Two Doses of Multimeric-001 (M-001) Followed by Influenza Vaccine
Official Title
A Phase II, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial to Assess the Safety, Reactogenicity and Immunogenicity of Two Doses of Multimeric-001 (M-001) Followed by Seasonal Quadrivalent Influenza Vaccine
Acronym
Not provided
Organization
National Institute of Allergy and Infectious Diseases (NIAID)NIH
Status Module
Record Verification Date
Nov 27, 2019
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Apr 9, 2018Actual
Primary Completion Date
Jan 14, 2019Actual
Completion Date
Jan 14, 2019Actual
First Submitted Date
Feb 9, 2017
First Submission Date that Met QC Criteria
Feb 16, 2017
First Posted Date
Feb 23, 2017Actual
Results Waived
Not provided
Results First Submitted Date
Jan 14, 2020
Results First Submitted that Met QC Criteria
Jan 14, 2020
Results First Posted Date
Feb 5, 2020Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jun 2, 2020
Last Update Posted Date
Jun 18, 2020Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)NIH
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Not provided
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
No
FDAAA801 Violation
Not provided
Description Module
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.
Conditions Module
Conditions
Influenza
Influenza Immunisation
Keywords
Immunogenicity
Influenza Vaccine
M-001 vaccine
Reactogenicity
Safety
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
120Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
M-001 + IIV4
Experimental
0.4 ml injection of M-001 (1 mg dose) intramuscularly on Day 1 and Day 22, followed by 0.5 ml injection of IIV4 (60 mcg HA) intramuscularly on Day 172 (n=60)
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.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
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.
Day 1 through Day 36
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.
Day 1 through Day 36
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.
Day 1 through Day 36
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.
Secondary Outcomes
Measure
Description
Time Frame
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.
Day 1 through Day 200
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Provide written informed consent prior to initiation of any study procedures.
Are able to understand and comply with planned study procedures and be available for all study visits.
Are males or non-pregnant females, 18 to 49 years old, inclusive.
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.
Oral temperature is less than 100.0 degrees F.
Pulse** is 50 to 100 bpm, inclusive.
**Acceptable pulse range prior to IIV4 dose is 45 to 115 bpm, inclusive and no symptoms.
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.
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.
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.
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.
Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 24 hours prior to study vaccination.
Exclusion Criteria:
Have an acute illness*, as determined by the site PI or appropriate sub-investigator, within 72 hours prior to study vaccination.
An acute illness which is nearly resolved with only minor residual symptoms remaining is allowable if, in the opinion of the site PI or appropriate sub-investigator, the residual symptoms will not interfere with the ability to assess safety parameters as required by the protocol.
Have any medical disease or condition that, in the opinion of the site PI or appropriate sub-investigator, is a contraindication to study participation**.
**Including acute or chronic medical disease or condition, defined as persisting for at least 90 days, that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject's successful completion of this study.
Have immunosuppression as a result of an underlying illness or treatment, or use of anticancer chemotherapy or radiation therapy (cytotoxic) within 3 years prior to study vaccination.
Have known active neoplastic disease or a history of any hematologic malignancy. Non-melanoma skin cancers that are not active are permitted.
Have known HIV, hepatitis B, or hepatitis C infection.
Have known hypersensitivity or allergy to eggs, egg or chicken protein, or other components of the study vaccine.
Have a history of severe reactions following previous immunization with licensed or unlicensed influenza vaccines.
Have a history of alcohol or drug abuse within 5 years prior to study vaccination.
Have any diagnosis, current or past, of schizophrenia, bipolar disease, or other psychiatric diagnosis that may interfere with subject compliance or safety evaluations.
Have been hospitalized for psychiatric illness, history of suicide attempt, or confinement for danger to self or others within 10 years prior to study vaccination.
Have taken oral or parenteral (including intraarticular) corticosteroids of any dose within 30 days prior to study vaccination.
Have taken high-dose*** dose inhaled corticosteroids within 30 days prior to study vaccination****.
Received any licensed live vaccine or plan to receive a licensed live vaccine within 30 days prior or 21 days after each M-001 study vaccination.
Received a licensed inactivated vaccine within 14 days prior to or 21 days after each M-001 study vaccination.
Plans to or received the current 2018-2019 influenza vaccine (inactivated or live prior to ordering the study (the 2018-2019 influenza vaccine will be given during the trial.))
Received immunoglobulin or other blood products (with exception of Rho D immunoglobulin) within 90 days prior to study vaccination.
Received an experimental agent***** within 30 days prior to the first study vaccination, or expects to receive an experimental agent****** during the 7-month trial-reporting period.
*****Including vaccine, drug, biologic, device, blood product, or medication.
******Other than from participation in this study.
Are participating or plan to participate in another clinical trial with an interventional agent******* that will be received during the 7-month trial-reporting period.
*******Including agent (licensed or unlicensed vaccine, drug, biologic, device, blood product, or medication) during the 9-month study period.
Plan to travel outside the U.S. (continental U.S., Hawaii and Alaska) in the time between the first study vaccination and 21 days after the last study vaccination********.
********Study vaccination refers to investigational study product vaccination.
Female subjects who are breastfeeding or plan to breastfeed at any given time from the first study vaccination until 30 days after the last study vaccination.
Blood donation or planned blood donation within 30 days prior to the study vaccination through 30 days after the last blood drawn for this study.
Have signs or symptoms that could confound or confuse assessment of study vaccine reactogenicity*********.
*********The study vaccination should be postponed/deferred until signs or symptoms have resolved and if within the acceptable protocol-specified window for that visit.
Have a history of convulsions or encephalomyelitis within 90 days prior to study vaccination.
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
49 Years
Standard Ages
Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Not provided
Locations
Facility
Status
City
State
ZIP
Country
Contacts
University of Iowa - Vaccine Research and Education Unit
Atmar RL, Bernstein DI, Winokur P, Frey SE, Angelo LS, Bryant C, Ben-Yedidia T, Roberts PC, El Sahly HM, Keitel WA. Safety and immunogenicity of Multimeric-001 (M-001) followed by seasonal quadrivalent inactivated influenza vaccine in young adults - A randomized clinical trial. Vaccine. 2023 Apr 17;41(16):2716-2722. doi: 10.1016/j.vaccine.2023.03.023. Epub 2023 Mar 21.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Not provided
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.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
M-001 + IIV4
0.4 ml injection of M-001 (1 mg dose) intramuscularly on Day 1 and Day 22, followed by 0.5 ml injection of IIV4 (60 mcg HA) intramuscularly on Day 172
Influenza 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.
Quadrivalent Recombinant Seasonal Influenza Vaccine: 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.
FG001
Placebo + IIV4
0.4 ml injection of placebo intramuscularly on Day 1 and Day 22, followed by 0.5 ml injection of IIV4 (60 mcg HA) intramuscularly on Day 172
Placebo: Placebo is saline injection
Quadrivalent Recombinant Seasonal Influenza Vaccine: 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.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG00061 subjects
FG00159 subjects
COMPLETED
FG00058 subjects
FG00157 subjects
NOT COMPLETED
FG0003 subjects
FG0012 subjects
Type
Comment
Reasons
Lost to Follow-up
FG0002 subjects
FG0011 subjects
Withdrawal by Subject
FG0001 subjects
FG001
Baseline Characteristics Module
Baseline Analysis Population Description
The baseline analysis population includes all subjects.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
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
BG001
Placebo + IIV4
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Outcome Measures Module
Outcome Measures
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
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.
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.
Posted
Mean
95% Confidence Interval
percentage of cells
Day 1 through Day 36
ID
Title
Description
OG000
M-001 + IIV4
Adverse Events Module
Frequency Threshold
5
Time Frame
Solicited events were collected for 8 days after each vaccination, unsolicited non-serious AEs through 28 days after the second study vaccination, and SAEs through approximately Day 200.
Description
For events solicited on the Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
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
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.
M-001 + IIV4
Placebo+ IIV4
Day 1 through Day 36
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.
Day 1 through Day 36
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.
Day 1 through Day 36
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.
Day 1 through Day 36
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.
Day 1 through Day 36
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.
Day 1 through Day 36
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.
Day 1 through Day 36
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.
Day 1 through Day 36
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.
Day 1 through Day 36
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.
Day 1 through Day 36
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.
Day 1 through Day 36
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.
Day 1 through Day 36
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.
Day 1 through Day 36
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.
Day 1 through Day 36
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.
Day 1 through Day 36
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.
Day 1 through Day 36
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.
Day 1 through Day 36
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.
Day 1 through Day 36
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.
Day 1 through Day 36
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.
Day 1 through Day 36
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.
Day 1 through Day 36
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.
Day 1 through Day 36
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.
Day 1 through Day 36
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.
Day 1 through Day 36
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.
Day 1 through Day 36
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.
Day 1 through Day 36
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.
Day 1 through Day 36
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.
Day 1 through Day 36
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.
Day 1 through Day 36
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.
Day 1 through Day 36
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.
Day 1 through Day 36
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.
Day 1 through Day 36
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.
Day 1 through Day 36
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.
Day 1 through Day 36
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.
Day 9
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.
Day 22 through Day 29
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.
Day 1 through Day 8
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.
Day 22 through Day 29
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.
Day 1 through Day 200
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.
Day 1 through Day 43
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.
Day 172 to Day 200
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.
Day 172 to Day 200
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.
Day 1
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.
Day 43
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.
Day 172
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.
Day 200
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.
Day 1
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.
Day 43
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.
Day 172
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.
Day 200
Cincinnati Children's Hospital Medical Center - Infectious Diseases
Cincinnati
Ohio
45229-3039
United States
Baylor College of Medicine - Molecular Virology and Microbiology
Houston
Texas
77030-3411
United States
1 subjects
BG002
Total
Total of all reporting groups
61
BG00159
BG002120
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
Between 18 and 65 years
BG00061
BG00159
BG002120
>=65 years
BG0000
BG0010
BG0020
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00032.6± 7.9
BG00133.5± 7.8
BG00233.0± 7.8
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00042
BG00133
BG00275
Male
BG00019
BG00126
BG00245
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0005
BG0016
BG00211
Not Hispanic or Latino
BG00056
BG00153
BG002109
Unknown or Not Reported
BG0000
BG0010
BG0020
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG0020
Asian
BG0008
BG0015
BG00213
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
Black or African American
BG0003
BG0013
BG0026
White
BG00049
BG00150
BG00299
More than one race
BG0001
BG0011
BG0022
Unknown or Not Reported
BG0000
BG0010
BG0020
Region of Enrollment
Number
participants
Title
Denominators
Categories
United States
Title
Measurements
BG00061
BG00159
BG002120
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
OG001
Placebo + IIV4
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172
Units
Counts
Participants
OG00058
OG00159
Title
Denominators
Categories
Perforin+ CD4+ at Day 1
Title
Measurements
OG0001.180(0.724 to 1.700)
OG0010.781(0.464 to 1.140)
Perforin+ CD4+ Day 36
Title
Measurements
OG0001.090(0.649 to 1.610)
OG0010.779(0.470 to 1.140)
Perforin+ CD8+ Day 1
Title
Measurements
OG00016.1(12.9 to 19.4)
OG00112.4(10.4 to 14.5)
Perforin+ CD8+ Day 36
Title
Measurements
OG00016.3(13.1 to 19.7)
OG00113.8(11.4 to 16.3)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
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.
Wilcoxon (Mann-Whitney)
0.53
As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.
Other
OG000
OG001
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.
Wilcoxon (Mann-Whitney)
0.56
As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.
Other
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.
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.
Posted
Mean
95% Confidence Interval
percentage of cells
Day 1 through Day 36
ID
Title
Description
OG000
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.
OG001
Placebo + IIV4
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Units
Counts
Participants
OG00058
OG00159
Title
Denominators
Categories
CD107a+ CD4+ at Day 1
Title
Measurements
OG0000.255(0.195 to 0.323)
OG0010.264(0.198 to 0.342)
CD107a+ CD4+ Day 36
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
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.
Wilcoxon (Mann-Whitney)
0.74
As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.
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.
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.
Posted
Mean
95% Confidence Interval
percentage of cells
Day 1 through Day 36
ID
Title
Description
OG000
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.
OG001
Placebo + IIV4
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Units
Counts
Participants
OG00058
OG00159
Title
Denominators
Categories
IL-2+ CD4+ at Day 1
Title
Measurements
OG0000.0682(0.0481 to 0.0910)
OG0010.0634(0.0503 to 0.0776)
IL-2+ CD4+ Day 36
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
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.
Wilcoxon (Mann-Whitney)
0.66
As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.
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.
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.
Posted
Mean
95% Confidence Interval
percentage of cells
Day 1 through Day 36
ID
Title
Description
OG000
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.
OG001
Placebo + IIV4
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Units
Counts
Participants
OG00058
OG00159
Title
Denominators
Categories
TNF+ CD4+ at Day 1
Title
Measurements
OG0000.437(0.321 to 0.567)
OG0010.530(0.366 to 0.733)
TNF+ CD4+ Day 36
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
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.
Wilcoxon (Mann-Whitney)
0.32
As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.
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.
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.
Posted
Mean
95% Confidence Interval
percentage of cells
Day 1 through Day 36
ID
Title
Description
OG000
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.
OG001
Placebo + IIV4
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Units
Counts
Participants
OG00058
OG00159
Title
Denominators
Categories
INFg+ CD4+ at Day 1
Title
Measurements
OG0000.0418(0.0329 to 0.0532)
OG0010.0333(0.0274 to 0.0406)
INFg+ CD4+ Day 36
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
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.
Wilcoxon (Mann-Whitney)
0.0078
As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.
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.
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.
Posted
Mean
95% Confidence Interval
percentage of cells
Day 1 through Day 36
ID
Title
Description
OG000
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.
OG001
Placebo + IIV4
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172
Units
Counts
Participants
OG00058
OG00159
Title
Denominators
Categories
Perforin+CD107a+IL-2+TNF+IFNg+ CD4+ at Day 1
Title
Measurements
OG0000(NA to NA)Not calculable, no cells positive for markers
OG0010.000067(0 to 0.000174)
Perforin+CD107a+IL-2+TNF+IFNg+ CD4+ Day 36
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
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.
Other
No non-zero results were reported for either group so statistical testing was not performed.
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.
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.
Posted
Mean
95% Confidence Interval
percentage of cells
Day 1 through Day 36
ID
Title
Description
OG000
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.
OG001
Placebo + IIV4
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Units
Counts
Participants
OG00058
OG00159
Title
Denominators
Categories
Perforin+CD107a+IL-2+TNF+IFNg- CD4+ Day 1
Title
Measurements
OG0000(NA to NA)Not calculable, no cells positive for markers
OG0010(NA to NA)Not calculable, no cells positive for markers
Perforin+CD107a+IL-2+TNF+IFNg- CD4+ Day 36
Title
Measurements
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
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.
Other
No non-zero results were reported for either group so statistical testing was not performed.
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.
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.
Posted
Mean
95% Confidence Interval
percentage of cells
Day 1 through Day 36
ID
Title
Description
OG000
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.
OG001
Placebo + IIV4
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Units
Counts
Participants
OG00058
OG00159
Title
Denominators
Categories
Perforin+CD107a+IL-2+TNF- IFNg+ CD4+ Day 1
Title
Measurements
OG0000(NA to NA)Not calculable, no cells positive for markers
OG0010(NA to NA)Not calculable, no cells positive for markers
Perforin+CD107a+IL-2+TNF- IFNg+ CD4+ Day 36
Title
Measurements
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
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.
Other
No non-zero results were reported for either group so statistical testing was not performed.
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.
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.
Posted
Mean
95% Confidence Interval
percentage of cells
Day 1 through Day 36
ID
Title
Description
OG000
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.
OG001
Placebo + IIV4
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Units
Counts
Participants
OG00058
OG00159
Title
Denominators
Categories
Perforin+CD107a+IL-2+TNF- IFNg- CD4+ Day 1
Title
Measurements
OG0000(NA to NA)Not calculable, no cells positive for markers
OG0010(NA to NA)Not calculable, no cells positive for markers
Perforin+CD107a+IL-2+TNF- IFNg- CD4+ Day 36
Title
Measurements
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
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.
Other
No non-zero results were reported for either group so statistical testing was not performed.
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.
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.
Posted
Mean
95% Confidence Interval
percentage of cells
Day 1 through Day 36
ID
Title
Description
OG000
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.
OG001
Placebo + IIV4
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Units
Counts
Participants
OG00058
OG00159
Title
Denominators
Categories
Perforin+CD107a+IL-2-TNF+IFNg+ CD4+ at Day 1
Title
Measurements
OG0000.0000741(0 to 0.000191)
OG0010.000107(0 to 0.000245)
Perforin+CD107a+IL-2-TNF+IFNg+ CD4+ Day 36
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
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.
Wilcoxon (Mann-Whitney)
>0.99
As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.
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.
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.
Posted
Mean
95% Confidence Interval
percentage of cells
Day 1 through Day 36
ID
Title
Description
OG000
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.
OG001
Placebo + IIV4
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Units
Counts
Participants
OG00058
OG00159
Title
Denominators
Categories
Perforin+CD107a+IL-2-TNF+IFNg- CD4+ at Day 1
Title
Measurements
OG0000.000036(0 to 0.000108)
OG0010(NA to NA)Not calculable, no cells positive for markers
Perforin+CD107a+IL-2-TNF+IFNg- CD4+ Day 36
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
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.
Wilcoxon (Mann-Whitney)
0.50
As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.
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.
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.
Posted
Mean
95% Confidence Interval
percentage of cells
Day 1 through Day 36
ID
Title
Description
OG000
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.
OG001
Placebo + IIV4
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Units
Counts
Participants
OG00058
OG00159
Title
Denominators
Categories
Perforin+CD107a+IL-2-TNF- IFNg+ CD4+ at Day 1
Title
Measurements
OG0000(NA to NA)Not calculable, no cells positive for markers
OG0010(NA to NA)Not calculable, no cells positive for markers
Perforin+CD107a+IL-2-TNF- IFNg+ CD4+ Day 36
Title
Measurements
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
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.
Wilcoxon (Mann-Whitney)
0.87
As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.
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.
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.
Posted
Mean
95% Confidence Interval
percentage of cells
Day 1 through Day 36
ID
Title
Description
OG000
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.
OG001
Placebo + IIV4
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Units
Counts
Participants
OG00058
OG00159
Title
Denominators
Categories
Perforin+CD107a+IL-2-TNF- IFNg- CD4+ at Day 1
Title
Measurements
OG0000.00104(0.000455 to 0.00175)
OG0010.000728(0.000330 to 0.00122)
Perforin+CD107a+IL-2-TNF- IFNg- CD4+ Day 36
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
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.
Wilcoxon (Mann-Whitney)
0.82
As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.
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.
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.
Posted
Mean
95% Confidence Interval
percentage of cells
Day 1 through Day 36
ID
Title
Description
OG000
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.
OG001
Placebo + IIV4
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Units
Counts
Participants
OG00058
OG00159
Title
Denominators
Categories
Perforin+CD107a- IL-2+TNF+IFNg+ CD4+ at Day 1
Title
Measurements
OG0000.0000621(0 to 0.000186)
OG0010.0000457(0 to 0.000137)
Perforin+CD107a- IL-2+TNF+IFNg+ CD4+ Day 36
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
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.
Wilcoxon (Mann-Whitney)
>0.99
As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.
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.
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.
Posted
Mean
95% Confidence Interval
percentage of cells
Day 1 through Day 36
ID
Title
Description
OG000
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.
OG001
Placebo + IIV4
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Units
Counts
Participants
OG00058
OG00159
Title
Denominators
Categories
Perforin+CD107a- IL-2+TNF+IFNg- CD4+ at Day 1
Title
Measurements
OG0000.0000375(0 to 0.0001130)
OG0010(NA to NA)Not calculable, no cells positive for markers
Perforin+CD107a- IL-2+TNF+IFNg- CD4+ Day 36
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
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.
Wilcoxon (Mann-Whitney)
0.50
As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.
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.
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.
Posted
Mean
95% Confidence Interval
percentage of cells
Day 1 through Day 36
ID
Title
Description
OG000
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.
OG001
Placebo + IIV4
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Units
Counts
Participants
OG00058
OG00159
Title
Denominators
Categories
Perforin+CD107a- IL-2+TNF- IFNg+ CD4+ at Day 1
Title
Measurements
OG0000(NA to NA)Not calculable, no cells positive for markers
OG0010.000101(0 to 0.000303)
Perforin+CD107a- IL-2+TNF- IFNg+ CD4+ Day 36
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
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.
Wilcoxon (Mann-Whitney)
>.99
As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.
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.
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.
Posted
Mean
95% Confidence Interval
percentage of cells
Day 1 through Day 36
ID
Title
Description
OG000
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.
OG001
Placebo + IIV4
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Units
Counts
Participants
OG00058
OG00159
Title
Denominators
Categories
Perforin+CD107a- IL-2+TNF- IFNg- CD4+ at Day 1
Title
Measurements
OG0000.00399(0.00211 to 0.00635)
OG0010.00307(0.00134 to 0.00550)
Perforin+CD107a- IL-2+TNF- IFNg- CD4+ Day 36
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
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.
Wilcoxon (Mann-Whitney)
0.81
As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.
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.
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.
Posted
Mean
95% Confidence Interval
percentage of cells
Day 1 through Day 36
ID
Title
Description
OG000
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.
OG001
Placebo + IIV4
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Units
Counts
Participants
OG00058
OG00159
Title
Denominators
Categories
Perforin+CD107a- IL-2- TNF+IFNg+ CD4+ at Day 1
Title
Measurements
OG0000.0000639(0 to 0.000164)
OG0010.000372(0.0000658 to 0.000818)
Perforin+CD107a- IL-2- TNF+IFNg+ CD4+ Day 36
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
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.
Wilcoxon (Mann-Whitney)
0.0061
As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.
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.
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.
Posted
Mean
95% Confidence Interval
percentage of cells
Day 1 through Day 36
ID
Title
Description
OG000
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.
OG001
Placebo + IIV4
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Units
Counts
Participants
OG00058
OG00159
Title
Denominators
Categories
Perforin+CD107a- IL-2- TNF+IFNg- CD4+ at Day 1
Title
Measurements
OG0000.001100(0.000455 to 0.002030)
OG0010.000199(0.0000519 to 0.000389)
Perforin+CD107a- IL-2- TNF+IFNg- CD4+ Day 36
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
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.
Wilcoxon (Mann-Whitney)
0.36
As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.
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.
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.
Posted
Mean
95% Confidence Interval
percentage of cells
Day 1 through Day 36
ID
Title
Description
OG000
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.
OG001
Placebo + IIV4
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Units
Counts
Participants
OG00058
OG00159
Title
Denominators
Categories
Perforin+CD107a- IL-2- TNF- IFNg+ CD4+ at Day 1
Title
Measurements
OG0000.000421(0.000135 to 0.000761)
OG0010.000436(0.000198 to 0.000700)
Perforin+CD107a- IL-2- TNF- IFNg+ CD4+ Day 36
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
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.
Wilcoxon (Mann-Whitney)
0.42
As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.
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.
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.
Posted
Mean
95% Confidence Interval
percentage of cells
Day 1 through Day 36
ID
Title
Description
OG000
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.
OG001
Placebo + IIV4
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Units
Counts
Participants
OG00058
OG00159
Title
Denominators
Categories
Perforin+CD107a- IL-2- TNF- IFNg- CD4+ at Day 1
Title
Measurements
OG0001.180(0.714 to 1.700)
OG0010.775(0.458 to 1.140)
Perforin+CD107a- IL-2- TNF- IFNg- CD4+ Day 36
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
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.
Wilcoxon (Mann-Whitney)
0.53
As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.
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.
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.
Posted
Mean
95% Confidence Interval
percentage of cells
Day 1 through Day 36
ID
Title
Description
OG000
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.
OG001
Placebo + IIV4
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Units
Counts
Participants
OG00058
OG00159
Title
Denominators
Categories
Perforin- CD107a+IL-2+TNF+IFNg+ CD4+ at Day 1
Title
Measurements
OG0000.00135(0.000809 to 0.00194)
OG0010.00122(0.000714 to 0.00182)
Perforin- CD107a+IL-2+TNF+IFNg+ CD4+ Day 36
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
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.
Wilcoxon (Mann-Whitney)
0.97
As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.
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.
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.
Posted
Mean
95% Confidence Interval
percentage of cells
Day 1 through Day 36
ID
Title
Description
OG000
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.
OG001
Placebo + IIV4
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Units
Counts
Participants
OG00058
OG00159
Title
Denominators
Categories
Perforin- CD107a+IL-2+TNF+IFNg- CD4+ at Day 1
Title
Measurements
OG0000.00230(0.000984 to 0.00403)
OG0010.00200(0.001110 to 0.00317)
Perforin- CD107a+IL-2+TNF+IFNg- CD4+ Day 36
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
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.
Wilcoxon (Mann-Whitney)
0.15
As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.
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.
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.
Posted
Mean
95% Confidence Interval
percentage of cells
Day 1 through Day 36
ID
Title
Description
OG000
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.
OG001
Placebo + IIV4
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Units
Counts
Participants
OG00058
OG00159
Title
Denominators
Categories
Perforin- CD107a+IL-2+TNF- IFNg+ CD4+ at Day 1
Title
Measurements
OG0000(NA to NA)Not calculable, no cells positive for markers
OG0010.000156(0 to 0.000365)
Perforin- CD107a+IL-2+TNF- IFNg+ CD4+ Day 36
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
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.
Wilcoxon (Mann-Whitney)
0.94
As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.
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.
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.
Posted
Mean
95% Confidence Interval
percentage of cells
Day 1 through Day 36
ID
Title
Description
OG000
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.
OG001
Placebo + IIV4
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Units
Counts
Participants
OG00058
OG00159
Title
Denominators
Categories
Perforin- CD107a+IL-2+TNF- IFNg- CD4+ at Day 1
Title
Measurements
OG0000.000809(0.000198 to 0.00185)
OG0010.000263(0.0000905 to 0.000468)
Perforin- CD107a+IL-2+TNF- IFNg- CD4+ Day 36
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
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.
Wilcoxon (Mann-Whitney)
0.14
As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.
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.
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.
Posted
Mean
95% Confidence Interval
percentage of cells
Day 1 through Day 36
ID
Title
Description
OG000
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.
OG001
Placebo + IIV4
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Units
Counts
Participants
OG00058
OG00159
Title
Denominators
Categories
Perforin- CD107a+IL-2- TNF+IFNg+ CD4+ at Day 1
Title
Measurements
OG0000.00269(0.00166 to 0.00390)
OG0010.00248(0.00183 to 0.00319)
Perforin- CD107a+IL-2- TNF+IFNg+ CD4+ Day 36
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
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.
Wilcoxon (Mann-Whitney)
0.72
As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.
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.
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.
Posted
Mean
95% Confidence Interval
percentage of cells
Day 1 through Day 36
ID
Title
Description
OG000
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.
OG001
Placebo + IIV4
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Units
Counts
Participants
OG00058
OG00159
Title
Denominators
Categories
Perforin- CD107a+IL-2- TNF+IFNg- CD4+ at Day 1
Title
Measurements
OG0000.0147(0.00813 to 0.0239)
OG0010.0160(0.01060 to 0.0230)
Perforin- CD107a+IL-2- TNF+IFNg- CD4+ Day 36
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
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.
Wilcoxon (Mann-Whitney)
0.31
As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.
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.
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.
Posted
Mean
95% Confidence Interval
percentage of cells
Day 1 through Day 36
ID
Title
Description
OG000
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.
OG001
Placebo + IIV4
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Units
Counts
Participants
OG00058
OG00159
Title
Denominators
Categories
Perforin- CD107a+IL-2- TNF- IFNg+ CD4+ at Day 1
Title
Measurements
OG0000.000511(0.000253 to 0.000815)
OG0010.000694(0.000345 to 0.001090)
Perforin- CD107a+IL-2- TNF- IFNg+ CD4+ Day 36
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
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.
Wilcoxon (Mann-Whitney)
0.16
As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.
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.
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.
Posted
Mean
95% Confidence Interval
percentage of cells
Day 1 through Day 36
ID
Title
Description
OG000
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.
OG001
Placebo + IIV4
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Units
Counts
Participants
OG00058
OG00159
Title
Denominators
Categories
Perforin- CD107a+IL-2- TNF- IFNg- CD4+ at Day 1
Title
Measurements
OG0000.231(0.178 to 0.292)
OG0010.240(0.179 to 0.314)
Perforin- CD107a+IL-2- TNF- IFNg- CD4+ Day 36
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
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.
Wilcoxon (Mann-Whitney)
0.67
As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.
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.
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.
Posted
Mean
95% Confidence Interval
percentage of cells
Day 1 through Day 36
ID
Title
Description
OG000
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.
OG001
Placebo + IIV4
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Units
Counts
Participants
OG00058
OG00159
Title
Denominators
Categories
Perforin- CD107a- IL-2+TNF+IFNg+ CD4+ at Day 1
Title
Measurements
OG0000.00328(0.00238 to 0.00430)
OG0010.00365(0.00230 to 0.00548)
Perforin- CD107a- IL-2+TNF+IFNg+ CD4+ Day 36
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
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.
Wilcoxon (Mann-Whitney)
<0.001
As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.
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.
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.
Posted
Mean
95% Confidence Interval
percentage of cells
Day 1 through Day 36
ID
Title
Description
OG000
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.
OG001
Placebo + IIV4
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Units
Counts
Participants
OG00058
OG00159
Title
Denominators
Categories
Perforin- CD107a- IL-2+TNF+IFNg- CD4+ at Day 1
Title
Measurements
OG0000.01170(0.00784 to 0.01600)
OG0010.01240(0.00958 to 0.01540)
Perforin- CD107a- IL-2+TNF+IFNg- CD4+ Day 36
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
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.
Wilcoxon (Mann-Whitney)
0.0093
As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.
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.
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.
Posted
Mean
95% Confidence Interval
percentage of cells
Day 1 through Day 36
ID
Title
Description
OG000
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.
OG001
Placebo + IIV4
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Units
Counts
Participants
OG00058
OG00159
Title
Denominators
Categories
Perforin- CD107a- IL-2+TNF- IFNg+ CD4+ at Day 1
Title
Measurements
OG0000.000169(0.0000294 to 0.000355)
OG0010.000438(0.000195 to 0.000714)
Perforin- CD107a- IL-2+TNF- IFNg+ CD4+ Day 36
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
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.
Wilcoxon (Mann-Whitney)
0.54
As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.
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.
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.
Posted
Mean
95% Confidence Interval
percentage of cells
Day 1 through Day 36
ID
Title
Description
OG000
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.
OG001
Placebo + IIV4
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Units
Counts
Participants
OG00058
OG00159
Title
Denominators
Categories
Perforin- CD107a- IL-2+TNF- IFNg- CD4+ at Day 1
Title
Measurements
OG0000.0445(0.0285 to 0.0625)
OG0010.0400(0.0283 to 0.0530)
Perforin- CD107a- IL-2+TNF- IFNg- CD4+ Day 36
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
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.
Wilcoxon (Mann-Whitney)
0.44
As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.
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.
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.
Posted
Mean
95% Confidence Interval
percentage of cells
Day 1 through Day 36
ID
Title
Description
OG000
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.
OG001
Placebo + IIV4
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Units
Counts
Participants
OG00058
OG00159
Title
Denominators
Categories
Perforin- CD107a- IL-2- TNF+IFNg+ CD4+ at Day 1
Title
Measurements
OG0000.00935(0.00716 to 0.01180)
OG0010.00881(0.00622 to 0.01190)
Perforin- CD107a- IL-2- TNF+IFNg+ CD4+ Day 36
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
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.
Wilcoxon (Mann-Whitney)
<0.001
As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.
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.
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.
Posted
Mean
95% Confidence Interval
percentage of cells
Day 1 through Day 36
ID
Title
Description
OG000
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.
OG001
Placebo + IIV4
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Units
Counts
Participants
OG00058
OG00159
Title
Denominators
Categories
Perforin- CD107a- IL-2- TNF+IFNg- CD4+ at Day 1
Title
Measurements
OG0000.390(0.288 to 0.508)
OG0010.483(0.331 to 0.669)
Perforin- CD107a- IL-2- TNF+IFNg- CD4+ Day 36
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
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.
Wilcoxon (Mann-Whitney)
0.65
As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.
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.
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.
Posted
Mean
95% Confidence Interval
percentage of cells
Day 1 through Day 36
ID
Title
Description
OG000
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.
OG001
Placebo + IIV4
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Units
Counts
Participants
OG00058
OG00159
Title
Denominators
Categories
Perforin- CD107a- IL-2- TNF- IFNg+ CD4+ at Day 1
Title
Measurements
OG0000.0238(0.0164 to 0.0354)
OG0010.0147(0.0119 to 0.0178)
Perforin- CD107a- IL-2- TNF- IFNg+ CD4+ Day 36
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
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.
Wilcoxon (Mann-Whitney)
0.35
As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.
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.
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.
Posted
Mean
95% Confidence Interval
percentage of cells
Day 1 through Day 36
ID
Title
Description
OG000
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.
OG001
Placebo + IIV4
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Units
Counts
Participants
OG00058
OG00159
Title
Denominators
Categories
Perforin- CD107a- IL-2- TNF- IFNg- CD4+ at Day 1
Title
Measurements
OG00098.1(97.5 to 98.6)
OG00198.4(98.0 to 98.8)
Perforin- CD107a- IL-2- TNF- IFNg- CD4+ Day 36
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
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.
Wilcoxon (Mann-Whitney)
0.86
As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.
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.
The Safety Analysis population includes all participants who received the first dose of study product and have a result reported for the parameter.
Posted
Count of Participants
Participants
Day 9
ID
Title
Description
OG000
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.
OG001
Placebo + IIV4
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Units
Counts
Participants
OG00061
OG00159
Title
Denominators
Categories
WBC
ParticipantsOG00061
ParticipantsOG00159
Title
Measurements
OG0005
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.
The Safety Analysis population includes all participants who received the second dose of study product and have a result reported for the parameter.
Posted
Count of Participants
Participants
Day 22 through Day 29
ID
Title
Description
OG000
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.
OG001
Placebo + IIV4
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Units
Counts
Participants
OG00054
OG00155
Title
Denominators
Categories
WBC
ParticipantsOG00054
ParticipantsOG00155
Title
Measurements
OG0002
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.
The Safety Analysis population includes all participants who received the first study product.
Posted
Count of Participants
Participants
Day 1 through Day 8
ID
Title
Description
OG000
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.
OG001
Placebo + IIV4
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Units
Counts
Participants
OG00061
OG00159
Title
Denominators
Categories
Fever
Title
Measurements
OG0000
OG0011
Feverishness
Title
Measurements
OG000
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.
The Safety Analysis population includes all participants who received the second study product.
Posted
Count of Participants
Participants
Day 22 through Day 29
ID
Title
Description
OG000
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.
OG001
Placebo + IIV4
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Units
Counts
Participants
OG00055
OG00155
Title
Denominators
Categories
Fever
Title
Measurements
OG0001
OG0010
Feverishness
Title
Measurements
OG000
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.
The Safety Analysis population includes all participants who received at least one dose of study product.
Posted
Count of Participants
Participants
Day 1 through Day 200
ID
Title
Description
OG000
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.
OG001
Placebo + IIV4
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Units
Counts
Participants
OG00061
OG00159
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
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.
The Safety Analysis population includes all participants who received at least one dose of study product.
Posted
Count of Participants
Participants
Day 1 through Day 200
ID
Title
Description
OG000
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.
OG001
Placebo + IIV4
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Units
Counts
Participants
OG00061
OG00159
Title
Denominators
Categories
Title
Measurements
OG0001
OG0010
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.
The Safety Analysis population includes all participants who received at least one dose of study product.
Posted
Number
participants
Day 1 through Day 43
ID
Title
Description
OG000
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.
OG001
Placebo + IIV4
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Units
Counts
Participants
OG00061
OG00159
Title
Denominators
Categories
Blood and lymphatic system disorders
Title
Measurements
OG0000
OG0012
Eye Disorders
Title
Measurements
OG000
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.
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
Posted
Number
95% Confidence Interval
percentage of participants
Day 172 to Day 200
ID
Title
Description
OG000
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.
OG001
Placebo + IIV4
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Units
Counts
Participants
OG00052
OG00150
Title
Denominators
Categories
B/Colorado/6/2017
Title
Measurements
OG00013.5(5.6 to 25.8)
OG0016.0(1.3 to 16.5)
B/Phuket/3073/2013
Title
Measurements
OG000
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.
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
Posted
Number
95% Confidence Interval
percentage of participants
Day 172 to Day 200
ID
Title
Description
OG000
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.
OG001
Placebo + IIV4
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Units
Counts
Participants
OG00052
OG00150
Title
Denominators
Categories
B/Colorado/6/2017
Title
Measurements
OG00017.3(8.2 to 30.3)
OG0016.0(1.3 to 16.5)
B/Phuket/3073/2013
Title
Measurements
OG000
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.
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.
Posted
Number
95% Confidence Interval
percentage of participants
Day 1
ID
Title
Description
OG000
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.
OG001
Placebo + IIV4
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Units
Counts
Participants
OG00055
OG00155
Title
Denominators
Categories
B/Colorado/6/2017
Title
Measurements
OG00098.3(91.1 to 100)
OG00193.2(83.5 to 98.1)
B/Phuket/3073/2013
Title
Measurements
OG000
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.
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.
Posted
Number
95% Confidence Interval
percentage of participants
Day 43
ID
Title
Description
OG000
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.
OG001
Placebo + IIV4
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Units
Counts
Participants
OG00053
OG00153
Title
Denominators
Categories
B/Colorado/6/2017
Title
Measurements
OG00096.2(87.0 to 99.5)
OG00192.5(81.8 to 97.9)
B/Phuket/3073/2013
Title
Measurements
OG000
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.
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.
Posted
Number
95% Confidence Interval
percentage of participants
Day 172
ID
Title
Description
OG000
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.
OG001
Placebo + IIV4
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Units
Counts
Participants
OG00053
OG00152
Title
Denominators
Categories
B/Colorado/6/2017
Title
Measurements
OG00094.3(84.3 to 98.8)
OG00188.5(76.6 to 95.6)
B/Phuket/3073/2013
Title
Measurements
OG000
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.
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.
Posted
Number
95% Confidence Interval
percentage of participants
Day 200
ID
Title
Description
OG000
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.
OG001
Placebo + IIV4
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Units
Counts
Participants
OG00052
OG00150
Title
Denominators
Categories
B/Colorado/6/2017
Title
Measurements
OG00098.1(89.7 to 100)
OG00196.0(86.3 to 99.5)
B/Phuket/3073/2013
Title
Measurements
OG000
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.
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.
Posted
Number
95% Confidence Interval
percentage of participants
Day 1
ID
Title
Description
OG000
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.
OG001
Placebo + IIV4
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Units
Counts
Participants
OG00060
OG00159
Title
Denominators
Categories
B/Colorado/6/2017
Title
Measurements
OG00030.0(18.8 to 43.2)
OG00122.0(12.3 to 34.7)
B/Phuket/3073/2013
Title
Measurements
OG000
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.
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.
Posted
Number
95% Confidence Interval
percentage of participants
Day 43
ID
Title
Description
OG000
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.
OG001
Placebo + IIV4
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Units
Counts
Participants
OG00053
OG00153
Title
Denominators
Categories
B/Colorado/6/2017
Title
Measurements
OG00020.8(10.8 to 34.1)
OG00128.3(16.8 to 42.3)
B/Phuket/3073/2013
Title
Measurements
OG000
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.
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.
Posted
Number
95% Confidence Interval
percentage of participants
Day 172
ID
Title
Description
OG000
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.
OG001
Placebo + IIV4
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Units
Counts
Participants
OG00053
OG00152
Title
Denominators
Categories
B/Colorado/6/2017
Title
Measurements
OG00024.5(13.8 to 38.3)
OG00126.9(15.6 to 41.0)
B/Phuket/3073/2013
Title
Measurements
OG000
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.
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.
Posted
Number
95% Confidence Interval
percentage of participants
Day 200
ID
Title
Description
OG000
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.
OG001
Placebo + IIV4
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Units
Counts
Participants
OG00052
OG00150
Title
Denominators
Categories
B/Colorado/6/2017
Title
Measurements
OG00069.2(54.9 to 81.3)
OG00150.0(35.5 to 64.5)
B/Phuket/3073/2013
Title
Measurements
OG000
0
61
1
61
52
61
EG001
Placebo + IIV4
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172
0
59
0
59
44
59
EG0001 events1 affected61 at risk
EG0010 events0 affected59 at risk
EG0003 events3 affected61 at risk
EG0015 events5 affected59 at risk
Nausea
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0009 events9 affected61 at risk
EG0012 events1 affected59 at risk
Fatigue
General disorders
MedDRA (21.1)
Systematic Assessment
EG00022 events18 affected61 at risk
EG00121 events16 affected59 at risk
Feeling Hot
General disorders
MedDRA (21.1)
Systematic Assessment
Solicited as 'feverishness'
EG0002 events2 affected61 at risk
EG0015 events4 affected59 at risk
Injection Site Erythema
General disorders
MedDRA (21.1)
Systematic Assessment
EG00029 events22 affected61 at risk
EG00118 events14 affected59 at risk
Injection Site Haemorrhage
General disorders
MedDRA (21.1)
Systematic Assessment
EG0002 events2 affected61 at risk
EG0016 events5 affected59 at risk
Injection Site Induration
General disorders
MedDRA (21.1)
Systematic Assessment
EG0005 events5 affected61 at risk
EG0016 events5 affected59 at risk
Injection Site Pain
General disorders
MedDRA (21.1)
Systematic Assessment
EG00046 events33 affected61 at risk
EG00120 events14 affected59 at risk
Malaise
General disorders
MedDRA (21.1)
Systematic Assessment
EG00011 events9 affected61 at risk
EG0019 events7 affected59 at risk
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (21.1)
Systematic Assessment
EG0001 events1 affected61 at risk
EG0013 events3 affected59 at risk
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA (21.1)
Systematic Assessment
EG00010 events9 affected61 at risk
EG0018 events7 affected59 at risk
Headache
Nervous system disorders
MedDRA (21.1)
Systematic Assessment
EG00021 events17 affected61 at risk
EG00123 events18 affected59 at risk
Blood Bilirubin Increased
Investigations
MedDRA (21.1)
Systematic Assessment
EG0004 events2 affected61 at risk
EG0014 events3 affected59 at risk
Haemoglobin Decreased
Investigations
MedDRA (21.1)
Systematic Assessment
EG0006 events5 affected61 at risk
EG0011 events1 affected59 at risk
White Blood Cell Count Decreased
Investigations
MedDRA (21.1)
Systematic Assessment
EG0004 events3 affected61 at risk
EG0015 events5 affected59 at risk
White Blood Cell Count Increased
Investigations
MedDRA (21.1)
Systematic Assessment
EG0004 events4 affected61 at risk
EG0015 events4 affected59 at risk
LTE60
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Not provided
D014777
Virus Diseases
D012140
Respiratory Tract Diseases
0.242
(0.191 to 0.301)
OG0010.257(0.205 to 0.317)
CD107a+ CD8+ Day 1
Title
Measurements
OG0000.348(0.277 to 0.425)
OG0010.367(0.277 to 0.479)
CD107a+ CD8+ Day 36
Title
Measurements
OG0000.352(0.283 to 0.428)
OG0010.384(0.305 to 0.473)
Other
OG000
OG001
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.
Wilcoxon (Mann-Whitney)
0.73
As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.
Other
0.0749
(0.0584 to 0.0930)
OG0010.0692(0.0537 to 0.0866)
IL-2+ CD8+ Day 1
Title
Measurements
OG0000.1260(0.0789 to 0.1910)
OG0010.0939(0.0716 to 0.1180)
IL-2+ CD8+ Day 36
Title
Measurements
OG0000.1010(0.0763 to 0.1300)
OG0010.1170(0.0883 to 0.1480)
Other
OG000
OG001
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.
Wilcoxon (Mann-Whitney)
0.48
As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.
Other
0.450
(0.334 to 0.594)
OG0010.395(0.296 to 0.509)
TNF+ CD8+ Day 1
Title
Measurements
OG0000.0750(0.0492 to 0.1090)
OG0010.0716(0.0495 to 0.1000)
TNF+ CD8+ Day 36
Title
Measurements
OG0000.0676(0.0431 to 0.1060)
OG0010.0596(0.0437 to 0.0783)
Other
OG000
OG001
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.
Wilcoxon (Mann-Whitney)
>0.99
As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.
Other
0.0512
(0.0419 to 0.0621)
OG0010.0436(0.0298 to 0.0654)
INFg+ CD8+ Day 1
Title
Measurements
OG0000.0558(0.0345 to 0.0843)
OG0010.0400(0.0289 to 0.0546)
INFg+ CD8+ Day 36
Title
Measurements
OG0000.0529(0.0377 to 0.0709)
OG0010.0476(0.0341 to 0.0643)
Other
OG000
OG001
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.
Wilcoxon (Mann-Whitney)
0.94
As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.
Other
0
(NA to NA)
Not calculable, no cells positive for markers
OG0010(NA to NA)Not calculable, no cells positive for markers
Perforin+CD107a+IL-2+TNF+IFNg+ CD8+ Day 1
Title
Measurements
OG0000(NA to NA)Not calculable, no cells positive for markers
OG0010(NA to NA)Not calculable, no cells positive for markers
Perforin+CD107a+IL-2+TNF+IFNg+ CD8+ Day 36
Title
Measurements
OG0000.0000698(0 to 0.000209)
OG0010(NA to NA)Not calculable, no cells positive for markers
OG000
OG001
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.
Wilcoxon (Mann-Whitney)
0.5
As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.
Other
OG000
0
(NA to NA)
Not calculable, no cells positive for markers
OG0010(NA to NA)Not calculable, no cells positive for markers
Perforin+CD107a+IL-2+TNF+IFNg- CD8+ Day 1
Title
Measurements
OG0000(NA to NA)Not calculable, no cells positive for markers
OG0010(NA to NA)Not calculable, no cells positive for markers
Perforin+CD107a+IL-2+TNF+IFNg- CD8+ Day 36
Title
Measurements
OG0000(NA to NA)Not calculable, no cells positive for markers
OG0010(NA to NA)Not calculable, no cells positive for markers
OG000
OG001
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.
Other
No non-zero results were reported for either group so statistical testing was not performed.
OG000
0
(NA to NA)
Not calculable, no cells positive for markers
OG0010(NA to NA)Not calculable, no cells positive for markers
Perforin+CD107a+IL-2+TNF- IFNg+ CD8+ Day 1
Title
Measurements
OG0000(NA to NA)Not calculable, no cells positive for markers
OG0010(NA to NA)Not calculable, no cells positive for markers
Perforin+CD107a+IL-2+TNF- IFNg+ CD8+ Day 36
Title
Measurements
OG0000(NA to NA)Not calculable, no cells positive for markers
OG0010(NA to NA)Not calculable, no cells positive for markers
OG000
0
(NA to NA)
Not calculable, no cells positive for markers
OG0010(NA to NA)Not calculable, no cells positive for markers
Perforin+CD107a+IL-2+TNF- IFNg- CD8+ Day 1
Title
Measurements
OG0000.00033(0 to 0.00078)
OG0010.0000461(0 to 0.000138)
Perforin+CD107a+IL-2+TNF- IFNg- CD8+ Day 36
Title
Measurements
OG0000(NA to NA)Not calculable, no cells positive for markers
OG0010.0001540(0 to 0.000387)
OG000
OG001
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.
Wilcoxon (Mann-Whitney)
0.5
As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.
Other
0.0001600
(0 to 0.000370)
OG0010.000344(0 to 0.000907)
Perforin+CD107a+IL-2-TNF+IFNg+ CD8+ Day 1
Title
Measurements
OG0000.00271(0.000636 to 0.00586)
OG0010.000269(0 to 0.00062)
Perforin+CD107a+IL-2-TNF+IFNg+ CD8+ Day 36
Title
Measurements
OG0000.00187(0.000358 to 0.00384)
OG0010.00122(0.000475 to 0.00209)
Other
OG000
OG001
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.
Wilcoxon (Mann-Whitney)
0.74
As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.
Other
0
(NA to NA)
Not calculable, no cells positive for markers
OG0010.000161(0 to 0.000445)
Perforin+CD107a+IL-2-TNF+IFNg- CD8+ Day 1
Title
Measurements
OG0000.00288(0.000972 to 0.00536)
OG0010.00172(0.000753 to 0.00294)
Perforin+CD107a+IL-2-TNF+IFNg- CD8+ Day 36
Title
Measurements
OG0000.00326(0.001060 to 0.00606)
OG0010.00134(0.000606 to 0.00223)
Other
OG000
OG001
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.
Wilcoxon (Mann-Whitney)
0.90
As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.
Other
OG000
0.0000566
(0 to 0.00017)
OG0010.000118(0 to 0.000318)
Perforin+CD107a+IL-2-TNF- IFNg+ CD8+ Day 1
Title
Measurements
OG0000.000444(0.0000800 to 0.000959)
OG0010.000409(0 to 0.000963)
Perforin+CD107a+IL-2-TNF- IFNg+ CD8+ Day 36
Title
Measurements
OG0000.000323(0.0000639 to 0.000672)
OG0010.000197(0 to 0.000518)
Other
OG000
OG001
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.
Wilcoxon (Mann-Whitney)
0.57
As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.
Other
0.00123
(0.000602 to 0.00199)
OG0010.000928(0.000505 to 0.00141)
Perforin+CD107a+IL-2-TNF- IFNg- CD8+ Day 1
Title
Measurements
OG0000.0317(0.0249 to 0.0390)
OG0010.0237(0.0148 to 0.0363)
Perforin+CD107a+IL-2-TNF- IFNg- CD8+ Day 36
Title
Measurements
OG0000.0368(0.0273 to 0.0472)
OG0010.0263(0.0171 to 0.0402)
Other
OG000
OG001
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.
Wilcoxon (Mann-Whitney)
0.076
As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.
Other
0.0000888
(0 to 0.000229)
OG0010.0001010(0 to 0.000276)
Perforin+CD107a- IL-2+TNF+IFNg+ CD8+ Day 1
Title
Measurements
OG0000.000123(0 to 0.000369)
OG0010(NA to NA)Not calculable, no cells positive for markers
Perforin+CD107a- IL-2+TNF+IFNg+ CD8+ Day 36
Title
Measurements
OG0000.000184(0 to 0.000482)
OG0010.000128(0 to 0.000333)
Other
OG000
OG001
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.
Wilcoxon (Mann-Whitney)
0.75
As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.
Other
0.0000327
(0 to 0.0000982)
OG0010(NA to NA)Not calculable, no cells positive for markers
Perforin+CD107a- IL-2+TNF+IFNg- CD8+ Day 1
Title
Measurements
OG0000.0005150(0 to 0.001160)
OG0010.000322(0 to 0.000966)
Perforin+CD107a- IL-2+TNF+IFNg- CD8+ Day 36
Title
Measurements
OG0000.0000524(0 to 0.000157)
OG0010(NA to NA)Not calculable, no cells positive for markers
Other
OG000
OG001
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.
Wilcoxon (Mann-Whitney)
0.50
As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.
Other
0
(NA to NA)
Not calculable, no cells positive for markers
OG0010.000061(0 to 0.000183)
Perforin+CD107a- IL-2+TNF- IFNg+ CD8+ Day 1
Title
Measurements
OG0000(NA to NA)Not calculable, no cells positive for markers
OG0010.0003780(0 to 0.00113)
Perforin+CD107a- IL-2+TNF- IFNg+ CD8+ Day 36
Title
Measurements
OG0000(NA to NA)Not calculable, no cells positive for markers
OG0010.0000966(0 to 0.00029)
Other
OG000
OG001
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.
Wilcoxon (Mann-Whitney)
>.99
As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.
Other
0.00458
(0.00216 to 0.00748)
OG0010.00354(0.00201 to 0.00530)
Perforin+CD107a- IL-2+TNF- IFNg- CD8+ Day 1
Title
Measurements
OG0000.0742(0.0385 to 0.1300)
OG0010.0434(0.0315 to 0.0568)
Perforin+CD107a- IL-2+TNF- IFNg- CD8+ Day 36
Title
Measurements
OG0000.0546(0.0398 to 0.0731)
OG0010.0612(0.0417 to 0.0841)
Other
OG000
OG001
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.
Wilcoxon (Mann-Whitney)
0.47
As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.
Other
0
(NA to NA)
Not calculable, no cells positive for markers
OG0010.000485(0.0001520 to 0.000925)
Perforin+CD107a- IL-2- TNF+IFNg+ CD8+ Day 1
Title
Measurements
OG0000.00122(0.000315 to 0.00239)
OG0010.00135(0.000376 to 0.00276)
Perforin+CD107a- IL-2- TNF+IFNg+ CD8+ Day 36
Title
Measurements
OG0000.00305(0.001150 to 0.00542)
OG0010.00168(0.000426 to 0.00360)
Other
OG000
OG001
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.
Wilcoxon (Mann-Whitney)
0.28
As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.
Other
0.000564
(0.000287 to 0.000874)
OG0010.000454(0.0001490 to 0.000809)
Perforin+CD107a- IL-2- TNF+IFNg- CD8+ Day 1
Title
Measurements
OG0000.00880(0.00375 to 0.0154)
OG0010.00426(0.00244 to 0.00638)
Perforin+CD107a- IL-2- TNF+IFNg- CD8+ Day 36
Title
Measurements
OG0000.00947(0.00564 to 0.0143)
OG0010.00595(0.00357 to 0.00874)
Other
OG000
OG001
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.
Wilcoxon (Mann-Whitney)
0.32
As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.
Other
0.00027
(0.0000719 to 0.000511)
OG0010.000438(0.00018 to 0.000732)
Perforin+CD107a- IL-2- TNF- IFNg+ CD8+ Day 1
Title
Measurements
OG0000.00654(0.00173 to 0.01520)
OG0010.00177(0.000981 to 0.00267)
Perforin+CD107a- IL-2- TNF- IFNg+ CD8+ Day 36
Title
Measurements
OG0000.00376(0.00151 to 0.00697)
OG0010.00370(0.002230 to 0.00543)
Other
OG000
OG001
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.
Wilcoxon (Mann-Whitney)
0.26
As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.
Other
1.080
(0.637 to 1.610)
OG0010.772(0.475 to 1.130)
Perforin+CD107a- IL-2- TNF- IFNg- CD8+ Day 1
Title
Measurements
OG00016.0(12.9 to 19.3)
OG00112.3(10.3 to 14.4)
Perforin+CD107a- IL-2- TNF- IFNg- CD8+ Day 36
Title
Measurements
OG00016.2(13.1 to 19.7)
OG00113.7(11.3 to 16.1)
Other
OG000
OG001
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.
Wilcoxon (Mann-Whitney)
0.56
As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.
Other
0.00156
(0.000895 to 0.00229)
OG0010.00138(0.00075 to 0.00211)
Perforin- CD107a+IL-2+TNF+IFNg+ CD8+ Day 1
Title
Measurements
OG0000.001170(0.000407 to 0.00208)
OG0010.001000(0.000406 to 0.001710)
Perforin- CD107a+IL-2+TNF+IFNg+ CD8+ Day 36
Title
Measurements
OG0000.000742(0.000173 to 0.00150)
OG0010.000465(0.000107 to 0.000935)
Other
OG000
OG001
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.
Wilcoxon (Mann-Whitney)
0.62
As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.
Other
0.00212
(0.001340 to 0.00302)
OG0010.00144(0.000759 to 0.00228)
Perforin- CD107a+IL-2+TNF+IFNg- CD8+ Day 1
Title
Measurements
OG0000.000197(0 to 0.000451)
OG0010.0005900(0.000134 to 0.001200)
Perforin- CD107a+IL-2+TNF+IFNg- CD8+ Day 36
Title
Measurements
OG0000.000346(0 to 0.000801)
OG0010.0000719(0 to 0.000216)
Other
OG000
OG001
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.
Wilcoxon (Mann-Whitney)
0.18
As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.
Other
0.0000725
(0 to 0.000187)
OG0010.000078(0 to 0.000196)
Perforin- CD107a+IL-2+TNF- IFNg+ CD8+ Day 1
Title
Measurements
OG0000(NA to NA)Not calculable, no cells positive for markers
OG0010(NA to NA)Not calculable, no cells positive for markers
Perforin- CD107a+IL-2+TNF- IFNg+ CD8+ Day 36
Title
Measurements
OG0000(NA to NA)Not calculable, no cells positive for markers
OG0010(NA to NA)Not calculable, no cells positive for markers
Other
OG000
OG001
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.
Other
No non-zero results were reported for either group so statistical testing was not performed.
0.000653
(0.000257 to 0.00114)
OG0010.000223(0.0000554 to 0.000436)
Perforin- CD107a+IL-2+TNF- IFNg- CD8+ Day 1
Title
Measurements
OG0000.000377(0.0000526 to 0.000828)
OG0010.000840(0.0003060 to 0.001480)
Perforin- CD107a+IL-2+TNF- IFNg- CD8+ Day 36
Title
Measurements
OG0000.000912(0.0002540 to 0.001770)
OG0010.000369(0.0000585 to 0.000796)
Other
OG000
OG001
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.
Wilcoxon (Mann-Whitney)
0.26
As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.
Other
0.00309
(0.00206 to 0.00426)
OG0010.00262(0.00171 to 0.00366)
Perforin- CD107a+IL-2- TNF+IFNg+ CD8+ Day 1
Title
Measurements
OG0000.00513(0.00259 to 0.00834)
OG0010.00617(0.00352 to 0.00921)
Perforin- CD107a+IL-2- TNF+IFNg+ CD8+ Day 36
Title
Measurements
OG0000.00604(0.00334 to 0.00963)
OG0010.00374(0.00228 to 0.00539)
Other
OG000
OG001
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.
Wilcoxon (Mann-Whitney)
0.31
As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.
Other
0.0123
(0.00948 to 0.0153)
OG0010.0127(0.00868 to 0.0177)
Perforin- CD107a+IL-2- TNF+IFNg- CD8+ Day 1
Title
Measurements
OG0000.00678(0.00414 to 0.00986)
OG0010.00725(0.00455 to 0.0104)
Perforin- CD107a+IL-2- TNF+IFNg- CD8+ Day 36
Title
Measurements
OG0000.00427(0.00197 to 0.00726)
OG0010.00630(0.00317 to 0.0107)
Other
OG000
OG001
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.
Wilcoxon (Mann-Whitney)
0.22
As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.
Other
0.000731
(0.000391 to 0.001110)
OG0010.001910(0.000921 to 0.003160)
Perforin- CD107a+IL-2- TNF- IFNg+ CD8+ Day 1
Title
Measurements
OG0000.001580(0.000815 to 0.002530)
OG0010.002160(0.001100 to 0.003380)
Perforin- CD107a+IL-2- TNF- IFNg+ CD8+ Day 36
Title
Measurements
OG0000.001780(0.000916 to 0.002790)
OG0010.002240(0.001290 to 0.003310)
Other
OG000
OG001
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.
Wilcoxon (Mann-Whitney)
0.44
As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.
Other
0.220
(0.172 to 0.277)
OG0010.236(0.184 to 0.293)
Perforin- CD107a+IL-2- TNF- IFNg- CD8+ Day 1
Title
Measurements
OG0000.294(0.226 to 0.374)
OG0010.323(0.237 to 0.434)
Perforin- CD107a+IL-2- TNF- IFNg- CD8+ Day 36
Title
Measurements
OG0000.295(0.232 to 0.366)
OG0010.341(0.267 to 0.424)
Other
OG000
OG001
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.
Wilcoxon (Mann-Whitney)
0.48
As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.
Other
0.00955
(0.00604 to 0.01470)
OG0010.00289(0.00201 to 0.00390)
Perforin- CD107a- IL-2+TNF+IFNg+ CD8+ Day 1
Title
Measurements
OG0000.000238(0 to 0.000657)
OG0010.000693(0.0000839 to 0.001620)
Perforin- CD107a- IL-2+TNF+IFNg+ IFNg- CD8+ Day 36
Title
Measurements
OG0000.000288(0.0000404 to 0.000626)
OG0010.000486(0 to 0.001300)
Other
OG000
OG001
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.
Wilcoxon (Mann-Whitney)
0.62
As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.
Other
0.01640
(0.01230 to 0.02130)
OG0010.01130(0.00789 to 0.01540)
Perforin- CD107a- IL-2+TNF+IFNg- CD8+ Day 1
Title
Measurements
OG0000.00161(0.000488 to 0.00318)
OG0010.00184(0.000851 to 0.00301)
Perforin- CD107a- IL-2+TNF+IFNg- IFNg- CD8+ Day 36
Title
Measurements
OG0000.00129(0.000535 to 0.00224)
OG0010.00102(0.000354 to 0.00186)
Other
OG000
OG001
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.
Wilcoxon (Mann-Whitney)
0.51
As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.
Other
0.000434
(0.0001960 to 0.000702)
OG0010.000372(0.000131 to 0.000680)
Perforin- CD107a- IL-2+TNF- IFNg+ CD8+ Day 1
Title
Measurements
OG0000.000397(0 to 0.000977)
OG0010.000339(0.0000652 to 0.000709)
Perforin- CD107a- IL-2+TNF- IFNg+ CD8+ Day 36
Title
Measurements
OG0000.000487(0 to 0.001360)
OG0010.000378(0.0000775 to 0.000736)
Other
OG000
OG001
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.
Wilcoxon (Mann-Whitney)
0.43
As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.
Other
0.0395
(0.0274 to 0.0524)
OG0010.0478(0.0343 to 0.0627)
Perforin- CD107a- IL-2+TNF- IFNg- CD8+ Day 1
Title
Measurements
OG0000.0468(0.0311 to 0.0645)
OG0010.0444(0.0310 to 0.0605)
Perforin- CD107a- IL-2+TNF- IFNg- CD8+ Day 36
Title
Measurements
OG0000.0417(0.0272 to 0.0588)
OG0010.0522(0.0402 to 0.0653)
Other
OG000
OG001
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.
Wilcoxon (Mann-Whitney)
0.014
As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.
Other
0.01520
(0.01160 to 0.01950)
OG0010.00731(0.00556 to 0.00926)
Perforin- CD107a- IL-2- TNF+IFNg+ CD8+ Day 1
Title
Measurements
OG0000.00488(0.00305 to 0.00702)
OG0010.00460(0.00242 to 0.00751)
Perforin- CD107a- IL-2- TNF+IFNg+CD8+ Day 36
Title
Measurements
OG0000.00257(0.00141 to 0.00398)
OG0010.00242(0.00139 to 0.00357)
Other
OG000
OG001
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.
Wilcoxon (Mann-Whitney)
0.96
As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.
Other
0.389
(0.280 to 0.524)
OG0010.354(0.263 to 0.459)
Perforin- CD107a- IL-2- TNF+IFNg- CD8+ Day 1
Title
Measurements
OG0000.0388(0.0201 to 0.0676)
OG0010.0415(0.0254 to 0.0618)
Perforin- CD107a- IL-2- TNF+IFNg- CD8+ Day 36
Title
Measurements
OG0000.0341(0.0175 to 0.0613)
OG0010.0348(0.0227 to 0.0503)
Other
OG000
OG001
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.
Wilcoxon (Mann-Whitney)
0.53
As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.
Other
0.0199
(0.0155 to 0.0252)
OG0010.0255(0.0133 to 0.0466)
Perforin- CD107a- IL-2- TNF- IFNg+ CD8+ Day 1
Title
Measurements
OG0000.0314(0.0165 to 0.0505)
OG0010.0209(0.0131 to 0.0307)
Perforin- CD107a- IL-2- TNF- IFNg+ CD8+ Day 36
Title
Measurements
OG0000.0318(0.0200 to 0.0467)
OG0010.0308(0.0180 to 0.0473)
Other
OG000
OG001
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.
Wilcoxon (Mann-Whitney)
0.66
As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.
Other
98.2
(97.6 to 98.7)
OG00198.5(98.2 to 98.8)
Perforin- CD107a- IL-2- TNF- IFNg- CD8+ Day 1
Title
Measurements
OG00083.5(80.2 to 86.6)
OG00187.2(85.1 to 89.1)
Perforin- CD107a- IL-2- TNF- IFNg- CD8+ Day 36
Title
Measurements
OG00083.2(79.8 to 86.5)
OG00185.8(83.3 to 88.2)
Other
OG000
OG001
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.
Wilcoxon (Mann-Whitney)
0.53
As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.