Trial Outcomes & Findings for Two Doses of Multimeric-001 (M-001) Followed by Influenza Vaccine (NCT NCT03058692)
NCT ID: NCT03058692
Last Updated: 2020-06-18
Results Overview
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.
COMPLETED
PHASE2
120 participants
Day 1 through Day 36
2020-06-18
Participant Flow
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.
Participant milestones
| Measure |
M-001 + IIV4
0.4 ml injection of M-001 (1 mg dose) intramuscularly on Day 1 and Day 22, followed by 0.5 ml injection of IIV4 (60 mcg HA) intramuscularly on Day 172
Influenza Multimeric-001 Vaccine: The M-001 vaccine consists of 3 repetitions of 9 conserved linear epitopes that are prepared as a single recombinant protein. The M-001 vaccine is expected to protect against existing as well as future seasonal and pandemic virus strains.
Quadrivalent Recombinant Seasonal Influenza Vaccine: Quadrivalent Inactivated Influenza Vaccine (IIV4) for intramuscular injection is indicated for active immunization against influenza disease caused by influenza virus subtypes A and type B present in the vaccine.
|
Placebo + IIV4
0.4 ml injection of placebo intramuscularly on Day 1 and Day 22, followed by 0.5 ml injection of IIV4 (60 mcg HA) intramuscularly on Day 172
Placebo: Placebo is saline injection
Quadrivalent Recombinant Seasonal Influenza Vaccine: Quadrivalent Inactivated Influenza Vaccine (IIV4) for intramuscular injection is indicated for active immunization against influenza disease caused by influenza virus subtypes A and type B present in the vaccine.
|
|---|---|---|
|
Overall Study
STARTED
|
61
|
59
|
|
Overall Study
COMPLETED
|
58
|
57
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
M-001 + IIV4
0.4 ml injection of M-001 (1 mg dose) intramuscularly on Day 1 and Day 22, followed by 0.5 ml injection of IIV4 (60 mcg HA) intramuscularly on Day 172
Influenza Multimeric-001 Vaccine: The M-001 vaccine consists of 3 repetitions of 9 conserved linear epitopes that are prepared as a single recombinant protein. The M-001 vaccine is expected to protect against existing as well as future seasonal and pandemic virus strains.
Quadrivalent Recombinant Seasonal Influenza Vaccine: Quadrivalent Inactivated Influenza Vaccine (IIV4) for intramuscular injection is indicated for active immunization against influenza disease caused by influenza virus subtypes A and type B present in the vaccine.
|
Placebo + IIV4
0.4 ml injection of placebo intramuscularly on Day 1 and Day 22, followed by 0.5 ml injection of IIV4 (60 mcg HA) intramuscularly on Day 172
Placebo: Placebo is saline injection
Quadrivalent Recombinant Seasonal Influenza Vaccine: Quadrivalent Inactivated Influenza Vaccine (IIV4) for intramuscular injection is indicated for active immunization against influenza disease caused by influenza virus subtypes A and type B present in the vaccine.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Two Doses of Multimeric-001 (M-001) Followed by Influenza Vaccine
Baseline characteristics by cohort
| Measure |
M-001 + IIV4
n=61 Participants
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172
|
Placebo + IIV4
n=59 Participants
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
61 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
32.6 years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
33.5 years
STANDARD_DEVIATION 7.8 • n=7 Participants
|
33.0 years
STANDARD_DEVIATION 7.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
56 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
49 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
61 participants
n=5 Participants
|
59 participants
n=7 Participants
|
120 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 36Population: 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.
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.
Outcome measures
| Measure |
M-001 + IIV4
n=58 Participants
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
|
Placebo + IIV4
n=59 Participants
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172
|
|---|---|---|
|
Mean Percentage of Perforin+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin+ CD4+ at Day 1
|
1.180 percentage of cells
Interval 0.724 to 1.7
|
0.781 percentage of cells
Interval 0.464 to 1.14
|
|
Mean Percentage of Perforin+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin+ CD4+ Day 36
|
1.090 percentage of cells
Interval 0.649 to 1.61
|
0.779 percentage of cells
Interval 0.47 to 1.14
|
|
Mean Percentage of Perforin+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin+ CD8+ Day 1
|
16.1 percentage of cells
Interval 12.9 to 19.4
|
12.4 percentage of cells
Interval 10.4 to 14.5
|
|
Mean Percentage of Perforin+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin+ CD8+ Day 36
|
16.3 percentage of cells
Interval 13.1 to 19.7
|
13.8 percentage of cells
Interval 11.4 to 16.3
|
PRIMARY outcome
Timeframe: Day 1 through Day 36Population: 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.
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.
Outcome measures
| Measure |
M-001 + IIV4
n=58 Participants
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
|
Placebo + IIV4
n=59 Participants
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172
|
|---|---|---|
|
Mean Percentage of Cluster of Differentiation 107a Positive (CD107a+) CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
CD107a+ CD4+ at Day 1
|
0.255 percentage of cells
Interval 0.195 to 0.323
|
0.264 percentage of cells
Interval 0.198 to 0.342
|
|
Mean Percentage of Cluster of Differentiation 107a Positive (CD107a+) CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
CD107a+ CD4+ Day 36
|
0.242 percentage of cells
Interval 0.191 to 0.301
|
0.257 percentage of cells
Interval 0.205 to 0.317
|
|
Mean Percentage of Cluster of Differentiation 107a Positive (CD107a+) CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
CD107a+ CD8+ Day 1
|
0.348 percentage of cells
Interval 0.277 to 0.425
|
0.367 percentage of cells
Interval 0.277 to 0.479
|
|
Mean Percentage of Cluster of Differentiation 107a Positive (CD107a+) CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
CD107a+ CD8+ Day 36
|
0.352 percentage of cells
Interval 0.283 to 0.428
|
0.384 percentage of cells
Interval 0.305 to 0.473
|
PRIMARY outcome
Timeframe: Day 1 through Day 36Population: 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.
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.
Outcome measures
| Measure |
M-001 + IIV4
n=58 Participants
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
|
Placebo + IIV4
n=59 Participants
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172
|
|---|---|---|
|
Mean Percentage of Interleukin-2 Positive (IL-2+) CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
IL-2+ CD4+ at Day 1
|
0.0682 percentage of cells
Interval 0.0481 to 0.091
|
0.0634 percentage of cells
Interval 0.0503 to 0.0776
|
|
Mean Percentage of Interleukin-2 Positive (IL-2+) CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
IL-2+ CD4+ Day 36
|
0.0749 percentage of cells
Interval 0.0584 to 0.093
|
0.0692 percentage of cells
Interval 0.0537 to 0.0866
|
|
Mean Percentage of Interleukin-2 Positive (IL-2+) CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
IL-2+ CD8+ Day 1
|
0.1260 percentage of cells
Interval 0.0789 to 0.191
|
0.0939 percentage of cells
Interval 0.0716 to 0.118
|
|
Mean Percentage of Interleukin-2 Positive (IL-2+) CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
IL-2+ CD8+ Day 36
|
0.1010 percentage of cells
Interval 0.0763 to 0.13
|
0.1170 percentage of cells
Interval 0.0883 to 0.148
|
PRIMARY outcome
Timeframe: Day 1 through Day 36Population: 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.
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.
Outcome measures
| Measure |
M-001 + IIV4
n=58 Participants
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
|
Placebo + IIV4
n=59 Participants
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172
|
|---|---|---|
|
Mean Percentage of Tumor Necrosis Factor Positive (TNF+) CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
TNF+ CD4+ at Day 1
|
0.437 percentage of cells
Interval 0.321 to 0.567
|
0.530 percentage of cells
Interval 0.366 to 0.733
|
|
Mean Percentage of Tumor Necrosis Factor Positive (TNF+) CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
TNF+ CD4+ Day 36
|
0.450 percentage of cells
Interval 0.334 to 0.594
|
0.395 percentage of cells
Interval 0.296 to 0.509
|
|
Mean Percentage of Tumor Necrosis Factor Positive (TNF+) CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
TNF+ CD8+ Day 1
|
0.0750 percentage of cells
Interval 0.0492 to 0.109
|
0.0716 percentage of cells
Interval 0.0495 to 0.1
|
|
Mean Percentage of Tumor Necrosis Factor Positive (TNF+) CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
TNF+ CD8+ Day 36
|
0.0676 percentage of cells
Interval 0.0431 to 0.106
|
0.0596 percentage of cells
Interval 0.0437 to 0.0783
|
PRIMARY outcome
Timeframe: Day 1 through Day 36Population: 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.
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.
Outcome measures
| Measure |
M-001 + IIV4
n=58 Participants
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
|
Placebo + IIV4
n=59 Participants
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172
|
|---|---|---|
|
Mean Percentage of Interferon Gamma Positive (IFNg+) CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
INFg+ CD8+ Day 1
|
0.0558 percentage of cells
Interval 0.0345 to 0.0843
|
0.0400 percentage of cells
Interval 0.0289 to 0.0546
|
|
Mean Percentage of Interferon Gamma Positive (IFNg+) CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
INFg+ CD8+ Day 36
|
0.0529 percentage of cells
Interval 0.0377 to 0.0709
|
0.0476 percentage of cells
Interval 0.0341 to 0.0643
|
|
Mean Percentage of Interferon Gamma Positive (IFNg+) CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
INFg+ CD4+ at Day 1
|
0.0418 percentage of cells
Interval 0.0329 to 0.0532
|
0.0333 percentage of cells
Interval 0.0274 to 0.0406
|
|
Mean Percentage of Interferon Gamma Positive (IFNg+) CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
INFg+ CD4+ Day 36
|
0.0512 percentage of cells
Interval 0.0419 to 0.0621
|
0.0436 percentage of cells
Interval 0.0298 to 0.0654
|
PRIMARY outcome
Timeframe: Day 1 through Day 36Population: 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.
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.
Outcome measures
| Measure |
M-001 + IIV4
n=58 Participants
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
|
Placebo + IIV4
n=59 Participants
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172
|
|---|---|---|
|
Mean Percentage of Perforin+CD107a+IL-2+TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin+CD107a+IL-2+TNF+IFNg+ CD4+ at Day 1
|
0 percentage of cells
Not calculable, no cells positive for markers
|
0.000067 percentage of cells
Interval 0.0 to 0.000174
|
|
Mean Percentage of Perforin+CD107a+IL-2+TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin+CD107a+IL-2+TNF+IFNg+ CD4+ Day 36
|
0 percentage of cells
Not calculable, no cells positive for markers
|
0 percentage of cells
Not calculable, no cells positive for markers
|
|
Mean Percentage of Perforin+CD107a+IL-2+TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin+CD107a+IL-2+TNF+IFNg+ CD8+ Day 1
|
0 percentage of cells
Not calculable, no cells positive for markers
|
0 percentage of cells
Not calculable, no cells positive for markers
|
|
Mean Percentage of Perforin+CD107a+IL-2+TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin+CD107a+IL-2+TNF+IFNg+ CD8+ Day 36
|
0.0000698 percentage of cells
Interval 0.0 to 0.000209
|
0 percentage of cells
Not calculable, no cells positive for markers
|
PRIMARY outcome
Timeframe: Day 1 through Day 36Population: 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.
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.
Outcome measures
| Measure |
M-001 + IIV4
n=58 Participants
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
|
Placebo + IIV4
n=59 Participants
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172
|
|---|---|---|
|
Mean Percentage of Perforin+CD107a+IL-2+TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin+CD107a+IL-2+TNF+IFNg- CD4+ Day 1
|
0 percentage of cells
Not calculable, no cells positive for markers
|
0 percentage of cells
Not calculable, no cells positive for markers
|
|
Mean Percentage of Perforin+CD107a+IL-2+TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin+CD107a+IL-2+TNF+IFNg- CD4+ Day 36
|
0 percentage of cells
Not calculable, no cells positive for markers
|
0 percentage of cells
Not calculable, no cells positive for markers
|
|
Mean Percentage of Perforin+CD107a+IL-2+TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin+CD107a+IL-2+TNF+IFNg- CD8+ Day 1
|
0 percentage of cells
Not calculable, no cells positive for markers
|
0 percentage of cells
Not calculable, no cells positive for markers
|
|
Mean Percentage of Perforin+CD107a+IL-2+TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin+CD107a+IL-2+TNF+IFNg- CD8+ Day 36
|
0 percentage of cells
Not calculable, no cells positive for markers
|
0 percentage of cells
Not calculable, no cells positive for markers
|
PRIMARY outcome
Timeframe: Day 1 through Day 36Population: 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.
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.
Outcome measures
| Measure |
M-001 + IIV4
n=58 Participants
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
|
Placebo + IIV4
n=59 Participants
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172
|
|---|---|---|
|
Mean Percentage of Perforin+CD107a+IL-2+TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin+CD107a+IL-2+TNF- IFNg+ CD4+ Day 1
|
0 percentage of cells
Not calculable, no cells positive for markers
|
0 percentage of cells
Not calculable, no cells positive for markers
|
|
Mean Percentage of Perforin+CD107a+IL-2+TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin+CD107a+IL-2+TNF- IFNg+ CD4+ Day 36
|
0 percentage of cells
Not calculable, no cells positive for markers
|
0 percentage of cells
Not calculable, no cells positive for markers
|
|
Mean Percentage of Perforin+CD107a+IL-2+TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin+CD107a+IL-2+TNF- IFNg+ CD8+ Day 1
|
0 percentage of cells
Not calculable, no cells positive for markers
|
0 percentage of cells
Not calculable, no cells positive for markers
|
|
Mean Percentage of Perforin+CD107a+IL-2+TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin+CD107a+IL-2+TNF- IFNg+ CD8+ Day 36
|
0 percentage of cells
Not calculable, no cells positive for markers
|
0 percentage of cells
Not calculable, no cells positive for markers
|
PRIMARY outcome
Timeframe: Day 1 through Day 36Population: 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.
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.
Outcome measures
| Measure |
M-001 + IIV4
n=58 Participants
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
|
Placebo + IIV4
n=59 Participants
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172
|
|---|---|---|
|
Mean Percentage of Perforin+CD107a+IL-2+TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin+CD107a+IL-2+TNF- IFNg- CD4+ Day 1
|
0 percentage of cells
Not calculable, no cells positive for markers
|
0 percentage of cells
Not calculable, no cells positive for markers
|
|
Mean Percentage of Perforin+CD107a+IL-2+TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin+CD107a+IL-2+TNF- IFNg- CD4+ Day 36
|
0 percentage of cells
Not calculable, no cells positive for markers
|
0 percentage of cells
Not calculable, no cells positive for markers
|
|
Mean Percentage of Perforin+CD107a+IL-2+TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin+CD107a+IL-2+TNF- IFNg- CD8+ Day 1
|
0.00033 percentage of cells
Interval 0.0 to 0.00078
|
0.0000461 percentage of cells
Interval 0.0 to 0.000138
|
|
Mean Percentage of Perforin+CD107a+IL-2+TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin+CD107a+IL-2+TNF- IFNg- CD8+ Day 36
|
0 percentage of cells
Not calculable, no cells positive for markers
|
0.0001540 percentage of cells
Interval 0.0 to 0.000387
|
PRIMARY outcome
Timeframe: Day 1 through Day 36Population: 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.
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.
Outcome measures
| Measure |
M-001 + IIV4
n=58 Participants
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
|
Placebo + IIV4
n=59 Participants
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172
|
|---|---|---|
|
Mean Percentage of Perforin+CD107a+IL-2-TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin+CD107a+IL-2-TNF+IFNg+ CD4+ at Day 1
|
0.0000741 percentage of cells
Interval 0.0 to 0.000191
|
0.000107 percentage of cells
Interval 0.0 to 0.000245
|
|
Mean Percentage of Perforin+CD107a+IL-2-TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin+CD107a+IL-2-TNF+IFNg+ CD4+ Day 36
|
0.0001600 percentage of cells
Interval 0.0 to 0.00037
|
0.000344 percentage of cells
Interval 0.0 to 0.000907
|
|
Mean Percentage of Perforin+CD107a+IL-2-TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin+CD107a+IL-2-TNF+IFNg+ CD8+ Day 1
|
0.00271 percentage of cells
Interval 0.000636 to 0.00586
|
0.000269 percentage of cells
Interval 0.0 to 0.00062
|
|
Mean Percentage of Perforin+CD107a+IL-2-TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin+CD107a+IL-2-TNF+IFNg+ CD8+ Day 36
|
0.00187 percentage of cells
Interval 0.000358 to 0.00384
|
0.00122 percentage of cells
Interval 0.000475 to 0.00209
|
PRIMARY outcome
Timeframe: Day 1 through Day 36Population: 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.
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.
Outcome measures
| Measure |
M-001 + IIV4
n=58 Participants
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
|
Placebo + IIV4
n=59 Participants
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172
|
|---|---|---|
|
Mean Percentage of Perforin+CD107a+IL-2- TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin+CD107a+IL-2-TNF+IFNg- CD4+ at Day 1
|
0.000036 percentage of cells
Interval 0.0 to 0.000108
|
0 percentage of cells
Not calculable, no cells positive for markers
|
|
Mean Percentage of Perforin+CD107a+IL-2- TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin+CD107a+IL-2-TNF+IFNg- CD4+ Day 36
|
0 percentage of cells
Not calculable, no cells positive for markers
|
0.000161 percentage of cells
Interval 0.0 to 0.000445
|
|
Mean Percentage of Perforin+CD107a+IL-2- TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin+CD107a+IL-2-TNF+IFNg- CD8+ Day 1
|
0.00288 percentage of cells
Interval 0.000972 to 0.00536
|
0.00172 percentage of cells
Interval 0.000753 to 0.00294
|
|
Mean Percentage of Perforin+CD107a+IL-2- TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin+CD107a+IL-2-TNF+IFNg- CD8+ Day 36
|
0.00326 percentage of cells
Interval 0.00106 to 0.00606
|
0.00134 percentage of cells
Interval 0.000606 to 0.00223
|
PRIMARY outcome
Timeframe: Day 1 through Day 36Population: 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.
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.
Outcome measures
| Measure |
M-001 + IIV4
n=58 Participants
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
|
Placebo + IIV4
n=59 Participants
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172
|
|---|---|---|
|
Mean Percentage of Perforin+CD107a+IL-2-TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin+CD107a+IL-2-TNF- IFNg+ CD4+ at Day 1
|
0 percentage of cells
Not calculable, no cells positive for markers
|
0 percentage of cells
Not calculable, no cells positive for markers
|
|
Mean Percentage of Perforin+CD107a+IL-2-TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin+CD107a+IL-2-TNF- IFNg+ CD4+ Day 36
|
0.0000566 percentage of cells
Interval 0.0 to 0.00017
|
0.000118 percentage of cells
Interval 0.0 to 0.000318
|
|
Mean Percentage of Perforin+CD107a+IL-2-TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin+CD107a+IL-2-TNF- IFNg+ CD8+ Day 1
|
0.000444 percentage of cells
Interval 0.00008 to 0.000959
|
0.000409 percentage of cells
Interval 0.0 to 0.000963
|
|
Mean Percentage of Perforin+CD107a+IL-2-TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin+CD107a+IL-2-TNF- IFNg+ CD8+ Day 36
|
0.000323 percentage of cells
Interval 0.0000639 to 0.000672
|
0.000197 percentage of cells
Interval 0.0 to 0.000518
|
PRIMARY outcome
Timeframe: Day 1 through Day 36Population: 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.
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.
Outcome measures
| Measure |
M-001 + IIV4
n=58 Participants
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
|
Placebo + IIV4
n=59 Participants
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172
|
|---|---|---|
|
Mean Percentage of Perforin+CD107a+IL-2-TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin+CD107a+IL-2-TNF- IFNg- CD4+ at Day 1
|
0.00104 percentage of cells
Interval 0.000455 to 0.00175
|
0.000728 percentage of cells
Interval 0.00033 to 0.00122
|
|
Mean Percentage of Perforin+CD107a+IL-2-TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin+CD107a+IL-2-TNF- IFNg- CD4+ Day 36
|
0.00123 percentage of cells
Interval 0.000602 to 0.00199
|
0.000928 percentage of cells
Interval 0.000505 to 0.00141
|
|
Mean Percentage of Perforin+CD107a+IL-2-TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin+CD107a+IL-2-TNF- IFNg- CD8+ Day 1
|
0.0317 percentage of cells
Interval 0.0249 to 0.039
|
0.0237 percentage of cells
Interval 0.0148 to 0.0363
|
|
Mean Percentage of Perforin+CD107a+IL-2-TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin+CD107a+IL-2-TNF- IFNg- CD8+ Day 36
|
0.0368 percentage of cells
Interval 0.0273 to 0.0472
|
0.0263 percentage of cells
Interval 0.0171 to 0.0402
|
PRIMARY outcome
Timeframe: Day 1 through Day 36Population: 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.
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.
Outcome measures
| Measure |
M-001 + IIV4
n=58 Participants
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
|
Placebo + IIV4
n=59 Participants
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172
|
|---|---|---|
|
Mean Percentage of Perforin+CD107a- IL-2+TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin+CD107a- IL-2+TNF+IFNg+ CD4+ at Day 1
|
0.0000621 percentage of cells
Interval 0.0 to 0.000186
|
0.0000457 percentage of cells
Interval 0.0 to 0.000137
|
|
Mean Percentage of Perforin+CD107a- IL-2+TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin+CD107a- IL-2+TNF+IFNg+ CD4+ Day 36
|
0.0000888 percentage of cells
Interval 0.0 to 0.000229
|
0.0001010 percentage of cells
Interval 0.0 to 0.000276
|
|
Mean Percentage of Perforin+CD107a- IL-2+TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin+CD107a- IL-2+TNF+IFNg+ CD8+ Day 1
|
0.000123 percentage of cells
Interval 0.0 to 0.000369
|
0 percentage of cells
Not calculable, no cells positive for markers
|
|
Mean Percentage of Perforin+CD107a- IL-2+TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin+CD107a- IL-2+TNF+IFNg+ CD8+ Day 36
|
0.000184 percentage of cells
Interval 0.0 to 0.000482
|
0.000128 percentage of cells
Interval 0.0 to 0.000333
|
PRIMARY outcome
Timeframe: Day 1 through Day 36Population: 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.
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.
Outcome measures
| Measure |
M-001 + IIV4
n=58 Participants
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
|
Placebo + IIV4
n=59 Participants
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172
|
|---|---|---|
|
Mean Percentage of Perforin+CD107a- IL-2+TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin+CD107a- IL-2+TNF+IFNg- CD4+ at Day 1
|
0.0000375 percentage of cells
Interval 0.0 to 0.000113
|
0 percentage of cells
Not calculable, no cells positive for markers
|
|
Mean Percentage of Perforin+CD107a- IL-2+TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin+CD107a- IL-2+TNF+IFNg- CD4+ Day 36
|
0.0000327 percentage of cells
Interval 0.0 to 0.0000982
|
0 percentage of cells
Not calculable, no cells positive for markers
|
|
Mean Percentage of Perforin+CD107a- IL-2+TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin+CD107a- IL-2+TNF+IFNg- CD8+ Day 1
|
0.0005150 percentage of cells
Interval 0.0 to 0.00116
|
0.000322 percentage of cells
Interval 0.0 to 0.000966
|
|
Mean Percentage of Perforin+CD107a- IL-2+TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin+CD107a- IL-2+TNF+IFNg- CD8+ Day 36
|
0.0000524 percentage of cells
Interval 0.0 to 0.000157
|
0 percentage of cells
Not calculable, no cells positive for markers
|
PRIMARY outcome
Timeframe: Day 1 through Day 36Population: 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.
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.
Outcome measures
| Measure |
M-001 + IIV4
n=58 Participants
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
|
Placebo + IIV4
n=59 Participants
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172
|
|---|---|---|
|
Mean Percentage of Perforin+CD107a- IL-2+TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin+CD107a- IL-2+TNF- IFNg+ CD4+ at Day 1
|
0 percentage of cells
Not calculable, no cells positive for markers
|
0.000101 percentage of cells
Interval 0.0 to 0.000303
|
|
Mean Percentage of Perforin+CD107a- IL-2+TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin+CD107a- IL-2+TNF- IFNg+ CD4+ Day 36
|
0 percentage of cells
Not calculable, no cells positive for markers
|
0.000061 percentage of cells
Interval 0.0 to 0.000183
|
|
Mean Percentage of Perforin+CD107a- IL-2+TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin+CD107a- IL-2+TNF- IFNg+ CD8+ Day 1
|
0 percentage of cells
Not calculable, no cells positive for markers
|
0.0003780 percentage of cells
Interval 0.0 to 0.00113
|
|
Mean Percentage of Perforin+CD107a- IL-2+TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin+CD107a- IL-2+TNF- IFNg+ CD8+ Day 36
|
0 percentage of cells
Not calculable, no cells positive for markers
|
0.0000966 percentage of cells
Interval 0.0 to 0.00029
|
PRIMARY outcome
Timeframe: Day 1 through Day 36Population: 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.
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.
Outcome measures
| Measure |
M-001 + IIV4
n=58 Participants
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
|
Placebo + IIV4
n=59 Participants
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172
|
|---|---|---|
|
Mean Percentage of Perforin+CD107a- IL-2+TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin+CD107a- IL-2+TNF- IFNg- CD4+ at Day 1
|
0.00399 percentage of cells
Interval 0.00211 to 0.00635
|
0.00307 percentage of cells
Interval 0.00134 to 0.0055
|
|
Mean Percentage of Perforin+CD107a- IL-2+TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin+CD107a- IL-2+TNF- IFNg- CD4+ Day 36
|
0.00458 percentage of cells
Interval 0.00216 to 0.00748
|
0.00354 percentage of cells
Interval 0.00201 to 0.0053
|
|
Mean Percentage of Perforin+CD107a- IL-2+TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin+CD107a- IL-2+TNF- IFNg- CD8+ Day 1
|
0.0742 percentage of cells
Interval 0.0385 to 0.13
|
0.0434 percentage of cells
Interval 0.0315 to 0.0568
|
|
Mean Percentage of Perforin+CD107a- IL-2+TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin+CD107a- IL-2+TNF- IFNg- CD8+ Day 36
|
0.0546 percentage of cells
Interval 0.0398 to 0.0731
|
0.0612 percentage of cells
Interval 0.0417 to 0.0841
|
PRIMARY outcome
Timeframe: Day 1 through Day 36Population: 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.
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.
Outcome measures
| Measure |
M-001 + IIV4
n=58 Participants
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
|
Placebo + IIV4
n=59 Participants
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172
|
|---|---|---|
|
Mean Percentage of Perforin+CD107a- IL-2- TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin+CD107a- IL-2- TNF+IFNg+ CD4+ at Day 1
|
0.0000639 percentage of cells
Interval 0.0 to 0.000164
|
0.000372 percentage of cells
Interval 0.0000658 to 0.000818
|
|
Mean Percentage of Perforin+CD107a- IL-2- TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin+CD107a- IL-2- TNF+IFNg+ CD4+ Day 36
|
0 percentage of cells
Not calculable, no cells positive for markers
|
0.000485 percentage of cells
Interval 0.000152 to 0.000925
|
|
Mean Percentage of Perforin+CD107a- IL-2- TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin+CD107a- IL-2- TNF+IFNg+ CD8+ Day 1
|
0.00122 percentage of cells
Interval 0.000315 to 0.00239
|
0.00135 percentage of cells
Interval 0.000376 to 0.00276
|
|
Mean Percentage of Perforin+CD107a- IL-2- TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin+CD107a- IL-2- TNF+IFNg+ CD8+ Day 36
|
0.00305 percentage of cells
Interval 0.00115 to 0.00542
|
0.00168 percentage of cells
Interval 0.000426 to 0.0036
|
PRIMARY outcome
Timeframe: Day 1 through Day 36Population: 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.
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.
Outcome measures
| Measure |
M-001 + IIV4
n=58 Participants
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
|
Placebo + IIV4
n=59 Participants
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172
|
|---|---|---|
|
Mean Percentage of Perforin+CD107a- IL-2- TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin+CD107a- IL-2- TNF+IFNg- CD4+ at Day 1
|
0.001100 percentage of cells
Interval 0.000455 to 0.00203
|
0.000199 percentage of cells
Interval 0.0000519 to 0.000389
|
|
Mean Percentage of Perforin+CD107a- IL-2- TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin+CD107a- IL-2- TNF+IFNg- CD4+ Day 36
|
0.000564 percentage of cells
Interval 0.000287 to 0.000874
|
0.000454 percentage of cells
Interval 0.000149 to 0.000809
|
|
Mean Percentage of Perforin+CD107a- IL-2- TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin+CD107a- IL-2- TNF+IFNg- CD8+ Day 1
|
0.00880 percentage of cells
Interval 0.00375 to 0.0154
|
0.00426 percentage of cells
Interval 0.00244 to 0.00638
|
|
Mean Percentage of Perforin+CD107a- IL-2- TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin+CD107a- IL-2- TNF+IFNg- CD8+ Day 36
|
0.00947 percentage of cells
Interval 0.00564 to 0.0143
|
0.00595 percentage of cells
Interval 0.00357 to 0.00874
|
PRIMARY outcome
Timeframe: Day 1 through Day 36Population: 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.
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.
Outcome measures
| Measure |
M-001 + IIV4
n=58 Participants
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
|
Placebo + IIV4
n=59 Participants
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172
|
|---|---|---|
|
Mean Percentage of Perforin+CD107a- IL-2- TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin+CD107a- IL-2- TNF- IFNg+ CD4+ at Day 1
|
0.000421 percentage of cells
Interval 0.000135 to 0.000761
|
0.000436 percentage of cells
Interval 0.000198 to 0.0007
|
|
Mean Percentage of Perforin+CD107a- IL-2- TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin+CD107a- IL-2- TNF- IFNg+ CD4+ Day 36
|
0.00027 percentage of cells
Interval 0.0000719 to 0.000511
|
0.000438 percentage of cells
Interval 0.00018 to 0.000732
|
|
Mean Percentage of Perforin+CD107a- IL-2- TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin+CD107a- IL-2- TNF- IFNg+ CD8+ Day 1
|
0.00654 percentage of cells
Interval 0.00173 to 0.0152
|
0.00177 percentage of cells
Interval 0.000981 to 0.00267
|
|
Mean Percentage of Perforin+CD107a- IL-2- TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin+CD107a- IL-2- TNF- IFNg+ CD8+ Day 36
|
0.00376 percentage of cells
Interval 0.00151 to 0.00697
|
0.00370 percentage of cells
Interval 0.00223 to 0.00543
|
PRIMARY outcome
Timeframe: Day 1 through Day 36Population: 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.
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.
Outcome measures
| Measure |
M-001 + IIV4
n=58 Participants
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
|
Placebo + IIV4
n=59 Participants
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172
|
|---|---|---|
|
Mean Percentage of Perforin+CD107a- IL-2- TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin+CD107a- IL-2- TNF- IFNg- CD4+ at Day 1
|
1.180 percentage of cells
Interval 0.714 to 1.7
|
0.775 percentage of cells
Interval 0.458 to 1.14
|
|
Mean Percentage of Perforin+CD107a- IL-2- TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin+CD107a- IL-2- TNF- IFNg- CD4+ Day 36
|
1.080 percentage of cells
Interval 0.637 to 1.61
|
0.772 percentage of cells
Interval 0.475 to 1.13
|
|
Mean Percentage of Perforin+CD107a- IL-2- TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin+CD107a- IL-2- TNF- IFNg- CD8+ Day 1
|
16.0 percentage of cells
Interval 12.9 to 19.3
|
12.3 percentage of cells
Interval 10.3 to 14.4
|
|
Mean Percentage of Perforin+CD107a- IL-2- TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin+CD107a- IL-2- TNF- IFNg- CD8+ Day 36
|
16.2 percentage of cells
Interval 13.1 to 19.7
|
13.7 percentage of cells
Interval 11.3 to 16.1
|
PRIMARY outcome
Timeframe: Day 1 through Day 36Population: 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.
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.
Outcome measures
| Measure |
M-001 + IIV4
n=58 Participants
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
|
Placebo + IIV4
n=59 Participants
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172
|
|---|---|---|
|
Mean Percentage of Perforin- CD107a+IL-2+TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin- CD107a+IL-2+TNF+IFNg+ CD4+ at Day 1
|
0.00135 percentage of cells
Interval 0.000809 to 0.00194
|
0.00122 percentage of cells
Interval 0.000714 to 0.00182
|
|
Mean Percentage of Perforin- CD107a+IL-2+TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin- CD107a+IL-2+TNF+IFNg+ CD4+ Day 36
|
0.00156 percentage of cells
Interval 0.000895 to 0.00229
|
0.00138 percentage of cells
Interval 0.00075 to 0.00211
|
|
Mean Percentage of Perforin- CD107a+IL-2+TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin- CD107a+IL-2+TNF+IFNg+ CD8+ Day 1
|
0.001170 percentage of cells
Interval 0.000407 to 0.00208
|
0.001000 percentage of cells
Interval 0.000406 to 0.00171
|
|
Mean Percentage of Perforin- CD107a+IL-2+TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin- CD107a+IL-2+TNF+IFNg+ CD8+ Day 36
|
0.000742 percentage of cells
Interval 0.000173 to 0.0015
|
0.000465 percentage of cells
Interval 0.000107 to 0.000935
|
PRIMARY outcome
Timeframe: Day 1 through Day 36Population: 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.
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.
Outcome measures
| Measure |
M-001 + IIV4
n=58 Participants
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
|
Placebo + IIV4
n=59 Participants
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172
|
|---|---|---|
|
Mean Percentage of Perforin- CD107a+IL-2+TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin- CD107a+IL-2+TNF+IFNg- CD4+ at Day 1
|
0.00230 percentage of cells
Interval 0.000984 to 0.00403
|
0.00200 percentage of cells
Interval 0.00111 to 0.00317
|
|
Mean Percentage of Perforin- CD107a+IL-2+TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin- CD107a+IL-2+TNF+IFNg- CD4+ Day 36
|
0.00212 percentage of cells
Interval 0.00134 to 0.00302
|
0.00144 percentage of cells
Interval 0.000759 to 0.00228
|
|
Mean Percentage of Perforin- CD107a+IL-2+TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin- CD107a+IL-2+TNF+IFNg- CD8+ Day 1
|
0.000197 percentage of cells
Interval 0.0 to 0.000451
|
0.0005900 percentage of cells
Interval 0.000134 to 0.0012
|
|
Mean Percentage of Perforin- CD107a+IL-2+TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin- CD107a+IL-2+TNF+IFNg- CD8+ Day 36
|
0.000346 percentage of cells
Interval 0.0 to 0.000801
|
0.0000719 percentage of cells
Interval 0.0 to 0.000216
|
PRIMARY outcome
Timeframe: Day 1 through Day 36Population: 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.
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.
Outcome measures
| Measure |
M-001 + IIV4
n=58 Participants
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
|
Placebo + IIV4
n=59 Participants
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172
|
|---|---|---|
|
Mean Percentage of Perforin- CD107a+IL-2+TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin- CD107a+IL-2+TNF- IFNg+ CD4+ at Day 1
|
0 percentage of cells
Not calculable, no cells positive for markers
|
0.000156 percentage of cells
Interval 0.0 to 0.000365
|
|
Mean Percentage of Perforin- CD107a+IL-2+TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin- CD107a+IL-2+TNF- IFNg+ CD4+ Day 36
|
0.0000725 percentage of cells
Interval 0.0 to 0.000187
|
0.000078 percentage of cells
Interval 0.0 to 0.000196
|
|
Mean Percentage of Perforin- CD107a+IL-2+TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin- CD107a+IL-2+TNF- IFNg+ CD8+ Day 1
|
0 percentage of cells
Not calculable, no cells positive for markers
|
0 percentage of cells
Not calculable, no cells positive for markers
|
|
Mean Percentage of Perforin- CD107a+IL-2+TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin- CD107a+IL-2+TNF- IFNg+ CD8+ Day 36
|
0 percentage of cells
Not calculable, no cells positive for markers
|
0 percentage of cells
Not calculable, no cells positive for markers
|
PRIMARY outcome
Timeframe: Day 1 through Day 36Population: 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.
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.
Outcome measures
| Measure |
M-001 + IIV4
n=58 Participants
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
|
Placebo + IIV4
n=59 Participants
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172
|
|---|---|---|
|
Mean Percentage of Perforin- CD107a+IL-2+TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin- CD107a+IL-2+TNF- IFNg- CD4+ at Day 1
|
0.000809 percentage of cells
Interval 0.000198 to 0.00185
|
0.000263 percentage of cells
Interval 0.0000905 to 0.000468
|
|
Mean Percentage of Perforin- CD107a+IL-2+TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin- CD107a+IL-2+TNF- IFNg- CD4+ Day 36
|
0.000653 percentage of cells
Interval 0.000257 to 0.00114
|
0.000223 percentage of cells
Interval 0.0000554 to 0.000436
|
|
Mean Percentage of Perforin- CD107a+IL-2+TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin- CD107a+IL-2+TNF- IFNg- CD8+ Day 1
|
0.000377 percentage of cells
Interval 0.0000526 to 0.000828
|
0.000840 percentage of cells
Interval 0.000306 to 0.00148
|
|
Mean Percentage of Perforin- CD107a+IL-2+TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin- CD107a+IL-2+TNF- IFNg- CD8+ Day 36
|
0.000912 percentage of cells
Interval 0.000254 to 0.00177
|
0.000369 percentage of cells
Interval 0.0000585 to 0.000796
|
PRIMARY outcome
Timeframe: Day 1 through Day 36Population: 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.
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.
Outcome measures
| Measure |
M-001 + IIV4
n=58 Participants
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
|
Placebo + IIV4
n=59 Participants
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172
|
|---|---|---|
|
Mean Percentage of Perforin- CD107a+IL-2- TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin- CD107a+IL-2- TNF+IFNg+ CD4+ at Day 1
|
0.00269 percentage of cells
Interval 0.00166 to 0.0039
|
0.00248 percentage of cells
Interval 0.00183 to 0.00319
|
|
Mean Percentage of Perforin- CD107a+IL-2- TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin- CD107a+IL-2- TNF+IFNg+ CD4+ Day 36
|
0.00309 percentage of cells
Interval 0.00206 to 0.00426
|
0.00262 percentage of cells
Interval 0.00171 to 0.00366
|
|
Mean Percentage of Perforin- CD107a+IL-2- TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin- CD107a+IL-2- TNF+IFNg+ CD8+ Day 1
|
0.00513 percentage of cells
Interval 0.00259 to 0.00834
|
0.00617 percentage of cells
Interval 0.00352 to 0.00921
|
|
Mean Percentage of Perforin- CD107a+IL-2- TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin- CD107a+IL-2- TNF+IFNg+ CD8+ Day 36
|
0.00604 percentage of cells
Interval 0.00334 to 0.00963
|
0.00374 percentage of cells
Interval 0.00228 to 0.00539
|
PRIMARY outcome
Timeframe: Day 1 through Day 36Population: 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.
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.
Outcome measures
| Measure |
M-001 + IIV4
n=58 Participants
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
|
Placebo + IIV4
n=59 Participants
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172
|
|---|---|---|
|
Mean Percentage of Perforin- CD107a+IL-2- TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin- CD107a+IL-2- TNF+IFNg- CD8+ Day 1
|
0.00678 percentage of cells
Interval 0.00414 to 0.00986
|
0.00725 percentage of cells
Interval 0.00455 to 0.0104
|
|
Mean Percentage of Perforin- CD107a+IL-2- TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin- CD107a+IL-2- TNF+IFNg- CD4+ at Day 1
|
0.0147 percentage of cells
Interval 0.00813 to 0.0239
|
0.0160 percentage of cells
Interval 0.0106 to 0.023
|
|
Mean Percentage of Perforin- CD107a+IL-2- TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin- CD107a+IL-2- TNF+IFNg- CD4+ Day 36
|
0.0123 percentage of cells
Interval 0.00948 to 0.0153
|
0.0127 percentage of cells
Interval 0.00868 to 0.0177
|
|
Mean Percentage of Perforin- CD107a+IL-2- TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin- CD107a+IL-2- TNF+IFNg- CD8+ Day 36
|
0.00427 percentage of cells
Interval 0.00197 to 0.00726
|
0.00630 percentage of cells
Interval 0.00317 to 0.0107
|
PRIMARY outcome
Timeframe: Day 1 through Day 36Population: 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.
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.
Outcome measures
| Measure |
M-001 + IIV4
n=58 Participants
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
|
Placebo + IIV4
n=59 Participants
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172
|
|---|---|---|
|
Mean Percentage of Perforin- CD107a+IL-2- TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin- CD107a+IL-2- TNF- IFNg+ CD8+ Day 36
|
0.001780 percentage of cells
Interval 0.000916 to 0.00279
|
0.002240 percentage of cells
Interval 0.00129 to 0.00331
|
|
Mean Percentage of Perforin- CD107a+IL-2- TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin- CD107a+IL-2- TNF- IFNg+ CD8+ Day 1
|
0.001580 percentage of cells
Interval 0.000815 to 0.00253
|
0.002160 percentage of cells
Interval 0.0011 to 0.00338
|
|
Mean Percentage of Perforin- CD107a+IL-2- TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin- CD107a+IL-2- TNF- IFNg+ CD4+ at Day 1
|
0.000511 percentage of cells
Interval 0.000253 to 0.000815
|
0.000694 percentage of cells
Interval 0.000345 to 0.00109
|
|
Mean Percentage of Perforin- CD107a+IL-2- TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin- CD107a+IL-2- TNF- IFNg+ CD4+ Day 36
|
0.000731 percentage of cells
Interval 0.000391 to 0.00111
|
0.001910 percentage of cells
Interval 0.000921 to 0.00316
|
PRIMARY outcome
Timeframe: Day 1 through Day 36Population: 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.
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.
Outcome measures
| Measure |
M-001 + IIV4
n=58 Participants
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
|
Placebo + IIV4
n=59 Participants
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172
|
|---|---|---|
|
Mean Percentage of Perforin- CD107a+IL-2- TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin- CD107a+IL-2- TNF- IFNg- CD4+ at Day 1
|
0.231 percentage of cells
Interval 0.178 to 0.292
|
0.240 percentage of cells
Interval 0.179 to 0.314
|
|
Mean Percentage of Perforin- CD107a+IL-2- TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin- CD107a+IL-2- TNF- IFNg- CD4+ Day 36
|
0.220 percentage of cells
Interval 0.172 to 0.277
|
0.236 percentage of cells
Interval 0.184 to 0.293
|
|
Mean Percentage of Perforin- CD107a+IL-2- TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin- CD107a+IL-2- TNF- IFNg- CD8+ Day 1
|
0.294 percentage of cells
Interval 0.226 to 0.374
|
0.323 percentage of cells
Interval 0.237 to 0.434
|
|
Mean Percentage of Perforin- CD107a+IL-2- TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin- CD107a+IL-2- TNF- IFNg- CD8+ Day 36
|
0.295 percentage of cells
Interval 0.232 to 0.366
|
0.341 percentage of cells
Interval 0.267 to 0.424
|
PRIMARY outcome
Timeframe: Day 1 through Day 36Population: 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.
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.
Outcome measures
| Measure |
M-001 + IIV4
n=58 Participants
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
|
Placebo + IIV4
n=59 Participants
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172
|
|---|---|---|
|
Mean Percentage of Perforin- CD107a- IL-2+TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin- CD107a- IL-2+TNF+IFNg+ CD4+ at Day 1
|
0.00328 percentage of cells
Interval 0.00238 to 0.0043
|
0.00365 percentage of cells
Interval 0.0023 to 0.00548
|
|
Mean Percentage of Perforin- CD107a- IL-2+TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin- CD107a- IL-2+TNF+IFNg+ CD4+ Day 36
|
0.00955 percentage of cells
Interval 0.00604 to 0.0147
|
0.00289 percentage of cells
Interval 0.00201 to 0.0039
|
|
Mean Percentage of Perforin- CD107a- IL-2+TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin- CD107a- IL-2+TNF+IFNg+ CD8+ Day 1
|
0.000238 percentage of cells
Interval 0.0 to 0.000657
|
0.000693 percentage of cells
Interval 0.0000839 to 0.00162
|
|
Mean Percentage of Perforin- CD107a- IL-2+TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin- CD107a- IL-2+TNF+IFNg+ IFNg- CD8+ Day 36
|
0.000288 percentage of cells
Interval 0.0000404 to 0.000626
|
0.000486 percentage of cells
Interval 0.0 to 0.0013
|
PRIMARY outcome
Timeframe: Day 1 through Day 36Population: 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.
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.
Outcome measures
| Measure |
M-001 + IIV4
n=58 Participants
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
|
Placebo + IIV4
n=59 Participants
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172
|
|---|---|---|
|
Mean Percentage of Perforin- CD107a- IL-2+TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin- CD107a- IL-2+TNF+IFNg- CD4+ at Day 1
|
0.01170 percentage of cells
Interval 0.00784 to 0.016
|
0.01240 percentage of cells
Interval 0.00958 to 0.0154
|
|
Mean Percentage of Perforin- CD107a- IL-2+TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin- CD107a- IL-2+TNF+IFNg- CD4+ Day 36
|
0.01640 percentage of cells
Interval 0.0123 to 0.0213
|
0.01130 percentage of cells
Interval 0.00789 to 0.0154
|
|
Mean Percentage of Perforin- CD107a- IL-2+TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin- CD107a- IL-2+TNF+IFNg- CD8+ Day 1
|
0.00161 percentage of cells
Interval 0.000488 to 0.00318
|
0.00184 percentage of cells
Interval 0.000851 to 0.00301
|
|
Mean Percentage of Perforin- CD107a- IL-2+TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin- CD107a- IL-2+TNF+IFNg- IFNg- CD8+ Day 36
|
0.00129 percentage of cells
Interval 0.000535 to 0.00224
|
0.00102 percentage of cells
Interval 0.000354 to 0.00186
|
PRIMARY outcome
Timeframe: Day 1 through Day 36Population: 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.
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.
Outcome measures
| Measure |
M-001 + IIV4
n=58 Participants
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
|
Placebo + IIV4
n=59 Participants
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172
|
|---|---|---|
|
Mean Percentage of Perforin- CD107a- IL-2+TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin- CD107a- IL-2+TNF- IFNg+ CD4+ at Day 1
|
0.000169 percentage of cells
Interval 0.0000294 to 0.000355
|
0.000438 percentage of cells
Interval 0.000195 to 0.000714
|
|
Mean Percentage of Perforin- CD107a- IL-2+TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin- CD107a- IL-2+TNF- IFNg+ CD4+ Day 36
|
0.000434 percentage of cells
Interval 0.000196 to 0.000702
|
0.000372 percentage of cells
Interval 0.000131 to 0.00068
|
|
Mean Percentage of Perforin- CD107a- IL-2+TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin- CD107a- IL-2+TNF- IFNg+ CD8+ Day 1
|
0.000397 percentage of cells
Interval 0.0 to 0.000977
|
0.000339 percentage of cells
Interval 0.0000652 to 0.000709
|
|
Mean Percentage of Perforin- CD107a- IL-2+TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin- CD107a- IL-2+TNF- IFNg+ CD8+ Day 36
|
0.000487 percentage of cells
Interval 0.0 to 0.00136
|
0.000378 percentage of cells
Interval 0.0000775 to 0.000736
|
PRIMARY outcome
Timeframe: Day 1 through Day 36Population: 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.
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.
Outcome measures
| Measure |
M-001 + IIV4
n=58 Participants
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
|
Placebo + IIV4
n=59 Participants
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172
|
|---|---|---|
|
Mean Percentage of Perforin- CD107a- IL-2+TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin- CD107a- IL-2+TNF- IFNg- CD4+ at Day 1
|
0.0445 percentage of cells
Interval 0.0285 to 0.0625
|
0.0400 percentage of cells
Interval 0.0283 to 0.053
|
|
Mean Percentage of Perforin- CD107a- IL-2+TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin- CD107a- IL-2+TNF- IFNg- CD4+ Day 36
|
0.0395 percentage of cells
Interval 0.0274 to 0.0524
|
0.0478 percentage of cells
Interval 0.0343 to 0.0627
|
|
Mean Percentage of Perforin- CD107a- IL-2+TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin- CD107a- IL-2+TNF- IFNg- CD8+ Day 1
|
0.0468 percentage of cells
Interval 0.0311 to 0.0645
|
0.0444 percentage of cells
Interval 0.031 to 0.0605
|
|
Mean Percentage of Perforin- CD107a- IL-2+TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin- CD107a- IL-2+TNF- IFNg- CD8+ Day 36
|
0.0417 percentage of cells
Interval 0.0272 to 0.0588
|
0.0522 percentage of cells
Interval 0.0402 to 0.0653
|
PRIMARY outcome
Timeframe: Day 1 through Day 36Population: 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.
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.
Outcome measures
| Measure |
M-001 + IIV4
n=58 Participants
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
|
Placebo + IIV4
n=59 Participants
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172
|
|---|---|---|
|
Mean Percentage of Perforin- CD107a- IL-2- TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin- CD107a- IL-2- TNF+IFNg+ CD4+ at Day 1
|
0.00935 percentage of cells
Interval 0.00716 to 0.0118
|
0.00881 percentage of cells
Interval 0.00622 to 0.0119
|
|
Mean Percentage of Perforin- CD107a- IL-2- TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin- CD107a- IL-2- TNF+IFNg+ CD4+ Day 36
|
0.01520 percentage of cells
Interval 0.0116 to 0.0195
|
0.00731 percentage of cells
Interval 0.00556 to 0.00926
|
|
Mean Percentage of Perforin- CD107a- IL-2- TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin- CD107a- IL-2- TNF+IFNg+ CD8+ Day 1
|
0.00488 percentage of cells
Interval 0.00305 to 0.00702
|
0.00460 percentage of cells
Interval 0.00242 to 0.00751
|
|
Mean Percentage of Perforin- CD107a- IL-2- TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin- CD107a- IL-2- TNF+IFNg+CD8+ Day 36
|
0.00257 percentage of cells
Interval 0.00141 to 0.00398
|
0.00242 percentage of cells
Interval 0.00139 to 0.00357
|
PRIMARY outcome
Timeframe: Day 1 through Day 36Population: 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.
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.
Outcome measures
| Measure |
M-001 + IIV4
n=58 Participants
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
|
Placebo + IIV4
n=59 Participants
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172
|
|---|---|---|
|
Mean Percentage of Perforin- CD107a- IL-2- TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin- CD107a- IL-2- TNF+IFNg- CD8+ Day 36
|
0.0341 percentage of cells
Interval 0.0175 to 0.0613
|
0.0348 percentage of cells
Interval 0.0227 to 0.0503
|
|
Mean Percentage of Perforin- CD107a- IL-2- TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin- CD107a- IL-2- TNF+IFNg- CD4+ at Day 1
|
0.390 percentage of cells
Interval 0.288 to 0.508
|
0.483 percentage of cells
Interval 0.331 to 0.669
|
|
Mean Percentage of Perforin- CD107a- IL-2- TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin- CD107a- IL-2- TNF+IFNg- CD4+ Day 36
|
0.389 percentage of cells
Interval 0.28 to 0.524
|
0.354 percentage of cells
Interval 0.263 to 0.459
|
|
Mean Percentage of Perforin- CD107a- IL-2- TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin- CD107a- IL-2- TNF+IFNg- CD8+ Day 1
|
0.0388 percentage of cells
Interval 0.0201 to 0.0676
|
0.0415 percentage of cells
Interval 0.0254 to 0.0618
|
PRIMARY outcome
Timeframe: Day 1 through Day 36Population: 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.
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.
Outcome measures
| Measure |
M-001 + IIV4
n=58 Participants
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
|
Placebo + IIV4
n=59 Participants
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172
|
|---|---|---|
|
Mean Percentage of Perforin- CD107a- IL-2- TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin- CD107a- IL-2- TNF- IFNg+ CD4+ at Day 1
|
0.0238 percentage of cells
Interval 0.0164 to 0.0354
|
0.0147 percentage of cells
Interval 0.0119 to 0.0178
|
|
Mean Percentage of Perforin- CD107a- IL-2- TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin- CD107a- IL-2- TNF- IFNg+ CD4+ Day 36
|
0.0199 percentage of cells
Interval 0.0155 to 0.0252
|
0.0255 percentage of cells
Interval 0.0133 to 0.0466
|
|
Mean Percentage of Perforin- CD107a- IL-2- TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin- CD107a- IL-2- TNF- IFNg+ CD8+ Day 1
|
0.0314 percentage of cells
Interval 0.0165 to 0.0505
|
0.0209 percentage of cells
Interval 0.0131 to 0.0307
|
|
Mean Percentage of Perforin- CD107a- IL-2- TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin- CD107a- IL-2- TNF- IFNg+ CD8+ Day 36
|
0.0318 percentage of cells
Interval 0.02 to 0.0467
|
0.0308 percentage of cells
Interval 0.018 to 0.0473
|
PRIMARY outcome
Timeframe: Day 1 through Day 36Population: 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.
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.
Outcome measures
| Measure |
M-001 + IIV4
n=58 Participants
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
|
Placebo + IIV4
n=59 Participants
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172
|
|---|---|---|
|
Mean Percentage of Perforin- CD107a- IL-2- TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin- CD107a- IL-2- TNF- IFNg- CD8+ Day 1
|
83.5 percentage of cells
Interval 80.2 to 86.6
|
87.2 percentage of cells
Interval 85.1 to 89.1
|
|
Mean Percentage of Perforin- CD107a- IL-2- TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin- CD107a- IL-2- TNF- IFNg- CD8+ Day 36
|
83.2 percentage of cells
Interval 79.8 to 86.5
|
85.8 percentage of cells
Interval 83.3 to 88.2
|
|
Mean Percentage of Perforin- CD107a- IL-2- TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin- CD107a- IL-2- TNF- IFNg- CD4+ at Day 1
|
98.1 percentage of cells
Interval 97.5 to 98.6
|
98.4 percentage of cells
Interval 98.0 to 98.8
|
|
Mean Percentage of Perforin- CD107a- IL-2- TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides
Perforin- CD107a- IL-2- TNF- IFNg- CD4+ Day 36
|
98.2 percentage of cells
Interval 97.6 to 98.7
|
98.5 percentage of cells
Interval 98.2 to 98.8
|
PRIMARY outcome
Timeframe: Day 9Population: The Safety Analysis population includes all participants who received the first dose of study product and have a result reported for the parameter.
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.
Outcome measures
| Measure |
M-001 + IIV4
n=61 Participants
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
|
Placebo + IIV4
n=59 Participants
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172
|
|---|---|---|
|
Number of Participants With Clinical Safety Laboratory Adverse Events After the First M-001 Vaccination
WBC
|
5 Participants
|
7 Participants
|
|
Number of Participants With Clinical Safety Laboratory Adverse Events After the First M-001 Vaccination
platelets
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinical Safety Laboratory Adverse Events After the First M-001 Vaccination
hemoglobin
|
3 Participants
|
1 Participants
|
|
Number of Participants With Clinical Safety Laboratory Adverse Events After the First M-001 Vaccination
ALT
|
2 Participants
|
0 Participants
|
|
Number of Participants With Clinical Safety Laboratory Adverse Events After the First M-001 Vaccination
creatinine
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Safety Laboratory Adverse Events After the First M-001 Vaccination
total bilirubin
|
2 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Day 22 through Day 29Population: The Safety Analysis population includes all participants who received the second dose of study product and have a result reported for the parameter.
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.
Outcome measures
| Measure |
M-001 + IIV4
n=54 Participants
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
|
Placebo + IIV4
n=55 Participants
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172
|
|---|---|---|
|
Number of Participants With Clinical Safety Laboratory Adverse Events After Second M-001 Vaccination
platelets
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Safety Laboratory Adverse Events After Second M-001 Vaccination
creatinine
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Safety Laboratory Adverse Events After Second M-001 Vaccination
total bilirubin
|
2 Participants
|
2 Participants
|
|
Number of Participants With Clinical Safety Laboratory Adverse Events After Second M-001 Vaccination
WBC
|
2 Participants
|
3 Participants
|
|
Number of Participants With Clinical Safety Laboratory Adverse Events After Second M-001 Vaccination
hemoglobin
|
2 Participants
|
0 Participants
|
|
Number of Participants With Clinical Safety Laboratory Adverse Events After Second M-001 Vaccination
ALT
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 8Population: The Safety Analysis population includes all participants who received the first study product.
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.
Outcome measures
| Measure |
M-001 + IIV4
n=61 Participants
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
|
Placebo + IIV4
n=59 Participants
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172
|
|---|---|---|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the First M-001 Vaccination
Fever
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the First M-001 Vaccination
Feverishness
|
1 Participants
|
3 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the First M-001 Vaccination
Fatigue
|
14 Participants
|
14 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the First M-001 Vaccination
Malaise
|
5 Participants
|
5 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the First M-001 Vaccination
Myalgia
|
6 Participants
|
6 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the First M-001 Vaccination
Arthralgia
|
1 Participants
|
1 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the First M-001 Vaccination
Headache
|
13 Participants
|
15 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the First M-001 Vaccination
Nausea
|
7 Participants
|
1 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the First M-001 Vaccination
Injection site pain
|
12 Participants
|
2 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the First M-001 Vaccination
Injection site tenderness
|
24 Participants
|
9 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the First M-001 Vaccination
Injection site itchiness/pruritus
|
2 Participants
|
1 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the First M-001 Vaccination
Injection site ecchymosis
|
2 Participants
|
3 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the First M-001 Vaccination
Injection site erythema
|
14 Participants
|
11 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the First M-001 Vaccination
Injection site induration/swelling
|
3 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Day 22 through Day 29Population: The Safety Analysis population includes all participants who received the second study product.
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.
Outcome measures
| Measure |
M-001 + IIV4
n=55 Participants
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
|
Placebo + IIV4
n=55 Participants
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172
|
|---|---|---|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the Second M-001 Vaccination
Fever
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the Second M-001 Vaccination
Fatigue
|
8 Participants
|
7 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the Second M-001 Vaccination
Malaise
|
6 Participants
|
4 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the Second M-001 Vaccination
Myalgia
|
4 Participants
|
2 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the Second M-001 Vaccination
Arthralgia
|
0 Participants
|
2 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the Second M-001 Vaccination
Headache
|
8 Participants
|
8 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the Second M-001 Vaccination
Nausea
|
2 Participants
|
1 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the Second M-001 Vaccination
Injection site pain
|
13 Participants
|
2 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the Second M-001 Vaccination
Injection site tenderness
|
16 Participants
|
11 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the Second M-001 Vaccination
Injection site itchiness/pruritus
|
2 Participants
|
1 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the Second M-001 Vaccination
Injection site ecchymosis
|
0 Participants
|
3 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the Second M-001 Vaccination
Injection site erythema
|
15 Participants
|
7 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the Second M-001 Vaccination
Injection site induration/swelling
|
2 Participants
|
2 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the Second M-001 Vaccination
Feverishness
|
1 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 200Population: The Safety Analysis population includes all participants who received at least one dose of study product.
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.
Outcome measures
| Measure |
M-001 + IIV4
n=61 Participants
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
|
Placebo + IIV4
n=59 Participants
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172
|
|---|---|---|
|
Number of Participants Reporting Vaccine-related Serious Adverse Events (SAEs) After M-001 Vaccination
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 200Population: The Safety Analysis population includes all participants who received at least one dose of study product.
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.
Outcome measures
| Measure |
M-001 + IIV4
n=61 Participants
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
|
Placebo + IIV4
n=59 Participants
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172
|
|---|---|---|
|
Number of Participants Reporting Serious Adverse Events (SAEs) After M-001 Vaccination
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 43Population: The Safety Analysis population includes all participants who received at least one dose of study product.
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.
Outcome measures
| Measure |
M-001 + IIV4
n=61 Participants
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
|
Placebo + IIV4
n=59 Participants
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172
|
|---|---|---|
|
Incidence of Unsolicited Non-serious Adverse Events (AEs) After M-001 Vaccination
Blood and lymphatic system disorders
|
0 participants
|
2 participants
|
|
Incidence of Unsolicited Non-serious Adverse Events (AEs) After M-001 Vaccination
Gastrointestinal disorders
|
2 participants
|
1 participants
|
|
Incidence of Unsolicited Non-serious Adverse Events (AEs) After M-001 Vaccination
Immune system disorders
|
0 participants
|
1 participants
|
|
Incidence of Unsolicited Non-serious Adverse Events (AEs) After M-001 Vaccination
Infections and Infestations
|
11 participants
|
12 participants
|
|
Incidence of Unsolicited Non-serious Adverse Events (AEs) After M-001 Vaccination
Injury, poisoning and procedural complications
|
2 participants
|
2 participants
|
|
Incidence of Unsolicited Non-serious Adverse Events (AEs) After M-001 Vaccination
Musculoskeletal and connective tissue disorders
|
4 participants
|
1 participants
|
|
Incidence of Unsolicited Non-serious Adverse Events (AEs) After M-001 Vaccination
Respiratory, thoracic and mediastinal disorders
|
3 participants
|
2 participants
|
|
Incidence of Unsolicited Non-serious Adverse Events (AEs) After M-001 Vaccination
Eye Disorders
|
1 participants
|
1 participants
|
|
Incidence of Unsolicited Non-serious Adverse Events (AEs) After M-001 Vaccination
Nervous system disorders
|
3 participants
|
2 participants
|
|
Incidence of Unsolicited Non-serious Adverse Events (AEs) After M-001 Vaccination
Reproductive system and breast disorders
|
1 participants
|
0 participants
|
|
Incidence of Unsolicited Non-serious Adverse Events (AEs) After M-001 Vaccination
Skin and subcutaneous tissue disorders
|
3 participants
|
3 participants
|
|
Incidence of Unsolicited Non-serious Adverse Events (AEs) After M-001 Vaccination
Vascular disorders
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Day 172 to Day 200Population: 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
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.
Outcome measures
| Measure |
M-001 + IIV4
n=52 Participants
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
|
Placebo + IIV4
n=50 Participants
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172
|
|---|---|---|
|
The Percentage of Subjects Achieving HAI Seroconversion to IIV4 Vaccine Virus From Day 172 to Day 200
B/Colorado/6/2017
|
13.5 percentage of participants
Interval 5.6 to 25.8
|
6.0 percentage of participants
Interval 1.3 to 16.5
|
|
The Percentage of Subjects Achieving HAI Seroconversion to IIV4 Vaccine Virus From Day 172 to Day 200
B/Phuket/3073/2013
|
11.5 percentage of participants
Interval 4.4 to 23.4
|
8.0 percentage of participants
Interval 2.2 to 19.2
|
|
The Percentage of Subjects Achieving HAI Seroconversion to IIV4 Vaccine Virus From Day 172 to Day 200
A/Michigan/45/2015 X-275
|
15.4 percentage of participants
Interval 6.9 to 28.1
|
16.0 percentage of participants
Interval 7.2 to 29.1
|
|
The Percentage of Subjects Achieving HAI Seroconversion to IIV4 Vaccine Virus From Day 172 to Day 200
A/Singapore/INFIMH-16-0019/2016 NIB-104
|
25.0 percentage of participants
Interval 14.0 to 38.9
|
20.0 percentage of participants
Interval 10.0 to 33.7
|
SECONDARY outcome
Timeframe: Day 172 to Day 200Population: 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
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.
Outcome measures
| Measure |
M-001 + IIV4
n=52 Participants
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
|
Placebo + IIV4
n=50 Participants
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172
|
|---|---|---|
|
The Percentage of Subjects Achieving Neutralizing Antibody Seroconversion to IIV4 Vaccine Virus From Day 172 to Day 200
B/Colorado/6/2017
|
17.3 percentage of participants
Interval 8.2 to 30.3
|
6.0 percentage of participants
Interval 1.3 to 16.5
|
|
The Percentage of Subjects Achieving Neutralizing Antibody Seroconversion to IIV4 Vaccine Virus From Day 172 to Day 200
B/Phuket/3073/2013
|
13.5 percentage of participants
Interval 5.6 to 25.8
|
8.0 percentage of participants
Interval 2.2 to 19.2
|
|
The Percentage of Subjects Achieving Neutralizing Antibody Seroconversion to IIV4 Vaccine Virus From Day 172 to Day 200
A/Michigan/45/2015 X-275
|
19.2 percentage of participants
Interval 9.6 to 32.5
|
16.0 percentage of participants
Interval 7.2 to 29.1
|
|
The Percentage of Subjects Achieving Neutralizing Antibody Seroconversion to IIV4 Vaccine Virus From Day 172 to Day 200
A/Singapore/INFIMH-16-0019/2016 NIB-104
|
46.2 percentage of participants
Interval 32.2 to 60.5
|
26.0 percentage of participants
Interval 14.6 to 40.3
|
SECONDARY outcome
Timeframe: Day 1Population: 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.
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.
Outcome measures
| Measure |
M-001 + IIV4
n=55 Participants
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
|
Placebo + IIV4
n=55 Participants
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172
|
|---|---|---|
|
The Percentage of Participants With an HAI Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 1
A/Singapore/INFIMH-16-0019/2016 NIB-104
|
43.3 percentage of participants
Interval 30.6 to 56.8
|
33.9 percentage of participants
Interval 22.1 to 47.4
|
|
The Percentage of Participants With an HAI Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 1
B/Colorado/6/2017
|
98.3 percentage of participants
Interval 91.1 to 100.0
|
93.2 percentage of participants
Interval 83.5 to 98.1
|
|
The Percentage of Participants With an HAI Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 1
B/Phuket/3073/2013
|
93.3 percentage of participants
Interval 83.8 to 98.2
|
93.2 percentage of participants
Interval 83.5 to 98.1
|
|
The Percentage of Participants With an HAI Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 1
A/Michigan/45/2015 X-275
|
80.0 percentage of participants
Interval 67.7 to 89.2
|
81.4 percentage of participants
Interval 69.1 to 90.3
|
SECONDARY outcome
Timeframe: Day 43Population: 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.
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.
Outcome measures
| Measure |
M-001 + IIV4
n=53 Participants
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
|
Placebo + IIV4
n=53 Participants
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172
|
|---|---|---|
|
The Percentage of Participants With an HAI Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 43
B/Colorado/6/2017
|
96.2 percentage of participants
Interval 87.0 to 99.5
|
92.5 percentage of participants
Interval 81.8 to 97.9
|
|
The Percentage of Participants With an HAI Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 43
B/Phuket/3073/2013
|
94.3 percentage of participants
Interval 84.3 to 98.8
|
92.5 percentage of participants
Interval 81.8 to 97.9
|
|
The Percentage of Participants With an HAI Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 43
A/Michigan/45/2015 X-275
|
79.2 percentage of participants
Interval 65.9 to 89.2
|
79.2 percentage of participants
Interval 65.9 to 89.2
|
|
The Percentage of Participants With an HAI Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 43
A/Singapore/INFIMH-16-0019/2016 NIB-104
|
39.6 percentage of participants
Interval 26.5 to 54.0
|
35.8 percentage of participants
Interval 23.1 to 50.2
|
SECONDARY outcome
Timeframe: Day 172Population: 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.
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.
Outcome measures
| Measure |
M-001 + IIV4
n=53 Participants
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
|
Placebo + IIV4
n=52 Participants
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172
|
|---|---|---|
|
The Percentage of Participants With an HAI Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 172
B/Colorado/6/2017
|
94.3 percentage of participants
Interval 84.3 to 98.8
|
88.5 percentage of participants
Interval 76.6 to 95.6
|
|
The Percentage of Participants With an HAI Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 172
B/Phuket/3073/2013
|
94.3 percentage of participants
Interval 84.3 to 98.8
|
88.5 percentage of participants
Interval 76.6 to 95.6
|
|
The Percentage of Participants With an HAI Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 172
A/Michigan/45/2015 X-275
|
81.1 percentage of participants
Interval 68.0 to 90.6
|
78.8 percentage of participants
Interval 65.3 to 88.9
|
|
The Percentage of Participants With an HAI Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 172
A/Singapore/INFIMH-16-0019/2016 NIB-104
|
39.6 percentage of participants
Interval 26.5 to 54.0
|
30.8 percentage of participants
Interval 18.7 to 45.1
|
SECONDARY outcome
Timeframe: Day 200Population: 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.
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.
Outcome measures
| Measure |
M-001 + IIV4
n=52 Participants
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
|
Placebo + IIV4
n=50 Participants
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172
|
|---|---|---|
|
The Percentage of Participants With an HAI Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 200
A/Singapore/INFIMH-16-0019/2016 NIB-104
|
67.3 percentage of participants
Interval 52.9 to 79.7
|
60 percentage of participants
Interval 45.2 to 73.6
|
|
The Percentage of Participants With an HAI Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 200
B/Colorado/6/2017
|
98.1 percentage of participants
Interval 89.7 to 100.0
|
96.0 percentage of participants
Interval 86.3 to 99.5
|
|
The Percentage of Participants With an HAI Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 200
B/Phuket/3073/2013
|
98.1 percentage of participants
Interval 89.7 to 100.0
|
96.0 percentage of participants
Interval 86.3 to 99.5
|
|
The Percentage of Participants With an HAI Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 200
A/Michigan/45/2015 X-275
|
94.2 percentage of participants
Interval 84.1 to 98.8
|
88.0 percentage of participants
Interval 75.7 to 95.5
|
SECONDARY outcome
Timeframe: Day 1Population: 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.
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.
Outcome measures
| Measure |
M-001 + IIV4
n=60 Participants
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
|
Placebo + IIV4
n=59 Participants
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172
|
|---|---|---|
|
The Percentage of Participants With a Neutralizing Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 1
B/Colorado/6/2017
|
30.0 percentage of participants
Interval 18.8 to 43.2
|
22.0 percentage of participants
Interval 12.3 to 34.7
|
|
The Percentage of Participants With a Neutralizing Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 1
B/Phuket/3073/2013
|
71.7 percentage of participants
Interval 58.6 to 82.5
|
74.6 percentage of participants
Interval 61.6 to 85.0
|
|
The Percentage of Participants With a Neutralizing Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 1
A/Michigan/45/2015 X-275
|
100 percentage of participants
Interval 94.0 to 100.0
|
96.6 percentage of participants
Interval 88.3 to 99.6
|
|
The Percentage of Participants With a Neutralizing Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 1
A/Singapore/INFIMH-16-0019/2016 NIB-104
|
91.7 percentage of participants
Interval 81.6 to 97.2
|
93.2 percentage of participants
Interval 83.5 to 989.1
|
SECONDARY outcome
Timeframe: Day 43Population: 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.
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.
Outcome measures
| Measure |
M-001 + IIV4
n=53 Participants
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
|
Placebo + IIV4
n=53 Participants
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172
|
|---|---|---|
|
The Percentage of Participants With a Neutralizing Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 43
B/Colorado/6/2017
|
20.8 percentage of participants
Interval 10.8 to 34.1
|
28.3 percentage of participants
Interval 16.8 to 42.3
|
|
The Percentage of Participants With a Neutralizing Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 43
B/Phuket/3073/2013
|
77.4 percentage of participants
Interval 63.8 to 87.7
|
69.8 percentage of participants
Interval 55.7 to 81.7
|
|
The Percentage of Participants With a Neutralizing Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 43
A/Michigan/45/2015 X-275
|
98.1 percentage of participants
Interval 89.9 to 100.0
|
98.1 percentage of participants
Interval 89.9 to 100.0
|
|
The Percentage of Participants With a Neutralizing Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 43
A/Singapore/INFIMH-16-0019/2016 NIB-104
|
90.6 percentage of participants
Interval 79.3 to 96.9
|
92.5 percentage of participants
Interval 81.8 to 97.9
|
SECONDARY outcome
Timeframe: Day 172Population: 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.
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.
Outcome measures
| Measure |
M-001 + IIV4
n=53 Participants
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
|
Placebo + IIV4
n=52 Participants
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172
|
|---|---|---|
|
The Percentage of Participants With a Neutralizing Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 172
B/Colorado/6/2017
|
24.5 percentage of participants
Interval 13.8 to 38.3
|
26.9 percentage of participants
Interval 15.6 to 41.0
|
|
The Percentage of Participants With a Neutralizing Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 172
B/Phuket/3073/2013
|
67.9 percentage of participants
Interval 53.7 to 80.1
|
69.2 percentage of participants
Interval 54.9 to 81.3
|
|
The Percentage of Participants With a Neutralizing Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 172
A/Michigan/45/2015 X-275
|
98.1 percentage of participants
Interval 89.9 to 100.0
|
96.2 percentage of participants
Interval 86.8 to 99.5
|
|
The Percentage of Participants With a Neutralizing Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 172
A/Singapore/INFIMH-16-0019/2016 NIB-104
|
86.8 percentage of participants
Interval 74.7 to 94.5
|
92.3 percentage of participants
Interval 81.5 to 97.9
|
SECONDARY outcome
Timeframe: Day 200Population: 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.
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.
Outcome measures
| Measure |
M-001 + IIV4
n=52 Participants
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172.
|
Placebo + IIV4
n=50 Participants
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172
|
|---|---|---|
|
The Percentage of Participants With a Neutralizing Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 200
B/Colorado/6/2017
|
69.2 percentage of participants
Interval 54.9 to 81.3
|
50.0 percentage of participants
Interval 35.5 to 64.5
|
|
The Percentage of Participants With a Neutralizing Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 200
B/Phuket/3073/2013
|
86.5 percentage of participants
Interval 74.2 to 94.4
|
82.0 percentage of participants
Interval 68.6 to 91.4
|
|
The Percentage of Participants With a Neutralizing Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 200
A/Michigan/45/2015 X-275
|
100 percentage of participants
Interval 93.2 to 100.0
|
100 percentage of participants
Interval 92.9 to 100.0
|
|
The Percentage of Participants With a Neutralizing Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 200
A/Singapore/INFIMH-16-0019/2016 NIB-104
|
98.1 percentage of participants
Interval 89.7 to 100.0
|
98.0 percentage of participants
Interval 89.4 to 99.9
|
Adverse Events
M-001 + IIV4
Placebo + IIV4
Serious adverse events
| Measure |
M-001 + IIV4
n=61 participants at risk
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172
|
Placebo + IIV4
n=59 participants at risk
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172
|
|---|---|---|
|
Ear and labyrinth disorders
Deafness
|
1.6%
1/61 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited non-serious AEs through 28 days after the second study vaccination, and SAEs through approximately Day 200.
For events solicited on the Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
0.00%
0/59 • Solicited events were collected for 8 days after each vaccination, unsolicited non-serious AEs through 28 days after the second study vaccination, and SAEs through approximately Day 200.
For events solicited on the Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
Other adverse events
| Measure |
M-001 + IIV4
n=61 participants at risk
0.4 ml (1 mg) M-001 IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172
|
Placebo + IIV4
n=59 participants at risk
0.4 ml Placebo IM on Day 1 and Day 22, followed by 0.5 ml IIV4 IM on Day 172
|
|---|---|---|
|
Infections and infestations
Respiratory Tract Infection
|
4.9%
3/61 • Number of events 3 • Solicited events were collected for 8 days after each vaccination, unsolicited non-serious AEs through 28 days after the second study vaccination, and SAEs through approximately Day 200.
For events solicited on the Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
8.5%
5/59 • Number of events 5 • Solicited events were collected for 8 days after each vaccination, unsolicited non-serious AEs through 28 days after the second study vaccination, and SAEs through approximately Day 200.
For events solicited on the Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
|
Gastrointestinal disorders
Nausea
|
14.8%
9/61 • Number of events 9 • Solicited events were collected for 8 days after each vaccination, unsolicited non-serious AEs through 28 days after the second study vaccination, and SAEs through approximately Day 200.
For events solicited on the Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
1.7%
1/59 • Number of events 2 • Solicited events were collected for 8 days after each vaccination, unsolicited non-serious AEs through 28 days after the second study vaccination, and SAEs through approximately Day 200.
For events solicited on the Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
|
General disorders
Fatigue
|
29.5%
18/61 • Number of events 22 • Solicited events were collected for 8 days after each vaccination, unsolicited non-serious AEs through 28 days after the second study vaccination, and SAEs through approximately Day 200.
For events solicited on the Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
27.1%
16/59 • Number of events 21 • Solicited events were collected for 8 days after each vaccination, unsolicited non-serious AEs through 28 days after the second study vaccination, and SAEs through approximately Day 200.
For events solicited on the Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
|
General disorders
Feeling Hot
|
3.3%
2/61 • Number of events 2 • Solicited events were collected for 8 days after each vaccination, unsolicited non-serious AEs through 28 days after the second study vaccination, and SAEs through approximately Day 200.
For events solicited on the Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
6.8%
4/59 • Number of events 5 • Solicited events were collected for 8 days after each vaccination, unsolicited non-serious AEs through 28 days after the second study vaccination, and SAEs through approximately Day 200.
For events solicited on the Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
|
General disorders
Injection Site Erythema
|
36.1%
22/61 • Number of events 29 • Solicited events were collected for 8 days after each vaccination, unsolicited non-serious AEs through 28 days after the second study vaccination, and SAEs through approximately Day 200.
For events solicited on the Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
23.7%
14/59 • Number of events 18 • Solicited events were collected for 8 days after each vaccination, unsolicited non-serious AEs through 28 days after the second study vaccination, and SAEs through approximately Day 200.
For events solicited on the Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
|
General disorders
Injection Site Haemorrhage
|
3.3%
2/61 • Number of events 2 • Solicited events were collected for 8 days after each vaccination, unsolicited non-serious AEs through 28 days after the second study vaccination, and SAEs through approximately Day 200.
For events solicited on the Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
8.5%
5/59 • Number of events 6 • Solicited events were collected for 8 days after each vaccination, unsolicited non-serious AEs through 28 days after the second study vaccination, and SAEs through approximately Day 200.
For events solicited on the Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
|
General disorders
Injection Site Induration
|
8.2%
5/61 • Number of events 5 • Solicited events were collected for 8 days after each vaccination, unsolicited non-serious AEs through 28 days after the second study vaccination, and SAEs through approximately Day 200.
For events solicited on the Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
8.5%
5/59 • Number of events 6 • Solicited events were collected for 8 days after each vaccination, unsolicited non-serious AEs through 28 days after the second study vaccination, and SAEs through approximately Day 200.
For events solicited on the Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
|
General disorders
Injection Site Pain
|
54.1%
33/61 • Number of events 46 • Solicited events were collected for 8 days after each vaccination, unsolicited non-serious AEs through 28 days after the second study vaccination, and SAEs through approximately Day 200.
For events solicited on the Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
23.7%
14/59 • Number of events 20 • Solicited events were collected for 8 days after each vaccination, unsolicited non-serious AEs through 28 days after the second study vaccination, and SAEs through approximately Day 200.
For events solicited on the Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
|
General disorders
Malaise
|
14.8%
9/61 • Number of events 11 • Solicited events were collected for 8 days after each vaccination, unsolicited non-serious AEs through 28 days after the second study vaccination, and SAEs through approximately Day 200.
For events solicited on the Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
11.9%
7/59 • Number of events 9 • Solicited events were collected for 8 days after each vaccination, unsolicited non-serious AEs through 28 days after the second study vaccination, and SAEs through approximately Day 200.
For events solicited on the Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.6%
1/61 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited non-serious AEs through 28 days after the second study vaccination, and SAEs through approximately Day 200.
For events solicited on the Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
5.1%
3/59 • Number of events 3 • Solicited events were collected for 8 days after each vaccination, unsolicited non-serious AEs through 28 days after the second study vaccination, and SAEs through approximately Day 200.
For events solicited on the Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
14.8%
9/61 • Number of events 10 • Solicited events were collected for 8 days after each vaccination, unsolicited non-serious AEs through 28 days after the second study vaccination, and SAEs through approximately Day 200.
For events solicited on the Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
11.9%
7/59 • Number of events 8 • Solicited events were collected for 8 days after each vaccination, unsolicited non-serious AEs through 28 days after the second study vaccination, and SAEs through approximately Day 200.
For events solicited on the Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
|
Nervous system disorders
Headache
|
27.9%
17/61 • Number of events 21 • Solicited events were collected for 8 days after each vaccination, unsolicited non-serious AEs through 28 days after the second study vaccination, and SAEs through approximately Day 200.
For events solicited on the Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
30.5%
18/59 • Number of events 23 • Solicited events were collected for 8 days after each vaccination, unsolicited non-serious AEs through 28 days after the second study vaccination, and SAEs through approximately Day 200.
For events solicited on the Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
|
Investigations
Blood Bilirubin Increased
|
3.3%
2/61 • Number of events 4 • Solicited events were collected for 8 days after each vaccination, unsolicited non-serious AEs through 28 days after the second study vaccination, and SAEs through approximately Day 200.
For events solicited on the Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
5.1%
3/59 • Number of events 4 • Solicited events were collected for 8 days after each vaccination, unsolicited non-serious AEs through 28 days after the second study vaccination, and SAEs through approximately Day 200.
For events solicited on the Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
|
Investigations
Haemoglobin Decreased
|
8.2%
5/61 • Number of events 6 • Solicited events were collected for 8 days after each vaccination, unsolicited non-serious AEs through 28 days after the second study vaccination, and SAEs through approximately Day 200.
For events solicited on the Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
1.7%
1/59 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited non-serious AEs through 28 days after the second study vaccination, and SAEs through approximately Day 200.
For events solicited on the Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
|
Investigations
White Blood Cell Count Decreased
|
4.9%
3/61 • Number of events 4 • Solicited events were collected for 8 days after each vaccination, unsolicited non-serious AEs through 28 days after the second study vaccination, and SAEs through approximately Day 200.
For events solicited on the Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
8.5%
5/59 • Number of events 5 • Solicited events were collected for 8 days after each vaccination, unsolicited non-serious AEs through 28 days after the second study vaccination, and SAEs through approximately Day 200.
For events solicited on the Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
|
Investigations
White Blood Cell Count Increased
|
6.6%
4/61 • Number of events 4 • Solicited events were collected for 8 days after each vaccination, unsolicited non-serious AEs through 28 days after the second study vaccination, and SAEs through approximately Day 200.
For events solicited on the Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
6.8%
4/59 • Number of events 5 • Solicited events were collected for 8 days after each vaccination, unsolicited non-serious AEs through 28 days after the second study vaccination, and SAEs through approximately Day 200.
For events solicited on the Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60