National Institute of Allergy and Infectious Diseases (NIAID)
Who can join
Adults 9 to 17, any sex, with Influenza or Influenza Immunisation. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Adverse Events of Special Interest (AESIs)Primary· Day 1 through Day 92
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.
Group
Value
95% CI
M2SR
0
Placebo
0
Number of Participants With New Onset Chronic Medical Conditions (NOCMCs)Primary· Day 1 through Day 92
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.
Group
Value
95% CI
M2SR
0
Placebo
0
Number of Participants With Serious Adverse Events (SAEs)Primary· Day 1 through Day 366
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.
Group
Value
95% CI
M2SR
0
Placebo
0
Number of Participants With Solicited ReactogenicityPrimary· Day 1 through Day 8
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 (tiredn
Upper Respiratory Symptoms
Group
Value
95% CI
M2SR
5
Placebo
7
Systemic Symptoms
Group
Value
95% CI
M2SR
11
Placebo
10
Number of Participants With Unsolicited Non-Serious Adverse EventsPrimary· Day 1 through Day 22
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).
Group
Value
95% CI
M2SR
6
Placebo
5
Frequency of Conserved Internal Viral Protein-specific Spot Forming CellsSecondary· Day 1 through Day 113
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 periphera
Day 1
Group
Value
95% CI
M2SR
17.2
12.6 – 23.3
Placebo
23.0
12.8 – 41.2
Day 8
Group
Value
95% CI
M2SR
24.1
17.3 – 33.5
Placebo
23.5
13.7 – 40.2
Day 22
Group
Value
95% CI
M2SR
24.5
17.1 – 35.0
Placebo
20.2
11.2 – 36.2
Day 57
Group
Value
95% CI
M2SR
16.2
11.3 – 23.4
Placebo
21.4
13.5 – 33.8
Day 92
Group
Value
95% CI
M2SR
16.3
9.7 – 27.3
Placebo
17.0
9.6 – 30.1
Day 113
Group
Value
95% CI
M2SR
20.8
13.4 – 32.2
Placebo
22.3
12.6 – 39.6
Frequency of Influenza H3 HA-specific Spot Forming Cells for the H3N2 M2SR-like Virus A/Brisbane/10/2007Secondary· Day 1 through Day 113
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).
Day 1
Group
Value
95% CI
M2SR
37.5
22.1 – 63.6
Placebo
50.2
33.7 – 74.6
Day 8
Group
Value
95% CI
M2SR
48.9
26.0 – 91.8
Placebo
59.0
35.5 – 98.1
Day 22
Group
Value
95% CI
M2SR
65.8
35.3 – 122.6
Placebo
46.3
21.6 – 99.2
Day 57
Group
Value
95% CI
M2SR
41.8
22.8 – 76.9
Placebo
45.1
26.5 – 76.8
Day 92
Group
Value
95% CI
M2SR
30.2
14.2 – 64.2
Placebo
32.2
15.6 – 66.3
Day 113
Group
Value
95% CI
M2SR
34.0
18.4 – 62.7
Placebo
50.4
29.3 – 86.5
Frequency of Influenza H3 HA-specific Spot Forming Cells for the H3N2 QIV-like Virus A/North Carolina/04/2016Secondary· Day 1 through Day 113
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).
Day 1
Group
Value
95% CI
M2SR
30.7
17.7 – 53.4
Placebo
42.5
27.0 – 66.9
Day 8
Group
Value
95% CI
M2SR
39.7
22.1 – 71.6
Placebo
45.1
27.5 – 74.0
Day 22
Group
Value
95% CI
M2SR
49.5
26.0 – 94.2
Placebo
40.0
19.0 – 84.0
Day 57
Group
Value
95% CI
M2SR
30.0
15.7 – 57.2
Placebo
40.5
24.7 – 66.5
Day 92
Group
Value
95% CI
M2SR
18.5
7.5 – 45.4
Placebo
30.0
15.0 – 60.1
Day 113
Group
Value
95% CI
M2SR
25.2
13.2 – 47.9
Placebo
39.8
23.6 – 67.0
Frequency of Influenza H3 HA-specific Spot Forming Cells for the H3N2 QIV-like Virus A/Singapore/INFIMH-16-0019/2016Secondary· Day 1 through Day 113
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 PBMC
Day 1
Group
Value
95% CI
M2SR
31.5
18.9 – 52.5
Placebo
42.1
27.8 – 63.6
Day 8
Group
Value
95% CI
M2SR
40.5
23.9 – 68.8
Placebo
46.0
28.4 – 74.5
Day 22
Group
Value
95% CI
M2SR
50.9
26.5 – 97.8
Placebo
40.2
19.4 – 83.3
Day 57
Group
Value
95% CI
M2SR
35.3
21.0 – 59.6
Placebo
39.2
24.1 – 63.9
Day 92
Group
Value
95% CI
M2SR
26.2
13.8 – 49.6
Placebo
29.6
16.0 – 54.9
Day 113
Group
Value
95% CI
M2SR
25.2
14.0 – 45.1
Placebo
40.7
23.7 – 69.9
Frequency of Influenza H3 HA-specific Spot Forming Cells for the H3N2 QIV-like Virus A/Kansas/14/2017Secondary· Day 1 through Day 113
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).
Day 1
Group
Value
95% CI
M2SR
5.3
3.8 – 7.4
Placebo
5.3
3.5 – 7.9
Day 8
Group
Value
95% CI
M2SR
7.1
4.9 – 10.3
Placebo
6.0
3.6 – 10.0
Day 22
Group
Value
95% CI
M2SR
5.4
3.6 – 8.1
Placebo
6.6
3.9 – 11.3
Day 57
Group
Value
95% CI
M2SR
4.7
3.4 – 6.3
Placebo
5.2
3.4 – 7.9
Day 92
Group
Value
95% CI
M2SR
4.3
2.9 – 6.5
Placebo
4.3
2.7 – 6.8
Day 113
Group
Value
95% CI
M2SR
4.9
3.2 – 7.4
Placebo
6.4
3.9 – 10.7
Geometric Mean Fold Rise (GMFR) of Nasal Secretory Immunoglobulin A (sIgA) Responses Directed Against the H3N2 M2SR-like Virus A/Brisbane/10/2007Secondary· Day 8 through Day 113
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 wit
Day 8
Group
Value
95% CI
M2SR
1.1
0.4 – 2.9
Placebo
1.2
0.5 – 3.3
Day 22
Group
Value
95% CI
M2SR
1.3
0.4 – 4.2
Placebo
1.9
1.0 – 3.4
Day 57
Group
Value
95% CI
M2SR
0.8
0.2 – 3.1
Placebo
1.9
0.7 – 5.1
Day 92
Group
Value
95% CI
M2SR
1.3
0.5 – 3.7
Placebo
1.4
0.7 – 3.1
Day 113
Group
Value
95% CI
M2SR
1.8
0.6 – 5.6
Placebo
4.9
2.3 – 10.6
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 sIgASecondary· Day 8 through Day 113
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
Day 8
Group
Value
95% CI
M2SR
1.9
0.9 – 4.1
Placebo
1.6
0.8 – 3.5
Day 22
Group
Value
95% CI
M2SR
1.9
0.9 – 4.1
Placebo
1.3
0.8 – 1.9
Day 57
Group
Value
95% CI
M2SR
1.0
0.4 – 2.4
Placebo
1.2
0.5 – 2.5
Day 92
Group
Value
95% CI
M2SR
1.3
0.6 – 2.6
Placebo
0.8
0.3 – 2.0
Day 113
Group
Value
95% CI
M2SR
1.1
0.7 – 1.8
Placebo
1.6
0.7 – 3.7
Adverse events — posted to ClinicalTrials.gov
Time frame: 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..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This is a Phase I double-blind, randomized, placebo-controlled study in 50 healthy adolescents and children, 9-17 years of age, inclusive, who are in good health and meet all eligibility criteria. This clinical trial is designed to assess the safety and immunogenicity of a prime-boost regimen of H3N2 M2SR intranasal influenza vaccine (manufactured by FluGen) followed by licensed inactivated Quadrivalent Influenza Vaccine (QIV) boost administered intramuscularly Subjects will be enrolled in one of two groups in a 1:1 ratio. Arm 1 will receive one dose of M2SR intranasally on Day 1 and one dose of QIV on Day 92. Arm 2 will receive one dose of placebo (saline) intranasally on Day 1, and one dose of QIV on Day 92. Study duration will be approximately 28 months with patient participation duration approximately 13 months. The primary study objective is to assess the safety and reactogenicity of a monovalent live attenuated influenza H3N2 M2SR vaccine.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06987318 — A Study to Evaluate the Safety and Antiviral Activity of Two Human Monoclonal Antibodies (VRC07-523LS and PGT121.414.LS)
· Phase 1
· not yet recruiting
NCT07124559 — A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of
· Phase 1, PHASE2
· not yet recruiting
NCT07342491 — Dasatinib for HIV-1 Reservoir Reduction
· Phase 1
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Institute of Allergy and Infectious Diseases (NIAID)
Last refreshed: 21 October 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03553940.