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Two Doses of Multimeric-001 (M-001) Followed by Influenza Vaccine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03058692
Recruitment Status : Completed
First Posted : February 23, 2017
Results First Posted : February 5, 2020
Last Update Posted : June 18, 2020
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Conditions Influenza
Influenza Immunisation
Interventions Biological: Influenza Multimeric-001 Vaccine
Other: Placebo
Biological: Quadrivalent Recombinant Seasonal Influenza Vaccine
Enrollment 120
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.
Pre-assignment Details  
Arm/Group Title M-001 + IIV4 Placebo + IIV4
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 61 59
Completed 58 57
Not Completed 3 2
Reason Not Completed
Lost to Follow-up             2             1
Withdrawal by Subject             1             1
Arm/Group Title M-001 + IIV4 Placebo + IIV4 Total
Hide Arm/Group Description 0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172 0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172 Total of all reporting groups
Overall Number of Baseline Participants 61 59 120
Hide Baseline Analysis Population Description
The baseline analysis population includes all subjects.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 59 participants 120 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
61
 100.0%
59
 100.0%
120
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 61 participants 59 participants 120 participants
32.6  (7.9) 33.5  (7.8) 33.0  (7.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 59 participants 120 participants
Female
42
  68.9%
33
  55.9%
75
  62.5%
Male
19
  31.1%
26
  44.1%
45
  37.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 59 participants 120 participants
Hispanic or Latino
5
   8.2%
6
  10.2%
11
   9.2%
Not Hispanic or Latino
56
  91.8%
53
  89.8%
109
  90.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 59 participants 120 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
8
  13.1%
5
   8.5%
13
  10.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
   4.9%
3
   5.1%
6
   5.0%
White
49
  80.3%
50
  84.7%
99
  82.5%
More than one race
1
   1.6%
1
   1.7%
2
   1.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 61 participants 59 participants 120 participants
61 59 120
1.Primary Outcome
Title Mean Percentage of Perforin+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Hide Description The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.
Time Frame Day 1 through Day 36
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
Arm/Group Title M-001 + IIV4 Placebo + IIV4
Hide Arm/Group Description:
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172
Overall Number of Participants Analyzed 58 59
Mean (95% Confidence Interval)
Unit of Measure: percentage of cells
Perforin+ CD4+ at Day 1
1.180
(0.724 to 1.700)
0.781
(0.464 to 1.140)
Perforin+ CD4+ Day 36
1.090
(0.649 to 1.610)
0.779
(0.470 to 1.140)
Perforin+ CD8+ Day 1
16.1
(12.9 to 19.4)
12.4
(10.4 to 14.5)
Perforin+ CD8+ Day 36
16.3
(13.1 to 19.7)
13.8
(11.4 to 16.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection M-001 + IIV4, Placebo + IIV4
Comments 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.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.53
Comments 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.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection M-001 + IIV4, Placebo + IIV4
Comments 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.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.56
Comments 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.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Primary Outcome
Title Mean Percentage of Cluster of Differentiation 107a Positive (CD107a+) CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Hide Description The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.
Time Frame Day 1 through Day 36
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
Arm/Group Title M-001 + IIV4 Placebo + IIV4
Hide Arm/Group Description:
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Overall Number of Participants Analyzed 58 59
Mean (95% Confidence Interval)
Unit of Measure: percentage of cells
CD107a+ CD4+ at Day 1
0.255
(0.195 to 0.323)
0.264
(0.198 to 0.342)
CD107a+ CD4+ Day 36
0.242
(0.191 to 0.301)
0.257
(0.205 to 0.317)
CD107a+ CD8+ Day 1
0.348
(0.277 to 0.425)
0.367
(0.277 to 0.479)
CD107a+ CD8+ Day 36
0.352
(0.283 to 0.428)
0.384
(0.305 to 0.473)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection M-001 + IIV4, Placebo + IIV4
Comments 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.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.74
Comments 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.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection M-001 + IIV4, Placebo + IIV4
Comments 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.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.73
Comments 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.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
3.Primary Outcome
Title Mean Percentage of Interleukin-2 Positive (IL-2+) CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Hide Description The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.
Time Frame Day 1 through Day 36
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
Arm/Group Title M-001 + IIV4 Placebo + IIV4
Hide Arm/Group Description:
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Overall Number of Participants Analyzed 58 59
Mean (95% Confidence Interval)
Unit of Measure: percentage of cells
IL-2+ CD4+ at Day 1
0.0682
(0.0481 to 0.0910)
0.0634
(0.0503 to 0.0776)
IL-2+ CD4+ Day 36
0.0749
(0.0584 to 0.0930)
0.0692
(0.0537 to 0.0866)
IL-2+ CD8+ Day 1
0.1260
(0.0789 to 0.1910)
0.0939
(0.0716 to 0.1180)
IL-2+ CD8+ Day 36
0.1010
(0.0763 to 0.1300)
0.1170
(0.0883 to 0.1480)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection M-001 + IIV4, Placebo + IIV4
Comments 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.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.66
Comments 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.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection M-001 + IIV4, Placebo + IIV4
Comments 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.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.48
Comments 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.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
4.Primary Outcome
Title Mean Percentage of Tumor Necrosis Factor Positive (TNF+) CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Hide Description The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.
Time Frame Day 1 through Day 36
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
Arm/Group Title M-001 + IIV4 Placebo + IIV4
Hide Arm/Group Description:
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Overall Number of Participants Analyzed 58 59
Mean (95% Confidence Interval)
Unit of Measure: percentage of cells
TNF+ CD4+ at Day 1
0.437
(0.321 to 0.567)
0.530
(0.366 to 0.733)
TNF+ CD4+ Day 36
0.450
(0.334 to 0.594)
0.395
(0.296 to 0.509)
TNF+ CD8+ Day 1
0.0750
(0.0492 to 0.1090)
0.0716
(0.0495 to 0.1000)
TNF+ CD8+ Day 36
0.0676
(0.0431 to 0.1060)
0.0596
(0.0437 to 0.0783)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection M-001 + IIV4, Placebo + IIV4
Comments 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.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.32
Comments 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.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection M-001 + IIV4, Placebo + IIV4
Comments 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.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.99
Comments 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.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
5.Primary Outcome
Title Mean Percentage of Interferon Gamma Positive (IFNg+) CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Hide Description The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.
Time Frame Day 1 through Day 36
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
Arm/Group Title M-001 + IIV4 Placebo + IIV4
Hide Arm/Group Description:
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Overall Number of Participants Analyzed 58 59
Mean (95% Confidence Interval)
Unit of Measure: percentage of cells
INFg+ CD4+ at Day 1
0.0418
(0.0329 to 0.0532)
0.0333
(0.0274 to 0.0406)
INFg+ CD4+ Day 36
0.0512
(0.0419 to 0.0621)
0.0436
(0.0298 to 0.0654)
INFg+ CD8+ Day 1
0.0558
(0.0345 to 0.0843)
0.0400
(0.0289 to 0.0546)
INFg+ CD8+ Day 36
0.0529
(0.0377 to 0.0709)
0.0476
(0.0341 to 0.0643)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection M-001 + IIV4, Placebo + IIV4
Comments 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.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0078
Comments 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.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection M-001 + IIV4, Placebo + IIV4
Comments 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.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.94
Comments 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.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
6.Primary Outcome
Title Mean Percentage of Perforin+CD107a+IL-2+TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Hide Description The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.
Time Frame Day 1 through Day 36
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
Arm/Group Title M-001 + IIV4 Placebo + IIV4
Hide Arm/Group Description:
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172
Overall Number of Participants Analyzed 58 59
Mean (95% Confidence Interval)
Unit of Measure: percentage of cells
Perforin+CD107a+IL-2+TNF+IFNg+ CD4+ at Day 1
0 [1] 
(NA to NA)
0.000067
(0 to 0.000174)
Perforin+CD107a+IL-2+TNF+IFNg+ CD4+ Day 36
0 [1] 
(NA to NA)
0 [1] 
(NA to NA)
Perforin+CD107a+IL-2+TNF+IFNg+ CD8+ Day 1
0 [1] 
(NA to NA)
0 [1] 
(NA to NA)
Perforin+CD107a+IL-2+TNF+IFNg+ CD8+ Day 36
0.0000698
(0 to 0.000209)
0 [1] 
(NA to NA)
[1]
Not calculable, no cells positive for markers
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection M-001 + IIV4, Placebo + IIV4
Comments 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.
Type of Statistical Test Other
Comments [Not Specified]
Other Statistical Analysis No non-zero results were reported for either group so statistical testing was not performed.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection M-001 + IIV4, Placebo + IIV4
Comments 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.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5
Comments 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.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
7.Primary Outcome
Title Mean Percentage of Perforin+CD107a+IL-2+TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Hide Description The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.
Time Frame Day 1 through Day 36
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
Arm/Group Title M-001 + IIV4 Placebo + IIV4
Hide Arm/Group Description:
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Overall Number of Participants Analyzed 58 59
Mean (95% Confidence Interval)
Unit of Measure: percentage of cells
Perforin+CD107a+IL-2+TNF+IFNg- CD4+ Day 1
0 [1] 
(NA to NA)
0 [1] 
(NA to NA)
Perforin+CD107a+IL-2+TNF+IFNg- CD4+ Day 36
0 [1] 
(NA to NA)
0 [1] 
(NA to NA)
Perforin+CD107a+IL-2+TNF+IFNg- CD8+ Day 1
0 [1] 
(NA to NA)
0 [1] 
(NA to NA)
Perforin+CD107a+IL-2+TNF+IFNg- CD8+ Day 36
0 [1] 
(NA to NA)
0 [1] 
(NA to NA)
[1]
Not calculable, no cells positive for markers
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection M-001 + IIV4, Placebo + IIV4
Comments 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.
Type of Statistical Test Other
Comments [Not Specified]
Other Statistical Analysis No non-zero results were reported for either group so statistical testing was not performed.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection M-001 + IIV4, Placebo + IIV4
Comments 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.
Type of Statistical Test Other
Comments [Not Specified]
Other Statistical Analysis No non-zero results were reported for either group so statistical testing was not performed.
8.Primary Outcome
Title Mean Percentage of Perforin+CD107a+IL-2+TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Hide Description The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.
Time Frame Day 1 through Day 36
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
Arm/Group Title M-001 + IIV4 Placebo + IIV4
Hide Arm/Group Description:
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Overall Number of Participants Analyzed 58 59
Mean (95% Confidence Interval)
Unit of Measure: percentage of cells
Perforin+CD107a+IL-2+TNF- IFNg+ CD4+ Day 1
0 [1] 
(NA to NA)
0 [1] 
(NA to NA)
Perforin+CD107a+IL-2+TNF- IFNg+ CD4+ Day 36
0 [1] 
(NA to NA)
0 [1] 
(NA to NA)
Perforin+CD107a+IL-2+TNF- IFNg+ CD8+ Day 1
0 [1] 
(NA to NA)
0 [1] 
(NA to NA)
Perforin+CD107a+IL-2+TNF- IFNg+ CD8+ Day 36
0 [1] 
(NA to NA)
0 [1] 
(NA to NA)
[1]
Not calculable, no cells positive for markers
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection M-001 + IIV4, Placebo + IIV4
Comments 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.
Type of Statistical Test Other
Comments [Not Specified]
Other Statistical Analysis No non-zero results were reported for either group so statistical testing was not performed.
9.Primary Outcome
Title Mean Percentage of Perforin+CD107a+IL-2+TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Hide Description The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.
Time Frame Day 1 through Day 36
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
Arm/Group Title M-001 + IIV4 Placebo + IIV4
Hide Arm/Group Description:
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Overall Number of Participants Analyzed 58 59
Mean (95% Confidence Interval)
Unit of Measure: percentage of cells
Perforin+CD107a+IL-2+TNF- IFNg- CD4+ Day 1
0 [1] 
(NA to NA)
0 [1] 
(NA to NA)
Perforin+CD107a+IL-2+TNF- IFNg- CD4+ Day 36
0 [1] 
(NA to NA)
0 [1] 
(NA to NA)
Perforin+CD107a+IL-2+TNF- IFNg- CD8+ Day 1
0.00033
(0 to 0.00078)
0.0000461
(0 to 0.000138)
Perforin+CD107a+IL-2+TNF- IFNg- CD8+ Day 36
0 [1] 
(NA to NA)
0.0001540
(0 to 0.000387)
[1]
Not calculable, no cells positive for markers
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection M-001 + IIV4, Placebo + IIV4
Comments 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.
Type of Statistical Test Other
Comments [Not Specified]
Other Statistical Analysis No non-zero results were reported for either group so statistical testing was not performed.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection M-001 + IIV4, Placebo + IIV4
Comments 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.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5
Comments 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.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
10.Primary Outcome
Title Mean Percentage of Perforin+CD107a+IL-2-TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Hide Description The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.
Time Frame Day 1 through Day 36
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
Arm/Group Title M-001 + IIV4 Placebo + IIV4
Hide Arm/Group Description:
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Overall Number of Participants Analyzed 58 59
Mean (95% Confidence Interval)
Unit of Measure: percentage of cells
Perforin+CD107a+IL-2-TNF+IFNg+ CD4+ at Day 1
0.0000741
(0 to 0.000191)
0.000107
(0 to 0.000245)
Perforin+CD107a+IL-2-TNF+IFNg+ CD4+ Day 36
0.0001600
(0 to 0.000370)
0.000344
(0 to 0.000907)
Perforin+CD107a+IL-2-TNF+IFNg+ CD8+ Day 1
0.00271
(0.000636 to 0.00586)
0.000269
(0 to 0.00062)
Perforin+CD107a+IL-2-TNF+IFNg+ CD8+ Day 36
0.00187
(0.000358 to 0.00384)
0.00122
(0.000475 to 0.00209)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection M-001 + IIV4, Placebo + IIV4
Comments 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.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.99
Comments 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.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection M-001 + IIV4, Placebo + IIV4
Comments 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.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.74
Comments 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.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
11.Primary Outcome
Title Mean Percentage of Perforin+CD107a+IL-2- TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Hide Description The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.
Time Frame Day 1 through Day 36
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
Arm/Group Title M-001 + IIV4 Placebo + IIV4
Hide Arm/Group Description:
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Overall Number of Participants Analyzed 58 59
Mean (95% Confidence Interval)
Unit of Measure: percentage of cells
Perforin+CD107a+IL-2-TNF+IFNg- CD4+ at Day 1
0.000036
(0 to 0.000108)
0 [1] 
(NA to NA)
Perforin+CD107a+IL-2-TNF+IFNg- CD4+ Day 36
0 [1] 
(NA to NA)
0.000161
(0 to 0.000445)
Perforin+CD107a+IL-2-TNF+IFNg- CD8+ Day 1
0.00288
(0.000972 to 0.00536)
0.00172
(0.000753 to 0.00294)
Perforin+CD107a+IL-2-TNF+IFNg- CD8+ Day 36
0.00326
(0.001060 to 0.00606)
0.00134
(0.000606 to 0.00223)
[1]
Not calculable, no cells positive for markers
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection M-001 + IIV4, Placebo + IIV4
Comments 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.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.50
Comments 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.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection M-001 + IIV4, Placebo + IIV4
Comments 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.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.90
Comments 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.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
12.Primary Outcome
Title Mean Percentage of Perforin+CD107a+IL-2-TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Hide Description The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.
Time Frame Day 1 through Day 36
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
Arm/Group Title M-001 + IIV4 Placebo + IIV4
Hide Arm/Group Description:
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Overall Number of Participants Analyzed 58 59
Mean (95% Confidence Interval)
Unit of Measure: percentage of cells
Perforin+CD107a+IL-2-TNF- IFNg+ CD4+ at Day 1
0 [1] 
(NA to NA)
0 [1] 
(NA to NA)
Perforin+CD107a+IL-2-TNF- IFNg+ CD4+ Day 36
0.0000566
(0 to 0.00017)
0.000118
(0 to 0.000318)
Perforin+CD107a+IL-2-TNF- IFNg+ CD8+ Day 1
0.000444
(0.0000800 to 0.000959)
0.000409
(0 to 0.000963)
Perforin+CD107a+IL-2-TNF- IFNg+ CD8+ Day 36
0.000323
(0.0000639 to 0.000672)
0.000197
(0 to 0.000518)
[1]
Not calculable, no cells positive for markers
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection M-001 + IIV4, Placebo + IIV4
Comments 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.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.87
Comments 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.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection M-001 + IIV4, Placebo + IIV4
Comments 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.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.57
Comments 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.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
13.Primary Outcome
Title Mean Percentage of Perforin+CD107a+IL-2-TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Hide Description The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.
Time Frame Day 1 through Day 36
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
Arm/Group Title M-001 + IIV4 Placebo + IIV4
Hide Arm/Group Description:
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Overall Number of Participants Analyzed 58 59
Mean (95% Confidence Interval)
Unit of Measure: percentage of cells
Perforin+CD107a+IL-2-TNF- IFNg- CD4+ at Day 1
0.00104
(0.000455 to 0.00175)
0.000728
(0.000330 to 0.00122)
Perforin+CD107a+IL-2-TNF- IFNg- CD4+ Day 36
0.00123
(0.000602 to 0.00199)
0.000928
(0.000505 to 0.00141)
Perforin+CD107a+IL-2-TNF- IFNg- CD8+ Day 1
0.0317
(0.0249 to 0.0390)
0.0237
(0.0148 to 0.0363)
Perforin+CD107a+IL-2-TNF- IFNg- CD8+ Day 36
0.0368
(0.0273 to 0.0472)
0.0263
(0.0171 to 0.0402)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection M-001 + IIV4, Placebo + IIV4
Comments 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.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.82
Comments 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.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection M-001 + IIV4, Placebo + IIV4
Comments 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.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.076
Comments 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.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
14.Primary Outcome
Title Mean Percentage of Perforin+CD107a- IL-2+TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Hide Description The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.
Time Frame Day 1 through Day 36
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
Arm/Group Title M-001 + IIV4 Placebo + IIV4
Hide Arm/Group Description:
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Overall Number of Participants Analyzed 58 59
Mean (95% Confidence Interval)
Unit of Measure: percentage of cells
Perforin+CD107a- IL-2+TNF+IFNg+ CD4+ at Day 1
0.0000621
(0 to 0.000186)
0.0000457
(0 to 0.000137)
Perforin+CD107a- IL-2+TNF+IFNg+ CD4+ Day 36
0.0000888
(0 to 0.000229)
0.0001010
(0 to 0.000276)
Perforin+CD107a- IL-2+TNF+IFNg+ CD8+ Day 1
0.000123
(0 to 0.000369)
0 [1] 
(NA to NA)
Perforin+CD107a- IL-2+TNF+IFNg+ CD8+ Day 36
0.000184
(0 to 0.000482)
0.000128
(0 to 0.000333)
[1]
Not calculable, no cells positive for markers
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection M-001 + IIV4, Placebo + IIV4
Comments 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.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.99
Comments 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.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection M-001 + IIV4, Placebo + IIV4
Comments 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.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.75
Comments 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.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
15.Primary Outcome
Title Mean Percentage of Perforin+CD107a- IL-2+TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Hide Description The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.
Time Frame Day 1 through Day 36
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
Arm/Group Title M-001 + IIV4 Placebo + IIV4
Hide Arm/Group Description:
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Overall Number of Participants Analyzed 58 59
Mean (95% Confidence Interval)
Unit of Measure: percentage of cells
Perforin+CD107a- IL-2+TNF+IFNg- CD4+ at Day 1
0.0000375
(0 to 0.0001130)
0 [1] 
(NA to NA)
Perforin+CD107a- IL-2+TNF+IFNg- CD4+ Day 36
0.0000327
(0 to 0.0000982)
0 [1] 
(NA to NA)
Perforin+CD107a- IL-2+TNF+IFNg- CD8+ Day 1
0.0005150
(0 to 0.001160)
0.000322
(0 to 0.000966)
Perforin+CD107a- IL-2+TNF+IFNg- CD8+ Day 36
0.0000524
(0 to 0.000157)
0 [1] 
(NA to NA)
[1]
Not calculable, no cells positive for markers
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection M-001 + IIV4, Placebo + IIV4
Comments 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.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.50
Comments 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.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection M-001 + IIV4, Placebo + IIV4
Comments 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.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.50
Comments 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.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
16.Primary Outcome
Title Mean Percentage of Perforin+CD107a- IL-2+TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Hide Description The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.
Time Frame Day 1 through Day 36
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
Arm/Group Title M-001 + IIV4 Placebo + IIV4
Hide Arm/Group Description:
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Overall Number of Participants Analyzed 58 59
Mean (95% Confidence Interval)
Unit of Measure: percentage of cells
Perforin+CD107a- IL-2+TNF- IFNg+ CD4+ at Day 1
0 [1] 
(NA to NA)
0.000101
(0 to 0.000303)
Perforin+CD107a- IL-2+TNF- IFNg+ CD4+ Day 36
0 [1] 
(NA to NA)
0.000061
(0 to 0.000183)
Perforin+CD107a- IL-2+TNF- IFNg+ CD8+ Day 1
0 [1] 
(NA to NA)
0.0003780
(0 to 0.00113)
Perforin+CD107a- IL-2+TNF- IFNg+ CD8+ Day 36
0 [1] 
(NA to NA)
0.0000966
(0 to 0.00029)
[1]
Not calculable, no cells positive for markers
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection M-001 + IIV4, Placebo + IIV4
Comments 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.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >.99
Comments 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.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection M-001 + IIV4, Placebo + IIV4
Comments 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.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >.99
Comments 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.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
17.Primary Outcome
Title Mean Percentage of Perforin+CD107a- IL-2+TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Hide Description The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.
Time Frame Day 1 through Day 36
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
Arm/Group Title M-001 + IIV4 Placebo + IIV4
Hide Arm/Group Description:
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Overall Number of Participants Analyzed 58 59
Mean (95% Confidence Interval)
Unit of Measure: percentage of cells
Perforin+CD107a- IL-2+TNF- IFNg- CD4+ at Day 1
0.00399
(0.00211 to 0.00635)
0.00307
(0.00134 to 0.00550)
Perforin+CD107a- IL-2+TNF- IFNg- CD4+ Day 36
0.00458
(0.00216 to 0.00748)
0.00354
(0.00201 to 0.00530)
Perforin+CD107a- IL-2+TNF- IFNg- CD8+ Day 1
0.0742
(0.0385 to 0.1300)
0.0434
(0.0315 to 0.0568)
Perforin+CD107a- IL-2+TNF- IFNg- CD8+ Day 36
0.0546
(0.0398 to 0.0731)
0.0612
(0.0417 to 0.0841)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection M-001 + IIV4, Placebo + IIV4
Comments 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.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.81
Comments 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.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection M-001 + IIV4, Placebo + IIV4
Comments 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.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.47
Comments 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.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
18.Primary Outcome
Title Mean Percentage of Perforin+CD107a- IL-2- TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Hide Description The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.
Time Frame Day 1 through Day 36
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
Arm/Group Title M-001 + IIV4 Placebo + IIV4
Hide Arm/Group Description:
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Overall Number of Participants Analyzed 58 59
Mean (95% Confidence Interval)
Unit of Measure: percentage of cells
Perforin+CD107a- IL-2- TNF+IFNg+ CD4+ at Day 1
0.0000639
(0 to 0.000164)
0.000372
(0.0000658 to 0.000818)
Perforin+CD107a- IL-2- TNF+IFNg+ CD4+ Day 36
0 [1] 
(NA to NA)
0.000485
(0.0001520 to 0.000925)
Perforin+CD107a- IL-2- TNF+IFNg+ CD8+ Day 1
0.00122
(0.000315 to 0.00239)
0.00135
(0.000376 to 0.00276)
Perforin+CD107a- IL-2- TNF+IFNg+ CD8+ Day 36
0.00305
(0.001150 to 0.00542)
0.00168
(0.000426 to 0.00360)
[1]
Not calculable, no cells positive for markers
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection M-001 + IIV4, Placebo + IIV4
Comments 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.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0061
Comments 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.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection M-001 + IIV4, Placebo + IIV4
Comments 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.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.28
Comments 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.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
19.Primary Outcome
Title Mean Percentage of Perforin+CD107a- IL-2- TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Hide Description The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.
Time Frame Day 1 through Day 36
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
Arm/Group Title M-001 + IIV4 Placebo + IIV4
Hide Arm/Group Description:
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Overall Number of Participants Analyzed 58 59
Mean (95% Confidence Interval)
Unit of Measure: percentage of cells
Perforin+CD107a- IL-2- TNF+IFNg- CD4+ at Day 1
0.001100
(0.000455 to 0.002030)
0.000199
(0.0000519 to 0.000389)
Perforin+CD107a- IL-2- TNF+IFNg- CD4+ Day 36
0.000564
(0.000287 to 0.000874)
0.000454
(0.0001490 to 0.000809)
Perforin+CD107a- IL-2- TNF+IFNg- CD8+ Day 1
0.00880
(0.00375 to 0.0154)
0.00426
(0.00244 to 0.00638)
Perforin+CD107a- IL-2- TNF+IFNg- CD8+ Day 36
0.00947
(0.00564 to 0.0143)
0.00595
(0.00357 to 0.00874)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection M-001 + IIV4, Placebo + IIV4
Comments 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.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.36
Comments 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.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection M-001 + IIV4, Placebo + IIV4
Comments 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.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.32
Comments 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.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
20.Primary Outcome
Title Mean Percentage of Perforin+CD107a- IL-2- TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Hide Description The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.
Time Frame Day 1 through Day 36
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
Arm/Group Title M-001 + IIV4 Placebo + IIV4
Hide Arm/Group Description:
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Overall Number of Participants Analyzed 58 59
Mean (95% Confidence Interval)
Unit of Measure: percentage of cells
Perforin+CD107a- IL-2- TNF- IFNg+ CD4+ at Day 1
0.000421
(0.000135 to 0.000761)
0.000436
(0.000198 to 0.000700)
Perforin+CD107a- IL-2- TNF- IFNg+ CD4+ Day 36
0.00027
(0.0000719 to 0.000511)
0.000438
(0.00018 to 0.000732)
Perforin+CD107a- IL-2- TNF- IFNg+ CD8+ Day 1
0.00654
(0.00173 to 0.01520)
0.00177
(0.000981 to 0.00267)
Perforin+CD107a- IL-2- TNF- IFNg+ CD8+ Day 36
0.00376
(0.00151 to 0.00697)
0.00370
(0.002230 to 0.00543)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection M-001 + IIV4, Placebo + IIV4
Comments 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.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.42
Comments 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.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection M-001 + IIV4, Placebo + IIV4
Comments 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.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.26
Comments 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.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
21.Primary Outcome
Title Mean Percentage of Perforin+CD107a- IL-2- TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Hide Description The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.
Time Frame Day 1 through Day 36
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
Arm/Group Title M-001 + IIV4 Placebo + IIV4
Hide Arm/Group Description:
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Overall Number of Participants Analyzed 58 59
Mean (95% Confidence Interval)
Unit of Measure: percentage of cells
Perforin+CD107a- IL-2- TNF- IFNg- CD4+ at Day 1
1.180
(0.714 to 1.700)
0.775
(0.458 to 1.140)
Perforin+CD107a- IL-2- TNF- IFNg- CD4+ Day 36
1.080
(0.637 to 1.610)
0.772
(0.475 to 1.130)
Perforin+CD107a- IL-2- TNF- IFNg- CD8+ Day 1
16.0
(12.9 to 19.3)
12.3
(10.3 to 14.4)
Perforin+CD107a- IL-2- TNF- IFNg- CD8+ Day 36
16.2
(13.1 to 19.7)
13.7
(11.3 to 16.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection M-001 + IIV4, Placebo + IIV4
Comments 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.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.53
Comments 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.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection M-001 + IIV4, Placebo + IIV4
Comments 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.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.56
Comments 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.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
22.Primary Outcome
Title Mean Percentage of Perforin- CD107a+IL-2+TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Hide Description The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.
Time Frame Day 1 through Day 36
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
Arm/Group Title M-001 + IIV4 Placebo + IIV4
Hide Arm/Group Description:
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Overall Number of Participants Analyzed 58 59
Mean (95% Confidence Interval)
Unit of Measure: percentage of cells
Perforin- CD107a+IL-2+TNF+IFNg+ CD4+ at Day 1
0.00135
(0.000809 to 0.00194)
0.00122
(0.000714 to 0.00182)
Perforin- CD107a+IL-2+TNF+IFNg+ CD4+ Day 36
0.00156
(0.000895 to 0.00229)
0.00138
(0.00075 to 0.00211)
Perforin- CD107a+IL-2+TNF+IFNg+ CD8+ Day 1
0.001170
(0.000407 to 0.00208)
0.001000
(0.000406 to 0.001710)
Perforin- CD107a+IL-2+TNF+IFNg+ CD8+ Day 36
0.000742
(0.000173 to 0.00150)
0.000465
(0.000107 to 0.000935)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection M-001 + IIV4, Placebo + IIV4
Comments 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.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.97
Comments 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.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection M-001 + IIV4, Placebo + IIV4
Comments 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.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.62
Comments 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.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
23.Primary Outcome
Title Mean Percentage of Perforin- CD107a+IL-2+TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Hide Description The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.
Time Frame Day 1 through Day 36
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
Arm/Group Title M-001 + IIV4 Placebo + IIV4
Hide Arm/Group Description:
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Overall Number of Participants Analyzed 58 59
Mean (95% Confidence Interval)
Unit of Measure: percentage of cells
Perforin- CD107a+IL-2+TNF+IFNg- CD4+ at Day 1
0.00230
(0.000984 to 0.00403)
0.00200
(0.001110 to 0.00317)
Perforin- CD107a+IL-2+TNF+IFNg- CD4+ Day 36
0.00212
(0.001340 to 0.00302)
0.00144
(0.000759 to 0.00228)
Perforin- CD107a+IL-2+TNF+IFNg- CD8+ Day 1
0.000197
(0 to 0.000451)
0.0005900
(0.000134 to 0.001200)
Perforin- CD107a+IL-2+TNF+IFNg- CD8+ Day 36
0.000346
(0 to 0.000801)
0.0000719
(0 to 0.000216)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection M-001 + IIV4, Placebo + IIV4
Comments 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.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.15
Comments 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.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection M-001 + IIV4, Placebo + IIV4
Comments 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.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.18
Comments 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.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
24.Primary Outcome
Title Mean Percentage of Perforin- CD107a+IL-2+TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Hide Description The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.
Time Frame Day 1 through Day 36
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
Arm/Group Title M-001 + IIV4 Placebo + IIV4
Hide Arm/Group Description:
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Overall Number of Participants Analyzed 58 59
Mean (95% Confidence Interval)
Unit of Measure: percentage of cells
Perforin- CD107a+IL-2+TNF- IFNg+ CD4+ at Day 1
0 [1] 
(NA to NA)
0.000156
(0 to 0.000365)
Perforin- CD107a+IL-2+TNF- IFNg+ CD4+ Day 36
0.0000725
(0 to 0.000187)
0.000078
(0 to 0.000196)
Perforin- CD107a+IL-2+TNF- IFNg+ CD8+ Day 1
0 [1] 
(NA to NA)
0 [1] 
(NA to NA)
Perforin- CD107a+IL-2+TNF- IFNg+ CD8+ Day 36
0 [1] 
(NA to NA)
0 [1] 
(NA to NA)
[1]
Not calculable, no cells positive for markers
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection M-001 + IIV4, Placebo + IIV4
Comments 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.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.94
Comments 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.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection M-001 + IIV4, Placebo + IIV4
Comments 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.
Type of Statistical Test Other
Comments [Not Specified]
Other Statistical Analysis No non-zero results were reported for either group so statistical testing was not performed.
25.Primary Outcome
Title Mean Percentage of Perforin- CD107a+IL-2+TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Hide Description The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.
Time Frame Day 1 through Day 36
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
Arm/Group Title M-001 + IIV4 Placebo + IIV4
Hide Arm/Group Description:
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Overall Number of Participants Analyzed 58 59
Mean (95% Confidence Interval)
Unit of Measure: percentage of cells
Perforin- CD107a+IL-2+TNF- IFNg- CD4+ at Day 1
0.000809
(0.000198 to 0.00185)
0.000263
(0.0000905 to 0.000468)
Perforin- CD107a+IL-2+TNF- IFNg- CD4+ Day 36
0.000653
(0.000257 to 0.00114)
0.000223
(0.0000554 to 0.000436)
Perforin- CD107a+IL-2+TNF- IFNg- CD8+ Day 1
0.000377
(0.0000526 to 0.000828)
0.000840
(0.0003060 to 0.001480)
Perforin- CD107a+IL-2+TNF- IFNg- CD8+ Day 36
0.000912
(0.0002540 to 0.001770)
0.000369
(0.0000585 to 0.000796)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection M-001 + IIV4, Placebo + IIV4
Comments 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.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.14
Comments 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.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection M-001 + IIV4, Placebo + IIV4
Comments 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.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.26
Comments 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.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
26.Primary Outcome
Title Mean Percentage of Perforin- CD107a+IL-2- TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Hide Description The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.
Time Frame Day 1 through Day 36
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
Arm/Group Title M-001 + IIV4 Placebo + IIV4
Hide Arm/Group Description:
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Overall Number of Participants Analyzed 58 59
Mean (95% Confidence Interval)
Unit of Measure: percentage of cells
Perforin- CD107a+IL-2- TNF+IFNg+ CD4+ at Day 1
0.00269
(0.00166 to 0.00390)
0.00248
(0.00183 to 0.00319)
Perforin- CD107a+IL-2- TNF+IFNg+ CD4+ Day 36
0.00309
(0.00206 to 0.00426)
0.00262
(0.00171 to 0.00366)
Perforin- CD107a+IL-2- TNF+IFNg+ CD8+ Day 1
0.00513
(0.00259 to 0.00834)
0.00617
(0.00352 to 0.00921)
Perforin- CD107a+IL-2- TNF+IFNg+ CD8+ Day 36
0.00604
(0.00334 to 0.00963)
0.00374
(0.00228 to 0.00539)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection M-001 + IIV4, Placebo + IIV4
Comments 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.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.72
Comments 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.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection M-001 + IIV4, Placebo + IIV4
Comments 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.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.31
Comments 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.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
27.Primary Outcome
Title Mean Percentage of Perforin- CD107a+IL-2- TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Hide Description The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.
Time Frame Day 1 through Day 36
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
Arm/Group Title M-001 + IIV4 Placebo + IIV4
Hide Arm/Group Description:
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Overall Number of Participants Analyzed 58 59
Mean (95% Confidence Interval)
Unit of Measure: percentage of cells
Perforin- CD107a+IL-2- TNF+IFNg- CD4+ at Day 1
0.0147
(0.00813 to 0.0239)
0.0160
(0.01060 to 0.0230)
Perforin- CD107a+IL-2- TNF+IFNg- CD4+ Day 36
0.0123
(0.00948 to 0.0153)
0.0127
(0.00868 to 0.0177)
Perforin- CD107a+IL-2- TNF+IFNg- CD8+ Day 1
0.00678
(0.00414 to 0.00986)
0.00725
(0.00455 to 0.0104)
Perforin- CD107a+IL-2- TNF+IFNg- CD8+ Day 36
0.00427
(0.00197 to 0.00726)
0.00630
(0.00317 to 0.0107)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection M-001 + IIV4, Placebo + IIV4
Comments 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.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.31
Comments 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.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection M-001 + IIV4, Placebo + IIV4
Comments 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.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.22
Comments 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.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
28.Primary Outcome
Title Mean Percentage of Perforin- CD107a+IL-2- TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Hide Description The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.
Time Frame Day 1 through Day 36
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
Arm/Group Title M-001 + IIV4 Placebo + IIV4
Hide Arm/Group Description:
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Overall Number of Participants Analyzed 58 59
Mean (95% Confidence Interval)
Unit of Measure: percentage of cells
Perforin- CD107a+IL-2- TNF- IFNg+ CD4+ at Day 1
0.000511
(0.000253 to 0.000815)
0.000694
(0.000345 to 0.001090)
Perforin- CD107a+IL-2- TNF- IFNg+ CD4+ Day 36
0.000731
(0.000391 to 0.001110)
0.001910
(0.000921 to 0.003160)
Perforin- CD107a+IL-2- TNF- IFNg+ CD8+ Day 1
0.001580
(0.000815 to 0.002530)
0.002160
(0.001100 to 0.003380)
Perforin- CD107a+IL-2- TNF- IFNg+ CD8+ Day 36
0.001780
(0.000916 to 0.002790)
0.002240
(0.001290 to 0.003310)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection M-001 + IIV4, Placebo + IIV4
Comments 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.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.16
Comments 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.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection M-001 + IIV4, Placebo + IIV4
Comments 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.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.44
Comments 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.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
29.Primary Outcome
Title Mean Percentage of Perforin- CD107a+IL-2- TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Hide Description The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.
Time Frame Day 1 through Day 36
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
Arm/Group Title M-001 + IIV4 Placebo + IIV4
Hide Arm/Group Description:
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Overall Number of Participants Analyzed 58 59
Mean (95% Confidence Interval)
Unit of Measure: percentage of cells
Perforin- CD107a+IL-2- TNF- IFNg- CD4+ at Day 1
0.231
(0.178 to 0.292)
0.240
(0.179 to 0.314)
Perforin- CD107a+IL-2- TNF- IFNg- CD4+ Day 36
0.220
(0.172 to 0.277)
0.236
(0.184 to 0.293)
Perforin- CD107a+IL-2- TNF- IFNg- CD8+ Day 1
0.294
(0.226 to 0.374)
0.323
(0.237 to 0.434)
Perforin- CD107a+IL-2- TNF- IFNg- CD8+ Day 36
0.295
(0.232 to 0.366)
0.341
(0.267 to 0.424)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection M-001 + IIV4, Placebo + IIV4
Comments 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.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.67
Comments 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.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection M-001 + IIV4, Placebo + IIV4
Comments 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.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.48
Comments 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.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
30.Primary Outcome
Title Mean Percentage of Perforin- CD107a- IL-2+TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Hide Description The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.
Time Frame Day 1 through Day 36
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
Arm/Group Title M-001 + IIV4 Placebo + IIV4
Hide Arm/Group Description:
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Overall Number of Participants Analyzed 58 59
Mean (95% Confidence Interval)
Unit of Measure: percentage of cells
Perforin- CD107a- IL-2+TNF+IFNg+ CD4+ at Day 1
0.00328
(0.00238 to 0.00430)
0.00365
(0.00230 to 0.00548)
Perforin- CD107a- IL-2+TNF+IFNg+ CD4+ Day 36
0.00955
(0.00604 to 0.01470)
0.00289
(0.00201 to 0.00390)
Perforin- CD107a- IL-2+TNF+IFNg+ CD8+ Day 1
0.000238
(0 to 0.000657)
0.000693
(0.0000839 to 0.001620)
Perforin- CD107a- IL-2+TNF+IFNg+ IFNg- CD8+ Day 36
0.000288
(0.0000404 to 0.000626)
0.000486
(0 to 0.001300)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection M-001 + IIV4, Placebo + IIV4
Comments 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.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments 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.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection M-001 + IIV4, Placebo + IIV4
Comments 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.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.62
Comments 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.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
31.Primary Outcome
Title Mean Percentage of Perforin- CD107a- IL-2+TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Hide Description The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.
Time Frame Day 1 through Day 36
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
Arm/Group Title M-001 + IIV4 Placebo + IIV4
Hide Arm/Group Description:
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Overall Number of Participants Analyzed 58 59
Mean (95% Confidence Interval)
Unit of Measure: percentage of cells
Perforin- CD107a- IL-2+TNF+IFNg- CD4+ at Day 1
0.01170
(0.00784 to 0.01600)
0.01240
(0.00958 to 0.01540)
Perforin- CD107a- IL-2+TNF+IFNg- CD4+ Day 36
0.01640
(0.01230 to 0.02130)
0.01130
(0.00789 to 0.01540)
Perforin- CD107a- IL-2+TNF+IFNg- CD8+ Day 1
0.00161
(0.000488 to 0.00318)
0.00184
(0.000851 to 0.00301)
Perforin- CD107a- IL-2+TNF+IFNg- IFNg- CD8+ Day 36
0.00129
(0.000535 to 0.00224)
0.00102
(0.000354 to 0.00186)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection M-001 + IIV4, Placebo + IIV4
Comments 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.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0093
Comments 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.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection M-001 + IIV4, Placebo + IIV4
Comments 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.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.51
Comments 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.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
32.Primary Outcome
Title Mean Percentage of Perforin- CD107a- IL-2+TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Hide Description The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.
Time Frame Day 1 through Day 36
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
Arm/Group Title M-001 + IIV4 Placebo + IIV4
Hide Arm/Group Description:
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Overall Number of Participants Analyzed 58 59
Mean (95% Confidence Interval)
Unit of Measure: percentage of cells
Perforin- CD107a- IL-2+TNF- IFNg+ CD4+ at Day 1
0.000169
(0.0000294 to 0.000355)
0.000438
(0.000195 to 0.000714)
Perforin- CD107a- IL-2+TNF- IFNg+ CD4+ Day 36
0.000434
(0.0001960 to 0.000702)
0.000372
(0.000131 to 0.000680)
Perforin- CD107a- IL-2+TNF- IFNg+ CD8+ Day 1
0.000397
(0 to 0.000977)
0.000339
(0.0000652 to 0.000709)
Perforin- CD107a- IL-2+TNF- IFNg+ CD8+ Day 36
0.000487
(0 to 0.001360)
0.000378
(0.0000775 to 0.000736)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection M-001 + IIV4, Placebo + IIV4
Comments 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.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.54
Comments 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.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection M-001 + IIV4, Placebo + IIV4
Comments 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.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.43
Comments 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.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
33.Primary Outcome
Title Mean Percentage of Perforin- CD107a- IL-2+TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Hide Description The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.
Time Frame Day 1 through Day 36
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
Arm/Group Title M-001 + IIV4 Placebo + IIV4
Hide Arm/Group Description:
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Overall Number of Participants Analyzed 58 59
Mean (95% Confidence Interval)
Unit of Measure: percentage of cells
Perforin- CD107a- IL-2+TNF- IFNg- CD4+ at Day 1
0.0445
(0.0285 to 0.0625)
0.0400
(0.0283 to 0.0530)
Perforin- CD107a- IL-2+TNF- IFNg- CD4+ Day 36
0.0395
(0.0274 to 0.0524)
0.0478
(0.0343 to 0.0627)
Perforin- CD107a- IL-2+TNF- IFNg- CD8+ Day 1
0.0468
(0.0311 to 0.0645)
0.0444
(0.0310 to 0.0605)
Perforin- CD107a- IL-2+TNF- IFNg- CD8+ Day 36
0.0417
(0.0272 to 0.0588)
0.0522
(0.0402 to 0.0653)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection M-001 + IIV4, Placebo + IIV4
Comments 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.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.44
Comments 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.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection M-001 + IIV4, Placebo + IIV4
Comments 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.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.014
Comments 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.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
34.Primary Outcome
Title Mean Percentage of Perforin- CD107a- IL-2- TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Hide Description The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.
Time Frame Day 1 through Day 36
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
Arm/Group Title M-001 + IIV4 Placebo + IIV4
Hide Arm/Group Description:
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Overall Number of Participants Analyzed 58 59
Mean (95% Confidence Interval)
Unit of Measure: percentage of cells
Perforin- CD107a- IL-2- TNF+IFNg+ CD4+ at Day 1
0.00935
(0.00716 to 0.01180)
0.00881
(0.00622 to 0.01190)
Perforin- CD107a- IL-2- TNF+IFNg+ CD4+ Day 36
0.01520
(0.01160 to 0.01950)
0.00731
(0.00556 to 0.00926)
Perforin- CD107a- IL-2- TNF+IFNg+ CD8+ Day 1
0.00488
(0.00305 to 0.00702)
0.00460
(0.00242 to 0.00751)
Perforin- CD107a- IL-2- TNF+IFNg+CD8+ Day 36
0.00257
(0.00141 to 0.00398)
0.00242
(0.00139 to 0.00357)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection M-001 + IIV4, Placebo + IIV4
Comments 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.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments 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.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection M-001 + IIV4, Placebo + IIV4
Comments 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.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.96
Comments 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.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
35.Primary Outcome
Title Mean Percentage of Perforin- CD107a- IL-2- TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Hide Description The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.
Time Frame Day 1 through Day 36
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
Arm/Group Title M-001 + IIV4 Placebo + IIV4
Hide Arm/Group Description:
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Overall Number of Participants Analyzed 58 59
Mean (95% Confidence Interval)
Unit of Measure: percentage of cells
Perforin- CD107a- IL-2- TNF+IFNg- CD4+ at Day 1
0.390
(0.288 to 0.508)
0.483
(0.331 to 0.669)
Perforin- CD107a- IL-2- TNF+IFNg- CD4+ Day 36
0.389
(0.280 to 0.524)
0.354
(0.263 to 0.459)
Perforin- CD107a- IL-2- TNF+IFNg- CD8+ Day 1
0.0388
(0.0201 to 0.0676)
0.0415
(0.0254 to 0.0618)
Perforin- CD107a- IL-2- TNF+IFNg- CD8+ Day 36
0.0341
(0.0175 to 0.0613)
0.0348
(0.0227 to 0.0503)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection M-001 + IIV4, Placebo + IIV4
Comments 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.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.65
Comments 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.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection M-001 + IIV4, Placebo + IIV4
Comments 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.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.53
Comments 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.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
36.Primary Outcome
Title Mean Percentage of Perforin- CD107a- IL-2- TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Hide Description The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.
Time Frame Day 1 through Day 36
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
Arm/Group Title M-001 + IIV4 Placebo + IIV4
Hide Arm/Group Description:
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Overall Number of Participants Analyzed 58 59
Mean (95% Confidence Interval)
Unit of Measure: percentage of cells
Perforin- CD107a- IL-2- TNF- IFNg+ CD4+ at Day 1
0.0238
(0.0164 to 0.0354)
0.0147
(0.0119 to 0.0178)
Perforin- CD107a- IL-2- TNF- IFNg+ CD4+ Day 36
0.0199
(0.0155 to 0.0252)
0.0255
(0.0133 to 0.0466)
Perforin- CD107a- IL-2- TNF- IFNg+ CD8+ Day 1
0.0314
(0.0165 to 0.0505)
0.0209
(0.0131 to 0.0307)
Perforin- CD107a- IL-2- TNF- IFNg+ CD8+ Day 36
0.0318
(0.0200 to 0.0467)
0.0308
(0.0180 to 0.0473)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection M-001 + IIV4, Placebo + IIV4
Comments 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.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.35
Comments 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.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection M-001 + IIV4, Placebo + IIV4
Comments 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.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.66
Comments 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.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
37.Primary Outcome
Title Mean Percentage of Perforin- CD107a- IL-2- TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Hide Description The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.
Time Frame Day 1 through Day 36
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
Arm/Group Title M-001 + IIV4 Placebo + IIV4
Hide Arm/Group Description:
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Overall Number of Participants Analyzed 58 59
Mean (95% Confidence Interval)
Unit of Measure: percentage of cells
Perforin- CD107a- IL-2- TNF- IFNg- CD4+ at Day 1
98.1
(97.5 to 98.6)
98.4
(98.0 to 98.8)
Perforin- CD107a- IL-2- TNF- IFNg- CD4+ Day 36
98.2
(97.6 to 98.7)
98.5
(98.2 to 98.8)
Perforin- CD107a- IL-2- TNF- IFNg- CD8+ Day 1
83.5
(80.2 to 86.6)
87.2
(85.1 to 89.1)
Perforin- CD107a- IL-2- TNF- IFNg- CD8+ Day 36
83.2
(79.8 to 86.5)
85.8
(83.3 to 88.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection M-001 + IIV4, Placebo + IIV4
Comments 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.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.86
Comments 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.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection M-001 + IIV4, Placebo + IIV4
Comments 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.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.53
Comments 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.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
38.Primary Outcome
Title Number of Participants With Clinical Safety Laboratory Adverse Events After the First M-001 Vaccination
Hide Description Blood was collected after first vaccination for assessment by a central clinical laboratory. Clinical safety laboratory adverse events included white blood cells (WBC) </=3900/uL or >/=10,600/uL; platelets </=139,000/uL or >/=416,000/uL; hemoglobin </=11.4 g/dL (female) or </=12.4 g/dL (male); alanine aminotransferase (ALT) >/=44 IU/L (female) or >/=61 IU/L (male); creatinine >/=1.1 mg/dL (female) or >/=1.4 (male); and total bilirubin >/=1.30 mg/dL.
Time Frame Day 9
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Analysis population includes all participants who received the first dose of study product and have a result reported for the parameter.
Arm/Group Title M-001 + IIV4 Placebo + IIV4
Hide Arm/Group Description:
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Overall Number of Participants Analyzed 61 59
Measure Type: Count of Participants
Unit of Measure: Participants
WBC Number Analyzed 61 participants 59 participants
5
   8.2%
7
  11.9%
platelets Number Analyzed 60 participants 59 participants
1
   1.7%
0
   0.0%
hemoglobin Number Analyzed 61 participants 59 participants
3
   4.9%
1
   1.7%
ALT Number Analyzed 61 participants 59 participants
2
   3.3%
0
   0.0%
creatinine Number Analyzed 61 participants 59 participants
0
   0.0%
0
   0.0%
total bilirubin Number Analyzed 60 participants 58 participants
2
   3.3%
2
   3.4%
39.Primary Outcome
Title Number of Participants With Clinical Safety Laboratory Adverse Events After Second M-001 Vaccination
Hide Description Clinical safety laboratory adverse events included WBC less than or equal to 3900/uL or greater than or equal to 10,600/uL; platelets less than or equal to 139,000/uL or greater than or equal to 416,000/uL; hemoglobin less than or equal to 11.4 g/dL (female) or less than or equal to 12.4 g/dL (male); alanine aminotransferase (ALT) greater than or equal to 44 IU/L (female) or greater than or equal to 61 IU/L (male); creatinine greater than or equal to 1.1 mg/dL (female) or greater than or equal to 1.4 (male); and total bilirubin greater than or equal to 1.30 mg/dL.
Time Frame Day 22 through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Analysis population includes all participants who received the second dose of study product and have a result reported for the parameter.
Arm/Group Title M-001 + IIV4 Placebo + IIV4
Hide Arm/Group Description:
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Overall Number of Participants Analyzed 54 55
Measure Type: Count of Participants
Unit of Measure: Participants
WBC Number Analyzed 54 participants 55 participants
2
   3.7%
3
   5.5%
platelets Number Analyzed 53 participants 55 participants
0
   0.0%
0
   0.0%
hemoglobin Number Analyzed 54 participants 55 participants
2
   3.7%
0
   0.0%
ALT Number Analyzed 54 participants 55 participants
2
   3.7%
0
   0.0%
creatinine Number Analyzed 54 participants 55 participants
0
   0.0%
0
   0.0%
total bilirubin Number Analyzed 52 participants 54 participants
2
   3.8%
2
   3.7%
40.Primary Outcome
Title Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the First M-001 Vaccination
Hide Description Participants maintained a memory aid and thermometer to record daily oral temperatures and the occurrence of systemic reactions of feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea, as well as local injection site reactions of pain, tenderness, redness, and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities, with a severity grade of mild meaning no interference, moderate as some interference and severe as significant interference/prevented daily activity. Fever was defined as an oral temperature of 38 degree Celsius or higher. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days post vaccination.
Time Frame Day 1 through Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Analysis population includes all participants who received the first study product.
Arm/Group Title M-001 + IIV4 Placebo + IIV4
Hide Arm/Group Description:
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Overall Number of Participants Analyzed 61 59
Measure Type: Count of Participants
Unit of Measure: Participants
Fever
0
   0.0%
1
   1.7%
Feverishness
1
   1.6%
3
   5.1%
Fatigue
14
  23.0%
14
  23.7%
Malaise
5
   8.2%
5
   8.5%
Myalgia
6
   9.8%
6
  10.2%
Arthralgia
1
   1.6%
1
   1.7%
Headache
13
  21.3%
15
  25.4%
Nausea
7
  11.5%
1
   1.7%
Injection site pain
12
  19.7%
2
   3.4%
Injection site tenderness
24
  39.3%
9
  15.3%
Injection site itchiness/pruritus
2
   3.3%
1
   1.7%
Injection site ecchymosis
2
   3.3%
3
   5.1%
Injection site erythema
14
  23.0%
11
  18.6%
Injection site induration/swelling
3
   4.9%
4
   6.8%
41.Primary Outcome
Title Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the Second M-001 Vaccination
Hide Description Participants maintained a memory aid and thermometer to record daily oral temperatures and the occurrence of systemic reactions of feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea, as well as local injection site reactions of pain, tenderness, redness, and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities, with a severity grade of mild meaning no interference, moderate as some interference and severe as significant interference/prevented daily activity. Fever was defined as an oral temperature of 38 degree Celsius or higher. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days post vaccination.
Time Frame Day 22 through Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Analysis population includes all participants who received the second study product.
Arm/Group Title M-001 + IIV4 Placebo + IIV4
Hide Arm/Group Description:
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Overall Number of Participants Analyzed 55 55
Measure Type: Count of Participants
Unit of Measure: Participants
Fever
1
   1.8%
0
   0.0%
Feverishness
1
   1.8%
2
   3.6%
Fatigue
8
  14.5%
7
  12.7%
Malaise
6
  10.9%
4
   7.3%
Myalgia
4
   7.3%
2
   3.6%
Arthralgia
0
   0.0%
2
   3.6%
Headache
8
  14.5%
8
  14.5%
Nausea
2
   3.6%
1
   1.8%
Injection site pain
13
  23.6%
2
   3.6%
Injection site tenderness
16
  29.1%
11
  20.0%
Injection site itchiness/pruritus
2
   3.6%
1
   1.8%
Injection site ecchymosis
0
   0.0%
3
   5.5%
Injection site erythema
15
  27.3%
7
  12.7%
Injection site induration/swelling
2
   3.6%
2
   3.6%
42.Primary Outcome
Title Number of Participants Reporting Vaccine-related Serious Adverse Events (SAEs) After M-001 Vaccination
Hide Description SAEs included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required inpatient hospitalization or prolongation or a congenital anomaly/birth defect. Relationship (related or unrelated to the study product) was determined by a site principal investigator blinded to the study product received by the participant.
Time Frame Day 1 through Day 200
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Analysis population includes all participants who received at least one dose of study product.
Arm/Group Title M-001 + IIV4 Placebo + IIV4
Hide Arm/Group Description:
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Overall Number of Participants Analyzed 61 59
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
43.Secondary Outcome
Title Number of Participants Reporting Serious Adverse Events (SAEs) After M-001 Vaccination
Hide Description SAEs included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required inpatient hospitalization or prolongation or a congenital anomaly/birth defect. All events are included regardless of relationship to the study product.
Time Frame Day 1 through Day 200
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Analysis population includes all participants who received at least one dose of study product.
Arm/Group Title M-001 + IIV4 Placebo + IIV4
Hide Arm/Group Description:
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Overall Number of Participants Analyzed 61 59
Measure Type: Count of Participants
Unit of Measure: Participants
1
   1.6%
0
   0.0%
44.Secondary Outcome
Title Incidence of Unsolicited Non-serious Adverse Events (AEs) After M-001 Vaccination
Hide Description Unsolicited adverse events were collected from the time of first vaccination and at each follow-up visit through Day 43. Adverse events were defined as any untoward medical occurrence regardless of its causal relationship to the study treatment. Events were coded with MedDRA and are reported by System Organ Class.
Time Frame Day 1 through Day 43
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Analysis population includes all participants who received at least one dose of study product.
Arm/Group Title M-001 + IIV4 Placebo + IIV4
Hide Arm/Group Description:
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Overall Number of Participants Analyzed 61 59
Measure Type: Number
Unit of Measure: participants
Blood and lymphatic system disorders 0 2
Eye Disorders 1 1
Gastrointestinal disorders 2 1
Immune system disorders 0 1
Infections and Infestations 11 12
Injury, poisoning and procedural complications 2 2
Musculoskeletal and connective tissue disorders 4 1
Nervous system disorders 3 2
Reproductive system and breast disorders 1 0
Respiratory, thoracic and mediastinal disorders 3 2
Skin and subcutaneous tissue disorders 3 3
Vascular disorders 0 1
45.Secondary Outcome
Title The Percentage of Subjects Achieving HAI Seroconversion to IIV4 Vaccine Virus From Day 172 to Day 200
Hide Description Blood was collected from participants for testing in the HAI assay with the vaccine viruses as the assay antigens. Seroconversion was defined as a Day 172 titer less than 10 and Day 200 titer greater than or equal to 40, or for those with a Day 172 titer of 10 or greater, a minimum 4-fold rise in Day 200 antibody titer.
Time Frame Day 172 to Day 200
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all participants who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported
Arm/Group Title M-001 + IIV4 Placebo + IIV4
Hide Arm/Group Description:
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Overall Number of Participants Analyzed 52 50
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
B/Colorado/6/2017
13.5
(5.6 to 25.8)
6.0
(1.3 to 16.5)
B/Phuket/3073/2013
11.5
(4.4 to 23.4)
8.0
(2.2 to 19.2)
A/Michigan/45/2015 X-275
15.4
(6.9 to 28.1)
16.0
(7.2 to 29.1)
A/Singapore/INFIMH-16-0019/2016 NIB-104
25.0
(14.0 to 38.9)
20.0
(10.0 to 33.7)
46.Secondary Outcome
Title The Percentage of Subjects Achieving Neutralizing Antibody Seroconversion to IIV4 Vaccine Virus From Day 172 to Day 200
Hide Description Blood was collected from participants for testing in the neutralizing antibody assay with the vaccine viruses as the assay antigens. Seroconversion was defined as a Day 172 titer less than 10 and Day 200 titer greater than or equal to 40, or for those with a Day 172 titer of 10 or greater, a minimum 4-fold rise in Day 200 antibody titer.
Time Frame Day 172 to Day 200
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all participants who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported
Arm/Group Title M-001 + IIV4 Placebo + IIV4
Hide Arm/Group Description:
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Overall Number of Participants Analyzed 52 50
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
B/Colorado/6/2017
17.3
(8.2 to 30.3)
6.0
(1.3 to 16.5)
B/Phuket/3073/2013
13.5
(5.6 to 25.8)
8.0
(2.2 to 19.2)
A/Michigan/45/2015 X-275
19.2
(9.6 to 32.5)
16.0
(7.2 to 29.1)
A/Singapore/INFIMH-16-0019/2016 NIB-104
46.2
(32.2 to 60.5)
26.0
(14.6 to 40.3)
47.Secondary Outcome
Title The Percentage of Participants With an HAI Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 1
Hide Description Blood was collected from participants for testing in the HAI assay with the vaccine viruses as the assay antigens. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 40 or greater.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
Arm/Group Title M-001 + IIV4 Placebo + IIV4
Hide Arm/Group Description:
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Overall Number of Participants Analyzed 55 55
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
B/Colorado/6/2017
98.3
(91.1 to 100)
93.2
(83.5 to 98.1)
B/Phuket/3073/2013
93.3
(83.8 to 98.2)
93.2
(83.5 to 98.1)
A/Michigan/45/2015 X-275
80.0
(67.7 to 89.2)
81.4
(69.1 to 90.3)
A/Singapore/INFIMH-16-0019/2016 NIB-104
43.3
(30.6 to 56.8)
33.9
(22.1 to 47.4)
48.Secondary Outcome
Title The Percentage of Participants With an HAI Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 43
Hide Description Blood was collected from participants for testing in the HAI assay with the vaccine viruses as the assay antigens. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 40 or greater.
Time Frame Day 43
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
Arm/Group Title M-001 + IIV4 Placebo + IIV4
Hide Arm/Group Description:
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Overall Number of Participants Analyzed 53 53
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
B/Colorado/6/2017
96.2
(87.0 to 99.5)
92.5
(81.8 to 97.9)
B/Phuket/3073/2013
94.3
(84.3 to 98.8)
92.5
(81.8 to 97.9)
A/Michigan/45/2015 X-275
79.2
(65.9 to 89.2)
79.2
(65.9 to 89.2)
A/Singapore/INFIMH-16-0019/2016 NIB-104
39.6
(26.5 to 54.0)
35.8
(23.1 to 50.2)
49.Secondary Outcome
Title The Percentage of Participants With an HAI Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 172
Hide Description Blood was collected from participants for testing in the HAI assay with the vaccine viruses as the assay antigens. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 40 or greater.
Time Frame Day 172
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
Arm/Group Title M-001 + IIV4 Placebo + IIV4
Hide Arm/Group Description:
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Overall Number of Participants Analyzed 53 52
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
B/Colorado/6/2017
94.3
(84.3 to 98.8)
88.5
(76.6 to 95.6)
B/Phuket/3073/2013
94.3
(84.3 to 98.8)
88.5
(76.6 to 95.6)
A/Michigan/45/2015 X-275
81.1
(68.0 to 90.6)
78.8
(65.3 to 88.9)
A/Singapore/INFIMH-16-0019/2016 NIB-104
39.6
(26.5 to 54.0)
30.8
(18.7 to 45.1)
50.Secondary Outcome
Title The Percentage of Participants With an HAI Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 200
Hide Description Blood was collected from participants for testing in the HAI assay with the vaccine viruses as the assay antigens. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 40 or greater.
Time Frame Day 200
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
Arm/Group Title M-001 + IIV4 Placebo + IIV4
Hide Arm/Group Description:
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Overall Number of Participants Analyzed 52 50
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
B/Colorado/6/2017
98.1
(89.7 to 100)
96.0
(86.3 to 99.5)
B/Phuket/3073/2013
98.1
(89.7 to 100)
96.0
(86.3 to 99.5)
A/Michigan/45/2015 X-275
94.2
(84.1 to 98.8)
88.0
(75.7 to 95.5)
A/Singapore/INFIMH-16-0019/2016 NIB-104
67.3
(52.9 to 79.7)
60
(45.2 to 73.6)
51.Secondary Outcome
Title The Percentage of Participants With a Neutralizing Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 1
Hide Description Blood was collected from participants for testing in the neutralizing antibody assay with the vaccine viruses as the assay antigens. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 40 or greater.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
Arm/Group Title M-001 + IIV4 Placebo + IIV4
Hide Arm/Group Description:
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Overall Number of Participants Analyzed 60 59
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
B/Colorado/6/2017
30.0
(18.8 to 43.2)
22.0
(12.3 to 34.7)
B/Phuket/3073/2013
71.7
(58.6 to 82.5)
74.6
(61.6 to 85.0)
A/Michigan/45/2015 X-275
100
(94.0 to 100)
96.6
(88.3 to 99.6)
A/Singapore/INFIMH-16-0019/2016 NIB-104
91.7
(81.6 to 97.2)
93.2
(83.5 to 989.1)
52.Secondary Outcome
Title The Percentage of Participants With a Neutralizing Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 43
Hide Description Blood was collected from participants for testing in the neutralizing antibody assay with the vaccine viruses as the assay antigens. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 40 or greater.
Time Frame Day 43
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
Arm/Group Title M-001 + IIV4 Placebo + IIV4
Hide Arm/Group Description:
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Overall Number of Participants Analyzed 53 53
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
B/Colorado/6/2017
20.8
(10.8 to 34.1)
28.3
(16.8 to 42.3)
B/Phuket/3073/2013
77.4
(63.8 to 87.7)
69.8
(55.7 to 81.7)
A/Michigan/45/2015 X-275
98.1
(89.9 to 100)
98.1
(89.9 to 100)
A/Singapore/INFIMH-16-0019/2016 NIB-104
90.6
(79.3 to 96.9)
92.5
(81.8 to 97.9)
53.Secondary Outcome
Title The Percentage of Participants With a Neutralizing Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 172
Hide Description Blood was collected from participants for testing in the neutralizing antibody assay with the vaccine viruses as the assay antigens. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 40 or greater.
Time Frame Day 172
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
Arm/Group Title M-001 + IIV4 Placebo + IIV4
Hide Arm/Group Description:
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
Overall Number of Participants Analyzed 53 52
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
B/Colorado/6/2017
24.5
(13.8 to 38.3)
26.9
(15.6 to 41.0)
B/Phuket/3073/2013
67.9
(53.7 to 80.1)
69.2
(54.9 to 81.3)
A/Michigan/45/2015 X-275
98.1
(89.9 to 100)
96.2
(86.8 to 99.5)
A/Singapore/INFIMH-16-0019/2016 NIB-104
86.8
(74.7 to 94.5)
92.3
(81.5 to 97.9)
54.Secondary Outcome
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Title The Percentage of Participants With a Neutralizing Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 200