CD107a+IL-2-TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a+IL-2-TNF- IFNg- CD4+ at Day 1 | 0.00104 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin+CD107a+IL-2-TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a+IL-2-TNF- IFNg- CD4+ Day 36 | 0.00123 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin+CD107a+IL-2-TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a+IL-2-TNF- IFNg- CD8+ Day 1 | 0.0317 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin+CD107a+IL-2-TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a+IL-2-TNF- IFNg- CD8+ Day 36 | 0.0368 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin+CD107a+IL-2-TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a+IL-2-TNF- IFNg- CD8+ Day 36 | 0.0263 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin+CD107a+IL-2-TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a+IL-2-TNF- IFNg- CD4+ at Day 1 | 0.000728 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin+CD107a+IL-2-TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a+IL-2-TNF- IFNg- CD8+ Day 1 | 0.0237 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin+CD107a+IL-2-TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a+IL-2-TNF- IFNg- CD4+ Day 36 | 0.000928 percentage of cells |
Comparison: This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.p-value: 0.82Wilcoxon (Mann-Whitney)
Comparison: This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.p-value: 0.076Wilcoxon (Mann-Whitney)
Primary
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.
Time frame: Day 1 through Day 36
Population: The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| M-001 + IIV4 | Mean Percentage of Perforin+CD107a+IL-2-TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a+IL-2-TNF- IFNg+ CD4+ at Day 1 | 0 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin+CD107a+IL-2-TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a+IL-2-TNF- IFNg+ CD4+ Day 36 | 0.0000566 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin+CD107a+IL-2-TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a+IL-2-TNF- IFNg+ CD8+ Day 1 | 0.000444 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin+CD107a+IL-2-TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a+IL-2-TNF- IFNg+ CD8+ Day 36 | 0.000323 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin+CD107a+IL-2-TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a+IL-2-TNF- IFNg+ CD8+ Day 36 | 0.000197 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin+CD107a+IL-2-TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a+IL-2-TNF- IFNg+ CD4+ at Day 1 | 0 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin+CD107a+IL-2-TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a+IL-2-TNF- IFNg+ CD8+ Day 1 | 0.000409 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin+CD107a+IL-2-TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a+IL-2-TNF- IFNg+ CD4+ Day 36 | 0.000118 percentage of cells |
Comparison: This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.p-value: 0.87Wilcoxon (Mann-Whitney)
Comparison: This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.p-value: 0.57Wilcoxon (Mann-Whitney)
Primary
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.
Time frame: Day 1 through Day 36
Population: The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| M-001 + IIV4 | Mean Percentage of Perforin+CD107a+IL-2-TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a+IL-2-TNF+IFNg+ CD4+ at Day 1 | 0.0000741 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin+CD107a+IL-2-TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a+IL-2-TNF+IFNg+ CD4+ Day 36 | 0.0001600 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin+CD107a+IL-2-TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a+IL-2-TNF+IFNg+ CD8+ Day 1 | 0.00271 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin+CD107a+IL-2-TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a+IL-2-TNF+IFNg+ CD8+ Day 36 | 0.00187 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin+CD107a+IL-2-TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a+IL-2-TNF+IFNg+ CD8+ Day 36 | 0.00122 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin+CD107a+IL-2-TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a+IL-2-TNF+IFNg+ CD4+ at Day 1 | 0.000107 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin+CD107a+IL-2-TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a+IL-2-TNF+IFNg+ CD8+ Day 1 | 0.000269 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin+CD107a+IL-2-TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a+IL-2-TNF+IFNg+ CD4+ Day 36 | 0.000344 percentage of cells |
Comparison: This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.p-value: >0.99Wilcoxon (Mann-Whitney)
Comparison: This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.p-value: 0.74Wilcoxon (Mann-Whitney)
Primary
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.
Time frame: Day 1 through Day 36
Population: The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| M-001 + IIV4 | Mean Percentage of Perforin+CD107a+IL-2+TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a+IL-2+TNF- IFNg- CD4+ Day 1 | 0 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin+CD107a+IL-2+TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a+IL-2+TNF- IFNg- CD4+ Day 36 | 0 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin+CD107a+IL-2+TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a+IL-2+TNF- IFNg- CD8+ Day 1 | 0.00033 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin+CD107a+IL-2+TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a+IL-2+TNF- IFNg- CD8+ Day 36 | 0 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin+CD107a+IL-2+TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a+IL-2+TNF- IFNg- CD8+ Day 36 | 0.0001540 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin+CD107a+IL-2+TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a+IL-2+TNF- IFNg- CD4+ Day 1 | 0 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin+CD107a+IL-2+TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a+IL-2+TNF- IFNg- CD8+ Day 1 | 0.0000461 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin+CD107a+IL-2+TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a+IL-2+TNF- IFNg- CD4+ Day 36 | 0 percentage of cells |
Comparison: This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.
Comparison: This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.p-value: 0.5Wilcoxon (Mann-Whitney)
Primary
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.
Time frame: Day 1 through Day 36
Population: The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| M-001 + IIV4 | Mean Percentage of Perforin+CD107a+IL-2+TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a+IL-2+TNF- IFNg+ CD4+ Day 1 | 0 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin+CD107a+IL-2+TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a+IL-2+TNF- IFNg+ CD4+ Day 36 | 0 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin+CD107a+IL-2+TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a+IL-2+TNF- IFNg+ CD8+ Day 1 | 0 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin+CD107a+IL-2+TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a+IL-2+TNF- IFNg+ CD8+ Day 36 | 0 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin+CD107a+IL-2+TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a+IL-2+TNF- IFNg+ CD8+ Day 36 | 0 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin+CD107a+IL-2+TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a+IL-2+TNF- IFNg+ CD4+ Day 1 | 0 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin+CD107a+IL-2+TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a+IL-2+TNF- IFNg+ CD8+ Day 1 | 0 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin+CD107a+IL-2+TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a+IL-2+TNF- IFNg+ CD4+ Day 36 | 0 percentage of cells |
Comparison: This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.
Primary
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.
Time frame: Day 1 through Day 36
Population: The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| M-001 + IIV4 | Mean Percentage of Perforin+CD107a+IL-2+TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a+IL-2+TNF+IFNg- CD4+ Day 1 | 0 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin+CD107a+IL-2+TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a+IL-2+TNF+IFNg- CD4+ Day 36 | 0 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin+CD107a+IL-2+TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a+IL-2+TNF+IFNg- CD8+ Day 1 | 0 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin+CD107a+IL-2+TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a+IL-2+TNF+IFNg- CD8+ Day 36 | 0 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin+CD107a+IL-2+TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a+IL-2+TNF+IFNg- CD8+ Day 36 | 0 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin+CD107a+IL-2+TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a+IL-2+TNF+IFNg- CD4+ Day 1 | 0 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin+CD107a+IL-2+TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a+IL-2+TNF+IFNg- CD8+ Day 1 | 0 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin+CD107a+IL-2+TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a+IL-2+TNF+IFNg- CD4+ Day 36 | 0 percentage of cells |
Comparison: This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.
Comparison: This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.
Primary
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.
Time frame: Day 1 through Day 36
Population: The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| M-001 + IIV4 | Mean Percentage of Perforin+CD107a+IL-2+TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a+IL-2+TNF+IFNg+ CD4+ at Day 1 | 0 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin+CD107a+IL-2+TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a+IL-2+TNF+IFNg+ CD4+ Day 36 | 0 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin+CD107a+IL-2+TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a+IL-2+TNF+IFNg+ CD8+ Day 1 | 0 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin+CD107a+IL-2+TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a+IL-2+TNF+IFNg+ CD8+ Day 36 | 0.0000698 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin+CD107a+IL-2+TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a+IL-2+TNF+IFNg+ CD8+ Day 36 | 0 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin+CD107a+IL-2+TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a+IL-2+TNF+IFNg+ CD4+ at Day 1 | 0.000067 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin+CD107a+IL-2+TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a+IL-2+TNF+IFNg+ CD8+ Day 1 | 0 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin+CD107a+IL-2+TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+CD107a+IL-2+TNF+IFNg+ CD4+ Day 36 | 0 percentage of cells |
Comparison: This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.
Comparison: This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.p-value: 0.5Wilcoxon (Mann-Whitney)
Primary
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.
Time frame: Day 1 through Day 36
Population: The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| M-001 + IIV4 | Mean Percentage of Perforin+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+ CD4+ at Day 1 | 1.180 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+ CD4+ Day 36 | 1.090 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+ CD8+ Day 1 | 16.1 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Perforin+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+ CD8+ Day 36 | 16.3 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+ CD8+ Day 36 | 13.8 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+ CD4+ at Day 1 | 0.781 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+ CD8+ Day 1 | 12.4 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Perforin+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | Perforin+ CD4+ Day 36 | 0.779 percentage of cells |
Comparison: This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.p-value: 0.53Wilcoxon (Mann-Whitney)
Comparison: This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.p-value: 0.56Wilcoxon (Mann-Whitney)
Primary
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.
Time frame: Day 1 through Day 36
Population: The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| M-001 + IIV4 | Mean Percentage of Tumor Necrosis Factor Positive (TNF+) CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | TNF+ CD4+ at Day 1 | 0.437 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Tumor Necrosis Factor Positive (TNF+) CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | TNF+ CD4+ Day 36 | 0.450 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Tumor Necrosis Factor Positive (TNF+) CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | TNF+ CD8+ Day 1 | 0.0750 percentage of cells |
| M-001 + IIV4 | Mean Percentage of Tumor Necrosis Factor Positive (TNF+) CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | TNF+ CD8+ Day 36 | 0.0676 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Tumor Necrosis Factor Positive (TNF+) CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | TNF+ CD8+ Day 36 | 0.0596 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Tumor Necrosis Factor Positive (TNF+) CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | TNF+ CD4+ at Day 1 | 0.530 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Tumor Necrosis Factor Positive (TNF+) CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | TNF+ CD8+ Day 1 | 0.0716 percentage of cells |
| Placebo + IIV4 | Mean Percentage of Tumor Necrosis Factor Positive (TNF+) CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides | TNF+ CD4+ Day 36 | 0.395 percentage of cells |
Comparison: This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.p-value: 0.32Wilcoxon (Mann-Whitney)
Comparison: This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.p-value: >0.99Wilcoxon (Mann-Whitney)
Primary
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.
Time frame: Day 1 through Day 8
Population: The Safety Analysis population includes all participants who received the first study product.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| M-001 + IIV4 | Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the First M-001 Vaccination | Fever | 0 Participants |
| M-001 + IIV4 | Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the First M-001 Vaccination | Feverishness | 1 Participants |
| M-001 + IIV4 | Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the First M-001 Vaccination | Fatigue | 14 Participants |
| M-001 + IIV4 | Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the First M-001 Vaccination | Malaise | 5 Participants |
| M-001 + IIV4 | Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the First M-001 Vaccination | Myalgia | 6 Participants |
| M-001 + IIV4 | Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the First M-001 Vaccination | Arthralgia | 1 Participants |
| M-001 + IIV4 | Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the First M-001 Vaccination | Headache | 13 Participants |
| M-001 + IIV4 | Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the First M-001 Vaccination | Nausea | 7 Participants |
| M-001 + IIV4 | Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the First M-001 Vaccination | Injection site pain | 12 Participants |
| M-001 + IIV4 | Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the First M-001 Vaccination | Injection site tenderness | 24 Participants |
| M-001 + IIV4 | Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the First M-001 Vaccination | Injection site itchiness/pruritus | 2 Participants |
| M-001 + IIV4 | Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the First M-001 Vaccination | Injection site ecchymosis | 2 Participants |
| M-001 + IIV4 | Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the First M-001 Vaccination | Injection site erythema | 14 Participants |
| M-001 + IIV4 | Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the First M-001 Vaccination | Injection site induration/swelling | 3 Participants |
| Placebo + IIV4 | Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the First M-001 Vaccination | Injection site itchiness/pruritus | 1 Participants |
| Placebo + IIV4 | Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the First M-001 Vaccination | Fever | 1 Participants |
| Placebo + IIV4 | Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the First M-001 Vaccination | Nausea | 1 Participants |
| Placebo + IIV4 | Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the First M-001 Vaccination | Feverishness | 3 Participants |
| Placebo + IIV4 | Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the First M-001 Vaccination | Injection site erythema | 11 Participants |
| Placebo + IIV4 | Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the First M-001 Vaccination | Fatigue | 14 Participants |
| Placebo + IIV4 | Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the First M-001 Vaccination | Injection site pain | 2 Participants |
| Placebo + IIV4 | Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the First M-001 Vaccination | Malaise | 5 Participants |
| Placebo + IIV4 | Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the First M-001 Vaccination | Injection site ecchymosis | 3 Participants |
| Placebo + IIV4 | Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the First M-001 Vaccination | Myalgia | 6 Participants |
| Placebo + IIV4 | Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the First M-001 Vaccination | Injection site tenderness | 9 Participants |
| Placebo + IIV4 | Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the First M-001 Vaccination | Arthralgia | 1 Participants |
| Placebo + IIV4 | Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the First M-001 Vaccination | Injection site induration/swelling | 4 Participants |
| Placebo + IIV4 | Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the First M-001 Vaccination | Headache | 15 Participants |
Primary
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.
Time frame: Day 22 through Day 29
Population: The Safety Analysis population includes all participants who received the second study product.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| M-001 + IIV4 | Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the Second M-001 Vaccination | Fever | 1 Participants |
| M-001 + IIV4 | Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the Second M-001 Vaccination | Feverishness | 1 Participants |
| M-001 + IIV4 | Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the Second M-001 Vaccination | Fatigue | 8 Participants |
| M-001 + IIV4 | Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the Second M-001 Vaccination | Malaise | 6 Participants |
| M-001 + IIV4 | Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the Second M-001 Vaccination | Myalgia | 4 Participants |
| M-001 + IIV4 | Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the Second M-001 Vaccination | Arthralgia | 0 Participants |
| M-001 + IIV4 | Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the Second M-001 Vaccination | Headache | 8 Participants |
| M-001 + IIV4 | Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the Second M-001 Vaccination | Nausea | 2 Participants |
| M-001 + IIV4 | Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the Second M-001 Vaccination | Injection site pain | 13 Participants |
| M-001 + IIV4 | Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the Second M-001 Vaccination | Injection site tenderness | 16 Participants |
| M-001 + IIV4 | Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the Second M-001 Vaccination | Injection site itchiness/pruritus | 2 Participants |
| M-001 + IIV4 | Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the Second M-001 Vaccination | Injection site ecchymosis | 0 Participants |
| M-001 + IIV4 | Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the Second M-001 Vaccination | Injection site erythema | 15 Participants |
| M-001 + IIV4 | Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the Second M-001 Vaccination | Injection site induration/swelling | 2 Participants |
| Placebo + IIV4 | Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the Second M-001 Vaccination | Injection site itchiness/pruritus | 1 Participants |
| Placebo + IIV4 | Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the Second M-001 Vaccination | Fever | 0 Participants |
| Placebo + IIV4 | Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the Second M-001 Vaccination | Nausea | 1 Participants |
| Placebo + IIV4 | Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the Second M-001 Vaccination | Feverishness | 2 Participants |
| Placebo + IIV4 | Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the Second M-001 Vaccination | Injection site erythema | 7 Participants |
| Placebo + IIV4 | Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the Second M-001 Vaccination | Fatigue | 7 Participants |
| Placebo + IIV4 | Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the Second M-001 Vaccination | Injection site pain | 2 Participants |
| Placebo + IIV4 | Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the Second M-001 Vaccination | Malaise | 4 Participants |
| Placebo + IIV4 | Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the Second M-001 Vaccination | Injection site ecchymosis | 3 Participants |
| Placebo + IIV4 | Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the Second M-001 Vaccination | Myalgia | 2 Participants |
| Placebo + IIV4 | Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the Second M-001 Vaccination | Injection site tenderness | 11 Participants |
| Placebo + IIV4 | Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the Second M-001 Vaccination | Arthralgia | 2 Participants |
| Placebo + IIV4 | Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the Second M-001 Vaccination | Injection site induration/swelling | 2 Participants |
| Placebo + IIV4 | Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the Second M-001 Vaccination | Headache | 8 Participants |
Primary
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.
Time frame: Day 1 through Day 200
Population: The Safety Analysis population includes all participants who received at least one dose of study product.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| M-001 + IIV4 | Number of Participants Reporting Vaccine-related Serious Adverse Events (SAEs) After M-001 Vaccination | 0 Participants |
| Placebo + IIV4 | Number of Participants Reporting Vaccine-related Serious Adverse Events (SAEs) After M-001 Vaccination | 0 Participants |
Primary
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.
Time frame: Day 22 through Day 29
Population: The Safety Analysis population includes all participants who received the second dose of study product and have a result reported for the parameter.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| M-001 + IIV4 | Number of Participants With Clinical Safety Laboratory Adverse Events After Second M-001 Vaccination | WBC | 2 Participants |
| M-001 + IIV4 | Number of Participants With Clinical Safety Laboratory Adverse Events After Second M-001 Vaccination | platelets | 0 Participants |
| M-001 + IIV4 | Number of Participants With Clinical Safety Laboratory Adverse Events After Second M-001 Vaccination | hemoglobin | 2 Participants |
| M-001 + IIV4 | Number of Participants With Clinical Safety Laboratory Adverse Events After Second M-001 Vaccination | ALT | 2 Participants |
| M-001 + IIV4 | Number of Participants With Clinical Safety Laboratory Adverse Events After Second M-001 Vaccination | creatinine | 0 Participants |
| M-001 + IIV4 | Number of Participants With Clinical Safety Laboratory Adverse Events After Second M-001 Vaccination | total bilirubin | 2 Participants |
| Placebo + IIV4 | Number of Participants With Clinical Safety Laboratory Adverse Events After Second M-001 Vaccination | creatinine | 0 Participants |
| Placebo + IIV4 | Number of Participants With Clinical Safety Laboratory Adverse Events After Second M-001 Vaccination | WBC | 3 Participants |
| Placebo + IIV4 | Number of Participants With Clinical Safety Laboratory Adverse Events After Second M-001 Vaccination | ALT | 0 Participants |
| Placebo + IIV4 | Number of Participants With Clinical Safety Laboratory Adverse Events After Second M-001 Vaccination | platelets | 0 Participants |
| Placebo + IIV4 | Number of Participants With Clinical Safety Laboratory Adverse Events After Second M-001 Vaccination | total bilirubin | 2 Participants |
| Placebo + IIV4 | Number of Participants With Clinical Safety Laboratory Adverse Events After Second M-001 Vaccination | hemoglobin | 0 Participants |
Primary
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.
Time frame: Day 9
Population: The Safety Analysis population includes all participants who received the first dose of study product and have a result reported for the parameter.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| M-001 + IIV4 | Number of Participants With Clinical Safety Laboratory Adverse Events After the First M-001 Vaccination | platelets | 1 Participants |
| M-001 + IIV4 | Number of Participants With Clinical Safety Laboratory Adverse Events After the First M-001 Vaccination | WBC | 5 Participants |
| M-001 + IIV4 | Number of Participants With Clinical Safety Laboratory Adverse Events After the First M-001 Vaccination | hemoglobin | 3 Participants |
| M-001 + IIV4 | Number of Participants With Clinical Safety Laboratory Adverse Events After the First M-001 Vaccination | ALT | 2 Participants |
| M-001 + IIV4 | Number of Participants With Clinical Safety Laboratory Adverse Events After the First M-001 Vaccination | creatinine | 0 Participants |
| M-001 + IIV4 | Number of Participants With Clinical Safety Laboratory Adverse Events After the First M-001 Vaccination | total bilirubin | 2 Participants |
| Placebo + IIV4 | Number of Participants With Clinical Safety Laboratory Adverse Events After the First M-001 Vaccination | creatinine | 0 Participants |
| Placebo + IIV4 | Number of Participants With Clinical Safety Laboratory Adverse Events After the First M-001 Vaccination | platelets | 0 Participants |
| Placebo + IIV4 | Number of Participants With Clinical Safety Laboratory Adverse Events After the First M-001 Vaccination | ALT | 0 Participants |
| Placebo + IIV4 | Number of Participants With Clinical Safety Laboratory Adverse Events After the First M-001 Vaccination | WBC | 7 Participants |
| Placebo + IIV4 | Number of Participants With Clinical Safety Laboratory Adverse Events After the First M-001 Vaccination | total bilirubin | 2 Participants |
| Placebo + IIV4 | Number of Participants With Clinical Safety Laboratory Adverse Events After the First M-001 Vaccination | hemoglobin | 1 Participants |
Secondary
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.
Time frame: Day 1 through Day 43
Population: The Safety Analysis population includes all participants who received at least one dose of study product.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| M-001 + IIV4 | Incidence of Unsolicited Non-serious Adverse Events (AEs) After M-001 Vaccination | Eye Disorders | 1 participants |
| M-001 + IIV4 | Incidence of Unsolicited Non-serious Adverse Events (AEs) After M-001 Vaccination | Immune system disorders | 0 participants |
| M-001 + IIV4 | Incidence of Unsolicited Non-serious Adverse Events (AEs) After M-001 Vaccination | Nervous system disorders | 3 participants |
| M-001 + IIV4 | Incidence of Unsolicited Non-serious Adverse Events (AEs) After M-001 Vaccination | Blood and lymphatic system disorders | 0 participants |
| M-001 + IIV4 | Incidence of Unsolicited Non-serious Adverse Events (AEs) After M-001 Vaccination | Reproductive system and breast disorders | 1 participants |
| M-001 + IIV4 | Incidence of Unsolicited Non-serious Adverse Events (AEs) After M-001 Vaccination | Infections and Infestations | 11 participants |
| M-001 + IIV4 | Incidence of Unsolicited Non-serious Adverse Events (AEs) After M-001 Vaccination | Respiratory, thoracic and mediastinal disorders | 3 participants |
| M-001 + IIV4 | Incidence of Unsolicited Non-serious Adverse Events (AEs) After M-001 Vaccination | Gastrointestinal disorders | 2 participants |
| M-001 + IIV4 | Incidence of Unsolicited Non-serious Adverse Events (AEs) After M-001 Vaccination | Skin and subcutaneous tissue disorders | 3 participants |
| M-001 + IIV4 | Incidence of Unsolicited Non-serious Adverse Events (AEs) After M-001 Vaccination | Injury, poisoning and procedural complications | 2 participants |
| M-001 + IIV4 | Incidence of Unsolicited Non-serious Adverse Events (AEs) After M-001 Vaccination | Vascular disorders | 0 participants |
| M-001 + IIV4 | Incidence of Unsolicited Non-serious Adverse Events (AEs) After M-001 Vaccination | Musculoskeletal and connective tissue disorders | 4 participants |
| Placebo + IIV4 | Incidence of Unsolicited Non-serious Adverse Events (AEs) After M-001 Vaccination | Vascular disorders | 1 participants |
| Placebo + IIV4 | Incidence of Unsolicited Non-serious Adverse Events (AEs) After M-001 Vaccination | Blood and lymphatic system disorders | 2 participants |
| Placebo + IIV4 | Incidence of Unsolicited Non-serious Adverse Events (AEs) After M-001 Vaccination | Eye Disorders | 1 participants |
| Placebo + IIV4 | Incidence of Unsolicited Non-serious Adverse Events (AEs) After M-001 Vaccination | Gastrointestinal disorders | 1 participants |
| Placebo + IIV4 | Incidence of Unsolicited Non-serious Adverse Events (AEs) After M-001 Vaccination | Immune system disorders | 1 participants |
| Placebo + IIV4 | Incidence of Unsolicited Non-serious Adverse Events (AEs) After M-001 Vaccination | Infections and Infestations | 12 participants |
| Placebo + IIV4 | Incidence of Unsolicited Non-serious Adverse Events (AEs) After M-001 Vaccination | Injury, poisoning and procedural complications | 2 participants |
| Placebo + IIV4 | Incidence of Unsolicited Non-serious Adverse Events (AEs) After M-001 Vaccination | Musculoskeletal and connective tissue disorders | 1 participants |
| Placebo + IIV4 | Incidence of Unsolicited Non-serious Adverse Events (AEs) After M-001 Vaccination | Nervous system disorders | 2 participants |
| Placebo + IIV4 | Incidence of Unsolicited Non-serious Adverse Events (AEs) After M-001 Vaccination | Reproductive system and breast disorders | 0 participants |
| Placebo + IIV4 | Incidence of Unsolicited Non-serious Adverse Events (AEs) After M-001 Vaccination | Respiratory, thoracic and mediastinal disorders | 2 participants |
| Placebo + IIV4 | Incidence of Unsolicited Non-serious Adverse Events (AEs) After M-001 Vaccination | Skin and subcutaneous tissue disorders | 3 participants |
Secondary
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.
Time frame: Day 1 through Day 200
Population: The Safety Analysis population includes all participants who received at least one dose of study product.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| M-001 + IIV4 | Number of Participants Reporting Serious Adverse Events (SAEs) After M-001 Vaccination | 1 Participants |
| Placebo + IIV4 | Number of Participants Reporting Serious Adverse Events (SAEs) After M-001 Vaccination | 0 Participants |
Secondary
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.
Time frame: Day 1
Population: The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| M-001 + IIV4 | The Percentage of Participants With a Neutralizing Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 1 | B/Colorado/6/2017 | 30.0 percentage of participants |
| M-001 + IIV4 | The Percentage of Participants With a Neutralizing Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 1 | B/Phuket/3073/2013 | 71.7 percentage of participants |
| M-001 + IIV4 | The Percentage of Participants With a Neutralizing Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 1 | A/Michigan/45/2015 X-275 | 100 percentage of participants |
| M-001 + IIV4 | The Percentage of Participants With a Neutralizing Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 1 | A/Singapore/INFIMH-16-0019/2016 NIB-104 | 91.7 percentage of participants |
| Placebo + IIV4 | The Percentage of Participants With a Neutralizing Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 1 | A/Singapore/INFIMH-16-0019/2016 NIB-104 | 93.2 percentage of participants |
| Placebo + IIV4 | The Percentage of Participants With a Neutralizing Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 1 | B/Colorado/6/2017 | 22.0 percentage of participants |
| Placebo + IIV4 | The Percentage of Participants With a Neutralizing Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 1 | A/Michigan/45/2015 X-275 | 96.6 percentage of participants |
| Placebo + IIV4 | The Percentage of Participants With a Neutralizing Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 1 | B/Phuket/3073/2013 | 74.6 percentage of participants |
Secondary
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.
Time frame: Day 172
Population: The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| M-001 + IIV4 | The Percentage of Participants With a Neutralizing Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 172 | B/Colorado/6/2017 | 24.5 percentage of participants |
| M-001 + IIV4 | The Percentage of Participants With a Neutralizing Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 172 | B/Phuket/3073/2013 | 67.9 percentage of participants |
| M-001 + IIV4 | The Percentage of Participants With a Neutralizing Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 172 | A/Michigan/45/2015 X-275 | 98.1 percentage of participants |
| M-001 + IIV4 | The Percentage of Participants With a Neutralizing Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 172 | A/Singapore/INFIMH-16-0019/2016 NIB-104 | 86.8 percentage of participants |
| Placebo + IIV4 | The Percentage of Participants With a Neutralizing Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 172 | A/Singapore/INFIMH-16-0019/2016 NIB-104 | 92.3 percentage of participants |
| Placebo + IIV4 | The Percentage of Participants With a Neutralizing Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 172 | B/Colorado/6/2017 | 26.9 percentage of participants |
| Placebo + IIV4 | The Percentage of Participants With a Neutralizing Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 172 | A/Michigan/45/2015 X-275 | 96.2 percentage of participants |
| Placebo + IIV4 | The Percentage of Participants With a Neutralizing Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 172 | B/Phuket/3073/2013 | 69.2 percentage of participants |
Secondary
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.
Time frame: Day 200
Population: The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| M-001 + IIV4 | The Percentage of Participants With a Neutralizing Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 200 | B/Colorado/6/2017 | 69.2 percentage of participants |
| M-001 + IIV4 | The Percentage of Participants With a Neutralizing Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 200 | B/Phuket/3073/2013 | 86.5 percentage of participants |
| M-001 + IIV4 | The Percentage of Participants With a Neutralizing Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 200 | A/Michigan/45/2015 X-275 | 100 percentage of participants |
| M-001 + IIV4 | The Percentage of Participants With a Neutralizing Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 200 | A/Singapore/INFIMH-16-0019/2016 NIB-104 | 98.1 percentage of participants |
| Placebo + IIV4 | The Percentage of Participants With a Neutralizing Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 200 | A/Singapore/INFIMH-16-0019/2016 NIB-104 | 98.0 percentage of participants |
| Placebo + IIV4 | The Percentage of Participants With a Neutralizing Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 200 | B/Colorado/6/2017 | 50.0 percentage of participants |
| Placebo + IIV4 | The Percentage of Participants With a Neutralizing Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 200 | A/Michigan/45/2015 X-275 | 100 percentage of participants |
| Placebo + IIV4 | The Percentage of Participants With a Neutralizing Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 200 | B/Phuket/3073/2013 | 82.0 percentage of participants |
Secondary
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.
Time frame: Day 43
Population: The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| M-001 + IIV4 | The Percentage of Participants With a Neutralizing Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 43 | B/Colorado/6/2017 | 20.8 percentage of participants |
| M-001 + IIV4 | The Percentage of Participants With a Neutralizing Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 43 | B/Phuket/3073/2013 | 77.4 percentage of participants |
| M-001 + IIV4 | The Percentage of Participants With a Neutralizing Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 43 | A/Michigan/45/2015 X-275 | 98.1 percentage of participants |
| M-001 + IIV4 | The Percentage of Participants With a Neutralizing Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 43 | A/Singapore/INFIMH-16-0019/2016 NIB-104 | 90.6 percentage of participants |
| Placebo + IIV4 | The Percentage of Participants With a Neutralizing Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 43 | A/Singapore/INFIMH-16-0019/2016 NIB-104 | 92.5 percentage of participants |
| Placebo + IIV4 | The Percentage of Participants With a Neutralizing Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 43 | B/Colorado/6/2017 | 28.3 percentage of participants |
| Placebo + IIV4 | The Percentage of Participants With a Neutralizing Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 43 | A/Michigan/45/2015 X-275 | 98.1 percentage of participants |
| Placebo + IIV4 | The Percentage of Participants With a Neutralizing Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 43 | B/Phuket/3073/2013 | 69.8 percentage of participants |
Secondary
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.
Time frame: Day 1
Population: The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| M-001 + IIV4 | The Percentage of Participants With an HAI Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 1 | B/Colorado/6/2017 | 98.3 percentage of participants |
| M-001 + IIV4 | The Percentage of Participants With an HAI Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 1 | B/Phuket/3073/2013 | 93.3 percentage of participants |
| M-001 + IIV4 | The Percentage of Participants With an HAI Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 1 | A/Michigan/45/2015 X-275 | 80.0 percentage of participants |
| M-001 + IIV4 | The Percentage of Participants With an HAI Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 1 | A/Singapore/INFIMH-16-0019/2016 NIB-104 | 43.3 percentage of participants |
| Placebo + IIV4 | The Percentage of Participants With an HAI Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 1 | A/Singapore/INFIMH-16-0019/2016 NIB-104 | 33.9 percentage of participants |
| Placebo + IIV4 | The Percentage of Participants With an HAI Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 1 | B/Colorado/6/2017 | 93.2 percentage of participants |
| Placebo + IIV4 | The Percentage of Participants With an HAI Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 1 | A/Michigan/45/2015 X-275 | 81.4 percentage of participants |
| Placebo + IIV4 | The Percentage of Participants With an HAI Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 1 | B/Phuket/3073/2013 | 93.2 percentage of participants |
Secondary
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.
Time frame: Day 172
Population: The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| M-001 + IIV4 | The Percentage of Participants With an HAI Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 172 | B/Colorado/6/2017 | 94.3 percentage of participants |
| M-001 + IIV4 | The Percentage of Participants With an HAI Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 172 | B/Phuket/3073/2013 | 94.3 percentage of participants |
| M-001 + IIV4 | The Percentage of Participants With an HAI Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 172 | A/Michigan/45/2015 X-275 | 81.1 percentage of participants |
| M-001 + IIV4 | The Percentage of Participants With an HAI Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 172 | A/Singapore/INFIMH-16-0019/2016 NIB-104 | 39.6 percentage of participants |
| Placebo + IIV4 | The Percentage of Participants With an HAI Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 172 | A/Singapore/INFIMH-16-0019/2016 NIB-104 | 30.8 percentage of participants |
| Placebo + IIV4 | The Percentage of Participants With an HAI Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 172 | B/Colorado/6/2017 | 88.5 percentage of participants |
| Placebo + IIV4 | The Percentage of Participants With an HAI Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 172 | A/Michigan/45/2015 X-275 | 78.8 percentage of participants |
| Placebo + IIV4 | The Percentage of Participants With an HAI Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 172 | B/Phuket/3073/2013 | 88.5 percentage of participants |
Secondary
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.
Time frame: Day 200
Population: The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| M-001 + IIV4 | The Percentage of Participants With an HAI Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 200 | B/Colorado/6/2017 | 98.1 percentage of participants |
| M-001 + IIV4 | The Percentage of Participants With an HAI Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 200 | B/Phuket/3073/2013 | 98.1 percentage of participants |
| M-001 + IIV4 | The Percentage of Participants With an HAI Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 200 | A/Michigan/45/2015 X-275 | 94.2 percentage of participants |
| M-001 + IIV4 | The Percentage of Participants With an HAI Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 200 | A/Singapore/INFIMH-16-0019/2016 NIB-104 | 67.3 percentage of participants |
| Placebo + IIV4 | The Percentage of Participants With an HAI Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 200 | A/Singapore/INFIMH-16-0019/2016 NIB-104 | 60 percentage of participants |
| Placebo + IIV4 | The Percentage of Participants With an HAI Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 200 | B/Colorado/6/2017 | 96.0 percentage of participants |
| Placebo + IIV4 | The Percentage of Participants With an HAI Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 200 | A/Michigan/45/2015 X-275 | 88.0 percentage of participants |
| Placebo + IIV4 | The Percentage of Participants With an HAI Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 200 | B/Phuket/3073/2013 | 96.0 percentage of participants |
Secondary
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.
Time frame: Day 43
Population: The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| M-001 + IIV4 | The Percentage of Participants With an HAI Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 43 | B/Colorado/6/2017 | 96.2 percentage of participants |
| M-001 + IIV4 | The Percentage of Participants With an HAI Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 43 | B/Phuket/3073/2013 | 94.3 percentage of participants |
| M-001 + IIV4 | The Percentage of Participants With an HAI Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 43 | A/Michigan/45/2015 X-275 | 79.2 percentage of participants |
| M-001 + IIV4 | The Percentage of Participants With an HAI Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 43 | A/Singapore/INFIMH-16-0019/2016 NIB-104 | 39.6 percentage of participants |
| Placebo + IIV4 | The Percentage of Participants With an HAI Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 43 | A/Singapore/INFIMH-16-0019/2016 NIB-104 | 35.8 percentage of participants |
| Placebo + IIV4 | The Percentage of Participants With an HAI Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 43 | B/Colorado/6/2017 | 92.5 percentage of participants |
| Placebo + IIV4 | The Percentage of Participants With an HAI Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 43 | A/Michigan/45/2015 X-275 | 79.2 percentage of participants |
| Placebo + IIV4 | The Percentage of Participants With an HAI Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 43 | B/Phuket/3073/2013 | 92.5 percentage of participants |
Secondary
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.
Time frame: Day 172 to Day 200
Population: The modified intent-to-treat (mITT) population includes all participants who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| M-001 + IIV4 | The Percentage of Subjects Achieving HAI Seroconversion to IIV4 Vaccine Virus From Day 172 to Day 200 | B/Colorado/6/2017 | 13.5 percentage of participants |
| M-001 + IIV4 | The Percentage of Subjects Achieving HAI Seroconversion to IIV4 Vaccine Virus From Day 172 to Day 200 | B/Phuket/3073/2013 | 11.5 percentage of participants |
| M-001 + IIV4 | The Percentage of Subjects Achieving HAI Seroconversion to IIV4 Vaccine Virus From Day 172 to Day 200 | A/Michigan/45/2015 X-275 | 15.4 percentage of participants |
| M-001 + IIV4 | The Percentage of Subjects Achieving HAI Seroconversion to IIV4 Vaccine Virus From Day 172 to Day 200 | A/Singapore/INFIMH-16-0019/2016 NIB-104 | 25.0 percentage of participants |
| Placebo + IIV4 | The Percentage of Subjects Achieving HAI Seroconversion to IIV4 Vaccine Virus From Day 172 to Day 200 | A/Singapore/INFIMH-16-0019/2016 NIB-104 | 20.0 percentage of participants |
| Placebo + IIV4 | The Percentage of Subjects Achieving HAI Seroconversion to IIV4 Vaccine Virus From Day 172 to Day 200 | B/Colorado/6/2017 | 6.0 percentage of participants |
| Placebo + IIV4 | The Percentage of Subjects Achieving HAI Seroconversion to IIV4 Vaccine Virus From Day 172 to Day 200 | A/Michigan/45/2015 X-275 | 16.0 percentage of participants |
| Placebo + IIV4 | The Percentage of Subjects Achieving HAI Seroconversion to IIV4 Vaccine Virus From Day 172 to Day 200 | B/Phuket/3073/2013 | 8.0 percentage of participants |
Secondary
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.
Time frame: Day 172 to Day 200
Population: The modified intent-to-treat (mITT) population includes all participants who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| M-001 + IIV4 | The Percentage of Subjects Achieving Neutralizing Antibody Seroconversion to IIV4 Vaccine Virus From Day 172 to Day 200 | B/Colorado/6/2017 | 17.3 percentage of participants |
| M-001 + IIV4 | The Percentage of Subjects Achieving Neutralizing Antibody Seroconversion to IIV4 Vaccine Virus From Day 172 to Day 200 | B/Phuket/3073/2013 | 13.5 percentage of participants |
| M-001 + IIV4 | The Percentage of Subjects Achieving Neutralizing Antibody Seroconversion to IIV4 Vaccine Virus From Day 172 to Day 200 | A/Michigan/45/2015 X-275 | 19.2 percentage of participants |
| M-001 + IIV4 | The Percentage of Subjects Achieving Neutralizing Antibody Seroconversion to IIV4 Vaccine Virus From Day 172 to Day 200 | A/Singapore/INFIMH-16-0019/2016 NIB-104 | 46.2 percentage of participants |
| Placebo + IIV4 | The Percentage of Subjects Achieving Neutralizing Antibody Seroconversion to IIV4 Vaccine Virus From Day 172 to Day 200 | A/Singapore/INFIMH-16-0019/2016 NIB-104 | 26.0 percentage of participants |
| Placebo + IIV4 | The Percentage of Subjects Achieving Neutralizing Antibody Seroconversion to IIV4 Vaccine Virus From Day 172 to Day 200 | B/Colorado/6/2017 | 6.0 percentage of participants |
| Placebo + IIV4 | The Percentage of Subjects Achieving Neutralizing Antibody Seroconversion to IIV4 Vaccine Virus From Day 172 to Day 200 | A/Michigan/45/2015 X-275 | 16.0 percentage of participants |
| Placebo + IIV4 | The Percentage of Subjects Achieving Neutralizing Antibody Seroconversion to IIV4 Vaccine Virus From Day 172 to Day 200 | B/Phuket/3073/2013 | 8.0 percentage of participants |