Trial Outcomes & Findings for H3N2 M2SR in Pediatric Population (NCT NCT03553940)
NCT ID: NCT03553940
Last Updated: 2021-10-21
Results Overview
Adverse Events of Special Interest (AESIs) included medically significant wheezing and otitis media. AESIs were collected from receipt of the first study vaccination through 3 months after first vaccination.
COMPLETED
PHASE1
43 participants
Day 1 through Day 92
2021-10-21
Participant Flow
Participants were healthy males and non-pregnant females between 9 and 17 years old, inclusively. They were recruited from the community at large around the clinic site. Participants were enrolled between 15AUG2018 and 20SEP2019.
Participant milestones
| Measure |
M2SR
A single dose of monovalent live attenuated influenza H3N2 M2SR vaccine (M2SR) administered intranasally on Day 1, and a single dose of licensed quadrivalent influenza vaccine (QIV) administered intramuscularly on Day 92.
Influenza Virus Monovalent A/H3N2/Bris 10 M2SR Live Vaccine: Live monovalent influenza A/H3N2-based M2SR (M2 defective Single Replication vaccine), comprised of 5 out of 8 gene segments on the donor virus influenza A/Puerto Rico/8/34. HA and NA derive from an A/Brisbane/10/2007-like virus. Administered intranasally as a single dose.
Quadrivalent MDCK Inactivated Influenza Vaccine: A quadrivalent cell culture inactivated vaccine (ccIV4) is an inactivated subunit influenza vaccine prepared from virus propagated in Madin Darby Canine Kidney (MDCK) cells indicated for the prevention of influenza disease caused by influenza virus subtypes A and B contained in the vaccine. Administered intramuscularly as a single dose.
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Placebo
A single dose of Placebo administered intranasally on Day 1, and a single dose of licensed QIV administered intramuscularly on Day 92.
Placebo: H3N2 M2SR vaccine placebo (normal saline). Administered intranasally as a single dose.
Quadrivalent MDCK Inactivated Influenza Vaccine: A quadrivalent cell culture inactivated vaccine (ccIV4) is an inactivated subunit influenza vaccine prepared from virus propagated in Madin Darby Canine Kidney (MDCK) cells indicated for the prevention of influenza disease caused by influenza virus subtypes A and B contained in the vaccine. Administered intramuscularly as a single dose.
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|---|---|---|
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Overall Study
STARTED
|
22
|
21
|
|
Overall Study
COMPLETED
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22
|
21
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
H3N2 M2SR in Pediatric Population
Baseline characteristics by cohort
| Measure |
M2SR
n=22 Participants
A single dose of monovalent live attenuated influenza H3N2 M2SR vaccine (M2SR) administered intranasally on Day 1, and a single dose of licensed quadrivalent influenza vaccine (QIV) administered intramuscularly on Day 92.
|
Placebo
n=21 Participants
A single dose of Placebo administered intranasally on Day 1, and a single dose of licensed QIV administered intramuscularly on Day 92.
|
Total
n=43 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
|
13.8 years
STANDARD_DEVIATION 1.8 • n=5 Participants
|
12.9 years
STANDARD_DEVIATION 2.2 • n=7 Participants
|
13.3 years
STANDARD_DEVIATION 2.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
39 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
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Region of Enrollment
United States
|
22 participants
n=5 Participants
|
21 participants
n=7 Participants
|
43 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 92Population: The Safety population includes all participants who received at least one dose of study vaccine.
Adverse Events of Special Interest (AESIs) included medically significant wheezing and otitis media. AESIs were collected from receipt of the first study vaccination through 3 months after first vaccination.
Outcome measures
| Measure |
M2SR
n=22 Participants
A single dose of monovalent live attenuated influenza H3N2 M2SR vaccine (M2SR) administered intranasally on Day 1, and a single dose of licensed quadrivalent influenza vaccine (QIV) administered intramuscularly on Day 92.
|
Placebo
n=21 Participants
A single dose of Placebo administered intranasally on Day 1, and a single dose of licensed QIV administered intramuscularly on Day 92.
|
|---|---|---|
|
Number of Participants With Adverse Events of Special Interest (AESIs)
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 92Population: The Safety population includes all participants who received at least one dose of study vaccine.
Participants were queried at each visit for the occurrence of new onset chronic medical conditions (NOCMCs). NOCMCs were collected from receipt of the first study vaccination through 3 months after first vaccination.
Outcome measures
| Measure |
M2SR
n=22 Participants
A single dose of monovalent live attenuated influenza H3N2 M2SR vaccine (M2SR) administered intranasally on Day 1, and a single dose of licensed quadrivalent influenza vaccine (QIV) administered intramuscularly on Day 92.
|
Placebo
n=21 Participants
A single dose of Placebo administered intranasally on Day 1, and a single dose of licensed QIV administered intramuscularly on Day 92.
|
|---|---|---|
|
Number of Participants With New Onset Chronic Medical Conditions (NOCMCs)
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 366Population: The Safety population includes all participants who received at least one dose of study vaccine.
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.
Outcome measures
| Measure |
M2SR
n=22 Participants
A single dose of monovalent live attenuated influenza H3N2 M2SR vaccine (M2SR) administered intranasally on Day 1, and a single dose of licensed quadrivalent influenza vaccine (QIV) administered intramuscularly on Day 92.
|
Placebo
n=21 Participants
A single dose of Placebo administered intranasally on Day 1, and a single dose of licensed QIV administered intramuscularly on Day 92.
|
|---|---|---|
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Number of Participants With Serious Adverse Events (SAEs)
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0 Participants
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0 Participants
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PRIMARY outcome
Timeframe: Day 1 through Day 8Population: The Safety population includes all participants who received at least one dose of study vaccine.
Reactogenicity assessments included an assessment of solicited AEs occurring from the time of first study vaccination through 7 days after first vaccination. For upper respiratory symptoms, this included an assessment of runny nose, stuffy nose/ congestion, sneezing, nasal pain/irritation/nasal dryness, nasal bleeding/epistaxis, sinus pressure/pain, sore throat/sore/scratchy, itchy or painful throat, cough, and trouble breathing/shortness of breath. For general systemic symptoms, this included an assessment of reactions including fever, feverishness (chills/shivering/sweating), fatigue (tiredness), malaise, myalgia (body aches/muscular pain), arthralgia (joint pain), headache, flushing, decreased activity, decreased appetite, abdominal pain, nausea, vomiting, diarrhea, eye pruritus, eye redness (conjunctivitis), allergy, and wheezing.
Outcome measures
| Measure |
M2SR
n=22 Participants
A single dose of monovalent live attenuated influenza H3N2 M2SR vaccine (M2SR) administered intranasally on Day 1, and a single dose of licensed quadrivalent influenza vaccine (QIV) administered intramuscularly on Day 92.
|
Placebo
n=21 Participants
A single dose of Placebo administered intranasally on Day 1, and a single dose of licensed QIV administered intramuscularly on Day 92.
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|---|---|---|
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Number of Participants With Solicited Reactogenicity
Upper Respiratory Symptoms
|
5 Participants
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7 Participants
|
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Number of Participants With Solicited Reactogenicity
Systemic Symptoms
|
11 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 22Population: The Safety population includes all participants who received at least one dose of study vaccine.
Adverse events were defined as any untoward medical occurrence in a participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Non-serious AEs were collected from the time of first study vaccination through 21 days after first vaccination. Adverse events were MedDRA coded and are summarized by MedDRA System Organ Class (SOC).
Outcome measures
| Measure |
M2SR
n=22 Participants
A single dose of monovalent live attenuated influenza H3N2 M2SR vaccine (M2SR) administered intranasally on Day 1, and a single dose of licensed quadrivalent influenza vaccine (QIV) administered intramuscularly on Day 92.
|
Placebo
n=21 Participants
A single dose of Placebo administered intranasally on Day 1, and a single dose of licensed QIV administered intramuscularly on Day 92.
|
|---|---|---|
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Number of Participants With Unsolicited Non-Serious Adverse Events
|
6 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 113Population: The Modified Intent-to-Treat (mITT) population includes all participants who received at least one dose of study vaccine and contributed both pre- and at least one post-study vaccination venous blood samples for which valid results were reported.
Blood was collected for ELISpot assays conducted with a peptide library consisting of conserved immunogenic peptides of internal flu virus proteins as the antigen . Collection took place on Day 1 (pre-vaccination), Days 8, 22, and 57 after first vaccination, immediately prior to second vaccination (Day 92), and 21 days after second vaccination (Day 113). Peripheral blood mononuclear cells (PBMCs) were harvested and retained from each whole blood collection. The geometric mean of each sample's replicate results was calculated from available results using spot forming cells per 3x10\^5 peripheral blood mononuclear cells (SFC/3x10\^5 PBMCs).
Outcome measures
| Measure |
M2SR
n=22 Participants
A single dose of monovalent live attenuated influenza H3N2 M2SR vaccine (M2SR) administered intranasally on Day 1, and a single dose of licensed quadrivalent influenza vaccine (QIV) administered intramuscularly on Day 92.
|
Placebo
n=21 Participants
A single dose of Placebo administered intranasally on Day 1, and a single dose of licensed QIV administered intramuscularly on Day 92.
|
|---|---|---|
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Frequency of Conserved Internal Viral Protein-specific Spot Forming Cells
Day 1
|
17.2 SFC/3x10^5 PBMCs
Interval 12.6 to 23.3
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23.0 SFC/3x10^5 PBMCs
Interval 12.8 to 41.2
|
|
Frequency of Conserved Internal Viral Protein-specific Spot Forming Cells
Day 8
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24.1 SFC/3x10^5 PBMCs
Interval 17.3 to 33.5
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23.5 SFC/3x10^5 PBMCs
Interval 13.7 to 40.2
|
|
Frequency of Conserved Internal Viral Protein-specific Spot Forming Cells
Day 22
|
24.5 SFC/3x10^5 PBMCs
Interval 17.1 to 35.0
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20.2 SFC/3x10^5 PBMCs
Interval 11.2 to 36.2
|
|
Frequency of Conserved Internal Viral Protein-specific Spot Forming Cells
Day 57
|
16.2 SFC/3x10^5 PBMCs
Interval 11.3 to 23.4
|
21.4 SFC/3x10^5 PBMCs
Interval 13.5 to 33.8
|
|
Frequency of Conserved Internal Viral Protein-specific Spot Forming Cells
Day 92
|
16.3 SFC/3x10^5 PBMCs
Interval 9.7 to 27.3
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17.0 SFC/3x10^5 PBMCs
Interval 9.6 to 30.1
|
|
Frequency of Conserved Internal Viral Protein-specific Spot Forming Cells
Day 113
|
20.8 SFC/3x10^5 PBMCs
Interval 13.4 to 32.2
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22.3 SFC/3x10^5 PBMCs
Interval 12.6 to 39.6
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SECONDARY outcome
Timeframe: Day 1 through Day 113Population: The Modified Intent-to-Treat (mITT) population includes all participants who received at least one dose of study vaccine and contributed both pre- and at least one post-study vaccination venous blood samples for which valid results were reported.
Blood was collected for ELISpot assays conducted with H3N2 M2SR-like virus A/Brisbane/10/2007 as the antigen. Collection took place on Day 1 (pre-vaccination), Days 8, 22, and 57 after first vaccination, immediately prior to second vaccination (Day 92), and 21 days after second vaccination (Day 113). Peripheral blood mononuclear cells (PBMCs) were harvested and retained from each whole blood collection. The geometric mean of each sample's replicate results was calculated from available results using spot forming cells per 3x10\^5 peripheral blood mononuclear cells (SFC/3x10\^5 PBMCs).
Outcome measures
| Measure |
M2SR
n=22 Participants
A single dose of monovalent live attenuated influenza H3N2 M2SR vaccine (M2SR) administered intranasally on Day 1, and a single dose of licensed quadrivalent influenza vaccine (QIV) administered intramuscularly on Day 92.
|
Placebo
n=21 Participants
A single dose of Placebo administered intranasally on Day 1, and a single dose of licensed QIV administered intramuscularly on Day 92.
|
|---|---|---|
|
Frequency of Influenza H3 HA-specific Spot Forming Cells for the H3N2 M2SR-like Virus A/Brisbane/10/2007
Day 1
|
37.5 SFC/3x10^5 PBMCs
Interval 22.1 to 63.6
|
50.2 SFC/3x10^5 PBMCs
Interval 33.7 to 74.6
|
|
Frequency of Influenza H3 HA-specific Spot Forming Cells for the H3N2 M2SR-like Virus A/Brisbane/10/2007
Day 8
|
48.9 SFC/3x10^5 PBMCs
Interval 26.0 to 91.8
|
59.0 SFC/3x10^5 PBMCs
Interval 35.5 to 98.1
|
|
Frequency of Influenza H3 HA-specific Spot Forming Cells for the H3N2 M2SR-like Virus A/Brisbane/10/2007
Day 22
|
65.8 SFC/3x10^5 PBMCs
Interval 35.3 to 122.6
|
46.3 SFC/3x10^5 PBMCs
Interval 21.6 to 99.2
|
|
Frequency of Influenza H3 HA-specific Spot Forming Cells for the H3N2 M2SR-like Virus A/Brisbane/10/2007
Day 57
|
41.8 SFC/3x10^5 PBMCs
Interval 22.8 to 76.9
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45.1 SFC/3x10^5 PBMCs
Interval 26.5 to 76.8
|
|
Frequency of Influenza H3 HA-specific Spot Forming Cells for the H3N2 M2SR-like Virus A/Brisbane/10/2007
Day 92
|
30.2 SFC/3x10^5 PBMCs
Interval 14.2 to 64.2
|
32.2 SFC/3x10^5 PBMCs
Interval 15.6 to 66.3
|
|
Frequency of Influenza H3 HA-specific Spot Forming Cells for the H3N2 M2SR-like Virus A/Brisbane/10/2007
Day 113
|
34.0 SFC/3x10^5 PBMCs
Interval 18.4 to 62.7
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50.4 SFC/3x10^5 PBMCs
Interval 29.3 to 86.5
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SECONDARY outcome
Timeframe: Day 1 through Day 113Population: The Modified Intent-to-Treat (mITT) population includes all participants who received at least one dose of study vaccine and contributed both pre- and at least one post-study vaccination venous blood samples for which valid results were reported.
Blood was collected for ELISpot assays conducted with H3N2 QIV-like virus A/North Carolina/04/2016 as the antigen. Collection took place on Day 1 (pre-vaccination), Days 8, 22, and 57 after first vaccination, immediately prior to second vaccination (Day 92), and 21 days after second vaccination (Day 113). Peripheral blood mononuclear cells (PBMCs) were harvested and retained from each whole blood collection. The geometric mean of each sample's replicate results was calculated from available results using spot forming cells per 3x10\^5 peripheral blood mononuclear cells (SFC/3x10\^5 PBMCs).
Outcome measures
| Measure |
M2SR
n=22 Participants
A single dose of monovalent live attenuated influenza H3N2 M2SR vaccine (M2SR) administered intranasally on Day 1, and a single dose of licensed quadrivalent influenza vaccine (QIV) administered intramuscularly on Day 92.
|
Placebo
n=21 Participants
A single dose of Placebo administered intranasally on Day 1, and a single dose of licensed QIV administered intramuscularly on Day 92.
|
|---|---|---|
|
Frequency of Influenza H3 HA-specific Spot Forming Cells for the H3N2 QIV-like Virus A/North Carolina/04/2016
Day 1
|
30.7 SFC/3x10^5 PBMCs
Interval 17.7 to 53.4
|
42.5 SFC/3x10^5 PBMCs
Interval 27.0 to 66.9
|
|
Frequency of Influenza H3 HA-specific Spot Forming Cells for the H3N2 QIV-like Virus A/North Carolina/04/2016
Day 8
|
39.7 SFC/3x10^5 PBMCs
Interval 22.1 to 71.6
|
45.1 SFC/3x10^5 PBMCs
Interval 27.5 to 74.0
|
|
Frequency of Influenza H3 HA-specific Spot Forming Cells for the H3N2 QIV-like Virus A/North Carolina/04/2016
Day 22
|
49.5 SFC/3x10^5 PBMCs
Interval 26.0 to 94.2
|
40.0 SFC/3x10^5 PBMCs
Interval 19.0 to 84.0
|
|
Frequency of Influenza H3 HA-specific Spot Forming Cells for the H3N2 QIV-like Virus A/North Carolina/04/2016
Day 57
|
30.0 SFC/3x10^5 PBMCs
Interval 15.7 to 57.2
|
40.5 SFC/3x10^5 PBMCs
Interval 24.7 to 66.5
|
|
Frequency of Influenza H3 HA-specific Spot Forming Cells for the H3N2 QIV-like Virus A/North Carolina/04/2016
Day 92
|
18.5 SFC/3x10^5 PBMCs
Interval 7.5 to 45.4
|
30.0 SFC/3x10^5 PBMCs
Interval 15.0 to 60.1
|
|
Frequency of Influenza H3 HA-specific Spot Forming Cells for the H3N2 QIV-like Virus A/North Carolina/04/2016
Day 113
|
25.2 SFC/3x10^5 PBMCs
Interval 13.2 to 47.9
|
39.8 SFC/3x10^5 PBMCs
Interval 23.6 to 67.0
|
SECONDARY outcome
Timeframe: Day 1 through Day 113Population: The Modified Intent-to-Treat (mITT) population includes all participants who received at least one dose of study vaccine and contributed both pre- and at least one post-study vaccination venous blood samples for which valid results were reported.
Blood was collected for ELISpot assays conducted with H3N2 QIV-like virus A/Singapore/INFIMH-16-0019/2016 as the antigen. Collection took place on Day 1 (pre-vaccination), Days 8, 22, and 57 after first vaccination, immediately prior to second vaccination (Day 92), and 21 days after second vaccination (Day 113). Peripheral blood mononuclear cells (PBMCs) were harvested and retained from each whole blood collection. The geometric mean of each sample's replicate results was calculated from available results using spot forming cells per 3x10\^5 peripheral blood mononuclear cells (SFC/3x10\^5 PBMCs).
Outcome measures
| Measure |
M2SR
n=22 Participants
A single dose of monovalent live attenuated influenza H3N2 M2SR vaccine (M2SR) administered intranasally on Day 1, and a single dose of licensed quadrivalent influenza vaccine (QIV) administered intramuscularly on Day 92.
|
Placebo
n=21 Participants
A single dose of Placebo administered intranasally on Day 1, and a single dose of licensed QIV administered intramuscularly on Day 92.
|
|---|---|---|
|
Frequency of Influenza H3 HA-specific Spot Forming Cells for the H3N2 QIV-like Virus A/Singapore/INFIMH-16-0019/2016
Day 1
|
31.5 SFC/3x10^5 PBMCs
Interval 18.9 to 52.5
|
42.1 SFC/3x10^5 PBMCs
Interval 27.8 to 63.6
|
|
Frequency of Influenza H3 HA-specific Spot Forming Cells for the H3N2 QIV-like Virus A/Singapore/INFIMH-16-0019/2016
Day 8
|
40.5 SFC/3x10^5 PBMCs
Interval 23.9 to 68.8
|
46.0 SFC/3x10^5 PBMCs
Interval 28.4 to 74.5
|
|
Frequency of Influenza H3 HA-specific Spot Forming Cells for the H3N2 QIV-like Virus A/Singapore/INFIMH-16-0019/2016
Day 22
|
50.9 SFC/3x10^5 PBMCs
Interval 26.5 to 97.8
|
40.2 SFC/3x10^5 PBMCs
Interval 19.4 to 83.3
|
|
Frequency of Influenza H3 HA-specific Spot Forming Cells for the H3N2 QIV-like Virus A/Singapore/INFIMH-16-0019/2016
Day 57
|
35.3 SFC/3x10^5 PBMCs
Interval 21.0 to 59.6
|
39.2 SFC/3x10^5 PBMCs
Interval 24.1 to 63.9
|
|
Frequency of Influenza H3 HA-specific Spot Forming Cells for the H3N2 QIV-like Virus A/Singapore/INFIMH-16-0019/2016
Day 92
|
26.2 SFC/3x10^5 PBMCs
Interval 13.8 to 49.6
|
29.6 SFC/3x10^5 PBMCs
Interval 16.0 to 54.9
|
|
Frequency of Influenza H3 HA-specific Spot Forming Cells for the H3N2 QIV-like Virus A/Singapore/INFIMH-16-0019/2016
Day 113
|
25.2 SFC/3x10^5 PBMCs
Interval 14.0 to 45.1
|
40.7 SFC/3x10^5 PBMCs
Interval 23.7 to 69.9
|
SECONDARY outcome
Timeframe: Day 1 through Day 113Population: The Modified Intent-to-Treat (mITT) population includes all participants who received at least one dose of study vaccine and contributed both pre- and at least one post-study vaccination venous blood samples for which valid results were reported.
Blood was collected for ELISpot assays conducted with H3N2 QIV-like virus A/Kansas/14/2017 as the antigen. Collection took place on Day 1 (pre-vaccination), Days 8, 22, and 57 after first vaccination, immediately prior to second vaccination (Day 92), and 21 days after second vaccination (Day 113). Peripheral blood mononuclear cells (PBMCs) were harvested and retained from each whole blood collection. The geometric mean of each sample's replicate results was calculated from available results using spot forming cells per 3x10\^5 peripheral blood mononuclear cells (SFC/3x10\^5 PBMCs).
Outcome measures
| Measure |
M2SR
n=22 Participants
A single dose of monovalent live attenuated influenza H3N2 M2SR vaccine (M2SR) administered intranasally on Day 1, and a single dose of licensed quadrivalent influenza vaccine (QIV) administered intramuscularly on Day 92.
|
Placebo
n=21 Participants
A single dose of Placebo administered intranasally on Day 1, and a single dose of licensed QIV administered intramuscularly on Day 92.
|
|---|---|---|
|
Frequency of Influenza H3 HA-specific Spot Forming Cells for the H3N2 QIV-like Virus A/Kansas/14/2017
Day 1
|
5.3 SFC/3x10^5 PBMCs
Interval 3.8 to 7.4
|
5.3 SFC/3x10^5 PBMCs
Interval 3.5 to 7.9
|
|
Frequency of Influenza H3 HA-specific Spot Forming Cells for the H3N2 QIV-like Virus A/Kansas/14/2017
Day 8
|
7.1 SFC/3x10^5 PBMCs
Interval 4.9 to 10.3
|
6.0 SFC/3x10^5 PBMCs
Interval 3.6 to 10.0
|
|
Frequency of Influenza H3 HA-specific Spot Forming Cells for the H3N2 QIV-like Virus A/Kansas/14/2017
Day 22
|
5.4 SFC/3x10^5 PBMCs
Interval 3.6 to 8.1
|
6.6 SFC/3x10^5 PBMCs
Interval 3.9 to 11.3
|
|
Frequency of Influenza H3 HA-specific Spot Forming Cells for the H3N2 QIV-like Virus A/Kansas/14/2017
Day 57
|
4.7 SFC/3x10^5 PBMCs
Interval 3.4 to 6.3
|
5.2 SFC/3x10^5 PBMCs
Interval 3.4 to 7.9
|
|
Frequency of Influenza H3 HA-specific Spot Forming Cells for the H3N2 QIV-like Virus A/Kansas/14/2017
Day 92
|
4.3 SFC/3x10^5 PBMCs
Interval 2.9 to 6.5
|
4.3 SFC/3x10^5 PBMCs
Interval 2.7 to 6.8
|
|
Frequency of Influenza H3 HA-specific Spot Forming Cells for the H3N2 QIV-like Virus A/Kansas/14/2017
Day 113
|
4.9 SFC/3x10^5 PBMCs
Interval 3.2 to 7.4
|
6.4 SFC/3x10^5 PBMCs
Interval 3.9 to 10.7
|
SECONDARY outcome
Timeframe: Day 8 through Day 113Population: The Modified Intent-to-Treat (mITT) population includes all participants who received at least one dose of study vaccine and contributed both pre- and at least one post-study vaccination venous blood samples for which valid results were reported.
Nasal swabs were collected for secretory immunoglobulin A (sIgA) assays conducted with H3N2 M2SR-like virus A/Brisbane/10/2007 as the antigen. Collection took place Day 1 (pre-vaccination), Days 8, 22, and 57 after first vaccination, immediately prior to second vaccination (Day 92), and 21 days after second vaccination (Day 113). The geometric mean of each sample's replicate results was calculated from available results. Geometric mean fold rise (GMFR) was calculated by dividing each post-baseline geometric mean titer by baseline geometric mean titer. The GMFR across samples was calculated within each study arm and analysis time point.
Outcome measures
| Measure |
M2SR
n=22 Participants
A single dose of monovalent live attenuated influenza H3N2 M2SR vaccine (M2SR) administered intranasally on Day 1, and a single dose of licensed quadrivalent influenza vaccine (QIV) administered intramuscularly on Day 92.
|
Placebo
n=21 Participants
A single dose of Placebo administered intranasally on Day 1, and a single dose of licensed QIV administered intramuscularly on Day 92.
|
|---|---|---|
|
Geometric Mean Fold Rise (GMFR) of Nasal Secretory Immunoglobulin A (sIgA) Responses Directed Against the H3N2 M2SR-like Virus A/Brisbane/10/2007
Day 8
|
1.1 ratio
Interval 0.4 to 2.9
|
1.2 ratio
Interval 0.5 to 3.3
|
|
Geometric Mean Fold Rise (GMFR) of Nasal Secretory Immunoglobulin A (sIgA) Responses Directed Against the H3N2 M2SR-like Virus A/Brisbane/10/2007
Day 22
|
1.3 ratio
Interval 0.4 to 4.2
|
1.9 ratio
Interval 1.0 to 3.4
|
|
Geometric Mean Fold Rise (GMFR) of Nasal Secretory Immunoglobulin A (sIgA) Responses Directed Against the H3N2 M2SR-like Virus A/Brisbane/10/2007
Day 57
|
0.8 ratio
Interval 0.2 to 3.1
|
1.9 ratio
Interval 0.7 to 5.1
|
|
Geometric Mean Fold Rise (GMFR) of Nasal Secretory Immunoglobulin A (sIgA) Responses Directed Against the H3N2 M2SR-like Virus A/Brisbane/10/2007
Day 92
|
1.3 ratio
Interval 0.5 to 3.7
|
1.4 ratio
Interval 0.7 to 3.1
|
|
Geometric Mean Fold Rise (GMFR) of Nasal Secretory Immunoglobulin A (sIgA) Responses Directed Against the H3N2 M2SR-like Virus A/Brisbane/10/2007
Day 113
|
1.8 ratio
Interval 0.6 to 5.6
|
4.9 ratio
Interval 2.3 to 10.6
|
SECONDARY outcome
Timeframe: Day 8 through Day 113Population: The Modified Intent-to-Treat (mITT) population includes all participants who received at least one dose of study vaccine and contributed both pre- and at least one post-study vaccination venous blood samples for which valid results were reported.
Nasal swabs were collected for secretory immunoglobulin A (sIgA) assays conducted with H3N2 M2SR-like virus A/Brisbane/10/2007 as the antigen. Collection took place on Day 1 (pre-vaccination), Days 8, 22, and 57 after first vaccination, immediately prior to second vaccination (Day 92), and 21 days after second vaccination (Day 113). The geometric mean of each sample's replicate results was calculated from available results. Results were normalized to total sIgA by dividing each geometric mean titer by total sIgA concentration (ng/mL). Geometric mean fold rise (GMFR) was calculated by dividing each post-baseline normalized geometric mean titer by baseline normalized geometric mean titer. The GMFR across samples was calculated within each study arm and analysis time point.
Outcome measures
| Measure |
M2SR
n=22 Participants
A single dose of monovalent live attenuated influenza H3N2 M2SR vaccine (M2SR) administered intranasally on Day 1, and a single dose of licensed quadrivalent influenza vaccine (QIV) administered intramuscularly on Day 92.
|
Placebo
n=21 Participants
A single dose of Placebo administered intranasally on Day 1, and a single dose of licensed QIV administered intramuscularly on Day 92.
|
|---|---|---|
|
Geometric Mean Fold Rise (GMFR) of Nasal Secretory Immunoglobulin A (sIgA) Responses Directed Against the H3N2 M2SR-like Virus A/Brisbane/10/2007 Normalized to Total sIgA
Day 22
|
1.9 ratio
Interval 0.9 to 4.1
|
1.3 ratio
Interval 0.8 to 1.9
|
|
Geometric Mean Fold Rise (GMFR) of Nasal Secretory Immunoglobulin A (sIgA) Responses Directed Against the H3N2 M2SR-like Virus A/Brisbane/10/2007 Normalized to Total sIgA
Day 57
|
1.0 ratio
Interval 0.4 to 2.4
|
1.2 ratio
Interval 0.5 to 2.5
|
|
Geometric Mean Fold Rise (GMFR) of Nasal Secretory Immunoglobulin A (sIgA) Responses Directed Against the H3N2 M2SR-like Virus A/Brisbane/10/2007 Normalized to Total sIgA
Day 92
|
1.3 ratio
Interval 0.6 to 2.6
|
0.8 ratio
Interval 0.3 to 2.0
|
|
Geometric Mean Fold Rise (GMFR) of Nasal Secretory Immunoglobulin A (sIgA) Responses Directed Against the H3N2 M2SR-like Virus A/Brisbane/10/2007 Normalized to Total sIgA
Day 113
|
1.1 ratio
Interval 0.7 to 1.8
|
1.6 ratio
Interval 0.7 to 3.7
|
|
Geometric Mean Fold Rise (GMFR) of Nasal Secretory Immunoglobulin A (sIgA) Responses Directed Against the H3N2 M2SR-like Virus A/Brisbane/10/2007 Normalized to Total sIgA
Day 8
|
1.9 ratio
Interval 0.9 to 4.1
|
1.6 ratio
Interval 0.8 to 3.5
|
SECONDARY outcome
Timeframe: Day 8 through Day 113Population: The Modified Intent-to-Treat (mITT) population includes all participants who received at least one dose of study vaccine and contributed both pre- and at least one post-study vaccination venous blood samples for which valid results were reported.
Nasal swabs were collected for secretory immunoglobulin A (sIgA) assays conducted with H3N2 QIV-like virus A/North Carolina/04/2016 as the antigen. Collection took place on Day 1 (pre-vaccination), Days 8, 22, and 57 after first vaccination, immediately prior to second vaccination (Day 92), and 21 days after second vaccination (Day 113). The geometric mean of each sample's replicate results was calculated from available results. Geometric mean fold rise (GMFR) was calculated by dividing each post-baseline geometric mean titer by baseline geometric mean titer. The GMFR across samples was calculated within each study arm and analysis time point.
Outcome measures
| Measure |
M2SR
n=22 Participants
A single dose of monovalent live attenuated influenza H3N2 M2SR vaccine (M2SR) administered intranasally on Day 1, and a single dose of licensed quadrivalent influenza vaccine (QIV) administered intramuscularly on Day 92.
|
Placebo
n=21 Participants
A single dose of Placebo administered intranasally on Day 1, and a single dose of licensed QIV administered intramuscularly on Day 92.
|
|---|---|---|
|
Geometric Mean Fold Rise (GMFR) of Nasal Secretory Immunoglobulin A (sIgA) Responses Directed Against the H3N2 QIV-like Virus A/North Carolina/04/2016
Day 8
|
0.7 ratio
Interval 0.2 to 1.9
|
0.7 ratio
Interval 0.3 to 1.9
|
|
Geometric Mean Fold Rise (GMFR) of Nasal Secretory Immunoglobulin A (sIgA) Responses Directed Against the H3N2 QIV-like Virus A/North Carolina/04/2016
Day 22
|
0.8 ratio
Interval 0.2 to 2.6
|
1.2 ratio
Interval 0.7 to 2.0
|
|
Geometric Mean Fold Rise (GMFR) of Nasal Secretory Immunoglobulin A (sIgA) Responses Directed Against the H3N2 QIV-like Virus A/North Carolina/04/2016
Day 57
|
0.7 ratio
Interval 0.2 to 2.0
|
1.1 ratio
Interval 0.4 to 3.1
|
|
Geometric Mean Fold Rise (GMFR) of Nasal Secretory Immunoglobulin A (sIgA) Responses Directed Against the H3N2 QIV-like Virus A/North Carolina/04/2016
Day 92
|
1.0 ratio
Interval 0.5 to 2.4
|
1.1 ratio
Interval 0.4 to 2.7
|
|
Geometric Mean Fold Rise (GMFR) of Nasal Secretory Immunoglobulin A (sIgA) Responses Directed Against the H3N2 QIV-like Virus A/North Carolina/04/2016
Day 113
|
1.6 ratio
Interval 0.5 to 5.2
|
2.5 ratio
Interval 0.9 to 6.9
|
SECONDARY outcome
Timeframe: Day 8 through Day 113Population: The Modified Intent-to-Treat (mITT) population includes all participants who received at least one dose of study vaccine and contributed both pre- and at least one post-study vaccination venous blood samples for which valid results were reported.
Nasal swabs were collected for secretory immunoglobulin A (sIgA) assays conducted with H3N2 QIV-like virus A/North Carolina/04/2016 as the antigen. Collection took place on Day 1 (pre-vaccination), Days 8, 22, and 57 after first vaccination, immediately prior to second vaccination (Day 92), and 21 days after second vaccination (Day 113). The geometric mean of each sample's replicate results was calculated from available results. Results were normalized to total sIgA by dividing each geometric mean titer by total sIgA concentration (ng/mL). Geometric mean fold rise (GMFR) was calculated by dividing each post-baseline normalized geometric mean titer by baseline normalized geometric mean titer. The GMFR across samples was calculated within each study arm and analysis time point.
Outcome measures
| Measure |
M2SR
n=22 Participants
A single dose of monovalent live attenuated influenza H3N2 M2SR vaccine (M2SR) administered intranasally on Day 1, and a single dose of licensed quadrivalent influenza vaccine (QIV) administered intramuscularly on Day 92.
|
Placebo
n=21 Participants
A single dose of Placebo administered intranasally on Day 1, and a single dose of licensed QIV administered intramuscularly on Day 92.
|
|---|---|---|
|
Geometric Mean Fold Rise (GMFR) of Nasal Secretory Immunoglobulin A (sIgA) Responses Directed Against the H3N2 QIV-like Virus A/North Carolina/04/2016 Normalized to Total sIgA
Day 8
|
1.2 ratio
Interval 0.6 to 2.6
|
1.0 ratio
Interval 0.5 to 1.9
|
|
Geometric Mean Fold Rise (GMFR) of Nasal Secretory Immunoglobulin A (sIgA) Responses Directed Against the H3N2 QIV-like Virus A/North Carolina/04/2016 Normalized to Total sIgA
Day 22
|
1.1 ratio
Interval 0.6 to 2.0
|
0.8 ratio
Interval 0.5 to 1.5
|
|
Geometric Mean Fold Rise (GMFR) of Nasal Secretory Immunoglobulin A (sIgA) Responses Directed Against the H3N2 QIV-like Virus A/North Carolina/04/2016 Normalized to Total sIgA
Day 57
|
0.8 ratio
Interval 0.4 to 1.7
|
0.7 ratio
Interval 0.4 to 1.3
|
|
Geometric Mean Fold Rise (GMFR) of Nasal Secretory Immunoglobulin A (sIgA) Responses Directed Against the H3N2 QIV-like Virus A/North Carolina/04/2016 Normalized to Total sIgA
Day 92
|
1.0 ratio
Interval 0.7 to 1.6
|
0.6 ratio
Interval 0.4 to 1.1
|
|
Geometric Mean Fold Rise (GMFR) of Nasal Secretory Immunoglobulin A (sIgA) Responses Directed Against the H3N2 QIV-like Virus A/North Carolina/04/2016 Normalized to Total sIgA
Day 113
|
1.0 ratio
Interval 0.6 to 1.7
|
0.8 ratio
Interval 0.4 to 1.5
|
SECONDARY outcome
Timeframe: Day 8 through Day 113Population: The Modified Intent-to-Treat (mITT) population includes all participants who received at least one dose of study vaccine and contributed both pre- and at least one post-study vaccination venous blood samples for which valid results were reported.
Nasal swabs were collected for secretory immunoglobulin A (sIgA) assays conducted with H3N2 QIV-like virus A/Singapore/INFIMH-16-0019/2016 as the antigen. Collection took place on Day 1 (pre-vaccination), Days 8, 22, and 57 after first vaccination, immediately prior to second vaccination (Day 92), and 21 days after second vaccination (Day 113). The geometric mean of each sample's replicate results was calculated from available results. Geometric mean fold rise (GMFR) was calculated by dividing each post-baseline geometric mean titer by baseline geometric mean titer. The GMFR across samples was calculated within each study arm and analysis time point.
Outcome measures
| Measure |
M2SR
n=22 Participants
A single dose of monovalent live attenuated influenza H3N2 M2SR vaccine (M2SR) administered intranasally on Day 1, and a single dose of licensed quadrivalent influenza vaccine (QIV) administered intramuscularly on Day 92.
|
Placebo
n=21 Participants
A single dose of Placebo administered intranasally on Day 1, and a single dose of licensed QIV administered intramuscularly on Day 92.
|
|---|---|---|
|
Geometric Mean Fold Rise (GMFR) of Nasal Secretory Immunoglobulin A (sIgA) Responses Directed Against the H3N2 QIV-like Virus A/Singapore/INFIMH-16-0019/2016
Day 8
|
0.7 ratio
Interval 0.3 to 1.5
|
0.5 ratio
Interval 0.2 to 1.0
|
|
Geometric Mean Fold Rise (GMFR) of Nasal Secretory Immunoglobulin A (sIgA) Responses Directed Against the H3N2 QIV-like Virus A/Singapore/INFIMH-16-0019/2016
Day 22
|
1.3 ratio
Interval 0.6 to 3.1
|
1.1 ratio
Interval 0.6 to 2.3
|
|
Geometric Mean Fold Rise (GMFR) of Nasal Secretory Immunoglobulin A (sIgA) Responses Directed Against the H3N2 QIV-like Virus A/Singapore/INFIMH-16-0019/2016
Day 57
|
0.6 ratio
Interval 0.3 to 1.1
|
0.8 ratio
Interval 0.4 to 1.6
|
|
Geometric Mean Fold Rise (GMFR) of Nasal Secretory Immunoglobulin A (sIgA) Responses Directed Against the H3N2 QIV-like Virus A/Singapore/INFIMH-16-0019/2016
Day 92
|
0.8 ratio
Interval 0.4 to 1.8
|
0.5 ratio
Interval 0.2 to 1.2
|
|
Geometric Mean Fold Rise (GMFR) of Nasal Secretory Immunoglobulin A (sIgA) Responses Directed Against the H3N2 QIV-like Virus A/Singapore/INFIMH-16-0019/2016
Day 113
|
0.9 ratio
Interval 0.3 to 2.7
|
0.9 ratio
Interval 0.4 to 2.2
|
SECONDARY outcome
Timeframe: Day 8 through Day 113Population: The Modified Intent-to-Treat (mITT) population includes all participants who received at least one dose of study vaccine and contributed both pre- and at least one post-study vaccination venous blood samples for which valid results were reported.
Nasal swabs were collected for secretory immunoglobulin A (sIgA) assays conducted with H3N2 QIV-like virus A/Singapore/INFIMH-16-0019/2016 as the antigen. Collection took place on Day 1 (pre-vaccination), Days 8, 22, and 57 after first vaccination, immediately prior to second vaccination (Day 92), and 21 days after second vaccination (Day 113). The geometric mean of each sample's replicate results was calculated from available results. Results were normalized to total sIgA by dividing each geometric mean titer by total sIgA concentration (ng/mL). Geometric mean fold rise (GMFR) was calculated by dividing each post-baseline normalized geometric mean titer by baseline normalized geometric mean titer. The GMFR across samples was calculated within each study arm and analysis time point.
Outcome measures
| Measure |
M2SR
n=22 Participants
A single dose of monovalent live attenuated influenza H3N2 M2SR vaccine (M2SR) administered intranasally on Day 1, and a single dose of licensed quadrivalent influenza vaccine (QIV) administered intramuscularly on Day 92.
|
Placebo
n=21 Participants
A single dose of Placebo administered intranasally on Day 1, and a single dose of licensed QIV administered intramuscularly on Day 92.
|
|---|---|---|
|
Geometric Mean Fold Rise (GMFR) of Nasal Secretory Immunoglobulin A (sIgA) Responses Directed Against the H3N2 QIV-like Virus A/Singapore/INFIMH-16-0019/2016 Normalized to Total sIgA
Day 8
|
1.2 ratio
Interval 0.6 to 2.5
|
0.7 ratio
Interval 0.3 to 1.6
|
|
Geometric Mean Fold Rise (GMFR) of Nasal Secretory Immunoglobulin A (sIgA) Responses Directed Against the H3N2 QIV-like Virus A/Singapore/INFIMH-16-0019/2016 Normalized to Total sIgA
Day 22
|
1.9 ratio
Interval 0.8 to 4.4
|
0.8 ratio
Interval 0.4 to 1.5
|
|
Geometric Mean Fold Rise (GMFR) of Nasal Secretory Immunoglobulin A (sIgA) Responses Directed Against the H3N2 QIV-like Virus A/Singapore/INFIMH-16-0019/2016 Normalized to Total sIgA
Day 57
|
0.7 ratio
Interval 0.3 to 1.8
|
0.5 ratio
Interval 0.2 to 1.2
|
|
Geometric Mean Fold Rise (GMFR) of Nasal Secretory Immunoglobulin A (sIgA) Responses Directed Against the H3N2 QIV-like Virus A/Singapore/INFIMH-16-0019/2016 Normalized to Total sIgA
Day 92
|
0.8 ratio
Interval 0.4 to 1.7
|
0.3 ratio
Interval 0.1 to 0.8
|
|
Geometric Mean Fold Rise (GMFR) of Nasal Secretory Immunoglobulin A (sIgA) Responses Directed Against the H3N2 QIV-like Virus A/Singapore/INFIMH-16-0019/2016 Normalized to Total sIgA
Day 113
|
0.6 ratio
Interval 0.2 to 1.7
|
0.3 ratio
Interval 0.1 to 0.8
|
SECONDARY outcome
Timeframe: Day 8 through Day 113Population: The Modified Intent-to-Treat (mITT) population includes all participants who received at least one dose of study vaccine and contributed both pre- and at least one post-study vaccination venous blood samples for which valid results were reported.
Nasal swabs were collected for secretory immunoglobulin A (sIgA) assays conducted with H3N2 QIV-like virus A/Kansas/14/2017 as the antigen. Collection took place on Day 1 (pre-vaccination), Days 8, 22, and 57 after first vaccination, immediately prior to second vaccination (Day 92), and 21 days after second vaccination (Day 113). The geometric mean of each sample's replicate results was calculated from available results. Geometric mean fold rise (GMFR) was calculated by dividing each post-baseline geometric mean titer by baseline geometric mean titer. The GMFR across samples was calculated within each study arm and analysis time point.
Outcome measures
| Measure |
M2SR
n=22 Participants
A single dose of monovalent live attenuated influenza H3N2 M2SR vaccine (M2SR) administered intranasally on Day 1, and a single dose of licensed quadrivalent influenza vaccine (QIV) administered intramuscularly on Day 92.
|
Placebo
n=21 Participants
A single dose of Placebo administered intranasally on Day 1, and a single dose of licensed QIV administered intramuscularly on Day 92.
|
|---|---|---|
|
Geometric Mean Fold Rise (GMFR) of Nasal Secretory Immunoglobulin A (sIgA) Responses Directed Against the H3N2 QIV-like Virus A/Kansas/14/2017
Day 8
|
0.6 ratio
Interval 0.2 to 1.7
|
0.5 ratio
Interval 0.2 to 1.3
|
|
Geometric Mean Fold Rise (GMFR) of Nasal Secretory Immunoglobulin A (sIgA) Responses Directed Against the H3N2 QIV-like Virus A/Kansas/14/2017
Day 22
|
1.1 ratio
Interval 0.4 to 2.8
|
1.3 ratio
Interval 0.5 to 3.4
|
|
Geometric Mean Fold Rise (GMFR) of Nasal Secretory Immunoglobulin A (sIgA) Responses Directed Against the H3N2 QIV-like Virus A/Kansas/14/2017
Day 57
|
0.6 ratio
Interval 0.2 to 1.7
|
1.2 ratio
Interval 0.4 to 3.6
|
|
Geometric Mean Fold Rise (GMFR) of Nasal Secretory Immunoglobulin A (sIgA) Responses Directed Against the H3N2 QIV-like Virus A/Kansas/14/2017
Day 92
|
1.4 ratio
Interval 0.6 to 3.5
|
1.1 ratio
Interval 0.5 to 2.3
|
|
Geometric Mean Fold Rise (GMFR) of Nasal Secretory Immunoglobulin A (sIgA) Responses Directed Against the H3N2 QIV-like Virus A/Kansas/14/2017
Day 113
|
1.3 ratio
Interval 0.3 to 5.4
|
3.8 ratio
Interval 1.4 to 10.2
|
SECONDARY outcome
Timeframe: Day 8 through Day 113Population: The Modified Intent-to-Treat (mITT) population includes all participants who received at least one dose of study vaccine and contributed both pre- and at least one post-study vaccination venous blood samples for which valid results were reported.
Nasal swabs were collected for secretory immunoglobulin A (sIgA) assays conducted with H3N2 QIV-like virus A/Kansas/14/2017 as the antigen. Collection took place on Day 1 (pre-vaccination), Days 8, 22, and 57 after first vaccination, immediately prior to second vaccination (Day 92), and 21 days after second vaccination (Day 113). The geometric mean of each sample's replicate results was calculated from available results. Results were normalized to total sIgA by dividing each geometric mean titer by total sIgA concentration (ng/mL). Geometric mean fold rise (GMFR) was calculated by dividing each post-baseline normalized geometric mean titer by baseline normalized geometric mean titer. The GMFR across samples was calculated within each study arm and analysis time point.
Outcome measures
| Measure |
M2SR
n=22 Participants
A single dose of monovalent live attenuated influenza H3N2 M2SR vaccine (M2SR) administered intranasally on Day 1, and a single dose of licensed quadrivalent influenza vaccine (QIV) administered intramuscularly on Day 92.
|
Placebo
n=21 Participants
A single dose of Placebo administered intranasally on Day 1, and a single dose of licensed QIV administered intramuscularly on Day 92.
|
|---|---|---|
|
Geometric Mean Fold Rise (GMFR) of Nasal Secretory Immunoglobulin A (sIgA) Responses Directed Against the H3N2 QIV-like Virus A/Kansas/14/2017 Normalized to Total sIgA
Day 8
|
1.1 ratio
Interval 0.6 to 2.1
|
0.7 ratio
Interval 0.3 to 1.5
|
|
Geometric Mean Fold Rise (GMFR) of Nasal Secretory Immunoglobulin A (sIgA) Responses Directed Against the H3N2 QIV-like Virus A/Kansas/14/2017 Normalized to Total sIgA
Day 22
|
1.6 ratio
Interval 0.8 to 3.3
|
0.8 ratio
Interval 0.4 to 1.9
|
|
Geometric Mean Fold Rise (GMFR) of Nasal Secretory Immunoglobulin A (sIgA) Responses Directed Against the H3N2 QIV-like Virus A/Kansas/14/2017 Normalized to Total sIgA
Day 92
|
1.4 ratio
Interval 0.8 to 2.3
|
0.6 ratio
Interval 0.3 to 1.3
|
|
Geometric Mean Fold Rise (GMFR) of Nasal Secretory Immunoglobulin A (sIgA) Responses Directed Against the H3N2 QIV-like Virus A/Kansas/14/2017 Normalized to Total sIgA
Day 113
|
0.9 ratio
Interval 0.4 to 2.0
|
1.2 ratio
Interval 0.6 to 2.6
|
|
Geometric Mean Fold Rise (GMFR) of Nasal Secretory Immunoglobulin A (sIgA) Responses Directed Against the H3N2 QIV-like Virus A/Kansas/14/2017 Normalized to Total sIgA
Day 57
|
0.7 ratio
Interval 0.3 to 1.7
|
0.8 ratio
Interval 0.4 to 1.7
|
SECONDARY outcome
Timeframe: Day 1 through Day 113Population: The Modified Intent-to-Treat (mITT) population includes all participants who received at least one dose of study vaccine and contributed both pre- and at least one post-study vaccination venous blood samples for which valid results were reported.
Nasal swabs were collected for secretory immunoglobulin A (sIgA) assays conducted with H3N2 M2SR-like virus A/Brisbane/10/2007 as the antigen. Collection took place on Day 1 (pre-vaccination), Days 8, 22, and 57 after first vaccination, immediately prior to second vaccination (Day 92), and 21 days after second vaccination (Day 113). The geometric mean of each sample's replicate results was calculated from available results. The geometric mean titer (GMT) across samples was calculated within each study arm and analysis time point.
Outcome measures
| Measure |
M2SR
n=22 Participants
A single dose of monovalent live attenuated influenza H3N2 M2SR vaccine (M2SR) administered intranasally on Day 1, and a single dose of licensed quadrivalent influenza vaccine (QIV) administered intramuscularly on Day 92.
|
Placebo
n=21 Participants
A single dose of Placebo administered intranasally on Day 1, and a single dose of licensed QIV administered intramuscularly on Day 92.
|
|---|---|---|
|
Geometric Mean Titer (GMT) of Nasal Secretory Immunoglobulin A (sIgA) Responses Directed Against the H3N2 M2SR-like Virus A/Brisbane/10/2007
Day 1
|
17.3 titer
Interval 7.0 to 42.4
|
8.4 titer
Interval 3.9 to 18.1
|
|
Geometric Mean Titer (GMT) of Nasal Secretory Immunoglobulin A (sIgA) Responses Directed Against the H3N2 M2SR-like Virus A/Brisbane/10/2007
Day 8
|
18.9 titer
Interval 7.4 to 48.3
|
10.3 titer
Interval 3.8 to 28.2
|
|
Geometric Mean Titer (GMT) of Nasal Secretory Immunoglobulin A (sIgA) Responses Directed Against the H3N2 M2SR-like Virus A/Brisbane/10/2007
Day 22
|
22.9 titer
Interval 8.5 to 61.5
|
15.9 titer
Interval 8.9 to 28.5
|
|
Geometric Mean Titer (GMT) of Nasal Secretory Immunoglobulin A (sIgA) Responses Directed Against the H3N2 M2SR-like Virus A/Brisbane/10/2007
Day 57
|
13.8 titer
Interval 5.4 to 35.3
|
16.0 titer
Interval 6.1 to 42.0
|
|
Geometric Mean Titer (GMT) of Nasal Secretory Immunoglobulin A (sIgA) Responses Directed Against the H3N2 M2SR-like Virus A/Brisbane/10/2007
Day 92
|
21.2 titer
Interval 10.2 to 44.0
|
12.0 titer
Interval 5.7 to 25.4
|
|
Geometric Mean Titer (GMT) of Nasal Secretory Immunoglobulin A (sIgA) Responses Directed Against the H3N2 M2SR-like Virus A/Brisbane/10/2007
Day 113
|
28.4 titer
Interval 11.5 to 70.1
|
41.2 titer
Interval 15.6 to 109.2
|
SECONDARY outcome
Timeframe: Day 1 through Day 113Population: The Modified Intent-to-Treat (mITT) population includes all participants who received at least one dose of study vaccine and contributed both pre- and at least one post-study vaccination venous blood samples for which valid results were reported.
Nasal swabs were collected for secretory immunoglobulin A (sIgA) assays conducted with H3N2 M2SR-like virus A/Brisbane/10/2007 as the antigen. Collection took place on Day 1 (pre-vaccination), Days 8, 22, and 57 after first vaccination, immediately prior to second vaccination (Day 92), and 21 days after second vaccination (Day 113). The geometric mean of each sample's replicate results was calculated from available results. Results were normalized to total sIgA by dividing each geometric mean titer by total sIgA concentration (ng/ml). The geometric mean titer (GMT) across samples was calculated within each study arm and analysis time point.
Outcome measures
| Measure |
M2SR
n=22 Participants
A single dose of monovalent live attenuated influenza H3N2 M2SR vaccine (M2SR) administered intranasally on Day 1, and a single dose of licensed quadrivalent influenza vaccine (QIV) administered intramuscularly on Day 92.
|
Placebo
n=21 Participants
A single dose of Placebo administered intranasally on Day 1, and a single dose of licensed QIV administered intramuscularly on Day 92.
|
|---|---|---|
|
Geometric Mean Titer (GMT) of Nasal Secretory Immunoglobulin A (sIgA) Responses Directed Against the H3N2 M2SR-like Virus A/Brisbane/10/2007 Normalized to Total sIgA
Day 1
|
1.5 titer per ng/mL sIgA
Interval 0.6 to 3.4
|
1.4 titer per ng/mL sIgA
Interval 0.7 to 3.0
|
|
Geometric Mean Titer (GMT) of Nasal Secretory Immunoglobulin A (sIgA) Responses Directed Against the H3N2 M2SR-like Virus A/Brisbane/10/2007 Normalized to Total sIgA
Day 8
|
2.9 titer per ng/mL sIgA
Interval 1.7 to 4.9
|
2.3 titer per ng/mL sIgA
Interval 1.2 to 4.7
|
|
Geometric Mean Titer (GMT) of Nasal Secretory Immunoglobulin A (sIgA) Responses Directed Against the H3N2 M2SR-like Virus A/Brisbane/10/2007 Normalized to Total sIgA
Day 22
|
2.8 titer per ng/mL sIgA
Interval 1.5 to 5.4
|
1.8 titer per ng/mL sIgA
Interval 0.9 to 3.6
|
|
Geometric Mean Titer (GMT) of Nasal Secretory Immunoglobulin A (sIgA) Responses Directed Against the H3N2 M2SR-like Virus A/Brisbane/10/2007 Normalized to Total sIgA
Day 57
|
1.5 titer per ng/mL sIgA
Interval 0.6 to 3.5
|
1.7 titer per ng/mL sIgA
Interval 0.7 to 3.7
|
|
Geometric Mean Titer (GMT) of Nasal Secretory Immunoglobulin A (sIgA) Responses Directed Against the H3N2 M2SR-like Virus A/Brisbane/10/2007 Normalized to Total sIgA
Day 92
|
1.8 titer per ng/mL sIgA
Interval 0.9 to 3.9
|
1.2 titer per ng/mL sIgA
Interval 0.4 to 3.3
|
|
Geometric Mean Titer (GMT) of Nasal Secretory Immunoglobulin A (sIgA) Responses Directed Against the H3N2 M2SR-like Virus A/Brisbane/10/2007 Normalized to Total sIgA
Day 113
|
1.6 titer per ng/mL sIgA
Interval 0.8 to 3.2
|
2.3 titer per ng/mL sIgA
Interval 0.9 to 5.8
|
SECONDARY outcome
Timeframe: Day 1 through Day 113Population: The Modified Intent-to-Treat (mITT) population includes all participants who received at least one dose of study vaccine and contributed both pre- and at least one post-study vaccination venous blood samples for which valid results were reported.
Nasal swabs were collected for secretory immunoglobulin A (sIgA) assays conducted with H3N2 QIV-like virus A/North Carolina/04/2016 as the antigen. Collection took place on Day 1 (pre-vaccination), Days 8, 22, and 57 after first vaccination, immediately prior to second vaccination (Day 92), and 21 days after second vaccination (Day 113). The geometric mean of each sample's replicate results was calculated from available results. The geometric mean titer (GMT) across samples was calculated within each study arm and analysis time point.
Outcome measures
| Measure |
M2SR
n=22 Participants
A single dose of monovalent live attenuated influenza H3N2 M2SR vaccine (M2SR) administered intranasally on Day 1, and a single dose of licensed quadrivalent influenza vaccine (QIV) administered intramuscularly on Day 92.
|
Placebo
n=21 Participants
A single dose of Placebo administered intranasally on Day 1, and a single dose of licensed QIV administered intramuscularly on Day 92.
|
|---|---|---|
|
Geometric Mean Titer (GMT) of Nasal Secretory Immunoglobulin A (sIgA) Responses Directed Against the H3N2 QIV-like Virus A/North Carolina/04/2016
Day 1
|
25.5 titer
Interval 10.9 to 59.4
|
16.7 titer
Interval 6.2 to 45.0
|
|
Geometric Mean Titer (GMT) of Nasal Secretory Immunoglobulin A (sIgA) Responses Directed Against the H3N2 QIV-like Virus A/North Carolina/04/2016
Day 8
|
17.5 titer
Interval 7.6 to 40.1
|
12.5 titer
Interval 4.9 to 31.7
|
|
Geometric Mean Titer (GMT) of Nasal Secretory Immunoglobulin A (sIgA) Responses Directed Against the H3N2 QIV-like Virus A/North Carolina/04/2016
Day 57
|
16.9 titer
Interval 7.3 to 39.0
|
18.6 titer
Interval 6.9 to 49.9
|
|
Geometric Mean Titer (GMT) of Nasal Secretory Immunoglobulin A (sIgA) Responses Directed Against the H3N2 QIV-like Virus A/North Carolina/04/2016
Day 92
|
25.8 titer
Interval 13.2 to 50.6
|
18.2 titer
Interval 8.1 to 41.2
|
|
Geometric Mean Titer (GMT) of Nasal Secretory Immunoglobulin A (sIgA) Responses Directed Against the H3N2 QIV-like Virus A/North Carolina/04/2016
Day 113
|
38.1 titer
Interval 16.6 to 87.2
|
41.3 titer
Interval 15.4 to 110.8
|
|
Geometric Mean Titer (GMT) of Nasal Secretory Immunoglobulin A (sIgA) Responses Directed Against the H3N2 QIV-like Virus A/North Carolina/04/2016
Day 22
|
19.5 titer
Interval 7.3 to 52.5
|
20.4 titer
Interval 9.8 to 42.3
|
SECONDARY outcome
Timeframe: Day 1 through Day 113Population: The Modified Intent-to-Treat (mITT) population includes all participants who received at least one dose of study vaccine and contributed both pre- and at least one post-study vaccination venous blood samples for which valid results were reported.
Nasal swabs were collected for secretory immunoglobulin A (sIgA) assays conducted with H3N2 QIV-like virus A/North Carolina/04/2016 as the antigen. Collection took place on Day 1 (pre-vaccination), Days 8, 22, and 57 after first vaccination, immediately prior to second vaccination (Day 92), and 21 days after second vaccination (Day 113). The geometric mean of each sample's replicate results was calculated from available results. Results were normalized to total sIgA by dividing each geometric mean titer by total sIgA concentration (ng/ml). The geometric mean titer (GMT) across samples was calculated within each study arm and analysis time point.
Outcome measures
| Measure |
M2SR
n=22 Participants
A single dose of monovalent live attenuated influenza H3N2 M2SR vaccine (M2SR) administered intranasally on Day 1, and a single dose of licensed quadrivalent influenza vaccine (QIV) administered intramuscularly on Day 92.
|
Placebo
n=21 Participants
A single dose of Placebo administered intranasally on Day 1, and a single dose of licensed QIV administered intramuscularly on Day 92.
|
|---|---|---|
|
Geometric Mean Titer (GMT) of Nasal Secretory Immunoglobulin A (sIgA) Responses Directed Against the H3N2 QIV-like Virus A/North Carolina/04/2016 Normalized to Total sIgA
Day 1
|
2.2 titer per ng/mL sIgA
Interval 1.2 to 4.0
|
2.8 titer per ng/mL sIgA
Interval 1.1 to 7.0
|
|
Geometric Mean Titer (GMT) of Nasal Secretory Immunoglobulin A (sIgA) Responses Directed Against the H3N2 QIV-like Virus A/North Carolina/04/2016 Normalized to Total sIgA
Day 8
|
2.7 titer per ng/mL sIgA
Interval 1.5 to 4.8
|
2.8 titer per ng/mL sIgA
Interval 1.4 to 5.7
|
|
Geometric Mean Titer (GMT) of Nasal Secretory Immunoglobulin A (sIgA) Responses Directed Against the H3N2 QIV-like Virus A/North Carolina/04/2016 Normalized to Total sIgA
Day 22
|
2.4 titer per ng/mL sIgA
Interval 1.4 to 4.3
|
2.3 titer per ng/mL sIgA
Interval 1.0 to 5.4
|
|
Geometric Mean Titer (GMT) of Nasal Secretory Immunoglobulin A (sIgA) Responses Directed Against the H3N2 QIV-like Virus A/North Carolina/04/2016 Normalized to Total sIgA
Day 57
|
1.8 titer per ng/mL sIgA
Interval 0.9 to 3.7
|
1.9 titer per ng/mL sIgA
Interval 0.8 to 4.5
|
|
Geometric Mean Titer (GMT) of Nasal Secretory Immunoglobulin A (sIgA) Responses Directed Against the H3N2 QIV-like Virus A/North Carolina/04/2016 Normalized to Total sIgA
Day 92
|
2.2 titer per ng/mL sIgA
Interval 1.3 to 3.9
|
1.8 titer per ng/mL sIgA
Interval 0.8 to 4.4
|
|
Geometric Mean Titer (GMT) of Nasal Secretory Immunoglobulin A (sIgA) Responses Directed Against the H3N2 QIV-like Virus A/North Carolina/04/2016 Normalized to Total sIgA
Day 113
|
2.1 titer per ng/mL sIgA
Interval 1.2 to 3.6
|
2.3 titer per ng/mL sIgA
Interval 0.9 to 5.9
|
SECONDARY outcome
Timeframe: Day 1 through Day 113Population: The Modified Intent-to-Treat (mITT) population includes all participants who received at least one dose of study vaccine and contributed both pre- and at least one post-study vaccination venous blood samples for which valid results were reported.
Nasal swabs were collected for secretory immunoglobulin A (sIgA) assays conducted with H3N2 QIV-like virus A/Singapore/INFIMH-16-0019/2016 as the antigen. Collection took place on Day 1 (pre-vaccination), Days 8, 22, and 57 after first vaccination, immediately prior to second vaccination (Day 92), and 21 days after second vaccination (Day 113). The geometric mean of each sample's replicate results was calculated from available results. The geometric mean titer (GMT) across samples was calculated within each study arm and analysis time point.
Outcome measures
| Measure |
M2SR
n=22 Participants
A single dose of monovalent live attenuated influenza H3N2 M2SR vaccine (M2SR) administered intranasally on Day 1, and a single dose of licensed quadrivalent influenza vaccine (QIV) administered intramuscularly on Day 92.
|
Placebo
n=21 Participants
A single dose of Placebo administered intranasally on Day 1, and a single dose of licensed QIV administered intramuscularly on Day 92.
|
|---|---|---|
|
Geometric Mean Titer (GMT) of Nasal Secretory Immunoglobulin A (sIgA) Responses Directed Against the H3N2 QIV-like Virus A/Singapore/INFIMH-16-0019/2016
Day 1
|
29.7 titer
Interval 15.0 to 58.6
|
26.1 titer
Interval 10.9 to 62.1
|
|
Geometric Mean Titer (GMT) of Nasal Secretory Immunoglobulin A (sIgA) Responses Directed Against the H3N2 QIV-like Virus A/Singapore/INFIMH-16-0019/2016
Day 8
|
20.2 titer
Interval 9.3 to 44.0
|
12.8 titer
Interval 5.4 to 30.4
|
|
Geometric Mean Titer (GMT) of Nasal Secretory Immunoglobulin A (sIgA) Responses Directed Against the H3N2 QIV-like Virus A/Singapore/INFIMH-16-0019/2016
Day 22
|
39.0 titer
Interval 18.0 to 84.4
|
29.8 titer
Interval 14.2 to 62.4
|
|
Geometric Mean Titer (GMT) of Nasal Secretory Immunoglobulin A (sIgA) Responses Directed Against the H3N2 QIV-like Virus A/Singapore/INFIMH-16-0019/2016
Day 57
|
16.7 titer
Interval 8.6 to 32.7
|
21.4 titer
Interval 9.6 to 47.5
|
|
Geometric Mean Titer (GMT) of Nasal Secretory Immunoglobulin A (sIgA) Responses Directed Against the H3N2 QIV-like Virus A/Singapore/INFIMH-16-0019/2016
Day 92
|
24.6 titer
Interval 12.3 to 49.1
|
14.3 titer
Interval 6.8 to 30.0
|
|
Geometric Mean Titer (GMT) of Nasal Secretory Immunoglobulin A (sIgA) Responses Directed Against the H3N2 QIV-like Virus A/Singapore/INFIMH-16-0019/2016
Day 113
|
25.7 titer
Interval 11.9 to 55.6
|
23.0 titer
Interval 8.9 to 59.2
|
SECONDARY outcome
Timeframe: Day 1 through Day 113Population: The Modified Intent-to-Treat (mITT) population includes all participants who received at least one dose of study vaccine and contributed both pre- and at least one post-study vaccination venous blood samples for which valid results were reported.
Nasal swabs were collected for secretory immunoglobulin A (sIgA) assays conducted with H3N2 QIV-like virus A/Singapore/INFIMH-16-0019/2016 as the antigen. Collection took place on Day 1 (pre-vaccination), Days 8, 22, and 57 after first vaccination, immediately prior to second vaccination (Day 92), and 21 days after second vaccination (Day 113). The geometric mean of each sample's replicate results was calculated from available results. Results were normalized to total sIgA by dividing each geometric mean titer by total sIgA concentration (ng/ml). The geometric mean titer (GMT) across samples was calculated within each study arm and analysis time point.
Outcome measures
| Measure |
M2SR
n=22 Participants
A single dose of monovalent live attenuated influenza H3N2 M2SR vaccine (M2SR) administered intranasally on Day 1, and a single dose of licensed quadrivalent influenza vaccine (QIV) administered intramuscularly on Day 92.
|
Placebo
n=21 Participants
A single dose of Placebo administered intranasally on Day 1, and a single dose of licensed QIV administered intramuscularly on Day 92.
|
|---|---|---|
|
Geometric Mean Titer (GMT) of Nasal Secretory Immunoglobulin A (sIgA) Responses Directed Against the H3N2 QIV-like Virus A/Singapore/INFIMH-16-0019/2016 Normalized to Total sIgA
Day 1
|
2.6 titer per ng/mL sIgA
Interval 1.3 to 5.1
|
4.4 titer per ng/mL sIgA
Interval 1.7 to 11.6
|
|
Geometric Mean Titer (GMT) of Nasal Secretory Immunoglobulin A (sIgA) Responses Directed Against the H3N2 QIV-like Virus A/Singapore/INFIMH-16-0019/2016 Normalized to Total sIgA
Day 8
|
3.1 titer per ng/mL sIgA
Interval 1.4 to 6.9
|
2.9 titer per ng/mL sIgA
Interval 1.1 to 7.5
|
|
Geometric Mean Titer (GMT) of Nasal Secretory Immunoglobulin A (sIgA) Responses Directed Against the H3N2 QIV-like Virus A/Singapore/INFIMH-16-0019/2016 Normalized to Total sIgA
Day 22
|
4.8 titer per ng/mL sIgA
Interval 2.7 to 8.8
|
3.4 titer per ng/mL sIgA
Interval 1.3 to 8.9
|
|
Geometric Mean Titer (GMT) of Nasal Secretory Immunoglobulin A (sIgA) Responses Directed Against the H3N2 QIV-like Virus A/Singapore/INFIMH-16-0019/2016 Normalized to Total sIgA
Day 57
|
1.8 titer per ng/mL sIgA
Interval 0.7 to 4.5
|
2.2 titer per ng/mL sIgA
Interval 0.8 to 6.1
|
|
Geometric Mean Titer (GMT) of Nasal Secretory Immunoglobulin A (sIgA) Responses Directed Against the H3N2 QIV-like Virus A/Singapore/INFIMH-16-0019/2016 Normalized to Total sIgA
Day 92
|
2.1 titer per ng/mL sIgA
Interval 1.0 to 4.5
|
1.4 titer per ng/mL sIgA
Interval 0.6 to 3.6
|
|
Geometric Mean Titer (GMT) of Nasal Secretory Immunoglobulin A (sIgA) Responses Directed Against the H3N2 QIV-like Virus A/Singapore/INFIMH-16-0019/2016 Normalized to Total sIgA
Day 113
|
1.4 titer per ng/mL sIgA
Interval 0.5 to 3.6
|
1.3 titer per ng/mL sIgA
Interval 0.4 to 4.4
|
SECONDARY outcome
Timeframe: Day 1 through Day 113Population: The Modified Intent-to-Treat (mITT) population includes all participants who received at least one dose of study vaccine and contributed both pre- and at least one post-study vaccination venous blood samples for which valid results were reported.
Nasal swabs were collected for secretory immunoglobulin A (sIgA) assays conducted with H3N2 QIV-like virus A/Kansas/14/2017 as the antigen. Collection took place on Day 1 (pre-vaccination), Days 8, 22, and 57 after first vaccination, immediately prior to second vaccination (Day 92), and 21 days after second vaccination (Day 113). The geometric mean of each sample's replicate results was calculated from available results. The geometric mean titer (GMT) across samples was calculated within each study arm and analysis time point.
Outcome measures
| Measure |
M2SR
n=22 Participants
A single dose of monovalent live attenuated influenza H3N2 M2SR vaccine (M2SR) administered intranasally on Day 1, and a single dose of licensed quadrivalent influenza vaccine (QIV) administered intramuscularly on Day 92.
|
Placebo
n=21 Participants
A single dose of Placebo administered intranasally on Day 1, and a single dose of licensed QIV administered intramuscularly on Day 92.
|
|---|---|---|
|
Geometric Mean Titer (GMT) of Nasal Secretory Immunoglobulin A (sIgA) Responses Directed Against the H3N2 QIV-like Virus A/Kansas/14/2017
Day 1
|
17.1 titer
Interval 6.8 to 43.1
|
9.9 titer
Interval 3.9 to 25.5
|
|
Geometric Mean Titer (GMT) of Nasal Secretory Immunoglobulin A (sIgA) Responses Directed Against the H3N2 QIV-like Virus A/Kansas/14/2017
Day 8
|
10.8 titer
Interval 4.2 to 27.6
|
5.0 titer
Interval 2.0 to 12.6
|
|
Geometric Mean Titer (GMT) of Nasal Secretory Immunoglobulin A (sIgA) Responses Directed Against the H3N2 QIV-like Virus A/Kansas/14/2017
Day 22
|
19.0 titer
Interval 8.3 to 43.5
|
12.5 titer
Interval 4.4 to 35.7
|
|
Geometric Mean Titer (GMT) of Nasal Secretory Immunoglobulin A (sIgA) Responses Directed Against the H3N2 QIV-like Virus A/Kansas/14/2017
Day 57
|
9.4 titer
Interval 4.1 to 21.5
|
12.4 titer
Interval 5.4 to 28.5
|
|
Geometric Mean Titer (GMT) of Nasal Secretory Immunoglobulin A (sIgA) Responses Directed Against the H3N2 QIV-like Virus A/Kansas/14/2017
Day 92
|
23.2 titer
Interval 12.2 to 44.3
|
10.7 titer
Interval 5.9 to 19.4
|
|
Geometric Mean Titer (GMT) of Nasal Secretory Immunoglobulin A (sIgA) Responses Directed Against the H3N2 QIV-like Virus A/Kansas/14/2017
Day 113
|
23.0 titer
Interval 9.5 to 55.7
|
38.0 titer
Interval 18.4 to 78.5
|
SECONDARY outcome
Timeframe: Day 1 through Day 113Population: The Modified Intent-to-Treat (mITT) population includes all participants who received at least one dose of study vaccine and contributed both pre- and at least one post-study vaccination venous blood samples for which valid results were reported.
Nasal swabs were collected for secretory immunoglobulin A (sIgA) assays conducted with H3N2 QIV-like virus A/Kansas/14/2017 as the antigen. Collection took place on Day 1 (pre-vaccination), Days 8, 22, and 57 after first vaccination, immediately prior to second vaccination (Day 92), and 21 days after second vaccination (Day 113). The geometric mean of each sample's replicate results was calculated from available results. Results were normalized to total sIgA by dividing each geometric mean titer by total sIgA concentration (ng/ml). The geometric mean titer (GMT) across samples was calculated within each study arm and analysis time point.
Outcome measures
| Measure |
M2SR
n=22 Participants
A single dose of monovalent live attenuated influenza H3N2 M2SR vaccine (M2SR) administered intranasally on Day 1, and a single dose of licensed quadrivalent influenza vaccine (QIV) administered intramuscularly on Day 92.
|
Placebo
n=21 Participants
A single dose of Placebo administered intranasally on Day 1, and a single dose of licensed QIV administered intramuscularly on Day 92.
|
|---|---|---|
|
Geometric Mean Titer (GMT) of Nasal Secretory Immunoglobulin A (sIgA) Responses Directed Against the H3N2 QIV-like Virus A/Kansas/14/2017 Normalized to Total sIgA
Day 1
|
1.5 titer per ng/mL sIgA
Interval 0.8 to 2.7
|
1.7 titer per ng/mL sIgA
Interval 0.7 to 4.1
|
|
Geometric Mean Titer (GMT) of Nasal Secretory Immunoglobulin A (sIgA) Responses Directed Against the H3N2 QIV-like Virus A/Kansas/14/2017 Normalized to Total sIgA
Day 8
|
1.6 titer per ng/mL sIgA
Interval 0.8 to 3.3
|
1.1 titer per ng/mL sIgA
Interval 0.5 to 2.4
|
|
Geometric Mean Titer (GMT) of Nasal Secretory Immunoglobulin A (sIgA) Responses Directed Against the H3N2 QIV-like Virus A/Kansas/14/2017 Normalized to Total sIgA
Day 22
|
2.4 titer per ng/mL sIgA
Interval 1.2 to 4.6
|
1.4 titer per ng/mL sIgA
Interval 0.6 to 3.6
|
|
Geometric Mean Titer (GMT) of Nasal Secretory Immunoglobulin A (sIgA) Responses Directed Against the H3N2 QIV-like Virus A/Kansas/14/2017 Normalized to Total sIgA
Day 57
|
1.0 titer per ng/mL sIgA
Interval 0.4 to 2.4
|
1.3 titer per ng/mL sIgA
Interval 0.7 to 2.5
|
|
Geometric Mean Titer (GMT) of Nasal Secretory Immunoglobulin A (sIgA) Responses Directed Against the H3N2 QIV-like Virus A/Kansas/14/2017 Normalized to Total sIgA
Day 92
|
2.0 titer per ng/mL sIgA
Interval 1.1 to 3.5
|
1.1 titer per ng/mL sIgA
Interval 0.5 to 2.1
|
|
Geometric Mean Titer (GMT) of Nasal Secretory Immunoglobulin A (sIgA) Responses Directed Against the H3N2 QIV-like Virus A/Kansas/14/2017 Normalized to Total sIgA
Day 113
|
1.3 titer per ng/mL sIgA
Interval 0.6 to 2.7
|
2.1 titer per ng/mL sIgA
Interval 1.0 to 4.3
|
SECONDARY outcome
Timeframe: Day 8 through Day 113Population: The Modified Intent-to-Treat (mITT) population includes all participants who received at least one dose of study vaccine and contributed both pre- and at least one post-study vaccination venous blood samples for which valid results were reported.
Blood was collected for HAI assays conducted with H3N2 M2SR-like virus A/Brisbane/10/2007 as the antigen. Collection took place on Day 1 (pre-vaccination), Days 8, 22, and 57 after first vaccination, immediately prior to second vaccination (Day 92), and 21 days after second vaccination (Day 113). The geometric mean of each sample's replicate results was calculated from available results. Geometric mean fold rise (GMFR) was calculated by dividing each post-baseline geometric mean titer by baseline geometric mean titer. The GMFR across samples was calculated within each study arm and analysis time point.
Outcome measures
| Measure |
M2SR
n=22 Participants
A single dose of monovalent live attenuated influenza H3N2 M2SR vaccine (M2SR) administered intranasally on Day 1, and a single dose of licensed quadrivalent influenza vaccine (QIV) administered intramuscularly on Day 92.
|
Placebo
n=21 Participants
A single dose of Placebo administered intranasally on Day 1, and a single dose of licensed QIV administered intramuscularly on Day 92.
|
|---|---|---|
|
Hemagglutination Inhibition (HAI) Antibody Geometric Mean Fold Rise (GMFR) to the H3N2 M2SR-like Virus A/Brisbane/10/2007
Day 8
|
1.0 ratio
Interval 1.0 to 1.1
|
1.0 ratio
Interval 0.9 to 1.0
|
|
Hemagglutination Inhibition (HAI) Antibody Geometric Mean Fold Rise (GMFR) to the H3N2 M2SR-like Virus A/Brisbane/10/2007
Day 22
|
1.2 ratio
Interval 1.0 to 1.3
|
1.0 ratio
Interval 0.9 to 1.0
|
|
Hemagglutination Inhibition (HAI) Antibody Geometric Mean Fold Rise (GMFR) to the H3N2 M2SR-like Virus A/Brisbane/10/2007
Day 57
|
1.1 ratio
Interval 0.9 to 1.3
|
1.0 ratio
Interval 0.9 to 1.1
|
|
Hemagglutination Inhibition (HAI) Antibody Geometric Mean Fold Rise (GMFR) to the H3N2 M2SR-like Virus A/Brisbane/10/2007
Day 92
|
1.1 ratio
Interval 1.0 to 1.3
|
1.0 ratio
Interval 0.9 to 1.0
|
|
Hemagglutination Inhibition (HAI) Antibody Geometric Mean Fold Rise (GMFR) to the H3N2 M2SR-like Virus A/Brisbane/10/2007
Day 113
|
1.9 ratio
Interval 1.3 to 2.9
|
1.9 ratio
Interval 1.3 to 2.9
|
SECONDARY outcome
Timeframe: Day 8 through Day 113Population: The Modified Intent-to-Treat (mITT) population includes all participants who received at least one dose of study vaccine and contributed both pre- and at least one post-study vaccination venous blood samples for which valid results were reported.
Blood was collected for HAI assays conducted with H3N2 QIV-like virus A/North Carolina/04/2016 as the antigen. Collection took place on Day 1 (pre-vaccination), Days 8, 22, and 57 after first vaccination, immediately prior to second vaccination (Day 92), and 21 days after second vaccination (Day 113). The geometric mean of each sample's replicate results was calculated from available results. Geometric mean fold rise (GMFR) was calculated by dividing each post-baseline geometric mean titer by baseline geometric mean titer. The GMFR across samples was calculated within each study arm and analysis time point.
Outcome measures
| Measure |
M2SR
n=22 Participants
A single dose of monovalent live attenuated influenza H3N2 M2SR vaccine (M2SR) administered intranasally on Day 1, and a single dose of licensed quadrivalent influenza vaccine (QIV) administered intramuscularly on Day 92.
|
Placebo
n=21 Participants
A single dose of Placebo administered intranasally on Day 1, and a single dose of licensed QIV administered intramuscularly on Day 92.
|
|---|---|---|
|
Hemagglutination Inhibition (HAI) Antibody Geometric Mean Fold Rise (GMFR) to the H3N2 QIV-like Virus A/North Carolina/04/2016
Day 8
|
1.0 ratio
Interval 0.9 to 1.0
|
1.0 ratio
Not calculable due to insufficient variability.
|
|
Hemagglutination Inhibition (HAI) Antibody Geometric Mean Fold Rise (GMFR) to the H3N2 QIV-like Virus A/North Carolina/04/2016
Day 22
|
1.0 ratio
Interval 0.9 to 1.0
|
1.0 ratio
Not calculable due to insufficient variability.
|
|
Hemagglutination Inhibition (HAI) Antibody Geometric Mean Fold Rise (GMFR) to the H3N2 QIV-like Virus A/North Carolina/04/2016
Day 57
|
1.0 ratio
Interval 0.9 to 1.0
|
1.0 ratio
Not calculable due to insufficient variability.
|
|
Hemagglutination Inhibition (HAI) Antibody Geometric Mean Fold Rise (GMFR) to the H3N2 QIV-like Virus A/North Carolina/04/2016
Day 92
|
1.0 ratio
Not calculable due to insufficient variability.
|
1.0 ratio
Not calculable due to insufficient variability.
|
|
Hemagglutination Inhibition (HAI) Antibody Geometric Mean Fold Rise (GMFR) to the H3N2 QIV-like Virus A/North Carolina/04/2016
Day 113
|
2.3 ratio
Interval 1.8 to 2.8
|
3.2 ratio
Interval 2.4 to 4.2
|
SECONDARY outcome
Timeframe: Day 8 through Day 113Population: The Modified Intent-to-Treat (mITT) population includes all participants who received at least one dose of study vaccine and contributed both pre- and at least one post-study vaccination venous blood samples for which valid results were reported.
Blood was collected for HAI assays conducted with H3N2 QIV-like virus A/Singapore/INFIMH-16-0019/2016 as the antigen. Collection took place on Day 1 (pre-vaccination), Days 8, 22, and 57 after first vaccination, immediately prior to second vaccination (Day 92), and 21 days after second vaccination (Day 113). The geometric mean of each sample's replicate results was calculated from available results. Geometric mean fold rise (GMFR) was calculated by dividing each post-baseline geometric mean titer by baseline geometric mean titer. The GMFR across samples was calculated within each study arm and analysis time point.
Outcome measures
| Measure |
M2SR
n=22 Participants
A single dose of monovalent live attenuated influenza H3N2 M2SR vaccine (M2SR) administered intranasally on Day 1, and a single dose of licensed quadrivalent influenza vaccine (QIV) administered intramuscularly on Day 92.
|
Placebo
n=21 Participants
A single dose of Placebo administered intranasally on Day 1, and a single dose of licensed QIV administered intramuscularly on Day 92.
|
|---|---|---|
|
Hemagglutination Inhibition (HAI) Antibody Geometric Mean Fold Rise (GMFR) to the H3N2 QIV-like Virus A/Singapore/INFIMH-16-0019/2016
Day 8
|
1.0 ratio
Not calculable due to insufficient variability.
|
0.9 ratio
Interval 0.9 to 1.0
|
|
Hemagglutination Inhibition (HAI) Antibody Geometric Mean Fold Rise (GMFR) to the H3N2 QIV-like Virus A/Singapore/INFIMH-16-0019/2016
Day 22
|
1.0 ratio
Interval 1.0 to 1.1
|
0.9 ratio
Interval 0.9 to 1.0
|
|
Hemagglutination Inhibition (HAI) Antibody Geometric Mean Fold Rise (GMFR) to the H3N2 QIV-like Virus A/Singapore/INFIMH-16-0019/2016
Day 57
|
1.0 ratio
Interval 1.0 to 1.1
|
0.9 ratio
Interval 0.9 to 1.0
|
|
Hemagglutination Inhibition (HAI) Antibody Geometric Mean Fold Rise (GMFR) to the H3N2 QIV-like Virus A/Singapore/INFIMH-16-0019/2016
Day 92
|
1.0 ratio
Interval 0.9 to 1.1
|
0.9 ratio
Interval 0.8 to 1.0
|
|
Hemagglutination Inhibition (HAI) Antibody Geometric Mean Fold Rise (GMFR) to the H3N2 QIV-like Virus A/Singapore/INFIMH-16-0019/2016
Day 113
|
2.3 ratio
Interval 1.4 to 3.8
|
2.4 ratio
Interval 1.7 to 3.6
|
SECONDARY outcome
Timeframe: Day 8 through Day 113Population: The Modified Intent-to-Treat (mITT) population includes all participants who received at least one dose of study vaccine and contributed both pre- and at least one post-study vaccination venous blood samples for which valid results were reported.
Blood was collected for HAI assays conducted with H3N2 QIV-like virus A/Kansas/14/2017 as the antigen. Collection took place on Day 1 (pre-vaccination), Days 8, 22, and 57 after first vaccination, immediately prior to second vaccination (Day 92), and 21 days after second vaccination (Day 113). The geometric mean of each sample's replicate results was calculated from available results. Geometric mean fold rise (GMFR) was calculated by dividing each post-baseline geometric mean titer by baseline geometric mean titer. The GMFR across samples was calculated within each study arm and analysis time point.
Outcome measures
| Measure |
M2SR
n=22 Participants
A single dose of monovalent live attenuated influenza H3N2 M2SR vaccine (M2SR) administered intranasally on Day 1, and a single dose of licensed quadrivalent influenza vaccine (QIV) administered intramuscularly on Day 92.
|
Placebo
n=21 Participants
A single dose of Placebo administered intranasally on Day 1, and a single dose of licensed QIV administered intramuscularly on Day 92.
|
|---|---|---|
|
Hemagglutination Inhibition (HAI) Antibody Geometric Mean Fold Rise (GMFR) to the H3N2 QIV-like Virus A/Kansas/14/2017
Day 8
|
1.0 ratio
Not calculable due to insufficient variability.
|
1.0 ratio
Interval 0.9 to 1.1
|
|
Hemagglutination Inhibition (HAI) Antibody Geometric Mean Fold Rise (GMFR) to the H3N2 QIV-like Virus A/Kansas/14/2017
Day 22
|
1.0 ratio
Not calculable due to insufficient variability.
|
0.9 ratio
Interval 0.9 to 1.0
|
|
Hemagglutination Inhibition (HAI) Antibody Geometric Mean Fold Rise (GMFR) to the H3N2 QIV-like Virus A/Kansas/14/2017
Day 57
|
1.0 ratio
Interval 1.0 to 1.1
|
1.0 ratio
Interval 0.9 to 1.2
|
|
Hemagglutination Inhibition (HAI) Antibody Geometric Mean Fold Rise (GMFR) to the H3N2 QIV-like Virus A/Kansas/14/2017
Day 92
|
1.0 ratio
Interval 1.0 to 1.1
|
1.0 ratio
Interval 0.9 to 1.1
|
|
Hemagglutination Inhibition (HAI) Antibody Geometric Mean Fold Rise (GMFR) to the H3N2 QIV-like Virus A/Kansas/14/2017
Day 113
|
3.2 ratio
Interval 1.7 to 5.8
|
4.4 ratio
Interval 2.5 to 7.9
|
SECONDARY outcome
Timeframe: Day 1 through Day 113Population: The Modified Intent-to-Treat (mITT) population includes all participants who received at least one dose of study vaccine and contributed both pre- and at least one post-study vaccination venous blood samples for which valid results were reported.
Blood was collected for HAI assays conducted with H3N2 M2SR-like virus A/Brisbane/10/2007 as the antigen. Collection took place on Day 1 (pre-vaccination), Days 8, 22, and 57 after first vaccination, immediately prior to second vaccination (Day 92), and 21 days after second vaccination (Day 113). The geometric mean of each sample's replicate results was calculated from available results. The geometric mean titer (GMT) across samples was calculated within each study arm and analysis time point.
Outcome measures
| Measure |
M2SR
n=22 Participants
A single dose of monovalent live attenuated influenza H3N2 M2SR vaccine (M2SR) administered intranasally on Day 1, and a single dose of licensed quadrivalent influenza vaccine (QIV) administered intramuscularly on Day 92.
|
Placebo
n=21 Participants
A single dose of Placebo administered intranasally on Day 1, and a single dose of licensed QIV administered intramuscularly on Day 92.
|
|---|---|---|
|
Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMTs) to the H3N2 M2SR-like Virus A/Brisbane/10/2007
Day 1
|
93.6 titer
Interval 55.7 to 157.3
|
67.8 titer
Interval 42.5 to 108.2
|
|
Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMTs) to the H3N2 M2SR-like Virus A/Brisbane/10/2007
Day 8
|
96.6 titer
Interval 57.4 to 162.7
|
65.6 titer
Interval 41.9 to 102.7
|
|
Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMTs) to the H3N2 M2SR-like Virus A/Brisbane/10/2007
Day 22
|
109.6 titer
Interval 68.4 to 175.7
|
65.6 titer
Interval 41.9 to 102.7
|
|
Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMTs) to the H3N2 M2SR-like Virus A/Brisbane/10/2007
Day 57
|
102.9 titer
Interval 66.3 to 159.9
|
67.8 titer
Interval 43.0 to 107.0
|
|
Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMTs) to the H3N2 M2SR-like Virus A/Brisbane/10/2007
Day 92
|
107.7 titer
Interval 68.5 to 169.3
|
65.6 titer
Interval 41.9 to 102.7
|
|
Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMTs) to the H3N2 M2SR-like Virus A/Brisbane/10/2007
Day 113
|
188.7 titer
Interval 133.7 to 266.3
|
131.3 titer
Interval 87.9 to 196.0
|
SECONDARY outcome
Timeframe: Day 1 through Day 113Population: The Modified Intent-to-Treat (mITT) population includes all participants who received at least one dose of study vaccine and contributed both pre- and at least one post-study vaccination venous blood samples for which valid results were reported.
Blood was collected for HAI assays conducted with H3N2 QIV-like virus A/North Carolina/04/2016 as the antigen. Collection took place on Day 1 (pre-vaccination), Days 8, 22, and 57 after first vaccination, immediately prior to second vaccination (Day 92), and 21 days after second vaccination (Day 113). The geometric mean of each sample's replicate results was calculated from available results. The geometric mean titer (GMT) across samples was calculated within each study arm and analysis time point.
Outcome measures
| Measure |
M2SR
n=22 Participants
A single dose of monovalent live attenuated influenza H3N2 M2SR vaccine (M2SR) administered intranasally on Day 1, and a single dose of licensed quadrivalent influenza vaccine (QIV) administered intramuscularly on Day 92.
|
Placebo
n=21 Participants
A single dose of Placebo administered intranasally on Day 1, and a single dose of licensed QIV administered intramuscularly on Day 92.
|
|---|---|---|
|
Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMTs) to the H3N2 QIV-like Virus A/North Carolina/04/2016
Day 1
|
14.1 titer
Interval 11.1 to 18.1
|
13.5 titer
Interval 10.2 to 17.7
|
|
Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMTs) to the H3N2 QIV-like Virus A/North Carolina/04/2016
Day 8
|
13.7 titer
Interval 10.5 to 17.8
|
13.5 titer
Interval 10.2 to 17.7
|
|
Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMTs) to the H3N2 QIV-like Virus A/North Carolina/04/2016
Day 22
|
13.7 titer
Interval 10.5 to 17.8
|
13.5 titer
Interval 10.2 to 17.7
|
|
Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMTs) to the H3N2 QIV-like Virus A/North Carolina/04/2016
Day 57
|
13.7 titer
Interval 10.5 to 17.8
|
13.5 titer
Interval 10.2 to 17.7
|
|
Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMTs) to the H3N2 QIV-like Virus A/North Carolina/04/2016
Day 92
|
14.4 titer
Interval 11.1 to 18.6
|
13.5 titer
Interval 10.2 to 17.7
|
|
Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMTs) to the H3N2 QIV-like Virus A/North Carolina/04/2016
Day 113
|
31.7 titer
Interval 24.2 to 41.6
|
42.7 titer
Interval 28.7 to 63.6
|
SECONDARY outcome
Timeframe: Day 1 through Day 113Population: The Modified Intent-to-Treat (mITT) population includes all participants who received at least one dose of study vaccine and contributed both pre- and at least one post-study vaccination venous blood samples for which valid results were reported.
Blood was collected for HAI assays conducted with H3N2 QIV-like virus A/Singapore/INFIMH-16-0019/2016 as the antigen. Collection took place on Day 1 (pre-vaccination), Days 8, 22, and 57 after first vaccination, immediately prior to second vaccination (Day 92), and 21 days after second vaccination (Day 113). The geometric mean of each sample's replicate results was calculated from available results. The geometric mean titer (GMT) across samples was calculated within each study arm and analysis time point.
Outcome measures
| Measure |
M2SR
n=22 Participants
A single dose of monovalent live attenuated influenza H3N2 M2SR vaccine (M2SR) administered intranasally on Day 1, and a single dose of licensed quadrivalent influenza vaccine (QIV) administered intramuscularly on Day 92.
|
Placebo
n=21 Participants
A single dose of Placebo administered intranasally on Day 1, and a single dose of licensed QIV administered intramuscularly on Day 92.
|
|---|---|---|
|
Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMTs) to the H3N2 QIV-like Virus A/Singapore/INFIMH-16-0019/2016
Day 1
|
96.6 titer
Interval 61.8 to 151.1
|
88.3 titer
Interval 61.4 to 127.1
|
|
Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMTs) to the H3N2 QIV-like Virus A/Singapore/INFIMH-16-0019/2016
Day 8
|
96.6 titer
Interval 61.8 to 151.1
|
82.7 titer
Interval 58.1 to 117.6
|
|
Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMTs) to the H3N2 QIV-like Virus A/Singapore/INFIMH-16-0019/2016
Day 22
|
99.7 titer
Interval 64.3 to 154.7
|
82.7 titer
Interval 58.1 to 117.6
|
|
Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMTs) to the H3N2 QIV-like Virus A/Singapore/INFIMH-16-0019/2016
Day 57
|
99.7 titer
Interval 64.3 to 154.7
|
82.7 titer
Interval 58.1 to 117.6
|
|
Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMTs) to the H3N2 QIV-like Virus A/Singapore/INFIMH-16-0019/2016
Day 92
|
94.4 titer
Interval 60.5 to 147.3
|
80.0 titer
Interval 55.8 to 114.6
|
|
Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMTs) to the H3N2 QIV-like Virus A/Singapore/INFIMH-16-0019/2016
Day 113
|
230.0 titer
Interval 153.2 to 345.5
|
215.3 titer
Interval 151.2 to 306.7
|
SECONDARY outcome
Timeframe: Day 1 through Day 113Population: The Modified Intent-to-Treat (mITT) population includes all participants who received at least one dose of study vaccine and contributed both pre- and at least one post-study vaccination venous blood samples for which valid results were reported.
Blood was collected for HAI assays conducted with H3N2 QIV-like virus A/Kansas/14/2017 as the antigen. Collection took place on Day 1 (pre-vaccination), Days 8, 22, and 57 after first vaccination, immediately prior to second vaccination (Day 92), and 21 days after second vaccination (Day 113). The geometric mean of each sample's replicate results was calculated from available results. The geometric mean titer (GMT) across samples was calculated within each study arm and analysis time point.
Outcome measures
| Measure |
M2SR
n=22 Participants
A single dose of monovalent live attenuated influenza H3N2 M2SR vaccine (M2SR) administered intranasally on Day 1, and a single dose of licensed quadrivalent influenza vaccine (QIV) administered intramuscularly on Day 92.
|
Placebo
n=21 Participants
A single dose of Placebo administered intranasally on Day 1, and a single dose of licensed QIV administered intramuscularly on Day 92.
|
|---|---|---|
|
Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMTs) to the H3N2 QIV-like Virus A/Kansas/14/2017
Day 1
|
25.7 titer
Interval 18.2 to 36.5
|
25.2 titer
Interval 17.5 to 36.3
|
|
Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMTs) to the H3N2 QIV-like Virus A/Kansas/14/2017
Day 8
|
25.7 titer
Interval 18.2 to 36.5
|
25.2 titer
Interval 17.3 to 36.8
|
|
Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMTs) to the H3N2 QIV-like Virus A/Kansas/14/2017
Day 22
|
25.7 titer
Interval 18.2 to 36.5
|
23.6 titer
Interval 17.0 to 32.8
|
|
Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMTs) to the H3N2 QIV-like Virus A/Kansas/14/2017
Day 57
|
26.6 titer
Interval 19.0 to 37.2
|
25.2 titer
Interval 17.3 to 36.8
|
|
Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMTs) to the H3N2 QIV-like Virus A/Kansas/14/2017
Day 92
|
26.0 titer
Interval 18.3 to 37.0
|
25.2 titer
Interval 17.7 to 35.8
|
|
Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMTs) to the H3N2 QIV-like Virus A/Kansas/14/2017
Day 113
|
85.5 titer
Interval 44.1 to 165.5
|
111.3 titer
Interval 62.9 to 196.8
|
SECONDARY outcome
Timeframe: Day 8 through Day 113Population: The Modified Intent-to-Treat (mITT) population includes all participants who received at least one dose of study vaccine and contributed both pre- and at least one post-study vaccination venous blood samples for which valid results were reported.
Blood was collected for Neutralizing assays conducted with H3N2 M2SR-like virus A/Brisbane/10/2007 as the antigen. Collection took place on Day 1 (pre-vaccination), Days 8, 22, and 57 after first vaccination, immediately prior to second vaccination (Day 92), and 21 days after second vaccination (Day 113). The geometric mean of each sample's replicate results was calculated from available results. Geometric mean fold rise (GMFR) was calculated by dividing each post-baseline geometric mean titer by baseline geometric mean titer. The GMFR across samples was calculated within each study arm and analysis time point.
Outcome measures
| Measure |
M2SR
n=22 Participants
A single dose of monovalent live attenuated influenza H3N2 M2SR vaccine (M2SR) administered intranasally on Day 1, and a single dose of licensed quadrivalent influenza vaccine (QIV) administered intramuscularly on Day 92.
|
Placebo
n=21 Participants
A single dose of Placebo administered intranasally on Day 1, and a single dose of licensed QIV administered intramuscularly on Day 92.
|
|---|---|---|
|
Neutralizing Antibody Geometric Mean Fold Rise (GMFR) to the H3N2 M2SR-like Virus A/Brisbane/10/2007
Day 8
|
1.0 ratio
Interval 0.9 to 1.2
|
1.0 ratio
Interval 0.9 to 1.1
|
|
Neutralizing Antibody Geometric Mean Fold Rise (GMFR) to the H3N2 M2SR-like Virus A/Brisbane/10/2007
Day 22
|
1.1 ratio
Interval 0.9 to 1.4
|
1.0 ratio
Interval 0.9 to 1.1
|
|
Neutralizing Antibody Geometric Mean Fold Rise (GMFR) to the H3N2 M2SR-like Virus A/Brisbane/10/2007
Day 57
|
1.2 ratio
Interval 1.0 to 1.4
|
0.9 ratio
Interval 0.8 to 1.0
|
|
Neutralizing Antibody Geometric Mean Fold Rise (GMFR) to the H3N2 M2SR-like Virus A/Brisbane/10/2007
Day 92
|
1.1 ratio
Interval 0.9 to 1.3
|
0.9 ratio
Interval 0.8 to 1.1
|
|
Neutralizing Antibody Geometric Mean Fold Rise (GMFR) to the H3N2 M2SR-like Virus A/Brisbane/10/2007
Day 113
|
1.8 ratio
Interval 1.2 to 2.6
|
1.9 ratio
Interval 1.3 to 2.8
|
SECONDARY outcome
Timeframe: Day 8 through Day 113Population: The Modified Intent-to-Treat (mITT) population includes all participants who received at least one dose of study vaccine and contributed both pre- and at least one post-study vaccination venous blood samples for which valid results were reported.
Blood was collected for Neutralizing assays conducted with H3N2 QIV-like virus A/North Carolina/04/2016 as the antigen. Collection took place on Day 1 (pre-vaccination), Days 8, 22, and 57 after first vaccination, immediately prior to second vaccination (Day 92), and 21 days after second vaccination (Day 113). The geometric mean of each sample's replicate results was calculated from available results. Geometric mean fold rise (GMFR) was calculated by dividing each post-baseline geometric mean titer by baseline geometric mean titer. The GMFR across samples was calculated within each study arm and analysis time point.
Outcome measures
| Measure |
M2SR
n=22 Participants
A single dose of monovalent live attenuated influenza H3N2 M2SR vaccine (M2SR) administered intranasally on Day 1, and a single dose of licensed quadrivalent influenza vaccine (QIV) administered intramuscularly on Day 92.
|
Placebo
n=21 Participants
A single dose of Placebo administered intranasally on Day 1, and a single dose of licensed QIV administered intramuscularly on Day 92.
|
|---|---|---|
|
Neutralizing Antibody Geometric Mean Fold Rise (GMFR) to the H3N2 QIV-like Virus A/North Carolina/04/2016
Day 8
|
1.1 ratio
Interval 0.9 to 1.2
|
1.0 ratio
Interval 0.9 to 1.1
|
|
Neutralizing Antibody Geometric Mean Fold Rise (GMFR) to the H3N2 QIV-like Virus A/North Carolina/04/2016
Day 22
|
1.0 ratio
Interval 0.9 to 1.2
|
1.0 ratio
Interval 0.9 to 1.1
|
|
Neutralizing Antibody Geometric Mean Fold Rise (GMFR) to the H3N2 QIV-like Virus A/North Carolina/04/2016
Day 57
|
1.0 ratio
Interval 0.9 to 1.2
|
1.0 ratio
Interval 0.9 to 1.1
|
|
Neutralizing Antibody Geometric Mean Fold Rise (GMFR) to the H3N2 QIV-like Virus A/North Carolina/04/2016
Day 92
|
1.0 ratio
Interval 0.9 to 1.2
|
0.9 ratio
Interval 0.8 to 1.0
|
|
Neutralizing Antibody Geometric Mean Fold Rise (GMFR) to the H3N2 QIV-like Virus A/North Carolina/04/2016
Day 113
|
2.6 ratio
Interval 1.9 to 3.8
|
4.5 ratio
Interval 2.9 to 6.8
|
SECONDARY outcome
Timeframe: Day 8 through Day 113Population: The Modified Intent-to-Treat (mITT) population includes all participants who received at least one dose of study vaccine and contributed both pre- and at least one post-study vaccination venous blood samples for which valid results were reported.
Blood was collected for Neutralizing assays conducted with H3N2 QIV-like virus A/Singapore/INFIMH-16-0019/2016 as the antigen. Collection took place on Day 1 (pre-vaccination), Days 8, 22, and 57 after first vaccination, immediately prior to second vaccination (Day 92), and 21 days after second vaccination (Day 113). The geometric mean of each sample's replicate results was calculated from available results. Geometric mean fold rise (GMFR) was calculated by dividing each post-baseline geometric mean titer by baseline geometric mean titer. The GMFR across samples was calculated within each study arm and analysis time point.
Outcome measures
| Measure |
M2SR
n=22 Participants
A single dose of monovalent live attenuated influenza H3N2 M2SR vaccine (M2SR) administered intranasally on Day 1, and a single dose of licensed quadrivalent influenza vaccine (QIV) administered intramuscularly on Day 92.
|
Placebo
n=21 Participants
A single dose of Placebo administered intranasally on Day 1, and a single dose of licensed QIV administered intramuscularly on Day 92.
|
|---|---|---|
|
Neutralizing Antibody Geometric Mean Fold Rise (GMFR) to the H3N2 QIV-like Virus A/Singapore/INFIMH-16-0019/2016
Day 8
|
1.0 ratio
Interval 0.9 to 1.2
|
1.0 ratio
Interval 0.9 to 1.1
|
|
Neutralizing Antibody Geometric Mean Fold Rise (GMFR) to the H3N2 QIV-like Virus A/Singapore/INFIMH-16-0019/2016
Day 22
|
1.0 ratio
Interval 0.9 to 1.1
|
1.0 ratio
Interval 0.9 to 1.0
|
|
Neutralizing Antibody Geometric Mean Fold Rise (GMFR) to the H3N2 QIV-like Virus A/Singapore/INFIMH-16-0019/2016
Day 57
|
1.0 ratio
Interval 0.9 to 1.2
|
0.9 ratio
Interval 0.9 to 1.0
|
|
Neutralizing Antibody Geometric Mean Fold Rise (GMFR) to the H3N2 QIV-like Virus A/Singapore/INFIMH-16-0019/2016
Day 92
|
1.0 ratio
Interval 0.9 to 1.1
|
1.0 ratio
Interval 0.9 to 1.1
|
|
Neutralizing Antibody Geometric Mean Fold Rise (GMFR) to the H3N2 QIV-like Virus A/Singapore/INFIMH-16-0019/2016
Day 113
|
2.9 ratio
Interval 1.6 to 5.3
|
2.9 ratio
Interval 2.0 to 4.3
|
SECONDARY outcome
Timeframe: Day 8 through Day 113Population: The Modified Intent-to-Treat (mITT) population includes all participants who received at least one dose of study vaccine and contributed both pre- and at least one post-study vaccination venous blood samples for which valid results were reported.
Blood was collected for Neutralizing assays conducted with H3N2 QIV-like virus A/Kansas/14/2017 as the antigen. Collection took place on Day 1 (pre-vaccination), Days 8, 22, and 57 after first vaccination, immediately prior to second vaccination (Day 92), and 21 days after second vaccination (Day 113). The geometric mean of each sample's replicate results was calculated from available results. Geometric mean fold rise (GMFR) was calculated by dividing each post-baseline geometric mean titer by baseline geometric mean titer. The GMFR across samples was calculated within each study arm and analysis time point.
Outcome measures
| Measure |
M2SR
n=22 Participants
A single dose of monovalent live attenuated influenza H3N2 M2SR vaccine (M2SR) administered intranasally on Day 1, and a single dose of licensed quadrivalent influenza vaccine (QIV) administered intramuscularly on Day 92.
|
Placebo
n=21 Participants
A single dose of Placebo administered intranasally on Day 1, and a single dose of licensed QIV administered intramuscularly on Day 92.
|
|---|---|---|
|
Neutralizing Antibody Geometric Mean Fold Rise (GMFR) to the H3N2 QIV-like Virus A/Kansas/14/2017
Day 8
|
1.0 ratio
Interval 0.8 to 1.1
|
1.1 ratio
Interval 0.9 to 1.3
|
|
Neutralizing Antibody Geometric Mean Fold Rise (GMFR) to the H3N2 QIV-like Virus A/Kansas/14/2017
Day 22
|
1.0 ratio
Interval 0.8 to 1.1
|
1.1 ratio
Interval 0.9 to 1.3
|
|
Neutralizing Antibody Geometric Mean Fold Rise (GMFR) to the H3N2 QIV-like Virus A/Kansas/14/2017
Day 57
|
0.9 ratio
Interval 0.8 to 1.0
|
0.9 ratio
Interval 0.8 to 1.0
|
|
Neutralizing Antibody Geometric Mean Fold Rise (GMFR) to the H3N2 QIV-like Virus A/Kansas/14/2017
Day 92
|
0.9 ratio
Interval 0.7 to 1.1
|
1.0 ratio
Interval 0.9 to 1.1
|
|
Neutralizing Antibody Geometric Mean Fold Rise (GMFR) to the H3N2 QIV-like Virus A/Kansas/14/2017
Day 113
|
3.0 ratio
Interval 1.6 to 5.4
|
4.7 ratio
Interval 2.6 to 8.5
|
SECONDARY outcome
Timeframe: Day 1 through Day 113Population: The Modified Intent-to-Treat (mITT) population includes all participants who received at least one dose of study vaccine and contributed both pre- and at least one post-study vaccination venous blood samples for which valid results were reported.
Blood was collected for Neutralizing assays conducted with H3N2 M2SR-like virus A/Brisbane/10/2007 as the antigen. Collection took place on Day 1 (pre-vaccination), Days 8, 22, and 57 after first vaccination, immediately prior to second vaccination (Day 92), and 21 days after second vaccination (Day 113). The geometric mean of each sample's replicate results was calculated from available results. The geometric mean titer (GMT) across samples was calculated within each study arm and analysis time point.
Outcome measures
| Measure |
M2SR
n=22 Participants
A single dose of monovalent live attenuated influenza H3N2 M2SR vaccine (M2SR) administered intranasally on Day 1, and a single dose of licensed quadrivalent influenza vaccine (QIV) administered intramuscularly on Day 92.
|
Placebo
n=21 Participants
A single dose of Placebo administered intranasally on Day 1, and a single dose of licensed QIV administered intramuscularly on Day 92.
|
|---|---|---|
|
Neutralizing Antibody Geometric Mean Titers (GMTs) to the H3N2 M2SR-like Virus A/Brisbane/10/2007
Day 1
|
1374.0 titer
Interval 818.4 to 2307.0
|
1178.6 titer
Interval 754.0 to 1842.2
|
|
Neutralizing Antibody Geometric Mean Titers (GMTs) to the H3N2 M2SR-like Virus A/Brisbane/10/2007
Day 8
|
1418.0 titer
Interval 847.3 to 2373.1
|
1159.3 titer
Interval 707.2 to 1900.4
|
|
Neutralizing Antibody Geometric Mean Titers (GMTs) to the H3N2 M2SR-like Virus A/Brisbane/10/2007
Day 22
|
1558.6 titer
Interval 1036.3 to 2344.1
|
1188.4 titer
Interval 755.6 to 1869.0
|
|
Neutralizing Antibody Geometric Mean Titers (GMTs) to the H3N2 M2SR-like Virus A/Brisbane/10/2007
Day 57
|
1595.9 titer
Interval 1035.2 to 2460.1
|
1076.3 titer
Interval 679.5 to 1704.9
|
|
Neutralizing Antibody Geometric Mean Titers (GMTs) to the H3N2 M2SR-like Virus A/Brisbane/10/2007
Day 92
|
1509.7 titer
Interval 978.3 to 2329.6
|
1112.5 titer
Interval 703.5 to 1759.3
|
|
Neutralizing Antibody Geometric Mean Titers (GMTs) to the H3N2 M2SR-like Virus A/Brisbane/10/2007
Day 113
|
2497.4 titer
Interval 1658.5 to 3760.6
|
2206.7 titer
Interval 1405.3 to 3465.1
|
SECONDARY outcome
Timeframe: Day 1 through Day 113Population: The Modified Intent-to-Treat (mITT) population includes all participants who received at least one dose of study vaccine and contributed both pre- and at least one post-study vaccination venous blood samples for which valid results were reported.
Blood was collected for Neutralizing assays conducted with H3N2 QIV-like virus A/North Carolina/04/2016 as the antigen. Collection took place on Day 1 (pre-vaccination), Days 8, 22, and 57 after first vaccination, immediately prior to second vaccination (Day 92), and 21 days after second vaccination (Day 113). The geometric mean of each sample's replicate results was calculated from available results. The geometric mean titer (GMT) across samples was calculated within each study arm and analysis time point.
Outcome measures
| Measure |
M2SR
n=22 Participants
A single dose of monovalent live attenuated influenza H3N2 M2SR vaccine (M2SR) administered intranasally on Day 1, and a single dose of licensed quadrivalent influenza vaccine (QIV) administered intramuscularly on Day 92.
|
Placebo
n=21 Participants
A single dose of Placebo administered intranasally on Day 1, and a single dose of licensed QIV administered intramuscularly on Day 92.
|
|---|---|---|
|
Neutralizing Antibody Geometric Mean Titers (GMTs) to the H3N2 QIV-like Virus A/North Carolina/04/2016
Day 1
|
70.5 titer
Interval 47.2 to 105.5
|
83.4 titer
Interval 52.0 to 133.7
|
|
Neutralizing Antibody Geometric Mean Titers (GMTs) to the H3N2 QIV-like Virus A/North Carolina/04/2016
Day 8
|
74.5 titer
Interval 48.9 to 113.5
|
80.0 titer
Interval 47.9 to 133.5
|
|
Neutralizing Antibody Geometric Mean Titers (GMTs) to the H3N2 QIV-like Virus A/North Carolina/04/2016
Day 22
|
72.8 titer
Interval 47.1 to 112.5
|
84.1 titer
Interval 51.0 to 138.6
|
|
Neutralizing Antibody Geometric Mean Titers (GMTs) to the H3N2 QIV-like Virus A/North Carolina/04/2016
Day 57
|
71.1 titer
Interval 44.8 to 112.7
|
81.3 titer
Interval 50.9 to 129.9
|
|
Neutralizing Antibody Geometric Mean Titers (GMTs) to the H3N2 QIV-like Virus A/North Carolina/04/2016
Day 92
|
75.5 titer
Interval 50.0 to 114.1
|
77.4 titer
Interval 47.2 to 126.8
|
|
Neutralizing Antibody Geometric Mean Titers (GMTs) to the H3N2 QIV-like Virus A/North Carolina/04/2016
Day 113
|
185.6 titer
Interval 108.6 to 317.2
|
371.2 titer
Interval 221.7 to 621.7
|
SECONDARY outcome
Timeframe: Day 1 through Day 113Population: The Modified Intent-to-Treat (mITT) population includes all participants who received at least one dose of study vaccine and contributed both pre- and at least one post-study vaccination venous blood samples for which valid results were reported.
Blood was collected for Neutralizing assays conducted with H3N2 QIV-like virus A/Singapore/INFIMH-16-0019/2016 as the antigen. Collection took place on Day 1 (pre-vaccination), Days 8, 22, and 57 after first vaccination, immediately prior to second vaccination (Day 92), and 21 days after second vaccination (Day 113). The geometric mean of each sample's replicate results was calculated from available results. The geometric mean titer (GMT) across samples was calculated within each study arm and analysis time point.
Outcome measures
| Measure |
M2SR
n=22 Participants
A single dose of monovalent live attenuated influenza H3N2 M2SR vaccine (M2SR) administered intranasally on Day 1, and a single dose of licensed quadrivalent influenza vaccine (QIV) administered intramuscularly on Day 92.
|
Placebo
n=21 Participants
A single dose of Placebo administered intranasally on Day 1, and a single dose of licensed QIV administered intramuscularly on Day 92.
|
|---|---|---|
|
Neutralizing Antibody Geometric Mean Titers (GMTs) to the H3N2 QIV-like Virus A/Singapore/INFIMH-16-0019/2016
Day 1
|
726.0 titer
Interval 428.1 to 1231.1
|
700.8 titer
Interval 511.4 to 960.4
|
|
Neutralizing Antibody Geometric Mean Titers (GMTs) to the H3N2 QIV-like Virus A/Singapore/INFIMH-16-0019/2016
Day 8
|
755.1 titer
Interval 438.3 to 1301.0
|
706.6 titer
Interval 508.2 to 982.5
|
|
Neutralizing Antibody Geometric Mean Titers (GMTs) to the H3N2 QIV-like Virus A/Singapore/INFIMH-16-0019/2016
Day 22
|
726.0 titer
Interval 442.9 to 1189.8
|
667.0 titer
Interval 476.9 to 932.8
|
|
Neutralizing Antibody Geometric Mean Titers (GMTs) to the H3N2 QIV-like Virus A/Singapore/INFIMH-16-0019/2016
Day 92
|
700.8 titer
Interval 413.7 to 1187.2
|
683.7 titer
Interval 488.6 to 956.7
|
|
Neutralizing Antibody Geometric Mean Titers (GMTs) to the H3N2 QIV-like Virus A/Singapore/INFIMH-16-0019/2016
Day 113
|
2206.7 titer
Interval 1390.0 to 3503.0
|
2031.9 titer
Interval 1530.0 to 2698.3
|
|
Neutralizing Antibody Geometric Mean Titers (GMTs) to the H3N2 QIV-like Virus A/Singapore/INFIMH-16-0019/2016
Day 57
|
755.1 titer
Interval 489.1 to 1165.8
|
661.5 titer
Interval 470.5 to 930.0
|
SECONDARY outcome
Timeframe: Day 1 through Day 113Population: The Modified Intent-to-Treat (mITT) population includes all participants who received at least one dose of study vaccine and contributed both pre- and at least one post-study vaccination venous blood samples for which valid results were reported.
Blood was collected for Neutralizing assays conducted with H3N2 QIV-like virus A/Kansas/14/2017 as the antigen. Collection took place on Day 1 (pre-vaccination), Days 8, 22, and 57 after first vaccination, immediately prior to second vaccination (Day 92), and 21 days after second vaccination (Day 113). The geometric mean of each sample's replicate results was calculated from available results. The geometric mean titer (GMT) across samples was calculated within each study arm and analysis time point.
Outcome measures
| Measure |
M2SR
n=22 Participants
A single dose of monovalent live attenuated influenza H3N2 M2SR vaccine (M2SR) administered intranasally on Day 1, and a single dose of licensed quadrivalent influenza vaccine (QIV) administered intramuscularly on Day 92.
|
Placebo
n=21 Participants
A single dose of Placebo administered intranasally on Day 1, and a single dose of licensed QIV administered intramuscularly on Day 92.
|
|---|---|---|
|
Neutralizing Antibody Geometric Mean Titers (GMTs) to the H3N2 QIV-like Virus A/Kansas/14/2017
Day 1
|
196.4 titer
Interval 126.6 to 304.6
|
165.4 titer
Interval 113.5 to 240.9
|
|
Neutralizing Antibody Geometric Mean Titers (GMTs) to the H3N2 QIV-like Virus A/Kansas/14/2017
Day 8
|
190.3 titer
Interval 122.3 to 295.9
|
176.7 titer
Interval 115.6 to 269.9
|
|
Neutralizing Antibody Geometric Mean Titers (GMTs) to the H3N2 QIV-like Virus A/Kansas/14/2017
Day 22
|
190.3 titer
Interval 135.7 to 266.7
|
182.6 titer
Interval 122.3 to 272.5
|
|
Neutralizing Antibody Geometric Mean Titers (GMTs) to the H3N2 QIV-like Virus A/Kansas/14/2017
Day 57
|
175.9 titer
Interval 114.7 to 269.6
|
152.3 titer
Interval 97.7 to 237.4
|
|
Neutralizing Antibody Geometric Mean Titers (GMTs) to the H3N2 QIV-like Virus A/Kansas/14/2017
Day 92
|
182.6 titer
Interval 126.3 to 263.9
|
162.7 titer
Interval 109.3 to 242.0
|
|
Neutralizing Antibody Geometric Mean Titers (GMTs) to the H3N2 QIV-like Virus A/Kansas/14/2017
Day 113
|
619.2 titer
Interval 331.5 to 1156.7
|
780.2 titer
Interval 411.4 to 1479.6
|
SECONDARY outcome
Timeframe: Day 1 through Day 113Population: The Modified Intent-to-Treat (mITT) population includes all participants who received at least one dose of study vaccine and contributed both pre- and at least one post-study vaccination venous blood samples for which valid results were reported.
Blood was collected for HAI assays conducted with H3N2 M2SR-like virus A/Brisbane/10/2007 as the antigen. Collection took place on Day 1 (pre-vaccination), Days 8, 22, and 57 after first vaccination, immediately prior to second vaccination (Day 92), and 21 days after second vaccination (Day 113). The geometric mean of each sample's replicate results was calculated from available results. The percentage of participants with HAI geometric mean titer \>= 1:40 was calculated within each study arm and analysis time point.
Outcome measures
| Measure |
M2SR
n=22 Participants
A single dose of monovalent live attenuated influenza H3N2 M2SR vaccine (M2SR) administered intranasally on Day 1, and a single dose of licensed quadrivalent influenza vaccine (QIV) administered intramuscularly on Day 92.
|
Placebo
n=21 Participants
A single dose of Placebo administered intranasally on Day 1, and a single dose of licensed QIV administered intramuscularly on Day 92.
|
|---|---|---|
|
Percentage of Participants Achieving a Serum Hemagglutination Inhibition (HAI) Antibody Titer of >= 1:40 Against the H3N2 M2SR-like Virus A/Brisbane/10/2007
Day 1
|
82 percentage of participants
Interval 61.0 to 94.0
|
86 percentage of participants
Interval 65.0 to 96.0
|
|
Percentage of Participants Achieving a Serum Hemagglutination Inhibition (HAI) Antibody Titer of >= 1:40 Against the H3N2 M2SR-like Virus A/Brisbane/10/2007
Day 8
|
82 percentage of participants
Interval 61.0 to 94.0
|
86 percentage of participants
Interval 65.0 to 96.0
|
|
Percentage of Participants Achieving a Serum Hemagglutination Inhibition (HAI) Antibody Titer of >= 1:40 Against the H3N2 M2SR-like Virus A/Brisbane/10/2007
Day 22
|
86 percentage of participants
Interval 67.0 to 96.0
|
86 percentage of participants
Interval 65.0 to 96.0
|
|
Percentage of Participants Achieving a Serum Hemagglutination Inhibition (HAI) Antibody Titer of >= 1:40 Against the H3N2 M2SR-like Virus A/Brisbane/10/2007
Day 57
|
86 percentage of participants
Interval 67.0 to 96.0
|
86 percentage of participants
Interval 65.0 to 96.0
|
|
Percentage of Participants Achieving a Serum Hemagglutination Inhibition (HAI) Antibody Titer of >= 1:40 Against the H3N2 M2SR-like Virus A/Brisbane/10/2007
Day 92
|
86 percentage of participants
Interval 65.0 to 96.0
|
86 percentage of participants
Interval 65.0 to 96.0
|
|
Percentage of Participants Achieving a Serum Hemagglutination Inhibition (HAI) Antibody Titer of >= 1:40 Against the H3N2 M2SR-like Virus A/Brisbane/10/2007
Day 113
|
100 percentage of participants
Interval 85.0 to 100.0
|
95 percentage of participants
Interval 77.0 to 100.0
|
SECONDARY outcome
Timeframe: Day 1 through Day 113Population: The Modified Intent-to-Treat (mITT) population includes all participants who received at least one dose of study vaccine and contributed both pre- and at least one post-study vaccination venous blood samples for which valid results were reported.
Blood was collected for HAI assays conducted with H3N2 QIV-like virus A/North Carolina/04/2016 as the antigen. Collection took place on Day 1 (pre-vaccination), Days 8, 22, and 57 after first vaccination, immediately prior to second vaccination (Day 92), and 21 days after second vaccination (Day 113). The geometric mean of each sample's replicate results was calculated from available results. The percentage of participants with HAI geometric mean titer \>= 1:40 was calculated within each study arm and analysis time point.
Outcome measures
| Measure |
M2SR
n=22 Participants
A single dose of monovalent live attenuated influenza H3N2 M2SR vaccine (M2SR) administered intranasally on Day 1, and a single dose of licensed quadrivalent influenza vaccine (QIV) administered intramuscularly on Day 92.
|
Placebo
n=21 Participants
A single dose of Placebo administered intranasally on Day 1, and a single dose of licensed QIV administered intramuscularly on Day 92.
|
|---|---|---|
|
Percentage of Participants Achieving a Serum Hemagglutination Inhibition (HAI) Antibody Titer of >= 1:40 Against the H3N2 QIV-like Virus A/North Carolina/04/2016
Day 1
|
9 percentage of participants
Interval 2.0 to 29.0
|
5 percentage of participants
Interval 0.0 to 23.0
|
|
Percentage of Participants Achieving a Serum Hemagglutination Inhibition (HAI) Antibody Titer of >= 1:40 Against the H3N2 QIV-like Virus A/North Carolina/04/2016
Day 8
|
9 percentage of participants
Interval 2.0 to 29.0
|
5 percentage of participants
Interval 0.0 to 23.0
|
|
Percentage of Participants Achieving a Serum Hemagglutination Inhibition (HAI) Antibody Titer of >= 1:40 Against the H3N2 QIV-like Virus A/North Carolina/04/2016
Day 22
|
9 percentage of participants
Interval 2.0 to 29.0
|
5 percentage of participants
Interval 0.0 to 23.0
|
|
Percentage of Participants Achieving a Serum Hemagglutination Inhibition (HAI) Antibody Titer of >= 1:40 Against the H3N2 QIV-like Virus A/North Carolina/04/2016
Day 57
|
9 percentage of participants
Interval 2.0 to 29.0
|
5 percentage of participants
Interval 0.0 to 23.0
|
|
Percentage of Participants Achieving a Serum Hemagglutination Inhibition (HAI) Antibody Titer of >= 1:40 Against the H3N2 QIV-like Virus A/North Carolina/04/2016
Day 92
|
10 percentage of participants
Interval 2.0 to 30.0
|
5 percentage of participants
Interval 0.0 to 23.0
|
|
Percentage of Participants Achieving a Serum Hemagglutination Inhibition (HAI) Antibody Titer of >= 1:40 Against the H3N2 QIV-like Virus A/North Carolina/04/2016
Day 113
|
57 percentage of participants
Interval 35.0 to 77.0
|
67 percentage of participants
Interval 45.0 to 85.0
|
SECONDARY outcome
Timeframe: Day 1 through Day 113Population: The Modified Intent-to-Treat (mITT) population includes all participants who received at least one dose of study vaccine and contributed both pre- and at least one post-study vaccination venous blood samples for which valid results were reported.
Blood was collected for HAI assays conducted with H3N2 QIV-like virus A/Singapore/INFIMH-16-0019/2016 as the antigen. Collection took place on Day 1 (pre-vaccination), Days 8, 22, and 57 after first vaccination, immediately prior to second vaccination (Day 92), and 21 days after second vaccination (Day 113). The geometric mean of each sample's replicate results was calculated from available results. The percentage of participants with HAI geometric mean titer \>= 1:40 was calculated within each study arm and analysis time point.
Outcome measures
| Measure |
M2SR
n=22 Participants
A single dose of monovalent live attenuated influenza H3N2 M2SR vaccine (M2SR) administered intranasally on Day 1, and a single dose of licensed quadrivalent influenza vaccine (QIV) administered intramuscularly on Day 92.
|
Placebo
n=21 Participants
A single dose of Placebo administered intranasally on Day 1, and a single dose of licensed QIV administered intramuscularly on Day 92.
|
|---|---|---|
|
Percentage of Participants Achieving a Serum Hemagglutination Inhibition (HAI) Antibody Titer of >= 1:40 Against the H3N2 QIV-like Virus A/Singapore/INFIMH-16-0019/2016
Day 1
|
91 percentage of participants
Interval 71.0 to 98.0
|
95 percentage of participants
Interval 77.0 to 100.0
|
|
Percentage of Participants Achieving a Serum Hemagglutination Inhibition (HAI) Antibody Titer of >= 1:40 Against the H3N2 QIV-like Virus A/Singapore/INFIMH-16-0019/2016
Day 8
|
91 percentage of participants
Interval 71.0 to 98.0
|
95 percentage of participants
Interval 77.0 to 100.0
|
|
Percentage of Participants Achieving a Serum Hemagglutination Inhibition (HAI) Antibody Titer of >= 1:40 Against the H3N2 QIV-like Virus A/Singapore/INFIMH-16-0019/2016
Day 22
|
91 percentage of participants
Interval 71.0 to 98.0
|
95 percentage of participants
Interval 77.0 to 100.0
|
|
Percentage of Participants Achieving a Serum Hemagglutination Inhibition (HAI) Antibody Titer of >= 1:40 Against the H3N2 QIV-like Virus A/Singapore/INFIMH-16-0019/2016
Day 57
|
91 percentage of participants
Interval 71.0 to 98.0
|
95 percentage of participants
Interval 77.0 to 100.0
|
|
Percentage of Participants Achieving a Serum Hemagglutination Inhibition (HAI) Antibody Titer of >= 1:40 Against the H3N2 QIV-like Virus A/Singapore/INFIMH-16-0019/2016
Day 92
|
90 percentage of participants
Interval 70.0 to 98.0
|
95 percentage of participants
Interval 77.0 to 100.0
|
|
Percentage of Participants Achieving a Serum Hemagglutination Inhibition (HAI) Antibody Titer of >= 1:40 Against the H3N2 QIV-like Virus A/Singapore/INFIMH-16-0019/2016
Day 113
|
95 percentage of participants
Interval 77.0 to 100.0
|
100 percentage of participants
Interval 85.0 to 100.0
|
SECONDARY outcome
Timeframe: Day 1 through Day 113Population: The Modified Intent-to-Treat (mITT) population includes all participants who received at least one dose of study vaccine and contributed both pre- and at least one post-study vaccination venous blood samples for which valid results were reported.
Blood was collected for HAI assays conducted with H3N2 QIV-like virus A/Kansas/14/2017 as the antigen. Collection took place on Day 1 (pre-vaccination), Days 8, 22, and 57 after first vaccination, immediately prior to second vaccination (Day 92), and 21 days after second vaccination (Day 113). The geometric mean of each sample's replicate results was calculated from available results. The percentage of participants with HAI geometric mean titer \>= 1:40 was calculated within each study arm and analysis time point.
Outcome measures
| Measure |
M2SR
n=22 Participants
A single dose of monovalent live attenuated influenza H3N2 M2SR vaccine (M2SR) administered intranasally on Day 1, and a single dose of licensed quadrivalent influenza vaccine (QIV) administered intramuscularly on Day 92.
|
Placebo
n=21 Participants
A single dose of Placebo administered intranasally on Day 1, and a single dose of licensed QIV administered intramuscularly on Day 92.
|
|---|---|---|
|
Percentage of Participants Achieving a Serum Hemagglutination Inhibition (HAI) Antibody Titer of >= 1:40 Against the H3N2 QIV-like Virus A/Kansas/14/2017
Day 8
|
41 percentage of participants
Interval 22.0 to 62.0
|
33 percentage of participants
Interval 15.0 to 55.0
|
|
Percentage of Participants Achieving a Serum Hemagglutination Inhibition (HAI) Antibody Titer of >= 1:40 Against the H3N2 QIV-like Virus A/Kansas/14/2017
Day 1
|
41 percentage of participants
Interval 22.0 to 62.0
|
38 percentage of participants
Interval 20.0 to 60.0
|
|
Percentage of Participants Achieving a Serum Hemagglutination Inhibition (HAI) Antibody Titer of >= 1:40 Against the H3N2 QIV-like Virus A/Kansas/14/2017
Day 22
|
41 percentage of participants
Interval 22.0 to 62.0
|
33 percentage of participants
Interval 15.0 to 55.0
|
|
Percentage of Participants Achieving a Serum Hemagglutination Inhibition (HAI) Antibody Titer of >= 1:40 Against the H3N2 QIV-like Virus A/Kansas/14/2017
Day 57
|
41 percentage of participants
Interval 22.0 to 62.0
|
33 percentage of participants
Interval 15.0 to 55.0
|
|
Percentage of Participants Achieving a Serum Hemagglutination Inhibition (HAI) Antibody Titer of >= 1:40 Against the H3N2 QIV-like Virus A/Kansas/14/2017
Day 92
|
38 percentage of participants
Interval 20.0 to 60.0
|
33 percentage of participants
Interval 15.0 to 55.0
|
|
Percentage of Participants Achieving a Serum Hemagglutination Inhibition (HAI) Antibody Titer of >= 1:40 Against the H3N2 QIV-like Virus A/Kansas/14/2017
Day 113
|
86 percentage of participants
Interval 65.0 to 96.0
|
90 percentage of participants
Interval 70.0 to 98.0
|
SECONDARY outcome
Timeframe: Day 1 through Day 113Population: The Modified Intent-to-Treat (mITT) population includes all participants who received at least one dose of study vaccine and contributed both pre- and at least one post-study vaccination venous blood samples for which valid results were reported.
Blood was collected for Neutralizing assays conducted with H3N2 M2SR-like virus A/Brisbane/10/2007 as the antigen. Collection took place on Day 1 (pre-vaccination), Days 8, 22, and 57 after first vaccination, immediately prior to second vaccination (Day 92), and 21 days after second vaccination (Day 113). The geometric mean of each sample's replicate results was calculated from available results. The percentage of participants with HAI geometric mean titer \>= 1:40 was calculated within each study arm and analysis time point.
Outcome measures
| Measure |
M2SR
n=22 Participants
A single dose of monovalent live attenuated influenza H3N2 M2SR vaccine (M2SR) administered intranasally on Day 1, and a single dose of licensed quadrivalent influenza vaccine (QIV) administered intramuscularly on Day 92.
|
Placebo
n=21 Participants
A single dose of Placebo administered intranasally on Day 1, and a single dose of licensed QIV administered intramuscularly on Day 92.
|
|---|---|---|
|
Percentage of Participants Achieving a Serum Neutralizing Antibody Titer of >= 1:40 Against the H3N2 M2SR-like Virus A/Brisbane/10/2007
Day 8
|
100 percentage of participants
Interval 85.0 to 100.0
|
100 percentage of participants
Interval 85.0 to 100.0
|
|
Percentage of Participants Achieving a Serum Neutralizing Antibody Titer of >= 1:40 Against the H3N2 M2SR-like Virus A/Brisbane/10/2007
Day 22
|
100 percentage of participants
Interval 85.0 to 100.0
|
100 percentage of participants
Interval 85.0 to 100.0
|
|
Percentage of Participants Achieving a Serum Neutralizing Antibody Titer of >= 1:40 Against the H3N2 M2SR-like Virus A/Brisbane/10/2007
Day 57
|
100 percentage of participants
Interval 85.0 to 100.0
|
100 percentage of participants
Interval 85.0 to 100.0
|
|
Percentage of Participants Achieving a Serum Neutralizing Antibody Titer of >= 1:40 Against the H3N2 M2SR-like Virus A/Brisbane/10/2007
Day 92
|
100 percentage of participants
Interval 85.0 to 100.0
|
100 percentage of participants
Interval 85.0 to 100.0
|
|
Percentage of Participants Achieving a Serum Neutralizing Antibody Titer of >= 1:40 Against the H3N2 M2SR-like Virus A/Brisbane/10/2007
Day 113
|
100 percentage of participants
Interval 85.0 to 100.0
|
100 percentage of participants
Interval 85.0 to 100.0
|
|
Percentage of Participants Achieving a Serum Neutralizing Antibody Titer of >= 1:40 Against the H3N2 M2SR-like Virus A/Brisbane/10/2007
Day 1
|
100 percentage of participants
Interval 85.0 to 100.0
|
100 percentage of participants
Interval 85.0 to 100.0
|
SECONDARY outcome
Timeframe: Day 1 through Day 113Population: The Modified Intent-to-Treat (mITT) population includes all participants who received at least one dose of study vaccine and contributed both pre- and at least one post-study vaccination venous blood samples for which valid results were reported.
Blood was collected for Neutralizing assays conducted with H3N2 QIV-like virus A/North Carolina/04/2016 as the antigen. Collection took place on Day 1 (pre-vaccination), Days 8, 22, and 57 after first vaccination, immediately prior to second vaccination (Day 92), and 21 days after second vaccination (Day 113). The geometric mean of each sample's replicate results was calculated from available results. The percentage of participants with HAI geometric mean titer \>= 1:40 was calculated within each study arm and analysis time point.
Outcome measures
| Measure |
M2SR
n=22 Participants
A single dose of monovalent live attenuated influenza H3N2 M2SR vaccine (M2SR) administered intranasally on Day 1, and a single dose of licensed quadrivalent influenza vaccine (QIV) administered intramuscularly on Day 92.
|
Placebo
n=21 Participants
A single dose of Placebo administered intranasally on Day 1, and a single dose of licensed QIV administered intramuscularly on Day 92.
|
|---|---|---|
|
Percentage of Participants Achieving a Serum Neutralizing Antibody Titer of >= 1:40 Against the H3N2 QIV-like Virus A/North Carolina/04/2016
Day 1
|
77 percentage of participants
Interval 55.0 to 91.0
|
81 percentage of participants
Interval 60.0 to 93.0
|
|
Percentage of Participants Achieving a Serum Neutralizing Antibody Titer of >= 1:40 Against the H3N2 QIV-like Virus A/North Carolina/04/2016
Day 8
|
82 percentage of participants
Interval 61.0 to 94.0
|
81 percentage of participants
Interval 60.0 to 93.0
|
|
Percentage of Participants Achieving a Serum Neutralizing Antibody Titer of >= 1:40 Against the H3N2 QIV-like Virus A/North Carolina/04/2016
Day 22
|
77 percentage of participants
Interval 55.0 to 91.0
|
81 percentage of participants
Interval 60.0 to 93.0
|
|
Percentage of Participants Achieving a Serum Neutralizing Antibody Titer of >= 1:40 Against the H3N2 QIV-like Virus A/North Carolina/04/2016
Day 57
|
77 percentage of participants
Interval 55.0 to 91.0
|
81 percentage of participants
Interval 60.0 to 93.0
|
|
Percentage of Participants Achieving a Serum Neutralizing Antibody Titer of >= 1:40 Against the H3N2 QIV-like Virus A/North Carolina/04/2016
Day 92
|
81 percentage of participants
Interval 60.0 to 93.0
|
81 percentage of participants
Interval 60.0 to 93.0
|
|
Percentage of Participants Achieving a Serum Neutralizing Antibody Titer of >= 1:40 Against the H3N2 QIV-like Virus A/North Carolina/04/2016
Day 113
|
100 percentage of participants
Interval 85.0 to 100.0
|
100 percentage of participants
Interval 85.0 to 100.0
|
SECONDARY outcome
Timeframe: Day 1 through Day 113Population: The Modified Intent-to-Treat (mITT) population includes all participants who received at least one dose of study vaccine and contributed both pre- and at least one post-study vaccination venous blood samples for which valid results were reported.
Blood was collected for Neutralizing assays conducted with H3N2 QIV-like virus A/Singapore/INFIMH-16-0019/2016 as the antigen. Collection took place on Day 1 (pre-vaccination), Days 8, 22, and 57 after first vaccination, immediately prior to second vaccination (Day 92), and 21 days after second vaccination (Day 113). The geometric mean of each sample's replicate results was calculated from available results. The percentage of participants with HAI geometric mean titer \>= 1:40 was calculated within each study arm and analysis time point.
Outcome measures
| Measure |
M2SR
n=22 Participants
A single dose of monovalent live attenuated influenza H3N2 M2SR vaccine (M2SR) administered intranasally on Day 1, and a single dose of licensed quadrivalent influenza vaccine (QIV) administered intramuscularly on Day 92.
|
Placebo
n=21 Participants
A single dose of Placebo administered intranasally on Day 1, and a single dose of licensed QIV administered intramuscularly on Day 92.
|
|---|---|---|
|
Percentage of Participants Achieving a Serum Neutralizing Antibody Titer of >= 1:40 Against the H3N2 QIV-like Virus A/Singapore/INFIMH-16-0019/2016
Day 1
|
95 percentage of participants
Interval 78.0 to 100.0
|
100 percentage of participants
Interval 85.0 to 100.0
|
|
Percentage of Participants Achieving a Serum Neutralizing Antibody Titer of >= 1:40 Against the H3N2 QIV-like Virus A/Singapore/INFIMH-16-0019/2016
Day 8
|
95 percentage of participants
Interval 78.0 to 100.0
|
100 percentage of participants
Interval 85.0 to 100.0
|
|
Percentage of Participants Achieving a Serum Neutralizing Antibody Titer of >= 1:40 Against the H3N2 QIV-like Virus A/Singapore/INFIMH-16-0019/2016
Day 22
|
95 percentage of participants
Interval 78.0 to 100.0
|
100 percentage of participants
Interval 85.0 to 100.0
|
|
Percentage of Participants Achieving a Serum Neutralizing Antibody Titer of >= 1:40 Against the H3N2 QIV-like Virus A/Singapore/INFIMH-16-0019/2016
Day 57
|
100 percentage of participants
Interval 85.0 to 100.0
|
100 percentage of participants
Interval 85.0 to 100.0
|
|
Percentage of Participants Achieving a Serum Neutralizing Antibody Titer of >= 1:40 Against the H3N2 QIV-like Virus A/Singapore/INFIMH-16-0019/2016
Day 92
|
95 percentage of participants
Interval 77.0 to 100.0
|
100 percentage of participants
Interval 85.0 to 100.0
|
|
Percentage of Participants Achieving a Serum Neutralizing Antibody Titer of >= 1:40 Against the H3N2 QIV-like Virus A/Singapore/INFIMH-16-0019/2016
Day 113
|
100 percentage of participants
Interval 85.0 to 100.0
|
100 percentage of participants
Interval 85.0 to 100.0
|
SECONDARY outcome
Timeframe: Day 1 through Day 113Population: The Modified Intent-to-Treat (mITT) population includes all participants who received at least one dose of study vaccine and contributed both pre- and at least one post-study vaccination venous blood samples for which valid results were reported.
Blood was collected for Neutralizing assays conducted with H3N2 QIV-like virus A/Kansas/14/2017 as the antigen. Collection took place on Day 1 (pre-vaccination), Days 8, 22, and 57 after first vaccination, immediately prior to second vaccination (Day 92), and 21 days after second vaccination (Day 113). The geometric mean of each sample's replicate results was calculated from available results. The percentage of participants with HAI geometric mean titer \>= 1:40 was calculated within each study arm and analysis time point.
Outcome measures
| Measure |
M2SR
n=22 Participants
A single dose of monovalent live attenuated influenza H3N2 M2SR vaccine (M2SR) administered intranasally on Day 1, and a single dose of licensed quadrivalent influenza vaccine (QIV) administered intramuscularly on Day 92.
|
Placebo
n=21 Participants
A single dose of Placebo administered intranasally on Day 1, and a single dose of licensed QIV administered intramuscularly on Day 92.
|
|---|---|---|
|
Percentage of Participants Achieving a Serum Neutralizing Antibody Titer of >= 1:40 Against the H3N2 QIV-like Virus A/Kansas/14/2017
Day 1
|
95 percentage of participants
Interval 78.0 to 100.0
|
100 percentage of participants
Interval 85.0 to 100.0
|
|
Percentage of Participants Achieving a Serum Neutralizing Antibody Titer of >= 1:40 Against the H3N2 QIV-like Virus A/Kansas/14/2017
Day 8
|
95 percentage of participants
Interval 78.0 to 100.0
|
100 percentage of participants
Interval 85.0 to 100.0
|
|
Percentage of Participants Achieving a Serum Neutralizing Antibody Titer of >= 1:40 Against the H3N2 QIV-like Virus A/Kansas/14/2017
Day 22
|
100 percentage of participants
Interval 85.0 to 100.0
|
100 percentage of participants
Interval 85.0 to 100.0
|
|
Percentage of Participants Achieving a Serum Neutralizing Antibody Titer of >= 1:40 Against the H3N2 QIV-like Virus A/Kansas/14/2017
Day 57
|
95 percentage of participants
Interval 78.0 to 100.0
|
95 percentage of participants
Interval 77.0 to 100.0
|
|
Percentage of Participants Achieving a Serum Neutralizing Antibody Titer of >= 1:40 Against the H3N2 QIV-like Virus A/Kansas/14/2017
Day 92
|
95 percentage of participants
Interval 77.0 to 100.0
|
95 percentage of participants
Interval 77.0 to 100.0
|
|
Percentage of Participants Achieving a Serum Neutralizing Antibody Titer of >= 1:40 Against the H3N2 QIV-like Virus A/Kansas/14/2017
Day 113
|
100 percentage of participants
Interval 85.0 to 100.0
|
100 percentage of participants
Interval 85.0 to 100.0
|
SECONDARY outcome
Timeframe: Day 8 through Day 113Population: The Modified Intent-to-Treat (mITT) population includes all participants who received at least one dose of study vaccine and contributed both pre- and at least one post-study vaccination venous blood samples for which valid results were reported.
Blood was collected for HAI assays conducted with H3N2 M2SR-like virus A/Brisbane/10/2007 as the antigen. Collection took place on Day 1 (pre-vaccination), Days 8, 22, and 57 after first vaccination, immediately prior to second vaccination (Day 92), and 21 days after second vaccination (Day 113). The geometric mean of each sample's replicate results was calculated from available results. Seroconversion is defined as either a pre-vaccination geometric mean titer (GMT) \< 1:10 and a post-vaccination GMT \>= 1:40, or a pre-vaccination GMT \>= 1:10 and a minimum 4-fold rise in post-vaccination GMT. The percentage of participants achieving seroconversion was calculated within each study arm and analysis time point.
Outcome measures
| Measure |
M2SR
n=22 Participants
A single dose of monovalent live attenuated influenza H3N2 M2SR vaccine (M2SR) administered intranasally on Day 1, and a single dose of licensed quadrivalent influenza vaccine (QIV) administered intramuscularly on Day 92.
|
Placebo
n=21 Participants
A single dose of Placebo administered intranasally on Day 1, and a single dose of licensed QIV administered intramuscularly on Day 92.
|
|---|---|---|
|
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the H3N2 M2SR-like Virus A/Brisbane/10/2007
Day 8
|
0 percentage of participants
Interval 0.0 to 15.0
|
0 percentage of participants
Interval 0.0 to 15.0
|
|
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the H3N2 M2SR-like Virus A/Brisbane/10/2007
Day 22
|
0 percentage of participants
Interval 0.0 to 15.0
|
0 percentage of participants
Interval 0.0 to 15.0
|
|
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the H3N2 M2SR-like Virus A/Brisbane/10/2007
Day 57
|
0 percentage of participants
Interval 0.0 to 15.0
|
0 percentage of participants
Interval 0.0 to 15.0
|
|
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the H3N2 M2SR-like Virus A/Brisbane/10/2007
Day 92
|
0 percentage of participants
Interval 0.0 to 15.0
|
0 percentage of participants
Interval 0.0 to 15.0
|
|
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the H3N2 M2SR-like Virus A/Brisbane/10/2007
Day 113
|
24 percentage of participants
Interval 10.0 to 46.0
|
19 percentage of participants
Interval 7.0 to 40.0
|
SECONDARY outcome
Timeframe: Day 8 through Day 113Population: The Modified Intent-to-Treat (mITT) population includes all participants who received at least one dose of study vaccine and contributed both pre- and at least one post-study vaccination venous blood samples for which valid results were reported.
Blood was collected for HAI assays conducted with H3N2 QIV-like virus A/North Carolina/04/2016 as the antigen. Collection took place on Day 1 (pre-vaccination), Days 8, 22, and 57 after first vaccination, immediately prior to second vaccination (Day 92), and 21 days after second vaccination (Day 113). The geometric mean of each sample's replicate results was calculated from available results. Seroconversion is defined as either a pre-vaccination geometric mean titer (GMT) \< 1:10 and a post-vaccination GMT \>= 1:40, or a pre-vaccination GMT \>= 1:10 and a minimum 4-fold rise in post-vaccination GMT. The percentage of participants achieving seroconversion was calculated within each study arm and analysis time point.
Outcome measures
| Measure |
M2SR
n=22 Participants
A single dose of monovalent live attenuated influenza H3N2 M2SR vaccine (M2SR) administered intranasally on Day 1, and a single dose of licensed quadrivalent influenza vaccine (QIV) administered intramuscularly on Day 92.
|
Placebo
n=21 Participants
A single dose of Placebo administered intranasally on Day 1, and a single dose of licensed QIV administered intramuscularly on Day 92.
|
|---|---|---|
|
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the H3N2 QIV-like Virus A/North Carolina/04/2016
Day 8
|
0 percentage of participants
Interval 0.0 to 15.0
|
0 percentage of participants
Interval 0.0 to 15.0
|
|
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the H3N2 QIV-like Virus A/North Carolina/04/2016
Day 22
|
0 percentage of participants
Interval 0.0 to 15.0
|
0 percentage of participants
Interval 0.0 to 15.0
|
|
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the H3N2 QIV-like Virus A/North Carolina/04/2016
Day 57
|
0 percentage of participants
Interval 0.0 to 15.0
|
0 percentage of participants
Interval 0.0 to 15.0
|
|
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the H3N2 QIV-like Virus A/North Carolina/04/2016
Day 92
|
0 percentage of participants
Interval 0.0 to 15.0
|
0 percentage of participants
Interval 0.0 to 15.0
|
|
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the H3N2 QIV-like Virus A/North Carolina/04/2016
Day 113
|
24 percentage of participants
Interval 10.0 to 46.0
|
62 percentage of participants
Interval 40.0 to 80.0
|
SECONDARY outcome
Timeframe: Day 8 through Day 113Population: The Modified Intent-to-Treat (mITT) population includes all participants who received at least one dose of study vaccine and contributed both pre- and at least one post-study vaccination venous blood samples for which valid results were reported.
Blood was collected for HAI assays conducted with H3N2 QIV-like virus A/Singapore/INFIMH-16-0019/2016 as the antigen. Collection took place on Day 1 (pre-vaccination), Days 8, 22, and 57 after first vaccination, immediately prior to second vaccination (Day 92), and 21 days after second vaccination (Day 113). The geometric mean of each sample's replicate results was calculated from available results. Seroconversion is defined as either a pre-vaccination geometric mean titer (GMT) \< 1:10 and a post-vaccination GMT \>= 1:40, or a pre-vaccination GMT \>= 1:10 and a minimum 4-fold rise in post-vaccination GMT. The percentage of participants achieving seroconversion was calculated within each study arm and analysis time point.
Outcome measures
| Measure |
M2SR
n=22 Participants
A single dose of monovalent live attenuated influenza H3N2 M2SR vaccine (M2SR) administered intranasally on Day 1, and a single dose of licensed quadrivalent influenza vaccine (QIV) administered intramuscularly on Day 92.
|
Placebo
n=21 Participants
A single dose of Placebo administered intranasally on Day 1, and a single dose of licensed QIV administered intramuscularly on Day 92.
|
|---|---|---|
|
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the H3N2 QIV-like Virus A/Singapore/INFIMH-16-0019/2016
Day 8
|
0 percentage of participants
Interval 0.0 to 15.0
|
0 percentage of participants
Interval 0.0 to 15.0
|
|
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the H3N2 QIV-like Virus A/Singapore/INFIMH-16-0019/2016
Day 22
|
0 percentage of participants
Interval 0.0 to 15.0
|
0 percentage of participants
Interval 0.0 to 15.0
|
|
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the H3N2 QIV-like Virus A/Singapore/INFIMH-16-0019/2016
Day 113
|
24 percentage of participants
Interval 10.0 to 46.0
|
33 percentage of participants
Interval 15.0 to 55.0
|
|
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the H3N2 QIV-like Virus A/Singapore/INFIMH-16-0019/2016
Day 57
|
0 percentage of participants
Interval 0.0 to 15.0
|
0 percentage of participants
Interval 0.0 to 15.0
|
|
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the H3N2 QIV-like Virus A/Singapore/INFIMH-16-0019/2016
Day 92
|
0 percentage of participants
Interval 0.0 to 15.0
|
0 percentage of participants
Interval 0.0 to 15.0
|
SECONDARY outcome
Timeframe: Day 8 through Day 113Population: The Modified Intent-to-Treat (mITT) population includes all participants who received at least one dose of study vaccine and contributed both pre- and at least one post-study vaccination venous blood samples for which valid results were reported.
Blood was collected for HAI assays conducted with H3N2 QIV-like virus A/Kansas/14/2017 as the antigen. Collection took place on Day 1 (pre-vaccination), Days 8, 22, and 57 after first vaccination, immediately prior to second vaccination (Day 92), and 21 days after second vaccination (Day 113). The geometric mean of each sample's replicate results was calculated from available results. Seroconversion is defined as either a pre-vaccination geometric mean titer (GMT) \< 1:10 and a post-vaccination GMT \>= 1:40, or a pre-vaccination GMT \>= 1:10 and a minimum 4-fold rise in post-vaccination GMT. The percentage of participants achieving seroconversion was calculated within each study arm and analysis time point.
Outcome measures
| Measure |
M2SR
n=22 Participants
A single dose of monovalent live attenuated influenza H3N2 M2SR vaccine (M2SR) administered intranasally on Day 1, and a single dose of licensed quadrivalent influenza vaccine (QIV) administered intramuscularly on Day 92.
|
Placebo
n=21 Participants
A single dose of Placebo administered intranasally on Day 1, and a single dose of licensed QIV administered intramuscularly on Day 92.
|
|---|---|---|
|
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the H3N2 QIV-like Virus A/Kansas/14/2017
Day 8
|
0 percentage of participants
Interval 0.0 to 15.0
|
0 percentage of participants
Interval 0.0 to 15.0
|
|
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the H3N2 QIV-like Virus A/Kansas/14/2017
Day 22
|
0 percentage of participants
Interval 0.0 to 15.0
|
0 percentage of participants
Interval 0.0 to 15.0
|
|
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the H3N2 QIV-like Virus A/Kansas/14/2017
Day 57
|
0 percentage of participants
Interval 0.0 to 15.0
|
0 percentage of participants
Interval 0.0 to 15.0
|
|
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the H3N2 QIV-like Virus A/Kansas/14/2017
Day 92
|
0 percentage of participants
Interval 0.0 to 15.0
|
0 percentage of participants
Interval 0.0 to 15.0
|
|
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibody Seroconversion Against the H3N2 QIV-like Virus A/Kansas/14/2017
Day 113
|
43 percentage of participants
Interval 23.0 to 65.0
|
52 percentage of participants
Interval 30.0 to 72.0
|
SECONDARY outcome
Timeframe: Day 8 through Day 113Population: The Modified Intent-to-Treat (mITT) population includes all participants who received at least one dose of study vaccine and contributed both pre- and at least one post-study vaccination venous blood samples for which valid results were reported.
Blood was collected for Neutralizing assays conducted with H3N2 M2SR-like virus A/Brisbane/10/2007 as the antigen. Collection took place on Day 1 (pre-vaccination), Days 8, 22, and 57 after first vaccination, immediately prior to second vaccination (Day 92), and 21 days after second vaccination (Day 113). The geometric mean of each sample's replicate results was calculated from available results. Seroconversion is defined as either a pre-vaccination geometric mean titer (GMT) \< 1:10 and a post-vaccination GMT \>= 1:40, or a pre-vaccination GMT \>= 1:10 and a minimum 4-fold rise in post-vaccination GMT. The percentage of participants achieving seroconversion was calculated within each study arm and analysis time point.
Outcome measures
| Measure |
M2SR
n=22 Participants
A single dose of monovalent live attenuated influenza H3N2 M2SR vaccine (M2SR) administered intranasally on Day 1, and a single dose of licensed quadrivalent influenza vaccine (QIV) administered intramuscularly on Day 92.
|
Placebo
n=21 Participants
A single dose of Placebo administered intranasally on Day 1, and a single dose of licensed QIV administered intramuscularly on Day 92.
|
|---|---|---|
|
Percentage of Participants Achieving Neutralizing Antibody Seroconversion Against the H3N2 M2SR-like Virus A/Brisbane/10/2007
Day 8
|
0 percentage of participants
Interval 0.0 to 15.0
|
0 percentage of participants
Interval 0.0 to 15.0
|
|
Percentage of Participants Achieving Neutralizing Antibody Seroconversion Against the H3N2 M2SR-like Virus A/Brisbane/10/2007
Day 22
|
0 percentage of participants
Interval 0.0 to 15.0
|
0 percentage of participants
Interval 0.0 to 15.0
|
|
Percentage of Participants Achieving Neutralizing Antibody Seroconversion Against the H3N2 M2SR-like Virus A/Brisbane/10/2007
Day 57
|
0 percentage of participants
Interval 0.0 to 15.0
|
0 percentage of participants
Interval 0.0 to 15.0
|
|
Percentage of Participants Achieving Neutralizing Antibody Seroconversion Against the H3N2 M2SR-like Virus A/Brisbane/10/2007
Day 92
|
0 percentage of participants
Interval 0.0 to 15.0
|
0 percentage of participants
Interval 0.0 to 15.0
|
|
Percentage of Participants Achieving Neutralizing Antibody Seroconversion Against the H3N2 M2SR-like Virus A/Brisbane/10/2007
Day 113
|
24 percentage of participants
Interval 10.0 to 46.0
|
19 percentage of participants
Interval 7.0 to 40.0
|
SECONDARY outcome
Timeframe: Day 8 through Day 113Population: The Modified Intent-to-Treat (mITT) population includes all participants who received at least one dose of study vaccine and contributed both pre- and at least one post-study vaccination venous blood samples for which valid results were reported.
Blood was collected for Neutralizing assays conducted with H3N2 QIV-like virus A/North Carolina/04/2016 as the antigen. Collection took place on Day 1 (pre-vaccination), Days 8, 22, and 57 after first vaccination, immediately prior to second vaccination (Day 92), and 21 days after second vaccination (Day 113). The geometric mean of each sample's replicate results was calculated from available results. Seroconversion is defined as either a pre-vaccination geometric mean titer (GMT) \< 1:10 and a post-vaccination GMT \>= 1:40, or a pre-vaccination GMT \>= 1:10 and a minimum 4-fold rise in post-vaccination GMT. The percentage of participants achieving seroconversion was calculated within each study arm and analysis time point.
Outcome measures
| Measure |
M2SR
n=22 Participants
A single dose of monovalent live attenuated influenza H3N2 M2SR vaccine (M2SR) administered intranasally on Day 1, and a single dose of licensed quadrivalent influenza vaccine (QIV) administered intramuscularly on Day 92.
|
Placebo
n=21 Participants
A single dose of Placebo administered intranasally on Day 1, and a single dose of licensed QIV administered intramuscularly on Day 92.
|
|---|---|---|
|
Percentage of Participants Achieving Neutralizing Antibody Seroconversion Against the H3N2 QIV-like Virus A/North Carolina/04/2016
Day 8
|
0 percentage of participants
Interval 0.0 to 15.0
|
0 percentage of participants
Interval 0.0 to 15.0
|
|
Percentage of Participants Achieving Neutralizing Antibody Seroconversion Against the H3N2 QIV-like Virus A/North Carolina/04/2016
Day 22
|
0 percentage of participants
Interval 0.0 to 15.0
|
0 percentage of participants
Interval 0.0 to 15.0
|
|
Percentage of Participants Achieving Neutralizing Antibody Seroconversion Against the H3N2 QIV-like Virus A/North Carolina/04/2016
Day 57
|
0 percentage of participants
Interval 0.0 to 15.0
|
0 percentage of participants
Interval 0.0 to 15.0
|
|
Percentage of Participants Achieving Neutralizing Antibody Seroconversion Against the H3N2 QIV-like Virus A/North Carolina/04/2016
Day 92
|
0 percentage of participants
Interval 0.0 to 15.0
|
0 percentage of participants
Interval 0.0 to 15.0
|
|
Percentage of Participants Achieving Neutralizing Antibody Seroconversion Against the H3N2 QIV-like Virus A/North Carolina/04/2016
Day 113
|
33 percentage of participants
Interval 15.0 to 55.0
|
62 percentage of participants
Interval 40.0 to 80.0
|
SECONDARY outcome
Timeframe: Day 8 through Day 113Population: The Modified Intent-to-Treat (mITT) population includes all participants who received at least one dose of study vaccine and contributed both pre- and at least one post-study vaccination venous blood samples for which valid results were reported.
Blood was collected for Neutralizing assays conducted with H3N2 QIV-like virus A/Singapore/INFIMH-16-0019/2016 as the antigen. Collection took place on Day 1 (pre-vaccination), Days 8, 22, and 57 after first vaccination, immediately prior to second vaccination (Day 92), and 21 days after second vaccination (Day 113). The geometric mean of each sample's replicate results was calculated from available results. Seroconversion is defined as either a pre-vaccination geometric mean titer (GMT) \< 1:10 and a post-vaccination GMT \>= 1:40, or a pre-vaccination GMT \>= 1:10 and a minimum 4-fold rise in post-vaccination GMT. The percentage of participants achieving seroconversion was calculated within each study arm and analysis time point.
Outcome measures
| Measure |
M2SR
n=22 Participants
A single dose of monovalent live attenuated influenza H3N2 M2SR vaccine (M2SR) administered intranasally on Day 1, and a single dose of licensed quadrivalent influenza vaccine (QIV) administered intramuscularly on Day 92.
|
Placebo
n=21 Participants
A single dose of Placebo administered intranasally on Day 1, and a single dose of licensed QIV administered intramuscularly on Day 92.
|
|---|---|---|
|
Percentage of Participants Achieving Neutralizing Antibody Seroconversion Against the H3N2 QIV-like Virus A/Singapore/INFIMH-16-0019/2016
Day 8
|
0 percentage of participants
Interval 0.0 to 15.0
|
0 percentage of participants
Interval 0.0 to 15.0
|
|
Percentage of Participants Achieving Neutralizing Antibody Seroconversion Against the H3N2 QIV-like Virus A/Singapore/INFIMH-16-0019/2016
Day 22
|
0 percentage of participants
Interval 0.0 to 15.0
|
0 percentage of participants
Interval 0.0 to 15.0
|
|
Percentage of Participants Achieving Neutralizing Antibody Seroconversion Against the H3N2 QIV-like Virus A/Singapore/INFIMH-16-0019/2016
Day 57
|
0 percentage of participants
Interval 0.0 to 15.0
|
0 percentage of participants
Interval 0.0 to 15.0
|
|
Percentage of Participants Achieving Neutralizing Antibody Seroconversion Against the H3N2 QIV-like Virus A/Singapore/INFIMH-16-0019/2016
Day 92
|
0 percentage of participants
Interval 0.0 to 15.0
|
0 percentage of participants
Interval 0.0 to 15.0
|
|
Percentage of Participants Achieving Neutralizing Antibody Seroconversion Against the H3N2 QIV-like Virus A/Singapore/INFIMH-16-0019/2016
Day 113
|
38 percentage of participants
Interval 20.0 to 60.0
|
43 percentage of participants
Interval 23.0 to 65.0
|
SECONDARY outcome
Timeframe: Day 8 through Day 113Population: The Modified Intent-to-Treat (mITT) population includes all participants who received at least one dose of study vaccine and contributed both pre- and at least one post-study vaccination venous blood samples for which valid results were reported.
Blood was collected for Neutralizing assays conducted with H3N2 QIV-like virus A/Kansas/14/2017 as the antigen. Collection took place on Day 1 (pre-vaccination), Days 8, 22, and 57 after first vaccination, immediately prior to second vaccination (Day 92), and 21 days after second vaccination (Day 113). The geometric mean of each sample's replicate results was calculated from available results. Seroconversion is defined as either a pre-vaccination geometric mean titer (GMT) \< 1:10 and a post-vaccination GMT \>= 1:40, or a pre-vaccination GMT \>= 1:10 and a minimum 4-fold rise in post-vaccination GMT. The percentage of participants achieving seroconversion was calculated within each study arm and analysis time point.
Outcome measures
| Measure |
M2SR
n=22 Participants
A single dose of monovalent live attenuated influenza H3N2 M2SR vaccine (M2SR) administered intranasally on Day 1, and a single dose of licensed quadrivalent influenza vaccine (QIV) administered intramuscularly on Day 92.
|
Placebo
n=21 Participants
A single dose of Placebo administered intranasally on Day 1, and a single dose of licensed QIV administered intramuscularly on Day 92.
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|---|---|---|
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Percentage of Participants Achieving Neutralizing Antibody Seroconversion Against the H3N2 QIV-like Virus A/Kansas/14/2017
Day 8
|
0 percentage of participants
Interval 0.0 to 15.0
|
0 percentage of participants
Interval 0.0 to 15.0
|
|
Percentage of Participants Achieving Neutralizing Antibody Seroconversion Against the H3N2 QIV-like Virus A/Kansas/14/2017
Day 22
|
0 percentage of participants
Interval 0.0 to 15.0
|
0 percentage of participants
Interval 0.0 to 15.0
|
|
Percentage of Participants Achieving Neutralizing Antibody Seroconversion Against the H3N2 QIV-like Virus A/Kansas/14/2017
Day 57
|
0 percentage of participants
Interval 0.0 to 15.0
|
0 percentage of participants
Interval 0.0 to 15.0
|
|
Percentage of Participants Achieving Neutralizing Antibody Seroconversion Against the H3N2 QIV-like Virus A/Kansas/14/2017
Day 92
|
0 percentage of participants
Interval 0.0 to 15.0
|
0 percentage of participants
Interval 0.0 to 15.0
|
|
Percentage of Participants Achieving Neutralizing Antibody Seroconversion Against the H3N2 QIV-like Virus A/Kansas/14/2017
Day 113
|
43 percentage of participants
Interval 23.0 to 65.0
|
48 percentage of participants
Interval 28.0 to 70.0
|
Adverse Events
M2SR
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
M2SR
n=22 participants at risk
A single dose of monovalent live attenuated influenza H3N2 M2SR vaccine (M2SR) administered intranasally on Day 1, and a single dose of licensed quadrivalent influenza vaccine (QIV) administered intramuscularly on Day 92.
|
Placebo
n=21 participants at risk
A single dose of Placebo administered intranasally on Day 1, and a single dose of licensed QIV administered intramuscularly on Day 92.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
9.1%
2/22 • Number of events 2 • Solicited reactogenicity events were reported from the time of experimental (first) study vaccination through Day 8 after vaccination. Unsolicited non-serious AEs were reported from the time of the first study vaccination through Day 22 after the first study vaccination. SAEs were reported from the time of the first study vaccination through Day 366 after the first vaccination. AESIs and NOCMCs were reported from the time of first study vaccination through Day 92 after first study vaccination.
|
0.00%
0/21 • Solicited reactogenicity events were reported from the time of experimental (first) study vaccination through Day 8 after vaccination. Unsolicited non-serious AEs were reported from the time of the first study vaccination through Day 22 after the first study vaccination. SAEs were reported from the time of the first study vaccination through Day 366 after the first vaccination. AESIs and NOCMCs were reported from the time of first study vaccination through Day 92 after first study vaccination.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/22 • Solicited reactogenicity events were reported from the time of experimental (first) study vaccination through Day 8 after vaccination. Unsolicited non-serious AEs were reported from the time of the first study vaccination through Day 22 after the first study vaccination. SAEs were reported from the time of the first study vaccination through Day 366 after the first vaccination. AESIs and NOCMCs were reported from the time of first study vaccination through Day 92 after first study vaccination.
|
9.5%
2/21 • Number of events 2 • Solicited reactogenicity events were reported from the time of experimental (first) study vaccination through Day 8 after vaccination. Unsolicited non-serious AEs were reported from the time of the first study vaccination through Day 22 after the first study vaccination. SAEs were reported from the time of the first study vaccination through Day 366 after the first vaccination. AESIs and NOCMCs were reported from the time of first study vaccination through Day 92 after first study vaccination.
|
|
General disorders
Fatigue
|
22.7%
5/22 • Number of events 5 • Solicited reactogenicity events were reported from the time of experimental (first) study vaccination through Day 8 after vaccination. Unsolicited non-serious AEs were reported from the time of the first study vaccination through Day 22 after the first study vaccination. SAEs were reported from the time of the first study vaccination through Day 366 after the first vaccination. AESIs and NOCMCs were reported from the time of first study vaccination through Day 92 after first study vaccination.
|
19.0%
4/21 • Number of events 4 • Solicited reactogenicity events were reported from the time of experimental (first) study vaccination through Day 8 after vaccination. Unsolicited non-serious AEs were reported from the time of the first study vaccination through Day 22 after the first study vaccination. SAEs were reported from the time of the first study vaccination through Day 366 after the first vaccination. AESIs and NOCMCs were reported from the time of first study vaccination through Day 92 after first study vaccination.
|
|
General disorders
Malaise
|
13.6%
3/22 • Number of events 3 • Solicited reactogenicity events were reported from the time of experimental (first) study vaccination through Day 8 after vaccination. Unsolicited non-serious AEs were reported from the time of the first study vaccination through Day 22 after the first study vaccination. SAEs were reported from the time of the first study vaccination through Day 366 after the first vaccination. AESIs and NOCMCs were reported from the time of first study vaccination through Day 92 after first study vaccination.
|
4.8%
1/21 • Number of events 1 • Solicited reactogenicity events were reported from the time of experimental (first) study vaccination through Day 8 after vaccination. Unsolicited non-serious AEs were reported from the time of the first study vaccination through Day 22 after the first study vaccination. SAEs were reported from the time of the first study vaccination through Day 366 after the first vaccination. AESIs and NOCMCs were reported from the time of first study vaccination through Day 92 after first study vaccination.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
9.1%
2/22 • Number of events 2 • Solicited reactogenicity events were reported from the time of experimental (first) study vaccination through Day 8 after vaccination. Unsolicited non-serious AEs were reported from the time of the first study vaccination through Day 22 after the first study vaccination. SAEs were reported from the time of the first study vaccination through Day 366 after the first vaccination. AESIs and NOCMCs were reported from the time of first study vaccination through Day 92 after first study vaccination.
|
14.3%
3/21 • Number of events 3 • Solicited reactogenicity events were reported from the time of experimental (first) study vaccination through Day 8 after vaccination. Unsolicited non-serious AEs were reported from the time of the first study vaccination through Day 22 after the first study vaccination. SAEs were reported from the time of the first study vaccination through Day 366 after the first vaccination. AESIs and NOCMCs were reported from the time of first study vaccination through Day 92 after first study vaccination.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
9.1%
2/22 • Number of events 2 • Solicited reactogenicity events were reported from the time of experimental (first) study vaccination through Day 8 after vaccination. Unsolicited non-serious AEs were reported from the time of the first study vaccination through Day 22 after the first study vaccination. SAEs were reported from the time of the first study vaccination through Day 366 after the first vaccination. AESIs and NOCMCs were reported from the time of first study vaccination through Day 92 after first study vaccination.
|
4.8%
1/21 • Number of events 1 • Solicited reactogenicity events were reported from the time of experimental (first) study vaccination through Day 8 after vaccination. Unsolicited non-serious AEs were reported from the time of the first study vaccination through Day 22 after the first study vaccination. SAEs were reported from the time of the first study vaccination through Day 366 after the first vaccination. AESIs and NOCMCs were reported from the time of first study vaccination through Day 92 after first study vaccination.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
13.6%
3/22 • Number of events 3 • Solicited reactogenicity events were reported from the time of experimental (first) study vaccination through Day 8 after vaccination. Unsolicited non-serious AEs were reported from the time of the first study vaccination through Day 22 after the first study vaccination. SAEs were reported from the time of the first study vaccination through Day 366 after the first vaccination. AESIs and NOCMCs were reported from the time of first study vaccination through Day 92 after first study vaccination.
|
4.8%
1/21 • Number of events 1 • Solicited reactogenicity events were reported from the time of experimental (first) study vaccination through Day 8 after vaccination. Unsolicited non-serious AEs were reported from the time of the first study vaccination through Day 22 after the first study vaccination. SAEs were reported from the time of the first study vaccination through Day 366 after the first vaccination. AESIs and NOCMCs were reported from the time of first study vaccination through Day 92 after first study vaccination.
|
|
Nervous system disorders
Headache
|
36.4%
8/22 • Number of events 8 • Solicited reactogenicity events were reported from the time of experimental (first) study vaccination through Day 8 after vaccination. Unsolicited non-serious AEs were reported from the time of the first study vaccination through Day 22 after the first study vaccination. SAEs were reported from the time of the first study vaccination through Day 366 after the first vaccination. AESIs and NOCMCs were reported from the time of first study vaccination through Day 92 after first study vaccination.
|
14.3%
3/21 • Number of events 3 • Solicited reactogenicity events were reported from the time of experimental (first) study vaccination through Day 8 after vaccination. Unsolicited non-serious AEs were reported from the time of the first study vaccination through Day 22 after the first study vaccination. SAEs were reported from the time of the first study vaccination through Day 366 after the first vaccination. AESIs and NOCMCs were reported from the time of first study vaccination through Day 92 after first study vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.1%
2/22 • Number of events 2 • Solicited reactogenicity events were reported from the time of experimental (first) study vaccination through Day 8 after vaccination. Unsolicited non-serious AEs were reported from the time of the first study vaccination through Day 22 after the first study vaccination. SAEs were reported from the time of the first study vaccination through Day 366 after the first vaccination. AESIs and NOCMCs were reported from the time of first study vaccination through Day 92 after first study vaccination.
|
9.5%
2/21 • Number of events 2 • Solicited reactogenicity events were reported from the time of experimental (first) study vaccination through Day 8 after vaccination. Unsolicited non-serious AEs were reported from the time of the first study vaccination through Day 22 after the first study vaccination. SAEs were reported from the time of the first study vaccination through Day 366 after the first vaccination. AESIs and NOCMCs were reported from the time of first study vaccination through Day 92 after first study vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
22.7%
5/22 • Number of events 5 • Solicited reactogenicity events were reported from the time of experimental (first) study vaccination through Day 8 after vaccination. Unsolicited non-serious AEs were reported from the time of the first study vaccination through Day 22 after the first study vaccination. SAEs were reported from the time of the first study vaccination through Day 366 after the first vaccination. AESIs and NOCMCs were reported from the time of first study vaccination through Day 92 after first study vaccination.
|
23.8%
5/21 • Number of events 5 • Solicited reactogenicity events were reported from the time of experimental (first) study vaccination through Day 8 after vaccination. Unsolicited non-serious AEs were reported from the time of the first study vaccination through Day 22 after the first study vaccination. SAEs were reported from the time of the first study vaccination through Day 366 after the first vaccination. AESIs and NOCMCs were reported from the time of first study vaccination through Day 92 after first study vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
9.1%
2/22 • Number of events 2 • Solicited reactogenicity events were reported from the time of experimental (first) study vaccination through Day 8 after vaccination. Unsolicited non-serious AEs were reported from the time of the first study vaccination through Day 22 after the first study vaccination. SAEs were reported from the time of the first study vaccination through Day 366 after the first vaccination. AESIs and NOCMCs were reported from the time of first study vaccination through Day 92 after first study vaccination.
|
14.3%
3/21 • Number of events 3 • Solicited reactogenicity events were reported from the time of experimental (first) study vaccination through Day 8 after vaccination. Unsolicited non-serious AEs were reported from the time of the first study vaccination through Day 22 after the first study vaccination. SAEs were reported from the time of the first study vaccination through Day 366 after the first vaccination. AESIs and NOCMCs were reported from the time of first study vaccination through Day 92 after first study vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Pain
|
0.00%
0/22 • Solicited reactogenicity events were reported from the time of experimental (first) study vaccination through Day 8 after vaccination. Unsolicited non-serious AEs were reported from the time of the first study vaccination through Day 22 after the first study vaccination. SAEs were reported from the time of the first study vaccination through Day 366 after the first vaccination. AESIs and NOCMCs were reported from the time of first study vaccination through Day 92 after first study vaccination.
|
9.5%
2/21 • Number of events 2 • Solicited reactogenicity events were reported from the time of experimental (first) study vaccination through Day 8 after vaccination. Unsolicited non-serious AEs were reported from the time of the first study vaccination through Day 22 after the first study vaccination. SAEs were reported from the time of the first study vaccination through Day 366 after the first vaccination. AESIs and NOCMCs were reported from the time of first study vaccination through Day 92 after first study vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
13.6%
3/22 • Number of events 3 • Solicited reactogenicity events were reported from the time of experimental (first) study vaccination through Day 8 after vaccination. Unsolicited non-serious AEs were reported from the time of the first study vaccination through Day 22 after the first study vaccination. SAEs were reported from the time of the first study vaccination through Day 366 after the first vaccination. AESIs and NOCMCs were reported from the time of first study vaccination through Day 92 after first study vaccination.
|
23.8%
5/21 • Number of events 5 • Solicited reactogenicity events were reported from the time of experimental (first) study vaccination through Day 8 after vaccination. Unsolicited non-serious AEs were reported from the time of the first study vaccination through Day 22 after the first study vaccination. SAEs were reported from the time of the first study vaccination through Day 366 after the first vaccination. AESIs and NOCMCs were reported from the time of first study vaccination through Day 92 after first study vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Throat Irritation
|
4.5%
1/22 • Number of events 1 • Solicited reactogenicity events were reported from the time of experimental (first) study vaccination through Day 8 after vaccination. Unsolicited non-serious AEs were reported from the time of the first study vaccination through Day 22 after the first study vaccination. SAEs were reported from the time of the first study vaccination through Day 366 after the first vaccination. AESIs and NOCMCs were reported from the time of first study vaccination through Day 92 after first study vaccination.
|
9.5%
2/21 • Number of events 2 • Solicited reactogenicity events were reported from the time of experimental (first) study vaccination through Day 8 after vaccination. Unsolicited non-serious AEs were reported from the time of the first study vaccination through Day 22 after the first study vaccination. SAEs were reported from the time of the first study vaccination through Day 366 after the first vaccination. AESIs and NOCMCs were reported from the time of first study vaccination through Day 92 after first study vaccination.
|
|
Vascular disorders
Flushing
|
9.1%
2/22 • Number of events 2 • Solicited reactogenicity events were reported from the time of experimental (first) study vaccination through Day 8 after vaccination. Unsolicited non-serious AEs were reported from the time of the first study vaccination through Day 22 after the first study vaccination. SAEs were reported from the time of the first study vaccination through Day 366 after the first vaccination. AESIs and NOCMCs were reported from the time of first study vaccination through Day 92 after first study vaccination.
|
0.00%
0/21 • Solicited reactogenicity events were reported from the time of experimental (first) study vaccination through Day 8 after vaccination. Unsolicited non-serious AEs were reported from the time of the first study vaccination through Day 22 after the first study vaccination. SAEs were reported from the time of the first study vaccination through Day 366 after the first vaccination. AESIs and NOCMCs were reported from the time of first study vaccination through Day 92 after first study vaccination.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60