Trial Outcomes & Findings for Evaluation of the Safety and Immunogenicity of Influenza and COVID-19 Combination Vaccine (NCT NCT04961541)
NCT ID: NCT04961541
Last Updated: 2025-04-10
Results Overview
Numbers of participants with solicited local and systemic AEs over the 7 days post-injection after first and second doses.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
637 participants
Primary outcome timeframe
Day 0 to Day 63
Results posted on
2025-04-10
Participant Flow
Participant milestones
| Measure |
Group A and Group C - ICC Vaccine Formulation
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group O - qNIV With Matrix-M1 Adjuvant
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
80
|
40
|
39
|
37
|
41
|
41
|
81
|
39
|
39
|
40
|
40
|
41
|
39
|
40
|
|
Overall Study
COMPLETED
|
80
|
40
|
35
|
36
|
41
|
40
|
80
|
38
|
39
|
38
|
40
|
41
|
38
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
4
|
1
|
0
|
1
|
1
|
1
|
0
|
2
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Group A and Group C - ICC Vaccine Formulation
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group O - qNIV With Matrix-M1 Adjuvant
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
3
|
0
|
0
|
0
|
1
|
1
|
0
|
1
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Evaluation of the Safety and Immunogenicity of Influenza and COVID-19 Combination Vaccine
Baseline characteristics by cohort
| Measure |
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group O - qNIV With Matrix-M1 Adjuvant
n=39 Participants
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
n=40 Participants
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
Total
n=637 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
59 years
STANDARD_DEVIATION 5.3 • n=5 Participants
|
59 years
STANDARD_DEVIATION 5.5 • n=7 Participants
|
58 years
STANDARD_DEVIATION 5.5 • n=5 Participants
|
60 years
STANDARD_DEVIATION 5.4 • n=4 Participants
|
59 years
STANDARD_DEVIATION 6.1 • n=21 Participants
|
59 years
STANDARD_DEVIATION 6.0 • n=8 Participants
|
59 years
STANDARD_DEVIATION 6.1 • n=8 Participants
|
59 years
STANDARD_DEVIATION 6.5 • n=24 Participants
|
59 years
STANDARD_DEVIATION 5.7 • n=42 Participants
|
59 years
STANDARD_DEVIATION 5.1 • n=42 Participants
|
58 years
STANDARD_DEVIATION 6.3 • n=42 Participants
|
59 years
STANDARD_DEVIATION 5.7 • n=42 Participants
|
58 years
STANDARD_DEVIATION 5.5 • n=36 Participants
|
59 years
STANDARD_DEVIATION 6.0 • n=36 Participants
|
59 years
STANDARD_DEVIATION 5.7 • n=24 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
25 Participants
n=8 Participants
|
50 Participants
n=8 Participants
|
19 Participants
n=24 Participants
|
27 Participants
n=42 Participants
|
27 Participants
n=42 Participants
|
22 Participants
n=42 Participants
|
29 Participants
n=42 Participants
|
28 Participants
n=36 Participants
|
24 Participants
n=36 Participants
|
398 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
16 Participants
n=8 Participants
|
31 Participants
n=8 Participants
|
20 Participants
n=24 Participants
|
12 Participants
n=42 Participants
|
13 Participants
n=42 Participants
|
18 Participants
n=42 Participants
|
12 Participants
n=42 Participants
|
11 Participants
n=36 Participants
|
16 Participants
n=36 Participants
|
239 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
8 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
79 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
39 Participants
n=21 Participants
|
40 Participants
n=8 Participants
|
80 Participants
n=8 Participants
|
39 Participants
n=24 Participants
|
39 Participants
n=42 Participants
|
38 Participants
n=42 Participants
|
40 Participants
n=42 Participants
|
41 Participants
n=42 Participants
|
39 Participants
n=36 Participants
|
39 Participants
n=36 Participants
|
627 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
2 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
9 Participants
n=24 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
76 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
41 Participants
n=21 Participants
|
39 Participants
n=8 Participants
|
76 Participants
n=8 Participants
|
39 Participants
n=24 Participants
|
39 Participants
n=42 Participants
|
38 Participants
n=42 Participants
|
39 Participants
n=42 Participants
|
39 Participants
n=42 Participants
|
38 Participants
n=36 Participants
|
39 Participants
n=36 Participants
|
615 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
4 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
7 Participants
n=24 Participants
|
|
Regimen of Previous COVID Vaccine
Pfizer-BioNtech
|
30 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
14 Participants
n=8 Participants
|
29 Participants
n=8 Participants
|
8 Participants
n=24 Participants
|
11 Participants
n=42 Participants
|
16 Participants
n=42 Participants
|
10 Participants
n=42 Participants
|
9 Participants
n=42 Participants
|
13 Participants
n=36 Participants
|
11 Participants
n=36 Participants
|
198 Participants
n=24 Participants
|
|
Regimen of Previous COVID Vaccine
Oxford-AstraZeneca
|
50 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
26 Participants
n=8 Participants
|
52 Participants
n=8 Participants
|
30 Participants
n=24 Participants
|
28 Participants
n=42 Participants
|
24 Participants
n=42 Participants
|
30 Participants
n=42 Participants
|
31 Participants
n=42 Participants
|
26 Participants
n=36 Participants
|
29 Participants
n=36 Participants
|
435 Participants
n=24 Participants
|
|
Regimen of Previous COVID Vaccine
Mixed or Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
4 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Day 0 to Day 63Population: Safety Analysis Set Population
Numbers of participants with solicited local and systemic AEs over the 7 days post-injection after first and second doses.
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
n=39 Participants
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
n=40 Participants
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Solicited Local and Systemic Adverse Events (AE's)
Systemic AEs
|
27 participants
|
50 participants
|
17 participants
|
27 participants
|
24 participants
|
29 participants
|
27 participants
|
59 participants
|
29 participants
|
20 participants
|
28 participants
|
26 participants
|
30 participants
|
30 participants
|
|
Number of Participants With Solicited Local and Systemic Adverse Events (AE's)
Local AEs
|
34 participants
|
71 participants
|
32 participants
|
32 participants
|
28 participants
|
38 participants
|
36 participants
|
64 participants
|
32 participants
|
28 participants
|
34 participants
|
34 participants
|
39 participants
|
35 participants
|
PRIMARY outcome
Timeframe: Day 0 to Day 70Number of participants reporting all AEs, (solicited and unsolicited), over 70 days after the first dose.
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
n=39 Participants
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
n=40 Participants
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting All AE's
Solicited AEs
|
38 Participants
|
77 Participants
|
33 Participants
|
35 Participants
|
34 Participants
|
39 Participants
|
39 Participants
|
70 Participants
|
37 Participants
|
31 Participants
|
38 Participants
|
34 Participants
|
39 Participants
|
39 Participants
|
|
Number of Participants Reporting All AE's
Unsolicited AEs
|
18 Participants
|
25 Participants
|
15 Participants
|
14 Participants
|
17 Participants
|
16 Participants
|
20 Participants
|
30 Participants
|
9 Participants
|
17 Participants
|
19 Participants
|
10 Participants
|
16 Participants
|
14 Participants
|
PRIMARY outcome
Timeframe: Day 0 to Day 180Population: Safety Analysis Set
Number of participants with Medical Attended Adverse Events (MAAE's), Adverse events (AESI's), Including potential immune-mediated medical conditions (PIMMCs), Serious Adverse Events SAEs.
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
n=39 Participants
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
n=40 Participants
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With MAAEs, AESIs (Including PIMMCs), SAEs
SAEs
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With MAAEs, AESIs (Including PIMMCs), SAEs
AESIs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With MAAEs, AESIs (Including PIMMCs), SAEs
MAAEs
|
14 Participants
|
14 Participants
|
8 Participants
|
7 Participants
|
12 Participants
|
10 Participants
|
11 Participants
|
20 Participants
|
9 Participants
|
14 Participants
|
7 Participants
|
7 Participants
|
7 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Day 0 to Day 182Population: Per-Protocol Analysis Set Population
Hemagglutination-inhibition (HAI) antibody titers specific for the hemagglutinin (HA) receptor binding domains of vaccine homologous Influenza A/Brisbane (H1N1 Subtype) strain calculated as GMT, defined as the antilog of the mean of the log-transformed HAI titers on Days 56, 70, and other follow-up time points.
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
n=39 Participants
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs)
Day 0
|
83.6 Geometric Mean Titers
Interval 60.1 to 116.4
|
83.6 Geometric Mean Titers
Interval 66.4 to 105.3
|
66.7 Geometric Mean Titers
Interval 49.8 to 89.3
|
62.4 Geometric Mean Titers
Interval 44.8 to 86.9
|
91.2 Geometric Mean Titers
Interval 67.7 to 122.8
|
85.6 Geometric Mean Titers
Interval 62.6 to 117.1
|
77.3 Geometric Mean Titers
Interval 54.9 to 108.7
|
78.3 Geometric Mean Titers
Interval 61.6 to 99.4
|
89.8 Geometric Mean Titers
Interval 64.1 to 125.7
|
77.9 Geometric Mean Titers
Interval 55.4 to 109.5
|
96.8 Geometric Mean Titers
Interval 71.1 to 131.8
|
97.3 Geometric Mean Titers
Interval 68.1 to 138.9
|
81.4 Geometric Mean Titers
Interval 62.2 to 106.4
|
—
|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs)
Day 28
|
133.9 Geometric Mean Titers
Interval 104.2 to 172.2
|
141.1 Geometric Mean Titers
Interval 116.9 to 170.4
|
91.9 Geometric Mean Titers
Interval 67.8 to 103.8
|
81.5 Geometric Mean Titers
Interval 63.9 to 103.8
|
107.0 Geometric Mean Titers
Interval 83.6 to 136.8
|
112.2 Geometric Mean Titers
Interval 84.6 to 148.8
|
106.6 Geometric Mean Titers
Interval 78.1 to 145.6
|
126.4 Geometric Mean Titers
Interval 103.0 to 155.2
|
105.4 Geometric Mean Titers
Interval 79.1 to 140.4
|
105.4 Geometric Mean Titers
Interval 61.5 to 111.8
|
141.3 Geometric Mean Titers
Interval 107.0 to 186.6
|
129.3 Geometric Mean Titers
Interval 93.7 to 178.3
|
103.1 Geometric Mean Titers
Interval 80.7 to 131.7
|
—
|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs)
Day 56
|
118.3 Geometric Mean Titers
Interval 90.5 to 154.6
|
129.1 Geometric Mean Titers
Interval 107.5 to 154.9
|
86.7 Geometric Mean Titers
Interval 64.9 to 115.8
|
84.8 Geometric Mean Titers
Interval 63.9 to 112.4
|
100.8 Geometric Mean Titers
Interval 75.6 to 134.3
|
100.2 Geometric Mean Titers
Interval 75.4 to 133.2
|
95.1 Geometric Mean Titers
Interval 71.5 to 126.7
|
107.3 Geometric Mean Titers
Interval 88.4 to 130.4
|
94.7 Geometric Mean Titers
Interval 70.5 to 127.2
|
73.7 Geometric Mean Titers
Interval 54.3 to 100.1
|
126.6 Geometric Mean Titers
Interval 90.1 to 177.9
|
109.1 Geometric Mean Titers
Interval 77.4 to 153.7
|
99.3 Geometric Mean Titers
Interval 77.3 to 127.6
|
—
|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs)
Day 70
|
119.5 Geometric Mean Titers
Interval 93.0 to 153.5
|
149.6 Geometric Mean Titers
Interval 123.6 to 181.0
|
124.8 Geometric Mean Titers
Interval 93.9 to 165.8
|
113.1 Geometric Mean Titers
Interval 84.4 to 151.7
|
142.5 Geometric Mean Titers
Interval 105.7 to 192.3
|
135.7 Geometric Mean Titers
Interval 101.3 to 181.9
|
113.1 Geometric Mean Titers
Interval 86.7 to 147.6
|
128.5 Geometric Mean Titers
Interval 105.2 to 157.1
|
123.9 Geometric Mean Titers
Interval 96.6 to 159.0
|
95.1 Geometric Mean Titers
Interval 72.8 to 124.3
|
156.9 Geometric Mean Titers
Interval 118.8 to 207.4
|
148.4 Geometric Mean Titers
Interval 105.6 to 208.6
|
129.5 Geometric Mean Titers
Interval 106.9 to 157.0
|
—
|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs)
Day 84
|
90.1 Geometric Mean Titers
Interval 68.0 to 119.3
|
107.7 Geometric Mean Titers
Interval 89.2 to 130.1
|
85.1 Geometric Mean Titers
Interval 63.3 to 114.5
|
96.1 Geometric Mean Titers
Interval 73.6 to 125.5
|
98.5 Geometric Mean Titers
Interval 75.4 to 128.6
|
101.7 Geometric Mean Titers
Interval 72.4 to 142.8
|
68.5 Geometric Mean Titers
Interval 50.6 to 92.7
|
99.1 Geometric Mean Titers
Interval 80.6 to 122.0
|
75.1 Geometric Mean Titers
Interval 59.1 to 95.2
|
74.4 Geometric Mean Titers
Interval 58.7 to 94.3
|
103.2 Geometric Mean Titers
Interval 75.7 to 140.7
|
110.0 Geometric Mean Titers
Interval 76.1 to 158.9
|
89.3 Geometric Mean Titers
Interval 70.8 to 112.7
|
—
|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the Hemagglutinin (HA) Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Geometric Mean Titers (GMTs)
Day 182
|
66.1 Geometric Mean Titers
Interval 48.5 to 90.0
|
85.0 Geometric Mean Titers
Interval 69.8 to 103.4
|
57.1 Geometric Mean Titers
Interval 41.7 to 78.1
|
68.7 Geometric Mean Titers
Interval 51.1 to 92.2
|
72.5 Geometric Mean Titers
Interval 54.6 to 96.1
|
70.6 Geometric Mean Titers
Interval 51.3 to 97.3
|
60.9 Geometric Mean Titers
Interval 43.8 to 84.5
|
67.4 Geometric Mean Titers
Interval 53.9 to 84.3
|
58.7 Geometric Mean Titers
Interval 43.4 to 79.5
|
56.6 Geometric Mean Titers
Interval 43.9 to 72.9
|
83.1 Geometric Mean Titers
Interval 57.0 to 121.2
|
76.4 Geometric Mean Titers
Interval 53.9 to 108.3
|
65.2 Geometric Mean Titers
Interval 49.7 to 85.6
|
—
|
SECONDARY outcome
Timeframe: Day 0 to Day 182Population: Per-Protocol Analysis Set Population
Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A/Kansas (H3N2 Subtype) strain calculated as GMT, defined as the antilog of the mean of the log-transformed HAI titers on Days 56, 70, and other follow-up time points.
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
n=39 Participants
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs
Day 0
|
27.1 Geometric Mean Titers
Interval 20.2 to 36.2
|
27.1 Geometric Mean Titers
Interval 22.7 to 32.3
|
27.1 Geometric Mean Titers
Interval 20.4 to 35.9
|
21.1 Geometric Mean Titers
Interval 16.0 to 27.7
|
31.1 Geometric Mean Titers
Interval 22.9 to 42.2
|
32.4 Geometric Mean Titers
Interval 24.3 to 43.2
|
29.8 Geometric Mean Titers
Interval 22.8 to 38.9
|
26.0 Geometric Mean Titers
Interval 21.3 to 31.8
|
32.9 Geometric Mean Titers
Interval 24.5 to 44.2
|
37.3 Geometric Mean Titers
Interval 27.5 to 50.4
|
26.4 Geometric Mean Titers
Interval 20.9 to 33.3
|
28.3 Geometric Mean Titers
Interval 21.3 to 37.6
|
30.5 Geometric Mean Titers
Interval 23.5 to 39.6
|
—
|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs
Day 28
|
145.1 Geometric Mean Titers
Interval 103.0 to 204.4
|
110.7 Geometric Mean Titers
Interval 88.5 to 138.5
|
96.8 Geometric Mean Titers
Interval 60.1 to 155.9
|
58.1 Geometric Mean Titers
Interval 39.9 to 84.7
|
77.1 Geometric Mean Titers
Interval 53.8 to 110.3
|
110.3 Geometric Mean Titers
Interval 77.2 to 157.7
|
80.7 Geometric Mean Titers
Interval 60.1 to 108.4
|
104.9 Geometric Mean Titers
Interval 82.7 to 133.1
|
75.8 Geometric Mean Titers
Interval 55.8 to 103.1
|
81.4 Geometric Mean Titers
Interval 58.8 to 112.7
|
116.2 Geometric Mean Titers
Interval 78.5 to 172.0
|
112.1 Geometric Mean Titers
Interval 82.4 to 152.7
|
109.4 Geometric Mean Titers
Interval 80.6 to 148.4
|
—
|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs
Day 56
|
111.1 Geometric Mean Titers
Interval 79.7 to 155.1
|
98.8 Geometric Mean Titers
Interval 78.0 to 125.0
|
79.3 Geometric Mean Titers
Interval 50.7 to 124.0
|
60.5 Geometric Mean Titers
Interval 41.3 to 88.6
|
71.3 Geometric Mean Titers
Interval 49.7 to 102.3
|
82.8 Geometric Mean Titers
Interval 58.6 to 117.1
|
65.5 Geometric Mean Titers
Interval 49.6 to 86.7
|
93.7 Geometric Mean Titers
Interval 74.6 to 117.6
|
67.0 Geometric Mean Titers
Interval 48.8 to 91.9
|
80.7 Geometric Mean Titers
Interval 59.7 to 109.1
|
87.0 Geometric Mean Titers
Interval 57.5 to 131.8
|
91.7 Geometric Mean Titers
Interval 64.8 to 129.9
|
96.8 Geometric Mean Titers
Interval 69.7 to 134.5
|
—
|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs
Day 70
|
116.3 Geometric Mean Titers
Interval 81.8 to 165.3
|
122.1 Geometric Mean Titers
Interval 99.6 to 149.8
|
115.2 Geometric Mean Titers
Interval 75.9 to 174.6
|
77.7 Geometric Mean Titers
Interval 52.6 to 114.6
|
111.0 Geometric Mean Titers
Interval 81.9 to 150.5
|
127.7 Geometric Mean Titers
Interval 92.9 to 175.6
|
98.5 Geometric Mean Titers
Interval 74.9 to 129.5
|
125.6 Geometric Mean Titers
Interval 101.8 to 155.1
|
104.2 Geometric Mean Titers
Interval 80.6 to 134.8
|
102.3 Geometric Mean Titers
Interval 75.8 to 138.2
|
115.3 Geometric Mean Titers
Interval 78.0 to 170.6
|
111.0 Geometric Mean Titers
Interval 81.4 to 151.5
|
113.1 Geometric Mean Titers
Interval 83.2 to 153.9
|
—
|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs
Day 84
|
99.6 Geometric Mean Titers
Interval 73.2 to 135.5
|
110.7 Geometric Mean Titers
Interval 90.3 to 135.5
|
104.4 Geometric Mean Titers
Interval 72.2 to 151.0
|
82.5 Geometric Mean Titers
Interval 58.1 to 117.1
|
85.7 Geometric Mean Titers
Interval 63.5 to 115.7
|
118.3 Geometric Mean Titers
Interval 88.3 to 158.4
|
88.4 Geometric Mean Titers
Interval 65.6 to 119.2
|
114.2 Geometric Mean Titers
Interval 94.7 to 137.6
|
88.4 Geometric Mean Titers
Interval 65.6 to 119.2
|
93.4 Geometric Mean Titers
Interval 68.9 to 126.6
|
90.4 Geometric Mean Titers
Interval 64.6 to 126.6
|
101.1 Geometric Mean Titers
Interval 74.2 to 137.8
|
104.8 Geometric Mean Titers
Interval 77.6 to 141.7
|
—
|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as GMTs
Day 182
|
68.5 Geometric Mean Titers
Interval 50.6 to 92.7
|
83.8 Geometric Mean Titers
Interval 68.6 to 102.4
|
74.5 Geometric Mean Titers
Interval 51.5 to 107.9
|
57.7 Geometric Mean Titers
Interval 40.7 to 81.9
|
57.1 Geometric Mean Titers
Interval 44.0 to 74.1
|
82.2 Geometric Mean Titers
Interval 62.6 to 107.8
|
65.5 Geometric Mean Titers
Interval 48.5 to 88.3
|
75.0 Geometric Mean Titers
Interval 61.7 to 91.2
|
68.2 Geometric Mean Titers
Interval 51.8 to 89.8
|
80.0 Geometric Mean Titers
Interval 61.5 to 104.0
|
68.6 Geometric Mean Titers
Interval 50.9 to 92.3
|
70.4 Geometric Mean Titers
Interval 52.0 to 95.3
|
80.7 Geometric Mean Titers
Interval 59.5 to 109.4
|
—
|
SECONDARY outcome
Timeframe: Day 0 to Day 182Population: Per-Protocol Analysis Set Population
Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A/Wisconsin (H1N1 Subtype) strain calculated as GMT, defined as the antilog of the mean of the log-transformed HAI titers on Days 56, 70, and other follow-up time points.
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
n=39 Participants
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs
Day 0
|
115.2 Geometric Mean Titers
Interval 87.3 to 152.0
|
96.6 Geometric Mean Titers
Interval 79.9 to 116.8
|
85.0 Geometric Mean Titers
Interval 67.8 to 106.5
|
87.4 Geometric Mean Titers
Interval 70.2 to 108.9
|
100.2 Geometric Mean Titers
Interval 77.6 to 129.4
|
90.8 Geometric Mean Titers
Interval 67.9 to 121.5
|
96.0 Geometric Mean Titers
Interval 73.8 to 124.7
|
102.3 Geometric Mean Titers
Interval 82.6 to 126.6
|
89.0 Geometric Mean Titers
Interval 67.9 to 116.6
|
108.2 Geometric Mean Titers
Interval 83.5 to 140.2
|
104.6 Geometric Mean Titers
Interval 81.0 to 135.3
|
111.1 Geometric Mean Titers
Interval 83.1 to 148.6
|
87.8 Geometric Mean Titers
Interval 68.2 to 113.1
|
—
|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs
Day 28
|
146.4 Geometric Mean Titers
Interval 117.3 to 182.7
|
139.9 Geometric Mean Titers
Interval 118.1 to 165.7
|
108.3 Geometric Mean Titers
Interval 87.3 to 134.5
|
98.7 Geometric Mean Titers
Interval 80.6 to 120.8
|
111.0 Geometric Mean Titers
Interval 87.2 to 141.4
|
124.2 Geometric Mean Titers
Interval 100.0 to 154.1
|
117.0 Geometric Mean Titers
Interval 91.2 to 150.1
|
138.8 Geometric Mean Titers
Interval 116.3 to 165.6
|
100.8 Geometric Mean Titers
Interval 79.4 to 127.9
|
115.2 Geometric Mean Titers
Interval 91.9 to 144.4
|
132.8 Geometric Mean Titers
Interval 103.2 to 170.9
|
130.4 Geometric Mean Titers
Interval 98.7 to 172.3
|
114.1 Geometric Mean Titers
Interval 89.8 to 144.9
|
—
|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs
Day 56
|
135.1 Geometric Mean Titers
Interval 104.2 to 175.3
|
127.4 Geometric Mean Titers
Interval 106.8 to 151.8
|
95.6 Geometric Mean Titers
Interval 75.3 to 121.3
|
93.3 Geometric Mean Titers
Interval 73.9 to 117.9
|
105.8 Geometric Mean Titers
Interval 81.7 to 136.9
|
107.4 Geometric Mean Titers
Interval 82.9 to 139.2
|
100.2 Geometric Mean Titers
Interval 77.1 to 130.3
|
119.3 Geometric Mean Titers
Interval 101.4 to 140.2
|
98.1 Geometric Mean Titers
Interval 77.6 to 124.1
|
102.3 Geometric Mean Titers
Interval 79.7 to 131.4
|
126.6 Geometric Mean Titers
Interval 98.2 to 163.2
|
119.5 Geometric Mean Titers
Interval 91.2 to 156.7
|
98.5 Geometric Mean Titers
Interval 78.8 to 123.1
|
—
|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs
Day 70
|
137.0 Geometric Mean Titers
Interval 105.2 to 178.5
|
148.2 Geometric Mean Titers
Interval 123.4 to 178.0
|
109.2 Geometric Mean Titers
Interval 87.4 to 136.4
|
107.7 Geometric Mean Titers
Interval 85.3 to 135.9
|
125.8 Geometric Mean Titers
Interval 98.4 to 160.8
|
140.5 Geometric Mean Titers
Interval 107.5 to 183.6
|
107.4 Geometric Mean Titers
Interval 84.3 to 136.9
|
138.9 Geometric Mean Titers
Interval 116.5 to 165.6
|
114.2 Geometric Mean Titers
Interval 90.8 to 143.5
|
110.1 Geometric Mean Titers
Interval 88.9 to 136.4
|
146.7 Geometric Mean Titers
Interval 114.7 to 187.7
|
140.3 Geometric Mean Titers
Interval 108.2 to 182.1
|
121.1 Geometric Mean Titers
Interval 99.8 to 146.8
|
—
|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs
Day 84
|
75.7 Geometric Mean Titers
Interval 57.1 to 100.4
|
87.4 Geometric Mean Titers
Interval 73.2 to 104.5
|
68.2 Geometric Mean Titers
Interval 53.8 to 86.3
|
62.6 Geometric Mean Titers
Interval 47.8 to 82.1
|
69.6 Geometric Mean Titers
Interval 53.0 to 91.5
|
81.4 Geometric Mean Titers
Interval 62.0 to 107.0
|
72.4 Geometric Mean Titers
Interval 54.7 to 95.8
|
86.4 Geometric Mean Titers
Interval 71.0 to 105.3
|
66.7 Geometric Mean Titers
Interval 52.1 to 85.3
|
58.7 Geometric Mean Titers
Interval 46.1 to 74.7
|
79.2 Geometric Mean Titers
Interval 57.3 to 109.3
|
79.3 Geometric Mean Titers
Interval 55.7 to 112.7
|
74.1 Geometric Mean Titers
Interval 58.4 to 94.0
|
—
|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as GMTs
Day 182
|
64.9 Geometric Mean Titers
Interval 48.6 to 86.6
|
70.9 Geometric Mean Titers
Interval 59.1 to 85.2
|
50.4 Geometric Mean Titers
Interval 40.7 to 62.5
|
50.6 Geometric Mean Titers
Interval 38.4 to 66.5
|
57.1 Geometric Mean Titers
Interval 48.2 to 76.3
|
65.2 Geometric Mean Titers
Interval 49.8 to 85.4
|
60.3 Geometric Mean Titers
Interval 45.9 to 79.2
|
65.0 Geometric Mean Titers
Interval 53.6 to 78.7
|
54.0 Geometric Mean Titers
Interval 41.6 to 70.1
|
49.6 Geometric Mean Titers
Interval 39.2 to 62.8
|
70.6 Geometric Mean Titers
Interval 52.8 to 94.4
|
60.9 Geometric Mean Titers
Interval 44.5 to 83.3
|
61.3 Geometric Mean Titers
Interval 48.0 to 78.3
|
—
|
SECONDARY outcome
Timeframe: Day 0 to Day 182Population: Per-Protocol Analysis Set Population
Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A/Cambodia (H3N2 Subtype) strain calculated as GMT, defined as the antilog of the mean of the log-transformed HAI titers on Days 56, 70, and other follow-up time points.
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
n=39 Participants
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs
Day 0
|
46.9 Geometric Mean Titers
Interval 35.3 to 62.4
|
43.9 Geometric Mean Titers
Interval 36.6 to 52.5
|
41.8 Geometric Mean Titers
Interval 31.3 to 55.7
|
40.4 Geometric Mean Titers
Interval 30.1 to 54.2
|
42.3 Geometric Mean Titers
Interval 32.8 to 54.6
|
42.1 Geometric Mean Titers
Interval 32.5 to 54.4
|
45.6 Geometric Mean Titers
Interval 35.2 to 58.9
|
35.5 Geometric Mean Titers
Interval 29.7 to 42.5
|
40.7 Geometric Mean Titers
Interval 30.0 to 55.2
|
46.1 Geometric Mean Titers
Interval 34.0 to 62.5
|
36.4 Geometric Mean Titers
Interval 27.8 to 47.6
|
45.3 Geometric Mean Titers
Interval 34.1 to 60.1
|
41.4 Geometric Mean Titers
Interval 32.4 to 52.8
|
—
|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs
Day 28
|
104.4 Geometric Mean Titers
Interval 77.4 to 141.0
|
98.1 Geometric Mean Titers
Interval 77.3 to 124.4
|
90.3 Geometric Mean Titers
Interval 55.7 to 146.3
|
67.9 Geometric Mean Titers
Interval 46.8 to 98.4
|
70.2 Geometric Mean Titers
Interval 51.2 to 96.2
|
93.9 Geometric Mean Titers
Interval 64.9 to 135.9
|
84.2 Geometric Mean Titers
Interval 63.8 to 110.9
|
78.2 Geometric Mean Titers
Interval 61.7 to 99.2
|
66.4 Geometric Mean Titers
Interval 47.1 to 93.5
|
79.3 Geometric Mean Titers
Interval 55.8 to 112.7
|
89.0 Geometric Mean Titers
Interval 59.1 to 134.1
|
110.2 Geometric Mean Titers
Interval 76.9 to 157.8
|
76.0 Geometric Mean Titers
Interval 56.0 to 103.2
|
—
|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs
Day 56
|
89.0 Geometric Mean Titers
Interval 65.0 to 121.9
|
85.8 Geometric Mean Titers
Interval 66.9 to 110.1
|
80.0 Geometric Mean Titers
Interval 5.0 to 2560.0
|
68.3 Geometric Mean Titers
Interval 5.0 to 640.0
|
48.3 Geometric Mean Titers
Interval 10.0 to 640.0
|
73.4 Geometric Mean Titers
Interval 53.1 to 101.3
|
80.0 Geometric Mean Titers
Interval 10.0 to 1280.0
|
68.0 Geometric Mean Titers
Interval 53.8 to 85.9
|
40.0 Geometric Mean Titers
Interval 5.0 to 640.0
|
40.0 Geometric Mean Titers
Interval 5.0 to 640.0
|
79.3 Geometric Mean Titers
Interval 51.1 to 123.0
|
88.4 Geometric Mean Titers
Interval 59.5 to 131.5
|
64.4 Geometric Mean Titers
Interval 47.1 to 88.1
|
—
|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs
Day 70
|
94.3 Geometric Mean Titers
Interval 70.0 to 127.0
|
94.5 Geometric Mean Titers
Interval 75.3 to 118.6
|
92.2 Geometric Mean Titers
Interval 58.6 to 145.3
|
78.4 Geometric Mean Titers
Interval 53.3 to 115.4
|
74.1 Geometric Mean Titers
Interval 53.9 to 101.9
|
92.7 Geometric Mean Titers
Interval 67.6 to 127.2
|
85.7 Geometric Mean Titers
Interval 63.8 to 115.2
|
78.2 Geometric Mean Titers
Interval 62.0 to 98.6
|
83.0 Geometric Mean Titers
Interval 59.6 to 115.6
|
77.1 Geometric Mean Titers
Interval 52.9 to 112.6
|
85.6 Geometric Mean Titers
Interval 56.7 to 129.1
|
97.4 Geometric Mean Titers
Interval 67.7 to 140.1
|
79.3 Geometric Mean Titers
Interval 59.4 to 105.9
|
—
|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs
Day 84
|
51.2 Geometric Mean Titers
Interval 36.6 to 71.6
|
56.8 Geometric Mean Titers
Interval 45.0 to 71.7
|
65.2 Geometric Mean Titers
Interval 42.3 to 100.6
|
48.1 Geometric Mean Titers
Interval 33.0 to 69.9
|
45.5 Geometric Mean Titers
Interval 32.1 to 64.5
|
57.1 Geometric Mean Titers
Interval 40.7 to 80.1
|
55.5 Geometric Mean Titers
Interval 40.3 to 76.6
|
50.7 Geometric Mean Titers
Interval 40.4 to 63.6
|
51.6 Geometric Mean Titers
Interval 36.8 to 72.4
|
48.4 Geometric Mean Titers
Interval 33.3 to 70.6
|
53.8 Geometric Mean Titers
Interval 35.0 to 82.7
|
70.8 Geometric Mean Titers
Interval 48.7 to 102.9
|
46.6 Geometric Mean Titers
Interval 34.4 to 63.0
|
—
|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as GMTs
Day 182
|
41.9 Geometric Mean Titers
Interval 30.1 to 58.2
|
50.4 Geometric Mean Titers
Interval 40.5 to 62.7
|
55.6 Geometric Mean Titers
Interval 36.2 to 85.4
|
38.0 Geometric Mean Titers
Interval 25.7 to 56.2
|
33.5 Geometric Mean Titers
Interval 23.7 to 47.2
|
45.7 Geometric Mean Titers
Interval 33.9 to 61.6
|
42.6 Geometric Mean Titers
Interval 31.0 to 58.6
|
38.0 Geometric Mean Titers
Interval 30.6 to 47.3
|
44.8 Geometric Mean Titers
Interval 31.6 to 63.4
|
46.0 Geometric Mean Titers
Interval 32.9 to 64.5
|
44.9 Geometric Mean Titers
Interval 31.3 to 64.4
|
47.6 Geometric Mean Titers
Interval 33.3 to 68.0
|
38.6 Geometric Mean Titers
Interval 28.6 to 52.1
|
—
|
SECONDARY outcome
Timeframe: Day 0 to Day 182Population: Per-Protocol Analysis Set Population
Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A/Hong Kong (H3N2 Subtype) strain calculated as GMT, defined as the antilog of the mean of the log-transformed HAI titers on Days 56, 70, and other follow-up time points.
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
n=39 Participants
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs
Day 0
|
74.5 Geometric Mean Titers
Interval 57.1 to 97.3
|
71.4 Geometric Mean Titers
Interval 61.1 to 83.4
|
69.6 Geometric Mean Titers
Interval 55.0 to 88.2
|
68.2 Geometric Mean Titers
Interval 53.4 to 87.0
|
70.8 Geometric Mean Titers
Interval 54.6 to 91.9
|
78.0 Geometric Mean Titers
Interval 62.0 to 98.2
|
79.3 Geometric Mean Titers
Interval 60.5 to 104.0
|
58.6 Geometric Mean Titers
Interval 49.6 to 69.2
|
73.2 Geometric Mean Titers
Interval 56.5 to 94.8
|
77.2 Geometric Mean Titers
Interval 58.0 to 102.8
|
56.6 Geometric Mean Titers
Interval 45.2 to 70.8
|
81.4 Geometric Mean Titers
Interval 63.2 to 105.0
|
67.6 Geometric Mean Titers
Interval 52.6 to 86.7
|
—
|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs
Day 28
|
142.5 Geometric Mean Titers
Interval 107.2 to 189.6
|
134.0 Geometric Mean Titers
Interval 110.9 to 161.8
|
126.6 Geometric Mean Titers
Interval 83.9 to 191.2
|
98.7 Geometric Mean Titers
Interval 73.3 to 132.8
|
100.2 Geometric Mean Titers
Interval 73.9 to 135.9
|
134.0 Geometric Mean Titers
Interval 95.0 to 189.0
|
113.1 Geometric Mean Titers
Interval 88.6 to 144.5
|
115.7 Geometric Mean Titers
Interval 95.0 to 140.9
|
107.3 Geometric Mean Titers
Interval 82.0 to 140.3
|
125.9 Geometric Mean Titers
Interval 91.5 to 173.2
|
117.2 Geometric Mean Titers
Interval 86.4 to 159.0
|
150.4 Geometric Mean Titers
Interval 107.1 to 211.0
|
117.0 Geometric Mean Titers
Interval 88.5 to 154.8
|
—
|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs
Day 56
|
121.5 Geometric Mean Titers
Interval 92.2 to 160.0
|
121.9 Geometric Mean Titers
Interval 99.4 to 149.6
|
111.1 Geometric Mean Titers
Interval 74.1 to 166.6
|
91.5 Geometric Mean Titers
Interval 68.1 to 123.0
|
95.1 Geometric Mean Titers
Interval 69.7 to 129.9
|
102.9 Geometric Mean Titers
Interval 76.3 to 138.7
|
110.2 Geometric Mean Titers
Interval 84.0 to 144.7
|
104.1 Geometric Mean Titers
Interval 85.2 to 127.2
|
93.9 Geometric Mean Titers
Interval 70.2 to 125.5
|
113.1 Geometric Mean Titers
Interval 82.8 to 154.6
|
95.6 Geometric Mean Titers
Interval 68.7 to 133.1
|
130.9 Geometric Mean Titers
Interval 94.3 to 181.8
|
103.7 Geometric Mean Titers
Interval 79.6 to 135.3
|
—
|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs
Day 70
|
132.1 Geometric Mean Titers
Interval 101.4 to 172.1
|
137.9 Geometric Mean Titers
Interval 112.2 to 169.5
|
142.5 Geometric Mean Titers
Interval 95.4 to 212.9
|
115.4 Geometric Mean Titers
Interval 83.4 to 159.8
|
117.6 Geometric Mean Titers
Interval 89.4 to 154.7
|
131.1 Geometric Mean Titers
Interval 96.9 to 177.3
|
127.7 Geometric Mean Titers
Interval 98.0 to 166.5
|
112.1 Geometric Mean Titers
Interval 91.6 to 137.1
|
112.1 Geometric Mean Titers
Interval 85.7 to 146.6
|
123.9 Geometric Mean Titers
Interval 88.1 to 174.3
|
111.0 Geometric Mean Titers
Interval 82.0 to 150.3
|
155.0 Geometric Mean Titers
Interval 111.2 to 216.2
|
115.1 Geometric Mean Titers
Interval 86.8 to 152.6
|
—
|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs
Day 84
|
87.6 Geometric Mean Titers
Interval 64.6 to 118.9
|
88.6 Geometric Mean Titers
Interval 70.5 to 111.3
|
99.0 Geometric Mean Titers
Interval 66.4 to 147.6
|
76.0 Geometric Mean Titers
Interval 51.4 to 112.4
|
80.8 Geometric Mean Titers
Interval 57.3 to 113.9
|
97.3 Geometric Mean Titers
Interval 69.2 to 136.8
|
90.9 Geometric Mean Titers
Interval 64.8 to 127.5
|
86.8 Geometric Mean Titers
Interval 69.5 to 108.5
|
83.7 Geometric Mean Titers
Interval 60.3 to 116.3
|
83.7 Geometric Mean Titers
Interval 58.1 to 120.8
|
79.2 Geometric Mean Titers
Interval 52.7 to 118.9
|
113.1 Geometric Mean Titers
Interval 77.0 to 166.3
|
93.1 Geometric Mean Titers
Interval 68.4 to 126.8
|
—
|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as GMTs
Day 182
|
73.0 Geometric Mean Titers
Interval 53.7 to 99.3
|
72.6 Geometric Mean Titers
Interval 58.6 to 89.9
|
81.4 Geometric Mean Titers
Interval 54.3 to 122.1
|
59.5 Geometric Mean Titers
Interval 42.1 to 84.2
|
62.5 Geometric Mean Titers
Interval 44.6 to 87.5
|
77.9 Geometric Mean Titers
Interval 57.1 to 106.3
|
69.8 Geometric Mean Titers
Interval 50.3 to 96.8
|
61.8 Geometric Mean Titers
Interval 50.3 to 75.8
|
69.5 Geometric Mean Titers
Interval 50.7 to 95.3
|
74.9 Geometric Mean Titers
Interval 53.8 to 104.3
|
66.6 Geometric Mean Titers
Interval 48.4 to 91.7
|
85.3 Geometric Mean Titers
Interval 60.1 to 120.9
|
72.5 Geometric Mean Titers
Interval 52.2 to 100.8
|
—
|
SECONDARY outcome
Timeframe: Day 0 to Day 182Population: Per-Protocol Analysis Set Population
Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza B/Maryland (Victoria Subtype) strain calculated as GMT, defined as the antilog of the mean of the log-transformed HAI titers on Days 56, 70, and other follow-up time points.
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
n=39 Participants
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs
Day 28
|
65.8 Geometric Mean Titers
Interval 48.4 to 89.5
|
73.7 Geometric Mean Titers
Interval 62.3 to 87.2
|
63.3 Geometric Mean Titers
Interval 48.0 to 83.5
|
40.7 Geometric Mean Titers
Interval 31.2 to 53.2
|
52.0 Geometric Mean Titers
Interval 40.1 to 67.4
|
53.3 Geometric Mean Titers
Interval 40.2 to 70.8
|
47.0 Geometric Mean Titers
Interval 36.3 to 60.7
|
61.0 Geometric Mean Titers
Interval 51.0 to 73.0
|
49.1 Geometric Mean Titers
Interval 37.7 to 63.9
|
45.3 Geometric Mean Titers
Interval 33.4 to 61.4
|
59.7 Geometric Mean Titers
Interval 46.4 to 76.8
|
56.6 Geometric Mean Titers
Interval 42.6 to 75.1
|
58.0 Geometric Mean Titers
Interval 44.9 to 75.0
|
—
|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs
Day 182
|
56.1 Geometric Mean Titers
Interval 43.9 to 71.5
|
71.3 Geometric Mean Titers
Interval 59.5 to 85.3
|
60.2 Geometric Mean Titers
Interval 47.9 to 75.7
|
49.0 Geometric Mean Titers
Interval 37.0 to 65.0
|
50.7 Geometric Mean Titers
Interval 37.7 to 68.2
|
52.2 Geometric Mean Titers
Interval 40.8 to 66.9
|
48.0 Geometric Mean Titers
Interval 37.0 to 62.3
|
62.6 Geometric Mean Titers
Interval 52.1 to 75.2
|
49.6 Geometric Mean Titers
Interval 38.0 to 64.7
|
52.0 Geometric Mean Titers
Interval 41.0 to 66.0
|
55.5 Geometric Mean Titers
Interval 42.0 to 73.3
|
54.0 Geometric Mean Titers
Interval 40.5 to 72.2
|
55.1 Geometric Mean Titers
Interval 43.7 to 69.4
|
—
|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs
Day 0
|
36.0 Geometric Mean Titers
Interval 26.8 to 48.2
|
46.6 Geometric Mean Titers
Interval 38.7 to 56.2
|
40.3 Geometric Mean Titers
Interval 31.1 to 52.3
|
36.6 Geometric Mean Titers
Interval 36.6 to 48.8
|
39.3 Geometric Mean Titers
Interval 30.9 to 49.9
|
34.6 Geometric Mean Titers
Interval 27.0 to 44.4
|
36.4 Geometric Mean Titers
Interval 27.6 to 47.9
|
38.1 Geometric Mean Titers
Interval 31.2 to 46.6
|
41.4 Geometric Mean Titers
Interval 31.5 to 54.6
|
38.9 Geometric Mean Titers
Interval 28.2 to 53.7
|
45.9 Geometric Mean Titers
Interval 34.9 to 60.5
|
41.1 Geometric Mean Titers
Interval 31.8 to 53.1
|
42.1 Geometric Mean Titers
Interval 32.9 to 53.8
|
—
|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs
Day 56
|
58.1 Geometric Mean Titers
Interval 43.8 to 77.0
|
69.5 Geometric Mean Titers
Interval 58.1 to 83.2
|
54.6 Geometric Mean Titers
Interval 41.3 to 72.1
|
43.6 Geometric Mean Titers
Interval 32.7 to 58.2
|
55.5 Geometric Mean Titers
Interval 43.1 to 71.5
|
42.5 Geometric Mean Titers
Interval 31.7 to 56.9
|
44.8 Geometric Mean Titers
Interval 34.7 to 57.7
|
57.3 Geometric Mean Titers
Interval 47.7 to 68.8
|
47.8 Geometric Mean Titers
Interval 37.4 to 61.0
|
44.6 Geometric Mean Titers
Interval 33.4 to 59.6
|
57.1 Geometric Mean Titers
Interval 44.0 to 74.1
|
48.4 Geometric Mean Titers
Interval 36.2 to 64.8
|
52.3 Geometric Mean Titers
Interval 41.0 to 66.7
|
—
|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs
Day 70
|
58.1 Geometric Mean Titers
Interval 43.6 to 77.5
|
77.5 Geometric Mean Titers
Interval 64.8 to 92.8
|
65.2 Geometric Mean Titers
Interval 48.5 to 87.8
|
47.8 Geometric Mean Titers
Interval 34.6 to 66.1
|
61.1 Geometric Mean Titers
Interval 47.4 to 78.8
|
58.1 Geometric Mean Titers
Interval 44.2 to 76.3
|
50.5 Geometric Mean Titers
Interval 39.5 to 64.7
|
63.4 Geometric Mean Titers
Interval 53.3 to 75.4
|
55.5 Geometric Mean Titers
Interval 41.6 to 74.1
|
50.7 Geometric Mean Titers
Interval 38.9 to 66.1
|
66.0 Geometric Mean Titers
Interval 50.5 to 86.1
|
60.4 Geometric Mean Titers
Interval 45.2 to 80.8
|
64.2 Geometric Mean Titers
Interval 50.5 to 81.6
|
—
|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as GMTs
Day 84
|
63.1 Geometric Mean Titers
Interval 49.4 to 80.6
|
76.2 Geometric Mean Titers
Interval 63.2 to 91.9
|
69.4 Geometric Mean Titers
Interval 54.5 to 88.3
|
56.6 Geometric Mean Titers
Interval 41.9 to 76.4
|
57.7 Geometric Mean Titers
Interval 44.1 to 75.4
|
61.8 Geometric Mean Titers
Interval 47.8 to 80.0
|
56.6 Geometric Mean Titers
Interval 43.4 to 73.7
|
74.0 Geometric Mean Titers
Interval 62.5 to 87.7
|
51.6 Geometric Mean Titers
Interval 39.1 to 68.1
|
52.1 Geometric Mean Titers
Interval 39.9 to 68.0
|
65.2 Geometric Mean Titers
Interval 48.8 to 87.2
|
67.6 Geometric Mean Titers
Interval 51.9 to 88.0
|
65.3 Geometric Mean Titers
Interval 51.3 to 83.1
|
—
|
SECONDARY outcome
Timeframe: Day 0 to Day 182Population: Per-Protocol Analysis Set Population
Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza B/Phuket (Yamagata Subtype) strain calculated as GMT, defined as the antilog of the mean of the log-transformed HAI titers on Days 56, 70, and other follow-up time points.
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
n=39 Participants
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs
Day 0
|
40.0 Geometric Mean Titers
Interval 5.0 to 640.0
|
40.4 Geometric Mean Titers
Interval 33.7 to 48.3
|
36.1 Geometric Mean Titers
Interval 27.1 to 47.9
|
24.3 Geometric Mean Titers
Interval 18.3 to 32.4
|
33.2 Geometric Mean Titers
Interval 24.4 to 45.2
|
35.8 Geometric Mean Titers
Interval 27.5 to 46.7
|
35.4 Geometric Mean Titers
Interval 26.4 to 47.6
|
31.3 Geometric Mean Titers
Interval 25.7 to 38.1
|
38.3 Geometric Mean Titers
Interval 29.6 to 49.4
|
36.9 Geometric Mean Titers
Interval 28.9 to 47.2
|
36.1 Geometric Mean Titers
Interval 29.0 to 44.8
|
33.5 Geometric Mean Titers
Interval 26.9 to 41.7
|
35.5 Geometric Mean Titers
Interval 27.8 to 45.5
|
—
|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs
Day 28
|
100.8 Geometric Mean Titers
Interval 81.8 to 124.1
|
78.3 Geometric Mean Titers
Interval 65.2 to 93.9
|
57.6 Geometric Mean Titers
Interval 43.5 to 76.2
|
35.2 Geometric Mean Titers
Interval 26.7 to 46.4
|
47.8 Geometric Mean Titers
Interval 36.6 to 62.4
|
67.6 Geometric Mean Titers
Interval 53.0 to 86.2
|
50.7 Geometric Mean Titers
Interval 39.1 to 65.7
|
58.1 Geometric Mean Titers
Interval 48.5 to 69.6
|
60.2 Geometric Mean Titers
Interval 47.8 to 75.8
|
48.6 Geometric Mean Titers
Interval 38.1 to 62.0
|
59.7 Geometric Mean Titers
Interval 48.2 to 73.9
|
57.6 Geometric Mean Titers
Interval 45.9 to 72.2
|
68.7 Geometric Mean Titers
Interval 53.3 to 88.6
|
—
|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs
Day 56
|
86.7 Geometric Mean Titers
Interval 69.2 to 108.6
|
72.3 Geometric Mean Titers
Interval 60.5 to 86.4
|
53.2 Geometric Mean Titers
Interval 40.0 to 70.7
|
36.0 Geometric Mean Titers
Interval 26.7 to 48.5
|
44.5 Geometric Mean Titers
Interval 33.6 to 58.8
|
58.6 Geometric Mean Titers
Interval 45.0 to 76.3
|
47.2 Geometric Mean Titers
Interval 36.2 to 61.4
|
52.7 Geometric Mean Titers
Interval 43.8 to 63.4
|
57.1 Geometric Mean Titers
Interval 45.8 to 71.1
|
44.6 Geometric Mean Titers
Interval 35.8 to 55.6
|
55.5 Geometric Mean Titers
Interval 43.9 to 70.3
|
49.8 Geometric Mean Titers
Interval 39.1 to 63.3
|
62.2 Geometric Mean Titers
Interval 48.4 to 80.1
|
—
|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs
Day 70
|
85.3 Geometric Mean Titers
Interval 66.8 to 108.8
|
87.9 Geometric Mean Titers
Interval 71.9 to 107.6
|
72.5 Geometric Mean Titers
Interval 55.4 to 94.9
|
45.0 Geometric Mean Titers
Interval 32.8 to 61.9
|
61.7 Geometric Mean Titers
Interval 48.1 to 79.1
|
84.3 Geometric Mean Titers
Interval 64.8 to 109.6
|
59.1 Geometric Mean Titers
Interval 46.2 to 75.5
|
65.8 Geometric Mean Titers
Interval 54.6 to 79.2
|
67.9 Geometric Mean Titers
Interval 54.4 to 84.7
|
56.1 Geometric Mean Titers
Interval 44.6 to 70.5
|
69.9 Geometric Mean Titers
Interval 54.1 to 90.4
|
63.3 Geometric Mean Titers
Interval 49.9 to 80.3
|
74.1 Geometric Mean Titers
Interval 58.6 to 93.8
|
—
|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs
Day 182
|
68.5 Geometric Mean Titers
Interval 55.3 to 84.9
|
77.1 Geometric Mean Titers
Interval 64.4 to 92.3
|
61.3 Geometric Mean Titers
Interval 49.3 to 76.2
|
43.8 Geometric Mean Titers
Interval 33.4 to 57.6
|
53.3 Geometric Mean Titers
Interval 41.3 to 68.7
|
70.0 Geometric Mean Titers
Interval 54.9 to 89.2
|
52.6 Geometric Mean Titers
Interval 41.1 to 67.3
|
55.5 Geometric Mean Titers
Interval 46.8 to 65.9
|
57.1 Geometric Mean Titers
Interval 46.8 to 69.7
|
54.5 Geometric Mean Titers
Interval 44.1 to 67.3
|
61.7 Geometric Mean Titers
Interval 50.7 to 75.1
|
54.0 Geometric Mean Titers
Interval 42.9 to 68.1
|
60.7 Geometric Mean Titers
Interval 49.0 to 75.3
|
—
|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as GMTs
Day 84
|
89.3 Geometric Mean Titers
Interval 72.3 to 110.2
|
86.7 Geometric Mean Titers
Interval 73.0 to 102.9
|
71.9 Geometric Mean Titers
Interval 57.2 to 90.4
|
52.1 Geometric Mean Titers
Interval 39.9 to 68.1
|
60.6 Geometric Mean Titers
Interval 46.8 to 78.6
|
87.4 Geometric Mean Titers
Interval 69.8 to 109.6
|
63.7 Geometric Mean Titers
Interval 51.3 to 79.0
|
72.7 Geometric Mean Titers
Interval 60.9 to 86.7
|
65.5 Geometric Mean Titers
Interval 53.3 to 80.3
|
60.3 Geometric Mean Titers
Interval 47.9 to 75.9
|
73.0 Geometric Mean Titers
Interval 56.0 to 95.1
|
72.8 Geometric Mean Titers
Interval 57.1 to 92.9
|
76.7 Geometric Mean Titers
Interval 61.0 to 96.4
|
—
|
SECONDARY outcome
Timeframe: Day 0 to Day 182Population: Per-Protocol Analysis Set Population
Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza B/Washington (Victoria Subtype) strain calculated as GMT, defined as the antilog of the mean of the log-transformed HAI titers on Days 56, 70, and other follow-up time points.
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
n=39 Participants
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs
Day 0
|
64.6 Geometric Mean Titers
Interval 51.9 to 80.5
|
75.9 Geometric Mean Titers
Interval 65.7 to 87.7
|
67.9 Geometric Mean Titers
Interval 54.4 to 84.6
|
75.8 Geometric Mean Titers
Interval 60.7 to 94.7
|
67.6 Geometric Mean Titers
Interval 54.5 to 83.8
|
62.1 Geometric Mean Titers
Interval 49.2 to 78.3
|
65.5 Geometric Mean Titers
Interval 52.3 to 82.1
|
69.5 Geometric Mean Titers
Interval 59.9 to 80.7
|
65.2 Geometric Mean Titers
Interval 50.9 to 83.5
|
67.6 Geometric Mean Titers
Interval 51.3 to 89.1
|
72.7 Geometric Mean Titers
Interval 56.3 to 93.9
|
75.2 Geometric Mean Titers
Interval 60.9 to 92.8
|
74.8 Geometric Mean Titers
Interval 60.1 to 93.1
|
—
|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs
Day 28
|
99.9 Geometric Mean Titers
Interval 80.2 to 124.4
|
101.5 Geometric Mean Titers
Interval 88.4 to 116.6
|
84.3 Geometric Mean Titers
Interval 67.8 to 104.7
|
82.2 Geometric Mean Titers
Interval 65.0 to 103.9
|
81.5 Geometric Mean Titers
Interval 64.5 to 103.0
|
83.5 Geometric Mean Titers
Interval 67.0 to 103.9
|
78.0 Geometric Mean Titers
Interval 63.0 to 96.6
|
89.4 Geometric Mean Titers
Interval 75.3 to 106.2
|
73.9 Geometric Mean Titers
Interval 58.8 to 92.8
|
75.8 Geometric Mean Titers
Interval 58.9 to 97.7
|
87.4 Geometric Mean Titers
Interval 68.7 to 111.3
|
88.2 Geometric Mean Titers
Interval 67.4 to 115.4
|
90.8 Geometric Mean Titers
Interval 71.3 to 115.7
|
—
|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs
Day 182
|
58.7 Geometric Mean Titers
Interval 44.6 to 77.1
|
61.2 Geometric Mean Titers
Interval 51.8 to 72.3
|
52.7 Geometric Mean Titers
Interval 40.7 to 68.2
|
50.6 Geometric Mean Titers
Interval 37.4 to 68.4
|
49.7 Geometric Mean Titers
Interval 37.4 to 66.1
|
48.2 Geometric Mean Titers
Interval 37.5 to 62.0
|
43.4 Geometric Mean Titers
Interval 34.2 to 55.1
|
55.8 Geometric Mean Titers
Interval 46.2 to 67.3
|
45.6 Geometric Mean Titers
Interval 34.5 to 60.2
|
50.1 Geometric Mean Titers
Interval 39.2 to 63.9
|
56.0 Geometric Mean Titers
Interval 43.5 to 72.2
|
51.6 Geometric Mean Titers
Interval 38.4 to 69.4
|
57.1 Geometric Mean Titers
Interval 45.0 to 72.3
|
—
|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs
Day 56
|
91.4 Geometric Mean Titers
Interval 72.8 to 114.7
|
91.7 Geometric Mean Titers
Interval 79.2 to 106.1
|
83.6 Geometric Mean Titers
Interval 66.3 to 105.5
|
73.4 Geometric Mean Titers
Interval 57.6 to 93.4
|
80.8 Geometric Mean Titers
Interval 64.1 to 101.9
|
70.3 Geometric Mean Titers
Interval 56.6 to 87.1
|
70.3 Geometric Mean Titers
Interval 56.0 to 88.1
|
85.4 Geometric Mean Titers
Interval 72.6 to 100.5
|
70.0 Geometric Mean Titers
Interval 55.5 to 88.4
|
77.1 Geometric Mean Titers
Interval 59.8 to 99.6
|
77.8 Geometric Mean Titers
Interval 61.0 to 99.1
|
82.2 Geometric Mean Titers
Interval 62.9 to 107.5
|
85.7 Geometric Mean Titers
Interval 69.0 to 106.6
|
—
|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs
Day 70
|
94.3 Geometric Mean Titers
Interval 73.7 to 120.6
|
107.2 Geometric Mean Titers
Interval 92.8 to 123.8
|
89.8 Geometric Mean Titers
Interval 69.0 to 116.8
|
88.3 Geometric Mean Titers
Interval 68.6 to 113.7
|
91.5 Geometric Mean Titers
Interval 71.3 to 117.5
|
85.0 Geometric Mean Titers
Interval 66.5 to 108.7
|
77.3 Geometric Mean Titers
Interval 62.1 to 96.1
|
93.4 Geometric Mean Titers
Interval 79.0 to 110.4
|
75.1 Geometric Mean Titers
Interval 60.1 to 93.6
|
80.7 Geometric Mean Titers
Interval 60.9 to 107.0
|
95.1 Geometric Mean Titers
Interval 76.0 to 119.2
|
92.9 Geometric Mean Titers
Interval 70.5 to 122.4
|
90.8 Geometric Mean Titers
Interval 74.3 to 111.1
|
—
|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as GMTs
Day 84
|
65.5 Geometric Mean Titers
Interval 49.4 to 86.7
|
63.5 Geometric Mean Titers
Interval 53.5 to 75.4
|
62.4 Geometric Mean Titers
Interval 48.0 to 81.1
|
57.1 Geometric Mean Titers
Interval 42.5 to 76.8
|
54.9 Geometric Mean Titers
Interval 41.9 to 72.0
|
58.6 Geometric Mean Titers
Interval 46.0 to 74.7
|
48.4 Geometric Mean Titers
Interval 38.8 to 60.5
|
66.1 Geometric Mean Titers
Interval 54.9 to 79.5
|
48.4 Geometric Mean Titers
Interval 36.0 to 65.3
|
50.2 Geometric Mean Titers
Interval 37.6 to 67.1
|
58.3 Geometric Mean Titers
Interval 43.8 to 77.6
|
67.0 Geometric Mean Titers
Interval 51.3 to 87.4
|
63.1 Geometric Mean Titers
Interval 50.0 to 79.7
|
—
|
SECONDARY outcome
Timeframe: Day 28 to Day 182Population: Per-Protocol Analysis Set Population
Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A/Brisbane (H1N1 Subtype) calculated as (GMFRPost/Pre), defined as the within-group ratio of post-vaccination to pre-vaccination (Day 0) HAI GMTs within the same vaccine group on Days 56, 70, and other follow-up time points.
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
n=39 Participants
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Fold Rise (GMFRPost/Pre)
Day 84
|
1.1 geometric mean fold rise
Interval 0.8 to 1.5
|
1.3 geometric mean fold rise
Interval 1.0 to 1.6
|
1.3 geometric mean fold rise
Interval 0.9 to 1.8
|
1.4 geometric mean fold rise
Interval 1.1 to 1.7
|
1.1 geometric mean fold rise
Interval 0.9 to 1.3
|
1.1 geometric mean fold rise
Interval 0.9 to 1.5
|
0.9 geometric mean fold rise
Interval 0.7 to 1.2
|
1.3 geometric mean fold rise
Interval 1.1 to 1.5
|
0.8 geometric mean fold rise
Interval 0.6 to 1.0
|
1.0 geometric mean fold rise
Interval 0.8 to 1.3
|
1.0 geometric mean fold rise
Interval 0.8 to 1.2
|
1.1 geometric mean fold rise
Interval 0.8 to 1.4
|
1.1 geometric mean fold rise
Interval 0.9 to 1.4
|
—
|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Fold Rise (GMFRPost/Pre)
Day 28
|
1.6 geometric mean fold rise
Interval 1.3 to 2.0
|
1.7 geometric mean fold rise
Interval 1.4 to 2.0
|
1.4 geometric mean fold rise
Interval 1.0 to 1.4
|
1.3 geometric mean fold rise
Interval 1.1 to 1.6
|
1.2 geometric mean fold rise
Interval 1.0 to 1.4
|
1.3 geometric mean fold rise
Interval 1.0 to 1.6
|
1.3 geometric mean fold rise
Interval 1.1 to 1.5
|
1.6 geometric mean fold rise
Interval 1.4 to 1.8
|
1.2 geometric mean fold rise
Interval 1.0 to 1.4
|
1.1 geometric mean fold rise
Interval 0.9 to 1.2
|
1.5 geometric mean fold rise
Interval 1.2 to 1.8
|
1.3 geometric mean fold rise
Interval 1.1 to 1.6
|
1.3 geometric mean fold rise
Interval 1.1 to 1.5
|
—
|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Fold Rise (GMFRPost/Pre)
Day 56
|
1.4 geometric mean fold rise
Interval 1.1 to 1.8
|
1.5 geometric mean fold rise
Interval 1.3 to 1.8
|
1.3 geometric mean fold rise
Interval 1.0 to 1.8
|
1.3 geometric mean fold rise
Interval 1.0 to 1.6
|
1.1 geometric mean fold rise
Interval 1.0 to 1.2
|
1.1 geometric mean fold rise
Interval 1.0 to 1.3
|
1.2 geometric mean fold rise
Interval 1.1 to 1.4
|
1.4 geometric mean fold rise
Interval 1.2 to 1.6
|
1.1 geometric mean fold rise
Interval 0.9 to 1.3
|
1.0 geometric mean fold rise
Interval 0.9 to 1.2
|
1.3 geometric mean fold rise
Interval 1.0 to 1.6
|
1.1 geometric mean fold rise
Interval 0.9 to 1.4
|
1.2 geometric mean fold rise
Interval 1.1 to 1.5
|
—
|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Fold Rise (GMFRPost/Pre)
Day 70
|
1.5 geometric mean fold rise
Interval 1.2 to 1.8
|
1.7 geometric mean fold rise
Interval 1.4 to 2.1
|
1.9 geometric mean fold rise
Interval 1.4 to 2.6
|
1.7 geometric mean fold rise
Interval 1.4 to 2.1
|
1.6 geometric mean fold rise
Interval 1.3 to 1.9
|
1.5 geometric mean fold rise
Interval 1.2 to 1.9
|
1.5 geometric mean fold rise
Interval 1.2 to 1.8
|
1.6 geometric mean fold rise
Interval 1.4 to 1.9
|
1.4 geometric mean fold rise
Interval 1.1 to 1.7
|
1.3 geometric mean fold rise
Interval 1.1 to 1.6
|
1.5 geometric mean fold rise
Interval 1.2 to 1.9
|
1.5 geometric mean fold rise
Interval 1.2 to 1.9
|
1.6 geometric mean fold rise
Interval 1.3 to 1.9
|
—
|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Fold Rise (GMFRPost/Pre)
Day 182
|
0.8 geometric mean fold rise
Interval 0.6 to 1.0
|
1.0 geometric mean fold rise
Interval 0.8 to 1.3
|
0.9 geometric mean fold rise
Interval 0.6 to 1.2
|
1.0 geometric mean fold rise
Interval 0.8 to 1.2
|
0.8 geometric mean fold rise
Interval 0.7 to 0.9
|
0.8 geometric mean fold rise
Interval 0.6 to 1.0
|
0.8 geometric mean fold rise
Interval 0.6 to 1.0
|
0.9 geometric mean fold rise
Interval 0.7 to 1.0
|
0.6 geometric mean fold rise
Interval 0.5 to 0.8
|
0.8 geometric mean fold rise
Interval 0.6 to 0.9
|
0.8 geometric mean fold rise
Interval 0.6 to 1.0
|
0.8 geometric mean fold rise
Interval 0.6 to 1.0
|
0.8 geometric mean fold rise
Interval 0.7 to 1.0
|
—
|
SECONDARY outcome
Timeframe: Day 28 to Day 182Population: Per-Protocol Analysis Set Population
Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A/Kansas (H3N2 Subtype) calculated as (GMFRPost/Pre), defined as the within-group ratio of post-vaccination to pre-vaccination (Day 0) HAI GMTs within the same vaccine group on Days 56, 70, and other follow-up time points.
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
n=39 Participants
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as (GMFRPost/Pre)
Day 182
|
2.5 geometric mean fold rise
Interval 1.9 to 3.3
|
3.1 geometric mean fold rise
Interval 2.6 to 3.7
|
2.8 geometric mean fold rise
Interval 2.0 to 3.9
|
2.8 geometric mean fold rise
Interval 2.2 to 3.5
|
1.8 geometric mean fold rise
Interval 1.4 to 2.2
|
2.5 geometric mean fold rise
Interval 1.9 to 3.2
|
2.2 geometric mean fold rise
Interval 1.6 to 3.0
|
3.0 geometric mean fold rise
Interval 2.5 to 3.6
|
2.1 geometric mean fold rise
Interval 1.7 to 2.6
|
2.1 geometric mean fold rise
Interval 1.7 to 2.5
|
2.6 geometric mean fold rise
Interval 2.1 to 3.2
|
2.5 geometric mean fold rise
Interval 2.0 to 3.1
|
2.8 geometric mean fold rise
Interval 2.2 to 3.5
|
—
|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as (GMFRPost/Pre)
Day 28
|
5.4 geometric mean fold rise
Interval 3.8 to 7.5
|
4.1 geometric mean fold rise
Interval 3.3 to 4.9
|
3.6 geometric mean fold rise
Interval 2.3 to 5.5
|
2.7 geometric mean fold rise
Interval 2.1 to 3.5
|
2.5 geometric mean fold rise
Interval 1.9 to 3.2
|
3.4 geometric mean fold rise
Interval 2.4 to 4.7
|
2.7 geometric mean fold rise
Interval 2.0 to 3.5
|
4.1 geometric mean fold rise
Interval 3.3 to 5.0
|
2.3 geometric mean fold rise
Interval 1.8 to 3.0
|
2.2 geometric mean fold rise
Interval 1.7 to 2.8
|
4.4 geometric mean fold rise
Interval 3.1 to 6.1
|
4.0 geometric mean fold rise
Interval 3.2 to 5.0
|
3.6 geometric mean fold rise
Interval 2.7 to 4.8
|
—
|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as (GMFRPost/Pre)
Day 56
|
4.1 geometric mean fold rise
Interval 3.1 to 5.5
|
3.6 geometric mean fold rise
Interval 3.0 to 4.4
|
3.0 geometric mean fold rise
Interval 2.0 to 4.4
|
2.9 geometric mean fold rise
Interval 2.2 to 3.7
|
2.2 geometric mean fold rise
Interval 1.8 to 2.8
|
2.6 geometric mean fold rise
Interval 1.9 to 3.6
|
2.2 geometric mean fold rise
Interval 1.7 to 2.8
|
3.6 geometric mean fold rise
Interval 3.0 to 4.4
|
2.0 geometric mean fold rise
Interval 1.6 to 2.6
|
2.1 geometric mean fold rise
Interval 1.6 to 2.8
|
3.3 geometric mean fold rise
Interval 2.4 to 4.5
|
3.2 geometric mean fold rise
Interval 2.5 to 4.1
|
3.2 geometric mean fold rise
Interval 2.5 to 4.2
|
—
|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as (GMFRPost/Pre)
Day 70
|
4.2 geometric mean fold rise
Interval 3.0 to 5.8
|
4.5 geometric mean fold rise
Interval 3.7 to 5.4
|
4.3 geometric mean fold rise
Interval 2.9 to 6.4
|
3.8 geometric mean fold rise
Interval 2.7 to 5.2
|
3.5 geometric mean fold rise
Interval 2.8 to 4.3
|
4.0 geometric mean fold rise
Interval 2.9 to 5.4
|
3.3 geometric mean fold rise
Interval 2.5 to 4.3
|
4.8 geometric mean fold rise
Interval 3.9 to 5.9
|
3.1 geometric mean fold rise
Interval 2.4 to 4.0
|
2.7 geometric mean fold rise
Interval 2.1 to 3.5
|
4.4 geometric mean fold rise
Interval 3.1 to 6.2
|
3.8 geometric mean fold rise
Interval 3.0 to 4.7
|
3.7 geometric mean fold rise
Interval 2.8 to 4.8
|
—
|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as (GMFRPost/Pre)
Day 84
|
3.6 geometric mean fold rise
Interval 2.7 to 4.8
|
4.1 geometric mean fold rise
Interval 3.4 to 4.9
|
3.9 geometric mean fold rise
Interval 2.7 to 5.6
|
3.9 geometric mean fold rise
Interval 3.1 to 5.0
|
2.6 geometric mean fold rise
Interval 2.1 to 3.3
|
3.6 geometric mean fold rise
Interval 2.6 to 4.9
|
2.8 geometric mean fold rise
Interval 2.1 to 3.7
|
4.4 geometric mean fold rise
Interval 3.6 to 5.4
|
2.6 geometric mean fold rise
Interval 2.1 to 3.2
|
2.5 geometric mean fold rise
Interval 1.9 to 3.2
|
3.5 geometric mean fold rise
Interval 2.8 to 4.3
|
3.4 geometric mean fold rise
Interval 2.7 to 4.3
|
3.4 geometric mean fold rise
Interval 2.7 to 4.4
|
—
|
SECONDARY outcome
Timeframe: Day 28 to Day 182Population: Per-Protocol Analysis Set Population
Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A/Wisconsin (H1N1 Subtype) calculated as (GMFRPost/Pre), defined as the within-group ratio of post-vaccination to pre-vaccination (Day 0) HAI GMTs within the same vaccine group on Days 56, 70, and other follow-up time points.
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
n=39 Participants
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as (GMFRPost/Pre)
Day 28
|
1.3 geometric mean fold rise
Interval 1.1 to 1.5
|
1.4 geometric mean fold rise
Interval 1.3 to 1.6
|
1.3 geometric mean fold rise
Interval 1.1 to 1.5
|
1.2 geometric mean fold rise
Interval 1.0 to 1.3
|
1.1 geometric mean fold rise
Interval 1.0 to 1.2
|
1.4 geometric mean fold rise
Interval 1.2 to 1.6
|
1.2 geometric mean fold rise
Interval 1.1 to 1.3
|
1.4 geometric mean fold rise
Interval 1.2 to 1.5
|
1.1 geometric mean fold rise
Interval 1.0 to 1.3
|
1.1 geometric mean fold rise
Interval 0.9 to 1.2
|
1.3 geometric mean fold rise
Interval 1.1 to 1.5
|
1.2 geometric mean fold rise
Interval 1.1 to 1.3
|
1.3 geometric mean fold rise
Interval 1.1 to 1.5
|
—
|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as (GMFRPost/Pre)
Day 56
|
1.2 geometric mean fold rise
Interval 1.0 to 1.4
|
1.3 geometric mean fold rise
Interval 1.2 to 1.5
|
1.1 geometric mean fold rise
Interval 0.9 to 1.4
|
1.1 geometric mean fold rise
Interval 0.9 to 1.2
|
1.0 geometric mean fold rise
Interval 1.0 to 1.2
|
1.1 geometric mean fold rise
Interval 1.0 to 1.3
|
1.0 geometric mean fold rise
Interval 0.9 to 1.2
|
1.2 geometric mean fold rise
Interval 1.0 to 1.3
|
1.1 geometric mean fold rise
Interval 0.9 to 1.3
|
1.0 geometric mean fold rise
Interval 0.9 to 1.1
|
1.2 geometric mean fold rise
Interval 1.0 to 1.4
|
1.1 geometric mean fold rise
Interval 1.0 to 1.2
|
1.1 geometric mean fold rise
Interval 1.0 to 1.3
|
—
|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as (GMFRPost/Pre)
Day 84
|
0.7 geometric mean fold rise
Interval 0.6 to 0.8
|
0.9 geometric mean fold rise
Interval 0.8 to 1.0
|
0.8 geometric mean fold rise
Interval 0.6 to 1.0
|
0.7 geometric mean fold rise
Interval 0.6 to 0.8
|
0.7 geometric mean fold rise
Interval 0.6 to 0.8
|
0.9 geometric mean fold rise
Interval 0.7 to 1.0
|
0.8 geometric mean fold rise
Interval 0.6 to 1.0
|
0.8 geometric mean fold rise
Interval 0.7 to 1.0
|
0.7 geometric mean fold rise
Interval 0.6 to 0.9
|
0.6 geometric mean fold rise
Interval 0.5 to 0.7
|
0.7 geometric mean fold rise
Interval 0.5 to 0.9
|
0.7 geometric mean fold rise
Interval 0.6 to 0.8
|
0.8 geometric mean fold rise
Interval 0.7 to 1.0
|
—
|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as (GMFRPost/Pre)
Day 182
|
0.6 geometric mean fold rise
Interval 0.5 to 0.7
|
0.8 geometric mean fold rise
Interval 0.6 to 0.9
|
0.6 geometric mean fold rise
Interval 0.5 to 0.7
|
0.6 geometric mean fold rise
Interval 0.5 to 0.7
|
0.6 geometric mean fold rise
Interval 0.5 to 0.7
|
0.7 geometric mean fold rise
Interval 0.6 to 0.8
|
0.6 geometric mean fold rise
Interval 0.5 to 0.8
|
0.7 geometric mean fold rise
Interval 0.6 to 0.7
|
0.6 geometric mean fold rise
Interval 0.5 to 0.7
|
0.5 geometric mean fold rise
Interval 0.4 to 0.6
|
0.6 geometric mean fold rise
Interval 0.5 to 0.8
|
0.6 geometric mean fold rise
Interval 0.5 to 0.6
|
0.7 geometric mean fold rise
Interval 0.6 to 0.8
|
—
|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as (GMFRPost/Pre)
Day 70
|
1.2 geometric mean fold rise
Interval 1.0 to 1.4
|
1.5 geometric mean fold rise
Interval 1.3 to 1.8
|
1.3 geometric mean fold rise
Interval 1.0 to 1.6
|
1.2 geometric mean fold rise
Interval 1.1 to 1.4
|
1.2 geometric mean fold rise
Interval 1.1 to 1.4
|
1.5 geometric mean fold rise
Interval 1.2 to 1.8
|
1.1 geometric mean fold rise
Interval 1.0 to 1.3
|
1.4 geometric mean fold rise
Interval 1.2 to 1.5
|
1.3 geometric mean fold rise
Interval 1.1 to 1.5
|
1.1 geometric mean fold rise
Interval 1.0 to 1.2
|
1.3 geometric mean fold rise
Interval 1.1 to 1.6
|
1.2 geometric mean fold rise
Interval 1.1 to 1.4
|
1.4 geometric mean fold rise
Interval 1.2 to 1.6
|
—
|
SECONDARY outcome
Timeframe: Day 28 to Day 182Population: Per-Protocol Analysis Set Population
Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A/Cambodia (H3N2 Subtype) calculated as (GMFRPost/Pre), defined as the within-group ratio of post-vaccination to pre-vaccination (Day 0) HAI GMTs within the same vaccine group on Days 56, 70, and other follow-up time points.
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
n=39 Participants
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as (GMFRPost/Pre)
Day 28
|
2.2 geometric mean fold rise
Interval 1.7 to 3.0
|
2.2 geometric mean fold rise
Interval 1.9 to 2.6
|
2.2 geometric mean fold rise
Interval 1.4 to 3.2
|
1.7 geometric mean fold rise
Interval 1.3 to 2.1
|
1.7 geometric mean fold rise
Interval 1.3 to 2.0
|
2.2 geometric mean fold rise
Interval 1.6 to 3.0
|
1.8 geometric mean fold rise
Interval 1.4 to 2.4
|
2.2 geometric mean fold rise
Interval 1.9 to 2.6
|
1.6 geometric mean fold rise
Interval 1.3 to 2.0
|
1.7 geometric mean fold rise
Interval 1.4 to 2.1
|
2.4 geometric mean fold rise
Interval 1.8 to 3.3
|
2.4 geometric mean fold rise
Interval 1.9 to 3.0
|
1.8 geometric mean fold rise
Interval 1.5 to 2.3
|
—
|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as (GMFRPost/Pre)
Day 70
|
2.1 geometric mean fold rise
Interval 1.6 to 2.6
|
2.1 geometric mean fold rise
Interval 1.8 to 2.5
|
2.2 geometric mean fold rise
Interval 1.5 to 3.2
|
1.9 geometric mean fold rise
Interval 1.5 to 2.4
|
1.7 geometric mean fold rise
Interval 1.4 to 2.1
|
2.2 geometric mean fold rise
Interval 1.7 to 3.0
|
1.9 geometric mean fold rise
Interval 1.5 to 2.4
|
2.2 geometric mean fold rise
Interval 1.8 to 2.5
|
1.9 geometric mean fold rise
Interval 1.6 to 2.4
|
1.7 geometric mean fold rise
Interval 1.3 to 2.1
|
2.5 geometric mean fold rise
Interval 1.8 to 3.5
|
2.1 geometric mean fold rise
Interval 1.7 to 2.7
|
1.9 geometric mean fold rise
Interval 1.5 to 2.4
|
—
|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as (GMFRPost/Pre)
Day 56
|
1.9 geometric mean fold rise
Interval 1.5 to 2.5
|
1.9 geometric mean fold rise
Interval 1.6 to 2.3
|
1.9 geometric mean fold rise
Interval 1.3 to 2.7
|
1.6 geometric mean fold rise
Interval 1.3 to 2.0
|
1.5 geometric mean fold rise
Interval 1.2 to 1.9
|
1.8 geometric mean fold rise
Interval 1.4 to 2.3
|
1.6 geometric mean fold rise
Interval 1.3 to 1.9
|
1.9 geometric mean fold rise
Interval 1.6 to 2.2
|
1.5 geometric mean fold rise
Interval 1.2 to 1.8
|
1.5 geometric mean fold rise
Interval 1.2 to 1.9
|
2.2 geometric mean fold rise
Interval 1.6 to 3.1
|
2.0 geometric mean fold rise
Interval 1.6 to 2.5
|
1.6 geometric mean fold rise
Interval 1.3 to 2.1
|
—
|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as (GMFRPost/Pre)
Day 84
|
1.1 geometric mean fold rise
Interval 0.9 to 1.4
|
1.3 geometric mean fold rise
Interval 1.1 to 1.5
|
1.6 geometric mean fold rise
Interval 1.1 to 2.3
|
1.2 geometric mean fold rise
Interval 0.9 to 1.5
|
1.1 geometric mean fold rise
Interval 0.8 to 1.4
|
1.4 geometric mean fold rise
Interval 1.0 to 1.8
|
1.2 geometric mean fold rise
Interval 0.9 to 1.6
|
1.4 geometric mean fold rise
Interval 1.2 to 1.7
|
1.2 geometric mean fold rise
Interval 1.0 to 1.5
|
1.0 geometric mean fold rise
Interval 0.8 to 1.4
|
1.6 geometric mean fold rise
Interval 1.2 to 2.2
|
1.6 geometric mean fold rise
Interval 1.2 to 1.9
|
1.1 geometric mean fold rise
Interval 0.9 to 1.4
|
—
|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as (GMFRPost/Pre)
Day 182
|
0.9 geometric mean fold rise
Interval 0.7 to 1.2
|
1.2 geometric mean fold rise
Interval 1.0 to 1.4
|
1.3 geometric mean fold rise
Interval 0.9 to 1.9
|
0.9 geometric mean fold rise
Interval 0.7 to 1.2
|
0.8 geometric mean fold rise
Interval 0.6 to 1.0
|
1.1 geometric mean fold rise
Interval 0.8 to 1.4
|
0.9 geometric mean fold rise
Interval 0.7 to 1.2
|
1.1 geometric mean fold rise
Interval 0.9 to 1.3
|
1.0 geometric mean fold rise
Interval 0.8 to 1.2
|
1.0 geometric mean fold rise
Interval 0.8 to 1.2
|
1.3 geometric mean fold rise
Interval 1.0 to 1.7
|
1.1 geometric mean fold rise
Interval 0.8 to 1.4
|
0.9 geometric mean fold rise
Interval 0.8 to 1.2
|
—
|
SECONDARY outcome
Timeframe: Day 28 to Day 182Population: Per-Protocol Analysis Set Population
Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A/Hong Kong (H3N2 Subtype) calculated as (GMFRPost/Pre), defined as the within-group ratio of post-vaccination to pre-vaccination (Day 0) HAI GMTs within the same vaccine group on Days 56, 70, and other follow-up time points.
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
n=39 Participants
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as (GMFRPost/Pre)
Day 28
|
1.9 geometric mean fold rise
Interval 1.4 to 2.5
|
1.9 geometric mean fold rise
Interval 1.6 to 2.2
|
1.8 geometric mean fold rise
Interval 1.3 to 2.5
|
1.4 geometric mean fold rise
Interval 1.2 to 1.7
|
1.4 geometric mean fold rise
Interval 1.2 to 1.7
|
1.7 geometric mean fold rise
Interval 1.3 to 2.2
|
1.4 geometric mean fold rise
Interval 1.2 to 1.7
|
1.9 geometric mean fold rise
Interval 1.7 to 2.3
|
1.5 geometric mean fold rise
Interval 1.2 to 1.7
|
1.6 geometric mean fold rise
Interval 1.4 to 2.0
|
2.1 geometric mean fold rise
Interval 1.7 to 2.5
|
1.8 geometric mean fold rise
Interval 1.5 to 2.3
|
1.7 geometric mean fold rise
Interval 1.4 to 2.1
|
—
|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as (GMFRPost/Pre)
Day 70
|
1.8 geometric mean fold rise
Interval 1.4 to 2.2
|
1.9 geometric mean fold rise
Interval 1.6 to 2.2
|
2.1 geometric mean fold rise
Interval 1.5 to 2.8
|
1.8 geometric mean fold rise
Interval 1.4 to 2.2
|
1.6 geometric mean fold rise
Interval 1.3 to 2.0
|
1.7 geometric mean fold rise
Interval 1.4 to 2.1
|
1.6 geometric mean fold rise
Interval 1.3 to 1.9
|
1.9 geometric mean fold rise
Interval 1.6 to 2.2
|
1.5 geometric mean fold rise
Interval 1.2 to 1.8
|
1.6 geometric mean fold rise
Interval 1.3 to 1.9
|
2.0 geometric mean fold rise
Interval 1.7 to 2.5
|
1.9 geometric mean fold rise
Interval 1.5 to 2.4
|
1.7 geometric mean fold rise
Interval 1.4 to 2.1
|
—
|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as (GMFRPost/Pre)
Day 84
|
1.2 geometric mean fold rise
Interval 0.9 to 1.5
|
1.2 geometric mean fold rise
Interval 1.1 to 1.5
|
1.4 geometric mean fold rise
Interval 1.1 to 1.9
|
1.1 geometric mean fold rise
Interval 0.9 to 1.5
|
1.1 geometric mean fold rise
Interval 0.9 to 1.4
|
1.2 geometric mean fold rise
Interval 1.0 to 1.6
|
1.1 geometric mean fold rise
Interval 0.9 to 1.4
|
1.5 geometric mean fold rise
Interval 1.2 to 1.8
|
1.1 geometric mean fold rise
Interval 0.9 to 1.3
|
1.1 geometric mean fold rise
Interval 0.8 to 1.4
|
1.5 geometric mean fold rise
Interval 1.1 to 2.0
|
1.4 geometric mean fold rise
Interval 1.1 to 1.7
|
1.4 geometric mean fold rise
Interval 1.1 to 1.8
|
—
|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as (GMFRPost/Pre)
Day 182
|
1.0 geometric mean fold rise
Interval 0.8 to 1.3
|
1.0 geometric mean fold rise
Interval 0.9 to 1.2
|
1.2 geometric mean fold rise
Interval 0.8 to 1.6
|
0.9 geometric mean fold rise
Interval 0.7 to 1.1
|
0.9 geometric mean fold rise
Interval 0.7 to 1.1
|
1.0 geometric mean fold rise
Interval 0.8 to 1.2
|
0.9 geometric mean fold rise
Interval 0.7 to 1.2
|
1.1 geometric mean fold rise
Interval 0.9 to 1.3
|
0.9 geometric mean fold rise
Interval 0.8 to 1.1
|
1.0 geometric mean fold rise
Interval 0.8 to 1.2
|
1.2 geometric mean fold rise
Interval 1.0 to 1.5
|
1.1 geometric mean fold rise
Interval 0.9 to 1.3
|
1.1 geometric mean fold rise
Interval 0.8 to 1.4
|
—
|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as (GMFRPost/Pre)
Day 56
|
1.6 geometric mean fold rise
Interval 1.3 to 2.1
|
1.7 geometric mean fold rise
Interval 1.5 to 2.0
|
1.6 geometric mean fold rise
Interval 1.2 to 2.2
|
1.4 geometric mean fold rise
Interval 1.2 to 1.6
|
1.3 geometric mean fold rise
Interval 1.1 to 1.6
|
1.3 geometric mean fold rise
Interval 1.1 to 1.6
|
1.4 geometric mean fold rise
Interval 1.2 to 1.6
|
1.8 geometric mean fold rise
Interval 1.5 to 2.1
|
1.3 geometric mean fold rise
Interval 1.1 to 1.5
|
1.5 geometric mean fold rise
Interval 1.2 to 1.7
|
1.7 geometric mean fold rise
Interval 1.4 to 2.1
|
1.6 geometric mean fold rise
Interval 1.3 to 2.0
|
1.6 geometric mean fold rise
Interval 1.3 to 1.9
|
—
|
SECONDARY outcome
Timeframe: Day 28 to Day 182Population: Per-Protocol Analysis Set Population
Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza B/Maryland (Victoria Subtype) calculated as (GMFRPost/Pre), defined as the within-group ratio of post-vaccination to pre-vaccination (Day 0) HAI GMTs within the same vaccine group on Days 56, 70, and other follow-up time points.
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
n=39 Participants
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as (GMFRPost/Pre)
Day 28
|
1.8 geometric mean fold rise
Interval 1.4 to 2.4
|
1.6 geometric mean fold rise
Interval 1.4 to 1.9
|
1.6 geometric mean fold rise
Interval 1.3 to 2.0
|
1.1 geometric mean fold rise
Interval 0.9 to 1.4
|
1.3 geometric mean fold rise
Interval 1.1 to 1.6
|
1.5 geometric mean fold rise
Interval 1.2 to 1.9
|
1.3 geometric mean fold rise
Interval 1.1 to 1.5
|
1.6 geometric mean fold rise
Interval 1.4 to 1.9
|
1.2 geometric mean fold rise
Interval 1.0 to 1.3
|
1.2 geometric mean fold rise
Interval 1.0 to 1.3
|
1.3 geometric mean fold rise
Interval 1.1 to 1.6
|
1.4 geometric mean fold rise
Interval 1.1 to 1.7
|
1.4 geometric mean fold rise
Interval 1.2 to 1.6
|
—
|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as (GMFRPost/Pre)
Day 84
|
1.7 geometric mean fold rise
Interval 1.4 to 2.1
|
1.7 geometric mean fold rise
Interval 1.4 to 2.1
|
1.7 geometric mean fold rise
Interval 1.4 to 2.0
|
1.5 geometric mean fold rise
Interval 1.2 to 1.9
|
1.4 geometric mean fold rise
Interval 1.2 to 1.7
|
1.8 geometric mean fold rise
Interval 1.4 to 2.2
|
1.6 geometric mean fold rise
Interval 1.3 to 1.9
|
1.9 geometric mean fold rise
Interval 1.7 to 2.2
|
1.3 geometric mean fold rise
Interval 1.1 to 1.5
|
1.3 geometric mean fold rise
Interval 1.0 to 1.6
|
1.5 geometric mean fold rise
Interval 1.3 to 1.8
|
1.6 geometric mean fold rise
Interval 1.3 to 1.9
|
1.6 geometric mean fold rise
Interval 1.3 to 1.8
|
—
|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as (GMFRPost/Pre)
Day 182
|
1.5 geometric mean fold rise
Interval 1.2 to 1.8
|
1.6 geometric mean fold rise
Interval 1.3 to 1.9
|
1.5 geometric mean fold rise
Interval 1.2 to 1.7
|
1.3 geometric mean fold rise
Interval 1.1 to 1.6
|
1.3 geometric mean fold rise
Interval 1.0 to 1.5
|
1.5 geometric mean fold rise
Interval 1.2 to 1.8
|
1.3 geometric mean fold rise
Interval 1.1 to 1.5
|
1.6 geometric mean fold rise
Interval 1.4 to 1.8
|
1.3 geometric mean fold rise
Interval 1.1 to 1.5
|
1.3 geometric mean fold rise
Interval 1.1 to 1.6
|
1.3 geometric mean fold rise
Interval 1.1 to 1.5
|
1.3 geometric mean fold rise
Interval 1.1 to 1.5
|
1.3 geometric mean fold rise
Interval 1.1 to 1.6
|
—
|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as (GMFRPost/Pre)
Day 56
|
1.6 geometric mean fold rise
Interval 1.3 to 2.0
|
1.5 geometric mean fold rise
Interval 1.3 to 1.8
|
1.3 geometric mean fold rise
Interval 1.1 to 1.6
|
1.2 geometric mean fold rise
Interval 1.0 to 1.4
|
1.4 geometric mean fold rise
Interval 1.2 to 1.6
|
1.2 geometric mean fold rise
Interval 1.0 to 1.5
|
1.2 geometric mean fold rise
Interval 1.1 to 1.4
|
1.5 geometric mean fold rise
Interval 1.3 to 1.7
|
1.2 geometric mean fold rise
Interval 1.0 to 1.3
|
1.1 geometric mean fold rise
Interval 1.0 to 1.3
|
1.3 geometric mean fold rise
Interval 1.1 to 1.6
|
1.2 geometric mean fold rise
Interval 1.0 to 1.4
|
1.3 geometric mean fold rise
Interval 1.2 to 1.4
|
—
|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as (GMFRPost/Pre)
Day 70
|
1.6 geometric mean fold rise
Interval 1.3 to 1.9
|
1.7 geometric mean fold rise
Interval 1.4 to 2.0
|
1.6 geometric mean fold rise
Interval 1.3 to 1.9
|
1.3 geometric mean fold rise
Interval 1.1 to 1.5
|
1.5 geometric mean fold rise
Interval 1.3 to 1.8
|
1.7 geometric mean fold rise
Interval 1.4 to 2.0
|
1.4 geometric mean fold rise
Interval 1.2 to 1.6
|
1.6 geometric mean fold rise
Interval 1.4 to 1.8
|
1.4 geometric mean fold rise
Interval 1.2 to 1.6
|
1.3 geometric mean fold rise
Interval 1.1 to 1.5
|
1.5 geometric mean fold rise
Interval 1.3 to 1.8
|
1.4 geometric mean fold rise
Interval 1.2 to 1.7
|
1.5 geometric mean fold rise
Interval 1.3 to 1.8
|
—
|
SECONDARY outcome
Timeframe: Day 28 to Day 182Population: Per-Protocol Analysis Set Population
Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza B/Phuket (Yamagata Subtype) calculated as (GMFRPost/Pre), defined as the within-group ratio of post-vaccination to pre-vaccination (Day 0) HAI GMTs within the same vaccine group on Days 56, 70, and other follow-up time points.
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
n=39 Participants
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as (GMFRPost/Pre)
Day 28
|
2.7 geometric mean fold rise
Interval 2.0 to 3.6
|
2.0 geometric mean fold rise
Interval 1.6 to 2.3
|
1.6 geometric mean fold rise
Interval 1.3 to 2.0
|
1.4 geometric mean fold rise
Interval 1.1 to 1.7
|
1.4 geometric mean fold rise
Interval 1.2 to 1.8
|
1.9 geometric mean fold rise
Interval 1.4 to 2.5
|
1.4 geometric mean fold rise
Interval 1.1 to 1.7
|
1.9 geometric mean fold rise
Interval 1.6 to 2.2
|
1.6 geometric mean fold rise
Interval 1.3 to 1.9
|
1.3 geometric mean fold rise
Interval 1.1 to 1.5
|
1.6 geometric mean fold rise
Interval 1.3 to 2.0
|
1.7 geometric mean fold rise
Interval 1.4 to 2.0
|
1.9 geometric mean fold rise
Interval 1.6 to 2.4
|
—
|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as (GMFRPost/Pre)
Day 56
|
2.3 geometric mean fold rise
Interval 1.8 to 3.0
|
1.8 geometric mean fold rise
Interval 1.5 to 2.1
|
1.5 geometric mean fold rise
Interval 1.2 to 1.8
|
1.5 geometric mean fold rise
Interval 1.2 to 1.8
|
1.3 geometric mean fold rise
Interval 1.1 to 1.6
|
1.6 geometric mean fold rise
Interval 1.2 to 2.1
|
1.3 geometric mean fold rise
Interval 1.1 to 1.6
|
1.7 geometric mean fold rise
Interval 1.5 to 1.9
|
1.5 geometric mean fold rise
Interval 1.3 to 1.8
|
1.2 geometric mean fold rise
Interval 1.0 to 1.4
|
1.5 geometric mean fold rise
Interval 1.3 to 1.9
|
1.5 geometric mean fold rise
Interval 1.3 to 1.8
|
1.8 geometric mean fold rise
Interval 1.5 to 2.2
|
—
|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as (GMFRPost/Pre)
Day 70
|
2.3 geometric mean fold rise
Interval 1.7 to 3.0
|
2.3 geometric mean fold rise
Interval 1.9 to 2.7
|
2.0 geometric mean fold rise
Interval 1.6 to 2.4
|
1.9 geometric mean fold rise
Interval 1.5 to 2.3
|
1.8 geometric mean fold rise
Interval 1.5 to 2.3
|
2.3 geometric mean fold rise
Interval 1.8 to 3.1
|
1.7 geometric mean fold rise
Interval 1.4 to 2.0
|
2.1 geometric mean fold rise
Interval 1.8 to 2.4
|
1.8 geometric mean fold rise
Interval 1.5 to 2.2
|
1.5 geometric mean fold rise
Interval 1.3 to 1.7
|
2.0 geometric mean fold rise
Interval 1.6 to 2.5
|
1.9 geometric mean fold rise
Interval 1.6 to 2.3
|
2.1 geometric mean fold rise
Interval 1.7 to 2.5
|
—
|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as (GMFRPost/Pre)
Day 182
|
1.8 geometric mean fold rise
Interval 1.4 to 2.3
|
2.0 geometric mean fold rise
Interval 1.6 to 2.4
|
1.7 geometric mean fold rise
Interval 1.4 to 2.0
|
1.8 geometric mean fold rise
Interval 1.5 to 2.2
|
1.6 geometric mean fold rise
Interval 1.2 to 2.0
|
2.0 geometric mean fold rise
Interval 1.5 to 2.5
|
1.5 geometric mean fold rise
Interval 1.2 to 1.9
|
1.8 geometric mean fold rise
Interval 1.6 to 2.1
|
1.5 geometric mean fold rise
Interval 1.2 to 1.9
|
1.5 geometric mean fold rise
Interval 1.3 to 1.7
|
1.7 geometric mean fold rise
Interval 1.5 to 2.0
|
1.6 geometric mean fold rise
Interval 1.4 to 1.9
|
1.8 geometric mean fold rise
Interval 1.5 to 2.3
|
—
|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as (GMFRPost/Pre)
Day 84
|
2.4 geometric mean fold rise
Interval 1.8 to 3.1
|
2.2 geometric mean fold rise
Interval 1.8 to 2.6
|
2.0 geometric mean fold rise
Interval 1.6 to 2.4
|
2.1 geometric mean fold rise
Interval 1.8 to 2.6
|
1.8 geometric mean fold rise
Interval 1.4 to 2.3
|
2.5 geometric mean fold rise
Interval 1.9 to 3.2
|
1.8 geometric mean fold rise
Interval 1.4 to 2.2
|
2.3 geometric mean fold rise
Interval 2.0 to 2.7
|
1.7 geometric mean fold rise
Interval 1.4 to 2.1
|
1.6 geometric mean fold rise
Interval 1.3 to 1.9
|
2.2 geometric mean fold rise
Interval 1.8 to 2.6
|
2.2 geometric mean fold rise
Interval 1.8 to 2.7
|
2.2 geometric mean fold rise
Interval 1.8 to 2.6
|
—
|
SECONDARY outcome
Timeframe: Day 28 to Day 182Population: Per-Protocol Analysis Set Population
Hemagglutination-inhibition (HAI) antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza B/Washington (Victoria Subtype) calculated as (GMFRPost/Pre), defined as the within-group ratio of post-vaccination to pre-vaccination (Day 0) HAI GMTs within the same vaccine group on Days 56, 70, and other follow-up time points.
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
n=39 Participants
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as (GMFRPost/Pre)
Day 28
|
1.5 geometric mean fold rise
Interval 1.2 to 2.0
|
1.3 geometric mean fold rise
Interval 1.2 to 1.5
|
1.2 geometric mean fold rise
Interval 1.1 to 1.4
|
1.1 geometric mean fold rise
Interval 1.0 to 1.2
|
1.2 geometric mean fold rise
Interval 1.0 to 1.4
|
1.3 geometric mean fold rise
Interval 1.1 to 1.6
|
1.2 geometric mean fold rise
Interval 1.0 to 1.4
|
1.3 geometric mean fold rise
Interval 1.1 to 1.4
|
1.1 geometric mean fold rise
Interval 1.0 to 1.3
|
1.1 geometric mean fold rise
Interval 1.0 to 1.3
|
1.2 geometric mean fold rise
Interval 1.1 to 1.4
|
1.2 geometric mean fold rise
Interval 1.0 to 1.4
|
1.2 geometric mean fold rise
Interval 1.1 to 1.4
|
—
|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as (GMFRPost/Pre)
Day 56
|
1.4 geometric mean fold rise
Interval 1.1 to 1.8
|
1.2 geometric mean fold rise
Interval 1.1 to 1.4
|
1.2 geometric mean fold rise
Interval 1.1 to 1.4
|
1.0 geometric mean fold rise
Interval 0.9 to 1.1
|
1.2 geometric mean fold rise
Interval 1.0 to 1.4
|
1.1 geometric mean fold rise
Interval 1.0 to 1.3
|
1.1 geometric mean fold rise
Interval 0.9 to 1.2
|
1.2 geometric mean fold rise
Interval 1.1 to 1.3
|
1.1 geometric mean fold rise
Interval 1.0 to 1.2
|
1.1 geometric mean fold rise
Interval 1.0 to 1.2
|
1.1 geometric mean fold rise
Interval 1.0 to 1.3
|
1.1 geometric mean fold rise
Interval 0.9 to 1.3
|
1.2 geometric mean fold rise
Interval 1.1 to 1.3
|
—
|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as (GMFRPost/Pre)
Day 70
|
1.5 geometric mean fold rise
Interval 1.2 to 1.9
|
1.4 geometric mean fold rise
Interval 1.3 to 1.6
|
1.3 geometric mean fold rise
Interval 1.2 to 1.5
|
1.2 geometric mean fold rise
Interval 1.0 to 1.4
|
1.3 geometric mean fold rise
Interval 1.1 to 1.6
|
1.4 geometric mean fold rise
Interval 1.1 to 1.6
|
1.2 geometric mean fold rise
Interval 1.0 to 1.4
|
1.3 geometric mean fold rise
Interval 1.2 to 1.5
|
1.2 geometric mean fold rise
Interval 1.1 to 1.3
|
1.2 geometric mean fold rise
Interval 1.0 to 1.3
|
1.4 geometric mean fold rise
Interval 1.2 to 1.6
|
1.2 geometric mean fold rise
Interval 1.0 to 1.5
|
1.2 geometric mean fold rise
Interval 1.1 to 1.4
|
—
|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as (GMFRPost/Pre)
Day 84
|
1.0 geometric mean fold rise
Interval 0.8 to 1.3
|
0.9 geometric mean fold rise
Interval 0.8 to 1.0
|
0.9 geometric mean fold rise
Interval 0.8 to 1.0
|
0.8 geometric mean fold rise
Interval 0.7 to 0.9
|
0.8 geometric mean fold rise
Interval 0.7 to 1.0
|
0.9 geometric mean fold rise
Interval 0.8 to 1.1
|
0.7 geometric mean fold rise
Interval 0.6 to 0.9
|
0.9 geometric mean fold rise
Interval 0.8 to 1.1
|
0.8 geometric mean fold rise
Interval 0.6 to 0.9
|
0.7 geometric mean fold rise
Interval 0.6 to 0.9
|
0.9 geometric mean fold rise
Interval 0.7 to 1.0
|
0.9 geometric mean fold rise
Interval 0.7 to 1.1
|
0.8 geometric mean fold rise
Interval 0.7 to 1.0
|
—
|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as (GMFRPost/Pre)
Day 182
|
0.9 geometric mean fold rise
Interval 0.7 to 1.2
|
0.8 geometric mean fold rise
Interval 0.7 to 0.9
|
0.8 geometric mean fold rise
Interval 0.7 to 0.9
|
0.7 geometric mean fold rise
Interval 0.6 to 0.8
|
0.7 geometric mean fold rise
Interval 0.6 to 0.9
|
0.7 geometric mean fold rise
Interval 0.6 to 0.9
|
0.7 geometric mean fold rise
Interval 0.5 to 0.8
|
0.8 geometric mean fold rise
Interval 0.7 to 0.9
|
0.7 geometric mean fold rise
Interval 0.6 to 0.9
|
0.7 geometric mean fold rise
Interval 0.6 to 0.9
|
0.8 geometric mean fold rise
Interval 0.7 to 1.0
|
0.7 geometric mean fold rise
Interval 0.6 to 0.8
|
0.8 geometric mean fold rise
Interval 0.7 to 0.9
|
—
|
SECONDARY outcome
Timeframe: Day 28 to Day 182Population: Per-Protocol Analysis Set Population
Hemagglutination-Inhibition (HAI) Antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A/Brisbane (H1N1 Subtype) strain(s) calculated as SCR defined as the proportion of participants in a given treatment group with either a baseline reciprocal (Day 0) titer of \< 10 and a post-vaccination reciprocal titer ≥ 40, or a baseline reciprocal (Day 0) titer of ≥ 10 and a post-vaccination titer ≥ 4-fold higher than the baseline titer as measured on Days 56, 70, and other follow-up time points.
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
n=39 Participants
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Seroconversion Rate (SCR)
Day 28
|
15.4 percentage of participants
Interval 5.9 to 30.5
|
15.2 percentage of participants
Interval 8.1 to 25.0
|
10.0 percentage of participants
Interval 2.8 to 23.7
|
5.3 percentage of participants
Interval 0.6 to 17.7
|
2.7 percentage of participants
Interval 0.1 to 14.2
|
12.2 percentage of participants
Interval 4.1 to 26.2
|
5.0 percentage of participants
Interval 0.6 to 16.9
|
14.1 percentage of participants
Interval 7.3 to 23.8
|
5.1 percentage of participants
Interval 0.6 to 17.3
|
0 percentage of participants
Interval 0.0 to 9.0
|
12.8 percentage of participants
Interval 4.3 to 27.4
|
7.7 percentage of participants
Interval 1.6 to 20.9
|
4.9 percentage of participants
Interval 0.6 to 16.5
|
—
|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Seroconversion Rate (SCR)
Day 56
|
10.3 percentage of participants
Interval 2.9 to 24.2
|
12.8 percentage of participants
Interval 6.3 to 22.3
|
7.7 percentage of participants
Interval 1.6 to 20.9
|
8.3 percentage of participants
Interval 1.8 to 22.5
|
0 percentage of participants
Interval 0.0 to 9.7
|
5.0 percentage of participants
Interval 0.6 to 16.9
|
5.0 percentage of participants
Interval 0.6 to 16.9
|
10.1 percentage of participants
Interval 4.5 to 19.0
|
5.1 percentage of participants
Interval 0.6 to 17.3
|
0 percentage of participants
Interval 0.0 to 9.3
|
8.1 percentage of participants
Interval 1.7 to 21.9
|
5.3 percentage of participants
Interval 0.6 to 17.7
|
5.0 percentage of participants
Interval 0.6 to 16.9
|
—
|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Seroconversion Rate (SCR)
Day 70
|
10.5 percentage of participants
Interval 2.9 to 24.8
|
17.1 percentage of participants
Interval 9.4 to 27.5
|
15.4 percentage of participants
Interval 5.9 to 30.5
|
17.1 percentage of participants
Interval 6.6 to 33.6
|
11.1 percentage of participants
Interval 3.1 to 26.1
|
10.0 percentage of participants
Interval 2.8 to 23.7
|
7.5 percentage of participants
Interval 1.6 to 20.4
|
15.8 percentage of participants
Interval 8.4 to 26.0
|
10.5 percentage of participants
Interval 2.9 to 24.8
|
5.3 percentage of participants
Interval 0.6 to 17.7
|
13.9 percentage of participants
Interval 4.7 to 29.5
|
13.5 percentage of participants
Interval 4.5 to 28.8
|
17.1 percentage of participants
Interval 7.2 to 32.1
|
—
|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Seroconversion Rate (SCR)
Day 84
|
7.9 percentage of participants
Interval 1.7 to 21.4
|
14.5 percentage of participants
Interval 7.5 to 24.4
|
20.5 percentage of participants
Interval 9.3 to 36.5
|
11.8 percentage of participants
Interval 3.3 to 27.5
|
0 percentage of participants
Interval 0.0 to 10.0
|
7.7 percentage of participants
Interval 1.6 to 20.9
|
2.6 percentage of participants
Interval 0.1 to 13.8
|
14.5 percentage of participants
Interval 7.5 to 24.4
|
2.6 percentage of participants
Interval 0.1 to 13.8
|
5.3 percentage of participants
Interval 0.6 to 17.7
|
5.9 percentage of participants
Interval 0.7 to 19.7
|
10.8 percentage of participants
Interval 3.0 to 25.4
|
7.3 percentage of participants
Interval 1.5 to 19.9
|
—
|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as Seroconversion Rate (SCR)
Day 182
|
2.6 percentage of participants
Interval 0.1 to 13.8
|
10.8 percentage of participants
Interval 0.1 to 13.8
|
10.3 percentage of participants
Interval 2.9 to 24.2
|
2.9 percentage of participants
Interval 0.1 to 15.3
|
0 percentage of participants
Interval 0.0 to 10.0
|
2.6 percentage of participants
Interval 0.1 to 13.5
|
0 percentage of participants
Interval 0.0 to 9.3
|
6.7 percentage of participants
Interval 2.2 to 14.9
|
2.7 percentage of participants
Interval 0.1 to 14.2
|
0 percentage of participants
Interval 0.0 to 9.5
|
0 percentage of participants
Interval 0.0 to 9.7
|
5.3 percentage of participants
Interval 0.6 to 17.7
|
2.6 percentage of participants
Interval 0.1 to 13.5
|
—
|
SECONDARY outcome
Timeframe: Day 28 to Day 182Population: Per-Protocol Analysis Set Population
Hemagglutination-Inhibition (HAI) Antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A/Kansas (H3N2 Subtype) strain(s) calculated as SCR defined as the proportion of participants in a given treatment group with either a baseline reciprocal (Day 0) titer of \< 10 and a post-vaccination reciprocal titer ≥ 40, or a baseline reciprocal (Day 0) titer of ≥ 10 and a post-vaccination titer ≥ 4-fold higher than the baseline titer as measured on Days 56, 70, and other follow-up time points.
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
n=39 Participants
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR
Day 182
|
34.2 percentage of participants
Interval 19.6 to 51.4
|
39.2 percentage of participants
Interval 28.0 to 51.2
|
33.3 percentage of participants
Interval 19.1 to 50.2
|
41.2 percentage of participants
Interval 24.6 to 59.3
|
20.0 percentage of participants
Interval 8.4 to 36.9
|
38.5 percentage of participants
Interval 23.4 to 55.4
|
28.9 percentage of participants
Interval 15.4 to 45.9
|
46.7 percentage of participants
Interval 35.1 to 58.7
|
21.6 percentage of participants
Interval 9.8 to 38.2
|
21.6 percentage of participants
Interval 9.8 to 38.2
|
38.9 percentage of participants
Interval 23.1 to 56.5
|
28.9 percentage of participants
Interval 15.4 to 45.9
|
43.6 percentage of participants
Interval 27.8 to 60.4
|
—
|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR
Day 28
|
69.2 percentage of participants
Interval 52.4 to 83.0
|
63.3 percentage of participants
Interval 51.7 to 73.9
|
45.0 percentage of participants
Interval 29.3 to 61.5
|
42.1 percentage of participants
Interval 26.3 to 59.2
|
37.8 percentage of participants
Interval 22.5 to 55.2
|
51.2 percentage of participants
Interval 35.1 to 67.1
|
37.5 percentage of participants
Interval 22.7 to 54.2
|
56.4 percentage of participants
Interval 44.7 to 67.6
|
33.3 percentage of participants
Interval 19.1 to 50.2
|
28.2 percentage of participants
Interval 15.0 to 44.9
|
51.3 percentage of participants
Interval 34.8 to 67.6
|
61.5 percentage of participants
Interval 44.6 to 76.6
|
51.2 percentage of participants
Interval 35.1 to 67.1
|
—
|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR
Day 56
|
61.5 percentage of participants
Interval 44.6 to 76.6
|
60.3 percentage of participants
Interval 48.5 to 71.2
|
38.5 percentage of participants
Interval 23.4 to 55.4
|
41.7 percentage of participants
Interval 25.5 to 59.2
|
27.8 percentage of participants
Interval 14.2 to 45.2
|
37.5 percentage of participants
Interval 22.7 to 54.2
|
30.0 percentage of participants
Interval 16.6 to 46.5
|
51.9 percentage of participants
Interval 40.4 to 63.3
|
25.6 percentage of participants
Interval 13.0 to 42.1
|
26.3 percentage of participants
Interval 13.4 to 43.1
|
45.9 percentage of participants
Interval 29.5 to 63.1
|
44.7 percentage of participants
Interval 28.6 to 61.7
|
45.0 percentage of participants
Interval 29.3 to 61.5
|
—
|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR
Day 70
|
57.9 percentage of participants
Interval 40.8 to 73.7
|
71.1 percentage of participants
Interval 59.5 to 80.9
|
53.8 percentage of participants
Interval 37.2 to 69.9
|
54.3 percentage of participants
Interval 36.6 to 71.2
|
61.1 percentage of participants
Interval 43.5 to 76.9
|
67.5 percentage of participants
Interval 50.9 to 81.4
|
47.5 percentage of participants
Interval 31.5 to 63.9
|
65.8 percentage of participants
Interval 54.0 to 76.3
|
52.6 percentage of participants
Interval 35.8 to 69.0
|
39.5 percentage of participants
Interval 24.0 to 56.6
|
55.6 percentage of participants
Interval 38.1 to 72.1
|
64.9 percentage of participants
Interval 47.5 to 79.8
|
56.1 percentage of participants
Interval 39.7 to 71.5
|
—
|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR
Day 84
|
52.6 percentage of participants
Interval 35.8 to 69.0
|
67.5 percentage of participants
Interval 55.9 to 77.8
|
46.2 percentage of participants
Interval 30.1 to 62.8
|
52.9 percentage of participants
Interval 35.1 to 70.2
|
42.9 percentage of participants
Interval 26.3 to 60.6
|
53.8 percentage of participants
Interval 37.2 to 69.9
|
42.1 percentage of participants
Interval 26.3 to 59.2
|
65.8 percentage of participants
Interval 54.0 to 76.3
|
39.5 percentage of participants
Interval 24.0 to 56.6
|
36.8 percentage of participants
Interval 21.8 to 54.0
|
58.8 percentage of participants
Interval 40.7 to 75.4
|
54.1 percentage of participants
Interval 36.9 to 70.5
|
51.2 percentage of participants
Interval 35.1 to 67.1
|
—
|
SECONDARY outcome
Timeframe: Day 28 to Day 182Population: Per-Protocol Analysis Set Population
Hemagglutination-Inhibition (HAI) Antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A/Wisconsin (H1N1 Subtype) strain(s) calculated as SCR defined as the proportion of participants in a given treatment group with either a baseline reciprocal (Day 0) titer of \< 10 and a post-vaccination reciprocal titer ≥ 40, or a baseline reciprocal (Day 0) titer of ≥ 10 and a post-vaccination titer ≥ 4-fold higher than the baseline titer as measured on Days 56, 70, and other follow-up time points.
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
n=39 Participants
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR
Day 28
|
5.1 percentage of participants
Interval 0.6 to 17.3
|
10.1 percentage of participants
Interval 4.5 to 19.0
|
5.0 percentage of participants
Interval 0.6 to 16.9
|
2.6 percentage of participants
Interval 0.1 to 13.8
|
0 percentage of participants
Interval 0.0 to 9.5
|
4.9 percentage of participants
Interval 0.6 to 16.5
|
2.6 percentage of participants
Interval 0.1 to 13.5
|
9.0 percentage of participants
Interval 3.7 to 17.6
|
2.6 percentage of participants
Interval 0.1 to 13.5
|
0 percentage of participants
Interval 0.0 to 9.0
|
5.1 percentage of participants
Interval 0.6 to 17.3
|
2.6 percentage of participants
Interval 0.1 to 13.5
|
2.4 percentage of participants
Interval 0.1 to 12.9
|
—
|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR
Day 56
|
5.1 percentage of participants
Interval 0.6 to 17.3
|
6.4 percentage of participants
Interval 2.1 to 14.3
|
5.1 percentage of participants
Interval 0.6 to 17.3
|
0 percentage of participants
Interval 0.0 to 9.7
|
0 percentage of participants
Interval 0.0 to 9.7
|
2.5 percentage of participants
Interval 0.1 to 13.2
|
0 percentage of participants
Interval 0.0 to 8.8
|
5.1 percentage of participants
Interval 1.4 to 12.5
|
2.6 percentage of participants
Interval 0.1 to 13.5
|
0 percentage of participants
Interval 0.0 to 9.3
|
2.7 percentage of participants
Interval 0.1 to 14.2
|
2.6 percentage of participants
Interval 0.1 to 13.8
|
0 percentage of participants
Interval 0.0 to 8.8
|
—
|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR
Day 70
|
5.3 percentage of participants
Interval 0.6 to 17.7
|
9.2 percentage of participants
Interval 3.8 to 18.1
|
7.7 percentage of participants
Interval 1.6 to 20.9
|
0 percentage of participants
Interval 0.0 to 10.0
|
0 percentage of participants
Interval 0.0 to 9.7
|
7.5 percentage of participants
Interval 1.6 to 20.4
|
0 percentage of participants
Interval 0.0 to 8.8
|
6.6 percentage of participants
Interval 2.2 to 14.7
|
5.3 percentage of participants
Interval 0.6 to 17.7
|
0 percentage of participants
Interval 0.0 to 9.3
|
5.6 percentage of participants
Interval 0.7 to 18.7
|
2.7 percentage of participants
Interval 0.1 to 14.2
|
2.4 percentage of participants
Interval 0.1 to 12.9
|
—
|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR
Day 84
|
2.6 percentage of participants
Interval 0.1 to 13.8
|
3.9 percentage of participants
Interval 0.8 to 11.0
|
5.1 percentage of participants
Interval 0.6 to 17.3
|
0 percentage of participants
Interval 0.0 to 10.3
|
0 percentage of participants
Interval 0.0 to 10.0
|
2.6 percentage of participants
Interval 0.1 to 13.5
|
2.6 percentage of participants
Interval 0.1 to 13.8
|
2.6 percentage of participants
Interval 0.3 to 9.2
|
2.6 percentage of participants
Interval 0.1 to 13.8
|
0 percentage of participants
Interval 0.0 to 9.3
|
2.9 percentage of participants
Interval 0.1 to 15.3
|
0 percentage of participants
Interval 0.0 to 9.5
|
0 percentage of participants
Interval 0.0 to 8.6
|
—
|
|
Hemagglutination-Inhibition (HAI) Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR
Day 182
|
2.6 percentage of participants
Interval 0.1 to 13.8
|
2.7 percentage of participants
Interval 0.3 to 9.4
|
2.6 percentage of participants
Interval 0.1 to 13.5
|
0 percentage of participants
Interval 0.0 to 10.3
|
0 percentage of participants
Interval 0.0 to 10.0
|
2.6 percentage of participants
Interval 0.1 to 13.5
|
2.6 percentage of participants
Interval 0.1 to 13.8
|
2.7 percentage of participants
Interval 0.3 to 9.3
|
0 percentage of participants
Interval 0.0 to 9.5
|
0 percentage of participants
Interval 0.0 to 9.5
|
2.8 percentage of participants
Interval 0.1 to 14.5
|
0 percentage of participants
Interval 0.0 to 9.3
|
0 percentage of participants
Interval 0.0 to 9.0
|
—
|
SECONDARY outcome
Timeframe: Day 28 to Day 182Population: Per-Protocol Analysis Set Population
HAI antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A/Cambodia (H3N2 Subtype) strain(s) calculated as SCR defined as the proportion of participants in a given treatment group with either a baseline reciprocal (Day 0) titer of \< 10 and a post-vaccination reciprocal titer ≥ 40, or a baseline reciprocal (Day 0) titer of ≥ 10 and a post-vaccination titer ≥ 4-fold higher than the baseline titer as measured on Days 56, 70, and other follow-up time points.
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
n=39 Participants
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR
Day 28
|
30.8 percentage of participants
Interval 17.0 to 47.6
|
30.4 percentage of participants
Interval 20.5 to 41.8
|
22.5 percentage of participants
Interval 10.8 to 38.5
|
23.7 percentage of participants
Interval 11.4 to 40.2
|
13.5 percentage of participants
Interval 4.5 to 28.8
|
26.8 percentage of participants
Interval 14.2 to 42.9
|
20.0 percentage of participants
Interval 9.1 to 35.6
|
28.2 percentage of participants
Interval 18.6 to 39.5
|
12.8 percentage of participants
Interval 4.3 to 27.4
|
15.4 percentage of participants
Interval 5.9 to 30.5
|
41.0 percentage of participants
Interval 25.6 to 57.9
|
30.8 percentage of participants
Interval 17.0 to 47.6
|
19.5 percentage of participants
Interval 8.8 to 34.9
|
—
|
|
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR
Day 56
|
23.1 percentage of participants
Interval 11.1 to 39.3
|
23.1 percentage of participants
Interval 14.3 to 34.0
|
17.9 percentage of participants
Interval 7.5 to 33.5
|
19.4 percentage of participants
Interval 8.2 to 36.0
|
11.1 percentage of participants
Interval 3.1 to 26.1
|
15.0 percentage of participants
Interval 5.7 to 29.8
|
12.5 percentage of participants
Interval 4.2 to 26.8
|
20.3 percentage of participants
Interval 12.0 to 30.8
|
10.3 percentage of participants
Interval 2.9 to 24.2
|
13.2 percentage of participants
Interval 4.4 to 28.1
|
35.1 percentage of participants
Interval 20.2 to 52.5
|
26.3 percentage of participants
Interval 13.4 to 43.1
|
15.0 percentage of participants
Interval 5.7 to 29.8
|
—
|
|
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR
Day 70
|
21.1 percentage of participants
Interval 9.6 to 37.3
|
27.6 percentage of participants
Interval 18.0 to 39.1
|
30.8 percentage of participants
Interval 17.0 to 47.6
|
25.7 percentage of participants
Interval 12.5 to 43.3
|
13.9 percentage of participants
Interval 4.7 to 29.5
|
25.0 percentage of participants
Interval 12.7 to 41.2
|
22.5 percentage of participants
Interval 10.8 to 38.5
|
28.9 percentage of participants
Interval 19.1 to 40.5
|
18.4 percentage of participants
Interval 7.7 to 34.3
|
15.8 percentage of participants
Interval 6.0 to 31.3
|
36.1 percentage of participants
Interval 20.8 to 53.8
|
27.0 percentage of participants
Interval 13.8 to 44.1
|
17.1 percentage of participants
Interval 7.2 to 32.1
|
—
|
|
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR
Day 84
|
10.5 percentage of participants
Interval 2.9 to 24.8
|
14.3 percentage of participants
Interval 7.4 to 24.1
|
15.4 percentage of participants
Interval 5.9 to 30.5
|
8.8 percentage of participants
Interval 1.9 to 23.7
|
5.7 percentage of participants
Interval 0.7 to 19.2
|
12.8 percentage of participants
Interval 4.3 to 27.4
|
13.2 percentage of participants
Interval 4.4 to 28.1
|
15.8 percentage of participants
Interval 8.4 to 26.0
|
13.2 percentage of participants
Interval 4.4 to 28.1
|
10.5 percentage of participants
Interval 2.9 to 24.8
|
23.5 percentage of participants
Interval 10.7 to 41.2
|
13.5 percentage of participants
Interval 4.5 to 28.8
|
12.2 percentage of participants
Interval 4.1 to 26.2
|
—
|
|
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR
Day 182
|
7.9 percentage of participants
Interval 1.7 to 21.4
|
10.8 percentage of participants
Interval 4.8 to 20.2
|
17.9 percentage of participants
Interval 7.5 to 33.5
|
8.8 percentage of participants
Interval 1.9 to 23.7
|
5.7 percentage of participants
Interval 0.7 to 19.2
|
5.1 percentage of participants
Interval 0.6 to 17.3
|
10.5 percentage of participants
Interval 2.9 to 24.8
|
9.3 percentage of participants
Interval 3.8 to 18.3
|
5.4 percentage of participants
Interval 0.7 to 18.2
|
8.1 percentage of participants
Interval 1.7 to 21.9
|
11.1 percentage of participants
Interval 3.1 to 26.1
|
5.3 percentage of participants
Interval 0.6 to 17.7
|
5.1 percentage of participants
Interval 0.6 to 17.3
|
—
|
SECONDARY outcome
Timeframe: Day 28 to Day 182Population: Per-Protocol Analysis Set Population
HAI antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A/Hong Kong (H3N2 Subtype)strain(s) calculated as SCR defined as the proportion of participants in a given treatment group with either a baseline reciprocal (Day 0) titer of \< 10 and a post-vaccination reciprocal titer ≥ 40, or a baseline reciprocal (Day 0) titer of ≥ 10 and a post-vaccination titer ≥ 4-fold higher than the baseline titer as measured on Days 56, 70, and other follow-up time points.
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
n=39 Participants
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR
Day 84
|
13.2 percentage of participants
Interval 4.4 to 28.1
|
11.7 percentage of participants
Interval 5.5 to 21.0
|
15.4 percentage of participants
Interval 5.9 to 30.5
|
11.8 percentage of participants
Interval 3.3 to 27.5
|
5.7 percentage of participants
Interval 0.7 to 19.2
|
10.3 percentage of participants
Interval 2.9 to 24.2
|
5.3 percentage of participants
Interval 0.6 to 17.7
|
15.8 percentage of participants
Interval 8.4 to 26.0
|
5.3 percentage of participants
Interval 0.6 to 17.7
|
10.5 percentage of participants
Interval 2.9 to 24.8
|
20.6 percentage of participants
Interval 8.7 to 37.9
|
13.5 percentage of participants
Interval 4.5 to 28.8
|
9.8 percentage of participants
Interval 2.7 to 23.1
|
—
|
|
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR
Day 182
|
10.5 percentage of participants
Interval 2.9 to 24.8
|
6.8 percentage of participants
Interval 2.2 to 15.1
|
12.8 percentage of participants
Interval 4.3 to 27.4
|
5.9 percentage of participants
Interval 0.7 to 19.7
|
5.7 percentage of participants
Interval 0.7 to 19.2
|
5.1 percentage of participants
Interval 0.6 to 17.3
|
5.3 percentage of participants
Interval 0.6 to 17.7
|
9.3 percentage of participants
Interval 3.8 to 18.3
|
0 percentage of participants
Interval 0.0 to 9.5
|
0 percentage of participants
Interval 0.0 to 9.5
|
8.3 percentage of participants
Interval 1.8 to 22.5
|
2.6 percentage of participants
Interval 0.1 to 13.8
|
7.7 percentage of participants
Interval 1.6 to 20.9
|
—
|
|
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR
Day 28
|
20.5 percentage of participants
Interval 9.3 to 36.5
|
21.5 percentage of participants
Interval 13.1 to 32.2
|
22.5 percentage of participants
Interval 10.8 to 38.5
|
13.2 percentage of participants
Interval 4.4 to 28.1
|
10.8 percentage of participants
Interval 3.0 to 25.4
|
17.1 percentage of participants
Interval 7.2 to 32.1
|
5.0 percentage of participants
Interval 0.6 to 16.9
|
25.6 percentage of participants
Interval 16.4 to 36.8
|
7.7 percentage of participants
Interval 1.6 to 20.9
|
17.9 percentage of participants
Interval 7.5 to 33.5
|
28.2 percentage of participants
Interval 15.0 to 44.9
|
25.6 percentage of participants
Interval 13.0 to 42.1
|
17.1 percentage of participants
Interval 7.2 to 32.1
|
—
|
|
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR
Day 56
|
15.4 percentage of participants
Interval 5.9 to 30.5
|
19.2 percentage of participants
Interval 11.2 to 29.7
|
20.5 percentage of participants
Interval 9.3 to 36.5
|
13.9 percentage of participants
Interval 4.7 to 29.5
|
8.3 percentage of participants
Interval 1.8 to 22.5
|
10.0 percentage of participants
Interval 2.8 to 23.7
|
7.5 percentage of participants
Interval 1.6 to 20.4
|
19.0 percentage of participants
Interval 11.0 to 29.4
|
7.7 percentage of participants
Interval 1.6 to 20.9
|
10.5 percentage of participants
Interval 2.9 to 24.8
|
18.9 percentage of participants
Interval 8.0 to 35.2
|
10.5 percentage of participants
Interval 2.9 to 24.8
|
12.5 percentage of participants
Interval 4.2 to 26.8
|
—
|
|
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR
Day 70
|
13.2 percentage of participants
Interval 4.4 to 28.1
|
25.0 percentage of participants
Interval 15.8 to 36.3
|
23.1 percentage of participants
Interval 11.1 to 39.3
|
17.1 percentage of participants
Interval 6.6 to 33.6
|
11.1 percentage of participants
Interval 3.1 to 26.1
|
12.5 percentage of participants
Interval 4.2 to 26.8
|
12.5 percentage of participants
Interval 4.2 to 26.8
|
21.1 percentage of participants
Interval 12.5 to 31.9
|
13.2 percentage of participants
Interval 4.4 to 28.1
|
18.4 percentage of participants
Interval 7.7 to 34.3
|
27.8 percentage of participants
Interval 14.2 to 45.2
|
18.9 percentage of participants
Interval 8.0 to 35.2
|
12.2 percentage of participants
Interval 4.1 to 26.2
|
—
|
SECONDARY outcome
Timeframe: Day 28 to Day 182Population: Per-Protocol Analysis Set Population
HAI antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza B/Maryland (Victoria Subtype) strain(s) calculated as SCR defined as the proportion of participants in a given treatment group with either a baseline reciprocal (Day 0) titer of \< 10 and a post-vaccination reciprocal titer ≥ 40, or a baseline reciprocal (Day 0) titer of ≥ 10 and a post-vaccination titer ≥ 4-fold higher than the baseline titer as measured on Days 56, 70, and other follow-up time points.
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
n=39 Participants
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR
Day 28
|
20.5 percentage of participants
Interval 9.3 to 36.5
|
11.4 percentage of participants
Interval 5.3 to 20.5
|
17.5 percentage of participants
Interval 7.3 to 32.8
|
5.3 percentage of participants
Interval 0.6 to 17.7
|
5.4 percentage of participants
Interval 0.7 to 18.2
|
4.9 percentage of participants
Interval 0.6 to 16.5
|
5.0 percentage of participants
Interval 0.6 to 16.9
|
14.1 percentage of participants
Interval 7.3 to 23.8
|
0 percentage of participants
Interval 0.0 to 9.0
|
5.1 percentage of participants
Interval 0.6 to 17.3
|
10.3 percentage of participants
Interval 2.9 to 24.2
|
7.7 percentage of participants
Interval 1.6 to 20.9
|
4.9 percentage of participants
Interval 0.6 to 16.5
|
—
|
|
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR
Day 56
|
15.4 percentage of participants
Interval 5.9 to 30.5
|
12.8 percentage of participants
Interval 6.3 to 22.3
|
7.7 percentage of participants
Interval 1.6 to 20.9
|
0 percentage of participants
Interval 0.0 to 9.7
|
2.8 percentage of participants
Interval 0.1 to 14.5
|
2.5 percentage of participants
Interval 0.1 to 13.2
|
5.0 percentage of participants
Interval 0.6 to 16.9
|
10.1 percentage of participants
Interval 4.5 to 19.0
|
0 percentage of participants
Interval 0.0 to 9.0
|
2.6 percentage of participants
Interval 0.1 to 13.8
|
5.4 percentage of participants
Interval 0.7 to 18.2
|
5.3 percentage of participants
Interval 0.6 to 17.7
|
0 percentage of participants
Interval 0.0 to 8.8
|
—
|
|
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR
Day 70
|
10.5 percentage of participants
Interval 2.9 to 24.8
|
15.8 percentage of participants
Interval 8.4 to 26.0
|
12.8 percentage of participants
Interval 4.3 to 27.4
|
2.9 percentage of participants
Interval 0.1 to 14.9
|
8.3 percentage of participants
Interval 1.8 to 22.5
|
10.0 percentage of participants
Interval 2.8 to 23.7
|
7.5 percentage of participants
Interval 1.6 to 20.4
|
14.5 percentage of participants
Interval 7.5 to 24.4
|
2.6 percentage of participants
Interval 0.1 to 13.8
|
7.9 percentage of participants
Interval 1.7 to 21.4
|
8.3 percentage of participants
Interval 1.8 to 22.5
|
5.4 percentage of participants
Interval 0.7 to 18.2
|
7.3 percentage of participants
Interval 1.5 to 19.9
|
—
|
|
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR
Day 84
|
13.2 percentage of participants
Interval 4.4 to 28.1
|
22.1 percentage of participants
Interval 13.4 to 33.0
|
12.8 percentage of participants
Interval 4.3 to 27.4
|
11.8 percentage of participants
Interval 3.3 to 27.5
|
8.6 percentage of participants
Interval 1.8 to 23.1
|
17.9 percentage of participants
Interval 7.5 to 33.5
|
7.9 percentage of participants
Interval 1.7 to 21.4
|
19.7 percentage of participants
Interval 11.5 to 30.5
|
2.6 percentage of participants
Interval 0.1 to 13.8
|
10.5 percentage of participants
Interval 2.9 to 24.8
|
11.8 percentage of participants
Interval 3.3 to 27.5
|
8.1 percentage of participants
Interval 1.7 to 21.9
|
4.9 percentage of participants
Interval 0.6 to 16.5
|
—
|
|
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR
Day 182
|
13.2 percentage of participants
Interval 4.4 to 28.1
|
16.2 percentage of participants
Interval 8.7 to 26.6
|
10.3 percentage of participants
Interval 2.9 to 24.2
|
5.9 percentage of participants
Interval 0.7 to 19.7
|
8.6 percentage of participants
Interval 1.8 to 23.1
|
7.7 percentage of participants
Interval 1.6 to 20.9
|
2.6 percentage of participants
Interval 0.1 to 13.8
|
16.0 percentage of participants
Interval 8.6 to 26.3
|
0 percentage of participants
Interval 0.0 to 9.5
|
5.4 percentage of participants
Interval 0.7 to 18.2
|
0 percentage of participants
Interval 0.0 to 9.7
|
2.6 percentage of participants
Interval 0.1 to 13.8
|
2.6 percentage of participants
Interval 0.1 to 13.5
|
—
|
SECONDARY outcome
Timeframe: Day 28 to Day 182Population: Per-Protocol Analysis Set Population
HAI antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza B/Phuket (Yamagata Subtype) strain(s) calculated as SCR defined as the proportion of participants in a given treatment group with either a baseline reciprocal (Day 0) titer of \< 10 and a post-vaccination reciprocal titer ≥ 40, or a baseline reciprocal (Day 0) titer of ≥ 10 and a post-vaccination titer ≥ 4-fold higher than the baseline titer as measured on Days 56, 70, and other follow-up time points.
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
n=39 Participants
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR
Day 28
|
43.6 percentage of participants
Interval 27.8 to 60.4
|
20.3 percentage of participants
Interval 12.0 to 30.8
|
22.5 percentage of participants
Interval 10.8 to 38.5
|
2.6 percentage of participants
Interval 0.1 to 13.8
|
5.4 percentage of participants
Interval 0.7 to 18.2
|
22.0 percentage of participants
Interval 10.6 to 37.6
|
10.0 percentage of participants
Interval 2.8 to 23.7
|
17.9 percentage of participants
Interval 10.2 to 28.3
|
10.3 percentage of participants
Interval 2.9 to 24.2
|
10.3 percentage of participants
Interval 2.9 to 24.2
|
12.8 percentage of participants
Interval 4.3 to 27.4
|
15.4 percentage of participants
Interval 5.9 to 30.5
|
22.0 percentage of participants
Interval 10.6 to 37.6
|
—
|
|
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR
Day 56
|
38.5 percentage of participants
Interval 23.4 to 55.4
|
16.7 percentage of participants
Interval 9.2 to 26.8
|
15.4 percentage of participants
Interval 5.9 to 30.5
|
5.6 percentage of participants
Interval 0.7 to 18.7
|
5.6 percentage of participants
Interval 0.7 to 18.7
|
10.0 percentage of participants
Interval 2.8 to 23.7
|
7.5 percentage of participants
Interval 1.6 to 20.4
|
11.4 percentage of participants
Interval 5.3 to 20.5
|
7.7 percentage of participants
Interval 1.6 to 20.9
|
2.6 percentage of participants
Interval 0.1 to 13.8
|
8.1 percentage of participants
Interval 1.7 to 21.9
|
10.5 percentage of participants
Interval 2.9 to 24.8
|
17.5 percentage of participants
Interval 7.3 to 32.8
|
—
|
|
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR
Day 70
|
34.2 percentage of participants
Interval 19.6 to 51.4
|
25.0 percentage of participants
Interval 15.8 to 36.3
|
25.6 percentage of participants
Interval 13.0 to 42.1
|
17.1 percentage of participants
Interval 6.6 to 33.6
|
11.1 percentage of participants
Interval 3.1 to 26.1
|
37.5 percentage of participants
Interval 22.7 to 54.2
|
10.0 percentage of participants
Interval 2.8 to 23.7
|
21.1 percentage of participants
Interval 12.5 to 31.9
|
7.9 percentage of participants
Interval 1.7 to 21.4
|
7.9 percentage of participants
Interval 1.7 to 21.4
|
22.2 percentage of participants
Interval 10.1 to 39.2
|
13.5 percentage of participants
Interval 4.5 to 28.8
|
24.4 percentage of participants
Interval 12.4 to 40.3
|
—
|
|
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR
Day 84
|
42.1 percentage of participants
Interval 26.3 to 59.2
|
29.9 percentage of participants
Interval 20.0 to 41.4
|
30.8 percentage of participants
Interval 17.0 to 47.6
|
17.6 percentage of participants
Interval 6.8 to 34.5
|
20.0 percentage of participants
Interval 8.4 to 36.9
|
33.3 percentage of participants
Interval 19.1 to 50.2
|
13.2 percentage of participants
Interval 4.4 to 28.1
|
34.2 percentage of participants
Interval 23.7 to 46.0
|
18.4 percentage of participants
Interval 7.7 to 34.3
|
7.9 percentage of participants
Interval 1.7 to 21.4
|
26.5 percentage of participants
Interval 12.9 to 44.4
|
27.0 percentage of participants
Interval 13.8 to 44.1
|
22.0 percentage of participants
Interval 10.6 to 37.6
|
—
|
|
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR
Day 182
|
21.1 percentage of participants
Interval 9.6 to 37.3
|
20.3 percentage of participants
Interval 11.8 to 31.2
|
17.9 percentage of participants
Interval 7.5 to 33.5
|
11.8 percentage of participants
Interval 3.3 to 27.5
|
11.4 percentage of participants
Interval 3.2 to 26.7
|
17.9 percentage of participants
Interval 7.5 to 33.5
|
10.5 percentage of participants
Interval 2.9 to 24.8
|
18.7 percentage of participants
Interval 10.6 to 29.3
|
16.2 percentage of participants
Interval 6.2 to 32.0
|
5.4 percentage of participants
Interval 0.7 to 18.2
|
11.1 percentage of participants
Interval 3.1 to 26.1
|
7.9 percentage of participants
Interval 1.7 to 21.4
|
12.8 percentage of participants
Interval 4.3 to 27.4
|
—
|
SECONDARY outcome
Timeframe: Day 28 to Day 182Population: Per-Protocol Analysis Set Population
HAI antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza B/Washington (Victoria Subtype) calculated as SCR defined as the proportion of participants in a given treatment group with either a baseline reciprocal (Day 0) titer of \< 10 and a post-vaccination reciprocal titer ≥ 40, or a baseline reciprocal (Day 0) titer of ≥ 10 and a post-vaccination titer ≥ 4-fold higher than the baseline titer as measured on Days 56, 70, and other follow-up time points.
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
n=39 Participants
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR
Day 84
|
7.9 percentage of participants
Interval 1.7 to 21.4
|
1.3 percentage of participants
Interval 0.0 to 7.0
|
0 percentage of participants
Interval 0.0 to 9.0
|
0 percentage of participants
Interval 0.0 to 10.3
|
2.9 percentage of participants
Interval 0.1 to 14.9
|
2.6 percentage of participants
Interval 0.1 to 13.5
|
0 percentage of participants
Interval 0.0 to 9.3
|
1.3 percentage of participants
Interval 0.0 to 7.1
|
0 percentage of participants
Interval 0.0 to 9.3
|
2.6 percentage of participants
Interval 0.1 to 13.8
|
0 percentage of participants
Interval 0.0 to 10.3
|
2.7 percentage of participants
Interval 0.1 to 14.2
|
0 percentage of participants
Interval 0.0 to 8.6
|
—
|
|
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR
Day 182
|
5.3 percentage of participants
Interval 0.6 to 17.7
|
2.7 percentage of participants
Interval 0.3 to 9.4
|
0 percentage of participants
Interval 0.0 to 9.0
|
0 percentage of participants
Interval 0.0 to 10.3
|
2.9 percentage of participants
Interval 0.1 to 14.9
|
2.6 percentage of participants
Interval 0.1 to 13.5
|
0 percentage of participants
Interval 0.0 to 9.3
|
0 percentage of participants
Interval 0.0 to 4.8
|
0 percentage of participants
Interval 0.0 to 9.5
|
2.7 percentage of participants
Interval 0.1 to 14.2
|
0 percentage of participants
Interval 0.0 to 9.7
|
2.6 percentage of participants
Interval 0.1 to 13.8
|
0 percentage of participants
Interval 0.0 to 9.0
|
—
|
|
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR
Day 28
|
15.4 percentage of participants
Interval 5.9 to 30.5
|
5.1 percentage of participants
Interval 1.4 to 12.5
|
0 percentage of participants
Interval 0.0 to 8.8
|
0 percentage of participants
Interval 0.0 to 9.3
|
2.7 percentage of participants
Interval 0.1 to 14.2
|
4.9 percentage of participants
Interval 0.6 to 16.5
|
5.0 percentage of participants
Interval 0.6 to 16.9
|
6.4 percentage of participants
Interval 2.1 to 14.3
|
2.6 percentage of participants
Interval 0.1 to 13.5
|
2.6 percentage of participants
Interval 0.1 to 13.5
|
2.6 percentage of participants
Interval 0.1 to 13.5
|
7.7 percentage of participants
Interval 1.6 to 20.9
|
4.9 percentage of participants
Interval 0.6 to 16.5
|
—
|
|
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR
Day 56
|
15.4 percentage of participants
Interval 5.9 to 30.5
|
6.4 percentage of participants
Interval 2.1 to 14.3
|
0 percentage of participants
Interval 0.0 to 9.0
|
0 percentage of participants
Interval 0.0 to 9.7
|
2.8 percentage of participants
Interval 0.1 to 14.5
|
2.5 percentage of participants
Interval 0.1 to 13.2
|
2.5 percentage of participants
Interval 0.1 to 13.2
|
3.8 percentage of participants
Interval 0.8 to 10.7
|
0 percentage of participants
Interval 0.0 to 9.0
|
2.6 percentage of participants
Interval 0.1 to 13.8
|
3.8 percentage of participants
Interval 0.1 to 14.2
|
2.6 percentage of participants
Interval 0.1 to 13.8
|
0 percentage of participants
Interval 0.0 to 8.8
|
—
|
|
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR
Day 70
|
13.2 percentage of participants
Interval 4.4 to 28.1
|
6.6 percentage of participants
Interval 2.2 to 14.7
|
0 percentage of participants
Interval 0.0 to 9.0
|
0 percentage of participants
Interval 0.0 to 10.0
|
2.8 percentage of participants
Interval 0.1 to 14.5
|
7.5 percentage of participants
Interval 1.6 to 20.4
|
5.0 percentage of participants
Interval 0.6 to 16.9
|
5.3 percentage of participants
Interval 1.5 to 12.9
|
0 percentage of participants
Interval 0.0 to 9.3
|
0 percentage of participants
Interval 0.0 to 9.3
|
2.8 percentage of participants
Interval 0.1 to 14.5
|
8.1 percentage of participants
Interval 1.7 to 21.9
|
0 percentage of participants
Interval 0.0 to 8.6
|
—
|
SECONDARY outcome
Timeframe: Day 28 to Day 182Population: Per-Protocol Analysis Set Population
GMT ratio (GMTR) between select treatment arms at Days 28,56, 70, and other follow-up time points post-vaccination (adjusted for intergroup variation in baseline \[pre-vaccination\] titers)
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Titer Ratio (GMTR)
Day 28 (Comparison to qNIV Reference [Group O] Day 28)
|
—
|
1.04 Geometric mean titer ratio
Interval 0.81 to 1.34
|
0.77 Geometric mean titer ratio
Interval 0.55 to 1.07
|
0.73 Geometric mean titer ratio
Interval 0.58 to 0.91
|
0.76 Geometric mean titer ratio
Interval 0.61 to 0.94
|
0.83 Geometric mean titer ratio
Interval 0.64 to 1.07
|
0.80 Geometric mean titer ratio
Interval 0.64 to 1.01
|
0.98 Geometric mean titer ratio
Interval 0.79 to 1.21
|
0.75 Geometric mean titer ratio
Interval 0.59 to 0.96
|
0.65 Geometric mean titer ratio
Interval 0.52 to 0.81
|
0.97 Geometric mean titer ratio
Interval 0.76 to 1.25
|
0.87 Geometric mean titer ratio
Interval 0.69 to 1.1
|
0.78 Geometric mean titer ratio
Interval 0.63 to 0.98
|
—
|
|
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Titer Ratio (GMTR)
Day 56 (Comparison to qNIV Reference [Group O] Day 56)
|
—
|
1.08 Geometric mean titer ratio
Interval 0.86 to 1.36
|
0.83 Geometric mean titer ratio
Interval 0.61 to 1.13
|
0.83 Geometric mean titer ratio
Interval 0.65 to 1.07
|
0.80 Geometric mean titer ratio
Interval 0.65 to 0.99
|
0.81 Geometric mean titer ratio
Interval 0.65 to 1.02
|
0.85 Geometric mean titer ratio
Interval 0.68 to 1.06
|
0.95 Geometric mean titer ratio
Interval 0.77 to 1.16
|
0.76 Geometric mean titer ratio
Interval 0.6 to 0.97
|
0.68 Geometric mean titer ratio
Interval 0.54 to 0.86
|
0.94 Geometric mean titer ratio
Interval 0.72 to 1.23
|
0.83 Geometric mean titer ratio
Interval 0.64 to 1.07
|
0.87 Geometric mean titer ratio
Interval 0.69 to 1.08
|
—
|
|
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Titer Ratio (GMTR)
Day 182 (Comparison to qNIV Reference [Group O] Day 182)
|
—
|
1.28 Geometric mean titer ratio
Interval 0.95 to 1.72
|
0.96 Geometric mean titer ratio
Interval 0.65 to 1.4
|
1.18 Geometric mean titer ratio
Interval 0.89 to 1.57
|
1.03 Geometric mean titer ratio
Interval 0.78 to 1.35
|
1.01 Geometric mean titer ratio
Interval 0.74 to 1.36
|
0.98 Geometric mean titer ratio
Interval 0.72 to 1.31
|
1.07 Geometric mean titer ratio
Interval 0.82 to 1.39
|
0.84 Geometric mean titer ratio
Interval 0.63 to 1.11
|
0.92 Geometric mean titer ratio
Interval 0.7 to 1.21
|
1.06 Geometric mean titer ratio
Interval 0.76 to 1.49
|
1.02 Geometric mean titer ratio
Interval 0.75 to 1.39
|
1.00 Geometric mean titer ratio
Interval 0.75 to 1.35
|
—
|
|
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Titer Ratio (GMTR)
Day 70 (Comparison to qNIV Reference [Group O] Day 70)
|
—
|
1.22 Geometric mean titer ratio
Interval 0.96 to 1.54
|
1.16 Geometric mean titer ratio
Interval 0.85 to 1.58
|
1.09 Geometric mean titer ratio
Interval 0.85 to 1.39
|
1.11 Geometric mean titer ratio
Interval 0.87 to 1.42
|
1.08 Geometric mean titer ratio
Interval 0.83 to 1.41
|
0.98 Geometric mean titer ratio
Interval 0.8 to 1.21
|
1.11 Geometric mean titer ratio
Interval 0.9 to 1.36
|
0.97 Geometric mean titer ratio
Interval 0.78 to 1.22
|
0.85 Geometric mean titer ratio
Interval 0.68 to 1.06
|
1.15 Geometric mean titer ratio
Interval 0.9 to 1.46
|
1.09 Geometric mean titer ratio
Interval 0.84 to 1.41
|
1.09 Geometric mean titer ratio
Interval 0.89 to 1.34
|
—
|
|
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Titer Ratio (GMTR)
Day 84 (Comparison to qNIV Reference [Group O] Day 84)
|
—
|
1.17 Geometric mean titer ratio
Interval 0.88 to 1.54
|
1.03 Geometric mean titer ratio
Interval 0.72 to 1.48
|
1.17 Geometric mean titer ratio
Interval 0.88 to 1.56
|
1.03 Geometric mean titer ratio
Interval 0.79 to 1.35
|
1.07 Geometric mean titer ratio
Interval 0.77 to 1.49
|
0.81 Geometric mean titer ratio
Interval 0.6 to 1.09
|
1.14 Geometric mean titer ratio
Interval 0.88 to 1.47
|
0.79 Geometric mean titer ratio
Interval 0.6 to 1.04
|
0.87 Geometric mean titer ratio
Interval 0.66 to 1.15
|
0.99 Geometric mean titer ratio
Interval 0.73 to 1.36
|
1.08 Geometric mean titer ratio
Interval 0.77 to 1.5
|
1.00 Geometric mean titer ratio
Interval 0.75 to 1.32
|
—
|
|
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Geometric Mean Titer Ratio (GMTR)
Day70 (Comparison to qNIV Reference [Group O] Day 28)**
|
—
|
1.09 Geometric mean titer ratio
Interval 0.86 to 1.39
|
1.04 Geometric mean titer ratio
Interval 0.76 to 1.42
|
0.98 Geometric mean titer ratio
Interval 0.76 to 1.26
|
1.00 Geometric mean titer ratio
Interval 0.78 to 1.3
|
0.98 Geometric mean titer ratio
Interval 0.75 to 1.28
|
0.89 Geometric mean titer ratio
Interval 0.71 to 1.11
|
1.00 Geometric mean titer ratio
Interval 0.81 to 1.23
|
0.88 Geometric mean titer ratio
Interval 0.7 to 1.11
|
0.77 Geometric mean titer ratio
Interval 0.61 to 0.97
|
1.04 Geometric mean titer ratio
Interval 0.81 to 1.33
|
0.99 Geometric mean titer ratio
Interval 0.75 to 1.29
|
0.98 Geometric mean titer ratio
Interval 0.79 to 1.22
|
—
|
SECONDARY outcome
Timeframe: Day 28 to Day 182Population: Per-Protocol Analysis Set Population
GMT ratio (GMTR) between select treatment arms at Days 28,56, 70, and other follow-up time points post-vaccination (adjusted for intergroup variation in baseline \[pre-vaccination\] titers)
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR
Day 70 (Comparison to qNIV Reference [Group O] Day 70)
|
—
|
1.06 Geometric mean titer ratio
Interval 0.77 to 1.45
|
1.01 Geometric mean titer ratio
Interval 0.63 to 1.63
|
0.83 Geometric mean titer ratio
Interval 0.53 to 1.29
|
0.87 Geometric mean titer ratio
Interval 0.6 to 1.25
|
1.01 Geometric mean titer ratio
Interval 0.67 to 1.52
|
0.81 Geometric mean titer ratio
Interval 0.56 to 1.18
|
1.12 Geometric mean titer ratio
Interval 0.81 to 1.55
|
0.80 Geometric mean titer ratio
Interval 0.56 to 1.16
|
0.73 Geometric mean titer ratio
Interval 0.5 to 1.06
|
1.03 Geometric mean titer ratio
Interval 0.66 to 1.61
|
0.92 Geometric mean titer ratio
Interval 0.64 to 1.33
|
0.92 Geometric mean titer ratio
Interval 0.62 to 1.35
|
—
|
|
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR
Day 28 (Comparison to qNIV Reference [Group O] Day 28)
|
—
|
0.76 Geometric mean titer ratio
Interval 0.54 to 1.07
|
0.67 Geometric mean titer ratio
Interval 0.4 to 1.12
|
0.48 Geometric mean titer ratio
Interval 0.32 to 0.72
|
0.48 Geometric mean titer ratio
Interval 0.32 to 0.71
|
0.69 Geometric mean titer ratio
Interval 0.44 to 1.06
|
0.52 Geometric mean titer ratio
Interval 0.35 to 0.77
|
0.74 Geometric mean titer ratio
Interval 0.52 to 1.06
|
0.47 Geometric mean titer ratio
Interval 0.32 to 0.69
|
0.46 Geometric mean titer ratio
Interval 0.31 to 0.68
|
0.81 Geometric mean titer ratio
Interval 0.51 to 1.28
|
0.75 Geometric mean titer ratio
Interval 0.52 to 1.09
|
0.70 Geometric mean titer ratio
Interval 0.47 to 1.05
|
—
|
|
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR
Day 182 (Comparison to qNIV Reference [Group O] Day 182)
|
—
|
1.24 Geometric mean titer ratio
Interval 0.93 to 1.65
|
1.11 Geometric mean titer ratio
Interval 0.74 to 1.67
|
1.05 Geometric mean titer ratio
Interval 0.73 to 1.49
|
0.76 Geometric mean titer ratio
Interval 0.56 to 1.03
|
1.09 Geometric mean titer ratio
Interval 0.78 to 1.52
|
0.92 Geometric mean titer ratio
Interval 0.64 to 1.32
|
1.16 Geometric mean titer ratio
Interval 0.87 to 1.55
|
0.89 Geometric mean titer ratio
Interval 0.65 to 1.22
|
0.96 Geometric mean titer ratio
Interval 0.7 to 1.3
|
1.04 Geometric mean titer ratio
Interval 0.75 to 1.44
|
1.01 Geometric mean titer ratio
Interval 0.73 to 1.39
|
1.14 Geometric mean titer ratio
Interval 0.82 to 1.59
|
—
|
|
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR
Day 56 (Comparison to qNIV Reference [Group O] Day 56)
|
—
|
0.88 Geometric mean titer ratio
Interval 0.64 to 1.23
|
0.72 Geometric mean titer ratio
Interval 0.45 to 1.15
|
0.67 Geometric mean titer ratio
Interval 0.46 to 0.99
|
0.56 Geometric mean titer ratio
Interval 0.39 to 0.8
|
0.67 Geometric mean titer ratio
Interval 0.45 to 1.0
|
0.56 Geometric mean titer ratio
Interval 0.39 to 0.79
|
0.87 Geometric mean titer ratio
Interval 0.63 to 1.19
|
0.53 Geometric mean titer ratio
Interval 0.37 to 0.75
|
0.59 Geometric mean titer ratio
Interval 0.41 to 0.84
|
0.80 Geometric mean titer ratio
Interval 0.53 to 1.2
|
0.79 Geometric mean titer ratio
Interval 0.55 to 1.14
|
0.81 Geometric mean titer ratio
Interval 0.64 to 1.23
|
—
|
|
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR
Day 84 (Comparison to qNIV Reference [Group O] Day 84)
|
—
|
1.12 Geometric mean titer ratio
Interval 0.83 to 1.51
|
1.07 Geometric mean titer ratio
Interval 0.7 to 1.63
|
1.01 Geometric mean titer ratio
Interval 0.71 to 1.45
|
0.78 Geometric mean titer ratio
Interval 0.56 to 1.09
|
1.09 Geometric mean titer ratio
Interval 0.75 to 1.57
|
0.83 Geometric mean titer ratio
Interval 0.57 to 1.18
|
1.19 Geometric mean titer ratio
Interval 0.88 to 1.59
|
0.78 Geometric mean titer ratio
Interval 0.56 to 1.08
|
0.78 Geometric mean titer ratio
Interval 0.55 to 1.11
|
0.95 Geometric mean titer ratio
Interval 0.67 to 1.35
|
0.98 Geometric mean titer ratio
Interval 0.7 to 1.37
|
0.99 Geometric mean titer ratio
Interval 0.83 to 1.51
|
—
|
|
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR
Day70 (Comparison to qNIV Reference [Group O] Day 28)**
|
—
|
0.83 Geometric mean titer ratio
Interval 0.61 to 1.15
|
0.80 Geometric mean titer ratio
Interval 0.49 to 1.29
|
0.64 Geometric mean titer ratio
Interval 0.41 to 1.0
|
0.69 Geometric mean titer ratio
Interval 0.47 to 1.0
|
0.80 Geometric mean titer ratio
Interval 0.53 to 1.21
|
0.64 Geometric mean titer ratio
Interval 0.44 to 0.94
|
0.88 Geometric mean titer ratio
Interval 0.64 to 1.22
|
0.64 Geometric mean titer ratio
Interval 0.44 to 0.93
|
0.58 Geometric mean titer ratio
Interval 0.39 to 0.86
|
0.81 Geometric mean titer ratio
Interval 0.52 to 1.27
|
0.73 Geometric mean titer ratio
Interval 0.5 to 1.06
|
0.73 Geometric mean titer ratio
Interval 0.49 to 1.07
|
—
|
SECONDARY outcome
Timeframe: Day 28 to Day 182Population: Per-Protocol Analysis Set Population
GMT ratio (GMTR) between select treatment arms at Days 28,56, 70, and other follow-up time points post-vaccination (adjusted for intergroup variation in baseline \[pre-vaccination\] titers)
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR
Day 84 (Comparison to qNIV Reference [Group O] Day 84)
|
—
|
1.27 Geometric mean titer ratio
Interval 1.01 to 1.6
|
1.08 Geometric mean titer ratio
Interval 0.81 to 1.43
|
0.97 Geometric mean titer ratio
Interval 0.75 to 1.25
|
0.99 Geometric mean titer ratio
Interval 0.77 to 1.28
|
1.22 Geometric mean titer ratio
Interval 0.95 to 1.58
|
1.08 Geometric mean titer ratio
Interval 0.8 to 1.44
|
1.22 Geometric mean titer ratio
Interval 0.98 to 1.51
|
1.03 Geometric mean titer ratio
Interval 0.8 to 1.33
|
0.82 Geometric mean titer ratio
Interval 0.64 to 1.05
|
1.05 Geometric mean titer ratio
Interval 0.77 to 1.41
|
1.03 Geometric mean titer ratio
Interval 0.8 to 1.33
|
1.17 Geometric mean titer ratio
Interval 0.92 to 1.49
|
—
|
|
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR
Day 182 (Comparison to qNIV Reference [Group O] Day 182)
|
—
|
1.23 Geometric mean titer ratio
Interval 0.96 to 1.57
|
0.93 Geometric mean titer ratio
Interval 0.7 to 1.22
|
0.93 Geometric mean titer ratio
Interval 0.69 to 1.24
|
0.95 Geometric mean titer ratio
Interval 0.72 to 1.25
|
1.14 Geometric mean titer ratio
Interval 0.88 to 1.49
|
1.05 Geometric mean titer ratio
Interval 0.78 to 1.41
|
1.08 Geometric mean titer ratio
Interval 0.87 to 1.36
|
0.99 Geometric mean titer ratio
Interval 0.76 to 1.29
|
0.80 Geometric mean titer ratio
Interval 0.61 to 1.04
|
1.10 Geometric mean titer ratio
Interval 0.83 to 1.48
|
0.95 Geometric mean titer ratio
Interval 0.74 to 1.23
|
1.14 Geometric mean titer ratio
Interval 0.88 to 1.47
|
—
|
|
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR
Day 28 (Comparison to qNIV Reference [Group O] Day 28)
|
—
|
1.07 Geometric mean titer ratio
Interval 0.89 to 1.29
|
0.89 Geometric mean titer ratio
Interval 0.72 to 1.11
|
0.83 Geometric mean titer ratio
Interval 0.68 to 1.0
|
0.84 Geometric mean titer ratio
Interval 0.71 to 1.0
|
0.99 Geometric mean titer ratio
Interval 0.83 to 1.17
|
0.89 Geometric mean titer ratio
Interval 0.75 to 1.06
|
1.02 Geometric mean titer ratio
Interval 0.86 to 1.21
|
0.82 Geometric mean titer ratio
Interval 0.68 to 0.99
|
0.82 Geometric mean titer ratio
Interval 0.69 to 0.98
|
0.96 Geometric mean titer ratio
Interval 0.78 to 1.19
|
0.92 Geometric mean titer ratio
Interval 0.77 to 1.09
|
0.95 Geometric mean titer ratio
Interval 0.79 to 1.14
|
—
|
|
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR
Day 56 (Comparison to qNIV Reference [Group O] Day 56)
|
—
|
1.08 Geometric mean titer ratio
Interval 0.89 to 1.32
|
0.87 Geometric mean titer ratio
Interval 0.68 to 1.12
|
0.85 Geometric mean titer ratio
Interval 0.69 to 1.05
|
0.87 Geometric mean titer ratio
Interval 0.72 to 1.05
|
0.94 Geometric mean titer ratio
Interval 0.78 to 1.12
|
0.86 Geometric mean titer ratio
Interval 0.72 to 1.04
|
0.95 Geometric mean titer ratio
Interval 0.79 to 1.14
|
0.88 Geometric mean titer ratio
Interval 0.72 to 1.08
|
0.83 Geometric mean titer ratio
Interval 0.68 to 1.0
|
0.98 Geometric mean titer ratio
Interval 0.79 to 1.21
|
0.92 Geometric mean titer ratio
Interval 0.76 to 1.1
|
0.89 Geometric mean titer ratio
Interval 0.74 to 1.08
|
—
|
|
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR
Day 70 (Comparison to qNIV Reference [Group O] Day 70)
|
—
|
1.20 Geometric mean titer ratio
Interval 0.98 to 1.48
|
0.96 Geometric mean titer ratio
Interval 0.76 to 1.22
|
0.96 Geometric mean titer ratio
Interval 0.79 to 1.18
|
1.00 Geometric mean titer ratio
Interval 0.83 to 1.2
|
1.17 Geometric mean titer ratio
Interval 0.93 to 1.47
|
0.89 Geometric mean titer ratio
Interval 0.74 to 1.07
|
1.08 Geometric mean titer ratio
Interval 0.91 to 1.28
|
0.98 Geometric mean titer ratio
Interval 0.8 to 1.21
|
0.86 Geometric mean titer ratio
Interval 0.72 to 1.02
|
1.09 Geometric mean titer ratio
Interval 0.87 to 1.35
|
1.01 Geometric mean titer ratio
Interval 0.83 to 1.22
|
1.05 Geometric mean titer ratio
Interval 0.87 to 1.26
|
—
|
|
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR
Day70 (Comparison to qNIV Reference [Group O] Day 28)**
|
—
|
1.14 Geometric mean titer ratio
Interval 0.93 to 1.39
|
0.90 Geometric mean titer ratio
Interval 0.71 to 1.12
|
0.90 Geometric mean titer ratio
Interval 0.74 to 1.09
|
0.95 Geometric mean titer ratio
Interval 0.79 to 1.13
|
1.10 Geometric mean titer ratio
Interval 0.89 to 1.37
|
0.84 Geometric mean titer ratio
Interval 0.7 to 1.0
|
1.03 Geometric mean titer ratio
Interval 0.87 to 1.21
|
0.92 Geometric mean titer ratio
Interval 0.76 to 1.11
|
0.81 Geometric mean titer ratio
Interval 0.69 to 0.96
|
1.03 Geometric mean titer ratio
Interval 0.84 to 1.27
|
0.96 Geometric mean titer ratio
Interval 0.81 to 1.15
|
0.98 Geometric mean titer ratio
Interval 0.83 to 1.17
|
—
|
SECONDARY outcome
Timeframe: Day 28 to Day 182Population: Per-Protocol Analysis Set Population
GMT ratio (GMTR) between select treatment arms at Days 28,56, 70, and other follow-up time points post-vaccination (adjusted for intergroup variation in baseline \[pre-vaccination\] titers)
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR
Day 28 (Comparison to qNIV Reference [Group O] Day 28)
|
—
|
0.98 Geometric mean titer ratio
Interval 0.72 to 1.33
|
0.94 Geometric mean titer ratio
Interval 0.58 to 1.53
|
0.72 Geometric mean titer ratio
Interval 0.51 to 1.02
|
0.72 Geometric mean titer ratio
Interval 0.52 to 1.01
|
0.97 Geometric mean titer ratio
Interval 0.65 to 1.44
|
0.82 Geometric mean titer ratio
Interval 0.58 to 1.16
|
0.93 Geometric mean titer ratio
Interval 0.69 to 1.26
|
0.71 Geometric mean titer ratio
Interval 0.51 to 0.98
|
0.77 Geometric mean titer ratio
Interval 0.55 to 1.08
|
1.02 Geometric mean titer ratio
Interval 0.67 to 1.54
|
1.08 Geometric mean titer ratio
Interval 0.77 to 1.54
|
0.79 Geometric mean titer ratio
Interval 0.56 to 1.12
|
—
|
|
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR
Day 56 (Comparison to qNIV Reference [Group O] Day 56)
|
—
|
1.01 Geometric mean titer ratio
Interval 0.75 to 1.36
|
0.96 Geometric mean titer ratio
Interval 0.62 to 1.49
|
0.85 Geometric mean titer ratio
Interval 0.61 to 1.18
|
0.79 Geometric mean titer ratio
Interval 0.56 to 1.11
|
0.90 Geometric mean titer ratio
Interval 0.63 to 1.29
|
0.83 Geometric mean titer ratio
Interval 0.6 to 1.13
|
0.97 Geometric mean titer ratio
Interval 0.73 to 1.3
|
0.77 Geometric mean titer ratio
Interval 0.56 to 1.05
|
0.79 Geometric mean titer ratio
Interval 0.56 to 1.1
|
1.14 Geometric mean titer ratio
Interval 0.75 to 1.73
|
1.04 Geometric mean titer ratio
Interval 0.74 to 1.47
|
0.83 Geometric mean titer ratio
Interval 0.6 to 1.17
|
—
|
|
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR
Day 84 (Comparison to qNIV Reference [Group O] Day 84)
|
—
|
1.13 Geometric mean titer ratio
Interval 0.85 to 1.52
|
1.36 Geometric mean titer ratio
Interval 0.87 to 2.12
|
1.03 Geometric mean titer ratio
Interval 0.72 to 1.46
|
0.94 Geometric mean titer ratio
Interval 0.68 to 1.32
|
1.18 Geometric mean titer ratio
Interval 0.82 to 1.7
|
1.06 Geometric mean titer ratio
Interval 0.75 to 1.51
|
1.20 Geometric mean titer ratio
Interval 0.89 to 1.61
|
1.06 Geometric mean titer ratio
Interval 0.77 to 1.46
|
0.93 Geometric mean titer ratio
Interval 0.66 to 1.32
|
1.40 Geometric mean titer ratio
Interval 0.96 to 2.07
|
1.38 Geometric mean titer ratio
Interval 1.0 to 1.9
|
0.99 Geometric mean titer ratio
Interval 0.72 to 1.36
|
—
|
|
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR
Day 70 (Comparison to qNIV Reference [Group O] Day 70)
|
—
|
1.02 Geometric mean titer ratio
Interval 0.77 to 1.34
|
1.05 Geometric mean titer ratio
Interval 0.68 to 1.61
|
0.92 Geometric mean titer ratio
Interval 0.67 to 1.27
|
0.83 Geometric mean titer ratio
Interval 0.61 to 1.13
|
1.05 Geometric mean titer ratio
Interval 0.74 to 1.48
|
0.91 Geometric mean titer ratio
Interval 0.66 to 1.25
|
1.00 Geometric mean titer ratio
Interval 0.76 to 1.32
|
0.92 Geometric mean titer ratio
Interval 0.68 to 1.24
|
0.81 Geometric mean titer ratio
Interval 0.59 to 1.11
|
1.15 Geometric mean titer ratio
Interval 0.77 to 1.71
|
1.03 Geometric mean titer ratio
Interval 0.74 to 1.43
|
0.90 Geometric mean titer ratio
Interval 0.66 to 1.23
|
—
|
|
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR
Day 182 (Comparison to qNIV Reference [Group O] Day 182)
|
—
|
1.25 Geometric mean titer ratio
Interval 0.94 to 1.66
|
1.42 Geometric mean titer ratio
Interval 0.91 to 2.19
|
0.98 Geometric mean titer ratio
Interval 0.68 to 1.42
|
0.85 Geometric mean titer ratio
Interval 0.6 to 1.19
|
1.15 Geometric mean titer ratio
Interval 0.82 to 1.62
|
1.03 Geometric mean titer ratio
Interval 0.73 to 1.45
|
1.12 Geometric mean titer ratio
Interval 0.83 to 1.51
|
1.10 Geometric mean titer ratio
Interval 0.81 to 1.5
|
1.06 Geometric mean titer ratio
Interval 0.77 to 1.46
|
1.39 Geometric mean titer ratio
Interval 0.98 to 1.97
|
1.15 Geometric mean titer ratio
Interval 0.83 to 1.61
|
1.01 Geometric mean titer ratio
Interval 0.73 to 1.39
|
—
|
|
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR
Day70 (Comparison to qNIV Reference [Group O] Day 28)**
|
—
|
0.94 Geometric mean titer ratio
Interval 0.7 to 1.26
|
0.96 Geometric mean titer ratio
Interval 0.61 to 1.51
|
0.84 Geometric mean titer ratio
Interval 0.59 to 1.2
|
0.76 Geometric mean titer ratio
Interval 0.54 to 1.07
|
0.96 Geometric mean titer ratio
Interval 0.66 to 1.38
|
0.84 Geometric mean titer ratio
Interval 0.59 to 1.18
|
0.92 Geometric mean titer ratio
Interval 0.69 to 1.23
|
0.85 Geometric mean titer ratio
Interval 0.61 to 1.18
|
0.75 Geometric mean titer ratio
Interval 0.53 to 1.06
|
1.04 Geometric mean titer ratio
Interval 0.68 to 1.58
|
0.95 Geometric mean titer ratio
Interval 0.67 to 1.36
|
0.83 Geometric mean titer ratio
Interval 0.59 to 1.15
|
—
|
SECONDARY outcome
Timeframe: Day 28 to Day 182Population: Per-Protocol Analysis Set Population
GMT ratio (GMTR) between select treatment arms at Days 28,56, 70, and other follow-up time points post-vaccination (adjusted for intergroup variation in baseline \[pre-vaccination\] titers)
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR
Day 28 (Comparison to qNIV Reference [Group O] Day 28)
|
—
|
0.96 Geometric mean titer ratio
Interval 0.73 to 1.26
|
0.94 Geometric mean titer ratio
Interval 0.62 to 1.42
|
0.73 Geometric mean titer ratio
Interval 0.53 to 1.0
|
0.73 Geometric mean titer ratio
Interval 0.53 to 1.0
|
0.91 Geometric mean titer ratio
Interval 0.63 to 1.3
|
0.77 Geometric mean titer ratio
Interval 0.57 to 1.03
|
0.95 Geometric mean titer ratio
Interval 0.72 to 1.25
|
0.76 Geometric mean titer ratio
Interval 0.56 to 1.03
|
0.86 Geometric mean titer ratio
Interval 0.63 to 1.18
|
0.99 Geometric mean titer ratio
Interval 0.71 to 1.39
|
0.99 Geometric mean titer ratio
Interval 0.7 to 1.39
|
0.88 Geometric mean titer ratio
Interval 0.64 to 1.2
|
—
|
|
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR
Day 56 (Comparison to qNIV Reference [Group O] Day 56)
|
—
|
1.03 Geometric mean titer ratio
Interval 0.78 to 1.34
|
0.97 Geometric mean titer ratio
Interval 0.66 to 1.43
|
0.82 Geometric mean titer ratio
Interval 0.61 to 1.11
|
0.80 Geometric mean titer ratio
Interval 0.59 to 1.09
|
0.82 Geometric mean titer ratio
Interval 0.6 to 1.12
|
0.87 Geometric mean titer ratio
Interval 0.66 to 1.15
|
1.02 Geometric mean titer ratio
Interval 0.79 to 1.33
|
0.78 Geometric mean titer ratio
Interval 0.59 to 1.04
|
0.91 Geometric mean titer ratio
Interval 0.68 to 1.21
|
0.99 Geometric mean titer ratio
Interval 0.71 to 1.36
|
1.02 Geometric mean titer ratio
Interval 0.74 to 1.4
|
0.94 Geometric mean titer ratio
Interval 0.7 to 1.25
|
—
|
|
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR
Day70 (Comparison to qNIV Reference [Group O] Day 28)**
|
—
|
0.99 Geometric mean titer ratio
Interval 0.74 to 1.31
|
1.05 Geometric mean titer ratio
Interval 0.7 to 1.59
|
0.89 Geometric mean titer ratio
Interval 0.63 to 1.24
|
0.84 Geometric mean titer ratio
Interval 0.61 to 1.16
|
0.89 Geometric mean titer ratio
Interval 0.64 to 1.25
|
0.86 Geometric mean titer ratio
Interval 0.64 to 1.16
|
0.93 Geometric mean titer ratio
Interval 0.71 to 1.21
|
0.78 Geometric mean titer ratio
Interval 0.57 to 1.06
|
0.85 Geometric mean titer ratio
Interval 0.61 to 1.17
|
0.97 Geometric mean titer ratio
Interval 0.69 to 1.36
|
1.02 Geometric mean titer ratio
Interval 0.72 to 1.44
|
0.86 Geometric mean titer ratio
Interval 0.63 to 1.18
|
—
|
|
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR
Day 70 (Comparison to qNIV Reference [Group O] Day 70)
|
—
|
1.07 Geometric mean titer ratio
Interval 0.83 to 1.38
|
1.14 Geometric mean titer ratio
Interval 0.79 to 1.66
|
0.97 Geometric mean titer ratio
Interval 0.73 to 1.28
|
0.91 Geometric mean titer ratio
Interval 0.7 to 1.19
|
0.96 Geometric mean titer ratio
Interval 0.72 to 1.28
|
0.92 Geometric mean titer ratio
Interval 0.72 to 1.19
|
1.01 Geometric mean titer ratio
Interval 0.8 to 1.29
|
0.84 Geometric mean titer ratio
Interval 0.65 to 1.08
|
0.91 Geometric mean titer ratio
Interval 0.7 to 1.19
|
1.07 Geometric mean titer ratio
Interval 0.81 to 1.43
|
1.09 Geometric mean titer ratio
Interval 0.81 to 1.47
|
0.94 Geometric mean titer ratio
Interval 0.72 to 1.22
|
—
|
|
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR
Day 84 (Comparison to qNIV Reference [Group O] Day 84)
|
—
|
1.05 Geometric mean titer ratio
Interval 0.78 to 1.41
|
1.20 Geometric mean titer ratio
Interval 0.82 to 1.77
|
0.94 Geometric mean titer ratio
Interval 0.66 to 1.34
|
0.93 Geometric mean titer ratio
Interval 0.66 to 1.31
|
1.05 Geometric mean titer ratio
Interval 0.75 to 1.48
|
0.95 Geometric mean titer ratio
Interval 0.7 to 1.31
|
1.19 Geometric mean titer ratio
Interval 0.89 to 1.6
|
0.94 Geometric mean titer ratio
Interval 0.69 to 1.28
|
0.93 Geometric mean titer ratio
Interval 0.66 to 1.3
|
1.19 Geometric mean titer ratio
Interval 0.81 to 1.75
|
1.18 Geometric mean titer ratio
Interval 0.85 to 1.65
|
1.14 Geometric mean titer ratio
Interval 0.82 to 1.59
|
—
|
|
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR
Day 182 (Comparison to qNIV Reference [Group O] Day 182)
|
—
|
1.03 Geometric mean titer ratio
Interval 0.78 to 1.37
|
1.18 Geometric mean titer ratio
Interval 0.79 to 1.77
|
0.89 Geometric mean titer ratio
Interval 0.63 to 1.25
|
0.87 Geometric mean titer ratio
Interval 0.62 to 1.21
|
1.01 Geometric mean titer ratio
Interval 0.73 to 1.41
|
0.92 Geometric mean titer ratio
Interval 0.66 to 1.3
|
1.03 Geometric mean titer ratio
Interval 0.78 to 1.36
|
0.94 Geometric mean titer ratio
Interval 0.7 to 1.26
|
0.98 Geometric mean titer ratio
Interval 0.72 to 1.33
|
1.19 Geometric mean titer ratio
Interval 0.87 to 1.64
|
1.09 Geometric mean titer ratio
Interval 0.8 to 1.5
|
1.06 Geometric mean titer ratio
Interval 0.75 to 1.5
|
—
|
SECONDARY outcome
Timeframe: Day 28 to Day 182Population: Per-Protocol Analysis Set Population
GMT ratio (GMTR) between select treatment arms at Days 28,56, 70, and other follow-up time points post-vaccination (adjusted for intergroup variation in baseline \[pre-vaccination\] titers)
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as GMTR
Day 28 (Comparison to qNIV Reference [Group O] Day 28)
|
—
|
0.96 Geometric mean titer ratio
Interval 0.75 to 1.24
|
0.89 Geometric mean titer ratio
Interval 0.65 to 1.22
|
0.62 Geometric mean titer ratio
Interval 0.47 to 0.82
|
0.74 Geometric mean titer ratio
Interval 0.55 to 0.99
|
0.83 Geometric mean titer ratio
Interval 0.61 to 1.14
|
0.70 Geometric mean titer ratio
Interval 0.53 to 0.94
|
0.90 Geometric mean titer ratio
Interval 0.71 to 1.14
|
0.67 Geometric mean titer ratio
Interval 0.51 to 0.87
|
0.65 Geometric mean titer ratio
Interval 0.5 to 0.85
|
0.78 Geometric mean titer ratio
Interval 0.59 to 1.04
|
0.78 Geometric mean titer ratio
Interval 0.58 to 1.05
|
0.78 Geometric mean titer ratio
Interval 0.6 to 1.03
|
—
|
|
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as GMTR
Day 56 (Comparison to qNIV Reference [Group O] Day 56)
|
—
|
1.04 Geometric mean titer ratio
Interval 0.81 to 1.35
|
0.85 Geometric mean titer ratio
Interval 0.65 to 1.11
|
0.75 Geometric mean titer ratio
Interval 0.58 to 0.96
|
0.87 Geometric mean titer ratio
Interval 0.67 to 1.13
|
0.74 Geometric mean titer ratio
Interval 0.56 to 0.99
|
0.76 Geometric mean titer ratio
Interval 0.6 to 0.98
|
0.95 Geometric mean titer ratio
Interval 0.77 to 1.17
|
0.74 Geometric mean titer ratio
Interval 0.59 to 0.94
|
0.70 Geometric mean titer ratio
Interval 0.55 to 0.9
|
0.87 Geometric mean titer ratio
Interval 0.67 to 1.14
|
0.76 Geometric mean titer ratio
Interval 0.57 to 1.0
|
0.82 Geometric mean titer ratio
Interval 0.65 to 1.04
|
—
|
|
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as GMTR
Day 70 (Comparison to qNIV Reference [Group O] Day 70)
|
—
|
1.18 Geometric mean titer ratio
Interval 0.92 to 1.52
|
1.04 Geometric mean titer ratio
Interval 0.79 to 1.38
|
0.84 Geometric mean titer ratio
Interval 0.65 to 1.08
|
0.98 Geometric mean titer ratio
Interval 0.76 to 1.27
|
1.04 Geometric mean titer ratio
Interval 0.8 to 1.36
|
0.88 Geometric mean titer ratio
Interval 0.7 to 1.12
|
1.05 Geometric mean titer ratio
Interval 0.86 to 1.3
|
0.90 Geometric mean titer ratio
Interval 0.71 to 1.14
|
0.82 Geometric mean titer ratio
Interval 0.65 to 1.04
|
1.02 Geometric mean titer ratio
Interval 0.79 to 1.33
|
0.95 Geometric mean titer ratio
Interval 0.72 to 1.24
|
1.01 Geometric mean titer ratio
Interval 0.8 to 1.27
|
—
|
|
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as GMTR
Day 84 (Comparison to qNIV Reference [Group O] Day 84)
|
—
|
1.10 Geometric mean titer ratio
Interval 0.84 to 1.44
|
1.03 Geometric mean titer ratio
Interval 0.82 to 1.31
|
0.90 Geometric mean titer ratio
Interval 0.69 to 1.17
|
0.87 Geometric mean titer ratio
Interval 0.67 to 1.12
|
1.02 Geometric mean titer ratio
Interval 0.78 to 1.32
|
0.92 Geometric mean titer ratio
Interval 0.73 to 1.17
|
1.15 Geometric mean titer ratio
Interval 0.93 to 1.41
|
0.78 Geometric mean titer ratio
Interval 0.61 to 0.98
|
0.79 Geometric mean titer ratio
Interval 0.61 to 1.01
|
0.94 Geometric mean titer ratio
Interval 0.73 to 1.22
|
0.99 Geometric mean titer ratio
Interval 0.77 to 1.27
|
0.95 Geometric mean titer ratio
Interval 0.75 to 1.21
|
—
|
|
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as GMTR
Day70 (Comparison to qNIV Reference [Group O] Day 28)**
|
—
|
1.03 Geometric mean titer ratio
Interval 0.79 to 1.34
|
0.90 Geometric mean titer ratio
Interval 0.66 to 1.22
|
0.72 Geometric mean titer ratio
Interval 0.54 to 0.97
|
0.85 Geometric mean titer ratio
Interval 0.63 to 1.14
|
0.90 Geometric mean titer ratio
Interval 0.67 to 1.21
|
0.76 Geometric mean titer ratio
Interval 0.58 to 1.0
|
0.91 Geometric mean titer ratio
Interval 0.73 to 1.14
|
0.78 Geometric mean titer ratio
Interval 0.59 to 1.02
|
0.71 Geometric mean titer ratio
Interval 0.54 to 0.93
|
0.89 Geometric mean titer ratio
Interval 0.66 to 1.19
|
0.82 Geometric mean titer ratio
Interval 0.61 to 1.11
|
0.87 Geometric mean titer ratio
Interval 0.67 to 1.14
|
—
|
|
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as GMTR
Day 182 (Comparison to qNIV Reference [Group O] Day 182)
|
—
|
1.15 Geometric mean titer ratio
Interval 0.9 to 1.46
|
1.01 Geometric mean titer ratio
Interval 0.81 to 1.26
|
0.88 Geometric mean titer ratio
Interval 0.7 to 1.11
|
0.86 Geometric mean titer ratio
Interval 0.66 to 1.11
|
0.97 Geometric mean titer ratio
Interval 0.77 to 1.23
|
0.86 Geometric mean titer ratio
Interval 0.69 to 1.07
|
1.08 Geometric mean titer ratio
Interval 0.88 to 1.33
|
0.85 Geometric mean titer ratio
Interval 0.68 to 1.06
|
0.88 Geometric mean titer ratio
Interval 0.71 to 1.09
|
0.90 Geometric mean titer ratio
Interval 0.71 to 1.14
|
0.89 Geometric mean titer ratio
Interval 0.71 to 1.13
|
0.92 Geometric mean titer ratio
Interval 0.73 to 1.15
|
—
|
SECONDARY outcome
Timeframe: Day 28 to Day 182Population: Per-Protocol Analysis Set Population
GMT ratio (GMTR) between select treatment arms at Days 28,56, 70, and other follow-up time points post-vaccination (adjusted for intergroup variation in baseline \[pre-vaccination\] titers)
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR
Day 28 (Comparison to qNIV Reference [Group O] Day 28)
|
—
|
0.76 Geometric mean titer ratio
Interval 0.59 to 0.98
|
0.58 Geometric mean titer ratio
Interval 0.44 to 0.77
|
0.44 Geometric mean titer ratio
Interval 0.34 to 0.57
|
0.50 Geometric mean titer ratio
Interval 0.39 to 0.65
|
0.68 Geometric mean titer ratio
Interval 0.51 to 0.91
|
0.50 Geometric mean titer ratio
Interval 0.39 to 0.65
|
0.64 Geometric mean titer ratio
Interval 0.51 to 0.8
|
0.59 Geometric mean titer ratio
Interval 0.46 to 0.76
|
0.49 Geometric mean titer ratio
Interval 0.38 to 0.62
|
0.60 Geometric mean titer ratio
Interval 0.46 to 0.77
|
0.60 Geometric mean titer ratio
Interval 0.47 to 0.77
|
0.70 Geometric mean titer ratio
Interval 0.53 to 0.92
|
—
|
|
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR
Day 56 (Comparison to qNIV Reference [Group O] Day 56)
|
—
|
0.81 Geometric mean titer ratio
Interval 0.63 to 1.04
|
0.62 Geometric mean titer ratio
Interval 0.48 to 0.81
|
0.53 Geometric mean titer ratio
Interval 0.41 to 0.7
|
0.54 Geometric mean titer ratio
Interval 0.42 to 0.7
|
0.69 Geometric mean titer ratio
Interval 0.51 to 0.92
|
0.56 Geometric mean titer ratio
Interval 0.44 to 0.72
|
0.68 Geometric mean titer ratio
Interval 0.55 to 0.84
|
0.65 Geometric mean titer ratio
Interval 0.52 to 0.83
|
0.52 Geometric mean titer ratio
Interval 0.41 to 0.65
|
0.65 Geometric mean titer ratio
Interval 0.51 to 0.85
|
0.61 Geometric mean titer ratio
Interval 0.47 to 0.79
|
0.75 Geometric mean titer ratio
Interval 0.57 to 0.97
|
—
|
|
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR
Day 70 (Comparison to qNIV Reference [Group O] Day 70)
|
—
|
1.02 Geometric mean titer ratio
Interval 0.77 to 1.34
|
0.86 Geometric mean titer ratio
Interval 0.66 to 1.13
|
0.69 Geometric mean titer ratio
Interval 0.51 to 0.92
|
0.76 Geometric mean titer ratio
Interval 0.59 to 0.99
|
1.00 Geometric mean titer ratio
Interval 0.74 to 1.36
|
0.72 Geometric mean titer ratio
Interval 0.56 to 0.91
|
0.86 Geometric mean titer ratio
Interval 0.68 to 1.08
|
0.79 Geometric mean titer ratio
Interval 0.61 to 1.02
|
0.66 Geometric mean titer ratio
Interval 0.51 to 0.84
|
0.84 Geometric mean titer ratio
Interval 0.63 to 1.13
|
0.79 Geometric mean titer ratio
Interval 0.6 to 1.03
|
0.89 Geometric mean titer ratio
Interval 0.69 to 1.16
|
—
|
|
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR
Day 182 (Comparison to qNIV Reference [Group O] Day 182)
|
—
|
1.11 Geometric mean titer ratio
Interval 0.86 to 1.43
|
0.91 Geometric mean titer ratio
Interval 0.74 to 1.11
|
0.80 Geometric mean titer ratio
Interval 0.63 to 1.02
|
0.82 Geometric mean titer ratio
Interval 0.64 to 1.05
|
1.05 Geometric mean titer ratio
Interval 0.81 to 1.35
|
0.80 Geometric mean titer ratio
Interval 0.64 to 1.0
|
0.90 Geometric mean titer ratio
Interval 0.74 to 1.1
|
0.83 Geometric mean titer ratio
Interval 0.67 to 1.04
|
0.80 Geometric mean titer ratio
Interval 0.65 to 0.99
|
0.93 Geometric mean titer ratio
Interval 0.75 to 1.14
|
0.84 Geometric mean titer ratio
Interval 0.67 to 1.05
|
0.94 Geometric mean titer ratio
Interval 0.74 to 1.2
|
—
|
|
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR
Day70 (Comparison to qNIV Reference [Group O] Day 28)**
|
—
|
0.86 Geometric mean titer ratio
Interval 0.65 to 1.13
|
0.73 Geometric mean titer ratio
Interval 0.56 to 0.95
|
0.57 Geometric mean titer ratio
Interval 0.43 to 0.76
|
0.64 Geometric mean titer ratio
Interval 0.5 to 0.83
|
0.85 Geometric mean titer ratio
Interval 0.63 to 1.14
|
0.60 Geometric mean titer ratio
Interval 0.48 to 0.76
|
0.72 Geometric mean titer ratio
Interval 0.58 to 0.91
|
0.56 Geometric mean titer ratio
Interval 0.44 to 0.71
|
0.56 Geometric mean titer ratio
Interval 0.44 to 0.71
|
0.71 Geometric mean titer ratio
Interval 0.54 to 0.94
|
0.66 Geometric mean titer ratio
Interval 0.51 to 0.86
|
0.75 Geometric mean titer ratio
Interval 0.58 to 0.97
|
—
|
|
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR
Day 84 (Comparison to qNIV Reference [Group O] Day 84)
|
—
|
0.95 Geometric mean titer ratio
Interval 0.74 to 1.22
|
0.82 Geometric mean titer ratio
Interval 0.65 to 1.02
|
0.73 Geometric mean titer ratio
Interval 0.57 to 0.92
|
0.72 Geometric mean titer ratio
Interval 0.56 to 0.92
|
1.00 Geometric mean titer ratio
Interval 0.77 to 1.29
|
0.73 Geometric mean titer ratio
Interval 0.58 to 0.91
|
0.90 Geometric mean titer ratio
Interval 0.72 to 1.12
|
0.73 Geometric mean titer ratio
Interval 0.58 to 0.91
|
0.68 Geometric mean titer ratio
Interval 0.54 to 0.85
|
0.86 Geometric mean titer ratio
Interval 0.67 to 1.12
|
0.87 Geometric mean titer ratio
Interval 0.68 to 1.11
|
0.88 Geometric mean titer ratio
Interval 0.7 to 1.12
|
—
|
SECONDARY outcome
Timeframe: Day 28 to Day 182Population: Per-Protocol Analysis Set Population
GMT ratio (GMTR) between select treatment arms at Days 28,56, 70, and other follow-up time points post-vaccination (adjusted for intergroup variation in baseline \[pre-vaccination\] titers)
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype)Expressed as GMTR
Day 28 (Comparison to qNIV Reference [Group O] Day 28)
|
—
|
0.93 Geometric mean titer ratio
Interval 0.76 to 1.14
|
0.82 Geometric mean titer ratio
Interval 0.65 to 1.03
|
0.75 Geometric mean titer ratio
Interval 0.59 to 0.96
|
0.79 Geometric mean titer ratio
Interval 0.61 to 1.03
|
0.85 Geometric mean titer ratio
Interval 0.66 to 1.1
|
0.77 Geometric mean titer ratio
Interval 0.6 to 0.99
|
0.85 Geometric mean titer ratio
Interval 0.68 to 1.06
|
0.74 Geometric mean titer ratio
Interval 0.58 to 0.93
|
0.74 Geometric mean titer ratio
Interval 0.58 to 0.94
|
0.83 Geometric mean titer ratio
Interval 0.65 to 1.06
|
0.80 Geometric mean titer ratio
Interval 0.6 to 1.06
|
0.82 Geometric mean titer ratio
Interval 0.64 to 1.06
|
—
|
|
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype)Expressed as GMTR
Day 56 (Comparison to qNIV Reference [Group O] Day 56)
|
—
|
0.91 Geometric mean titer ratio
Interval 0.74 to 1.11
|
0.87 Geometric mean titer ratio
Interval 0.7 to 1.09
|
0.72 Geometric mean titer ratio
Interval 0.57 to 0.91
|
0.85 Geometric mean titer ratio
Interval 0.66 to 1.09
|
0.78 Geometric mean titer ratio
Interval 0.62 to 0.99
|
0.76 Geometric mean titer ratio
Interval 0.6 to 0.96
|
0.88 Geometric mean titer ratio
Interval 0.73 to 1.07
|
0.76 Geometric mean titer ratio
Interval 0.61 to 0.95
|
0.80 Geometric mean titer ratio
Interval 0.64 to 1.0
|
0.82 Geometric mean titer ratio
Interval 0.64 to 1.04
|
0.80 Geometric mean titer ratio
Interval 0.62 to 1.04
|
0.86 Geometric mean titer ratio
Interval 0.69 to 1.07
|
—
|
|
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype)Expressed as GMTR
Day 182 (Comparison to qNIV Reference [Group O] Day 182)
|
—
|
0.91 Geometric mean titer ratio
Interval 0.72 to 1.15
|
0.83 Geometric mean titer ratio
Interval 0.64 to 1.09
|
0.73 Geometric mean titer ratio
Interval 0.55 to 0.97
|
0.81 Geometric mean titer ratio
Interval 0.6 to 1.08
|
0.83 Geometric mean titer ratio
Interval 0.64 to 1.07
|
0.72 Geometric mean titer ratio
Interval 0.54 to 0.94
|
0.86 Geometric mean titer ratio
Interval 0.68 to 1.08
|
0.78 Geometric mean titer ratio
Interval 0.59 to 1.01
|
0.79 Geometric mean titer ratio
Interval 0.6 to 1.03
|
0.90 Geometric mean titer ratio
Interval 0.69 to 1.16
|
0.75 Geometric mean titer ratio
Interval 0.57 to 0.99
|
0.86 Geometric mean titer ratio
Interval 0.67 to 1.11
|
—
|
|
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype)Expressed as GMTR
Day70 (Comparison to qNIV Reference [Group O] Day 28)**
|
—
|
0.99 Geometric mean titer ratio
Interval 0.8 to 1.21
|
0.86 Geometric mean titer ratio
Interval 0.67 to 1.11
|
0.81 Geometric mean titer ratio
Interval 0.62 to 1.04
|
0.88 Geometric mean titer ratio
Interval 0.68 to 1.15
|
0.87 Geometric mean titer ratio
Interval 0.67 to 1.12
|
0.77 Geometric mean titer ratio
Interval 0.6 to 0.98
|
0.88 Geometric mean titer ratio
Interval 0.72 to 1.08
|
0.76 Geometric mean titer ratio
Interval 0.6 to 0.96
|
0.77 Geometric mean titer ratio
Interval 0.6 to 0.98
|
0.93 Geometric mean titer ratio
Interval 0.72 to 1.19
|
0.83 Geometric mean titer ratio
Interval 0.63 to 1.11
|
0.83 Geometric mean titer ratio
Interval 0.66 to 1.05
|
—
|
|
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype)Expressed as GMTR
Day 70 (Comparison to qNIV Reference [Group O] Day 70)
|
—
|
1.01 Geometric mean titer ratio
Interval 0.83 to 1.24
|
0.88 Geometric mean titer ratio
Interval 0.7 to 1.12
|
0.82 Geometric mean titer ratio
Interval 0.64 to 1.05
|
0.91 Geometric mean titer ratio
Interval 0.71 to 1.17
|
0.91 Geometric mean titer ratio
Interval 0.7 to 1.17
|
0.80 Geometric mean titer ratio
Interval 0.63 to 1.01
|
0.90 Geometric mean titer ratio
Interval 0.74 to 1.1
|
0.79 Geometric mean titer ratio
Interval 0.63 to 0.99
|
0.79 Geometric mean titer ratio
Interval 0.62 to 1.0
|
0.96 Geometric mean titer ratio
Interval 0.75 to 1.23
|
0.85 Geometric mean titer ratio
Interval 0.64 to 1.12
|
0.85 Geometric mean titer ratio
Interval 0.68 to 1.06
|
—
|
|
HAI Antibody Titers Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype)Expressed as GMTR
Day 84 (Comparison to qNIV Reference [Group O] Day 84)
|
—
|
0.86 Geometric mean titer ratio
Interval 0.68 to 1.1
|
0.88 Geometric mean titer ratio
Interval 0.68 to 1.15
|
0.74 Geometric mean titer ratio
Interval 0.56 to 0.98
|
0.80 Geometric mean titer ratio
Interval 0.6 to 1.06
|
0.90 Geometric mean titer ratio
Interval 0.68 to 1.2
|
0.73 Geometric mean titer ratio
Interval 0.56 to 0.94
|
0.92 Geometric mean titer ratio
Interval 0.73 to 1.16
|
0.73 Geometric mean titer ratio
Interval 0.55 to 0.99
|
0.71 Geometric mean titer ratio
Interval 0.53 to 0.95
|
0.84 Geometric mean titer ratio
Interval 0.63 to 1.13
|
0.88 Geometric mean titer ratio
Interval 0.65 to 1.18
|
0.84 Geometric mean titer ratio
Interval 0.65 to 1.11
|
—
|
SECONDARY outcome
Timeframe: Day 28 to Day 182Population: Per-Protocol Analysis Set Population
Percentage of participants with a reciprocal HAI titer ≥ 40 specific for the HA receptor binding domains of vaccine homologous Influenza A/Brisbane (H1N1 Subtype) on Days 56, 70, and other follow-up time points.
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
n=39 Participants
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Seroprotection Rate (SPR).
Day 84
|
94.7 percentage of participants(SPR)
Interval 82.3 to 99.4
|
94.9 percentage of participants(SPR)
Interval 87.4 to 98.6
|
89.7 percentage of participants(SPR)
Interval 75.8 to 97.1
|
94.1 percentage of participants(SPR)
Interval 80.3 to 99.3
|
94.3 percentage of participants(SPR)
Interval 80.8 to 99.3
|
87.2 percentage of participants(SPR)
Interval 72.6 to 95.7
|
78.9 percentage of participants(SPR)
Interval 62.7 to 90.4
|
92.1 percentage of participants(SPR)
Interval 83.6 to 97.0
|
97.4 percentage of participants(SPR)
Interval 86.2 to 99.9
|
89.5 percentage of participants(SPR)
Interval 75.2 to 97.1
|
94.1 percentage of participants(SPR)
Interval 80.3 to 99.3
|
91.9 percentage of participants(SPR)
Interval 78.1 to 98.3
|
95.1 percentage of participants(SPR)
Interval 83.5 to 99.4
|
—
|
|
Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Seroprotection Rate (SPR).
Day 28
|
100.0 percentage of participants(SPR)
Interval 91.0 to 100.0
|
96.3 percentage of participants(SPR)
Interval 89.4 to 99.2
|
85.0 percentage of participants(SPR)
Interval 70.2 to 94.3
|
94.7 percentage of participants(SPR)
Interval 82.3 to 99.4
|
94.6 percentage of participants(SPR)
Interval 81.8 to 99.3
|
92.7 percentage of participants(SPR)
Interval 80.1 to 98.5
|
85.4 percentage of participants(SPR)
Interval 70.8 to 94.4
|
98.7 percentage of participants(SPR)
Interval 93.1 to 100.0
|
92.3 percentage of participants(SPR)
Interval 79.1 to 98.4
|
87.2 percentage of participants(SPR)
Interval 72.6 to 95.7
|
92.3 percentage of participants(SPR)
Interval 79.1 to 98.4
|
94.9 percentage of participants(SPR)
Interval 82.7 to 99.4
|
95.1 percentage of participants(SPR)
Interval 83.5 to 99.4
|
—
|
|
Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Seroprotection Rate (SPR).
Day 56
|
100.0 percentage of participants(SPR)
Interval 91.0 to 100.0
|
96.2 percentage of participants(SPR)
Interval 89.3 to 99.2
|
87.2 percentage of participants(SPR)
Interval 72.6 to 95.7
|
97.2 percentage of participants(SPR)
Interval 85.5 to 99.9
|
91.7 percentage of participants(SPR)
Interval 77.5 to 98.2
|
87.5 percentage of participants(SPR)
Interval 73.2 to 95.8
|
87.5 percentage of participants(SPR)
Interval 73.2 to 95.8
|
94.9 percentage of participants(SPR)
Interval 87.5 to 98.6
|
89.7 percentage of participants(SPR)
Interval 75.8 to 97.1
|
84.2 percentage of participants(SPR)
Interval 68.7 to 94.0
|
91.9 percentage of participants(SPR)
Interval 78.1 to 98.3
|
92.1 percentage of participants(SPR)
Interval 78.6 to 98.3
|
97.5 percentage of participants(SPR)
Interval 86.8 to 99.9
|
—
|
|
Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Seroprotection Rate (SPR).
Day 70
|
100.0 percentage of participants(SPR)
Interval 90.7 to 100.0
|
97.4 percentage of participants(SPR)
Interval 90.9 to 99.7
|
94.9 percentage of participants(SPR)
Interval 82.7 to 99.4
|
94.3 percentage of participants(SPR)
Interval 80.8 to 99.3
|
97.2 percentage of participants(SPR)
Interval 85.5 to 99.9
|
95.0 percentage of participants(SPR)
Interval 83.1 to 99.4
|
95.0 percentage of participants(SPR)
Interval 83.1 to 99.4
|
98.7 percentage of participants(SPR)
Interval 92.9 to 100.0
|
97.4 percentage of participants(SPR)
Interval 86.2 to 99.9
|
92.1 percentage of participants(SPR)
Interval 78.6 to 98.3
|
97.2 percentage of participants(SPR)
Interval 85.5 to 99.9
|
97.3 percentage of participants(SPR)
Interval 85.8 to 99.9
|
100.0 percentage of participants(SPR)
Interval 91.4 to 100.0
|
—
|
|
Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Expressed as Seroprotection Rate (SPR).
Day 182
|
78.9 percentage of participants(SPR)
Interval 62.7 to 90.4
|
90.7 percentage of participants(SPR)
Interval 81.7 to 96.2
|
82.1 percentage of participants(SPR)
Interval 66.5 to 92.5
|
85.3 percentage of participants(SPR)
Interval 68.9 to 95.0
|
85.7 percentage of participants(SPR)
Interval 69.7 to 95.2
|
79.5 percentage of participants(SPR)
Interval 63.5 to 90.7
|
68.4 percentage of participants(SPR)
Interval 51.3 to 82.5
|
82.7 percentage of participants(SPR)
Interval 72.2 to 90.4
|
75.7 percentage of participants(SPR)
Interval 58.8 to 88.2
|
78.4 percentage of participants(SPR)
Interval 61.8 to 90.2
|
83.3 percentage of participants(SPR)
Interval 67.2 to 93.6
|
81.6 percentage of participants(SPR)
Interval 65.7 to 92.3
|
82.1 percentage of participants(SPR)
Interval 66.5 to 92.5
|
—
|
SECONDARY outcome
Timeframe: Day 28 to Day 182Population: Per-Protocol Analysis Set Population
Percentage of participants with a reciprocal HAI titer ≥ 40 specific for the HA receptor binding domains of vaccine homologous Influenza A/Kansas (H3N2 Subtype) on Days 56, 70, and other follow-up time points.
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
n=39 Participants
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as SPR
Day 28
|
92.3 percentage of participants(SPR)
Interval 79.1 to 98.4
|
93.8 percentage of participants(SPR)
Interval 86.0 to 97.9
|
75.0 percentage of participants(SPR)
Interval 58.8 to 87.3
|
73.7 percentage of participants(SPR)
Interval 56.9 to 86.6
|
78.4 percentage of participants(SPR)
Interval 61.8 to 90.2
|
87.8 percentage of participants(SPR)
Interval 73.8 to 95.9
|
85.4 percentage of participants(SPR)
Interval 70.8 to 94.4
|
89.7 percentage of participants(SPR)
Interval 80.8 to 95.5
|
79.5 percentage of participants(SPR)
Interval 63.5 to 90.7
|
89.7 percentage of participants(SPR)
Interval 75.8 to 97.1
|
87.2 percentage of participants(SPR)
Interval 72.6 to 95.7
|
92.3 percentage of participants(SPR)
Interval 79.1 to 98.4
|
90.2 percentage of participants(SPR)
Interval 76.9 to 97.3
|
—
|
|
Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as SPR
Day 56
|
89.7 percentage of participants(SPR)
Interval 75.8 to 97.1
|
89.9 percentage of participants(SPR)
Interval 81.0 to 95.5
|
71.8 percentage of participants(SPR)
Interval 55.1 to 85.0
|
77.8 percentage of participants(SPR)
Interval 60.8 to 89.9
|
75.0 percentage of participants(SPR)
Interval 57.8 to 87.9
|
85.0 percentage of participants(SPR)
Interval 70.2 to 94.3
|
85.0 percentage of participants(SPR)
Interval 70.2 to 94.3
|
91.1 percentage of participants(SPR)
Interval 82.6 to 96.4
|
79.5 percentage of participants(SPR)
Interval 63.5 to 90.7
|
89.5 percentage of participants(SPR)
Interval 75.2 to 97.1
|
83.8 percentage of participants(SPR)
Interval 68.0 to 93.8
|
81.6 percentage of participants(SPR)
Interval 65.7 to 92.3
|
85.0 percentage of participants(SPR)
Interval 70.2 to 94.3
|
—
|
|
Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as SPR
Day 84
|
86.8 percentage of participants(SPR)
Interval 71.9 to 95.6
|
94.9 percentage of participants(SPR)
Interval 87.4 to 98.6
|
89.7 percentage of participants(SPR)
Interval 75.8 to 97.1
|
82.4 percentage of participants(SPR)
Interval 65.5 to 93.2
|
91.4 percentage of participants(SPR)
Interval 76.9 to 98.2
|
94.9 percentage of participants(SPR)
Interval 82.7 to 99.4
|
92.1 percentage of participants(SPR)
Interval 78.6 to 98.3
|
96.1 percentage of participants(SPR)
Interval 88.9 to 99.2
|
92.1 percentage of participants(SPR)
Interval 78.6 to 98.3
|
94.7 percentage of participants(SPR)
Interval 82.3 to 99.4
|
85.3 percentage of participants(SPR)
Interval 68.9 to 95.0
|
91.9 percentage of participants(SPR)
Interval 78.1 to 98.3
|
87.8 percentage of participants(SPR)
Interval 73.8 to 95.9
|
—
|
|
Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as SPR
Day 182
|
81.6 percentage of participants(SPR)
Interval 65.7 to 92.3
|
86.7 percentage of participants(SPR)
Interval 76.8 to 93.4
|
79.5 percentage of participants(SPR)
Interval 63.5 to 90.7
|
73.5 percentage of participants(SPR)
Interval 55.7 to 87.1
|
77.1 percentage of participants(SPR)
Interval 59.9 to 89.6
|
92.3 percentage of participants(SPR)
Interval 79.1 to 98.4
|
81.6 percentage of participants(SPR)
Interval 65.7 to 92.3
|
90.7 percentage of participants(SPR)
Interval 81.7 to 96.2
|
83.8 percentage of participants(SPR)
Interval 68.0 to 93.8
|
97.3 percentage of participants(SPR)
Interval 85.8 to 99.9
|
83.3 percentage of participants(SPR)
Interval 67.2 to 93.6
|
86.8 percentage of participants(SPR)
Interval 71.9 to 95.6
|
84.6 percentage of participants(SPR)
Interval 69.5 to 94.1
|
—
|
|
Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Expressed as SPR
Day 70
|
89.5 percentage of participants(SPR)
Interval 75.2 to 97.1
|
98.7 percentage of participants(SPR)
Interval 93.0 to 100.0
|
89.7 percentage of participants(SPR)
Interval 75.8 to 97.1
|
85.7 percentage of participants(SPR)
Interval 69.7 to 95.2
|
97.2 percentage of participants(SPR)
Interval 85.5 to 99.9
|
90.0 percentage of participants(SPR)
Interval 76.3 to 97.2
|
95.0 percentage of participants(SPR)
Interval 83.1 to 99.4
|
94.7 percentage of participants(SPR)
Interval 87.1 to 98.5
|
94.7 percentage of participants(SPR)
Interval 82.3 to 99.4
|
92.1 percentage of participants(SPR)
Interval 78.6 to 98.3
|
83.3 percentage of participants(SPR)
Interval 67.2 to 93.6
|
91.9 percentage of participants(SPR)
Interval 78.1 to 98.3
|
87.8 percentage of participants(SPR)
Interval 73.8 to 95.9
|
—
|
SECONDARY outcome
Timeframe: Day 28 to Day 182Population: Per-Protocol Analysis Set Population
Percentage of participants with a reciprocal HAI titer ≥ 40 specific for the HA receptor binding domains of vaccine homologous Influenza A/Wisconsin (H1N1 Subtype) on Days 56, 70, and other follow-up time points.
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
n=39 Participants
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as SPR
Day 28
|
100.0 percentage of participants
Interval 91.0 to 100.0
|
98.8 percentage of participants
Interval 93.2 to 100.0
|
100.0 percentage of participants
Interval 91.2 to 100.0
|
100.0 percentage of participants
Interval 90.7 to 100.0
|
100.0 percentage of participants
Interval 90.5 to 100.0
|
100.0 percentage of participants
Interval 91.4 to 100.0
|
97.6 percentage of participants
Interval 87.1 to 99.9
|
100.0 percentage of participants
Interval 95.4 to 100.0
|
100.0 percentage of participants
Interval 91.0 to 100.0
|
100.0 percentage of participants
Interval 91.0 to 100.0
|
97.4 percentage of participants
Interval 86.5 to 99.9
|
100.0 percentage of participants
Interval 91.0 to 100.0
|
97.6 percentage of participants
Interval 87.1 to 99.9
|
—
|
|
Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as SPR
Day 56
|
97.4 percentage of participants
Interval 86.5 to 99.9
|
97.5 percentage of participants
Interval 91.2 to 99.7
|
97.4 percentage of participants
Interval 86.5 to 99.9
|
100.0 percentage of participants
Interval 90.3 to 100.0
|
97.2 percentage of participants
Interval 85.5 to 99.9
|
97.5 percentage of participants
Interval 86.8 to 99.9
|
95.0 percentage of participants
Interval 83.1 to 99.4
|
98.7 percentage of participants
Interval 93.1 to 100.0
|
100.0 percentage of participants
Interval 91.0 to 100.0
|
97.4 percentage of participants
Interval 86.2 to 99.9
|
100.0 percentage of participants
Interval 90.5 to 100.0
|
100.0 percentage of participants
Interval 90.7 to 100.0
|
97.5 percentage of participants
Interval 86.8 to 99.9
|
—
|
|
Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as SPR
Day 84
|
86.8 percentage of participants
Interval 71.9 to 95.6
|
93.6 percentage of participants
Interval 85.7 to 97.9
|
89.7 percentage of participants
Interval 75.8 to 97.1
|
88.2 percentage of participants
Interval 72.5 to 96.7
|
88.6 percentage of participants
Interval 73.3 to 96.8
|
87.2 percentage of participants
Interval 72.6 to 95.7
|
86.8 percentage of participants
Interval 71.9 to 95.6
|
90.8 percentage of participants
Interval 81.9 to 96.2
|
89.5 percentage of participants
Interval 75.2 to 97.1
|
81.6 percentage of participants
Interval 65.7 to 92.3
|
88.2 percentage of participants
Interval 72.5 to 96.7
|
89.2 percentage of participants
Interval 74.6 to 97.0
|
92.7 percentage of participants
Interval 80.1 to 98.5
|
—
|
|
Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as SPR
Day 70
|
100.0 percentage of participants
Interval 90.7 to 100.0
|
98.7 percentage of participants
Interval 93.0 to 100.0
|
100.0 percentage of participants
Interval 91.0 to 100.0
|
100.0 percentage of participants
Interval 90.0 to 100.0
|
100.0 percentage of participants
Interval 90.3 to 100.0
|
100.0 percentage of participants
Interval 91.2 to 100.0
|
97.5 percentage of participants
Interval 86.8 to 99.9
|
98.7 percentage of participants
Interval 92.9 to 100.0
|
100.0 percentage of participants
Interval 90.7 to 100.0
|
100.0 percentage of participants
Interval 90.7 to 100.0
|
100.0 percentage of participants
Interval 90.3 to 100.0
|
97.3 percentage of participants
Interval 85.8 to 99.9
|
100.0 percentage of participants
Interval 91.4 to 100.0
|
—
|
|
Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Expressed as SPR
Day 182
|
86.8 percentage of participants
Interval 71.9 to 95.6
|
89.3 percentage of participants
Interval 80.1 to 95.3
|
79.5 percentage of participants
Interval 63.5 to 90.7
|
88.2 percentage of participants
Interval 72.5 to 96.7
|
77.1 percentage of participants
Interval 59.9 to 89.6
|
87.2 percentage of participants
Interval 72.6 to 95.7
|
76.3 percentage of participants
Interval 59.8 to 88.6
|
86.7 percentage of participants
Interval 76.8 to 93.4
|
75.7 percentage of participants
Interval 58.8 to 88.2
|
73.0 percentage of participants
Interval 55.9 to 86.2
|
83.3 percentage of participants
Interval 67.2 to 93.6
|
73.7 percentage of participants
Interval 56.9 to 86.6
|
89.7 percentage of participants
Interval 75.8 to 97.1
|
—
|
SECONDARY outcome
Timeframe: Day 28 to Day 182Population: Per-Protocol Analysis Set Population
Percentage of participants with a reciprocal HAI titer ≥ 40 specific for the HA receptor binding domains of vaccine homologous Influenza A/Cambodia (H3N2 Subtype) on Days 56, 70, and other follow-up time points.
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
n=39 Participants
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as SPR
Day 28
|
100.0 percentage of participants
Interval 91.0 to 100.0
|
90.0 percentage of participants
Interval 81.2 to 95.6
|
77.5 percentage of participants
Interval 61.5 to 89.2
|
71.1 percentage of participants
Interval 54.1 to 84.6
|
89.2 percentage of participants
Interval 74.6 to 97.0
|
90.2 percentage of participants
Interval 76.9 to 97.3
|
87.8 percentage of participants
Interval 73.8 to 95.9
|
87.2 percentage of participants
Interval 77.7 to 93.7
|
82.1 percentage of participants
Interval 66.5 to 92.5
|
87.2 percentage of participants
Interval 72.6 to 95.7
|
76.9 percentage of participants
Interval 60.7 to 88.9
|
94.9 percentage of participants
Interval 82.7 to 99.4
|
85.4 percentage of participants
Interval 70.8 to 94.4
|
—
|
|
Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as SPR
Day 56
|
89.7 percentage of participants
Interval 75.8 to 97.1
|
86.1 percentage of participants
Interval 76.5 to 92.8
|
79.5 percentage of participants
Interval 63.5 to 90.7
|
72.2 percentage of participants
Interval 54.8 to 85.8
|
77.8 percentage of participants
Interval 60.8 to 89.9
|
87.5 percentage of participants
Interval 73.2 to 95.8
|
82.5 percentage of participants
Interval 67.2 to 92.7
|
82.3 percentage of participants
Interval 72.1 to 90.0
|
74.4 percentage of participants
Interval 57.9 to 87.0
|
78.9 percentage of participants
Interval 62.7 to 90.4
|
75.7 percentage of participants
Interval 58.8 to 88.2
|
76.3 percentage of participants
Interval 59.8 to 88.6
|
75.0 percentage of participants
Interval 58.8 to 87.3
|
—
|
|
Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as SPR
Day 70
|
97.4 percentage of participants
Interval 86.2 to 99.9
|
90.9 percentage of participants
Interval 82.2 to 96.3
|
84.6 percentage of participants
Interval 69.5 to 94.1
|
80.0 percentage of participants
Interval 63.1 to 91.6
|
88.9 percentage of participants
Interval 73.9 to 96.9
|
95.0 percentage of participants
Interval 83.1 to 99.4
|
85.0 percentage of participants
Interval 70.2 to 94.3
|
92.1 percentage of participants
Interval 83.6 to 97.0
|
84.2 percentage of participants
Interval 68.7 to 94.0
|
81.6 percentage of participants
Interval 65.7 to 92.3
|
80.6 percentage of participants
Interval 64.0 to 91.8
|
89.2 percentage of participants
Interval 74.6 to 97.0
|
92.7 percentage of participants
Interval 80.1 to 98.5
|
—
|
|
Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as SPR
Day 84
|
78.9 percentage of participants
Interval 62.7 to 90.4
|
73.1 percentage of participants
Interval 61.8 to 82.5
|
71.8 percentage of participants
Interval 55.1 to 85.0
|
64.7 percentage of participants
Interval 46.5 to 80.3
|
62.9 percentage of participants
Interval 44.9 to 78.5
|
76.9 percentage of participants
Interval 60.7 to 88.9
|
68.4 percentage of participants
Interval 51.3 to 82.5
|
71.1 percentage of participants
Interval 59.5 to 80.9
|
71.1 percentage of participants
Interval 54.1 to 84.6
|
63.2 percentage of participants
Interval 46.0 to 78.2
|
61.8 percentage of participants
Interval 43.6 to 77.8
|
75.7 percentage of participants
Interval 58.8 to 88.2
|
61.0 percentage of participants
Interval 44.5 to 75.8
|
—
|
|
Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Expressed as SPR
Day 182
|
65.8 percentage of participants
Interval 48.6 to 80.4
|
66.7 percentage of participants
Interval 54.8 to 77.1
|
71.8 percentage of participants
Interval 55.1 to 85.0
|
50.0 percentage of participants
Interval 32.4 to 67.6
|
45.7 percentage of participants
Interval 28.8 to 63.4
|
66.7 percentage of participants
Interval 49.8 to 80.9
|
63.2 percentage of participants
Interval 46.0 to 78.2
|
57.3 percentage of participants
Interval 45.4 to 68.7
|
62.2 percentage of participants
Interval 44.8 to 77.5
|
64.9 percentage of participants
Interval 47.5 to 79.8
|
55.6 percentage of participants
Interval 38.1 to 72.1
|
63.2 percentage of participants
Interval 46.0 to 78.2
|
56.4 percentage of participants
Interval 39.6 to 72.2
|
—
|
SECONDARY outcome
Timeframe: Day 28 to Day 182Population: Per-Protocol Analysis Set Population
Percentage of participants with a reciprocal HAI titer ≥ 40 specific for the HA receptor binding domains of vaccine homologous Influenza A/Hong Kong (H3N2 Subtype)on Days 56, 70, and other follow-up time points.
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
n=39 Participants
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as SPR
Day 84
|
89.5 percentage of participants(SPR)
Interval 75.2 to 97.1
|
88.5 percentage of participants(SPR)
Interval 79.2 to 94.6
|
84.6 percentage of participants(SPR)
Interval 69.5 to 94.1
|
85.3 percentage of participants(SPR)
Interval 68.9 to 95.0
|
82.9 percentage of participants(SPR)
Interval 66.4 to 93.4
|
92.3 percentage of participants(SPR)
Interval 79.1 to 98.4
|
86.8 percentage of participants(SPR)
Interval 71.9 to 95.6
|
88.2 percentage of participants(SPR)
Interval 78.7 to 94.4
|
86.8 percentage of participants(SPR)
Interval 71.9 to 95.6
|
81.6 percentage of participants(SPR)
Interval 65.7 to 92.3
|
88.2 percentage of participants(SPR)
Interval 72.5 to 96.7
|
89.2 percentage of participants(SPR)
Interval 74.6 to 97.0
|
87.8 percentage of participants(SPR)
Interval 73.8 to 95.9
|
—
|
|
Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as SPR
Day 182
|
86.8 percentage of participants(SPR)
Interval 71.9 to 95.6
|
84.0 percentage of participants(SPR)
Interval 73.7 to 91.4
|
82.1 percentage of participants(SPR)
Interval 66.5 to 92.5
|
73.5 percentage of participants(SPR)
Interval 55.6 to 87.1
|
77.1 percentage of participants(SPR)
Interval 59.9 to 89.6
|
84.6 percentage of participants(SPR)
Interval 69.5 to 94.1
|
78.9 percentage of participants(SPR)
Interval 62.7 to 90.4
|
85.3 percentage of participants(SPR)
Interval 75.3 to 92.4
|
86.5 percentage of participants(SPR)
Interval 71.2 to 95.5
|
86.5 percentage of participants(SPR)
Interval 71.2 to 95.5
|
88.9 percentage of participants(SPR)
Interval 73.9 to 96.9
|
81.6 percentage of participants(SPR)
Interval 65.7 to 92.3
|
84.6 percentage of participants(SPR)
Interval 69.5 to 94.1
|
—
|
|
Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as SPR
Day 28
|
97.4 percentage of participants(SPR)
Interval 86.5 to 99.9
|
98.8 percentage of participants(SPR)
Interval 93.2 to 100.0
|
92.5 percentage of participants(SPR)
Interval 79.6 to 98.4
|
97.4 percentage of participants(SPR)
Interval 86.2 to 99.9
|
91.9 percentage of participants(SPR)
Interval 78.1 to 98.3
|
95.1 percentage of participants(SPR)
Interval 83.5 to 99.4
|
97.6 percentage of participants(SPR)
Interval 87.1 to 99.9
|
100.0 percentage of participants(SPR)
Interval 95.4 to 100.0
|
100.0 percentage of participants(SPR)
Interval 91.0 to 100.0
|
100.0 percentage of participants(SPR)
Interval 91.0 to 100.0
|
97.4 percentage of participants(SPR)
Interval 86.5 to 99.9
|
100.0 percentage of participants(SPR)
Interval 91.0 to 100.0
|
95.1 percentage of participants(SPR)
Interval 83.5 to 99.4
|
—
|
|
Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as SPR
Day 56
|
100.0 percentage of participants(SPR)
Interval 91.0 to 100.0
|
97.5 percentage of participants(SPR)
Interval 91.2 to 99.7
|
89.7 percentage of participants(SPR)
Interval 75.8 to 97.1
|
97.2 percentage of participants(SPR)
Interval 85.5 to 99.9
|
88.9 percentage of participants(SPR)
Interval 73.9 to 96.9
|
95.0 percentage of participants(SPR)
Interval 83.1 to 99.4
|
95.0 percentage of participants(SPR)
Interval 83.1 to 99.4
|
97.5 percentage of participants(SPR)
Interval 91.2 to 99.7
|
92.3 percentage of participants(SPR)
Interval 79.1 to 98.4
|
100.0 percentage of participants(SPR)
Interval 90.7 to 100.0
|
97.3 percentage of participants(SPR)
Interval 85.8 to 99.9
|
100.0 percentage of participants(SPR)
Interval 90.7 to 100.0
|
95.0 percentage of participants(SPR)
Interval 83.1 to 99.4
|
—
|
|
Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Expressed as SPR
Day 70
|
100.0 percentage of participants(SPR)
Interval 90.7 to 100.0
|
97.4 percentage of participants(SPR)
Interval 90.9 to 99.7
|
94.9 percentage of participants(SPR)
Interval 82.7 to 99.4
|
100.0 percentage of participants(SPR)
Interval 90.0 to 100.0
|
97.2 percentage of participants(SPR)
Interval 85.5 to 99.9
|
97.5 percentage of participants(SPR)
Interval 86.8 to 99.9
|
97.5 percentage of participants(SPR)
Interval 86.8 to 99.9
|
100.0 percentage of participants(SPR)
Interval 95.3 to 100.0
|
100.0 percentage of participants(SPR)
Interval 90.7 to 100.0
|
97.4 percentage of participants(SPR)
Interval 86.2 to 99.9
|
97.2 percentage of participants(SPR)
Interval 85.5 to 99.9
|
100.0 percentage of participants(SPR)
Interval 90.5 to 100.0
|
97.6 percentage of participants(SPR)
Interval 87.1 to 99.9
|
—
|
SECONDARY outcome
Timeframe: Day 28 to Day 182Population: Per-Protocol Analysis Set Population
Percentage of participants with a reciprocal HAI titer ≥ 40 specific for the HA receptor binding domains of vaccine homologous Influenza B/Maryland (Victoria Subtype) on Days 56, 70, and other follow-up time points.
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
n=39 Participants
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as SPR
Day 182
|
84.2 percentage of participants
Interval 68.7 to 94.0
|
88.0 percentage of participants
Interval 78.4 to 94.0
|
89.7 percentage of participants
Interval 75.8 to 97.1
|
73.5 percentage of participants
Interval 55.6 to 87.1
|
80.0 percentage of participants
Interval 63.1 to 91.6
|
84.6 percentage of participants
Interval 69.5 to 94.1
|
76.3 percentage of participants
Interval 59.8 to 88.6
|
84.0 percentage of participants
Interval 73.7 to 91.4
|
73.0 percentage of participants
Interval 55.9 to 86.2
|
81.1 percentage of participants
Interval 64.8 to 92.0
|
75.0 percentage of participants
Interval 57.8 to 87.9
|
76.3 percentage of participants
Interval 59.8 to 88.6
|
79.5 percentage of participants
Interval 63.5 to 90.7
|
—
|
|
Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as SPR
Day 84
|
86.8 percentage of participants
Interval 71.9 to 95.6
|
85.9 percentage of participants
Interval 76.2 to 92.7
|
89.7 percentage of participants
Interval 75.8 to 97.1
|
82.4 percentage of participants
Interval 65.5 to 93.2
|
88.6 percentage of participants
Interval 73.3 to 96.8
|
84.6 percentage of participants
Interval 69.5 to 94.1
|
81.6 percentage of participants
Interval 65.7 to 92.3
|
89.5 percentage of participants
Interval 80.3 to 95.3
|
76.3 percentage of participants
Interval 59.8 to 88.6
|
78.9 percentage of participants
Interval 62.7 to 90.4
|
85.3 percentage of participants
Interval 68.9 to 95.0
|
91.9 percentage of participants
Interval 78.1 to 98.3
|
85.4 percentage of participants
Interval 70.8 to 94.4
|
—
|
|
Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as SPR
Day 56
|
76.9 percentage of participants
Interval 60.7 to 88.9
|
87.3 percentage of participants
Interval 78.0 to 93.8
|
74.4 percentage of participants
Interval 57.9 to 87.0
|
66.7 percentage of participants
Interval 49.0 to 81.4
|
83.3 percentage of participants
Interval 67.2 to 93.6
|
67.5 percentage of participants
Interval 50.9 to 81.4
|
70.0 percentage of participants
Interval 53.5 to 83.4
|
79.7 percentage of participants
Interval 69.2 to 88.0
|
74.4 percentage of participants
Interval 57.9 to 87.0
|
65.8 percentage of participants
Interval 48.6 to 80.4
|
83.8 percentage of participants
Interval 68.0 to 93.8
|
71.1 percentage of participants
Interval 54.1 to 84.6
|
85.0 percentage of participants
Interval 70.2 to 94.3
|
—
|
|
Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as SPR
Day 70
|
84.2 percentage of participants
Interval 68.7 to 94.0
|
92.2 percentage of participants
Interval 83.8 to 97.1
|
82.1 percentage of participants
Interval 66.5 to 92.5
|
74.3 percentage of participants
Interval 56.7 to 87.5
|
88.9 percentage of participants
Interval 73.9 to 96.9
|
77.5 percentage of participants
Interval 61.5 to 89.2
|
77.5 percentage of participants
Interval 61.5 to 89.2
|
88.2 percentage of participants
Interval 78.7 to 94.4
|
81.6 percentage of participants
Interval 65.7 to 92.3
|
76.3 percentage of participants
Interval 59.8 to 88.6
|
88.9 percentage of participants
Interval 73.9 to 96.9
|
81.1 percentage of participants
Interval 64.8 to 92.0
|
87.8 percentage of participants
Interval 73.8 to 95.9
|
—
|
|
Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Expressed as SPR
Day 28
|
87.2 percentage of participants
Interval 72.6 to 95.7
|
90.0 percentage of participants
Interval 81.2 to 95.6
|
77.5 percentage of participants
Interval 61.5 to 89.2
|
73.7 percentage of participants
Interval 56.9 to 86.6
|
75.7 percentage of participants
Interval 58.8 to 88.2
|
78.0 percentage of participants
Interval 62.4 to 89.4
|
73.2 percentage of participants
Interval 57.1 to 85.8
|
83.3 percentage of participants
Interval 73.2 to 90.8
|
76.9 percentage of participants
Interval 60.7 to 88.9
|
66.7 percentage of participants
Interval 49.8 to 80.9
|
82.1 percentage of participants
Interval 66.5 to 92.5
|
76.9 percentage of participants
Interval 60.7 to 88.9
|
80.5 percentage of participants
Interval 65.1 to 91.2
|
—
|
SECONDARY outcome
Timeframe: Day 28 to Day 182Population: Per-Protocol Analysis Set Population
Percentage of participants with a reciprocal HAI titer ≥ 40 specific for the HA receptor binding domains of vaccine homologous Influenza B/Phuket (Yamagata Subtype) on Days 56, 70, and other follow-up time points.
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
n=39 Participants
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as SPR
Day 28
|
97.4 percentage of participants(SPR)
Interval 86.5 to 99.9
|
90.0 percentage of participants(SPR)
Interval 81.2 to 95.6
|
80.0 percentage of participants(SPR)
Interval 64.4 to 90.9
|
57.9 percentage of participants(SPR)
Interval 40.8 to 73.7
|
67.6 percentage of participants(SPR)
Interval 50.2 to 82.0
|
92.7 percentage of participants(SPR)
Interval 80.1 to 98.5
|
73.2 percentage of participants(SPR)
Interval 57.1 to 85.8
|
83.3 percentage of participants(SPR)
Interval 73.2 to 90.8
|
87.2 percentage of participants(SPR)
Interval 72.6 to 95.7
|
74.4 percentage of participants(SPR)
Interval 57.9 to 87.0
|
89.7 percentage of participants(SPR)
Interval 75.8 to 97.1
|
79.5 percentage of participants(SPR)
Interval 63.5 to 90.7
|
85.4 percentage of participants(SPR)
Interval 70.8 to 94.4
|
—
|
|
Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as SPR
Day 56
|
97.4 percentage of participants(SPR)
Interval 86.5 to 99.9
|
89.9 percentage of participants(SPR)
Interval 81.0 to 95.5
|
76.9 percentage of participants(SPR)
Interval 60.7 to 88.9
|
55.6 percentage of participants(SPR)
Interval 38.1 to 72.1
|
66.7 percentage of participants(SPR)
Interval 49.0 to 81.4
|
85.0 percentage of participants(SPR)
Interval 70.2 to 94.3
|
75.0 percentage of participants(SPR)
Interval 58.8 to 87.3
|
77.2 percentage of participants(SPR)
Interval 66.4 to 85.9
|
89.7 percentage of participants(SPR)
Interval 75.8 to 97.1
|
68.4 percentage of participants(SPR)
Interval 51.3 to 82.5
|
89.2 percentage of participants(SPR)
Interval 74.6 to 97.0
|
73.7 percentage of participants(SPR)
Interval 56.9 to 86.6
|
85.0 percentage of participants(SPR)
Interval 70.2 to 94.3
|
—
|
|
Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as SPR
Day 84
|
100.0 percentage of participants(SPR)
Interval 90.7 to 100.0
|
94.9 percentage of participants(SPR)
Interval 87.4 to 98.6
|
94.9 percentage of participants(SPR)
Interval 82.7 to 99.4
|
73.5 percentage of participants(SPR)
Interval 55.6 to 87.1
|
80.0 percentage of participants(SPR)
Interval 63.1 to 91.6
|
97.4 percentage of participants(SPR)
Interval 86.5 to 99.9
|
89.5 percentage of participants(SPR)
Interval 75.2 to 97.1
|
92.1 percentage of participants(SPR)
Interval 83.6 to 97.0
|
92.1 percentage of participants(SPR)
Interval 78.6 to 98.1
|
86.8 percentage of participants(SPR)
Interval 71.9 to 95.6
|
88.2 percentage of participants(SPR)
Interval 72.5 to 96.7
|
89.2 percentage of participants(SPR)
Interval 74.6 to 97.0
|
90.2 percentage of participants(SPR)
Interval 76.9 to 97.3
|
—
|
|
Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as SPR
Day 182
|
92.1 percentage of participants(SPR)
Interval 78.6 to 98.3
|
92.0 percentage of participants(SPR)
Interval 83.4 to 97.0
|
87.2 percentage of participants(SPR)
Interval 72.6 to 95.7
|
73.5 percentage of participants(SPR)
Interval 55.6 to 87.1
|
77.1 percentage of participants(SPR)
Interval 59.9 to 89.6
|
89.7 percentage of participants(SPR)
Interval 75.8 to 97.1
|
76.3 percentage of participants(SPR)
Interval 59.8 to 88.6
|
82.7 percentage of participants(SPR)
Interval 72.2 to 90.4
|
89.2 percentage of participants(SPR)
Interval 74.6 to 97.0
|
83.8 percentage of participants(SPR)
Interval 68.0 to 93.8
|
88.9 percentage of participants(SPR)
Interval 73.9 to 96.9
|
78.9 percentage of participants(SPR)
Interval 62.7 to 90.4
|
89.7 percentage of participants(SPR)
Interval 75.8 to 97.1
|
—
|
|
Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Expressed as SPR
Day 70
|
94.7 percentage of participants(SPR)
Interval 82.3 to 99.4
|
90.9 percentage of participants(SPR)
Interval 82.2 to 96.3
|
87.2 percentage of participants(SPR)
Interval 72.6 to 95.7
|
62.9 percentage of participants(SPR)
Interval 44.9 to 78.5
|
80.6 percentage of participants(SPR)
Interval 64.0 to 91.8
|
90.0 percentage of participants(SPR)
Interval 76.3 to 97.2
|
82.5 percentage of participants(SPR)
Interval 67.2 to 92.7
|
88.2 percentage of participants(SPR)
Interval 78.7 to 94.4
|
89.5 percentage of participants(SPR)
Interval 75.2 to 97.1
|
84.2 percentage of participants(SPR)
Interval 68.7 to 94.0
|
91.7 percentage of participants(SPR)
Interval 77.5 to 98.2
|
86.5 percentage of participants(SPR)
Interval 71.2 to 95.5
|
92.7 percentage of participants(SPR)
Interval 80.1 to 98.5
|
—
|
SECONDARY outcome
Timeframe: Day 28 to Day 182Population: Per-Protocol Analysis Set Population
Percentage of participants with a reciprocal HAI titer ≥ 40 specific for the HA receptor binding domains of vaccine homologous Influenza B/Washington (Victoria Subtype) on Days 56, 70, and other follow-up time points.
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
n=39 Participants
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as SPR
Day 70
|
97.4 percentage of participants(SPR)
Interval 86.2 to 99.9
|
98.7 percentage of participants(SPR)
Interval 93.0 to 100.0
|
97.4 percentage of participants(SPR)
Interval 86.5 to 99.9
|
97.1 percentage of participants(SPR)
Interval 85.1 to 99.9
|
100.0 percentage of participants(SPR)
Interval 90.3 to 100.0
|
92.5 percentage of participants(SPR)
Interval 79.6 to 98.4
|
90.0 percentage of participants(SPR)
Interval 76.3 to 97.2
|
98.7 percentage of participants(SPR)
Interval 92.9 to 100.0
|
94.7 percentage of participants(SPR)
Interval 82.3 to 99.4
|
94.7 percentage of participants(SPR)
Interval 82.3 to 99.4
|
100.0 percentage of participants(SPR)
Interval 90.3 to 100.0
|
94.6 percentage of participants(SPR)
Interval 81.8 to 99.3
|
97.6 percentage of participants(SPR)
Interval 87.1 to 99.9
|
—
|
|
Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as SPR
Day 182
|
78.9 percentage of participants(SPR)
Interval 62.7 to 90.4
|
82.7 percentage of participants(SPR)
Interval 72.2 to 90.4
|
82.1 percentage of participants(SPR)
Interval 66.5 to 92.5
|
76.5 percentage of participants(SPR)
Interval 58.8 to 89.3
|
77.1 percentage of participants(SPR)
Interval 59.9 to 89.6
|
79.5 percentage of participants(SPR)
Interval 63.5 to 90.7
|
71.1 percentage of participants(SPR)
Interval 54.1 to 84.6
|
82.7 percentage of participants(SPR)
Interval 72.2 to 90.4
|
70.3 percentage of participants(SPR)
Interval 53.0 to 84.1
|
81.1 percentage of participants(SPR)
Interval 64.8 to 92.0
|
80.6 percentage of participants(SPR)
Interval 64.0 to 91.8
|
73.7 percentage of participants(SPR)
Interval 56.9 to 86.6
|
82.1 percentage of participants(SPR)
Interval 66.5 to 92.5
|
—
|
|
Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as SPR
Day 84
|
78.9 percentage of participants(SPR)
Interval 62.7 to 90.4
|
83.3 percentage of participants(SPR)
Interval 73.2 to 90.8
|
84.6 percentage of participants(SPR)
Interval 69.5 to 94.1
|
79.4 percentage of participants(SPR)
Interval 62.1 to 91.3
|
82.9 percentage of participants(SPR)
Interval 66.4 to 93.6
|
82.1 percentage of participants(SPR)
Interval 66.5 to 92.5
|
78.9 percentage of participants(SPR)
Interval 62.7 to 90.4
|
85.5 percentage of participants(SPR)
Interval 75.6 to 92.5
|
71.1 percentage of participants(SPR)
Interval 54.1 to 84.6
|
73.7 percentage of participants(SPR)
Interval 56.9 to 86.6
|
82.4 percentage of participants(SPR)
Interval 65.5 to 93.2
|
91.9 percentage of participants(SPR)
Interval 78.1 to 98.3
|
85.4 percentage of participants(SPR)
Interval 70.8 to 94.4
|
—
|
|
Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as SPR
Day 28
|
97.4 percentage of participants(SPR)
Interval 86.5 to 99.9
|
97.5 percentage of participants(SPR)
Interval 91.3 to 99.7
|
100.0 percentage of participants(SPR)
Interval 91.2 to 100.0
|
97.4 percentage of participants(SPR)
Interval 86.2 to 99.9
|
100.0 percentage of participants(SPR)
Interval 90.5 to 100.0
|
95.1 percentage of participants(SPR)
Interval 83.5 to 99.4
|
92.7 percentage of participants(SPR)
Interval 80.1 to 98.5
|
96.2 percentage of participants(SPR)
Interval 89.2 to 99.2
|
92.3 percentage of participants(SPR)
Interval 79.1 to 98.4
|
94.9 percentage of participants(SPR)
Interval 82.7 to 99.4
|
97.4 percentage of participants(SPR)
Interval 86.5 to 99.9
|
94.9 percentage of participants(SPR)
Interval 82.7 to 99.4
|
95.1 percentage of participants(SPR)
Interval 83.5 to 99.4
|
—
|
|
Percentage of Participants With a Reciprocal HAI Titer ≥ 40 Specific for the HA Receptor Binding Domains of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Expressed as SPR
Day 56
|
97.4 percentage of participants(SPR)
Interval 86.5 to 99.9
|
98.7 percentage of participants(SPR)
Interval 93.1 to 100.0
|
97.4 percentage of participants(SPR)
Interval 86.5 to 99.9
|
91.7 percentage of participants(SPR)
Interval 77.5 to 98.2
|
97.2 percentage of participants(SPR)
Interval 85.5 to 99.9
|
90.0 percentage of participants(SPR)
Interval 76.3 to 97.2
|
90.0 percentage of participants(SPR)
Interval 76.3 to 97.2
|
97.5 percentage of participants(SPR)
Interval 91.2 to 99.7
|
89.7 percentage of participants(SPR)
Interval 75.8 to 97.1
|
97.4 percentage of participants(SPR)
Interval 86.2 to 99.9
|
97.3 percentage of participants(SPR)
Interval 85.8 to 99.9
|
94.7 percentage of participants(SPR)
Interval 82.3 to 99.4
|
95.0 percentage of participants(SPR)
Interval 83.1 to 99.4
|
—
|
SECONDARY outcome
Timeframe: Day 0 to Day 182Population: Per Protocol Analysis Set population
MN50 GMTs to the SARS-CoV-2 Wuhan Strain from the matched vaccine construct (and mismatched variant if available), at Days 0, 56, 70, and other follow-up time points.
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
n=40 Participants
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Titers (GMT)
Day 28
|
617.7 geometric mean titer
Interval 470.3 to 811.1
|
476.7 geometric mean titer
Interval 385.0 to 590.2
|
293.4 geometric mean titer
Interval 188.3 to 457.4
|
377.1 geometric mean titer
Interval 275.1 to 516.9
|
729.7 geometric mean titer
Interval 536.6 to 992.2
|
378.9 geometric mean titer
Interval 282.8 to 507.8
|
568.6 geometric mean titer
Interval 419.1 to 771.4
|
331.7 geometric mean titer
Interval 271.8 to 404.8
|
331.6 geometric mean titer
Interval 239.4 to 459.3
|
356.0 geometric mean titer
Interval 274.4 to 462.0
|
469.4 geometric mean titer
Interval 353.4 to 623.4
|
245.1 geometric mean titer
Interval 171.1 to 351.1
|
367.6 geometric mean titer
Interval 262.3 to 515.1
|
—
|
|
MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Titers (GMT)
Day 56
|
432.9 geometric mean titer
Interval 338.4 to 553.7
|
328.5 geometric mean titer
Interval 264.0 to 408.9
|
168.8 geometric mean titer
Interval 110.2 to 258.5
|
290.6 geometric mean titer
Interval 221.9 to 380.6
|
419.0 geometric mean titer
Interval 316.1 to 555.4
|
259.9 geometric mean titer
Interval 192.2 to 351.6
|
452.5 geometric mean titer
Interval 315.1 to 649.9
|
232.4 geometric mean titer
Interval 182.1 to 296.5
|
232.4 geometric mean titer
Interval 167.2 to 323.1
|
226.3 geometric mean titer
Interval 172.1 to 297.6
|
332.6 geometric mean titer
Interval 237.6 to 465.4
|
169.0 geometric mean titer
Interval 124.4 to 229.5
|
226.3 geometric mean titer
Interval 168.9 to 303.2
|
—
|
|
MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Titers (GMT)
Day 70
|
956.0 geometric mean titer
Interval 747.3 to 1223.1
|
554.2 geometric mean titer
Interval 442.7 to 693.6
|
298.0 geometric mean titer
Interval 223.9 to 396.7
|
430.7 geometric mean titer
Interval 315.1 to 588.7
|
665.1 geometric mean titer
Interval 524.5 to 843.4
|
407.9 geometric mean titer
Interval 316.5 to 525.7
|
607.6 geometric mean titer
Interval 462.8 to 797.6
|
286.4 geometric mean titer
Interval 223.6 to 366.8
|
338.0 geometric mean titer
Interval 246.6 to 463.2
|
292.1 geometric mean titer
Interval 216.3 to 394.5
|
579.7 geometric mean titer
Interval 405.8 to 828.1
|
224.2 geometric mean titer
Interval 168.4 to 298.5
|
325.6 geometric mean titer
Interval 245.7 to 431.5
|
—
|
|
MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Titers (GMT)
Day 84
|
1280.0 geometric mean titer
Interval 977.0 to 1676.9
|
731.3 geometric mean titer
Interval 580.5 to 921.2
|
403.2 geometric mean titer
Interval 294.2 to 552.4
|
452.5 geometric mean titer
Interval 364.4 to 562.1
|
932.4 geometric mean titer
Interval 714.1 to 1217.5
|
535.8 geometric mean titer
Interval 416.8 to 688.7
|
905.1 geometric mean titer
Interval 674.7 to 1214.1
|
430.1 geometric mean titer
Interval 347.0 to 533.2
|
478.0 geometric mean titer
Interval 353.2 to 646.9
|
428.4 geometric mean titer
Interval 333.0 to 551.2
|
518.8 geometric mean titer
Interval 365.5 to 736.3
|
320.0 geometric mean titer
Interval 239.9 to 426.9
|
460.5 geometric mean titer
Interval 345.1 to 614.3
|
—
|
|
MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Titers (GMT)
Day 182
|
1403.9 geometric mean titer
Interval 940.5 to 2095.7
|
711.7 geometric mean titer
Interval 501.7 to 1009.7
|
823.5 geometric mean titer
Interval 498.3 to 1360.7
|
702.0 geometric mean titer
Interval 447.8 to 1100.4
|
1000.9 geometric mean titer
Interval 649.0 to 1543.6
|
535.5 geometric mean titer
Interval 347.2 to 826.1
|
895.6 geometric mean titer
Interval 604.0 to 1328.2
|
610.9 geometric mean titer
Interval 421.0 to 886.4
|
721.2 geometric mean titer
Interval 449.4 to 1157.5
|
699.9 geometric mean titer
Interval 406.1 to 1206.1
|
752.4 geometric mean titer
Interval 519.5 to 1089.6
|
503.9 geometric mean titer
Interval 287.7 to 882.7
|
452.5 geometric mean titer
Interval 248.6 to 823.7
|
—
|
|
MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Titers (GMT)
Day 0
|
106.3 geometric mean titer
Interval 78.1 to 144.7
|
127.7 geometric mean titer
Interval 97.2 to 167.8
|
123.4 geometric mean titer
Interval 75.5 to 201.6
|
112.1 geometric mean titer
Interval 82.0 to 153.4
|
140.3 geometric mean titer
Interval 105.3 to 187.1
|
126.3 geometric mean titer
Interval 91.8 to 173.8
|
114.1 geometric mean titer
Interval 79.6 to 163.5
|
158.6 geometric mean titer
Interval 124.6 to 201.8
|
95.6 geometric mean titer
Interval 69.9 to 130.6
|
124.8 geometric mean titer
Interval 93.4 to 166.6
|
116.2 geometric mean titer
Interval 83.6 to 161.5
|
136.3 geometric mean titer
Interval 96.3 to 193.0
|
125.5 geometric mean titer
Interval 87.5 to 180.0
|
—
|
SECONDARY outcome
Timeframe: Day 0 to Day 70Population: Per Protocol Analysis Set population
MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant from the matched vaccine construct (and mismatched variant if available), at Days 0, 56, 70, and other follow-up time points.
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
n=40 Participants
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMT
Day 0
|
10.7 geometric mean titer
Interval 9.7 to 11.9
|
10.7 geometric mean titer
Interval 10.1 to 11.4
|
11.9 geometric mean titer
Interval 9.3 to 15.3
|
10.2 geometric mean titer
Interval 9.8 to 10.6
|
10.2 geometric mean titer
Interval 9.8 to 10.6
|
10.3 geometric mean titer
Interval 9.9 to 10.8
|
10.0 geometric mean titer
Interval 10.0 to 10.0
|
10.8 geometric mean titer
Interval 10.0 to 11.7
|
10.0 geometric mean titer
Interval 10.0 to 10.0
|
10.7 geometric mean titer
Interval 9.6 to 12.0
|
10.4 geometric mean titer
Interval 9.9 to 10.9
|
10.4 geometric mean titer
Interval 9.9 to 10.9
|
10.9 geometric mean titer
Interval 9.4 to 12.6
|
—
|
|
MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMT
Day 28
|
19.0 geometric mean titer
Interval 14.6 to 24.7
|
17.0 geometric mean titer
Interval 14.5 to 19.9
|
12.3 geometric mean titer
Interval 9.8 to 15.4
|
13.1 geometric mean titer
Interval 11.0 to 15.7
|
16.6 geometric mean titer
Interval 13.7 to 20.1
|
12.9 geometric mean titer
Interval 11.2 to 14.8
|
20.7 geometric mean titer
Interval 15.7 to 27.3
|
12.4 geometric mean titer
Interval 11.3 to 13.7
|
13.3 geometric mean titer
Interval 10.9 to 16.2
|
12.4 geometric mean titer
Interval 10.7 to 14.3
|
16.4 geometric mean titer
Interval 12.6 to 21.3
|
11.1 geometric mean titer
Interval 10.2 to 12.1
|
13.4 geometric mean titer
Interval 11.1 to 16.2
|
—
|
|
MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMT
Day 70
|
36.5 geometric mean titer
Interval 27.6 to 48.4
|
24.2 geometric mean titer
Interval 20.1 to 29.0
|
14.8 geometric mean titer
Interval 12.1 to 18.0
|
19.6 geometric mean titer
Interval 15.7 to 24.4
|
23.8 geometric mean titer
Interval 18.1 to 31.2
|
17.1 geometric mean titer
Interval 13.9 to 21.1
|
24.2 geometric mean titer
Interval 18.7 to 31.3
|
15.4 geometric mean titer
Interval 13.4 to 17.8
|
17.6 geometric mean titer
Interval 13.8 to 22.4
|
15.8 geometric mean titer
Interval 13.1 to 19.0
|
21.6 geometric mean titer
Interval 16.0 to 29.3
|
13.2 geometric mean titer
Interval 11.4 to 15.4
|
16.2 geometric mean titer
Interval 13.3 to 19.9
|
—
|
|
MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMT
Day 56
|
15.6 geometric mean titer
Interval 12.5 to 19.5
|
15.0 geometric mean titer
Interval 13.3 to 16.9
|
10.9 geometric mean titer
Interval 9.4 to 12.7
|
13.3 geometric mean titer
Interval 11.2 to 15.8
|
14.4 geometric mean titer
Interval 11.8 to 17.6
|
12.3 geometric mean titer
Interval 10.8 to 14.1
|
18.3 geometric mean titer
Interval 15.0 to 22.4
|
11.7 geometric mean titer
Interval 10.7 to 12.8
|
12.2 geometric mean titer
Interval 10.7 to 13.8
|
11.8 geometric mean titer
Interval 10.5 to 13.2
|
13.9 geometric mean titer
Interval 11.3 to 17.0
|
10.6 geometric mean titer
Interval 9.9 to 11.2
|
13.7 geometric mean titer
Interval 11.3 to 16.6
|
—
|
SECONDARY outcome
Timeframe: Day 28 to Day 182Population: Per Protocol Analysis Set population
MN50 GMTs to the SARS-CoV-2 Wuhan Strain from the matched vaccine construct (and mismatched variant if available), at Days 0, 56, 70, and other follow-up time points.
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
n=40 Participants
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Fold Rise (GMFR)
Day 70
|
9.1 geometric mean fold rise
Interval 6.5 to 12.6
|
4.2 geometric mean fold rise
Interval 3.2 to 5.4
|
2.7 geometric mean fold rise
Interval 2.0 to 3.7
|
3.4 geometric mean fold rise
Interval 2.5 to 4.6
|
4.8 geometric mean fold rise
Interval 3.6 to 6.3
|
3.3 geometric mean fold rise
Interval 2.4 to 4.5
|
5.0 geometric mean fold rise
Interval 3.6 to 6.9
|
1.8 geometric mean fold rise
Interval 1.5 to 2.2
|
3.5 geometric mean fold rise
Interval 2.5 to 4.9
|
2.4 geometric mean fold rise
Interval 1.7 to 3.3
|
5.5 geometric mean fold rise
Interval 3.7 to 8.1
|
1.6 geometric mean fold rise
Interval 1.2 to 2.2
|
2.6 geometric mean fold rise
Interval 1.9 to 3.6
|
—
|
|
MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Fold Rise (GMFR)
Day 182
|
13.3 geometric mean fold rise
Interval 8.0 to 22.2
|
5.5 geometric mean fold rise
Interval 3.9 to 7.8
|
6.0 geometric mean fold rise
Interval 3.2 to 11.1
|
5.2 geometric mean fold rise
Interval 3.1 to 8.7
|
7.2 geometric mean fold rise
Interval 4.8 to 10.7
|
4.2 geometric mean fold rise
Interval 2.5 to 7.1
|
7.4 geometric mean fold rise
Interval 4.6 to 11.7
|
3.8 geometric mean fold rise
Interval 2.6 to 5.6
|
7.4 geometric mean fold rise
Interval 4.4 to 12.6
|
6.0 geometric mean fold rise
Interval 3.4 to 10.4
|
7.0 geometric mean fold rise
Interval 4.4 to 11.0
|
3.5 geometric mean fold rise
Interval 2.0 to 6.2
|
3.3 geometric mean fold rise
Interval 2.6 to 5.6
|
—
|
|
MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Fold Rise (GMFR)
Day 84
|
12.2 geometric mean fold rise
Interval 8.8 to 16.8
|
5.6 geometric mean fold rise
Interval 4.4 to 7.1
|
3.7 geometric mean fold rise
Interval 2.6 to 5.1
|
4.0 geometric mean fold rise
Interval 3.0 to 5.3
|
6.8 geometric mean fold rise
Interval 4.8 to 9.7
|
4.1 geometric mean fold rise
Interval 2.9 to 5.9
|
7.4 geometric mean fold rise
Interval 5.4 to 10.3
|
2.8 geometric mean fold rise
Interval 2.2 to 3.5
|
5.0 geometric mean fold rise
Interval 3.6 to 6.9
|
3.5 geometric mean fold rise
Interval 2.4 to 5.0
|
4.8 geometric mean fold rise
Interval 3.4 to 6.8
|
2.3 geometric mean fold rise
Interval 1.8 to 2.9
|
3.7 geometric mean fold rise
Interval 2.5 to 5.3
|
—
|
|
MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Fold Rise (GMFR)
Day 28
|
5.8 geometric mean fold rise
Interval 4.3 to 7.9
|
3.7 geometric mean fold rise
Interval 3.1 to 4.6
|
2.4 geometric mean fold rise
Interval 1.8 to 3.1
|
3.4 geometric mean fold rise
Interval 2.6 to 4.4
|
5.2 geometric mean fold rise
Interval 3.8 to 7.1
|
3.0 geometric mean fold rise
Interval 2.1 to 4.3
|
5.0 geometric mean fold rise
Interval 3.8 to 6.5
|
2.1 geometric mean fold rise
Interval 1.8 to 2.5
|
3.5 geometric mean fold rise
Interval 2.6 to 4.6
|
2.9 geometric mean fold rise
Interval 2.2 to 3.7
|
4.1 geometric mean fold rise
Interval 3.0 to 5.7
|
1.8 geometric mean fold rise
Interval 1.3 to 2.5
|
2.9 geometric mean fold rise
Interval 2.1 to 4.0
|
—
|
|
MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as Geometric Mean Fold Rise (GMFR)
Day 56
|
4.1 geometric mean fold rise
Interval 3.0 to 5.4
|
2.5 geometric mean fold rise
Interval 2.0 to 3.2
|
1.5 geometric mean fold rise
Interval 1.2 to 2.0
|
2.5 geometric mean fold rise
Interval 1.8 to 3.3
|
3.0 geometric mean fold rise
Interval 2.2 to 4.0
|
2.1 geometric mean fold rise
Interval 1.6 to 2.9
|
3.7 geometric mean fold rise
Interval 2.8 to 5.0
|
1.5 geometric mean fold rise
Interval 1.2 to 1.8
|
2.4 geometric mean fold rise
Interval 1.9 to 3.2
|
1.8 geometric mean fold rise
Interval 1.4 to 2.5
|
3.0 geometric mean fold rise
Interval 2.2 to 4.1
|
1.3 geometric mean fold rise
Interval 0.9 to 1.8
|
1.8 geometric mean fold rise
Interval 1.3 to 2.4
|
—
|
SECONDARY outcome
Timeframe: Day 28 to Day 70Population: Per Protocol Analysis Set population
MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant from the matched vaccine construct (and mismatched variant if available), at Days 0, 56, 70, and other follow-up time points.
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
n=40 Participants
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMFR
Day 56
|
1.5 geometric mean fold rise
Interval 1.2 to 1.8
|
1.4 geometric mean fold rise
Interval 1.3 to 1.5
|
1.0 geometric mean fold rise
Interval 1.0 to 1.1
|
1.3 geometric mean fold rise
Interval 1.1 to 1.5
|
1.4 geometric mean fold rise
Interval 1.2 to 1.7
|
1.2 geometric mean fold rise
Interval 1.0 to 1.4
|
1.8 geometric mean fold rise
Interval 1.5 to 2.2
|
1.1 geometric mean fold rise
Interval 1.0 to 1.2
|
1.2 geometric mean fold rise
Interval 1.1 to 1.4
|
1.1 geometric mean fold rise
Interval 1.0 to 1.2
|
1.3 geometric mean fold rise
Interval 1.1 to 1.6
|
1.0 geometric mean fold rise
Interval 1.0 to 1.1
|
1.3 geometric mean fold rise
Interval 1.1 to 1.5
|
—
|
|
MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMFR
Day 28
|
1.8 geometric mean fold rise
Interval 1.4 to 2.2
|
1.6 geometric mean fold rise
Interval 1.4 to 1.8
|
1.0 geometric mean fold rise
Interval 1.0 to 1.1
|
1.3 geometric mean fold rise
Interval 1.1 to 1.5
|
1.6 geometric mean fold rise
Interval 1.3 to 2.0
|
1.2 geometric mean fold rise
Interval 1.1 to 1.4
|
2.1 geometric mean fold rise
Interval 1.6 to 2.7
|
1.1 geometric mean fold rise
Interval 1.1 to 1.2
|
1.3 geometric mean fold rise
Interval 1.1 to 1.6
|
1.2 geometric mean fold rise
Interval 1.0 to 1.3
|
1.6 geometric mean fold rise
Interval 1.2 to 2.0
|
1.1 geometric mean fold rise
Interval 1.0 to 1.2
|
1.2 geometric mean fold rise
Interval 1.0 to 1.5
|
—
|
|
MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as GMFR
Day 70
|
3.4 geometric mean fold rise
Interval 2.5 to 4.5
|
2.2 geometric mean fold rise
Interval 1.9 to 2.7
|
1.4 geometric mean fold rise
Interval 1.2 to 1.6
|
1.9 geometric mean fold rise
Interval 1.5 to 2.4
|
2.3 geometric mean fold rise
Interval 1.8 to 3.0
|
1.7 geometric mean fold rise
Interval 1.3 to 2.0
|
2.4 geometric mean fold rise
Interval 1.9 to 3.1
|
1.4 geometric mean fold rise
Interval 1.2 to 1.6
|
1.8 geometric mean fold rise
Interval 1.4 to 2.2
|
1.5 geometric mean fold rise
Interval 1.2 to 1.7
|
2.1 geometric mean fold rise
Interval 1.6 to 2.8
|
1.3 geometric mean fold rise
Interval 1.1 to 1.5
|
1.5 geometric mean fold rise
Interval 1.2 to 1.8
|
—
|
SECONDARY outcome
Timeframe: Day 28 to Day 182Population: Per-Protocol Analysis Set Population
MN50 GMTs to the SARS-CoV-2 Wuhan Strain from the matched vaccine construct (and mismatched variant if available), at Days 0, 56, 70, and other follow-up time points.
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
n=40 Participants
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as SCR
Day 28
|
76.9 Percentage of participants
Interval 60.7 to 88.9
|
67.5 Percentage of participants
Interval 56.1 to 77.6
|
42.5 Percentage of participants
Interval 27.0 to 59.1
|
55.3 Percentage of participants
Interval 38.3 to 71.4
|
70.3 Percentage of participants
Interval 53.0 to 84.1
|
41.5 Percentage of participants
Interval 26.3 to 57.9
|
82.9 Percentage of participants
Interval 67.9 to 92.8
|
36.4 Percentage of participants
Interval 25.7 to 48.1
|
61.5 Percentage of participants
Interval 44.6 to 76.6
|
51.3 Percentage of participants
Interval 34.8 to 67.6
|
60.5 Percentage of participants
Interval 43.4 to 76.0
|
28.2 Percentage of participants
Interval 15.0 to 44.9
|
52.5 Percentage of participants
Interval 36.1 to 68.5
|
—
|
|
MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as SCR
Day 56
|
61.5 Percentage of participants
Interval 44.6 to 76.6
|
44.3 Percentage of participants
Interval 33.1 to 55.9
|
17.9 Percentage of participants
Interval 7.5 to 33.5
|
44.4 Percentage of participants
Interval 27.9 to 61.9
|
44.4 Percentage of participants
Interval 27.9 to 61.9
|
37.5 Percentage of participants
Interval 22.7 to 54.2
|
62.5 Percentage of participants
Interval 45.8 to 77.3
|
23.1 Percentage of participants
Interval 14.3 to 34.0
|
33.3 Percentage of participants
Interval 19.1 to 50.2
|
28.9 Percentage of participants
Interval 15.4 to 45.9
|
52.8 Percentage of participants
Interval 35.5 to 69.6
|
10.5 Percentage of participants
Interval 2.9 to 24.8
|
27.5 Percentage of participants
Interval 14.6 to 43.9
|
—
|
|
MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as SCR
Day 70
|
86.8 Percentage of participants
Interval 71.9 to 95.6
|
64.9 Percentage of participants
Interval 53.2 to 75.5
|
48.7 Percentage of participants
Interval 32.4 to 65.2
|
54.3 Percentage of participants
Interval 36.6 to 71.2
|
69.4 Percentage of participants
Interval 51.9 to 83.7
|
52.5 Percentage of participants
Interval 36.1 to 68.5
|
75.0 Percentage of participants
Interval 58.8 to 87.3
|
29.3 Percentage of participants
Interval 19.4 to 41.0
|
55.3 Percentage of participants
Interval 38.3 to 71.4
|
39.5 Percentage of participants
Interval 24.0 to 56.6
|
74.3 Percentage of participants
Interval 56.7 to 87.5
|
29.7 Percentage of participants
Interval 15.9 to 47.0
|
50.0 Percentage of participants
Interval 33.8 to 66.2
|
—
|
|
MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as SCR
Day 182
|
86.7 Percentage of participants
Interval 69.3 to 96.2
|
69.4 Percentage of participants
Interval 56.3 to 80.4
|
60.6 Percentage of participants
Interval 42.1 to 77.1
|
66.7 Percentage of participants
Interval 47.2 to 82.7
|
80.6 Percentage of participants
Interval 62.5 to 92.5
|
54.3 Percentage of participants
Interval 36.6 to 71.2
|
81.8 Percentage of participants
Interval 64.5 to 93.0
|
56.7 Percentage of participants
Interval 44.0 to 68.8
|
72.4 Percentage of participants
Interval 52.8 to 87.3
|
67.7 Percentage of participants
Interval 48.6 to 83.3
|
86.7 Percentage of participants
Interval 69.3 to 96.2
|
65.5 Percentage of participants
Interval 45.7 to 82.1
|
45.2 Percentage of participants
Interval 27.3 to 64.0
|
—
|
|
MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as SCR
Day 84
|
94.7 Percentage of participants
Interval 82.3 to 99.4
|
75.6 Percentage of participants
Interval 64.6 to 84.7
|
61.5 Percentage of participants
Interval 44.6 to 76.6
|
67.6 Percentage of participants
Interval 49.5 to 82.6
|
77.1 Percentage of participants
Interval 59.9 to 89.6
|
53.8 Percentage of participants
Interval 37.2 to 69.9
|
84.2 Percentage of participants
Interval 68.7 to 94.0
|
52.0 Percentage of participants
Interval 40.2 to 63.7
|
71.1 Percentage of participants
Interval 54.1 to 84.6
|
52.6 Percentage of participants
Interval 35.8 to 69.0
|
69.7 Percentage of participants
Interval 51.3 to 84.4
|
35.1 Percentage of participants
Interval 20.2 to 52.5
|
57.5 Percentage of participants
Interval 40.9 to 73.0
|
—
|
SECONDARY outcome
Timeframe: Day 28 to Day 182Population: Per-Protocol Analysis Set Population
MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant from the matched vaccine construct (and mismatched variant if available), at Days 0, 56, 70, and other follow-up time points.
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
n=40 Participants
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as SCR
Day 28
|
17.9 Percentage of participants
Interval 7.5 to 33.5
|
21.3 Percentage of participants
Interval 12.9 to 31.8
|
0 Percentage of participants
Interval 0.0 to 8.8
|
13.2 Percentage of participants
Interval 4.4 to 28.1
|
21.6 Percentage of participants
Interval 9.8 to 38.2
|
7.3 Percentage of participants
Interval 1.5 to 19.9
|
29.3 Percentage of participants
Interval 16.1 to 45.5
|
2.6 Percentage of participants
Interval 0.3 to 9.1
|
12.8 Percentage of participants
Interval 4.3 to 27.4
|
7.7 Percentage of participants
Interval 1.6 to 20.9
|
21.1 Percentage of participants
Interval 9.6 to 37.3
|
0 Percentage of participants
Interval 0.0 to 9.0
|
15.0 Percentage of participants
Interval 5.7 to 29.8
|
—
|
|
MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as SCR
Day 56
|
12.8 Percentage of participants
Interval 4.3 to 27.4
|
8.9 Percentage of participants
Interval 3.6 to 17.4
|
0 Percentage of participants
Interval 0.0 to 9.0
|
11.1 Percentage of participants
Interval 3.1 to 26.1
|
16.7 Percentage of participants
Interval 6.4 to 32.8
|
7.5 Percentage of participants
Interval 1.6 to 20.4
|
22.5 Percentage of participants
Interval 10.8 to 38.5
|
2.6 Percentage of participants
Interval 0.3 to 9.0
|
5.1 Percentage of participants
Interval 0.6 to 17.3
|
2.6 Percentage of participants
Interval 0.1 to 13.8
|
13.9 Percentage of participants
Interval 4.7 to 29.5
|
0 Percentage of participants
Interval 0.0 to 9.3
|
10.0 Percentage of participants
Interval 2.8 to 23.7
|
—
|
|
MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Variant Expressed as SCR
Day 70
|
63.2 Percentage of participants
Interval 46.0 to 78.2
|
32.5 Percentage of participants
Interval 22.2 to 44.1
|
10.3 Percentage of participants
Interval 2.9 to 24.2
|
28.6 Percentage of participants
Interval 14.6 to 46.3
|
41.7 Percentage of participants
Interval 25.5 to 59.2
|
22.5 Percentage of participants
Interval 10.8 to 38.5
|
45.0 Percentage of participants
Interval 29.3 to 61.5
|
14.7 Percentage of participants
Interval 7.6 to 24.7
|
23.7 Percentage of participants
Interval 11.4 to 40.2
|
13.2 Percentage of participants
Interval 4.4 to 28.1
|
31.4 Percentage of participants
Interval 16.9 to 49.3
|
8.1 Percentage of participants
Interval 1.7 to 21.9
|
17.5 Percentage of participants
Interval 7.3 to 32.8
|
—
|
SECONDARY outcome
Timeframe: Day 28 to Day 182Population: Per-Protocol Analysis Set Population
MN50 GMTs to the SARS-CoV-2 Wuhan Strain from the matched vaccine construct (and mismatched variant if available), at Days 0, 56, 70, and other follow-up time points.
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as GMTR
Day 28 (Comparison to SARS-CoV-2 Reference [Group P])
|
—
|
0.70 Geometric mean titer ratio
Interval 0.53 to 0.93
|
0.43 Geometric mean titer ratio
Interval 0.3 to 0.61
|
0.60 Geometric mean titer ratio
Interval 0.42 to 0.84
|
1.05 Geometric mean titer ratio
Interval 0.73 to 1.51
|
0.58 Geometric mean titer ratio
Interval 0.4 to 0.84
|
0.89 Geometric mean titer ratio
Interval 0.64 to 1.23
|
0.44 Geometric mean titer ratio
Interval 0.34 to 0.58
|
0.57 Geometric mean titer ratio
Interval 0.4 to 0.81
|
0.54 Geometric mean titer ratio
Interval 0.39 to 0.74
|
0.74 Geometric mean titer ratio
Interval 0.52 to 1.05
|
0.35 Geometric mean titer ratio
Interval 0.24 to 0.51
|
0.55 Geometric mean titer ratio
Interval 0.38 to 0.79
|
—
|
|
MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as GMTR
Day 56 (Comparison to SARS-CoV-2 Reference [Group P])
|
—
|
0.69 Geometric mean titer ratio
Interval 0.52 to 0.92
|
0.38 Geometric mean titer ratio
Interval 0.27 to 0.53
|
0.64 Geometric mean titer ratio
Interval 0.47 to 0.88
|
0.86 Geometric mean titer ratio
Interval 0.62 to 1.2
|
0.56 Geometric mean titer ratio
Interval 0.4 to 0.79
|
0.97 Geometric mean titer ratio
Interval 0.68 to 1.38
|
0.42 Geometric mean titer ratio
Interval 0.31 to 0.57
|
0.57 Geometric mean titer ratio
Interval 0.41 to 0.79
|
0.49 Geometric mean titer ratio
Interval 0.36 to 0.68
|
0.75 Geometric mean titer ratio
Interval 0.53 to 1.06
|
0.36 Geometric mean titer ratio
Interval 0.26 to 0.5
|
0.69 Geometric mean titer ratio
Interval 0.52 to 0.92
|
—
|
|
MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as GMTR
Day 70 (Comparison to SARS-CoV-2 Reference [Group P]0)
|
—
|
0.53 Geometric mean titer ratio
Interval 0.39 to 0.73
|
0.31 Geometric mean titer ratio
Interval 0.22 to 0.42
|
0.42 Geometric mean titer ratio
Interval 0.29 to 0.6
|
0.64 Geometric mean titer ratio
Interval 0.46 to 0.87
|
0.41 Geometric mean titer ratio
Interval 0.29 to 0.56
|
0.61 Geometric mean titer ratio
Interval 0.43 to 0.85
|
0.24 Geometric mean titer ratio
Interval 0.17 to 0.34
|
0.36 Geometric mean titer ratio
Interval 0.25 to 0.53
|
0.29 Geometric mean titer ratio
Interval 0.2 to 0.42
|
0.61 Geometric mean titer ratio
Interval 0.41 to 0.9
|
0.21 Geometric mean titer ratio
Interval 0.15 to 0.3
|
0.53 Geometric mean titer ratio
Interval 0.39 to 0.73
|
—
|
|
MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as GMTR
Day 84 (Comparison to SARS-CoV-2 Reference [Group P])
|
—
|
0.52 Geometric mean titer ratio
Interval 0.38 to 0.72
|
0.31 Geometric mean titer ratio
Interval 0.22 to 0.43
|
0.34 Geometric mean titer ratio
Interval 0.25 to 0.47
|
0.67 Geometric mean titer ratio
Interval 0.47 to 0.96
|
0.40 Geometric mean titer ratio
Interval 0.28 to 0.56
|
0.67 Geometric mean titer ratio
Interval 0.47 to 0.95
|
0.28 Geometric mean titer ratio
Interval 0.21 to 0.39
|
0.39 Geometric mean titer ratio
Interval 0.27 to 0.56
|
0.32 Geometric mean titer ratio
Interval 0.23 to 0.46
|
0.40 Geometric mean titer ratio
Interval 0.28 to 0.59
|
0.22 Geometric mean titer ratio
Interval 0.16 to 0.3
|
0.34 Geometric mean titer ratio
Interval 0.24 to 0.49
|
—
|
|
MN50 GMTs to the SARS-CoV-2 Wuhan Strain Expressed as GMTR
Day 182 (Comparison to SARS-CoV-2 Reference [Group P])
|
—
|
0.47 Geometric mean titer ratio
Interval 0.27 to 0.8
|
0.56 Geometric mean titer ratio
Interval 0.3 to 1.07
|
0.48 Geometric mean titer ratio
Interval 0.27 to 0.87
|
0.64 Geometric mean titer ratio
Interval 0.37 to 1.13
|
0.37 Geometric mean titer ratio
Interval 0.21 to 0.67
|
0.62 Geometric mean titer ratio
Interval 0.36 to 1.06
|
0.38 Geometric mean titer ratio
Interval 0.21 to 0.69
|
0.52 Geometric mean titer ratio
Interval 0.29 to 0.95
|
0.48 Geometric mean titer ratio
Interval 0.25 to 0.93
|
0.53 Geometric mean titer ratio
Interval 0.32 to 0.9
|
0.32 Geometric mean titer ratio
Interval 0.17 to 0.62
|
0.28 Geometric mean titer ratio
Interval 0.15 to 0.52
|
—
|
SECONDARY outcome
Timeframe: Day 28 to Day 182Population: Per-Protocol Analysis Set Population
MN50 GMTs to the SARS-CoV-2 Omicron BA.1 from the matched vaccine construct (and mismatched variant if available), at Days 0, 56, 70, and other follow-up time points.
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Expressed as GMTR
Day 56 (Comparison to SARS-CoV-2 Reference [Group P])
|
—
|
0.96 Geometric mean titer ratio
Interval 0.78 to 1.18
|
0.70 Geometric mean titer ratio
Interval 0.57 to 0.87
|
0.89 Geometric mean titer ratio
Interval 0.68 to 1.17
|
0.96 Geometric mean titer ratio
Interval 0.72 to 1.28
|
0.81 Geometric mean titer ratio
Interval 0.64 to 1.03
|
1.24 Geometric mean titer ratio
Interval 0.92 to 1.66
|
0.75 Geometric mean titer ratio
Interval 0.63 to 0.9
|
0.82 Geometric mean titer ratio
Interval 0.64 to 1.05
|
0.75 Geometric mean titer ratio
Interval 0.6 to 0.96
|
0.92 Geometric mean titer ratio
Interval 0.7 to 1.21
|
0.70 Geometric mean titer ratio
Interval 0.56 to 0.86
|
0.87 Geometric mean titer ratio
Interval 0.67 to 1.13
|
—
|
|
MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Expressed as GMTR
Day 70 (Comparison to SARS-CoV-2 Reference [Group P]0)
|
—
|
0.66 Geometric mean titer ratio
Interval 0.48 to 0.91
|
0.41 Geometric mean titer ratio
Interval 0.3 to 0.56
|
0.55 Geometric mean titer ratio
Interval 0.38 to 0.78
|
0.67 Geometric mean titer ratio
Interval 0.45 to 0.98
|
0.48 Geometric mean titer ratio
Interval 0.34 to 0.67
|
0.42 Geometric mean titer ratio
Interval 0.32 to 0.55
|
0.75 Geometric mean titer ratio
Interval 0.63 to 0.9
|
0.49 Geometric mean titer ratio
Interval 0.34 to 0.72
|
0.43 Geometric mean titer ratio
Interval 0.31 to 0.6
|
0.61 Geometric mean titer ratio
Interval 0.41 to 0.91
|
0.37 Geometric mean titer ratio
Interval 0.27 to 0.5
|
0.44 Geometric mean titer ratio
Interval 0.32 to 0.61
|
—
|
|
MN50 GMTs to the SARS-CoV-2 Omicron BA.1 Expressed as GMTR
Day 28 (Comparison to SARS-CoV-2 Reference [Group P])
|
—
|
0.90 Geometric mean titer ratio
Interval 0.69 to 1.17
|
0.59 Geometric mean titer ratio
Interval 0.46 to 0.76
|
0.73 Geometric mean titer ratio
Interval 0.54 to 0.99
|
0.93 Geometric mean titer ratio
Interval 0.68 to 1.26
|
0.71 Geometric mean titer ratio
Interval 0.54 to 0.92
|
1.18 Geometric mean titer ratio
Interval 0.81 to 1.71
|
0.65 Geometric mean titer ratio
Interval 0.53 to 0.79
|
0.76 Geometric mean titer ratio
Interval 0.55 to 1.04
|
0.65 Geometric mean titer ratio
Interval 0.5 to 0.86
|
0.91 Geometric mean titer ratio
Interval 0.65 to 1.27
|
0.61 Geometric mean titer ratio
Interval 0.47 to 0.78
|
0.70 Geometric mean titer ratio
Interval 0.52 to 0.93
|
—
|
SECONDARY outcome
Timeframe: Day 0 to Day 182Population: Per Protocol Analysis Set population
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type Influenza A/Brisbane (H1N1 Subtype) and/or antigenically-drifted influenza strains, as measured by an MN assay, expressed as GMT.
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
n=39 Participants
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMT
Day 56
|
1637.7 geometric mean titer
Interval 1018.5 to 2633.5
|
1503.2 geometric mean titer
Interval 1148.5 to 1967.5
|
947.1 geometric mean titer
Interval 607.6 to 1476.4
|
1078.1 geometric mean titer
Interval 772.7 to 1504.0
|
1000.7 geometric mean titer
Interval 632.7 to 1582.8
|
1514.7 geometric mean titer
Interval 733.9 to 1616.7
|
952.5 geometric mean titer
Interval 632.1 to 1435.2
|
1139.6 geometric mean titer
Interval 829.2 to 1566.1
|
954.7 geometric mean titer
Interval 598.4 to 1523.2
|
831.2 geometric mean titer
Interval 536.6 to 1287.7
|
1229.2 geometric mean titer
Interval 750.0 to 2014.5
|
1514.7 geometric mean titer
Interval 952.2 to 2409.5
|
1093.0 geometric mean titer
Interval 775.8 to 1539.8
|
—
|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMT
Day 70
|
1381.8 geometric mean titer
Interval 894.1 to 2135.6
|
2022.0 geometric mean titer
Interval 1538.7 to 2656.9
|
1462.2 geometric mean titer
Interval 995.2 to 2148.6
|
1482.5 geometric mean titer
Interval 1079.9 to 2035.3
|
1768.3 geometric mean titer
Interval 1219.8 to 2563.3
|
1750.8 geometric mean titer
Interval 1213.7 to 2525.8
|
1316.3 geometric mean titer
Interval 916.8 to 1889.8
|
1570.6 geometric mean titer
Interval 1158.4 to 2129.4
|
1463.6 geometric mean titer
Interval 971.7 to 2204.6
|
1062.2 geometric mean titer
Interval 695.6 to 1622.1
|
1756.8 geometric mean titer
Interval 1134.3 to 2720.9
|
2095.7 geometric mean titer
Interval 1346.2 to 3262.4
|
1600.4 geometric mean titer
Interval 1164.6 to 2199.3
|
—
|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMT
Day 182
|
2849.4 geometric mean titer
Interval 1747.4 to 4646.5
|
3339.6 geometric mean titer
Interval 2470.1 to 4515.3
|
2097.3 geometric mean titer
Interval 1424.6 to 3087.6
|
2368.2 geometric mean titer
Interval 1634.0 to 3432.5
|
2287.1 geometric mean titer
Interval 1526.9 to 3425.8
|
2646.0 geometric mean titer
Interval 1739.3 to 4025.4
|
1882.2 geometric mean titer
Interval 1169.0 to 3030.5
|
2846.0 geometric mean titer
Interval 2099.5 to 3857.9
|
2341.7 geometric mean titer
Interval 1486.1 to 3689.9
|
1660.1 geometric mean titer
Interval 1062.9 to 2592.8
|
3172.3 geometric mean titer
Interval 1940.1 to 5187.0
|
2407.0 geometric mean titer
Interval 1310.2 to 4421.9
|
2684.6 geometric mean titer
Interval 1789.3 to 4027.8
|
—
|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMT
Day 0
|
923.8 geometric mean titer
Interval 524.3 to 1627.7
|
844.5 geometric mean titer
Interval 593.8 to 1200.9
|
561.5 geometric mean titer
Interval 350.8 to 898.9
|
737.2 geometric mean titer
Interval 467.1 to 1163.5
|
737.0 geometric mean titer
Interval 443.4 to 1225.0
|
723.6 geometric mean titer
Interval 453.9 to 1153.6
|
865.1 geometric mean titer
Interval 528.4 to 1416.4
|
746.4 geometric mean titer
Interval 515.7 to 1080.5
|
806.4 geometric mean titer
Interval 462.7 to 1405.3
|
794.3 geometric mean titer
Interval 473.6 to 1332.2
|
837.0 geometric mean titer
Interval 501.5 to 1396.8
|
1197.5 geometric mean titer
Interval 678.2 to 2114.6
|
761.1 geometric mean titer
Interval 493.8 to 1173.2
|
—
|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMT
Day 28
|
1935.2 geometric mean titer
Interval 1278.7 to 2929.0
|
1597.5 geometric mean titer
Interval 1225.6 to 2082.1
|
1043.8 geometric mean titer
Interval 692.5 to 1573.3
|
1099.4 geometric mean titer
Interval 796.1 to 1518.3
|
1065.2 geometric mean titer
Interval 689.3 to 1646.0
|
1225.2 geometric mean titer
Interval 833.6 to 1800.6
|
1088.6 geometric mean titer
Interval 744.0 to 1592.8
|
1426.2 geometric mean titer
Interval 1042.0 to 1952.2
|
1102.0 geometric mean titer
Interval 685.5 to 1771.7
|
971.8 geometric mean titer
Interval 629.8 to 1499.4
|
1426.2 geometric mean titer
Interval 858.4 to 2228.9
|
1617.1 geometric mean titer
Interval 1012.2 to 2583.6
|
1173.6 geometric mean titer
Interval 839.5 to 1640.8
|
—
|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMT
Day 84
|
3576.7 geometric mean titer
Interval 2299.3 to 5563.7
|
4673.3 geometric mean titer
Interval 3529.7 to 6187.4
|
3767.7 geometric mean titer
Interval 2509.4 to 5656.7
|
3539.2 geometric mean titer
Interval 2480.9 to 5049.0
|
3530.8 geometric mean titer
Interval 2308.5 to 5400.3
|
4025.5 geometric mean titer
Interval 2712.5 to 5974.2
|
2248.0 geometric mean titer
Interval 1478.4 to 3418.2
|
3979.8 geometric mean titer
Interval 2961.8 to 5347.8
|
3938.5 geometric mean titer
Interval 2499.2 to 6206.5
|
2636.7 geometric mean titer
Interval 1774.8 to 3917.4
|
5100.1 geometric mean titer
Interval 3166.7 to 8213.9
|
4844.1 geometric mean titer
Interval 3089.4 to 7595.6
|
3887.2 geometric mean titer
Interval 2577.5 to 5862.3
|
—
|
SECONDARY outcome
Timeframe: Day 0 to Day 182Population: Per Protocol Analysis Set population
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type Influenza A/Kansas (H3N2 Subtype) and/or antigenically-drifted influenza strains, as measured by an MN assay, expressed as GMT.
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
n=39 Participants
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMT
Day 0
|
162.5 geometric mean titer
Interval 105.9 to 249.4
|
184.4 geometric mean titer
Interval 144.2 to 235.8
|
220.6 geometric mean titer
Interval 153.2 to 317.4
|
153.5 geometric mean titer
Interval 98.9 to 238.2
|
178.9 geometric mean titer
Interval 126.7 to 252.5
|
177.5 geometric mean titer
Interval 130.4 to 241.7
|
203.9 geometric mean titer
Interval 142.7 to 291.3
|
185.3 geometric mean titer
Interval 148.8 to 230.8
|
185.7 geometric mean titer
Interval 123.0 to 280.4
|
276.6 geometric mean titer
Interval 181.4 to 422.0
|
156.4 geometric mean titer
Interval 114.1 to 214.4
|
220.0 geometric mean titer
Interval 154.4 to 313.5
|
218.2 geometric mean titer
Interval 158.2 to 301.0
|
—
|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMT
Day 28
|
1013.1 geometric mean titer
Interval 714.1 to 1437.1
|
794.0 geometric mean titer
Interval 615.3 to 1024.5
|
749.1 geometric mean titer
Interval 416.2 to 1348.3
|
416.9 geometric mean titer
Interval 272.4 to 638.1
|
550.5 geometric mean titer
Interval 370.5 to 817.9
|
654.0 geometric mean titer
Interval 441.1 to 969.9
|
583.6 geometric mean titer
Interval 414.4 to 821.9
|
764.3 geometric mean titer
Interval 577.2 to 1012.0
|
461.8 geometric mean titer
Interval 318.7 to 669.0
|
607.2 geometric mean titer
Interval 399.6 to 922.7
|
713.9 geometric mean titer
Interval 577.2 to 1012.0
|
790.6 geometric mean titer
Interval 521.2 to 1199.2
|
781.7 geometric mean titer
Interval 524.9 to 1164.2
|
—
|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMT
Day 70
|
747.7 geometric mean titer
Interval 519.9 to 1075.3
|
917.5 geometric mean titer
Interval 754.7 to 1115.3
|
922.9 geometric mean titer
Interval 534.9 to 1592.2
|
588.6 geometric mean titer
Interval 392.8 to 882.1
|
812.2 geometric mean titer
Interval 573.8 to 1149.6
|
736.1 geometric mean titer
Interval 537.4 to 1008.3
|
722.8 geometric mean titer
Interval 500.4 to 1044.1
|
899.2 geometric mean titer
Interval 705.9 to 1145.3
|
614.5 geometric mean titer
Interval 443.2 to 852.0
|
772.9 geometric mean titer
Interval 525.0 to 1137.9
|
691.4 geometric mean titer
Interval 455.9 to 1048.5
|
884.9 geometric mean titer
Interval 608.1 to 1287.7
|
866.1 geometric mean titer
Interval 605.8 to 1238.2
|
—
|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMT
Day 84
|
754.5 geometric mean titer
Interval 515.2 to 1104.7
|
874.0 geometric mean titer
Interval 717.5 to 1064.5
|
810.7 geometric mean titer
Interval 475.0 to 1383.9
|
617.5 geometric mean titer
Interval 408.6 to 933.2
|
664.6 geometric mean titer
Interval 457.6 to 965.4
|
802.3 geometric mean titer
Interval 560.7 to 1148.0
|
637.5 geometric mean titer
Interval 431.8 to 941.1
|
907.2 geometric mean titer
Interval 727.8 to 1130.9
|
681.8 geometric mean titer
Interval 487.6 to 953.5
|
768.0 geometric mean titer
Interval 537.2 to 1098.1
|
714.4 geometric mean titer
Interval 470.5 to 1084.8
|
865.7 geometric mean titer
Interval 608.7 to 1231.1
|
902.3 geometric mean titer
Interval 629.0 to 1294.3
|
—
|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMT
Day 182
|
510.1 geometric mean titer
Interval 356.1 to 730.6
|
611.6 geometric mean titer
Interval 487.9 to 766.6
|
520.7 geometric mean titer
Interval 315.5 to 859.2
|
339.1 geometric mean titer
Interval 224.4 to 512.4
|
449.5 geometric mean titer
Interval 308.6 to 654.9
|
539.1 geometric mean titer
Interval 384.3 to 756.2
|
436.4 geometric mean titer
Interval 301.2 to 632.4
|
563.7 geometric mean titer
Interval 444.7 to 714.7
|
415.6 geometric mean titer
Interval 296.7 to 582.0
|
528.7 geometric mean titer
Interval 372.2 to 751.0
|
486.3 geometric mean titer
Interval 328.4 to 720.2
|
497.1 geometric mean titer
Interval 344.6 to 717.0
|
547.9 geometric mean titer
Interval 376.6 to 797.1
|
—
|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMT
Day 56
|
788.9 geometric mean titer
Interval 552.7 to 1126.0
|
682.7 geometric mean titer
Interval 531.1 to 877.5
|
613.1 geometric mean titer
Interval 339.6 to 1106.7
|
416.9 geometric mean titer
Interval 272.4 to 638.1
|
550.5 geometric mean titer
Interval 370.5 to 817.9
|
654.0 geometric mean titer
Interval 441.1 to 969.9
|
583.6 geometric mean titer
Interval 414.4 to 821.9
|
764.3 geometric mean titer
Interval 577.2 to 1012.0
|
394.5 geometric mean titer
Interval 273.2 to 569.7
|
561.4 geometric mean titer
Interval 368.2 to 856.0
|
544.4 geometric mean titer
Interval 359.7 to 823.8
|
650.7 geometric mean titer
Interval 419.5 to 1009.3
|
688.7 geometric mean titer
Interval 464.4 to 1021.2
|
—
|
SECONDARY outcome
Timeframe: Day 0 to Day 182Population: Per Protocol Analysis Set population
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type Influenza A/Wisconsin (H1N1 Subtype) and/or antigenically-drifted influenza strains, as measured by an MN assay, expressed as GMT.
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
n=39 Participants
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMT
Day 0
|
99.8 geometric mean titer
Interval 64.7 to 153.8
|
88.8 geometric mean titer
Interval 66.5 to 118.7
|
64.3 geometric mean titer
Interval 53.4 to 99.0
|
56.0 geometric mean titer
Interval 43.2 to 74.6
|
71.9 geometric mean titer
Interval 54.0 to 100.8
|
74.9 geometric mean titer
Interval 55.2 to 111.4
|
74.9 geometric mean titer
Interval 55.2 to 117.3
|
80.5 geometric mean titer
Interval 69.6 to 126.0
|
84.3 geometric mean titer
Interval 50.6 to 123.6
|
87.2 geometric mean titer
Interval 52.9 to 110.4
|
76.7 geometric mean titer
Interval 74.6 to 150.7
|
95.5 geometric mean titer
Interval 61.4 to 152.7
|
71.8 geometric mean titer
Interval 49.7 to 103.7
|
—
|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMT
Day 28
|
112.5 geometric mean titer
Interval 73.4 to 172.4
|
103.9 geometric mean titer
Interval 78.6 to 137.2
|
72.7 geometric mean titer
Interval 53.4 to 99.0
|
56.7 geometric mean titer
Interval 43.2 to 74.6
|
73.8 geometric mean titer
Interval 54.0 to 100.8
|
78.4 geometric mean titer
Interval 55.2 to 111.4
|
80.4 geometric mean titer
Interval 55.2 to 117.3
|
93.7 geometric mean titer
Interval 69.6 to 126.0
|
79.1 geometric mean titer
Interval 50.6 to 123.6
|
76.4 geometric mean titer
Interval 52.9 to 110.4
|
106.0 geometric mean titer
Interval 74.6 to 150.7
|
96.8 geometric mean titer
Interval 61.4 to 152.7
|
79.0 geometric mean titer
Interval 54.2 to 115.1
|
—
|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMT
Day 56
|
106.7 geometric mean titer
Interval 69.2 to 164.4
|
95.3 geometric mean titer
Interval 72.7 to 125.1
|
68.0 geometric mean titer
Interval 50.6 to 91.5
|
58.2 geometric mean titer
Interval 43.6 to 77.7
|
67.5 geometric mean titer
Interval 50.1 to 91.1
|
73.4 geometric mean titer
Interval 51.7 to 104.3
|
68.9 geometric mean titer
Interval 48.1 to 98.8
|
78.9 geometric mean titer
Interval 59.9 to 104.0
|
76.0 geometric mean titer
Interval 49.9 to 115.9
|
69.5 geometric mean titer
Interval 49.5 to 97.5
|
87.9 geometric mean titer
Interval 62.5 to 123.6
|
85.0 geometric mean titer
Interval 54.1 to 133.6
|
77.4 geometric mean titer
Interval 53.4 to 112.4
|
—
|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMT
Day 84
|
126.1 geometric mean titer
Interval 81.4 to 195.4
|
135.6 geometric mean titer
Interval 102.8 to 178.9
|
87.5 geometric mean titer
Interval 62.9 to 121.8
|
87.1 geometric mean titer
Interval 61.6 to 123.2
|
100.0 geometric mean titer
Interval 70.4 to 142.0
|
115.5 geometric mean titer
Interval 76.9 to 173.3
|
79.9 geometric mean titer
Interval 54.8 to 116.5
|
115.9 geometric mean titer
Interval 85.1 to 157.9
|
101.8 geometric mean titer
Interval 64.7 to 160.2
|
81.1 geometric mean titer
Interval 57.1 to 115.1
|
154.7 geometric mean titer
Interval 101.0 to 236.8
|
129.5 geometric mean titer
Interval 82.1 to 204.3
|
113.6 geometric mean titer
Interval 76.8 to 168.0
|
—
|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMT
Day 182
|
104.1 geometric mean titer
Interval 67.2 to 161.4
|
97.4 geometric mean titer
Interval 74.8 to 126.7
|
66.0 geometric mean titer
Interval 50.0 to 87.3
|
64.6 geometric mean titer
Interval 47.6 to 87.6
|
81.1 geometric mean titer
Interval 59.0 to 111.6
|
86.3 geometric mean titer
Interval 58.0 to 128.5
|
68.9 geometric mean titer
Interval 47.3 to 100.2
|
92.9 geometric mean titer
Interval 68.9 to 125.1
|
80.1 geometric mean titer
Interval 51.8 to 123.8
|
66.3 geometric mean titer
Interval 48.2 to 91.3
|
115.3 geometric mean titer
Interval 81.2 to 163.8
|
95.8 geometric mean titer
Interval 62.0 to 148.1
|
89.9 geometric mean titer
Interval 62.6 to 129.3
|
—
|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMT
Day 70
|
109.8 geometric mean titer
Interval 71.8 to 168.1
|
122.6 geometric mean titer
Interval 92.2 to 163.1
|
78.1 geometric mean titer
Interval 56.1 to 108.8
|
74.4 geometric mean titer
Interval 54.3 to 102.1
|
96.3 geometric mean titer
Interval 68.9 to 134.8
|
97.5 geometric mean titer
Interval 65.8 to 144.3
|
77.2 geometric mean titer
Interval 53.0 to 112.5
|
102.7 geometric mean titer
Interval 75.8 to 139.0
|
90.5 geometric mean titer
Interval 58.3 to 140.4
|
74.6 geometric mean titer
Interval 52.5 to 105.9
|
114.8 geometric mean titer
Interval 81.0 to 162.6
|
113.3 geometric mean titer
Interval 73.2 to 175.3
|
94.0 geometric mean titer
Interval 64.7 to 136.7
|
—
|
SECONDARY outcome
Timeframe: Day 0 to Day 182Population: Per Protocol Analysis Set population
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type Influenza A/Cambodia (H3N2 Subtype) and/or antigenically-drifted influenza strains, as measured by an MN assay, expressed as GMT.
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
n=39 Participants
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMT
Day 182
|
34.6 geometric mean titer
Interval 25.8 to 46.2
|
40.4 geometric mean titer
Interval 32.7 to 50.0
|
48.2 geometric mean titer
Interval 30.6 to 76.0
|
38.6 geometric mean titer
Interval 26.8 to 55.5
|
42.1 geometric mean titer
Interval 31.0 to 57.1
|
40.5 geometric mean titer
Interval 28.5 to 57.6
|
37.1 geometric mean titer
Interval 25.3 to 54.3
|
35.5 geometric mean titer
Interval 28.4 to 44.4
|
39.6 geometric mean titer
Interval 27.2 to 57.6
|
32.9 geometric mean titer
Interval 23.0 to 47.2
|
44.7 geometric mean titer
Interval 29.7 to 67.3
|
45.9 geometric mean titer
Interval 31.9 to 65.9
|
32.2 geometric mean titer
Interval 24.1 to 43.1
|
—
|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMT
Day 0
|
28.5 geometric mean titer
Interval 22.1 to 36.8
|
29.1 geometric mean titer
Interval 24.9 to 33.9
|
31.6 geometric mean titer
Interval 25.7 to 38.9
|
29.0 geometric mean titer
Interval 21.8 to 38.4
|
30.3 geometric mean titer
Interval 23.2 to 39.4
|
28.4 geometric mean titer
Interval 22.6 to 35.7
|
30.8 geometric mean titer
Interval 23.5 to 40.5
|
26.7 geometric mean titer
Interval 22.4 to 31.7
|
32.7 geometric mean titer
Interval 23.9 to 44.8
|
27.5 geometric mean titer
Interval 21.0 to 36.1
|
24.6 geometric mean titer
Interval 19.0 to 32.1
|
30.6 geometric mean titer
Interval 23.1 to 40.5
|
24.2 geometric mean titer
Interval 19.6 to 29.8
|
—
|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMT
Day 28
|
51.2 geometric mean titer
Interval 36.9 to 70.9
|
56.5 geometric mean titer
Interval 44.6 to 71.4
|
64.3 geometric mean titer
Interval 39.9 to 103.8
|
43.7 geometric mean titer
Interval 30.4 to 62.7
|
50.8 geometric mean titer
Interval 36.1 to 71.4
|
61.6 geometric mean titer
Interval 41.4 to 91.8
|
45.9 geometric mean titer
Interval 33.5 to 62.8
|
48.4 geometric mean titer
Interval 37.5 to 62.5
|
45.2 geometric mean titer
Interval 31.4 to 64.9
|
40.5 geometric mean titer
Interval 28.5 to 57.5
|
63.4 geometric mean titer
Interval 42.3 to 95.1
|
59.4 geometric mean titer
Interval 39.2 to 89.8
|
39.2 geometric mean titer
Interval 27.4 to 56.2
|
—
|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMT
Day 84
|
39.0 geometric mean titer
Interval 28.8 to 52.9
|
51.4 geometric mean titer
Interval 40.9 to 64.7
|
64.5 geometric mean titer
Interval 39.7 to 104.8
|
49.3 geometric mean titer
Interval 32.7 to 74.4
|
54.5 geometric mean titer
Interval 38.9 to 76.4
|
54.7 geometric mean titer
Interval 36.8 to 81.3
|
44.6 geometric mean titer
Interval 30.5 to 65.4
|
45.9 geometric mean titer
Interval 35.8 to 58.7
|
48.9 geometric mean titer
Interval 33.4 to 71.7
|
41.9 geometric mean titer
Interval 28.7 to 61.2
|
66.4 geometric mean titer
Interval 42.0 to 104.8
|
62.4 geometric mean titer
Interval 42.0 to 92.9
|
39.3 geometric mean titer
Interval 28.3 to 54.5
|
—
|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMT
Day 70
|
39.5 geometric mean titer
Interval 28.3 to 54.9
|
57.8 geometric mean titer
Interval 46.1 to 72.3
|
71.2 geometric mean titer
Interval 43.9 to 115.2
|
51.7 geometric mean titer
Interval 34.6 to 77.2
|
56.6 geometric mean titer
Interval 40.1 to 79.8
|
63.2 geometric mean titer
Interval 43.6 to 91.5
|
50.8 geometric mean titer
Interval 35.6 to 72.4
|
51.9 geometric mean titer
Interval 40.3 to 66.8
|
51.0 geometric mean titer
Interval 34.7 to 75.0
|
43.5 geometric mean titer
Interval 29.9 to 63.2
|
55.6 geometric mean titer
Interval 35.6 to 86.6
|
63.1 geometric mean titer
Interval 42.2 to 94.4
|
43.1 geometric mean titer
Interval 30.6 to 60.7
|
—
|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMT
Day 56
|
42.9 geometric mean titer
Interval 30.9 to 59.5
|
51.1 geometric mean titer
Interval 40.9 to 63.9
|
56.9 geometric mean titer
Interval 35.2 to 91.9
|
42.1 geometric mean titer
Interval 28.9 to 61.3
|
45.7 geometric mean titer
Interval 33.0 to 63.5
|
46.6 geometric mean titer
Interval 32.2 to 67.5
|
40.7 geometric mean titer
Interval 29.7 to 55.8
|
43.3 geometric mean titer
Interval 34.2 to 54.9
|
41.3 geometric mean titer
Interval 28.6 to 59.6
|
37.8 geometric mean titer
Interval 26.1 to 54.6
|
49.7 geometric mean titer
Interval 33.0 to 74.8
|
51.6 geometric mean titer
Interval 35.2 to 75.7
|
36.5 geometric mean titer
Interval 26.4 to 50.5
|
—
|
SECONDARY outcome
Timeframe: Day 0 to Day 182Population: Per Protocol Analysis Set population
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type Influenza A/Hong Kong (H3N2 Subtype) and/or antigenically-drifted influenza strains, as measured by an MN assay, expressed as GMT.
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
n=39 Participants
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMT
Day 0
|
68.7 geometric mean titer
Interval 44.4 to 106.2
|
74.6 geometric mean titer
Interval 57.1 to 97.5
|
64.4 geometric mean titer
Interval 43.3 to 95.8
|
64.4 geometric mean titer
Interval 40.6 to 102.2
|
60.9 geometric mean titer
Interval 40.6 to 91.4
|
67.3 geometric mean titer
Interval 45.5 to 99.7
|
77.0 geometric mean titer
Interval 48.4 to 122.4
|
57.0 geometric mean titer
Interval 43.7 to 74.5
|
69.6 geometric mean titer
Interval 44.3 to 109.3
|
71.1 geometric mean titer
Interval 43.5 to 116.3
|
50.0 geometric mean titer
Interval 33.4 to 74.8
|
89.4 geometric mean titer
Interval 55.8 to 143.4
|
55.9 geometric mean titer
Interval 37.9 to 82.5
|
—
|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMT
Day 84
|
122.4 geometric mean titer
Interval 76.9 to 194.8
|
154.8 geometric mean titer
Interval 114.2 to 209.7
|
202.2 geometric mean titer
Interval 106.1 to 385.5
|
143.1 geometric mean titer
Interval 84.6 to 241.9
|
130.0 geometric mean titer
Interval 82.2 to 205.7
|
157.2 geometric mean titer
Interval 94.2 to 262.4
|
143.5 geometric mean titer
Interval 84.8 to 242.9
|
150.2 geometric mean titer
Interval 110.5 to 204.1
|
144.5 geometric mean titer
Interval 90.3 to 231.3
|
161.5 geometric mean titer
Interval 96.4 to 270.5
|
150.9 geometric mean titer
Interval 92.2 to 246.9
|
212.1 geometric mean titer
Interval 121.4 to 370.7
|
130.0 geometric mean titer
Interval 82.3 to 205.5
|
—
|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMT
Day 182
|
101.4 geometric mean titer
Interval 65.0 to 158.1
|
113.5 geometric mean titer
Interval 82.3 to 156.6
|
138.0 geometric mean titer
Interval 74.8 to 254.5
|
92.7 geometric mean titer
Interval 55.1 to 156.0
|
101.2 geometric mean titer
Interval 64.2 to 159.6
|
119.3 geometric mean titer
Interval 71.7 to 198.5
|
109.3 geometric mean titer
Interval 67.2 to 177.8
|
98.5 geometric mean titer
Interval 72.1 to 134.5
|
101.9 geometric mean titer
Interval 65.5 to 158.5
|
118.3 geometric mean titer
Interval 70.0 to 199.8
|
102.5 geometric mean titer
Interval 62.7 to 167.6
|
134.7 geometric mean titer
Interval 78.8 to 230.3
|
103.2 geometric mean titer
Interval 65.3 to 163.2
|
—
|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMT
Day 28
|
165.8 geometric mean titer
Interval 105.5 to 260.5
|
162.5 geometric mean titer
Interval 120.4 to 219.5
|
167.7 geometric mean titer
Interval 86.8 to 324.2
|
113.1 geometric mean titer
Interval 67.5 to 189.5
|
123.0 geometric mean titer
Interval 77.9 to 194.3
|
154.2 geometric mean titer
Interval 89.9 to 264.5
|
141.7 geometric mean titer
Interval 88.8 to 226.2
|
152.9 geometric mean titer
Interval 111.7 to 209.5
|
110.7 geometric mean titer
Interval 70.6 to 173.5
|
136.1 geometric mean titer
Interval 79.6 to 232.8
|
157.2 geometric mean titer
Interval 96.6 to 256.1
|
209.5 geometric mean titer
Interval 117.4 to 373.6
|
128.7 geometric mean titer
Interval 81.1 to 204.2
|
—
|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMT
Day 56
|
135.9 geometric mean titer
Interval 85.4 to 216.2
|
141.2 geometric mean titer
Interval 104.5 to 190.6
|
141.8 geometric mean titer
Interval 74.7 to 269.2
|
100.6 geometric mean titer
Interval 59.6 to 169.8
|
102.6 geometric mean titer
Interval 64.1 to 164.4
|
116.7 geometric mean titer
Interval 70.7 to 192.8
|
120.8 geometric mean titer
Interval 75.8 to 192.4
|
120.2 geometric mean titer
Interval 86.7 to 166.5
|
98.4 geometric mean titer
Interval 64.2 to 150.9
|
128.4 geometric mean titer
Interval 74.1 to 222.6
|
112.3 geometric mean titer
Interval 68.3 to 184.6
|
182.5 geometric mean titer
Interval 104.0 to 320.4
|
104.6 geometric mean titer
Interval 65.9 to 165.9
|
—
|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMT
Day 70
|
133.6 geometric mean titer
Interval 81.8 to 218.3
|
174.2 geometric mean titer
Interval 129.6 to 234.2
|
194.0 geometric mean titer
Interval 100.7 to 373.8
|
145.0 geometric mean titer
Interval 87.3 to 240.6
|
139.8 geometric mean titer
Interval 89.8 to 217.7
|
165.5 geometric mean titer
Interval 99.9 to 274.3
|
163.2 geometric mean titer
Interval 101.1 to 263.4
|
160.0 geometric mean titer
Interval 117.2 to 218.3
|
129.3 geometric mean titer
Interval 81.9 to 204.1
|
155.5 geometric mean titer
Interval 92.0 to 262.7
|
129.7 geometric mean titer
Interval 78.6 to 214.0
|
225.9 geometric mean titer
Interval 129.2 to 395.0
|
142.6 geometric mean titer
Interval 90.6 to 224.5
|
—
|
SECONDARY outcome
Timeframe: Day 0 to Day 182Population: Per Protocol Analysis Set population
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type Influenza B/Phuket (Yamagata Subtype) and/or antigenically-drifted influenza strains, as measured by an MN assay, expressed as GMT.
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
n=39 Participants
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMT
Day 84
|
135.0 geometric mean titer
Interval 103.6 to 176.0
|
195.6 geometric mean titer
Interval 155.4 to 246.2
|
137.8 geometric mean titer
Interval 97.4 to 194.9
|
120.1 geometric mean titer
Interval 89.5 to 161.2
|
143.5 geometric mean titer
Interval 101.7 to 202.6
|
159.5 geometric mean titer
Interval 115.2 to 220.7
|
117.2 geometric mean titer
Interval 87.0 to 157.9
|
144.9 geometric mean titer
Interval 117.7 to 178.4
|
135.9 geometric mean titer
Interval 102.7 to 179.8
|
120.7 geometric mean titer
Interval 89.8 to 162.1
|
187.7 geometric mean titer
Interval 125.0 to 282.0
|
129.6 geometric mean titer
Interval 92.6 to 181.5
|
187.5 geometric mean titer
Interval 133.9 to 262.6
|
—
|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMT
Day 182
|
118.3 geometric mean titer
Interval 90.3 to 155.1
|
158.7 geometric mean titer
Interval 125.9 to 200.2
|
100.0 geometric mean titer
Interval 72.1 to 138.8
|
83.0 geometric mean titer
Interval 60.1 to 114.8
|
121.0 geometric mean titer
Interval 85.8 to 170.7
|
125.7 geometric mean titer
Interval 92.2 to 171.4
|
96.3 geometric mean titer
Interval 72.8 to 127.3
|
108.4 geometric mean titer
Interval 87.9 to 133.7
|
101.4 geometric mean titer
Interval 77.6 to 132.5
|
91.9 geometric mean titer
Interval 69.5 to 121.6
|
142.5 geometric mean titer
Interval 99.2 to 204.7
|
106.2 geometric mean titer
Interval 79.5 to 142.0
|
128.1 geometric mean titer
Interval 92.6 to 177.3
|
—
|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMT
Day 0
|
65.2 geometric mean titer
Interval 50.8 to 83.5
|
69.4 geometric mean titer
Interval 57.9 to 83.2
|
76.9 geometric mean titer
Interval 57.7 to 102.5
|
57.8 geometric mean titer
Interval 44.0 to 75.9
|
65.0 geometric mean titer
Interval 50.0 to 84.7
|
60.8 geometric mean titer
Interval 49.0 to 75.3
|
69.9 geometric mean titer
Interval 53.5 to 91.2
|
61.3 geometric mean titer
Interval 52.5 to 71.6
|
66.4 geometric mean titer
Interval 53.1 to 83.1
|
62.1 geometric mean titer
Interval 48.7 to 79.1
|
69.0 geometric mean titer
Interval 53.7 to 88.5
|
67.6 geometric mean titer
Interval 52.6 to 86.9
|
63.0 geometric mean titer
Interval 49.1 to 80.9
|
—
|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMT
Day 28
|
111.5 geometric mean titer
Interval 83.8 to 148.4
|
118.4 geometric mean titer
Interval 95.0 to 147.5
|
97.7 geometric mean titer
Interval 70.7 to 134.9
|
63.3 geometric mean titer
Interval 48.5 to 82.4
|
79.7 geometric mean titer
Interval 59.1 to 107.6
|
97.5 geometric mean titer
Interval 69.0 to 137.7
|
87.8 geometric mean titer
Interval 66.9 to 115.3
|
89.6 geometric mean titer
Interval 74.0 to 108.4
|
85.1 geometric mean titer
Interval 65.6 to 110.5
|
73.1 geometric mean titer
Interval 57.1 to 93.6
|
111.9 geometric mean titer
Interval 82.4 to 152.1
|
89.9 geometric mean titer
Interval 66.9 to 120.9
|
99.0 geometric mean titer
Interval 71.5 to 136.9
|
—
|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMT
Day 56
|
102.0 geometric mean titer
Interval 75.8 to 137.3
|
110.2 geometric mean titer
Interval 87.4 to 138.9
|
86.4 geometric mean titer
Interval 62.5 to 119.4
|
63.0 geometric mean titer
Interval 47.7 to 83.1
|
76.3 geometric mean titer
Interval 56.3 to 103.3
|
89.9 geometric mean titer
Interval 63.1 to 127.9
|
84.2 geometric mean titer
Interval 64.7 to 109.6
|
81.3 geometric mean titer
Interval 67.5 to 98.0
|
79.4 geometric mean titer
Interval 61.7 to 102.4
|
70.0 geometric mean titer
Interval 54.5 to 89.9
|
92.8 geometric mean titer
Interval 66.5 to 129.6
|
84.2 geometric mean titer
Interval 61.7 to 114.8
|
91.5 geometric mean titer
Interval 66.3 to 126.3
|
—
|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMT
Day 70
|
95.3 geometric mean titer
Interval 71.3 to 127.4
|
132.3 geometric mean titer
Interval 105.0 to 166.7
|
110.8 geometric mean titer
Interval 78.5 to 156.2
|
73.9 geometric mean titer
Interval 54.7 to 100.0
|
100.3 geometric mean titer
Interval 73.0 to 137.8
|
118.6 geometric mean titer
Interval 84.6 to 166.2
|
95.5 geometric mean titer
Interval 71.1 to 128.2
|
96.0 geometric mean titer
Interval 77.8 to 118.5
|
98.3 geometric mean titer
Interval 75.5 to 127.9
|
82.3 geometric mean titer
Interval 62.7 to 108.1
|
135.9 geometric mean titer
Interval 97.3 to 189.9
|
93.4 geometric mean titer
Interval 67.8 to 128.8
|
109.8 geometric mean titer
Interval 79.5 to 151.6
|
—
|
SECONDARY outcome
Timeframe: Day 0 to Day 182Population: Per Protocol Analysis Set population
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type Influenza B/Maryland (Victoria Subtype) and/or antigenically-drifted influenza strains, as measured by an MN assay, expressed as GMT.
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
n=39 Participants
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype) Expressed as GMT
Day 0
|
129.4 geometric mean titer
Interval 97.4 to 171.8
|
153.4 geometric mean titer
Interval 127.0 to 185.3
|
153.1 geometric mean titer
Interval 113.5 to 206.4
|
136.2 geometric mean titer
Interval 103.3 to 179.7
|
125.9 geometric mean titer
Interval 93.7 to 169.1
|
145.0 geometric mean titer
Interval 114.3 to 183.9
|
148.2 geometric mean titer
Interval 115.9 to 189.4
|
163.7 geometric mean titer
Interval 138.0 to 194.2
|
167.2 geometric mean titer
Interval 128.2 to 218.1
|
162.5 geometric mean titer
Interval 123.5 to 213.9
|
176.9 geometric mean titer
Interval 132.4 to 236.4
|
152.1 geometric mean titer
Interval 121.2 to 191.0
|
148.6 geometric mean titer
Interval 111.5 to 198.0
|
—
|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype) Expressed as GMT
Day 28
|
280.6 geometric mean titer
Interval 215.8 to 364.7
|
265.9 geometric mean titer
Interval 225.4 to 313.7
|
236.3 geometric mean titer
Interval 178.5 to 312.9
|
173.3 geometric mean titer
Interval 130.1 to 230.8
|
183.1 geometric mean titer
Interval 130.7 to 256.6
|
249.0 geometric mean titer
Interval 196.9 to 314.9
|
184.7 geometric mean titer
Interval 148.1 to 230.3
|
270.0 geometric mean titer
Interval 226.9 to 321.1
|
207.8 geometric mean titer
Interval 165.9 to 260.3
|
196.5 geometric mean titer
Interval 151.3 to 255.4
|
261.9 geometric mean titer
Interval 199.1 to 344.6
|
229.4 geometric mean titer
Interval 177.4 to 296.7
|
218.7 geometric mean titer
Interval 168.1 to 284.6
|
—
|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype) Expressed as GMT
Day 56
|
246.7 geometric mean titer
Interval 182.8 to 333.0
|
242.3 geometric mean titer
Interval 205.0 to 286.5
|
209.6 geometric mean titer
Interval 157.2 to 279.5
|
168.8 geometric mean titer
Interval 128.1 to 222.2
|
165.3 geometric mean titer
Interval 119.9 to 227.8
|
215.9 geometric mean titer
Interval 173.0 to 269.4
|
179.1 geometric mean titer
Interval 142.0 to 225.9
|
243.7 geometric mean titer
Interval 204.8 to 290.1
|
197.1 geometric mean titer
Interval 157.0 to 247.4
|
193.0 geometric mean titer
Interval 149.1 to 249.7
|
236.4 geometric mean titer
Interval 182.1 to 307.0
|
210.9 geometric mean titer
Interval 161.2 to 275.8
|
205.6 geometric mean titer
Interval 155.7 to 271.5
|
—
|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype) Expressed as GMT
Day 84
|
364.1 geometric mean titer
Interval 261.8 to 506.4
|
508.5 geometric mean titer
Interval 425.0 to 608.4
|
396.5 geometric mean titer
Interval 288.0 to 546.1
|
330.6 geometric mean titer
Interval 245.8 to 444.7
|
364.4 geometric mean titer
Interval 265.1 to 500.8
|
390.7 geometric mean titer
Interval 298.3 to 511.7
|
310.1 geometric mean titer
Interval 238.6 to 403.0
|
464.3 geometric mean titer
Interval 383.2 to 562.5
|
365.9 geometric mean titer
Interval 274.7 to 487.4
|
335.4 geometric mean titer
Interval 249.0 to 451.7
|
521.9 geometric mean titer
Interval 362.2 to 752.1
|
381.4 geometric mean titer
Interval 271.2 to 536.3
|
477.2 geometric mean titer
Interval 350.6 to 649.7
|
—
|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype) Expressed as GMT
Day 182
|
312.4 geometric mean titer
Interval 226.0 to 431.8
|
433.4 geometric mean titer
Interval 359.3 to 522.7
|
300.7 geometric mean titer
Interval 221.0 to 409.2
|
267.3 geometric mean titer
Interval 197.4 to 361.9
|
302.6 geometric mean titer
Interval 219.1 to 417.8
|
302.7 geometric mean titer
Interval 235.7 to 388.9
|
278.6 geometric mean titer
Interval 215.6 to 360.1
|
384.4 geometric mean titer
Interval 311.2 to 474.8
|
272.3 geometric mean titer
Interval 206.5 to 359.0
|
284.5 geometric mean titer
Interval 208.8 to 387.8
|
407.3 geometric mean titer
Interval 301.5 to 550.3
|
306.6 geometric mean titer
Interval 220.2 to 426.8
|
337.3 geometric mean titer
Interval 250.6 to 453.9
|
—
|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype) Expressed as GMT
Day 70
|
219.4 geometric mean titer
Interval 163.6 to 294.2
|
284.8 geometric mean titer
Interval 239.2 to 339.0
|
266.5 geometric mean titer
Interval 198.8 to 357.1
|
194.0 geometric mean titer
Interval 149.1 to 252.6
|
199.4 geometric mean titer
Interval 144.1 to 276.0
|
267.4 geometric mean titer
Interval 213.7 to 334.7
|
203.2 geometric mean titer
Interval 162.8 to 253.8
|
274.2 geometric mean titer
Interval 229.9 to 326.9
|
209.2 geometric mean titer
Interval 158.6 to 275.8
|
212.9 geometric mean titer
Interval 164.6 to 275.3
|
271.3 geometric mean titer
Interval 198.5 to 370.7
|
242.7 geometric mean titer
Interval 188.6 to 312.4
|
245.1 geometric mean titer
Interval 192.1 to 312.7
|
—
|
SECONDARY outcome
Timeframe: Day 0 to Day 182Population: Per Protocol Analysis Set population
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type Influenza B/Washington (Victoria Subtype) and/or antigenically-drifted influenza strains, as measured by an MN assay, expressed as GMT.
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
n=39 Participants
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington (Victoria Subtype)Expressed as GMT
Day 0
|
124.4 geometric mean titer
Interval 91.4 to 169.4
|
155.0 geometric mean titer
Interval 125.0 to 192.2
|
131.8 geometric mean titer
Interval 91.6 to 189.6
|
148.6 geometric mean titer
Interval 106.0 to 208.2
|
131.1 geometric mean titer
Interval 95.5 to 179.9
|
136.5 geometric mean titer
Interval 97.9 to 190.1
|
143.9 geometric mean titer
Interval 112.5 to 184.2
|
149.2 geometric mean titer
Interval 120.6 to 189.0
|
158.6 geometric mean titer
Interval 112.4 to 223.8
|
131.6 geometric mean titer
Interval 96.2 to 179.9
|
173.0 geometric mean titer
Interval 120.6 to 248.0
|
147.1 geometric mean titer
Interval 106.1 to 204.1
|
148.8 geometric mean titer
Interval 102.1 to 216.6
|
—
|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington (Victoria Subtype)Expressed as GMT
Day 28
|
282.0 geometric mean titer
Interval 199.5 to 398.8
|
269.6 geometric mean titer
Interval 220.9 to 328.9
|
221.3 geometric mean titer
Interval 160.1 to 306.0
|
177.5 geometric mean titer
Interval 130.7 to 241.0
|
210.5 geometric mean titer
Interval 150.9 to 293.6
|
242.5 geometric mean titer
Interval 175.4 to 335.3
|
194.5 geometric mean titer
Interval 149.1 to 253.8
|
252.7 geometric mean titer
Interval 202.8 to 314.9
|
206.7 geometric mean titer
Interval 149.4 to 286.1
|
161.9 geometric mean titer
Interval 117.8 to 222.5
|
246.3 geometric mean titer
Interval 175.7 to 345.3
|
239.2 geometric mean titer
Interval 170.1 to 336.4
|
219.0 geometric mean titer
Interval 157.1 to 305.2
|
—
|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington (Victoria Subtype)Expressed as GMT
Day 56
|
238.1 geometric mean titer
Interval 171.4 to 331.0
|
245.2 geometric mean titer
Interval 200.4 to 299.9
|
191.9 geometric mean titer
Interval 137.1 to 268.5
|
168.2 geometric mean titer
Interval 120.4 to 234.8
|
180.9 geometric mean titer
Interval 132.4 to 247.1
|
204.2 geometric mean titer
Interval 148.7 to 280.4
|
180.7 geometric mean titer
Interval 136.9 to 238.5
|
223.3 geometric mean titer
Interval 179.4 to 277.8
|
184.3 geometric mean titer
Interval 132.3 to 256.7
|
162.9 geometric mean titer
Interval 118.7 to 223.5
|
215.2 geometric mean titer
Interval 156.4 to 296.0
|
225.3 geometric mean titer
Interval 160.2 to 316.8
|
214.6 geometric mean titer
Interval 145.3 to 316.8
|
—
|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington (Victoria Subtype)Expressed as GMT
Day 70
|
285.7 geometric mean titer
Interval 232.5 to 351.2
|
285.7 geometric mean titer
Interval 232.5 to 351.2
|
238.8 geometric mean titer
Interval 167.9 to 339.7
|
199.8 geometric mean titer
Interval 147.8 to 270.1
|
217.7 geometric mean titer
Interval 157.1 to 301.9
|
250.5 geometric mean titer
Interval 181.4 to 345.8
|
210.8 geometric mean titer
Interval 161.9 to 274.4
|
250.9 geometric mean titer
Interval 202.5 to 310.9
|
204.3 geometric mean titer
Interval 146.3 to 285.4
|
183.9 geometric mean titer
Interval 132.1 to 256.1
|
246.1 geometric mean titer
Interval 171.9 to 352.2
|
253.9 geometric mean titer
Interval 193.1 to 333.9
|
237.1 geometric mean titer
Interval 173.8 to 323.3
|
—
|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington (Victoria Subtype)Expressed as GMT
Day 84
|
241.5 geometric mean titer
Interval 169.7 to 343.8
|
297.3 geometric mean titer
Interval 245.1 to 360.7
|
240.2 geometric mean titer
Interval 171.1 to 337.3
|
236.2 geometric mean titer
Interval 177.6 to 314.2
|
259.5 geometric mean titer
Interval 189.5 to 355.2
|
259.0 geometric mean titer
Interval 180.2 to 372.2
|
200.4 geometric mean titer
Interval 149.2 to 269.2
|
270.6 geometric mean titer
Interval 218.8 to 334.5
|
217.8 geometric mean titer
Interval 159.3 to 297.9
|
216.5 geometric mean titer
Interval 155.9 to 300.7
|
320.5 geometric mean titer
Interval 226.0 to 454.5
|
280.0 geometric mean titer
Interval 197.0 to 398.0
|
268.8 geometric mean titer
Interval 193.8 to 372.8
|
—
|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington (Victoria Subtype)Expressed as GMT
Day 182
|
196.7 geometric mean titer
Interval 140.8 to 274.9
|
247.3 geometric mean titer
Interval 200.0 to 305.8
|
178.3 geometric mean titer
Interval 129.2 to 246.1
|
176.1 geometric mean titer
Interval 127.1 to 244.0
|
219.9 geometric mean titer
Interval 159.2 to 303.6
|
192.1 geometric mean titer
Interval 135.6 to 272.1
|
176.6 geometric mean titer
Interval 132.6 to 235.1
|
235.9 geometric mean titer
Interval 188.3 to 295.7
|
173.5 geometric mean titer
Interval 127.0 to 236.9
|
179.4 geometric mean titer
Interval 128.2 to 251.1
|
245.3 geometric mean titer
Interval 176.0 to 341.9
|
227.5 geometric mean titer
Interval 158.0 to 327.5
|
203.3 geometric mean titer
Interval 144.4 to 286.2
|
—
|
SECONDARY outcome
Timeframe: Day 28 to Day 182Population: Per Protocol Analysis Set population
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine Influenza A/Brisbane (H1N1 Subtype) antigenically-drifted influenza strains, as measured by a MN assay, expressed as GMFR.
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
n=39 Participants
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Microneutralization (MN50) Antibody Responses Influenza A/Brisbane (H1N1 Subtype) Expressed as GMFR
Day 28
|
2.1 geometric mean fold rise
Interval 1.6 to 2.8
|
1.9 geometric mean fold rise
Interval 1.4 to 2.4
|
1.9 geometric mean fold rise
Interval 1.2 to 3.0
|
1.5 geometric mean fold rise
Interval 1.2 to 2.0
|
1.7 geometric mean fold rise
Interval 1.3 to 2.2
|
1.7 geometric mean fold rise
Interval 1.3 to 2.2
|
1.2 geometric mean fold rise
Interval 1.0 to 1.4
|
1.9 geometric mean fold rise
Interval 1.5 to 2.3
|
1.4 geometric mean fold rise
Interval 1.1 to 1.8
|
1.2 geometric mean fold rise
Interval 1.0 to 1.4
|
1.7 geometric mean fold rise
Interval 1.3 to 2.3
|
1.4 geometric mean fold rise
Interval 1.0 to 1.7
|
1.5 geometric mean fold rise
Interval 1.2 to 1.9
|
—
|
|
Microneutralization (MN50) Antibody Responses Influenza A/Brisbane (H1N1 Subtype) Expressed as GMFR
Day 56
|
1.8 geometric mean fold rise
Interval 1.3 to 2.4
|
1.8 geometric mean fold rise
Interval 1.4 to 2.3
|
1.6 geometric mean fold rise
Interval 1.0 to 2.8
|
1.3 geometric mean fold rise
Interval 1.0 to 1.7
|
1.4 geometric mean fold rise
Interval 1.1 to 1.7
|
1.4 geometric mean fold rise
Interval 1.2 to 1.7
|
1.1 geometric mean fold rise
Interval 0.9 to 1.3
|
1.5 geometric mean fold rise
Interval 1.2 to 1.9
|
1.2 geometric mean fold rise
Interval 0.9 to 1.5
|
1.1 geometric mean fold rise
Interval 1.0 to 1.3
|
1.4 geometric mean fold rise
Interval 1.1 to 1.9
|
1.3 geometric mean fold rise
Interval 1.0 to 1.6
|
1.5 geometric mean fold rise
Interval 1.2 to 1.9
|
—
|
|
Microneutralization (MN50) Antibody Responses Influenza A/Brisbane (H1N1 Subtype) Expressed as GMFR
Day 70
|
1.6 geometric mean fold rise
Interval 1.3 to 2.2
|
2.4 geometric mean fold rise
Interval 1.8 to 3.2
|
2.5 geometric mean fold rise
Interval 1.5 to 4.3
|
1.8 geometric mean fold rise
Interval 1.3 to 2.5
|
2.4 geometric mean fold rise
Interval 1.6 to 3.6
|
2.3 geometric mean fold rise
Interval 1.6 to 3.2
|
1.5 geometric mean fold rise
Interval 1.2 to 2.0
|
2.1 geometric mean fold rise
Interval 1.7 to 2.7
|
1.8 geometric mean fold rise
Interval 1.3 to 2.5
|
1.5 geometric mean fold rise
Interval 1.1 to 1.9
|
2.0 geometric mean fold rise
Interval 1.4 to 3.0
|
1.7 geometric mean fold rise
Interval 1.2 to 2.4
|
2.1 geometric mean fold rise
Interval 1.6 to 2.8
|
—
|
|
Microneutralization (MN50) Antibody Responses Influenza A/Brisbane (H1N1 Subtype) Expressed as GMFR
Day 84
|
4.3 geometric mean fold rise
Interval 3.2 to 5.8
|
5.5 geometric mean fold rise
Interval 4.1 to 7.4
|
6.6 geometric mean fold rise
Interval 3.7 to 11.7
|
4.2 geometric mean fold rise
Interval 2.8 to 6.2
|
5.0 geometric mean fold rise
Interval 3.4 to 7.5
|
5.2 geometric mean fold rise
Interval 3.5 to 7.8
|
2.8 geometric mean fold rise
Interval 2.1 to 3.7
|
5.5 geometric mean fold rise
Interval 4.3 to 7.0
|
4.8 geometric mean fold rise
Interval 3.3 to 7.0
|
3.6 geometric mean fold rise
Interval 2.7 to 4.9
|
5.7 geometric mean fold rise
Interval 3.6 to 9.0
|
3.8 geometric mean fold rise
Interval 2.5 to 5.8
|
5.1 geometric mean fold rise
Interval 3.8 to 6.8
|
—
|
|
Microneutralization (MN50) Antibody Responses Influenza A/Brisbane (H1N1 Subtype) Expressed as GMFR
Day 182
|
3.4 geometric mean fold rise
Interval 2.6 to 4.4
|
4.1 geometric mean fold rise
Interval 3.1 to 5.5
|
3.6 geometric mean fold rise
Interval 2.1 to 6.3
|
2.7 geometric mean fold rise
Interval 2.0 to 3.8
|
3.3 geometric mean fold rise
Interval 2.3 to 4.7
|
3.4 geometric mean fold rise
Interval 2.4 to 4.8
|
2.2 geometric mean fold rise
Interval 1.7 to 2.9
|
3.8 geometric mean fold rise
Interval 2.9 to 4.9
|
2.9 geometric mean fold rise
Interval 2.1 to 4.0
|
2.3 geometric mean fold rise
Interval 1.8 to 2.9
|
3.7 geometric mean fold rise
Interval 2.5 to 5.4
|
2.0 geometric mean fold rise
Interval 1.2 to 3.3
|
3.5 geometric mean fold rise
Interval 2.6 to 4.9
|
—
|
SECONDARY outcome
Timeframe: Day 28 to Day 182Population: Per Protocol Analysis Set population
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine Influenza A/Kansas (H3N2 Subtype) antigenically-drifted influenza strains, as measured by a MN assay, expressed as GMFR.
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
n=39 Participants
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Microneutralization (MN50) Antibody Responses Influenza A/Kansas (H3N2 Subtype) Expressed as GMFR
Day 182
|
3.2 geometric mean fold rise
Interval 2.2 to 4.6
|
3.3 geometric mean fold rise
Interval 2.6 to 4.3
|
2.3 geometric mean fold rise
Interval 1.5 to 3.6
|
2.1 geometric mean fold rise
Interval 1.5 to 3.0
|
2.4 geometric mean fold rise
Interval 1.8 to 3.3
|
2.9 geometric mean fold rise
Interval 2.1 to 3.9
|
2.2 geometric mean fold rise
Interval 1.6 to 3.1
|
3.2 geometric mean fold rise
Interval 2.6 to 3.9
|
2.1 geometric mean fold rise
Interval 1.6 to 2.9
|
1.8 geometric mean fold rise
Interval 1.3 to 2.3
|
3.3 geometric mean fold rise
Interval 2.3 to 4.8
|
2.3 geometric mean fold rise
Interval 1.7 to 3.2
|
2.7 geometric mean fold rise
Interval 2.0 to 3.6
|
—
|
|
Microneutralization (MN50) Antibody Responses Influenza A/Kansas (H3N2 Subtype) Expressed as GMFR
Day 28
|
6.2 geometric mean fold rise
Interval 4.1 to 9.4
|
4.3 geometric mean fold rise
Interval 3.4 to 5.4
|
3.4 geometric mean fold rise
Interval 2.1 to 5.5
|
2.7 geometric mean fold rise
Interval 2.1 to 3.6
|
3.1 geometric mean fold rise
Interval 2.3 to 4.1
|
3.7 geometric mean fold rise
Interval 2.5 to 5.4
|
2.8 geometric mean fold rise
Interval 2.1 to 3.8
|
4.1 geometric mean fold rise
Interval 3.3 to 5.2
|
2.5 geometric mean fold rise
Interval 1.9 to 3.3
|
2.2 geometric mean fold rise
Interval 1.6 to 2.9
|
4.7 geometric mean fold rise
Interval 3.2 to 7.0
|
3.6 geometric mean fold rise
Interval 2.7 to 4.7
|
3.6 geometric mean fold rise
Interval 2.6 to 5.0
|
—
|
|
Microneutralization (MN50) Antibody Responses Influenza A/Kansas (H3N2 Subtype) Expressed as GMFR
Day 56
|
4.9 geometric mean fold rise
Interval 3.2 to 7.3
|
3.7 geometric mean fold rise
Interval 2.9 to 4.7
|
2.7 geometric mean fold rise
Interval 1.7 to 4.5
|
2.3 geometric mean fold rise
Interval 1.7 to 3.1
|
2.6 geometric mean fold rise
Interval 2.0 to 3.4
|
2.7 geometric mean fold rise
Interval 1.9 to 3.7
|
2.5 geometric mean fold rise
Interval 1.8 to 3.4
|
3.4 geometric mean fold rise
Interval 2.8 to 4.3
|
2.1 geometric mean fold rise
Interval 1.6 to 2.8
|
2.0 geometric mean fold rise
Interval 1.5 to 2.7
|
3.6 geometric mean fold rise
Interval 2.5 to 5.2
|
3.1 geometric mean fold rise
Interval 2.3 to 4.1
|
3.2 geometric mean fold rise
Interval 2.3 to 4.5
|
—
|
|
Microneutralization (MN50) Antibody Responses Influenza A/Kansas (H3N2 Subtype) Expressed as GMFR
Day 70
|
4.7 geometric mean fold rise
Interval 3.2 to 7.1
|
5.0 geometric mean fold rise
Interval 3.9 to 6.4
|
4.1 geometric mean fold rise
Interval 2.5 to 6.7
|
3.6 geometric mean fold rise
Interval 2.6 to 5.1
|
4.4 geometric mean fold rise
Interval 3.3 to 5.8
|
4.1 geometric mean fold rise
Interval 3.0 to 5.6
|
3.5 geometric mean fold rise
Interval 2.5 to 5.0
|
4.9 geometric mean fold rise
Interval 3.9 to 6.0
|
3.1 geometric mean fold rise
Interval 2.2 to 4.2
|
2.7 geometric mean fold rise
Interval 2.0 to 3.7
|
4.7 geometric mean fold rise
Interval 3.2 to 6.9
|
3.9 geometric mean fold rise
Interval 2.9 to 5.3
|
4.0 geometric mean fold rise
Interval 2.9 to 5.3
|
—
|
|
Microneutralization (MN50) Antibody Responses Influenza A/Kansas (H3N2 Subtype) Expressed as GMFR
Day 84
|
4.8 geometric mean fold rise
Interval 3.0 to 7.6
|
4.8 geometric mean fold rise
Interval 3.8 to 6.2
|
3.6 geometric mean fold rise
Interval 2.3 to 5.7
|
3.7 geometric mean fold rise
Interval 2.5 to 5.4
|
3.6 geometric mean fold rise
Interval 2.6 to 5.0
|
4.2 geometric mean fold rise
Interval 2.9 to 6.3
|
3.0 geometric mean fold rise
Interval 2.2 to 4.3
|
5.0 geometric mean fold rise
Interval 4.0 to 6.2
|
3.4 geometric mean fold rise
Interval 2.5 to 4.7
|
2.7 geometric mean fold rise
Interval 2.0 to 3.6
|
5.0 geometric mean fold rise
Interval 3.2 to 7.6
|
3.9 geometric mean fold rise
Interval 2.8 to 5.3
|
4.1 geometric mean fold rise
Interval 3.1 to 5.5
|
—
|
SECONDARY outcome
Timeframe: Day 28 to Day 182Population: Per Protocol Analysis Set population
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine Influenza A/Wisconsin (H1N1 Subtype) antigenically-drifted influenza strains, as measured by a MN assay, expressed as GMFR.
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
n=39 Participants
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Microneutralization (MN50) Antibody Responses Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMFR
Day 28
|
1.1 geometric mean fold rise
Interval 0.9 to 1.3
|
1.2 geometric mean fold rise
Interval 1.0 to 1.3
|
1.1 geometric mean fold rise
Interval 0.9 to 1.4
|
1.1 geometric mean fold rise
Interval 0.9 to 1.2
|
1.0 geometric mean fold rise
Interval 0.9 to 1.1
|
1.0 geometric mean fold rise
Interval 1.0 to 1.1
|
1.0 geometric mean fold rise
Interval 0.9 to 1.1
|
1.2 geometric mean fold rise
Interval 1.0 to 1.3
|
0.9 geometric mean fold rise
Interval 0.9 to 1.0
|
0.9 geometric mean fold rise
Interval 0.8 to 1.0
|
1.4 geometric mean fold rise
Interval 1.1 to 1.7
|
1.0 geometric mean fold rise
Interval 0.9 to 1.1
|
1.1 geometric mean fold rise
Interval 0.9 to 1.3
|
—
|
|
Microneutralization (MN50) Antibody Responses Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMFR
Day 56
|
1.1 geometric mean fold rise
Interval 0.9 to 1.3
|
1.1 geometric mean fold rise
Interval 0.9 to 1.2
|
1.0 geometric mean fold rise
Interval 0.9 to 1.3
|
1.0 geometric mean fold rise
Interval 0.9 to 1.1
|
0.9 geometric mean fold rise
Interval 0.8 to 1.0
|
1.0 geometric mean fold rise
Interval 0.9 to 1.1
|
0.9 geometric mean fold rise
Interval 0.8 to 1.0
|
1.0 geometric mean fold rise
Interval 0.8 to 1.1
|
0.9 geometric mean fold rise
Interval 0.8 to 1.0
|
0.9 geometric mean fold rise
Interval 0.8 to 1.0
|
1.1 geometric mean fold rise
Interval 0.9 to 1.3
|
0.9 geometric mean fold rise
Interval 0.8 to 1.0
|
1.1 geometric mean fold rise
Interval 0.9 to 1.3
|
—
|
|
Microneutralization (MN50) Antibody Responses Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMFR
Day 70
|
1.1 geometric mean fold rise
Interval 0.9 to 1.4
|
1.4 geometric mean fold rise
Interval 1.1 to 1.6
|
1.2 geometric mean fold rise
Interval 1.0 to 1.5
|
1.3 geometric mean fold rise
Interval 1.0 to 1.5
|
1.3 geometric mean fold rise
Interval 1.1 to 1.5
|
1.3 geometric mean fold rise
Interval 1.1 to 1.5
|
1.0 geometric mean fold rise
Interval 0.9 to 1.2
|
1.3 geometric mean fold rise
Interval 1.1 to 1.5
|
1.0 geometric mean fold rise
Interval 0.9 to 1.3
|
0.9 geometric mean fold rise
Interval 0.8 to 1.1
|
1.4 geometric mean fold rise
Interval 1.1 to 1.8
|
1.2 geometric mean fold rise
Interval 1.0 to 1.4
|
1.3 geometric mean fold rise
Interval 1.1 to 1.6
|
—
|
|
Microneutralization (MN50) Antibody Responses Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMFR
Day 84
|
1.3 geometric mean fold rise
Interval 1.0 to 1.6
|
1.5 geometric mean fold rise
Interval 1.3 to 1.8
|
1.3 geometric mean fold rise
Interval 1.1 to 1.7
|
1.4 geometric mean fold rise
Interval 1.2 to 1.8
|
1.4 geometric mean fold rise
Interval 1.1 to 1.7
|
1.5 geometric mean fold rise
Interval 1.2 to 1.8
|
1.2 geometric mean fold rise
Interval 1.0 to 1.4
|
1.4 geometric mean fold rise
Interval 1.2 to 1.7
|
1.2 geometric mean fold rise
Interval 1.0 to 1.4
|
1.0 geometric mean fold rise
Interval 0.9 to 1.2
|
1.8 geometric mean fold rise
Interval 1.3 to 2.4
|
1.4 geometric mean fold rise
Interval 1.1 to 1.7
|
1.6 geometric mean fold rise
Interval 1.3 to 2.0
|
—
|
|
Microneutralization (MN50) Antibody Responses Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMFR
Day 182
|
1.1 geometric mean fold rise
Interval 0.9 to 1.3
|
1.2 geometric mean fold rise
Interval 1.0 to 1.4
|
1.0 geometric mean fold rise
Interval 0.8 to 1.2
|
1.1 geometric mean fold rise
Interval 0.9 to 1.2
|
1.1 geometric mean fold rise
Interval 1.0 to 1.3
|
1.1 geometric mean fold rise
Interval 1.0 to 1.3
|
1.0 geometric mean fold rise
Interval 0.9 to 1.1
|
1.2 geometric mean fold rise
Interval 1.0 to 1.3
|
0.9 geometric mean fold rise
Interval 0.8 to 1.1
|
0.8 geometric mean fold rise
Interval 0.7 to 1.0
|
1.4 geometric mean fold rise
Interval 1.0 to 1.8
|
1.0 geometric mean fold rise
Interval 0.9 to 1.2
|
1.3 geometric mean fold rise
Interval 1.0 to 1.5
|
—
|
SECONDARY outcome
Timeframe: Day 28 to Day 182Population: Per Protocol Analysis Set population
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine Influenza A/Cambodia (H3N2 Subtype) antigenically-drifted influenza strains, as measured by a MN assay, expressed as GMFR.
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
n=39 Participants
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Microneutralization (MN50) Antibody Responses Influenza A/Cambodia (H3N2 Subtype) Expressed as GMFR
Day 28
|
1.8 geometric mean fold rise
Interval 1.4 to 2.3
|
1.9 geometric mean fold rise
Interval 1.6 to 2.3
|
2.0 geometric mean fold rise
Interval 1.4 to 3.0
|
1.5 geometric mean fold rise
Interval 1.2 to 1.8
|
1.7 geometric mean fold rise
Interval 1.3 to 2.2
|
2.2 geometric mean fold rise
Interval 1.5 to 3.1
|
1.5 geometric mean fold rise
Interval 1.2 to 1.8
|
1.8 geometric mean fold rise
Interval 1.5 to 2.2
|
1.4 geometric mean fold rise
Interval 1.2 to 1.6
|
1.5 geometric mean fold rise
Interval 1.2 to 1.8
|
2.6 geometric mean fold rise
Interval 1.8 to 3.7
|
1.9 geometric mean fold rise
Interval 1.4 to 2.6
|
1.6 geometric mean fold rise
Interval 1.2 to 2.2
|
—
|
|
Microneutralization (MN50) Antibody Responses Influenza A/Cambodia (H3N2 Subtype) Expressed as GMFR
Day 56
|
1.5 geometric mean fold rise
Interval 1.2 to 1.9
|
1.7 geometric mean fold rise
Interval 1.5 to 2.1
|
1.8 geometric mean fold rise
Interval 1.2 to 2.7
|
1.5 geometric mean fold rise
Interval 1.1 to 1.9
|
1.5 geometric mean fold rise
Interval 1.2 to 1.9
|
1.6 geometric mean fold rise
Interval 1.2 to 2.2
|
1.3 geometric mean fold rise
Interval 1.1 to 1.6
|
1.6 geometric mean fold rise
Interval 1.4 to 1.9
|
1.3 geometric mean fold rise
Interval 1.1 to 1.5
|
1.4 geometric mean fold rise
Interval 1.1 to 1.7
|
2.2 geometric mean fold rise
Interval 1.5 to 3.1
|
1.7 geometric mean fold rise
Interval 1.3 to 2.2
|
1.6 geometric mean fold rise
Interval 1.2 to 2.0
|
—
|
|
Microneutralization (MN50) Antibody Responses Influenza A/Cambodia (H3N2 Subtype) Expressed as GMFR
Day 182
|
1.2 geometric mean fold rise
Interval 1.0 to 1.5
|
1.4 geometric mean fold rise
Interval 1.2 to 1.6
|
1.5 geometric mean fold rise
Interval 1.0 to 2.3
|
1.3 geometric mean fold rise
Interval 1.0 to 1.7
|
1.3 geometric mean fold rise
Interval 1.0 to 1.8
|
1.4 geometric mean fold rise
Interval 1.0 to 1.9
|
1.2 geometric mean fold rise
Interval 0.9 to 1.5
|
1.3 geometric mean fold rise
Interval 1.1 to 1.6
|
1.2 geometric mean fold rise
Interval 1.0 to 1.4
|
1.2 geometric mean fold rise
Interval 0.9 to 1.5
|
1.9 geometric mean fold rise
Interval 1.3 to 2.8
|
1.5 geometric mean fold rise
Interval 1.2 to 2.0
|
1.3 geometric mean fold rise
Interval 1.1 to 1.7
|
—
|
|
Microneutralization (MN50) Antibody Responses Influenza A/Cambodia (H3N2 Subtype) Expressed as GMFR
Day 70
|
1.4 geometric mean fold rise
Interval 1.1 to 1.7
|
2.0 geometric mean fold rise
Interval 1.7 to 2.3
|
2.2 geometric mean fold rise
Interval 1.5 to 3.3
|
1.8 geometric mean fold rise
Interval 1.4 to 2.3
|
1.8 geometric mean fold rise
Interval 1.4 to 2.4
|
2.2 geometric mean fold rise
Interval 1.6 to 3.0
|
1.6 geometric mean fold rise
Interval 1.3 to 2.1
|
1.9 geometric mean fold rise
Interval 1.6 to 2.3
|
1.5 geometric mean fold rise
Interval 1.3 to 1.9
|
1.6 geometric mean fold rise
Interval 1.2 to 2.0
|
2.4 geometric mean fold rise
Interval 1.6 to 3.5
|
2.1 geometric mean fold rise
Interval 1.5 to 2.8
|
1.8 geometric mean fold rise
Interval 1.4 to 2.3
|
—
|
|
Microneutralization (MN50) Antibody Responses Influenza A/Cambodia (H3N2 Subtype) Expressed as GMFR
Day 84
|
1.3 geometric mean fold rise
Interval 1.1 to 1.7
|
1.8 geometric mean fold rise
Interval 1.5 to 2.1
|
2.0 geometric mean fold rise
Interval 1.3 to 3.1
|
1.7 geometric mean fold rise
Interval 1.3 to 2.2
|
1.7 geometric mean fold rise
Interval 1.3 to 2.4
|
1.9 geometric mean fold rise
Interval 1.3 to 2.7
|
1.4 geometric mean fold rise
Interval 1.1 to 1.9
|
1.7 geometric mean fold rise
Interval 1.4 to 2.1
|
1.5 geometric mean fold rise
Interval 1.2 to 1.8
|
1.5 geometric mean fold rise
Interval 1.2 to 2.0
|
2.8 geometric mean fold rise
Interval 1.8 to 4.3
|
2.1 geometric mean fold rise
Interval 1.5 to 2.8
|
1.6 geometric mean fold rise
Interval 1.3 to 2.1
|
—
|
SECONDARY outcome
Timeframe: Day 28 to Day 182Population: Per Protocol Analysis Set population
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine Influenza A/Hong Kong (H3N2 Subtype) antigenically-drifted influenza strains, as measured by a MN assay, expressed as GMFR.
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
n=39 Participants
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Microneutralization (MN50) Antibody Responses Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMFR
Day 28
|
2.4 geometric mean fold rise
Interval 1.7 to 3.4
|
2.2 geometric mean fold rise
Interval 1.8 to 2.7
|
2.6 geometric mean fold rise
Interval 1.6 to 4.3
|
1.7 geometric mean fold rise
Interval 1.3 to 2.2
|
2.0 geometric mean fold rise
Interval 1.5 to 2.7
|
2.3 geometric mean fold rise
Interval 1.5 to 3.5
|
1.8 geometric mean fold rise
Interval 1.4 to 2.5
|
2.6 geometric mean fold rise
Interval 2.1 to 3.3
|
1.6 geometric mean fold rise
Interval 1.3 to 2.0
|
1.9 geometric mean fold rise
Interval 1.5 to 2.5
|
3.2 geometric mean fold rise
Interval 2.3 to 4.5
|
2.3 geometric mean fold rise
Interval 1.7 to 3.3
|
2.3 geometric mean fold rise
Interval 1.6 to 3.2
|
—
|
|
Microneutralization (MN50) Antibody Responses Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMFR
Day 70
|
1.9 geometric mean fold rise
Interval 1.3 to 2.7
|
2.3 geometric mean fold rise
Interval 1.9 to 2.8
|
2.9 geometric mean fold rise
Interval 1.8 to 4.8
|
2.2 geometric mean fold rise
Interval 1.6 to 3.0
|
2.2 geometric mean fold rise
Interval 1.6 to 3.0
|
2.5 geometric mean fold rise
Interval 1.7 to 3.5
|
2.1 geometric mean fold rise
Interval 1.5 to 2.9
|
2.7 geometric mean fold rise
Interval 2.2 to 3.4
|
1.8 geometric mean fold rise
Interval 1.3 to 2.4
|
2.2 geometric mean fold rise
Interval 1.6 to 2.9
|
2.8 geometric mean fold rise
Interval 2.1 to 3.8
|
2.5 geometric mean fold rise
Interval 1.8 to 3.4
|
2.6 geometric mean fold rise
Interval 1.8 to 3.5
|
—
|
|
Microneutralization (MN50) Antibody Responses Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMFR
Day 84
|
1.7 geometric mean fold rise
Interval 1.2 to 2.6
|
2.1 geometric mean fold rise
Interval 1.7 to 2.6
|
3.0 geometric mean fold rise
Interval 1.9 to 4.9
|
2.0 geometric mean fold rise
Interval 1.5 to 2.9
|
2.0 geometric mean fold rise
Interval 1.5 to 2.8
|
2.2 geometric mean fold rise
Interval 1.5 to 3.3
|
1.8 geometric mean fold rise
Interval 1.2 to 2.6
|
2.6 geometric mean fold rise
Interval 2.1 to 3.2
|
2.0 geometric mean fold rise
Interval 1.5 to 2.6
|
2.2 geometric mean fold rise
Interval 1.6 to 3.1
|
3.2 geometric mean fold rise
Interval 2.2 to 4.5
|
2.3 geometric mean fold rise
Interval 1.7 to 3.3
|
2.3 geometric mean fold rise
Interval 1.7 to 3.2
|
—
|
|
Microneutralization (MN50) Antibody Responses Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMFR
Day 182
|
1.4 geometric mean fold rise
Interval 1.1 to 2.0
|
1.5 geometric mean fold rise
Interval 1.3 to 1.9
|
2.1 geometric mean fold rise
Interval 1.3 to 3.3
|
1.4 geometric mean fold rise
Interval 1.0 to 1.9
|
1.6 geometric mean fold rise
Interval 1.1 to 2.2
|
1.7 geometric mean fold rise
Interval 1.2 to 2.4
|
1.5 geometric mean fold rise
Interval 1.0 to 2.2
|
1.8 geometric mean fold rise
Interval 1.5 to 2.2
|
1.4 geometric mean fold rise
Interval 1.1 to 1.8
|
1.6 geometric mean fold rise
Interval 1.2 to 2.1
|
2.2 geometric mean fold rise
Interval 1.6 to 3.1
|
1.6 geometric mean fold rise
Interval 1.1 to 2.1
|
1.8 geometric mean fold rise
Interval 1.3 to 2.6
|
—
|
|
Microneutralization (MN50) Antibody Responses Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMFR
Day 56
|
2.0 geometric mean fold rise
Interval 1.4 to 2.7
|
1.9 geometric mean fold rise
Interval 1.6 to 2.3
|
2.1 geometric mean fold rise
Interval 1.3 to 3.4
|
1.5 geometric mean fold rise
Interval 1.2 to 2.0
|
1.6 geometric mean fold rise
Interval 1.2 to 2.2
|
1.7 geometric mean fold rise
Interval 1.2 to 2.5
|
1.6 geometric mean fold rise
Interval 1.2 to 2.0
|
2.1 geometric mean fold rise
Interval 1.7 to 2.6
|
1.4 geometric mean fold rise
Interval 1.1 to 1.7
|
1.8 geometric mean fold rise
Interval 1.4 to 2.3
|
2.4 geometric mean fold rise
Interval 1.8 to 3.2
|
2.1 geometric mean fold rise
Interval 1.5 to 2.9
|
2.0 geometric mean fold rise
Interval 1.4 to 2.7
|
—
|
SECONDARY outcome
Timeframe: Day 28 to Day 182Population: Per Protocol Analysis Set population
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine Influenza B/Maryland (Victoria Subtype) antigenically-drifted influenza strains, as measured by a MN assay, expressed as GMFR.
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
n=39 Participants
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Microneutralization (MN50) Antibody Responses Influenza B/Maryland (Victoria Subtype) Expressed as GMFR
Day 70
|
1.7 geometric mean fold rise
Interval 1.2 to 2.4
|
1.9 geometric mean fold rise
Interval 1.6 to 2.2
|
1.7 geometric mean fold rise
Interval 1.4 to 2.1
|
1.4 geometric mean fold rise
Interval 1.2 to 1.7
|
1.6 geometric mean fold rise
Interval 1.3 to 2.0
|
1.8 geometric mean fold rise
Interval 1.5 to 2.2
|
1.4 geometric mean fold rise
Interval 1.2 to 1.6
|
1.7 geometric mean fold rise
Interval 1.5 to 1.9
|
1.3 geometric mean fold rise
Interval 1.1 to 1.5
|
1.3 geometric mean fold rise
Interval 1.1 to 1.4
|
1.6 geometric mean fold rise
Interval 1.2 to 2.1
|
1.6 geometric mean fold rise
Interval 1.3 to 1.9
|
1.6 geometric mean fold rise
Interval 1.4 to 1.9
|
—
|
|
Microneutralization (MN50) Antibody Responses Influenza B/Maryland (Victoria Subtype) Expressed as GMFR
Day 28
|
2.2 geometric mean fold rise
Interval 1.5 to 3.0
|
1.7 geometric mean fold rise
Interval 1.5 to 2.0
|
1.5 geometric mean fold rise
Interval 1.3 to 1.9
|
1.3 geometric mean fold rise
Interval 1.1 to 1.5
|
1.5 geometric mean fold rise
Interval 1.2 to 1.8
|
1.7 geometric mean fold rise
Interval 1.4 to 2.2
|
1.3 geometric mean fold rise
Interval 1.1 to 1.5
|
1.6 geometric mean fold rise
Interval 1.4 to 1.9
|
1.2 geometric mean fold rise
Interval 1.1 to 1.4
|
1.2 geometric mean fold rise
Interval 1.1 to 1.4
|
1.5 geometric mean fold rise
Interval 1.2 to 1.9
|
1.5 geometric mean fold rise
Interval 1.2 to 1.8
|
1.5 geometric mean fold rise
Interval 1.2 to 1.8
|
—
|
|
Microneutralization (MN50) Antibody Responses Influenza B/Maryland (Victoria Subtype) Expressed as GMFR
Day 56
|
1.9 geometric mean fold rise
Interval 1.4 to 2.7
|
1.6 geometric mean fold rise
Interval 1.4 to 1.9
|
1.3 geometric mean fold rise
Interval 1.1 to 1.7
|
1.2 geometric mean fold rise
Interval 1.1 to 1.4
|
1.3 geometric mean fold rise
Interval 1.1 to 1.7
|
1.5 geometric mean fold rise
Interval 1.2 to 1.8
|
1.2 geometric mean fold rise
Interval 1.1 to 1.4
|
1.5 geometric mean fold rise
Interval 1.3 to 1.7
|
1.2 geometric mean fold rise
Interval 1.1 to 1.3
|
1.2 geometric mean fold rise
Interval 1.0 to 1.3
|
1.4 geometric mean fold rise
Interval 1.1 to 1.8
|
1.4 geometric mean fold rise
Interval 1.1 to 1.7
|
1.4 geometric mean fold rise
Interval 1.2 to 1.7
|
—
|
|
Microneutralization (MN50) Antibody Responses Influenza B/Maryland (Victoria Subtype) Expressed as GMFR
Day 84
|
2.8 geometric mean fold rise
Interval 2.0 to 4.0
|
3.4 geometric mean fold rise
Interval 2.9 to 4.1
|
2.5 geometric mean fold rise
Interval 2.0 to 3.3
|
2.4 geometric mean fold rise
Interval 1.9 to 3.0
|
3.0 geometric mean fold rise
Interval 2.2 to 4.1
|
2.7 geometric mean fold rise
Interval 2.0 to 3.6
|
2.1 geometric mean fold rise
Interval 1.7 to 2.7
|
2.8 geometric mean fold rise
Interval 2.4 to 3.3
|
2.2 geometric mean fold rise
Interval 1.9 to 2.7
|
2.0 geometric mean fold rise
Interval 1.7 to 2.3
|
3.2 geometric mean fold rise
Interval 2.4 to 4.4
|
2.5 geometric mean fold rise
Interval 1.9 to 3.2
|
3.2 geometric mean fold rise
Interval 2.6 to 4.0
|
—
|
|
Microneutralization (MN50) Antibody Responses Influenza B/Maryland (Victoria Subtype) Expressed as GMFR
Day 182
|
2.4 geometric mean fold rise
Interval 1.7 to 3.4
|
2.9 geometric mean fold rise
Interval 2.4 to 3.4
|
1.9 geometric mean fold rise
Interval 1.5 to 2.5
|
1.9 geometric mean fold rise
Interval 1.6 to 2.3
|
2.5 geometric mean fold rise
Interval 1.8 to 3.4
|
2.1 geometric mean fold rise
Interval 1.6 to 2.6
|
1.9 geometric mean fold rise
Interval 1.5 to 2.3
|
2.3 geometric mean fold rise
Interval 1.9 to 2.7
|
1.7 geometric mean fold rise
Interval 1.4 to 2.0
|
1.7 geometric mean fold rise
Interval 1.4 to 1.9
|
2.4 geometric mean fold rise
Interval 1.8 to 3.2
|
2.0 geometric mean fold rise
Interval 1.6 to 2.6
|
2.4 geometric mean fold rise
Interval 2.0 to 2.9
|
—
|
SECONDARY outcome
Timeframe: Day 28 to Day 182Population: Per Protocol Analysis Set population
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine Influenza B/Phuket (Yamagata Subtype) antigenically-drifted influenza strains, as measured by a MN assay, expressed as GMFR.
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
n=39 Participants
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Microneutralization (MN50) Antibody Responses Influenza B/Phuket (Yamagata Subtype) Expressed as GMFR
Day 182
|
1.8 geometric mean fold rise
Interval 1.5 to 2.3
|
2.3 geometric mean fold rise
Interval 1.9 to 2.8
|
1.3 geometric mean fold rise
Interval 1.1 to 1.5
|
1.4 geometric mean fold rise
Interval 1.1 to 1.7
|
1.8 geometric mean fold rise
Interval 1.5 to 2.2
|
2.0 geometric mean fold rise
Interval 1.5 to 2.7
|
1.3 geometric mean fold rise
Interval 1.1 to 1.6
|
1.8 geometric mean fold rise
Interval 1.5 to 2.1
|
1.5 geometric mean fold rise
Interval 1.3 to 1.8
|
1.4 geometric mean fold rise
Interval 1.2 to 1.7
|
2.1 geometric mean fold rise
Interval 1.6 to 2.8
|
1.6 geometric mean fold rise
Interval 1.3 to 2.0
|
2.2 geometric mean fold rise
Interval 1.7 to 2.7
|
—
|
|
Microneutralization (MN50) Antibody Responses Influenza B/Phuket (Yamagata Subtype) Expressed as GMFR
Day 28
|
1.7 geometric mean fold rise
Interval 1.3 to 2.2
|
1.7 geometric mean fold rise
Interval 1.4 to 2.0
|
1.3 geometric mean fold rise
Interval 1.1 to 1.5
|
1.1 geometric mean fold rise
Interval 0.9 to 1.3
|
1.2 geometric mean fold rise
Interval 1.0 to 1.4
|
1.6 geometric mean fold rise
Interval 1.2 to 2.2
|
1.2 geometric mean fold rise
Interval 1.1 to 1.4
|
1.5 geometric mean fold rise
Interval 1.3 to 1.7
|
1.3 geometric mean fold rise
Interval 1.1 to 1.5
|
1.2 geometric mean fold rise
Interval 1.1 to 1.3
|
1.6 geometric mean fold rise
Interval 1.3 to 2.0
|
1.3 geometric mean fold rise
Interval 1.1 to 1.6
|
1.6 geometric mean fold rise
Interval 1.3 to 1.9
|
—
|
|
Microneutralization (MN50) Antibody Responses Influenza B/Phuket (Yamagata Subtype) Expressed as GMFR
Day 56
|
1.6 geometric mean fold rise
Interval 1.2 to 2.0
|
1.6 geometric mean fold rise
Interval 1.3 to 1.9
|
1.1 geometric mean fold rise
Interval 1.0 to 1.3
|
1.1 geometric mean fold rise
Interval 0.9 to 1.2
|
1.2 geometric mean fold rise
Interval 1.0 to 1.4
|
1.5 geometric mean fold rise
Interval 1.1 to 2.0
|
1.2 geometric mean fold rise
Interval 1.1 to 1.4
|
1.3 geometric mean fold rise
Interval 1.2 to 1.5
|
1.2 geometric mean fold rise
Interval 1.0 to 1.4
|
1.1 geometric mean fold rise
Interval 1.0 to 1.2
|
1.4 geometric mean fold rise
Interval 1.1 to 1.7
|
1.3 geometric mean fold rise
Interval 1.1 to 1.5
|
1.5 geometric mean fold rise
Interval 1.2 to 1.8
|
—
|
|
Microneutralization (MN50) Antibody Responses Influenza B/Phuket (Yamagata Subtype) Expressed as GMFR
Day 84
|
2.1 geometric mean fold rise
Interval 1.7 to 2.7
|
2.9 geometric mean fold rise
Interval 2.3 to 3.5
|
1.8 geometric mean fold rise
Interval 1.4 to 2.2
|
2.0 geometric mean fold rise
Interval 1.5 to 2.6
|
2.1 geometric mean fold rise
Interval 1.7 to 2.7
|
2.6 geometric mean fold rise
Interval 1.9 to 3.5
|
1.6 geometric mean fold rise
Interval 1.4 to 1.9
|
2.4 geometric mean fold rise
Interval 2.0 to 2.8
|
2.0 geometric mean fold rise
Interval 1.7 to 2.4
|
1.9 geometric mean fold rise
Interval 1.5 to 2.4
|
2.9 geometric mean fold rise
Interval 2.1 to 4.0
|
1.9 geometric mean fold rise
Interval 1.5 to 2.4
|
3.0 geometric mean fold rise
Interval 2.4 to 3.8
|
—
|
|
Microneutralization (MN50) Antibody Responses Influenza B/Phuket (Yamagata Subtype) Expressed as GMFR
Day 70
|
1.5 geometric mean fold rise
Interval 1.2 to 1.9
|
1.9 geometric mean fold rise
Interval 1.6 to 2.3
|
1.4 geometric mean fold rise
Interval 1.2 to 1.7
|
1.2 geometric mean fold rise
Interval 1.0 to 1.5
|
1.5 geometric mean fold rise
Interval 1.3 to 1.8
|
1.9 geometric mean fold rise
Interval 1.4 to 2.6
|
1.4 geometric mean fold rise
Interval 1.2 to 1.6
|
1.6 geometric mean fold rise
Interval 1.4 to 1.8
|
1.5 geometric mean fold rise
Interval 1.2 to 1.7
|
1.3 geometric mean fold rise
Interval 1.1 to 1.5
|
2.0 geometric mean fold rise
Interval 1.6 to 2.6
|
1.4 geometric mean fold rise
Interval 1.2 to 1.7
|
1.7 geometric mean fold rise
Interval 1.4 to 2.1
|
—
|
SECONDARY outcome
Timeframe: Day 28 to Day 182Population: Per Protocol Analysis Set population
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine Influenza B/Washington (Victoria Subtype) antigenically-drifted influenza strains, as measured by a MN assay, expressed as GMFR.
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
n=39 Participants
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Microneutralization (MN50) Antibody Responses Influenza B/Washington (Victoria Subtype) Expressed as GMFR
Day 56
|
1.9 geometric mean fold rise
Interval 1.3 to 2.7
|
1.6 geometric mean fold rise
Interval 1.4 to 1.9
|
1.4 geometric mean fold rise
Interval 1.2 to 1.8
|
1.1 geometric mean fold rise
Interval 0.9 to 1.3
|
1.4 geometric mean fold rise
Interval 1.1 to 1.8
|
1.5 geometric mean fold rise
Interval 1.2 to 1.8
|
1.3 geometric mean fold rise
Interval 1.1 to 1.5
|
1.5 geometric mean fold rise
Interval 1.3 to 1.7
|
1.2 geometric mean fold rise
Interval 1.0 to 1.3
|
1.2 geometric mean fold rise
Interval 1.0 to 1.4
|
1.4 geometric mean fold rise
Interval 1.1 to 1.7
|
1.5 geometric mean fold rise
Interval 1.2 to 1.9
|
1.4 geometric mean fold rise
Interval 1.1 to 1.8
|
—
|
|
Microneutralization (MN50) Antibody Responses Influenza B/Washington (Victoria Subtype) Expressed as GMFR
Day 70
|
1.8 geometric mean fold rise
Interval 1.3 to 2.5
|
1.9 geometric mean fold rise
Interval 1.6 to 2.2
|
1.8 geometric mean fold rise
Interval 1.4 to 2.3
|
1.3 geometric mean fold rise
Interval 1.0 to 1.6
|
1.7 geometric mean fold rise
Interval 1.3 to 2.1
|
1.8 geometric mean fold rise
Interval 1.5 to 2.2
|
1.5 geometric mean fold rise
Interval 1.2 to 1.8
|
1.7 geometric mean fold rise
Interval 1.4 to 1.9
|
1.3 geometric mean fold rise
Interval 1.1 to 1.5
|
1.4 geometric mean fold rise
Interval 1.2 to 1.6
|
1.6 geometric mean fold rise
Interval 1.2 to 2.0
|
1.6 geometric mean fold rise
Interval 1.2 to 2.0
|
1.6 geometric mean fold rise
Interval 1.4 to 1.9
|
—
|
|
Microneutralization (MN50) Antibody Responses Influenza B/Washington (Victoria Subtype) Expressed as GMFR
Day 84
|
1.9 geometric mean fold rise
Interval 1.3 to 2.8
|
2.0 geometric mean fold rise
Interval 1.6 to 2.3
|
1.8 geometric mean fold rise
Interval 1.4 to 2.4
|
1.5 geometric mean fold rise
Interval 1.2 to 2.0
|
2.1 geometric mean fold rise
Interval 1.6 to 2.7
|
1.9 geometric mean fold rise
Interval 1.5 to 2.4
|
1.5 geometric mean fold rise
Interval 1.1 to 1.9
|
1.8 geometric mean fold rise
Interval 1.5 to 2.1
|
1.4 geometric mean fold rise
Interval 1.1 to 1.7
|
1.6 geometric mean fold rise
Interval 1.3 to 1.9
|
2.1 geometric mean fold rise
Interval 1.6 to 2.8
|
1.7 geometric mean fold rise
Interval 1.3 to 2.2
|
1.8 geometric mean fold rise
Interval 1.4 to 2.3
|
—
|
|
Microneutralization (MN50) Antibody Responses Influenza B/Washington (Victoria Subtype) Expressed as GMFR
Day 182
|
1.6 geometric mean fold rise
Interval 1.1 to 2.2
|
1.6 geometric mean fold rise
Interval 1.3 to 1.9
|
1.3 geometric mean fold rise
Interval 1.0 to 1.7
|
1.1 geometric mean fold rise
Interval 0.9 to 1.3
|
1.7 geometric mean fold rise
Interval 1.3 to 2.3
|
1.4 geometric mean fold rise
Interval 1.1 to 1.7
|
1.2 geometric mean fold rise
Interval 1.0 to 1.5
|
1.6 geometric mean fold rise
Interval 1.3 to 1.8
|
1.1 geometric mean fold rise
Interval 0.9 to 1.4
|
1.3 geometric mean fold rise
Interval 1.1 to 1.6
|
1.6 geometric mean fold rise
Interval 1.2 to 2.0
|
1.5 geometric mean fold rise
Interval 1.2 to 1.9
|
1.4 geometric mean fold rise
Interval 1.2 to 1.7
|
—
|
|
Microneutralization (MN50) Antibody Responses Influenza B/Washington (Victoria Subtype) Expressed as GMFR
Day 28
|
2.3 geometric mean fold rise
Interval 1.5 to 3.3
|
1.7 geometric mean fold rise
Interval 1.5 to 2.1
|
1.7 geometric mean fold rise
Interval 1.3 to 2.1
|
1.2 geometric mean fold rise
Interval 1.0 to 1.5
|
1.6 geometric mean fold rise
Interval 1.2 to 2.1
|
1.8 geometric mean fold rise
Interval 1.4 to 2.3
|
1.4 geometric mean fold rise
Interval 1.1 to 1.6
|
1.7 geometric mean fold rise
Interval 1.4 to 2.0
|
1.3 geometric mean fold rise
Interval 1.1 to 1.5
|
1.2 geometric mean fold rise
Interval 1.1 to 1.4
|
1.5 geometric mean fold rise
Interval 1.2 to 2.0
|
1.6 geometric mean fold rise
Interval 1.3 to 2.1
|
1.5 geometric mean fold rise
Interval 1.2 to 1.8
|
—
|
SECONDARY outcome
Timeframe: Day 28 to Day 182Population: Per-Protocol Analysis Set Population
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine of vaccine homologous Influenza A/Brisbane (H1N1 Subtype) strain expressed as SCR and/or antigenically-drifted influenza strains, as measured by a MN assay, expressed as SCR.
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
n=39 Participants
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as SCR
Day 28
|
10.3 Percentage of participants
Interval 2.9 to 24.2
|
12.7 Percentage of participants
Interval 6.2 to 22.0
|
12.5 Percentage of participants
Interval 4.2 to 26.8
|
13.2 Percentage of participants
Interval 4.4 to 28.1
|
5.4 Percentage of participants
Interval 0.7 to 18.2
|
9.8 Percentage of participants
Interval 2.7 to 23.1
|
2.5 Percentage of participants
Interval 0.1 to 13.2
|
12.8 Percentage of participants
Interval 6.3 to 22.3
|
7.7 Percentage of participants
Interval 1.6 to 20.9
|
5.1 Percentage of participants
Interval 0.6 to 17.3
|
17.9 Percentage of participants
Interval 7.5 to 33.5
|
10.3 Percentage of participants
Interval 2.9 to 24.2
|
9.8 Percentage of participants
Interval 2.7 to 23.1
|
—
|
|
Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as SCR
Day 56
|
10.3 Percentage of participants
Interval 2.9 to 24.2
|
11.5 Percentage of participants
Interval 5.4 to 20.8
|
10.3 Percentage of participants
Interval 2.9 to 24.2
|
11.1 Percentage of participants
Interval 3.1 to 26.1
|
5.6 Percentage of participants
Interval 0.7 to 18.7
|
2.5 Percentage of participants
Interval 0.1 to 13.2
|
0 Percentage of participants
Interval 0.0 to 8.8
|
10.1 Percentage of participants
Interval 4.5 to 19.0
|
5.1 Percentage of participants
Interval 0.6 to 17.3
|
2.6 Percentage of participants
Interval 0.1 to 13.8
|
10.8 Percentage of participants
Interval 3.0 to 25.4
|
5.3 Percentage of participants
Interval 0.6 to 17.7
|
10.0 Percentage of participants
Interval 2.8 to 23.7
|
—
|
|
Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as SCR
Day 70
|
7.9 Percentage of participants
Interval 1.7 to 21.4
|
18.4 Percentage of participants
Interval 10.5 to 29.0
|
12.8 Percentage of participants
Interval 4.3 to 27.4
|
14.3 Percentage of participants
Interval 4.8 to 30.3
|
22.2 Percentage of participants
Interval 10.1 to 39.2
|
17.5 Percentage of participants
Interval 7.3 to 32.8
|
10.0 Percentage of participants
Interval 2.8 to 23.7
|
21.1 Percentage of participants
Interval 12.5 to 31.9
|
18.4 Percentage of participants
Interval 7.7 to 34.3
|
5.3 Percentage of participants
Interval 0.6 to 17.7
|
19.4 Percentage of participants
Interval 8.2 to 36.0
|
13.5 Percentage of participants
Interval 4.5 to 28.8
|
12.2 Percentage of participants
Interval 4.1 to 26.2
|
—
|
|
Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as SCR
Day 84
|
44.7 Percentage of participants
Interval 28.6 to 61.7
|
51.9 Percentage of participants
Interval 40.3 to 63.5
|
53.8 Percentage of participants
Interval 37.2 to 69.9
|
38.2 Percentage of participants
Interval 22.2 to 56.4
|
54.3 Percentage of participants
Interval 36.6 to 71.2
|
46.2 Percentage of participants
Interval 30.1 to 62.8
|
31.6 Percentage of participants
Interval 17.5 to 48.7
|
52.6 Percentage of participants
Interval 40.8 to 64.2
|
47.4 Percentage of participants
Interval 31.0 to 64.2
|
42.1 Percentage of participants
Interval 26.3 to 59.2
|
50.0 Percentage of participants
Interval 32.4 to 67.6
|
29.7 Percentage of participants
Interval 15.9 to 47.0
|
63.4 Percentage of participants
Interval 46.9 to 77.9
|
—
|
|
Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Brisbane (H1N1 Subtype) Strain Expressed as SCR
Day 182
|
28.9 Percentage of participants
Interval 15.4 to 45.9
|
40.5 Percentage of participants
Interval 29.3 to 52.6
|
28.2 Percentage of participants
Interval 15.0 to 44.9
|
26.5 Percentage of participants
Interval 12.9 to 44.4
|
28.6 Percentage of participants
Interval 14.6 to 46.3
|
38.5 Percentage of participants
Interval 23.4 to 55.4
|
21.1 Percentage of participants
Interval 9.6 to 37.3
|
37.3 Percentage of participants
Interval 26.4 to 49.3
|
21.6 Percentage of participants
Interval 9.8 to 38.2
|
21.6 Percentage of participants
Interval 9.8 to 38.2
|
38.9 Percentage of participants
Interval 23.1 to 56.5
|
21.1 Percentage of participants
Interval 9.6 to 37.3
|
33.3 Percentage of participants
Interval 19.1 to 50.2
|
—
|
SECONDARY outcome
Timeframe: Day 28 to Day 182Population: Per-Protocol Analysis Set Population
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine of vaccine homologous Influenza A/Kansas (H3N2 Subtype) strain expressed as SCR and/or antigenically-drifted influenza strains, as measured by a MN assay, expressed as SCR.
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
n=39 Participants
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR
Day 28
|
53.8 Percentage of participants
Interval 37.2 to 69.9
|
45.6 Percentage of participants
Interval 34.3 to 57.2
|
27.5 Percentage of participants
Interval 14.6 to 43.9
|
28.9 Percentage of participants
Interval 15.4 to 45.9
|
27.0 Percentage of participants
Interval 13.8 to 44.1
|
31.7 Percentage of participants
Interval 18.1 to 48.1
|
20.0 Percentage of participants
Interval 9.1 to 35.6
|
43.6 Percentage of participants
Interval 32.4 to 55.3
|
25.6 Percentage of participants
Interval 13.0 to 42.1
|
25.6 Percentage of participants
Interval 13.0 to 42.1
|
46.2 Percentage of participants
Interval 30.1 to 62.8
|
38.5 Percentage of participants
Interval 23.4 to 55.4
|
36.6 Percentage of participants
Interval 22.1 to 53.1
|
—
|
|
Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR
Day 56
|
48.7 Percentage of participants
Interval 32.4 to 65.2
|
38.5 Percentage of participants
Interval 27.7 to 50.2
|
28.2 Percentage of participants
Interval 15.0 to 44.9
|
22.2 Percentage of participants
Interval 10.1 to 39.2
|
27.8 Percentage of participants
Interval 14.2 to 45.2
|
27.5 Percentage of participants
Interval 14.2 to 45.2
|
27.5 Percentage of participants
Interval 14.6 to 43.9
|
39.2 Percentage of participants
Interval 28.4 to 50.9
|
23.1 Percentage of participants
Interval 11.1 to 39.3
|
21.1 Percentage of participants
Interval 9.6 to 37.3
|
40.5 Percentage of participants
Interval 24.8 to 50.9
|
28.9 Percentage of participants
Interval 15.4 to 45.9
|
30.0 Percentage of participants
Interval 16.6 to 46.5
|
—
|
|
Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR
Day 84
|
52.6 Percentage of participants
Interval 35.8 to 69.0
|
48.1 Percentage of participants
Interval 36.5 to 59.7
|
38.5 Percentage of participants
Interval 23.4 to 55.4
|
52.9 Percentage of participants
Interval 35.1 to 70.2
|
45.7 Percentage of participants
Interval 28.8 to 63.4
|
48.7 Percentage of participants
Interval 32.4 to 65.2
|
31.6 Percentage of participants
Interval 17.5 to 48.7
|
55.3 Percentage of participants
Interval 43.4 to 66.7
|
34.2 Percentage of participants
Interval 19.6 to 51.4
|
26.3 Percentage of participants
Interval 13.4 to 43.1
|
47.1 Percentage of participants
Interval 29.8 to 64.9
|
32.4 Percentage of participants
Interval 18.0 to 49.8
|
41.5 Percentage of participants
Interval 26.3 to 57.9
|
—
|
|
Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR
Day 70
|
47.4 Percentage of participants
Interval 31.0 to 64.2
|
51.3 Percentage of participants
Interval 39.6 to 63.0
|
38.5 Percentage of participants
Interval 23.4 to 55.4
|
48.6 Percentage of participants
Interval 31.4 to 66.0
|
55.6 Percentage of participants
Interval 38.1 to 72.1
|
47.5 Percentage of participants
Interval 31.5 to 63.9
|
32.5 Percentage of participants
Interval 18.6 to 49.1
|
56.6 Percentage of participants
Interval 44.7 to 67.9
|
31.6 Percentage of participants
Interval 17.5 to 48.7
|
28.9 Percentage of participants
Interval 15.4 to 45.9
|
50.0 Percentage of participants
Interval 32.9 to 67.1
|
40.5 Percentage of participants
Interval 24.8 to 57.9
|
43.9 Percentage of participants
Interval 28.5 to 60.3
|
—
|
|
Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Kansas (H3N2 Subtype) Strain Expressed as SCR
Day 182
|
39.5 Percentage of participants
Interval 24.0 to 56.6
|
36.5 Percentage of participants
Interval 25.6 to 48.5
|
25.6 Percentage of participants
Interval 13.0 to 42.1
|
26.5 Percentage of participants
Interval 12.9 to 44.4
|
22.9 Percentage of participants
Interval 10.4 to 40.1
|
25.6 Percentage of participants
Interval 13.0 to 42.1
|
26.3 Percentage of participants
Interval 13.4 to 43.1
|
38.7 Percentage of participants
Interval 27.6 to 50.6
|
21.6 Percentage of participants
Interval 9.8 to 38.2
|
16.2 Percentage of participants
Interval 6.2 to 32.0
|
30.6 Percentage of participants
Interval 16.3 to 48.1
|
13.2 Percentage of participants
Interval 4.4 to 28.1
|
28.2 Percentage of participants
Interval 15.0 to 44.9
|
—
|
SECONDARY outcome
Timeframe: Day 28 to Day 182Population: Per-Protocol Analysis Set Population
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine of vaccine homologous Influenza A/Wisconsin (H1N1 Subtype) strain expressed as SCR and/or antigenically-drifted influenza strains, as measured by a MN assay, expressed as SCR.
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
n=39 Participants
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR
Day 28
|
2.6 Percentage of participants
Interval 0.1 to 13.5
|
3.8 Percentage of participants
Interval 0.8 to 10.7
|
7.5 Percentage of participants
Interval 1.6 to 20.4
|
2.6 Percentage of participants
Interval 0.1 to 13.8
|
0 Percentage of participants
Interval 0.0 to 9.5
|
0 Percentage of participants
Interval 0.0 to 8.6
|
0 Percentage of participants
Interval 0.0 to 8.8
|
1.3 Percentage of participants
Interval 0.0 to 6.9
|
0 Percentage of participants
Interval 0.0 to 9.0
|
0 Percentage of participants
Interval 0.0 to 9.0
|
12.8 Percentage of participants
Interval 4.3 to 27.4
|
0 Percentage of participants
Interval 0.0 to 9.0
|
4.9 Percentage of participants
Interval 0.6 to 16.5
|
—
|
|
Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR
Day 70
|
2.6 Percentage of participants
Interval 0.1 to 13.8
|
6.6 Percentage of participants
Interval 2.2 to 14.7
|
7.7 Percentage of participants
Interval 1.6 to 20.9
|
2.9 Percentage of participants
Interval 0.1 to 14.9
|
2.8 Percentage of participants
Interval 0.1 to 14.5
|
2.5 Percentage of participants
Interval 0.1 to 13.2
|
2.5 Percentage of participants
Interval 0.1 to 13.2
|
7.9 Percentage of participants
Interval 3.0 to 16.4
|
2.6 Percentage of participants
Interval 0.1 to 13.8
|
0 Percentage of participants
Interval 0.0 to 9.3
|
11.1 Percentage of participants
Interval 3.1 to 26.1
|
2.7 Percentage of participants
Interval 0.1 to 14.2
|
4.9 Percentage of participants
Interval 0.6 to 16.5
|
—
|
|
Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR
Day 84
|
5.3 Percentage of participants
Interval 0.6 to 17.7
|
13.0 Percentage of participants
Interval 6.4 to 22.6
|
12.8 Percentage of participants
Interval 4.3 to 27.4
|
2.9 Percentage of participants
Interval 0.1 to 15.3
|
2.9 Percentage of participants
Interval 0.1 to 14.9
|
7.7 Percentage of participants
Interval 1.6 to 20.9
|
0 Percentage of participants
Interval 0.0 to 9.3
|
11.8 Percentage of participants
Interval 5.6 to 21.3
|
5.3 Percentage of participants
Interval 0.6 to 17.7
|
2.6 Percentage of participants
Interval 0.1 to 13.8
|
20.6 Percentage of participants
Interval 8.7 to 37.9
|
2.7 Percentage of participants
Interval 0.1 to 14.2
|
14.6 Percentage of participants
Interval 5.6 to 29.2
|
—
|
|
Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR
Day 56
|
2.6 Percentage of participants
Interval 0.1 to 13.5
|
1.3 Percentage of participants
Interval 0.0 to 6.9
|
5.1 Percentage of participants
Interval 0.6 to 17.3
|
0 Percentage of participants
Interval 0.0 to 9.7
|
0 Percentage of participants
Interval 0.0 to 9.7
|
0 Percentage of participants
Interval 0.0 to 8.8
|
0 Percentage of participants
Interval 0.0 to 8.8
|
1.3 Percentage of participants
Interval 0.0 to 6.9
|
0 Percentage of participants
Interval 0.0 to 9.0
|
0 Percentage of participants
Interval 0.0 to 9.3
|
8.1 Percentage of participants
Interval 1.7 to 21.9
|
0 Percentage of participants
Interval 0.0 to 9.3
|
5.0 Percentage of participants
Interval 0.6 to 16.9
|
—
|
|
Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Wisconsin (H1N1 Subtype) Strain Expressed as SCR
Day 182
|
5.3 Percentage of participants
Interval 0.6 to 17.7
|
5.4 Percentage of participants
Interval 1.5 to 13.3
|
5.1 Percentage of participants
Interval 0.6 to 17.3
|
0 Percentage of participants
Interval 0.0 to 10.3
|
2.9 Percentage of participants
Interval 0.1 to 14.9
|
2.6 Percentage of participants
Interval 0.1 to 13.5
|
0 Percentage of participants
Interval 0.0 to 9.3
|
5.3 Percentage of participants
Interval 1.5 to 13.1
|
2.7 Percentage of participants
Interval 0.1 to 14.2
|
0 Percentage of participants
Interval 0.0 to 9.5
|
13.9 Percentage of participants
Interval 4.7 to 29.5
|
2.6 Percentage of participants
Interval 0.1 to 13.8
|
2.6 Percentage of participants
Interval 0.1 to 13.5
|
—
|
SECONDARY outcome
Timeframe: Day 28 to Day 182Population: Per-Protocol Analysis Set Population
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine of vaccine homologous Influenza A/Cambodia (H3N2 Subtype) strain expressed as SCR and/or antigenically-drifted influenza strains, as measured by a MN assay, expressed as SCR.
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
n=39 Participants
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR
Day 28
|
10.3 Percentage of participants
Interval 2.9 to 24.2
|
10.3 Percentage of participants
Interval 2.9 to 24.2
|
17.5 Percentage of participants
Interval 7.3 to 32.8
|
13.2 Percentage of participants
Interval 4.4 to 28.1
|
10.8 Percentage of participants
Interval 3.0 to 25.4
|
14.6 Percentage of participants
Interval 5.6 to 29.2
|
10.0 Percentage of participants
Interval 2.8 to 23.7
|
15.4 Percentage of participants
Interval 8.2 to 25.3
|
5.1 Percentage of participants
Interval 0.6 to 17.3
|
10.3 Percentage of participants
Interval 2.9 to 24.2
|
30.8 Percentage of participants
Interval 17.0 to 47.6
|
17.9 Percentage of participants
Interval 7.5 to 33.5
|
14.6 Percentage of participants
Interval 5.6 to 29.2
|
—
|
|
Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR
Day 84
|
7.9 Percentage of participants
Interval 1.7 to 21.4
|
15.6 Percentage of participants
Interval 8.3 to 25.6
|
20.5 Percentage of participants
Interval 9.3 to 36.5
|
20.6 Percentage of participants
Interval 8.7 to 37.9
|
14.3 Percentage of participants
Interval 4.8 to 30.3
|
15.4 Percentage of participants
Interval 5.9 to 30.5
|
10.5 Percentage of participants
Interval 2.9 to 24.8
|
17.1 Percentage of participants
Interval 9.4 to 27.5
|
2.6 Percentage of participants
Interval 0.1 to 13.8
|
13.2 Percentage of participants
Interval 4.4 to 28.1
|
38.2 Percentage of participants
Interval 22.2 to 56.4
|
24.3 Percentage of participants
Interval 11.8 to 41.2
|
17.1 Percentage of participants
Interval 7.2 to 32.1
|
—
|
|
Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR
Day 182
|
5.3 Percentage of participants
Interval 0.6 to 17.7
|
8.1 Percentage of participants
Interval 3.0 to 16.8
|
17.9 Percentage of participants
Interval 7.5 to 33.5
|
2.9 Percentage of participants
Interval 0.1 to 15.3
|
8.6 Percentage of participants
Interval 1.8 to 23.1
|
10.3 Percentage of participants
Interval 2.9 to 24.2
|
5.3 Percentage of participants
Interval 0.6 to 17.7
|
8.0 Percentage of participants
Interval 3.0 to 16.6
|
2.7 Percentage of participants
Interval 0.1 to 14.2
|
8.1 Percentage of participants
Interval 1.7 to 21.9
|
19.4 Percentage of participants
Interval 8.2 to 36.0
|
10.5 Percentage of participants
Interval 2.9 to 24.8
|
7.7 Percentage of participants
Interval 1.6 to 20.9
|
—
|
|
Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR
Day 56
|
10.3 Percentage of participants
Interval 2.9 to 24.2
|
14.1 Percentage of participants
Interval 7.3 to 23.8
|
15.4 Percentage of participants
Interval 5.9 to 30.5
|
8.3 Percentage of participants
Interval 1.8 to 22.5
|
5.6 Percentage of participants
Interval 0.7 to 18.7
|
10.0 Percentage of participants
Interval 2.8 to 23.7
|
10.0 Percentage of participants
Interval 2.8 to 23.7
|
12.7 Percentage of participants
Interval 6.2 to 22.0
|
2.6 Percentage of participants
Interval 0.1 to 13.5
|
10.5 Percentage of participants
Interval 2.9 to 24.8
|
21.6 Percentage of participants
Interval 9.8 to 38.2
|
18.4 Percentage of participants
Interval 7.7 to 34.3
|
10.0 Percentage of participants
Interval 2.8 to 23.7
|
—
|
|
Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Cambodia (H3N2 Subtype) Strain Expressed as SCR
Day 70
|
10.5 Percentage of participants
Interval 2.9 to 24.8
|
18.4 Percentage of participants
Interval 10.5 to 29.0
|
23.1 Percentage of participants
Interval 11.1 to 39.3
|
22.9 Percentage of participants
Interval 10.4 to 40.1
|
16.7 Percentage of participants
Interval 6.4 to 32.8
|
20.0 Percentage of participants
Interval 9.1 to 35.6
|
17.5 Percentage of participants
Interval 7.3 to 32.8
|
15.8 Percentage of participants
Interval 8.4 to 26.0
|
7.9 Percentage of participants
Interval 1.7 to 21.4
|
15.8 Percentage of participants
Interval 6.0 to 31.3
|
30.6 Percentage of participants
Interval 16.3 to 48.1
|
21.6 Percentage of participants
Interval 9.8 to 38.2
|
12.2 Percentage of participants
Interval 4.1 to 26.2
|
—
|
SECONDARY outcome
Timeframe: Day 28 to Day 182Population: Per-Protocol Analysis Set Population
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine of vaccine homologous Influenza A/Hong Kong (H3N2 Subtype) strain expressed as SCR and/or antigenically-drifted influenza strains, as measured by a MN assay, expressed as SCR.
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
n=39 Participants
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR
Day 56
|
23.1 Percentage of participants
Interval 11.1 to 39.3
|
14.1 Percentage of participants
Interval 7.3 to 23.8
|
25.6 Percentage of participants
Interval 13.0 to 42.1
|
16.7 Percentage of participants
Interval 6.4 to 32.8
|
11.1 Percentage of participants
Interval 3.1 to 26.1
|
15.0 Percentage of participants
Interval 5.7 to 29.8
|
15.0 Percentage of participants
Interval 5.7 to 29.8
|
22.8 Percentage of participants
Interval 14.1 to 33.6
|
7.7 Percentage of participants
Interval 1.6 to 20.9
|
15.8 Percentage of participants
Interval 6.0 to 31.3
|
27.0 Percentage of participants
Interval 13.8 to 44.1
|
23.7 Percentage of participants
Interval 11.4 to 40.2
|
22.5 Percentage of participants
Interval 10.8 to 38.5
|
—
|
|
Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR
Day 84
|
18.4 Percentage of participants
Interval 7.7 to 34.3
|
18.2 Percentage of participants
Interval 10.3 to 28.6
|
28.2 Percentage of participants
Interval 15.0 to 44.9
|
26.5 Percentage of participants
Interval 12.9 to 44.4
|
14.3 Percentage of participants
Interval 4.8 to 30.3
|
17.9 Percentage of participants
Interval 7.5 to 33.5
|
26.3 Percentage of participants
Interval 13.4 to 43.1
|
34.2 Percentage of participants
Interval 23.7 to 46.0
|
23.7 Percentage of participants
Interval 11.4 to 40.2
|
28.9 Percentage of participants
Interval 15.4 to 45.9
|
32.4 Percentage of participants
Interval 17.4 to 50.5
|
27.0 Percentage of participants
Interval 13.8 to 44.1
|
26.8 Percentage of participants
Interval 14.2 to 42.9
|
—
|
|
Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR
Day 28
|
25.6 Percentage of participants
Interval 13.0 to 42.1
|
16.5 Percentage of participants
Interval 9.1 to 26.5
|
27.5 Percentage of participants
Interval 14.6 to 43.9
|
15.8 Percentage of participants
Interval 6.0 to 31.3
|
16.2 Percentage of participants
Interval 6.2 to 32.0
|
17.1 Percentage of participants
Interval 7.2 to 32.1
|
17.5 Percentage of participants
Interval 7.3 to 32.8
|
26.9 Percentage of participants
Interval 17.5 to 38.2
|
10.3 Percentage of participants
Interval 2.9 to 24.2
|
23.1 Percentage of participants
Interval 11.1 to 39.3
|
35.9 Percentage of participants
Interval 21.2 to 52.8
|
28.2 Percentage of participants
Interval 15.0 to 44.9
|
29.3 Percentage of participants
Interval 16.1 to 45.5
|
—
|
|
Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR
Day 70
|
26.3 Percentage of participants
Interval 13.4 to 43.1
|
15.8 Percentage of participants
Interval 8.4 to 26.0
|
33.3 Percentage of participants
Interval 19.1 to 50.2
|
22.9 Percentage of participants
Interval 10.4 to 40.1
|
22.2 Percentage of participants
Interval 10.1 to 39.2
|
25.0 Percentage of participants
Interval 12.7 to 41.2
|
20.0 Percentage of participants
Interval 9.1 to 35.6
|
30.3 Percentage of participants
Interval 20.2 to 41.9
|
18.4 Percentage of participants
Interval 7.7 to 34.3
|
31.6 Percentage of participants
Interval 17.5 to 48.7
|
30.6 Percentage of participants
Interval 16.3 to 48.1
|
18.9 Percentage of participants
Interval 8.0 to 35.2
|
26.8 Percentage of participants
Interval 14.2 to 42.9
|
—
|
|
Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza A/Hong Kong (H3N2 Subtype) Strain Expressed as SCR
Day 182
|
10.5 Percentage of participants
Interval 4.8 to 20.2
|
10.8 Percentage of participants
Interval 4.8 to 20.2
|
20.5 Percentage of participants
Interval 9.3 to 36.5
|
14.7 Percentage of participants
Interval 5.0 to 31.1
|
17.1 Percentage of participants
Interval 6.6 to 33.6
|
15.4 Percentage of participants
Interval 5.9 to 30.5
|
15.8 Percentage of participants
Interval 6.0 to 31.3
|
16.0 Percentage of participants
Interval 8.6 to 26.3
|
5.4 Percentage of participants
Interval 0.7 to 18.2
|
13.5 Percentage of participants
Interval 4.5 to 28.8
|
16.7 Percentage of participants
Interval 6.4 to 32.8
|
7.9 Percentage of participants
Interval 1.7 to 21.4
|
20.5 Percentage of participants
Interval 9.3 to 36.5
|
—
|
SECONDARY outcome
Timeframe: Day 28 to Day 182Population: Per-Protocol Analysis Set Population
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine of vaccine homologous Influenza B/Maryland (Victoria Subtype) strain expressed as SCR and/or antigenically-drifted influenza strains, as measured by a MN assay, expressed as SCR.
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
n=39 Participants
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR
Day 28
|
17.9 Percentage of participants
Interval 7.5 to 33.5
|
10.1 Percentage of participants
Interval 4.5 to 19.0
|
10.0 Percentage of participants
Interval 2.8 to 23.7
|
2.6 Percentage of participants
Interval 0.1 to 13.8
|
2.7 Percentage of participants
Interval 0.1 to 14.2
|
4.9 Percentage of participants
Interval 0.6 to 16.5
|
2.5 Percentage of participants
Interval 0.1 to 13.2
|
5.1 Percentage of participants
Interval 1.4 to 12.6
|
0 Percentage of participants
Interval 0.0 to 9.0
|
2.6 Percentage of participants
Interval 0.1 to 13.5
|
7.7 Percentage of participants
Interval 1.6 to 20.9
|
7.7 Percentage of participants
Interval 1.6 to 20.9
|
9.8 Percentage of participants
Interval 2.7 to 23.1
|
—
|
|
Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR
Day 84
|
21.1 Percentage of participants
Interval 9.6 to 37.3
|
35.1 Percentage of participants
Interval 24.5 to 46.8
|
23.1 Percentage of participants
Interval 11.1 to 39.3
|
20.6 Percentage of participants
Interval 8.7 to 37.9
|
20.0 Percentage of participants
Interval 8.4 to 36.9
|
20.5 Percentage of participants
Interval 9.3 to 36.5
|
21.1 Percentage of participants
Interval 9.6 to 37.3
|
25.0 Percentage of participants
Interval 15.8 to 36.3
|
15.8 Percentage of participants
Interval 6.0 to 31.3
|
10.5 Percentage of participants
Interval 2.9 to 24.8
|
38.2 Percentage of participants
Interval 22.2 to 56.4
|
16.2 Percentage of participants
Interval 6.2 to 32.0
|
31.7 Percentage of participants
Interval 18.1 to 48.1
|
—
|
|
Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR
Day 182
|
13.2 Percentage of participants
Interval 4.4 to 28.1
|
13.2 Percentage of participants
Interval 4.4 to 28.1
|
15.4 Percentage of participants
Interval 5.9 to 30.5
|
2.9 Percentage of participants
Interval 0.1 to 15.3
|
20.0 Percentage of participants
Interval 8.4 to 36.9
|
15.4 Percentage of participants
Interval 5.9 to 30.5
|
13.2 Percentage of participants
Interval 4.4 to 28.1
|
17.3 Percentage of participants
Interval 9.6 to 27.8
|
5.4 Percentage of participants
Interval 0.7 to 18.2
|
2.7 Percentage of participants
Interval 0.1 to 14.2
|
22.2 Percentage of participants
Interval 10.1 to 39.2
|
7.9 Percentage of participants
Interval 1.7 to 21.4
|
20.5 Percentage of participants
Interval 9.3 to 36.5
|
—
|
|
Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR
Day 56
|
15.4 Percentage of participants
Interval 5.9 to 30.5
|
10.3 Percentage of participants
Interval 4.5 to 19.2
|
7.7 Percentage of participants
Interval 1.6 to 20.9
|
2.8 Percentage of participants
Interval 0.1 to 14.5
|
2.8 Percentage of participants
Interval 0.1 to 14.5
|
2.5 Percentage of participants
Interval 0.1 to 13.2
|
2.5 Percentage of participants
Interval 0.1 to 13.2
|
5.1 Percentage of participants
Interval 1.4 to 12.5
|
0 Percentage of participants
Interval 0.0 to 9.0
|
0 Percentage of participants
Interval 0.0 to 9.3
|
8.1 Percentage of participants
Interval 1.7 to 21.9
|
5.3 Percentage of participants
Interval 0.6 to 17.7
|
5.0 Percentage of participants
Interval 0.6 to 16.9
|
—
|
|
Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Maryland (Victoria Subtype) Strain Expressed as SCR
Day 70
|
13.2 Percentage of participants
Interval 4.4 to 28.1
|
13.2 Percentage of participants
Interval 6.5 to 22.9
|
10.3 Percentage of participants
Interval 2.9 to 24.2
|
5.7 Percentage of participants
Interval 0.7 to 19.2
|
5.6 Percentage of participants
Interval 0.7 to 18.7
|
2.5 Percentage of participants
Interval 0.1 to 13.2
|
5.0 Percentage of participants
Interval 0.6 to 16.9
|
5.3 Percentage of participants
Interval 1.5 to 12.9
|
2.6 Percentage of participants
Interval 0.1 to 13.8
|
2.6 Percentage of participants
Interval 0.1 to 13.8
|
8.3 Percentage of participants
Interval 1.8 to 22.5
|
10.8 Percentage of participants
Interval 3.0 to 25.4
|
4.9 Percentage of participants
Interval 0.6 to 16.5
|
—
|
SECONDARY outcome
Timeframe: Day 28 to Day 182Population: Per-Protocol Analysis Set Population
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine of vaccine homologous Influenza B/Phuket (Yamagata Subtype) strain expressed as SCR and/or antigenically-drifted influenza strains, as measured by a MN assay, expressed as SCR.
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
n=39 Participants
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR
Day 70
|
13.2 Percentage of participants
Interval 4.4 to 28.1
|
10.5 Percentage of participants
Interval 4.7 to 19.7
|
5.1 Percentage of participants
Interval 0.6 to 17.3
|
5.7 Percentage of participants
Interval 0.7 to 19.2
|
8.3 Percentage of participants
Interval 1.8 to 22.5
|
12.5 Percentage of participants
Interval 4.2 to 26.8
|
0 Percentage of participants
Interval 0.0 to 8.8
|
9.2 Percentage of participants
Interval 3.8 to 18.1
|
5.3 Percentage of participants
Interval 0.6 to 17.7
|
2.6 Percentage of participants
Interval 0.1 to 13.8
|
13.9 Percentage of participants
Interval 4.7 to 29.5
|
5.4 Percentage of participants
Interval 0.7 to 18.2
|
9.8 Percentage of participants
Interval 2.7 to 23.1
|
—
|
|
Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR
Day 182
|
15.8 Percentage of participants
Interval 6.0 to 31.3
|
10.8 Percentage of participants
Interval 4.8 to 20.2
|
5.1 Percentage of participants
Interval 0.6 to 17.3
|
8.8 Percentage of participants
Interval 1.9 to 23.7
|
11.4 Percentage of participants
Interval 3.2 to 26.7
|
17.9 Percentage of participants
Interval 7.5 to 33.5
|
2.6 Percentage of participants
Interval 0.1 to 13.8
|
9.3 Percentage of participants
Interval 3.8 to 18.3
|
5.4 Percentage of participants
Interval 0.7 to 18.2
|
2.7 Percentage of participants
Interval 0.1 to 14.2
|
16.7 Percentage of participants
Interval 6.4 to 32.8
|
7.9 Percentage of participants
Interval 1.7 to 21.4
|
23.1 Percentage of participants
Interval 11.1 to 39.3
|
—
|
|
Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR
Day 28
|
15.4 Percentage of participants
Interval 5.9 to 30.5
|
7.6 Percentage of participants
Interval 2.8 to 15.8
|
5.0 Percentage of participants
Interval 0.6 to 16.9
|
2.6 Percentage of participants
Interval 0.1 to 13.8
|
5.4 Percentage of participants
Interval 0.7 to 18.2
|
9.8 Percentage of participants
Interval 2.7 to 23.1
|
0 Percentage of participants
Interval 0.0 to 8.8
|
5.1 Percentage of participants
Interval 1.4 to 12.6
|
5.1 Percentage of participants
Interval 0.6 to 17.3
|
0 Percentage of participants
Interval 0.0 to 9.0
|
5.1 Percentage of participants
Interval 0.6 to 17.3
|
2.6 Percentage of participants
Interval 0.1 to 13.5
|
7.3 Percentage of participants
Interval 1.5 to 19.9
|
—
|
|
Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR
Day 56
|
12.8 Percentage of participants
Interval 4.3 to 27.4
|
9.0 Percentage of participants
Interval 3.7 to 17.6
|
5.1 Percentage of participants
Interval 0.6 to 17.3
|
0 Percentage of participants
Interval 0.0 to 9.7
|
5.6 Percentage of participants
Interval 0.7 to 18.7
|
10.0 Percentage of participants
Interval 2.8 to 23.7
|
2.5 Percentage of participants
Interval 0.1 to 13.2
|
3.8 Percentage of participants
Interval 0.8 to 10.7
|
2.6 Percentage of participants
Interval 0.1 to 13.5
|
0 Percentage of participants
Interval 0.0 to 9.3
|
5.4 Percentage of participants
Interval 0.7 to 18.2
|
2.6 Percentage of participants
Interval 0.1 to 13.8
|
10.0 Percentage of participants
Interval 2.8 to 23.7
|
—
|
|
Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Phuket (Yamagata Subtype) Strain Expressed as SCR
Day 84
|
18.4 Percentage of participants
Interval 7.7 to 34.3
|
24.7 Percentage of participants
Interval 15.6 to 35.7
|
10.3 Percentage of participants
Interval 2.9 to 24.2
|
14.7 Percentage of participants
Interval 5.0 to 31.1
|
20.0 Percentage of participants
Interval 8.4 to 36.9
|
33.3 Percentage of participants
Interval 19.1 to 50.2
|
5.3 Percentage of participants
Interval 0.6 to 17.7
|
19.7 Percentage of participants
Interval 11.5 to 30.5
|
15.8 Percentage of participants
Interval 6.0 to 31.3
|
10.5 Percentage of participants
Interval 2.9 to 24.8
|
35.3 Percentage of participants
Interval 19.7 to 53.5
|
13.5 Percentage of participants
Interval 4.5 to 28.8
|
29.3 Percentage of participants
Interval 16.1 to 45.5
|
—
|
SECONDARY outcome
Timeframe: Day 28 to Day 182Population: Per-Protocol Analysis Set Population
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine of vaccine homologous Influenza B/Washington (Victoria Subtype) strain expressed as SCR and/or antigenically-drifted influenza strains, as measured by a MN assay, expressed as SCR.
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
n=39 Participants
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR
Day 70
|
15.8 Percentage of participants
Interval 6.0 to 31.3
|
9.2 Percentage of participants
Interval 3.8 to 18.1
|
15.4 Percentage of participants
Interval 5.9 to 30.5
|
5.7 Percentage of participants
Interval 0.7 to 19.2
|
11.1 Percentage of participants
Interval 3.1 to 26.1
|
7.5 Percentage of participants
Interval 1.6 to 20.4
|
7.5 Percentage of participants
Interval 1.6 to 20.4
|
9.2 Percentage of participants
Interval 3.8 to 18.1
|
2.6 Percentage of participants
Interval 0.1 to 13.8
|
5.3 Percentage of participants
Interval 0.6 to 17.7
|
8.3 Percentage of participants
Interval 1.8 to 22.5
|
13.5 Percentage of participants
Interval 4.5 to 28.8
|
4.9 Percentage of participants
Interval 0.6 to 16.5
|
—
|
|
Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR
Day 28
|
23.1 Percentage of participants
Interval 11.1 to 39.3
|
8.9 Percentage of participants
Interval 3.6 to 17.4
|
12.5 Percentage of participants
Interval 4.2 to 26.8
|
2.6 Percentage of participants
Interval 0.1 to 13.8
|
8.1 Percentage of participants
Interval 1.7 to 21.9
|
9.8 Percentage of participants
Interval 2.7 to 23.1
|
7.5 Percentage of participants
Interval 1.6 to 20.4
|
9.0 Percentage of participants
Interval 3.7 to 17.6
|
5.1 Percentage of participants
Interval 0.6 to 17.3
|
5.1 Percentage of participants
Interval 0.6 to 17.3
|
10.3 Percentage of participants
Interval 2.9 to 24.2
|
15.4 Percentage of participants
Interval 5.9 to 30.5
|
9.8 Percentage of participants
Interval 2.7 to 23.1
|
—
|
|
Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR
Day 56
|
17.9 Percentage of participants
Interval 7.5 to 33.5
|
7.7 Percentage of participants
Interval 2.9 to 16.0
|
10.3 Percentage of participants
Interval 2.9 to 24.2
|
0 Percentage of participants
Interval 0.0 to 9.7
|
5.6 Percentage of participants
Interval 0.7 to 18.7
|
5.0 Percentage of participants
Interval 0.6 to 16.9
|
5.0 Percentage of participants
Interval 0.6 to 16.9
|
6.3 Percentage of participants
Interval 2.1 to 14.2
|
0 Percentage of participants
Interval 0.0 to 9.0
|
2.6 Percentage of participants
Interval 0.1 to 13.8
|
8.1 Percentage of participants
Interval 1.7 to 21.9
|
7.9 Percentage of participants
Interval 1.7 to 21.4
|
7.5 Percentage of participants
Interval 1.6 to 20.4
|
—
|
|
Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR
Day 84
|
26.3 Percentage of participants
Interval 13.4 to 43.1
|
13.0 Percentage of participants
Interval 6.4 to 22.6
|
17.9 Percentage of participants
Interval 7.5 to 33.5
|
14.7 Percentage of participants
Interval 5.0 to 31.1
|
14.3 Percentage of participants
Interval 4.8 to 30.3
|
7.7 Percentage of participants
Interval 1.6 to 20.9
|
10.5 Percentage of participants
Interval 2.9 to 24.8
|
10.5 Percentage of participants
Interval 4.7 to 19.7
|
5.3 Percentage of participants
Interval 0.6 to 17.7
|
5.3 Percentage of participants
Interval 0.6 to 17.7
|
20.6 Percentage of participants
Interval 8.7 to 37.9
|
8.1 Percentage of participants
Interval 1.7 to 21.9
|
14.6 Percentage of participants
Interval 5.6 to 29.2
|
—
|
|
Microneutralization (MN50) Antibody Responses of Vaccine Homologous Influenza B/Washington (Victoria Subtype) Strain Expressed as SCR
Day 182
|
13.2 Percentage of participants
Interval 4.4 to 28.1
|
8.1 Percentage of participants
Interval 3.0 to 16.8
|
10.3 Percentage of participants
Interval 2.9 to 24.2
|
2.9 Percentage of participants
Interval 0.1 to 15.3
|
14.3 Percentage of participants
Interval 4.8 to 30.3
|
2.6 Percentage of participants
Interval 0.1 to 13.5
|
7.9 Percentage of participants
Interval 1.7 to 21.4
|
8.0 Percentage of participants
Interval 3.0 to 16.6
|
2.7 Percentage of participants
Interval 0.1 to 14.2
|
2.7 Percentage of participants
Interval 0.1 to 14.2
|
11.1 Percentage of participants
Interval 3.1 to 26.1
|
2.6 Percentage of participants
Interval 0.1 to 13.8
|
2.6 Percentage of participants
Interval 0.1 to 13.5
|
—
|
SECONDARY outcome
Timeframe: Day 28 to Day 182Population: Per Protocol Analysis Set population
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type Influenza A/Brisbane (H1N1 Subtype) and/or antigenically-drifted influenza strains, as measured by a MN assay , expressed as GMTR.
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMTR
Day 28 (Comparison to qNIV Reference [Group O] Day 28)
|
—
|
0.86 Geometric mean titer ratio
Interval 0.62 to 1.19
|
0.70 Geometric mean titer ratio
Interval 0.45 to 1.09
|
0.66 Geometric mean titer ratio
Interval 0.5 to 0.88
|
0.64 Geometric mean titer ratio
Interval 0.49 to 0.85
|
0.74 Geometric mean titer ratio
Interval 0.55 to 1.0
|
0.57 Geometric mean titer ratio
Interval 0.45 to 0.72
|
0.84 Geometric mean titer ratio
Interval 0.62 to 1.14
|
0.63 Geometric mean titer ratio
Interval 0.46 to 0.85
|
0.56 Geometric mean titer ratio
Interval 0.43 to 0.72
|
0.78 Geometric mean titer ratio
Interval 0.55 to 1.11
|
0.70 Geometric mean titer ratio
Interval 0.52 to 0.94
|
0.69 Geometric mean titer ratio
Interval 0.53 to 0.89
|
—
|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMTR
Day 56 (Comparison to qNIV Reference [Group O] Day 56)
|
—
|
0.97 Geometric mean titer ratio
Interval 0.7 to 1.36
|
0.76 Geometric mean titer ratio
Interval 0.46 to 1.24
|
0.72 Geometric mean titer ratio
Interval 0.52 to 1.0
|
0.73 Geometric mean titer ratio
Interval 0.53 to 1.0
|
0.76 Geometric mean titer ratio
Interval 0.57 to 1.02
|
0.61 Geometric mean titer ratio
Interval 0.46 to 0.81
|
0.81 Geometric mean titer ratio
Interval 0.6 to 1.1
|
0.64 Geometric mean titer ratio
Interval 0.47 to 0.88
|
0.61 Geometric mean titer ratio
Interval 0.46 to 0.81
|
0.79 Geometric mean titer ratio
Interval 0.55 to 1.13
|
0.77 Geometric mean titer ratio
Interval 0.57 to 1.03
|
0.78 Geometric mean titer ratio
Interval 0.57 to 1.06
|
—
|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMTR
Day 70 (Comparison to qNIV Reference [Group O] Day 70)
|
—
|
1.46 Geometric mean titer ratio
Interval 1.04 to 2.05
|
1.27 Geometric mean titer ratio
Interval 0.8 to 2.01
|
1.09 Geometric mean titer ratio
Interval 0.79 to 1.49
|
1.38 Geometric mean titer ratio
Interval 0.96 to 1.99
|
1.33 Geometric mean titer ratio
Interval 0.94 to 1.89
|
0.93 Geometric mean titer ratio
Interval 0.7 to 1.24
|
1.24 Geometric mean titer ratio
Interval 0.92 to 1.66
|
1.08 Geometric mean titer ratio
Interval 0.78 to 1.49
|
0.85 Geometric mean titer ratio
Interval 0.62 to 1.17
|
1.24 Geometric mean titer ratio
Interval 0.86 to 1.79
|
1.16 Geometric mean titer ratio
Interval 0.83 to 1.64
|
1.23 Geometric mean titer ratio
Interval 0.9 to 1.68
|
—
|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMTR
Day 84 (Comparison to qNIV Reference [Group O] Day 84)
|
—
|
1.29 Geometric mean titer ratio
Interval 0.9 to 1.86
|
1.24 Geometric mean titer ratio
Interval 0.75 to 2.06
|
0.98 Geometric mean titer ratio
Interval 0.67 to 1.45
|
1.10 Geometric mean titer ratio
Interval 0.74 to 1.64
|
1.18 Geometric mean titer ratio
Interval 0.78 to 1.77
|
0.64 Geometric mean titer ratio
Interval 0.46 to 0.9
|
1.22 Geometric mean titer ratio
Interval 0.9 to 1.67
|
1.12 Geometric mean titer ratio
Interval 0.77 to 1.64
|
0.81 Geometric mean titer ratio
Interval 0.57 to 1.14
|
1.37 Geometric mean titer ratio
Interval 0.88 to 2.13
|
1.06 Geometric mean titer ratio
Interval 0.71 to 1.57
|
1.16 Geometric mean titer ratio
Interval 0.82 to 1.66
|
—
|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMTR
Day 182 (Comparison to qNIV Reference [Group O] Day 182)
|
—
|
1.19 Geometric mean titer ratio
Interval 0.83 to 1.71
|
0.89 Geometric mean titer ratio
Interval 0.54 to 1.47
|
0.81 Geometric mean titer ratio
Interval 0.57 to 1.15
|
0.91 Geometric mean titer ratio
Interval 0.63 to 1.31
|
0.98 Geometric mean titer ratio
Interval 0.68 to 1.42
|
0.66 Geometric mean titer ratio
Interval 0.47 to 0.91
|
1.07 Geometric mean titer ratio
Interval 0.78 to 1.49
|
0.85 Geometric mean titer ratio
Interval 0.6 to 1.19
|
0.65 Geometric mean titer ratio
Interval 0.48 to 0.89
|
1.09 Geometric mean titer ratio
Interval 0.72 to 1.63
|
0.65 Geometric mean titer ratio
Interval 0.39 to 1.08
|
1.01 Geometric mean titer ratio
Interval 0.71 to 1.46
|
—
|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Brisbane (H1N1 Subtype) Expressed as GMTR
Day70 (Comparison to qNIV Reference [Group O] Day 28)**
|
—
|
1.10 Geometric mean titer ratio
Interval 0.79 to 1.53
|
0.94 Geometric mean titer ratio
Interval 0.6 to 1.48
|
0.82 Geometric mean titer ratio
Interval 0.6 to 1.12
|
1.04 Geometric mean titer ratio
Interval 0.72 to 1.49
|
1.00 Geometric mean titer ratio
Interval 0.71 to 1.42
|
0.71 Geometric mean titer ratio
Interval 0.53 to 0.94
|
0.94 Geometric mean titer ratio
Interval 0.7 to 1.26
|
0.82 Geometric mean titer ratio
Interval 0.59 to 1.13
|
0.64 Geometric mean titer ratio
Interval 0.47 to 0.88
|
0.94 Geometric mean titer ratio
Interval 0.66 to 1.35
|
0.93 Geometric mean titer ratio
Interval 0.68 to 1.26
|
1.10 Geometric mean titer ratio
Interval 0.79 to 1.53
|
—
|
SECONDARY outcome
Timeframe: Day 28 to Day 182Population: Per Protocol Analysis Set population
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type Influenza A/Kansas (H3N2 Subtype) and/or antigenically-drifted influenza strains, as measured by a MN assay , expressed as GMTR.
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR
Day70 (Comparison to qNIV Reference [Group O] Day 28)**
|
—
|
1.19 Geometric mean titer ratio
Interval 0.83 to 1.71
|
0.89 Geometric mean titer ratio
Interval 0.54 to 1.47
|
0.81 Geometric mean titer ratio
Interval 0.57 to 1.15
|
0.91 Geometric mean titer ratio
Interval 0.63 to 1.31
|
0.98 Geometric mean titer ratio
Interval 0.68 to 1.42
|
0.66 Geometric mean titer ratio
Interval 0.47 to 0.91
|
1.07 Geometric mean titer ratio
Interval 0.78 to 1.49
|
0.85 Geometric mean titer ratio
Interval 0.6 to 1.19
|
0.65 Geometric mean titer ratio
Interval 0.48 to 0.89
|
1.09 Geometric mean titer ratio
Interval 0.72 to 1.63
|
0.65 Geometric mean titer ratio
Interval 0.39 to 1.08
|
1.01 Geometric mean titer ratio
Interval 0.71 to 1.46
|
—
|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR
Day 28 (Comparison to qNIV Reference [Group O] Day 28)
|
—
|
0.73 Geometric mean titer ratio
Interval 0.5 to 1.07
|
0.61 Geometric mean titer ratio
Interval 0.34 to 1.11
|
0.43 Geometric mean titer ratio
Interval 0.28 to 0.64
|
0.52 Geometric mean titer ratio
Interval 0.33 to 0.8
|
0.62 Geometric mean titer ratio
Interval 0.39 to 1.0
|
0.51 Geometric mean titer ratio
Interval 0.33 to 0.77
|
0.70 Geometric mean titer ratio
Interval 0.47 to 1.04
|
0.43 Geometric mean titer ratio
Interval 0.28 to 0.64
|
0.44 Geometric mean titer ratio
Interval 0.29 to 0.68
|
0.73 Geometric mean titer ratio
Interval 0.45 to 1.17
|
0.65 Geometric mean titer ratio
Interval 0.42 to 1.01
|
0.66 Geometric mean titer ratio
Interval 0.42 to 1.05
|
—
|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR
Day 56 (Comparison to qNIV Reference [Group O] Day 56)
|
—
|
0.81 Geometric mean titer ratio
Interval 0.56 to 1.17
|
0.64 Geometric mean titer ratio
Interval 0.35 to 1.16
|
0.47 Geometric mean titer ratio
Interval 0.3 to 0.74
|
0.57 Geometric mean titer ratio
Interval 0.37 to 0.87
|
0.58 Geometric mean titer ratio
Interval 0.37 to 0.91
|
0.57 Geometric mean titer ratio
Interval 0.37 to 0.88
|
0.75 Geometric mean titer ratio
Interval 0.51 to 1.09
|
0.47 Geometric mean titer ratio
Interval 0.31 to 0.69
|
0.52 Geometric mean titer ratio
Interval 0.34 to 0.8
|
0.72 Geometric mean titer ratio
Interval 0.45 to 1.15
|
0.70 Geometric mean titer ratio
Interval 0.45 to 1.09
|
0.76 Geometric mean titer ratio
Interval 0.48 to 1.2
|
—
|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR
Day 70 (Comparison to qNIV Reference [Group O] Day 70)
|
—
|
1.16 Geometric mean titer ratio
Interval 0.83 to 1.62
|
1.02 Geometric mean titer ratio
Interval 0.57 to 1.83
|
0.78 Geometric mean titer ratio
Interval 0.5 to 1.2
|
1.00 Geometric mean titer ratio
Interval 0.67 to 1.51
|
0.93 Geometric mean titer ratio
Interval 0.62 to 1.4
|
0.86 Geometric mean titer ratio
Interval 0.55 to 1.33
|
1.11 Geometric mean titer ratio
Interval 0.78 to 1.58
|
0.74 Geometric mean titer ratio
Interval 0.49 to 1.1
|
0.76 Geometric mean titer ratio
Interval 0.5 to 1.16
|
0.96 Geometric mean titer ratio
Interval 0.6 to 1.54
|
0.98 Geometric mean titer ratio
Interval 0.64 to 1.51
|
0.98 Geometric mean titer ratio
Interval 0.64 to 1.5
|
—
|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR
Day 84 (Comparison to qNIV Reference [Group O] Day 84)
|
—
|
1.29 Geometric mean titer ratio
Interval 0.9 to 1.86
|
1.24 Geometric mean titer ratio
Interval 0.75 to 2.06
|
0.98 Geometric mean titer ratio
Interval 0.67 to 1.45
|
1.10 Geometric mean titer ratio
Interval 0.74 to 1.64
|
1.18 Geometric mean titer ratio
Interval 0.78 to 1.77
|
0.64 Geometric mean titer ratio
Interval 0.46 to 0.9
|
1.22 Geometric mean titer ratio
Interval 0.9 to 1.67
|
1.12 Geometric mean titer ratio
Interval 0.77 to 1.64
|
0.81 Geometric mean titer ratio
Interval 0.57 to 1.14
|
1.37 Geometric mean titer ratio
Interval 0.88 to 2.13
|
1.06 Geometric mean titer ratio
Interval 0.71 to 1.57
|
1.16 Geometric mean titer ratio
Interval 0.82 to 1.66
|
—
|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Kansas (H3N2 Subtype) Expressed as GMTR
Day 182 (Comparison to qNIV Reference [Group O] Day 182)
|
—
|
1.19 Geometric mean titer ratio
Interval 0.83 to 1.71
|
0.89 Geometric mean titer ratio
Interval 0.54 to 1.47
|
0.81 Geometric mean titer ratio
Interval 0.57 to 1.15
|
0.91 Geometric mean titer ratio
Interval 0.63 to 1.31
|
0.98 Geometric mean titer ratio
Interval 0.68 to 1.42
|
0.66 Geometric mean titer ratio
Interval 0.47 to 0.91
|
1.07 Geometric mean titer ratio
Interval 0.78 to 1.49
|
0.85 Geometric mean titer ratio
Interval 0.6 to 1.19
|
0.65 Geometric mean titer ratio
Interval 0.48 to 0.89
|
1.09 Geometric mean titer ratio
Interval 0.72 to 1.63
|
0.65 Geometric mean titer ratio
Interval 0.39 to 1.08
|
1.01 Geometric mean titer ratio
Interval 0.71 to 1.46
|
—
|
SECONDARY outcome
Timeframe: Day 28 to Day 182Population: Per Protocol Analysis Set population
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type Influenza A/Wisconsin (H1N1 Subtype) and/or antigenically-drifted influenza strains, as measured by a MN assay , expressed as GMTR.
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR
Day 28 (Comparison to qNIV Reference [Group O] Day 28)
|
—
|
1.02 Geometric mean titer ratio
Interval 0.82 to 1.26
|
0.95 Geometric mean titer ratio
Interval 0.73 to 1.23
|
0.88 Geometric mean titer ratio
Interval 0.71 to 1.08
|
0.88 Geometric mean titer ratio
Interval 0.73 to 1.07
|
0.91 Geometric mean titer ratio
Interval 0.76 to 1.09
|
0.86 Geometric mean titer ratio
Interval 0.71 to 1.04
|
0.99 Geometric mean titer ratio
Interval 0.81 to 1.22
|
0.82 Geometric mean titer ratio
Interval 0.69 to 0.98
|
0.77 Geometric mean titer ratio
Interval 0.64 to 0.92
|
1.16 Geometric mean titer ratio
Interval 0.86 to 1.56
|
0.90 Geometric mean titer ratio
Interval 0.74 to 1.08
|
0.95 Geometric mean titer ratio
Interval 0.76 to 1.19
|
—
|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR
Day 56 (Comparison to qNIV Reference [Group O] Day 56)
|
—
|
0.99 Geometric mean titer ratio
Interval 0.8 to 1.22
|
0.92 Geometric mean titer ratio
Interval 0.72 to 1.18
|
0.88 Geometric mean titer ratio
Interval 0.71 to 1.09
|
0.83 Geometric mean titer ratio
Interval 0.68 to 1.02
|
0.88 Geometric mean titer ratio
Interval 0.72 to 1.07
|
0.84 Geometric mean titer ratio
Interval 0.69 to 1.01
|
0.88 Geometric mean titer ratio
Interval 0.7 to 1.11
|
0.83 Geometric mean titer ratio
Interval 0.69 to 1.0
|
0.79 Geometric mean titer ratio
Interval 0.65 to 0.95
|
0.98 Geometric mean titer ratio
Interval 0.77 to 1.25
|
0.85 Geometric mean titer ratio
Interval 0.71 to 1.02
|
0.96 Geometric mean titer ratio
Interval 0.76 to 1.22
|
—
|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR
Day 70 (Comparison to qNIV Reference [Group O] Day 70)
|
—
|
1.20 Geometric mean titer ratio
Interval 0.93 to 1.54
|
1.01 Geometric mean titer ratio
Interval 0.75 to 1.34
|
1.04 Geometric mean titer ratio
Interval 0.8 to 1.35
|
1.13 Geometric mean titer ratio
Interval 0.88 to 1.45
|
1.12 Geometric mean titer ratio
Interval 0.88 to 1.43
|
0.90 Geometric mean titer ratio
Interval 0.72 to 1.12
|
1.09 Geometric mean titer ratio
Interval 0.86 to 1.38
|
0.92 Geometric mean titer ratio
Interval 0.71 to 1.19
|
0.81 Geometric mean titer ratio
Interval 0.65 to 1.01
|
1.19 Geometric mean titer ratio
Interval 0.88 to 1.61
|
1.06 Geometric mean titer ratio
Interval 0.83 to 1.35
|
1.13 Geometric mean titer ratio
Interval 0.87 to 1.47
|
—
|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR
Day 84 (Comparison to qNIV Reference [Group O] Day 84)
|
—
|
1.16 Geometric mean titer ratio
Interval 0.89 to 1.52
|
0.98 Geometric mean titer ratio
Interval 0.72 to 1.33
|
1.06 Geometric mean titer ratio
Interval 0.8 to 1.41
|
1.04 Geometric mean titer ratio
Interval 0.79 to 1.36
|
1.14 Geometric mean titer ratio
Interval 0.87 to 1.49
|
0.87 Geometric mean titer ratio
Interval 0.67 to 1.14
|
1.07 Geometric mean titer ratio
Interval 0.81 to 1.41
|
0.90 Geometric mean titer ratio
Interval 0.69 to 1.19
|
0.77 Geometric mean titer ratio
Interval 0.6 to 0.98
|
1.38 Geometric mean titer ratio
Interval 0.97 to 1.96
|
1.05 Geometric mean titer ratio
Interval 0.8 to 1.39
|
1.19 Geometric mean titer ratio
Interval 0.88 to 1.61
|
—
|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR
Day 182 (Comparison to qNIV Reference [Group O] Day 182)
|
—
|
1.08 Geometric mean titer ratio
Interval 0.84 to 1.37
|
0.89 Geometric mean titer ratio
Interval 0.68 to 1.16
|
0.94 Geometric mean titer ratio
Interval 0.72 to 1.22
|
1.01 Geometric mean titer ratio
Interval 0.78 to 1.31
|
1.03 Geometric mean titer ratio
Interval 0.8 to 1.32
|
0.90 Geometric mean titer ratio
Interval 0.7 to 1.15
|
1.06 Geometric mean titer ratio
Interval 0.83 to 1.35
|
0.84 Geometric mean titer ratio
Interval 0.66 to 1.08
|
0.74 Geometric mean titer ratio
Interval 0.57 to 0.95
|
1.26 Geometric mean titer ratio
Interval 0.91 to 1.74
|
0.97 Geometric mean titer ratio
Interval 0.74 to 1.25
|
1.13 Geometric mean titer ratio
Interval 0.86 to 1.49
|
—
|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Wisconsin (H1N1 Subtype) Expressed as GMTR
Day70 (Comparison to qNIV Reference [Group O] Day 28)**
|
—
|
1.18 Geometric mean titer ratio
Interval 0.92 to 1.51
|
1.01 Geometric mean titer ratio
Interval 0.76 to 1.33
|
1.04 Geometric mean titer ratio
Interval 0.81 to 1.34
|
1.13 Geometric mean titer ratio
Interval 0.89 to 1.43
|
1.12 Geometric mean titer ratio
Interval 0.89 to 1.4
|
0.89 Geometric mean titer ratio
Interval 0.72 to 1.1
|
1.08 Geometric mean titer ratio
Interval 0.86 to 1.36
|
0.91 Geometric mean titer ratio
Interval 0.71 to 1.17
|
0.80 Geometric mean titer ratio
Interval 0.65 to 0.98
|
1.18 Geometric mean titer ratio
Interval 0.88 to 1.58
|
1.04 Geometric mean titer ratio
Interval 0.83 to 1.32
|
1.12 Geometric mean titer ratio
Interval 0.88 to 1.44
|
—
|
SECONDARY outcome
Timeframe: Day 28 to Day 182Population: Per Protocol Analysis Set population
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type Influenza A/Cambodia (H3N2 Subtype) and/or antigenically-drifted influenza strains, as measured by a MN assay , expressed as GMTR.
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR
Day 70 (Comparison to qNIV Reference [Group O] Day 70)
|
—
|
1.44 Geometric mean titer ratio
Interval 1.09 to 1.89
|
1.61 Geometric mean titer ratio
Interval 1.02 to 2.54
|
1.30 Geometric mean titer ratio
Interval 0.94 to 1.8
|
1.36 Geometric mean titer ratio
Interval 0.96 to 1.92
|
1.61 Geometric mean titer ratio
Interval 1.1 to 2.35
|
1.21 Geometric mean titer ratio
Interval 0.88 to 1.66
|
1.40 Geometric mean titer ratio
Interval 1.04 to 1.88
|
1.12 Geometric mean titer ratio
Interval 0.84 to 1.49
|
1.14 Geometric mean titer ratio
Interval 0.84 to 1.56
|
1.74 Geometric mean titer ratio
Interval 1.14 to 2.67
|
1.52 Geometric mean titer ratio
Interval 1.06 to 2.19
|
1.31 Geometric mean titer ratio
Interval 0.93 to 1.84
|
—
|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR
Day 84 (Comparison to qNIV Reference [Group O] Day 84)
|
—
|
1.30 Geometric mean titer ratio
Interval 0.97 to 1.74
|
1.50 Geometric mean titer ratio
Interval 0.92 to 2.44
|
1.23 Geometric mean titer ratio
Interval 0.87 to 1.75
|
1.32 Geometric mean titer ratio
Interval 0.92 to 1.9
|
1.39 Geometric mean titer ratio
Interval 0.92 to 2.1
|
1.06 Geometric mean titer ratio
Interval 0.74 to 1.51
|
1.24 Geometric mean titer ratio
Interval 0.9 to 1.7
|
1.10 Geometric mean titer ratio
Interval 0.82 to 1.47
|
1.11 Geometric mean titer ratio
Interval 0.78 to 1.57
|
1.98 Geometric mean titer ratio
Interval 1.25 to 3.14
|
1.53 Geometric mean titer ratio
Interval 1.06 to 2.23
|
1.17 Geometric mean titer ratio
Interval 0.83 to 1.67
|
—
|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR
Day 182 (Comparison to qNIV Reference [Group O] Day 182)
|
—
|
1.14 Geometric mean titer ratio
Interval 0.89 to 1.47
|
1.27 Geometric mean titer ratio
Interval 0.81 to 2.01
|
1.09 Geometric mean titer ratio
Interval 0.8 to 1.5
|
1.15 Geometric mean titer ratio
Interval 0.83 to 1.61
|
1.16 Geometric mean titer ratio
Interval 0.82 to 1.66
|
0.99 Geometric mean titer ratio
Interval 0.7 to 1.38
|
1.09 Geometric mean titer ratio
Interval 0.82 to 1.45
|
1.03 Geometric mean titer ratio
Interval 0.79 to 1.34
|
0.97 Geometric mean titer ratio
Interval 0.71 to 1.32
|
1.54 Geometric mean titer ratio
Interval 1.03 to 2.32
|
1.29 Geometric mean titer ratio
Interval 0.93 to 1.78
|
1.09 Geometric mean titer ratio
Interval 0.81 to 1.47
|
—
|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR
Day70 (Comparison to qNIV Reference [Group O] Day 28)**
|
—
|
1.09 Geometric mean titer ratio
Interval 0.82 to 1.46
|
1.24 Geometric mean titer ratio
Interval 0.77 to 1.99
|
0.99 Geometric mean titer ratio
Interval 0.69 to 1.41
|
1.04 Geometric mean titer ratio
Interval 0.72 to 1.51
|
1.22 Geometric mean titer ratio
Interval 0.82 to 1.83
|
0.93 Geometric mean titer ratio
Interval 0.66 to 1.31
|
1.06 Geometric mean titer ratio
Interval 0.78 to 1.45
|
0.86 Geometric mean titer ratio
Interval 0.63 to 1.19
|
0.87 Geometric mean titer ratio
Interval 0.61 to 1.22
|
1.30 Geometric mean titer ratio
Interval 0.83 to 2.04
|
1.16 Geometric mean titer ratio
Interval 0.79 to 1.72
|
0.98 Geometric mean titer ratio
Interval 0.68 to 1.41
|
—
|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR
Day 28 (Comparison to qNIV Reference [Group O] Day 28)
|
—
|
1.07 Geometric mean titer ratio
Interval 0.78 to 1.46
|
1.13 Geometric mean titer ratio
Interval 0.7 to 1.82
|
0.83 Geometric mean titer ratio
Interval 0.6 to 1.16
|
0.94 Geometric mean titer ratio
Interval 0.66 to 1.34
|
1.21 Geometric mean titer ratio
Interval 0.78 to 1.88
|
0.83 Geometric mean titer ratio
Interval 0.61 to 1.14
|
1.00 Geometric mean titer ratio
Interval 0.73 to 1.38
|
0.78 Geometric mean titer ratio
Interval 0.57 to 1.05
|
0.82 Geometric mean titer ratio
Interval 0.59 to 1.13
|
1.40 Geometric mean titer ratio
Interval 0.91 to 2.15
|
1.09 Geometric mean titer ratio
Interval 0.73 to 1.62
|
0.89 Geometric mean titer ratio
Interval 0.61 to 1.31
|
—
|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Cambodia (H3N2 Subtype) Expressed as GMTR
Day 56 (Comparison to qNIV Reference [Group O] Day 56)
|
—
|
1.16 Geometric mean titer ratio
Interval 0.88 to 1.54
|
1.17 Geometric mean titer ratio
Interval 0.74 to 1.85
|
0.97 Geometric mean titer ratio
Interval 0.7 to 1.35
|
1.00 Geometric mean titer ratio
Interval 0.72 to 1.38
|
1.08 Geometric mean titer ratio
Interval 0.74 to 1.58
|
0.89 Geometric mean titer ratio
Interval 0.66 to 1.2
|
1.07 Geometric mean titer ratio
Interval 0.8 to 1.44
|
0.84 Geometric mean titer ratio
Interval 0.65 to 1.09
|
0.90 Geometric mean titer ratio
Interval 0.66 to 1.23
|
1.41 Geometric mean titer ratio
Interval 0.93 to 2.13
|
1.15 Geometric mean titer ratio
Interval 0.81 to 1.62
|
1.05 Geometric mean titer ratio
Interval 0.75 to 1.47
|
—
|
SECONDARY outcome
Timeframe: Day 28 to Day 182Population: Per Protocol Analysis Set population
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type Influenza A/Hong Kong (H3N2 Subtype) and/or antigenically-drifted influenza strains, as measured by a MN assay , expressed as GMTR.
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR
Day 28 (Comparison to qNIV Reference [Group O] Day 28)
|
—
|
0.91 Geometric mean titer ratio
Interval 0.64 to 1.31
|
1.07 Geometric mean titer ratio
Interval 0.58 to 1.97
|
0.70 Geometric mean titer ratio
Interval 0.46 to 1.06
|
0.82 Geometric mean titer ratio
Interval 0.53 to 1.26
|
0.95 Geometric mean titer ratio
Interval 0.55 to 1.62
|
0.78 Geometric mean titer ratio
Interval 0.51 to 1.2
|
1.05 Geometric mean titer ratio
Interval 0.71 to 1.55
|
0.66 Geometric mean titer ratio
Interval 0.45 to 0.98
|
0.80 Geometric mean titer ratio
Interval 0.52 to 1.22
|
1.22 Geometric mean titer ratio
Interval 0.76 to 1.96
|
1.00 Geometric mean titer ratio
Interval 0.63 to 1.61
|
0.91 Geometric mean titer ratio
Interval 0.57 to 1.45
|
—
|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR
Day 56 (Comparison to qNIV Reference [Group O] Day 56)
|
—
|
0.97 Geometric mean titer ratio
Interval 0.69 to 1.36
|
1.07 Geometric mean titer ratio
Interval 0.6 to 1.9
|
0.77 Geometric mean titer ratio
Interval 0.51 to 1.17
|
0.81 Geometric mean titer ratio
Interval 0.53 to 1.24
|
0.88 Geometric mean titer ratio
Interval 0.55 to 1.4
|
0.81 Geometric mean titer ratio
Interval 0.54 to 1.21
|
1.04 Geometric mean titer ratio
Interval 0.71 to 1.52
|
0.72 Geometric mean titer ratio
Interval 0.5 to 1.04
|
0.91 Geometric mean titer ratio
Interval 0.6 to 1.36
|
1.15 Geometric mean titer ratio
Interval 0.74 to 1.78
|
1.09 Geometric mean titer ratio
Interval 0.7 to 1.7
|
0.96 Geometric mean titer ratio
Interval 0.61 to 1.5
|
—
|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR
Day 70 (Comparison to qNIV Reference [Group O] Day 70)
|
—
|
1.22 Geometric mean titer ratio
Interval 0.86 to 1.74
|
1.52 Geometric mean titer ratio
Interval 0.82 to 2.79
|
1.14 Geometric mean titer ratio
Interval 0.72 to 1.8
|
1.13 Geometric mean titer ratio
Interval 0.72 to 1.79
|
1.29 Geometric mean titer ratio
Interval 0.79 to 2.1
|
1.14 Geometric mean titer ratio
Interval 0.72 to 1.8
|
1.39 Geometric mean titer ratio
Interval 0.95 to 2.04
|
0.94 Geometric mean titer ratio
Interval 0.61 to 1.45
|
1.14 Geometric mean titer ratio
Interval 0.73 to 1.77
|
1.41 Geometric mean titer ratio
Interval 0.88 to 2.25
|
1.34 Geometric mean titer ratio
Interval 0.84 to 2.15
|
1.28 Geometric mean titer ratio
Interval 0.81 to 2.04
|
—
|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR
Day 84 (Comparison to qNIV Reference [Group O] Day 84)
|
—
|
1.21 Geometric mean titer ratio
Interval 0.83 to 1.77
|
1.72 Geometric mean titer ratio
Interval 0.93 to 3.17
|
1.17 Geometric mean titer ratio
Interval 0.72 to 1.92
|
1.14 Geometric mean titer ratio
Interval 0.7 to 1.84
|
1.29 Geometric mean titer ratio
Interval 0.76 to 2.19
|
1.05 Geometric mean titer ratio
Interval 0.62 to 1.77
|
1.43 Geometric mean titer ratio
Interval 0.97 to 2.09
|
1.15 Geometric mean titer ratio
Interval 0.73 to 1.81
|
1.29 Geometric mean titer ratio
Interval 0.8 to 2.08
|
1.64 Geometric mean titer ratio
Interval 0.99 to 2.71
|
1.41 Geometric mean titer ratio
Interval 0.85 to 2.32
|
1.26 Geometric mean titer ratio
Interval 0.79 to 2.03
|
—
|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR
Day 182 (Comparison to qNIV Reference [Group O] Day 182)
|
—
|
1.07 Geometric mean titer ratio
Interval 0.76 to 1.53
|
1.42 Geometric mean titer ratio
Interval 0.81 to 2.47
|
0.94 Geometric mean titer ratio
Interval 0.61 to 1.45
|
1.07 Geometric mean titer ratio
Interval 0.7 to 1.65
|
1.18 Geometric mean titer ratio
Interval 0.74 to 1.87
|
1.04 Geometric mean titer ratio
Interval 0.66 to 1.64
|
1.21 Geometric mean titer ratio
Interval 0.86 to 1.71
|
0.99 Geometric mean titer ratio
Interval 0.68 to 1.44
|
1.10 Geometric mean titer ratio
Interval 0.73 to 1.66
|
1.43 Geometric mean titer ratio
Interval 0.91 to 2.24
|
1.11 Geometric mean titer ratio
Interval 0.73 to 1.7
|
1.21 Geometric mean titer ratio
Interval 0.79 to 1.87
|
—
|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza A/Hong Kong (H3N2 Subtype) Expressed as GMTR
Day70 (Comparison to qNIV Reference [Group O] Day 28)**
|
—
|
0.97 Geometric mean titer ratio
Interval 0.69 to 1.37
|
1.20 Geometric mean titer ratio
Interval 0.65 to 2.19
|
0.90 Geometric mean titer ratio
Interval 0.57 to 1.41
|
0.89 Geometric mean titer ratio
Interval 0.57 to 1.4
|
1.02 Geometric mean titer ratio
Interval 0.63 to 1.65
|
0.90 Geometric mean titer ratio
Interval 0.58 to 1.42
|
1.10 Geometric mean titer ratio
Interval 0.76 to 1.59
|
0.75 Geometric mean titer ratio
Interval 0.49 to 1.14
|
0.90 Geometric mean titer ratio
Interval 0.58 to 1.4
|
1.09 Geometric mean titer ratio
Interval 0.69 to 1.73
|
1.07 Geometric mean titer ratio
Interval 0.68 to 1.71
|
1.01 Geometric mean titer ratio
Interval 0.69 to 1.37
|
—
|
SECONDARY outcome
Timeframe: Day 28 to Day 182Population: Per Protocol Analysis Set population
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type Influenza B/Maryland (Victoria Subtype) and/or antigenically-drifted influenza strains, as measured by a MN assay , expressed as GMTR.
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype)Expressed as GMTR
Day 70 (Comparison to qNIV Reference [Group O] Day 70)
|
—
|
1.22 Geometric mean titer ratio
Interval 0.92 to 1.6
|
1.10 Geometric mean titer ratio
Interval 0.78 to 1.55
|
0.86 Geometric mean titer ratio
Interval 0.61 to 1.2
|
0.93 Geometric mean titer ratio
Interval 0.65 to 1.33
|
1.15 Geometric mean titer ratio
Interval 0.84 to 1.6
|
0.87 Geometric mean titer ratio
Interval 0.63 to 1.18
|
1.09 Geometric mean titer ratio
Interval 0.84 to 1.43
|
0.84 Geometric mean titer ratio
Interval 0.6 to 1.18
|
0.84 Geometric mean titer ratio
Interval 0.61 to 1.15
|
1.09 Geometric mean titer ratio
Interval 0.74 to 1.59
|
1.01 Geometric mean titer ratio
Interval 0.72 to 1.43
|
1.04 Geometric mean titer ratio
Interval 0.76 to 1.4
|
—
|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype)Expressed as GMTR
Day 84 (Comparison to qNIV Reference [Group O] Day 84)
|
—
|
1.31 Geometric mean titer ratio
Interval 0.96 to 1.78
|
0.99 Geometric mean titer ratio
Interval 0.66 to 1.47
|
0.87 Geometric mean titer ratio
Interval 0.6 to 1.28
|
1.03 Geometric mean titer ratio
Interval 0.68 to 1.56
|
1.02 Geometric mean titer ratio
Interval 0.69 to 1.51
|
0.81 Geometric mean titer ratio
Interval 0.55 to 1.17
|
1.10 Geometric mean titer ratio
Interval 0.81 to 1.49
|
0.88 Geometric mean titer ratio
Interval 0.61 to 1.27
|
0.78 Geometric mean titer ratio
Interval 0.54 to 1.12
|
1.28 Geometric mean titer ratio
Interval 0.82 to 1.98
|
0.85 Geometric mean titer ratio
Interval 0.62 to 1.44
|
1.21 Geometric mean titer ratio
Interval 0.83 to 1.76
|
—
|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype)Expressed as GMTR
Day 28 (Comparison to qNIV Reference [Group O] Day 28)
|
—
|
0.88 Geometric mean titer ratio
Interval 0.68 to 1.15
|
0.78 Geometric mean titer ratio
Interval 0.56 to 1.08
|
0.61 Geometric mean titer ratio
Interval 0.44 to 0.84
|
0.66 Geometric mean titer ratio
Interval 0.46 to 0.95
|
0.85 Geometric mean titer ratio
Interval 0.62 to 1.18
|
0.63 Geometric mean titer ratio
Interval 0.46 to 0.84
|
0.85 Geometric mean titer ratio
Interval 0.65 to 1.12
|
0.66 Geometric mean titer ratio
Interval 0.46 to 0.84
|
0.62 Geometric mean titer ratio
Interval 0.46 to 0.84
|
0.83 Geometric mean titer ratio
Interval 0.59 to 1.116
|
0.76 Geometric mean titer ratio
Interval 0.55 to 1.06
|
0.73 Geometric mean titer ratio
Interval 0.53 to 1.0
|
—
|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype)Expressed as GMTR
Day 56 (Comparison to qNIV Reference [Group O] Day 56)
|
—
|
0.91 Geometric mean titer ratio
Interval 0.7 to 1.19
|
0.77 Geometric mean titer ratio
Interval 0.54 to 1.08
|
0.66 Geometric mean titer ratio
Interval 0.47 to 0.91
|
0.69 Geometric mean titer ratio
Interval 0.48 to 0.99
|
0.83 Geometric mean titer ratio
Interval 0.6 to 1.21
|
0.67 Geometric mean titer ratio
Interval 0.49 to 0.92
|
0.86 Geometric mean titer ratio
Interval 0.66 to 11.3
|
0.69 Geometric mean titer ratio
Interval 0.51 to 0.94
|
0.67 Geometric mean titer ratio
Interval 0.49 to 0.92
|
0.85 Geometric mean titer ratio
Interval 0.6 to 1.21
|
0.78 Geometric mean titer ratio
Interval 0.55 to 1.11
|
00.78 Geometric mean titer ratio
Interval 0.56 to 1.08
|
—
|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype)Expressed as GMTR
Day 182 (Comparison to qNIV Reference [Group O] Day 182)
|
—
|
1.28 Geometric mean titer ratio
Interval 0.95 to 1.72
|
0.86 Geometric mean titer ratio
Interval 0.6 to 1.25
|
0.81 Geometric mean titer ratio
Interval 0.57 to 1.16
|
1.00 Geometric mean titer ratio
Interval 0.67 to 1.5
|
0.91 Geometric mean titer ratio
Interval 0.64 to 1.31
|
0.83 Geometric mean titer ratio
Interval 0.58 to 1.17
|
1.03 Geometric mean titer ratio
Interval 0.76 to 1.4
|
0.76 Geometric mean titer ratio
Interval 0.54 to 1.08
|
0.75 Geometric mean titer ratio
Interval 0.53 to 1.07
|
1.14 Geometric mean titer ratio
Interval 0.77 to 1.69
|
0.88 Geometric mean titer ratio
Interval 0.6 to 1.31
|
1.02 Geometric mean titer ratio
Interval 0.72 to 1.45
|
—
|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Maryland (Victoria Subtype)Expressed as GMTR
Day70 (Comparison to qNIV Reference [Group O] Day 28)**
|
—
|
0.96 Geometric mean titer ratio
Interval 0.73 to 1.25
|
0.87 Geometric mean titer ratio
Interval 0.62 to 1.21
|
0.67 Geometric mean titer ratio
Interval 0.49 to 0.93
|
0.73 Geometric mean titer ratio
Interval 0.51 to 1.03
|
0.91 Geometric mean titer ratio
Interval 0.67 to 1.24
|
0.68 Geometric mean titer ratio
Interval 0.51 to 0.92
|
0.87 Geometric mean titer ratio
Interval 0.67 to 1.12
|
0.67 Geometric mean titer ratio
Interval 0.48 to 0.93
|
0.67 Geometric mean titer ratio
Interval 0.49 to 0.9
|
0.87 Geometric mean titer ratio
Interval 0.6 to 1.25
|
0.80 Geometric mean titer ratio
Interval 0.58 to 1.12
|
0.82 Geometric mean titer ratio
Interval 0.61 to 1.1
|
—
|
SECONDARY outcome
Timeframe: Day 28 to Day 182Population: Per Protocol Analysis Set population
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type Influenza B/Phuket (Yamagata Subtype) and/or antigenically-drifted influenza strains, as measured by a MN assay , expressed as GMTR.
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR
Day 56 (Comparison to qNIV Reference [Group O] Day 56)
|
—
|
1.01 Geometric mean titer ratio
Interval 0.75 to 1.37
|
0.72 Geometric mean titer ratio
Interval 0.54 to 0.96
|
0.66 Geometric mean titer ratio
Interval 0.5 to 0.87
|
0.74 Geometric mean titer ratio
Interval 0.55 to 1.0
|
0.92 Geometric mean titer ratio
Interval 0.62 to 1.36
|
0.78 Geometric mean titer ratio
Interval 0.6 to 1.02
|
0.84 Geometric mean titer ratio
Interval 0.66 to 1.07
|
0.77 Geometric mean titer ratio
Interval 0.58 to 1.01
|
0.71 Geometric mean titer ratio
Interval 0.54 to 0.92
|
0.88 Geometric mean titer ratio
Interval 0.64 to 1.22
|
0.82 Geometric mean titer ratio
Interval 0.61 to 1.09
|
0.93 Geometric mean titer ratio
Interval 0.68 to 1.27
|
—
|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR
Day 84 (Comparison to qNIV Reference [Group O] Day 84)
|
—
|
1.39 Geometric mean titer ratio
Interval 1.01 to 1.9
|
0.87 Geometric mean titer ratio
Interval 0.64 to 1.19
|
0.91 Geometric mean titer ratio
Interval 0.66 to 1.25
|
1.03 Geometric mean titer ratio
Interval 0.75 to 1.4
|
1.20 Geometric mean titer ratio
Interval 0.84 to 1.73
|
0.79 Geometric mean titer ratio
Interval 0.6 to 1.04
|
1.12 Geometric mean titer ratio
Interval 0.85 to 1.47
|
0.97 Geometric mean titer ratio
Interval 0.73 to 1.29
|
0.91 Geometric mean titer ratio
Interval 0.67 to 1.23
|
1.37 Geometric mean titer ratio
Interval 0.93 to 2.01
|
0.93 Geometric mean titer ratio
Interval 0.67 to 1.28
|
1.41 Geometric mean titer ratio
Interval 1.02 to 1.95
|
—
|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR
Day 182 (Comparison to qNIV Reference [Group O] Day 182)
|
—
|
1.28 Geometric mean titer ratio
Interval 0.95 to 1.72
|
0.71 Geometric mean titer ratio
Interval 0.55 to 0.93
|
0.72 Geometric mean titer ratio
Interval 0.54 to 0.98
|
0.98 Geometric mean titer ratio
Interval 0.74 to 1.32
|
1.09 Geometric mean titer ratio
Interval 0.78 to 1.52
|
0.74 Geometric mean titer ratio
Interval 0.58 to 0.96
|
0.95 Geometric mean titer ratio
Interval 0.74 to 1.23
|
0.84 Geometric mean titer ratio
Interval 0.65 to 1.02
|
0.78 Geometric mean titer ratio
Interval 0.6 to 1.02
|
1.16 Geometric mean titer ratio
Interval 0.82 to 1.63
|
0.88 Geometric mean titer ratio
Interval 0.66 to 1.18
|
1.16 Geometric mean titer ratio
Interval 0.85 to 1.57
|
—
|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR
Day 28 (Comparison to qNIV Reference [Group O] Day 28)
|
—
|
1.01 Geometric mean titer ratio
Interval 0.75 to 1.36
|
0.76 Geometric mean titer ratio
Interval 0.57 to 1.03
|
0.62 Geometric mean titer ratio
Interval 0.46 to 0.83
|
0.72 Geometric mean titer ratio
Interval 0.53 to 0.97
|
0.92 Geometric mean titer ratio
Interval 0.62 to 1.35
|
0.73 Geometric mean titer ratio
Interval 0.55 to 0.96
|
0.85 Geometric mean titer ratio
Interval 0.66 to 1.1
|
0.75 Geometric mean titer ratio
Interval 0.56 to 1.01
|
0.68 Geometric mean titer ratio
Interval 0.52 to 0.89
|
0.95 Geometric mean titer ratio
Interval 0.69 to 1.32
|
0.78 Geometric mean titer ratio
Interval 0.58 to 1.06
|
0.91 Geometric mean titer ratio
Interval 0.66 to 1.26
|
—
|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR
Day 70 (Comparison to qNIV Reference [Group O] Day 70)
|
—
|
1.32 Geometric mean titer ratio
Interval 0.97 to 1.79
|
0.97 Geometric mean titer ratio
Interval 0.73 to 1.27
|
0.81 Geometric mean titer ratio
Interval 0.61 to 1.08
|
1.03 Geometric mean titer ratio
Interval 0.77 to 1.37
|
1.29 Geometric mean titer ratio
Interval 0.9 to 1.84
|
0.93 Geometric mean titer ratio
Interval 0.71 to 1.21
|
1.06 Geometric mean titer ratio
Interval 0.82 to 1.37
|
0.99 Geometric mean titer ratio
Interval 0.76 to 1.3
|
0.88 Geometric mean titer ratio
Interval 0.67 to 1.14
|
1.37 Geometric mean titer ratio
Interval 0.99 to 1.89
|
0.94 Geometric mean titer ratio
Interval 0.71 to 1.26
|
1.17 Geometric mean titer ratio
Interval 0.86 to 1.58
|
—
|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Phuket (Yamagata Subtype) Expressed as GMTR
Day70 (Comparison to qNIV Reference [Group O] Day 28)**
|
—
|
1.14 Geometric mean titer ratio
Interval 0.83 to 1.57
|
0.85 Geometric mean titer ratio
Interval 0.63 to 1.16
|
0.70 Geometric mean titer ratio
Interval 0.51 to 0.96
|
0.89 Geometric mean titer ratio
Interval 0.65 to 1.22
|
1.11 Geometric mean titer ratio
Interval 0.76 to 1.62
|
0.81 Geometric mean titer ratio
Interval 0.6 to 1.09
|
0.91 Geometric mean titer ratio
Interval 0.69 to 1.2
|
0.86 Geometric mean titer ratio
Interval 0.64 to 1.16
|
0.76 Geometric mean titer ratio
Interval 0.56 to 1.02
|
1.19 Geometric mean titer ratio
Interval 0.84 to 1.68
|
0.82 Geometric mean titer ratio
Interval 0.59 to 1.13
|
1.01 Geometric mean titer ratio
Interval 0.73 to 1.4
|
—
|
SECONDARY outcome
Timeframe: Day 28 to Day 182Population: Per Protocol Analysis Set population
Microneutralization (MN50) antibody responses: neutralizing antibody titers specific to vaccine homologous wild-type Influenza B/Washington(VictoriaSubtype) and/or antigenically-drifted influenza strains, as measured by a MN assay , expressed as GMTR.
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington(VictoriaSubtype) Expressed as GMTR
Day 56 (Comparison to qNIV Reference [Group O] Day 56)
|
—
|
0.91 Geometric mean titer ratio
Interval 0.68 to 1.23
|
0.78 Geometric mean titer ratio
Interval 0.54 to 1.12
|
0.62 Geometric mean titer ratio
Interval 0.44 to 0.89
|
0.74 Geometric mean titer ratio
Interval 0.51 to 1.09
|
0.81 Geometric mean titer ratio
Interval 0.56 to 1.16
|
0.70 Geometric mean titer ratio
Interval 0.49 to 1.0
|
0.83 Geometric mean titer ratio
Interval 0.63 to 1.1
|
0.66 Geometric mean titer ratio
Interval 0.46 to 0.93
|
0.65 Geometric mean titer ratio
Interval 0.46 to 0.93
|
0.79 Geometric mean titer ratio
Interval 0.54 to 1.15
|
0.84 Geometric mean titer ratio
Interval 0.57 to 1.23
|
0.80 Geometric mean titer ratio
Interval 0.54 to 1.17
|
—
|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington(VictoriaSubtype) Expressed as GMTR
Day 70 (Comparison to qNIV Reference [Group O] Day 70)
|
—
|
1.16 Geometric mean titer ratio
Interval 0.85 to 1.57
|
1.04 Geometric mean titer ratio
Interval 0.73 to 1.5
|
0.81 Geometric mean titer ratio
Interval 0.57 to 1.15
|
0.97 Geometric mean titer ratio
Interval 0.67 to 1.41
|
1.07 Geometric mean titer ratio
Interval 0.76 to 1.52
|
0.88 Geometric mean titer ratio
Interval 0.62 to 1.25
|
1.01 Geometric mean titer ratio
Interval 0.76 to 1.33
|
0.80 Geometric mean titer ratio
Interval 0.57 to 1.12
|
0.79 Geometric mean titer ratio
Interval 0.56 to 1.11
|
0.97 Geometric mean titer ratio
Interval 0.65 to 1.44
|
1.01 Geometric mean titer ratio
Interval 0.7 to 1.45
|
0.96 Geometric mean titer ratio
Interval 0.7 to 1.32
|
—
|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington(VictoriaSubtype) Expressed as GMTR
Day 84 (Comparison to qNIV Reference [Group O] Day 84)
|
—
|
1.11 Geometric mean titer ratio
Interval 0.81 to 1.52
|
0.96 Geometric mean titer ratio
Interval 0.64 to 1.45
|
0.87 Geometric mean titer ratio
Interval 0.59 to 1.29
|
1.07 Geometric mean titer ratio
Interval 0.71 to 1.6
|
1.00 Geometric mean titer ratio
Interval 0.67 to 1.5
|
0.79 Geometric mean titer ratio
Interval 0.53 to 1.18
|
1.01 Geometric mean titer ratio
Interval 0.74 to 1.37
|
0.79 Geometric mean titer ratio
Interval 0.54 to 1.16
|
0.85 Geometric mean titer ratio
Interval 0.58 to 1.25
|
1.19 Geometric mean titer ratio
Interval 0.78 to 1.82
|
0.99 Geometric mean titer ratio
Interval 0.65 to 1.51
|
1.00 Geometric mean titer ratio
Interval 0.69 to 1.46
|
—
|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington(VictoriaSubtype) Expressed as GMTR
Day 182 (Comparison to qNIV Reference [Group O] Day 182)
|
—
|
1.10 Geometric mean titer ratio
Interval 0.82 to 1.49
|
0.87 Geometric mean titer ratio
Interval 0.61 to 1.25
|
0.76 Geometric mean titer ratio
Interval 0.54 to 1.08
|
1.11 Geometric mean titer ratio
Interval 0.76 to 1.61
|
0.91 Geometric mean titer ratio
Interval 0.64 to 1.28
|
0.82 Geometric mean titer ratio
Interval 0.57 to 1.18
|
1.06 Geometric mean titer ratio
Interval 0.79 to 1.4
|
0.77 Geometric mean titer ratio
Interval 0.55 to 1.08
|
0.85 Geometric mean titer ratio
Interval 0.6 to 1.2
|
1.08 Geometric mean titer ratio
Interval 0.74 to 1.58
|
1.02 Geometric mean titer ratio
Interval 0.69 to 1.49
|
0.94 Geometric mean titer ratio
Interval 0.67 to 1.33
|
—
|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington(VictoriaSubtype) Expressed as GMTR
Day 28 (Comparison to qNIV Reference [Group O] Day 28)
|
—
|
0.85 Geometric mean titer ratio
Interval 0.62 to 1.17
|
0.76 Geometric mean titer ratio
Interval 0.52 to 1.12
|
0.58 Geometric mean titer ratio
Interval 0.4 to 0.84
|
0.73 Geometric mean titer ratio
Interval 0.48 to 1.1
|
0.82 Geometric mean titer ratio
Interval 0.55 to 1.22
|
0.64 Geometric mean titer ratio
Interval 0.44 to 0.94
|
0.81 Geometric mean titer ratio
Interval 0.59 to 1.11
|
0.63 Geometric mean titer ratio
Interval 0.43 to 0.92
|
0.55 Geometric mean titer ratio
Interval 0.38 to 0.81
|
0.76 Geometric mean titer ratio
Interval 0.5 to 1.14
|
0.77 Geometric mean titer ratio
Interval 0.51 to 1.17
|
0.70 Geometric mean titer ratio
Interval 0.48 to 1.01
|
—
|
|
Microneutralization (MN50) Antibody Responses Specific to Vaccine Homologous Wild-type Influenza B/Washington(VictoriaSubtype) Expressed as GMTR
Day70 (Comparison to qNIV Reference [Group O] Day 28)**
|
—
|
0.91 Geometric mean titer ratio
Interval 0.66 to 1.26
|
0.82 Geometric mean titer ratio
Interval 0.55 to 1.21
|
0.64 Geometric mean titer ratio
Interval 0.43 to 0.94
|
0.76 Geometric mean titer ratio
Interval 0.5 to 1.14
|
0.84 Geometric mean titer ratio
Interval 0.57 to 1.23
|
0.69 Geometric mean titer ratio
Interval 0.47 to 1.02
|
0.79 Geometric mean titer ratio
Interval 0.58 to 1.07
|
0.63 Geometric mean titer ratio
Interval 0.43 to 0.92
|
0.62 Geometric mean titer ratio
Interval 0.42 to 0.91
|
0.77 Geometric mean titer ratio
Interval 0.5 to 1.18
|
0.80 Geometric mean titer ratio
Interval 0.54 to 1.18
|
0.75 Geometric mean titer ratio
Interval 0.53 to 1.08
|
—
|
SECONDARY outcome
Timeframe: Day 0 to Day 182Population: Per-Protocol Analysis Set Population
IgG geometric mean ELISA unit concentrations (EU/mL) to the SARS-CoV-2 Wuhan Strain spike protein from the matched vaccine construct (and mismatched variant if available), at Days 0, 56, 70, and other follow-up time points.
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
n=40 Participants
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Serum Immunoglobulin G (IgG) Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as Geometric Mean ELISA Unit (GMEU)
Day 0
|
4429.2 EU/mL
Interval 3191.1 to 6147.7
|
5683.8 EU/mL
Interval 4450.9 to 7258.3
|
4454.2 EU/mL
Interval 2893.6 to 6856.4
|
3856.6 EU/mL
Interval 2822.3 to 5269.9
|
4495.9 EU/mL
Interval 3233.5 to 6251.3
|
4091.0 EU/mL
Interval 2950.8 to 5671.9
|
5180.7 EU/mL
Interval 3838.1 to 6992.9
|
5741.8 EU/mL
Interval 4568.3 to 7216.9
|
3804.2 EU/mL
Interval 2800.4 to 5167.9
|
4523.3 EU/mL
Interval 3465.3 to 5904.5
|
4544.0 EU/mL
Interval 3237.1 to 6378.6
|
4391.3 EU/mL
Interval 3132.1 to 6156.8
|
4626.8 EU/mL
Interval 3265.4 to 6555.7
|
—
|
|
Serum Immunoglobulin G (IgG) Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as Geometric Mean ELISA Unit (GMEU)
Day 28
|
16916.6 EU/mL
Interval 12692.9 to 22545.8
|
13942.2 EU/mL
Interval 11511.6 to 16885.9
|
7335.6 EU/mL
Interval 4979.4 to 10806.6
|
10956.0 EU/mL
Interval 8766.5 to 13692.2
|
17807.1 EU/mL
Interval 14049.0 to 22570.5
|
9117.3 EU/mL
Interval 6640.0 to 12518.8
|
16742.3 EU/mL
Interval 12369.2 to 22661.5
|
8417.5 EU/mL
Interval 6889.8 to 10284.0
|
8841.9 EU/mL
Interval 6584.3 to 11873.6
|
7891.9 EU/mL
Interval 5957.7 to 10454.0
|
14050.0 EU/mL
Interval 10829.5 to 18228.1
|
7458.5 EU/mL
Interval 5446.8 to 10213.0
|
9746.3 EU/mL
Interval 7411.8 to 12816.3
|
—
|
|
Serum Immunoglobulin G (IgG) Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as Geometric Mean ELISA Unit (GMEU)
Day 56
|
14045.3 EU/mL
Interval 10578.0 to 18649.1
|
11135.2 EU/mL
Interval 9073.1 to 13666.1
|
5386.6 EU/mL
Interval 3848.3 to 7539.6
|
8964.0 EU/mL
Interval 6963.9 to 11538.5
|
12767.0 EU/mL
Interval 9926.9 to 16419.7
|
6818.0 EU/mL
Interval 5175.7 to 8981.4
|
12182.9 EU/mL
Interval 9259.8 to 16028.8
|
6794.8 EU/mL
Interval 5516.7 to 8369.1
|
6241.6 EU/mL
Interval 4864.5 to 8008.4
|
7333.3 EU/mL
Interval 5785.2 to 9295.7
|
9943.2 EU/mL
Interval 6998.1 to 14127.7
|
5372.8 EU/mL
Interval 4000.2 to 7216.4
|
7345.8 EU/mL
Interval 5496.2 to 9817.9
|
—
|
|
Serum Immunoglobulin G (IgG) Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as Geometric Mean ELISA Unit (GMEU)
Day 70
|
49648.9 EU/mL
Interval 37172.2 to 66313.2
|
20242.6 EU/mL
Interval 16329.2 to 25093.8
|
10953.8 EU/mL
Interval 8261.7 to 14523.2
|
16790.1 EU/mL
Interval 12876.7 to 21892.9
|
31832.6 EU/mL
Interval 24731.8 to 40972.2
|
14239.8 EU/mL
Interval 11057.4 to 18338.1
|
30516.7 EU/mL
Interval 24805.8 to 37542.3
|
10034.7 EU/mL
Interval 8330.5 to 12087.7
|
14056.4 EU/mL
Interval 11065.9 to 17855.1
|
13323.0 EU/mL
Interval 10080.2 to 17608.9
|
20057.8 EU/mL
Interval 14905.1 to 26991.7
|
9499.5 EU/mL
Interval 7483.6 to 12058.5
|
12008.6 EU/mL
Interval 9222.7 to 15636.0
|
—
|
|
Serum Immunoglobulin G (IgG) Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as Geometric Mean ELISA Unit (GMEU)
Day 84
|
47019.7 EU/mL
Interval 35065.8 to 63048.7
|
18638.7 EU/mL
Interval 15052.6 to 23079.0
|
9995.0 EU/mL
Interval 7277.5 to 13727.2
|
14734.9 EU/mL
Interval 11353.6 to 19123.2
|
26887.4 EU/mL
Interval 21170.6 to 34147.9
|
13044.7 EU/mL
Interval 10008.3 to 17002.3
|
23187.1 EU/mL
Interval 18124.0 to 29664.6
|
9036.4 EU/mL
Interval 7508.0 to 10875.9
|
13272.6 EU/mL
Interval 9937.1 to 17727.7
|
12165.5 EU/mL
Interval 9252.7 to 15995.5
|
17551.8 EU/mL
Interval 12775.4 to 24114.0
|
8452.8 EU/mL
Interval 6297.0 to 11346.6
|
12333.7 EU/mL
Interval 9385.2 to 16208.7
|
—
|
|
Serum Immunoglobulin G (IgG) Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as Geometric Mean ELISA Unit (GMEU)
Day 182
|
50766.4 EU/mL
Interval 35129.2 to 73364.5
|
24291.7 EU/mL
Interval 17313.5 to 34082.3
|
30967.6 EU/mL
Interval 20184.3 to 47512.0
|
23902.3 EU/mL
Interval 16449.9 to 34731.0
|
33992.1 EU/mL
Interval 24097.1 to 47950.4
|
17658.7 EU/mL
Interval 12260.0 to 25434.7
|
26514.4 EU/mL
Interval 18000.1 to 39056.1
|
18724.8 EU/mL
Interval 13525.2 to 25923.4
|
27578.7 EU/mL
Interval 18550.2 to 41001.3
|
25514.6 EU/mL
Interval 15700.4 to 41463.6
|
26561.5 EU/mL
Interval 18880.7 to 37366.8
|
15001.9 EU/mL
Interval 8142.9 to 27638.6
|
13145.9 EU/mL
Interval 7396.4 to 23365.0
|
—
|
SECONDARY outcome
Timeframe: Day 0 to Day 182Population: Per-Protocol Analysis Set Population
IgG geometric mean ELISA unit concentrations (EU/mL) to the SARS-CoV-2 Omicron BA.1 spike protein from the matched vaccine construct (and mismatched variant if available), at Days 0, 56, 70, and other follow-up time points.
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
n=40 Participants
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMEU
Day 0
|
1924.5 EU/mL
Interval 1411.7 to 2623.7
|
2509.4 EU/mL
Interval 1957.1 to 3217.4
|
2352.1 EU/mL
Interval 1517.9 to 3644.7
|
1640.8 EU/mL
Interval 1144.5 to 2352.2
|
2223.5 EU/mL
Interval 1602.6 to 3085.0
|
1891.7 EU/mL
Interval 1367.8 to 2616.4
|
2118.1 EU/mL
Interval 1524.3 to 2943.1
|
2338.1 EU/mL
Interval 1833.3 to 2982.1
|
1546.0 EU/mL
Interval 1129.3 to 2116.4
|
2169.7 EU/mL
Interval 1652.6 to 2848.5
|
1836.6 EU/mL
Interval 1239.4 to 2721.6
|
2026.9 EU/mL
Interval 1377.9 to 2981.8
|
1907.4 EU/mL
Interval 1300.7 to 2797.0
|
—
|
|
Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMEU
Day 28
|
9022.0 EU/mL
Interval 6966.5 to 11684.0
|
7178.0 EU/mL
Interval 5886.3 to 8753.2
|
3681.8 EU/mL
Interval 2512.7 to 5395.0
|
5540.0 EU/mL
Interval 4089.2 to 7505.5
|
9164.6 EU/mL
Interval 7181.8 to 11694.8
|
5016.6 EU/mL
Interval 3863.2 to 6514.4
|
9532.8 EU/mL
Interval 7308.3 to 12434.3
|
4771.3 EU/mL
Interval 3897.6 to 5840.8
|
4523.6 EU/mL
Interval 3445.0 to 5939.8
|
4449.2 EU/mL
Interval 3422.2 to
|
6525.9 EU/mL
Interval 4832.6 to 8812.6
|
3337.6 EU/mL
Interval 2354.9 to 4730.3
|
5146.3 EU/mL
Interval 3778.5 to 7009.2
|
—
|
|
Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMEU
Day 56
|
6174.1 EU/mL
Interval 4706.2 to 8099.7
|
4944.6 EU/mL
Interval 4042.6 to 6047.8
|
2401.9 EU/mL
Interval 1686.2 to 3421.3
|
4066.0 EU/mL
Interval 3129.3 to 5283.1
|
6627.4 EU/mL
Interval 5200.3 to 8446.1
|
3169.4 EU/mL
Interval 2333.5 to 4304.6
|
5695.2 EU/mL
Interval 4018.5 to 8071.5
|
3153.4 EU/mL
Interval 2518.2 to 3948.8
|
3025.0 EU/mL
Interval 2285.5 to 4003.8
|
3104.4 EU/mL
Interval 2409.2 to 4000.2
|
4874.6 EU/mL
Interval 3484.8 to 6818.7
|
2486.6 EU/mL
Interval 1763.6 to 3506.0
|
3418.5 EU/mL
Interval 2490.4 to 4692.4
|
—
|
|
Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMEU
Day 70
|
29688.8 EU/mL
Interval 21629.2 to 40751.6
|
10131.1 EU/mL
Interval 8119.8 to 12640.7
|
5996.7 EU/mL
Interval 4255.9 to 8449.7
|
8505.0 EU/mL
Interval 6469.9 to 11180.4
|
17713.1 EU/mL
Interval 13344.9 to 23511.2
|
7554.2 EU/mL
Interval 5905.9 to 9662.7
|
15278.3 EU/mL
Interval 11882.4 to 19644.8
|
5213.9 EU/mL
Interval 4241.2 to 6409.6
|
8810.1 EU/mL
Interval 6663.7 to 11647.8
|
7595.8 EU/mL
Interval 5620.7 to 10264.9
|
9771.5 EU/mL
Interval 6885.5 to 13867.1
|
4807.0 EU/mL
Interval 3620.2 to 6382.9
|
5959.0 EU/mL
Interval 4480.2 to 7925.9
|
—
|
|
Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMEU
Day 84
|
29386.3 EU/mL
Interval 22037.7 to 39185.1
|
9816.0 EU/mL
Interval 7858.0 to 12261.8
|
5433.7 EU/mL
Interval 3861.9 to 7645.3
|
8251.7 EU/mL
Interval 5870.6 to 11598.5
|
17296.1 EU/mL
Interval 13366.6 to 22380.7
|
7548.7 EU/mL
Interval 5780.4 to 9857.9
|
17095.5 EU/mL
Interval 13534.1 to 21594.1
|
4820.6 EU/mL
Interval 3927.4 to 5916.8
|
9228.5 EU/mL
Interval 6671.3 to 12765.8
|
7392.8 EU/mL
Interval 5384.3 to 10150.6
|
9687.1 EU/mL
Interval 6844.1 to 13711.1
|
4501.4 EU/mL
Interval 3405.1 to 5950.5
|
5899.3 EU/mL
Interval 4311.0 to 8072.9
|
—
|
|
Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMEU
Day 182
|
25661.9 EU/mL
Interval 17621.8 to 37370.1
|
11537.2 EU/mL
Interval 8148.0 to 16336.1
|
13357.2 EU/mL
Interval 8842.6 to 20176.7
|
11651.7 EU/mL
Interval 7261.4 to 18696.5
|
18548.4 EU/mL
Interval 12711.6 to 27065.1
|
8631.2 EU/mL
Interval 6113.1 to 12186.5
|
13600.4 EU/mL
Interval 9274.6 to 19943.7
|
8827.8 EU/mL
Interval 6412.1 to 12153.5
|
14569.4 EU/mL
Interval 9359.6 to 22679.3
|
11423.9 EU/mL
Interval 7309.8 to 17853.3
|
9692.8 EU/mL
Interval 6381.5 to 14722.3
|
6533.1 EU/mL
Interval 3364.0 to 12687.8
|
6134.1 EU/mL
Interval 3521.6 to 10684.7
|
—
|
SECONDARY outcome
Timeframe: Day 28 to Day 182Population: Per Protocol Analysis Set population
IgG geometric mean ELISA unit concentrations (EU/mL) to the SARS-CoV-2 Wuhan Strain spike protein from the matched vaccine construct (and mismatched variant if available), at Days 0, 56, 70, and other follow-up time points.
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
n=40 Participants
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as GMFR
Day 56
|
3.2 geometric mean fold rise
Interval 2.5 to 4.1
|
1.9 geometric mean fold rise
Interval 1.7 to 2.2
|
1.4 geometric mean fold rise
Interval 1.1 to 1.6
|
2.1 geometric mean fold rise
Interval 1.7 to 2.6
|
2.8 geometric mean fold rise
Interval 2.1 to 3.8
|
1.7 geometric mean fold rise
Interval 1.4 to 2.1
|
2.4 geometric mean fold rise
Interval 1.9 to 3.0
|
1.2 geometric mean fold rise
Interval 1.1 to 1.3
|
1.6 geometric mean fold rise
Interval 1.3 to 2.1
|
1.7 geometric mean fold rise
Interval 1.3 to 2.1
|
2.3 geometric mean fold rise
Interval 1.8 to 2.9
|
1.2 geometric mean fold rise
Interval 1.0 to 1.5
|
1.6 geometric mean fold rise
Interval 1.3 to 2.0
|
—
|
|
Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as GMFR
Day 28
|
3.8 geometric mean fold rise
Interval 2.9 to 5.0
|
2.5 geometric mean fold rise
Interval 2.1 to 2.8
|
1.6 geometric mean fold rise
Interval 1.4 to 2.0
|
2.8 geometric mean fold rise
Interval 2.2 to 3.4
|
4.0 geometric mean fold rise
Interval 2.9 to 5.4
|
2.2 geometric mean fold rise
Interval 1.8 to 2.8
|
3.2 geometric mean fold rise
Interval 2.6 to 4.1
|
1.5 geometric mean fold rise
Interval 1.3 to 1.7
|
2.3 geometric mean fold rise
Interval 1.8 to 2.9
|
1.7 geometric mean fold rise
Interval 1.4 to 2.2
|
3.2 geometric mean fold rise
Interval 2.4 to 4.2
|
1.7 geometric mean fold rise
Interval 1.4 to 2.0
|
2.1 geometric mean fold rise
Interval 1.7 to 2.6
|
—
|
|
Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as GMFR
Day 70
|
11.2 geometric mean fold rise
Interval 8.2 to 15.3
|
3.5 geometric mean fold rise
Interval 2.9 to 4.1
|
2.7 geometric mean fold rise
Interval 2.2 to 3.5
|
3.9 geometric mean fold rise
Interval 3.0 to 5.0
|
7.1 geometric mean fold rise
Interval 4.8 to 10.4
|
3.5 geometric mean fold rise
Interval 2.7 to 4.6
|
5.9 geometric mean fold rise
Interval 4.4 to 7.9
|
1.8 geometric mean fold rise
Interval 1.5 to 2.1
|
3.8 geometric mean fold rise
Interval 2.8 to 5.1
|
3.0 geometric mean fold rise
Interval 2.3 to 4.0
|
4.8 geometric mean fold rise
Interval 3.7 to 6.4
|
2.0 geometric mean fold rise
Interval 1.6 to 2.4
|
2.6 geometric mean fold rise
Interval 2.0 to 3.3
|
—
|
|
Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as GMFR
Day 84
|
10.6 geometric mean fold rise
Interval 7.6 to 14.8
|
3.3 geometric mean fold rise
Interval 2.8 to 3.9
|
2.5 geometric mean fold rise
Interval 1.8 to 3.5
|
3.6 geometric mean fold rise
Interval 2.8 to 4.6
|
6.2 geometric mean fold rise
Interval 4.4 to 8.8
|
3.0 geometric mean fold rise
Interval 2.3 to 4.0
|
4.3 geometric mean fold rise
Interval 3.2 to 5.7
|
1.6 geometric mean fold rise
Interval 1.4 to 1.9
|
3.6 geometric mean fold rise
Interval 2.5 to 5.0
|
2.8 geometric mean fold rise
Interval 2.1 to 3.7
|
4.3 geometric mean fold rise
Interval 3.2 to 5.8
|
1.7 geometric mean fold rise
Interval 1.3 to 2.3
|
2.7 geometric mean fold rise
Interval 1.9 to 3.7
|
—
|
|
Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as GMFR
Day 182
|
10.7 geometric mean fold rise
Interval 6.6 to 17.3
|
4.5 geometric mean fold rise
Interval 3.4 to 5.9
|
6.2 geometric mean fold rise
Interval 3.6 to 10.8
|
5.0 geometric mean fold rise
Interval 3.4 to 7.5
|
7.6 geometric mean fold rise
Interval 4.8 to 12.1
|
4.0 geometric mean fold rise
Interval 2.5 to 6.3
|
5.0 geometric mean fold rise
Interval 3.4 to 7.3
|
3.0 geometric mean fold rise
Interval 2.1 to 4.4
|
7.2 geometric mean fold rise
Interval 4.1 to 12.3
|
6.1 geometric mean fold rise
Interval 3.9 to 9.6
|
6.5 geometric mean fold rise
Interval 4.3 to 9.8
|
3.5 geometric mean fold rise
Interval 2.1 to 5.9
|
2.6 geometric mean fold rise
Interval 1.6 to 4.1
|
—
|
SECONDARY outcome
Timeframe: Day 28 to Day 182Population: Per Protocol Analysis Set population
IgG geometric mean ELISA unit concentrations (EU/mL) to the SARS-CoV-2 Omicron BA.1 Variant spike protein from the matched vaccine construct (and mismatched variant if available), at Days 0, 56, 70, and other follow-up time points.
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
n=40 Participants
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMFR
Day 56
|
3.2 geometric mean fold rise
Interval 2.5 to 4.1
|
2.0 geometric mean fold rise
Interval 1.7 to 2.3
|
1.1 geometric mean fold rise
Interval 0.9 to 1.4
|
2.2 geometric mean fold rise
Interval 1.7 to 2.8
|
3.0 geometric mean fold rise
Interval 2.1 to 4.2
|
1.7 geometric mean fold rise
Interval 1.3 to 2.2
|
2.7 geometric mean fold rise
Interval 2.0 to 3.6
|
1.3 geometric mean fold rise
Interval 1.2 to 1.5
|
2.0 geometric mean fold rise
Interval 1.5 to 2.5
|
1.5 geometric mean fold rise
Interval 1.2 to 1.9
|
2.8 geometric mean fold rise
Interval 2.1 to 3.7
|
1.2 geometric mean fold rise
Interval 0.9 to 1.5
|
1.8 geometric mean fold rise
Interval 1.4 to 2.4
|
—
|
|
Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMFR
Day 84
|
15.3 geometric mean fold rise
Interval 10.8 to 21.7
|
3.9 geometric mean fold rise
Interval 3.3 to 4.7
|
2.6 geometric mean fold rise
Interval 2.0 to 3.4
|
4.6 geometric mean fold rise
Interval 3.2 to 6.6
|
8.1 geometric mean fold rise
Interval 5.4 to 12.1
|
3.9 geometric mean fold rise
Interval 2.7 to 5.6
|
7.6 geometric mean fold rise
Interval 5.3 to 10.8
|
2.1 geometric mean fold rise
Interval 1.8 to 2.5
|
6.2 geometric mean fold rise
Interval 4.1 to 9.5
|
3.5 geometric mean fold rise
Interval 2.5 to 4.9
|
5.6 geometric mean fold rise
Interval 4.1 to 7.6
|
2.0 geometric mean fold rise
Interval 1.5 to 2.6
|
3.1 geometric mean fold rise
Interval 2.1 to 4.5
|
—
|
|
Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMFR
Day 28
|
4.7 geometric mean fold rise
Interval 3.7 to 6.0
|
2.9 geometric mean fold rise
Interval 2.4 to 3.4
|
1.6 geometric mean fold rise
Interval 1.3 to 1.9
|
3.3 geometric mean fold rise
Interval 2.4 to 4.4
|
4.1 geometric mean fold rise
Interval 2.9 to 5.9
|
2.7 geometric mean fold rise
Interval 2.0 to 3.6
|
4.5 geometric mean fold rise
Interval 3.5 to 5.9
|
2.1 geometric mean fold rise
Interval 1.8 to 2.4
|
2.9 geometric mean fold rise
Interval 2.2 to 3.8
|
2.1 geometric mean fold rise
Interval 1.6 to 2.6
|
3.6 geometric mean fold rise
Interval 2.6 to 5.0
|
1.6 geometric mean fold rise
Interval 1.3 to 2.2
|
2.7 geometric mean fold rise
Interval 2.0 to 3.7
|
—
|
|
Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMFR
Day 70
|
15.4 geometric mean fold rise
Interval 10.9 to 21.8
|
4.0 geometric mean fold rise
Interval 3.2 to 4.9
|
2.9 geometric mean fold rise
Interval 2.2 to 3.8
|
4.4 geometric mean fold rise
Interval 3.3 to 5.9
|
8.0 geometric mean fold rise
Interval 5.4 to 11.8
|
4.1 geometric mean fold rise
Interval 2.9 to 5.8
|
7.2 geometric mean fold rise
Interval 5.1 to 10.2
|
2.2 geometric mean fold rise
Interval 1.9 to 2.6
|
5.9 geometric mean fold rise
Interval 4.1 to 8.6
|
3.6 geometric mean fold rise
Interval 2.6 to 5.1
|
5.8 geometric mean fold rise
Interval 4.1 to 8.3
|
2.1 geometric mean fold rise
Interval 1.6 to 2.8
|
3.1 geometric mean fold rise
Interval 2.1 to 4.7
|
—
|
|
Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as GMFR
Day 182
|
13.0 geometric mean fold rise
Interval 8.0 to 21.1
|
4.8 geometric mean fold rise
Interval 3.3 to 6.5
|
5.5 geometric mean fold rise
Interval 3.3 to 9.2
|
5.7 geometric mean fold rise
Interval 3.5 to 9.1
|
8.7 geometric mean fold rise
Interval 5.2 to 14.4
|
4.3 geometric mean fold rise
Interval 2.8 to 6.6
|
6.3 geometric mean fold rise
Interval 4.1 to 9.7
|
3.3 geometric mean fold rise
Interval 2.3 to 4.7
|
9.3 geometric mean fold rise
Interval 5.2 to 16.6
|
5.7 geometric mean fold rise
Interval 3.8 to 8.5
|
6.1 geometric mean fold rise
Interval 3.7 to 10.1
|
3.2 geometric mean fold rise
Interval 1.9 to 5.5
|
3.2 geometric mean fold rise
Interval 1.7 to 5.9
|
—
|
SECONDARY outcome
Timeframe: Day 28 to Day 182Population: Per Protocol Analysis Set
IgG geometric mean ELISA unit concentrations (EU/mL) to the SARS-CoV-2 Wuhan Strain spike protein from the matched vaccine construct (and mismatched variant if available), at Days 0, 56, 70, and other follow-up time points.
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
n=40 Participants
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as SCR
Day 28
|
35.9 Percentage of participants
Interval 21.2 to 52.8
|
17.7 Percentage of participants
Interval 10.0 to 27.9
|
10.0 Percentage of participants
Interval 2.8 to 23.7
|
28.9 Percentage of participants
Interval 15.4 to 45.9
|
48.6 Percentage of participants
Interval 31.9 to 65.6
|
12.2 Percentage of participants
Interval 4.1 to 26.2
|
40.0 Percentage of participants
Interval 24.9 to 56.7
|
3.9 Percentage of participants
Interval 0.8 to 11.0
|
30.8 Percentage of participants
Interval 17.0 to 47.6
|
10.3 Percentage of participants
Interval 2.9 to 24.2
|
34.2 Percentage of participants
Interval 19.6 to 51.4
|
5.1 Percentage of participants
Interval 0.6 to 17.3
|
17.5 Percentage of participants
Interval 7.3 to 32.8
|
—
|
|
Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as SCR
Day 56
|
30.8 Percentage of participants
Interval 17.0 to 47.6
|
9.0 Percentage of participants
Interval 3.7 to 17.6
|
5.1 Percentage of participants
Interval 0.6 to 17.3
|
19.4 Percentage of participants
Interval 8.2 to 36.0
|
27.8 Percentage of participants
Interval 14.2 to 45.2
|
12.5 Percentage of participants
Interval 4.2 to 26.8
|
20.0 Percentage of participants
Interval 9.1 to 35.6
|
0 Percentage of participants
Interval 0.0 to 4.7
|
12.8 Percentage of participants
Interval 4.3 to 27.4
|
10.5 Percentage of participants
Interval 2.9 to 24.8
|
22.2 Percentage of participants
Interval 10.1 to 39.2
|
2.6 Percentage of participants
Interval 0.1 to 13.8
|
7.5 Percentage of participants
Interval 1.6 to 20.4
|
—
|
|
Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as SCR
Day 70
|
86.8 Percentage of participants
Interval 71.9 to 95.6
|
44.7 Percentage of participants
Interval 33.3 to 56.6
|
23.1 Percentage of participants
Interval 11.1 to 39.3
|
54.3 Percentage of participants
Interval 36.6 to 71.2
|
63.9 Percentage of participants
Interval 46.2 to 79.2
|
42.5 Percentage of participants
Interval 27.0 to 59.1
|
62.5 Percentage of participants
Interval 45.8 to 77.3
|
12.0 Percentage of participants
Interval 5.6 to 21.6
|
42.1 Percentage of participants
Interval 26.3 to 59.2
|
31.6 Percentage of participants
Interval 17.5 to 48.7
|
57.1 Percentage of participants
Interval 39.4 to 73.7
|
10.8 Percentage of participants
Interval 3.0 to 25.4
|
25.0 Percentage of participants
Interval 12.7 to 41.2
|
—
|
|
Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as SCR
Day 84
|
78.9 Percentage of participants
Interval 62.7 to 90.4
|
39.0 Percentage of participants
Interval 28.0 to 50.8
|
25.6 Percentage of participants
Interval 13.0 to 42.1
|
32.4 Percentage of participants
Interval 17.4 to 50.5
|
62.9 Percentage of participants
Interval 44.9 to 78.5
|
35.9 Percentage of participants
Interval 21.2 to 52.8
|
55.3 Percentage of participants
Interval 38.3 to 71.4
|
6.7 Percentage of participants
Interval 2.2 to 14.9
|
42.1 Percentage of participants
Interval 26.3 to 59.2
|
21.1 Percentage of participants
Interval 9.6 to 37.3
|
54.5 Percentage of participants
Interval 36.4 to 71.9
|
8.1 Percentage of participants
Interval 1.7 to 21.9
|
30.0 Percentage of participants
Interval 16.6 to 46.5
|
—
|
|
Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Wuhan Strain Spike Protein Expressed as SCR
Day 182
|
76.7 Percentage of participants
Interval 57.7 to 90.1
|
50.8 Percentage of participants
Interval 37.7 to 63.9
|
63.6 Percentage of participants
Interval 45.1 to 79.6
|
60.0 Percentage of participants
Interval 40.6 to 77.3
|
64.5 Percentage of participants
Interval 45.4 to 80.8
|
52.8 Percentage of participants
Interval 35.5 to 69.6
|
60.6 Percentage of participants
Interval 42.1 to 77.1
|
43.3 Percentage of participants
Interval 31.2 to 56.0
|
65.5 Percentage of participants
Interval 45.7 to 82.1
|
64.5 Percentage of participants
Interval 45.4 to 80.8
|
66.7 Percentage of participants
Interval 47.2 to 82.7
|
58.6 Percentage of participants
Interval 38.9 to 76.5
|
32.3 Percentage of participants
Interval 16.7 to 51.4
|
—
|
SECONDARY outcome
Timeframe: Day 28 to Day 182Population: Per Protocol Analysis Set
IgG geometric mean ELISA unit concentrations (EU/mL) to the SARS-CoV-2 Omicron BA.1 Variant spike protein from the matched vaccine construct (and mismatched variant if available), at Days 0, 56, 70, and other follow-up time points.
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
n=40 Participants
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as SCR
Day 28
|
56.4 Percentage of participants
Interval 39.6 to 72.2
|
35.4 Percentage of participants
Interval 25.0 to 47.0
|
7.5 Percentage of participants
Interval 1.6 to 20.4
|
50.0 Percentage of participants
Interval 33.4 to 66.6
|
35.1 Percentage of participants
Interval 20.2 to 52.5
|
29.3 Percentage of participants
Interval 16.1 to 45.5
|
57.5 Percentage of participants
Interval 40.9 to 73.0
|
18.2 Percentage of participants
Interval 10.3 to 28.6
|
30.8 Percentage of participants
Interval 17.0 to 47.6
|
17.9 Percentage of participants
Interval 7.5 to 33.5
|
47.4 Percentage of participants
Interval 31.0 to 64.2
|
12.8 Percentage of participants
Interval 4.3 to 27.4
|
25.0 Percentage of participants
Interval 12.7 to 41.2
|
—
|
|
Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as SCR
Day 56
|
30.8 Percentage of participants
Interval 17.0 to 47.6
|
14.1 Percentage of participants
Interval 7.3 to 23.8
|
0 Percentage of participants
Interval 0.0 to 9.0
|
19.4 Percentage of participants
Interval 8.2 to 36.0
|
33.3 Percentage of participants
Interval 18.6 to 51.0
|
17.5 Percentage of participants
Interval 7.3 to 32.8
|
35.0 Percentage of participants
Interval 20.6 to 51.7
|
2.6 Percentage of participants
Interval 0.3 to 9.1
|
23.1 Percentage of participants
Interval 11.1 to 39.3
|
10.5 Percentage of participants
Interval 2.9 to 24.8
|
30.6 Percentage of participants
Interval 16.3 to 48.1
|
5.3 Percentage of participants
Interval 0.6 to 17.7
|
10.0 Percentage of participants
Interval 2.8 to 23.7
|
—
|
|
Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as SCR
Day 70
|
92.1 Percentage of participants
Interval 78.6 to 98.3
|
47.4 Percentage of participants
Interval 35.8 to 59.2
|
30.8 Percentage of participants
Interval 17.0 to 47.6
|
60.0 Percentage of participants
Interval 42.1 to 76.1
|
66.7 Percentage of participants
Interval 49.0 to 81.4
|
60.0 Percentage of participants
Interval 43.3 to 75.1
|
72.5 Percentage of participants
Interval 56.1 to 85.4
|
24.0 Percentage of participants
Interval 14.9 to 35.3
|
60.5 Percentage of participants
Interval 43.4 to 76.0
|
36.8 Percentage of participants
Interval 21.8 to 54.0
|
62.9 Percentage of participants
Interval 44.9 to 78.5
|
21.6 Percentage of participants
Interval 9.8 to 38.2
|
30.0 Percentage of participants
Interval 16.6 to 46.5
|
—
|
|
Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as SCR
Day 182
|
86.7 Percentage of participants
Interval 69.3 to 96.2
|
54.1 Percentage of participants
Interval 40.8 to 66.9
|
60.6 Percentage of participants
Interval 42.1 to 77.1
|
53.3 Percentage of participants
Interval 34.3 to 71.7
|
67.7 Percentage of participants
Interval 48.6 to 83.3
|
52.8 Percentage of participants
Interval 35.5 to 69.6
|
66.7 Percentage of participants
Interval 48.2 to 82.0
|
47.8 Percentage of participants
Interval 35.4 to 60.3
|
65.5 Percentage of participants
Interval 45.7 to 82.1
|
58.1 Percentage of participants
Interval 39.1 to 75.5
|
60.0 Percentage of participants
Interval 40.6 to 77.3
|
37.9 Percentage of participants
Interval 20.7 to 57.7
|
45.2 Percentage of participants
Interval 27.3 to 64.0
|
—
|
|
Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as SCR
Day 84
|
92.1 Percentage of participants
Interval 78.6 to 98.3
|
46.8 Percentage of participants
Interval 35.3 to 58.5
|
28.2 Percentage of participants
Interval 15.0 to 44.9
|
52.9 Percentage of participants
Interval 35.1 to 70.2
|
62.9 Percentage of participants
Interval 44.9 to 78.5
|
48.7 Percentage of participants
Interval 32.4 to 65.2
|
71.1 Percentage of participants
Interval 54.1 to 84.6
|
17.3 Percentage of participants
Interval 9.6 to 27.8
|
60.5 Percentage of participants
Interval 43.4 to 76.0
|
34.2 Percentage of participants
Interval 19.6 to 51.4
|
60.6 Percentage of participants
Interval 42.1 to 77.1
|
16.2 Percentage of participants
Interval 6.2 to 32.0
|
32.5 Percentage of participants
Interval 18.6 to 49.1
|
—
|
SECONDARY outcome
Timeframe: Day 28 to Day 182Population: Per-Protocol Analysis Set Population
IgG geometric mean ELISA unit concentrations (EU/mL) to the SARS-CoV-2 Omicron BA.1 Variant spike protein from the matched vaccine construct (and mismatched variant if available), at Days 0, 56, 70, and other follow-up time points.
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as Geometric Mean ELISA Unit Ratio (GMEUR)
Day 28 (Comparison to SARS-CoV-2 Reference [Group P])
|
—
|
0.68 ratio
Interval 0.54 to 0.86
|
0.35 ratio
Interval 0.27 to 0.46
|
0.66 ratio
Interval 0.49 to 0.89
|
0.97 ratio
Interval 0.7 to 1.33
|
0.56 ratio
Interval 0.41 to 0.76
|
1.01 ratio
Interval 0.76 to 1.35
|
0.47 ratio
Interval 0.38 to 0.59
|
0.56 ratio
Interval 0.42 to 0.75
|
0.46 ratio
Interval 0.35 to 0.62
|
0.75 ratio
Interval 0.55 to 1.02
|
0.36 ratio
Interval 0.26 to 0.49
|
0.57 ratio
Interval 0.42 to 0.78
|
—
|
|
Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as Geometric Mean ELISA Unit Ratio (GMEUR)
Day 56 (Comparison to SARS-CoV-2 Reference [Group P])
|
—
|
0.68 ratio
Interval 0.54 to 0.87
|
0.37 ratio
Interval 0.28 to 0.49
|
0.67 ratio
Interval 0.51 to 0.89
|
1.01 ratio
Interval 0.74 to 1.39
|
0.52 ratio
Interval 0.39 to 0.71
|
0.87 ratio
Interval 0.61 to 1.24
|
0.44 ratio
Interval 0.35 to 0.56
|
0.55 ratio
Interval 0.41 to 0.75
|
0.48 ratio
Interval 0.36 to 0.64
|
0.83 ratio
Interval 0.61 to 1.13
|
0.38 ratio
Interval 0.28 to 0.52
|
0.56 ratio
Interval 0.41 to 0.75
|
—
|
|
Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as Geometric Mean ELISA Unit Ratio (GMEUR)
Day 70 (Comparison to SARS-CoV-2 Reference [Group P])
|
—
|
0.30 ratio
Interval 0.21 to 0.41
|
0.19 ratio
Interval 0.13 to 0.28
|
0.29 ratio
Interval 0.2 to 0.41
|
0.57 ratio
Interval 0.38 to 0.86
|
0.26 ratio
Interval 0.18 to 0.37
|
0.50 ratio
Interval 0.34 to 0.72
|
0.16 ratio
Interval 0.12 to 0.21
|
0.32 ratio
Interval 0.22 to 0.48
|
0.25 ratio
Interval 0.17 to 0.37
|
0.35 ratio
Interval 0.23 to 0.52
|
0.15 ratio
Interval 0.11 to 0.22
|
0.20 ratio
Interval 0.14 to 0.3
|
—
|
|
Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as Geometric Mean ELISA Unit Ratio (GMEUR)
Day 84 (Comparison to SARS-CoV-2 Reference [Group P])
|
—
|
0.29 ratio
Interval 0.22 to 0.39
|
0.18 ratio
Interval 0.12 to 0.26
|
0.29 ratio
Interval 0.19 to 0.43
|
0.58 ratio
Interval 0.4 to 0.84
|
0.26 ratio
Interval 0.18 to 0.37
|
0.56 ratio
Interval 0.39 to 0.8
|
0.15 ratio
Interval 0.11 to 0.19
|
0.33 ratio
Interval 0.22 to 0.51
|
0.24 ratio
Interval 0.16 to 0.36
|
0.34 ratio
Interval 0.24 to 0.5
|
0.14 ratio
Interval 0.1 to 0.2
|
0.20 ratio
Interval 0.14 to 0.3
|
—
|
|
Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 Omicron BA.1 Variant Spike Protein Expressed as Geometric Mean ELISA Unit Ratio (GMEUR)
Day 182 (Comparison to SARS-CoV-2 Reference [Group P])
|
—
|
0.41 ratio
Interval 0.25 to 0.68
|
0.50 ratio
Interval 0.29 to 0.87
|
0.45 ratio
Interval 0.25 to 0.79
|
0.72 ratio
Interval 0.42 to 1.21
|
0.33 ratio
Interval 0.2 to 0.55
|
0.52 ratio
Interval 0.31 to 0.86
|
0.32 ratio
Interval 0.19 to 0.54
|
0.58 ratio
Interval 0.33 to 1.03
|
0.44 ratio
Interval 0.26 to 0.76
|
0.40 ratio
Interval 0.23 to 0.68
|
0.25 ratio
Interval 0.13 to 0.48
|
0.24 ratio
Interval 0.13 to 0.46
|
—
|
SECONDARY outcome
Timeframe: Day 28 to Day 182Population: Per-Protocol Analysis Set Population
IgG geometric mean ELISA unit concentrations (EU/mL) to the SARS-CoV-2 (Wuhan) spike protein from the matched vaccine construct (and mismatched variant if available), at Days 0, 56, 70, and other follow-up time points.
Outcome measures
| Measure |
Group O - qNIV With Matrix-M1 Adjuvant
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group A and Group C - ICC Vaccine Formulation
n=80 Participants
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 Participants
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 Participants
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 Participants
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 Participants
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 Participants
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 (Wuhan) Spike Protein Expressed as GMEUR
Day 28 (Comparison to SARS-CoV-2 Reference [Group P])
|
—
|
0.71 ratio
Interval 0.56 to 0.89
|
0.43 ratio
Interval 0.33 to 0.57
|
0.69 ratio
Interval 0.53 to 0.9
|
1.05 ratio
Interval 0.77 to 1.43
|
0.57 ratio
Interval 0.42 to 0.77
|
0.90 ratio
Interval 0.66 to 1.22
|
0.42 ratio
Interval 0.34 to 0.52
|
0.57 ratio
Interval 0.42 to 0.78
|
0.46 ratio
Interval 0.34 to 0.62
|
0.83 ratio
Interval 0.61 to 1.12
|
0.44 ratio
Interval 0.33 to 0.59
|
0.56 ratio
Interval 0.43 to 0.74
|
—
|
|
Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 (Wuhan) Spike Protein Expressed as GMEUR
Day 70 (Comparison to SARS-CoV-2 Reference [Group P])
|
—
|
0.35 ratio
Interval 0.27 to 0.46
|
0.23 ratio
Interval 0.17 to 0.32
|
0.34 ratio
Interval 0.25 to 0.47
|
0.64 ratio
Interval 0.45 to 0.91
|
0.30 ratio
Interval 0.22 to 0.41
|
0.58 ratio
Interval 0.43 to 0.79
|
0.18 ratio
Interval 0.14 to 0.22
|
0.30 ratio
Interval 0.22 to 0.42
|
0.27 ratio
Interval 0.19 to 0.38
|
0.42 ratio
Interval 0.3 to 0.58
|
0.18 ratio
Interval 0.14 to 0.25
|
0.24 ratio
Interval 0.17 to 0.32
|
—
|
|
Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 (Wuhan) Spike Protein Expressed as GMEUR
Day 84 (Comparison to SARS-CoV-2 Reference [Group P])
|
—
|
0.35 ratio
Interval 0.26 to 0.46
|
0.22 ratio
Interval 0.15 to 0.32
|
0.32 ratio
Interval 0.23 to 0.46
|
0.58 ratio
Interval 0.41 to 0.82
|
0.28 ratio
Interval 0.2 to 0.4
|
0.46 ratio
Interval 0.33 to 0.64
|
0.17 ratio
Interval 0.13 to 0.22
|
0.30 ratio
Interval 0.21 to 0.44
|
0.26 ratio
Interval 0.18 to 0.37
|
0.39 ratio
Interval 0.27 to 0.55
|
0.17 ratio
Interval 0.12 to 0.25
|
0.26 ratio
Interval 0.18 to 0.37
|
—
|
|
Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 (Wuhan) Spike Protein Expressed as GMEUR
Day 182 (Comparison to SARS-CoV-2 Reference [Group P])
|
—
|
0.45 ratio
Interval 0.28 to 0.72
|
0.61 ratio
Interval 0.35 to 1.06
|
0.47 ratio
Interval 0.29 to 0.77
|
0.68 ratio
Interval 0.42 to 1.1
|
0.35 ratio
Interval 0.21 to 0.59
|
0.50 ratio
Interval 0.3 to 0.82
|
0.35 ratio
Interval 0.2 to 0.59
|
0.55 ratio
Interval 0.33 to 0.95
|
0.53 ratio
Interval 0.3 to 0.94
|
0.54 ratio
Interval 0.34 to 0.87
|
0.31 ratio
Interval 0.17 to 0.59
|
0.25 ratio
Interval 0.13 to 0.46
|
—
|
|
Serum IgG Antibody Concentrations as ELISA Units to the SARS-CoV-2 (Wuhan) Spike Protein Expressed as GMEUR
Day 56 (Comparison to SARS-CoV-2 Reference [Group P])
|
—
|
0.67 ratio
Interval 0.54 to 0.83
|
0.41 ratio
Interval 0.32 to 0.54
|
0.66 ratio
Interval 0.51 to 0.85
|
0.90 ratio
Interval 0.67 to 1.22
|
0.51 ratio
Interval 0.39 to 0.68
|
0.79 ratio
Interval 0.59 to 1.05
|
0.40 ratio
Interval 0.33 to 0.5
|
0.48 ratio
Interval 0.36 to 0.64
|
0.52 ratio
Interval 0.4 to 0.69
|
0.72 ratio
Interval 0.53 to 0.97
|
0.39 ratio
Interval 0.3 to 0.5
|
0.67 ratio
Interval 0.54 to 0.83
|
—
|
Adverse Events
Group A and Group C - ICC Vaccine Formulation
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Group B -ICC Vaccine Formulation
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Group D - ICC Vaccine Formulation
Serious events: 2 serious events
Other events: 12 other events
Deaths: 0 deaths
Group E - ICC Vaccine Formulation
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Group F- ICC Vaccine Formulation
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Group G- ICC Vaccine Formulation
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Group H and Group N- ICC Vaccine Formulation
Serious events: 3 serious events
Other events: 19 other events
Deaths: 0 deaths
Group I- ICC Vaccine Formulation
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Group J -ICC Vaccine Formulation
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Group K - ICC Vaccine Formulation
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Group L - ICC Vaccine Formulation
Serious events: 5 serious events
Other events: 4 other events
Deaths: 0 deaths
Group M -ICC Vaccine Formulation
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Group O - qNIV With Matrix-M1 Adjuvant
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group A and Group C - ICC Vaccine Formulation
n=80 participants at risk
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 participants at risk
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 participants at risk
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 participants at risk
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 participants at risk
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 participants at risk
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 participants at risk
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 participants at risk
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 participants at risk
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 participants at risk
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 participants at risk
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 participants at risk
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group O - qNIV With Matrix-M1 Adjuvant
n=39 participants at risk
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
n=40 participants at risk
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/80 • 6 Month
|
0.00%
0/40 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/37 • 6 Month
|
2.4%
1/41 • Number of events 1 • 6 Month
|
0.00%
0/41 • 6 Month
|
1.2%
1/81 • Number of events 1 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/40 • 6 Month
|
0.00%
0/40 • 6 Month
|
0.00%
0/41 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/40 • 6 Month
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/80 • 6 Month
|
0.00%
0/40 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/37 • 6 Month
|
0.00%
0/41 • 6 Month
|
0.00%
0/41 • 6 Month
|
0.00%
0/81 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/40 • 6 Month
|
0.00%
0/40 • 6 Month
|
0.00%
0/41 • 6 Month
|
2.6%
1/39 • Number of events 1 • 6 Month
|
0.00%
0/40 • 6 Month
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/80 • 6 Month
|
0.00%
0/40 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/37 • 6 Month
|
0.00%
0/41 • 6 Month
|
0.00%
0/41 • 6 Month
|
0.00%
0/81 • 6 Month
|
2.6%
1/39 • Number of events 1 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/40 • 6 Month
|
0.00%
0/40 • 6 Month
|
0.00%
0/41 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/40 • 6 Month
|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
0/80 • 6 Month
|
0.00%
0/40 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/37 • 6 Month
|
2.4%
1/41 • Number of events 1 • 6 Month
|
0.00%
0/41 • 6 Month
|
0.00%
0/81 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/40 • 6 Month
|
0.00%
0/40 • 6 Month
|
0.00%
0/41 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/40 • 6 Month
|
|
Infections and infestations
Infected bite
|
1.2%
1/80 • Number of events 1 • 6 Month
|
0.00%
0/40 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/37 • 6 Month
|
0.00%
0/41 • 6 Month
|
0.00%
0/41 • 6 Month
|
0.00%
0/81 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/40 • 6 Month
|
0.00%
0/40 • 6 Month
|
0.00%
0/41 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/40 • 6 Month
|
|
Infections and infestations
Sialoadenitis
|
0.00%
0/80 • 6 Month
|
0.00%
0/40 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/37 • 6 Month
|
0.00%
0/41 • 6 Month
|
0.00%
0/41 • 6 Month
|
0.00%
0/81 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/40 • 6 Month
|
0.00%
0/40 • 6 Month
|
0.00%
0/41 • 6 Month
|
0.00%
0/39 • 6 Month
|
2.5%
1/40 • Number of events 1 • 6 Month
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/80 • 6 Month
|
0.00%
0/40 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/37 • 6 Month
|
0.00%
0/41 • 6 Month
|
0.00%
0/41 • 6 Month
|
0.00%
0/81 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/40 • 6 Month
|
2.5%
1/40 • Number of events 1 • 6 Month
|
0.00%
0/41 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/40 • 6 Month
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/80 • 6 Month
|
0.00%
0/40 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/37 • 6 Month
|
0.00%
0/41 • 6 Month
|
0.00%
0/41 • 6 Month
|
0.00%
0/81 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/40 • 6 Month
|
2.5%
1/40 • Number of events 1 • 6 Month
|
0.00%
0/41 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/40 • 6 Month
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/80 • 6 Month
|
0.00%
0/40 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/37 • 6 Month
|
0.00%
0/41 • 6 Month
|
0.00%
0/41 • 6 Month
|
0.00%
0/81 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/40 • 6 Month
|
2.5%
1/40 • Number of events 1 • 6 Month
|
0.00%
0/41 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/40 • 6 Month
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/80 • 6 Month
|
0.00%
0/40 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/37 • 6 Month
|
0.00%
0/41 • 6 Month
|
0.00%
0/41 • 6 Month
|
0.00%
0/81 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/40 • 6 Month
|
2.5%
1/40 • Number of events 1 • 6 Month
|
0.00%
0/41 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/40 • 6 Month
|
|
Injury, poisoning and procedural complications
Scapula fracture
|
0.00%
0/80 • 6 Month
|
0.00%
0/40 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/37 • 6 Month
|
0.00%
0/41 • 6 Month
|
0.00%
0/41 • 6 Month
|
0.00%
0/81 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/40 • 6 Month
|
2.5%
1/40 • Number of events 1 • 6 Month
|
0.00%
0/41 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/40 • 6 Month
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/80 • 6 Month
|
0.00%
0/40 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/37 • 6 Month
|
0.00%
0/41 • 6 Month
|
0.00%
0/41 • 6 Month
|
1.2%
1/81 • Number of events 1 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/40 • 6 Month
|
0.00%
0/40 • 6 Month
|
0.00%
0/41 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/40 • 6 Month
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/80 • 6 Month
|
0.00%
0/40 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/37 • 6 Month
|
0.00%
0/41 • 6 Month
|
2.4%
1/41 • Number of events 1 • 6 Month
|
0.00%
0/81 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/40 • 6 Month
|
0.00%
0/40 • 6 Month
|
0.00%
0/41 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/40 • 6 Month
|
|
Musculoskeletal and connective tissue disorders
Joint instability
|
1.2%
1/80 • Number of events 1 • 6 Month
|
0.00%
0/40 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/37 • 6 Month
|
0.00%
0/41 • 6 Month
|
0.00%
0/41 • 6 Month
|
0.00%
0/81 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/40 • 6 Month
|
0.00%
0/40 • 6 Month
|
0.00%
0/41 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/40 • 6 Month
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.00%
0/80 • 6 Month
|
0.00%
0/40 • 6 Month
|
2.6%
1/39 • Number of events 1 • 6 Month
|
0.00%
0/37 • 6 Month
|
0.00%
0/41 • 6 Month
|
0.00%
0/41 • 6 Month
|
0.00%
0/81 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/40 • 6 Month
|
0.00%
0/40 • 6 Month
|
0.00%
0/41 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/40 • 6 Month
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/80 • 6 Month
|
0.00%
0/40 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/37 • 6 Month
|
0.00%
0/41 • 6 Month
|
0.00%
0/41 • 6 Month
|
1.2%
1/81 • Number of events 1 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/40 • 6 Month
|
0.00%
0/40 • 6 Month
|
0.00%
0/41 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/40 • 6 Month
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/80 • 6 Month
|
0.00%
0/40 • 6 Month
|
2.6%
1/39 • Number of events 1 • 6 Month
|
0.00%
0/37 • 6 Month
|
0.00%
0/41 • 6 Month
|
0.00%
0/41 • 6 Month
|
0.00%
0/81 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/40 • 6 Month
|
0.00%
0/40 • 6 Month
|
0.00%
0/41 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/40 • 6 Month
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/80 • 6 Month
|
2.5%
1/40 • Number of events 1 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/37 • 6 Month
|
0.00%
0/41 • 6 Month
|
0.00%
0/41 • 6 Month
|
0.00%
0/81 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/40 • 6 Month
|
0.00%
0/40 • 6 Month
|
0.00%
0/41 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/40 • 6 Month
|
|
Vascular disorders
Hypertension
|
0.00%
0/80 • 6 Month
|
0.00%
0/40 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/37 • 6 Month
|
0.00%
0/41 • 6 Month
|
0.00%
0/41 • 6 Month
|
0.00%
0/81 • 6 Month
|
2.6%
1/39 • Number of events 1 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/40 • 6 Month
|
0.00%
0/40 • 6 Month
|
0.00%
0/41 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/40 • 6 Month
|
Other adverse events
| Measure |
Group A and Group C - ICC Vaccine Formulation
n=80 participants at risk
2 doses of Formulation 1. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group B -ICC Vaccine Formulation
n=40 participants at risk
2 doses of Formulation 2. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group D - ICC Vaccine Formulation
n=39 participants at risk
2 doses of Formulation 3. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group E - ICC Vaccine Formulation
n=37 participants at risk
2 doses of Formulation 4. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group F- ICC Vaccine Formulation
n=41 participants at risk
2 doses of Formulation 5. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group G- ICC Vaccine Formulation
n=41 participants at risk
2 doses of Formulation 6. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group H and Group N- ICC Vaccine Formulation
n=81 participants at risk
2 doses of Formulation 7. 1 dose each on Day 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group I- ICC Vaccine Formulation
n=39 participants at risk
2 doses of Formulation 8. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group J -ICC Vaccine Formulation
n=39 participants at risk
2 doses of Formulation 9. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group K - ICC Vaccine Formulation
n=40 participants at risk
2 doses of Formulation 10. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group L - ICC Vaccine Formulation
n=40 participants at risk
2 doses of Formulation 11. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group M -ICC Vaccine Formulation
n=41 participants at risk
2 doses of Formulation 12. 1 dose each on Days 0 and Day 56.
ICC Vaccine: Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
|
Group O - qNIV With Matrix-M1 Adjuvant
n=39 participants at risk
2 doses of Formulation 13. 1 dose each on Days 0 and Day 56 and an additional dose of 5 µg SARS-CoV-2 rS+50 µg Matrix-M1 at Day 70.
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
|
Group P- SARS-CoV-2 rS With Matrix-M1 Adjuvant
n=40 participants at risk
2 doses of Formulation 14. 1 dose each on Days 0 and Day 56.
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant: Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/80 • 6 Month
|
0.00%
0/40 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/37 • 6 Month
|
0.00%
0/41 • 6 Month
|
0.00%
0/41 • 6 Month
|
0.00%
0/81 • 6 Month
|
5.1%
2/39 • Number of events 2 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/40 • 6 Month
|
0.00%
0/40 • 6 Month
|
0.00%
0/41 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/40 • 6 Month
|
|
General disorders
Injection site erythema
|
1.2%
1/80 • Number of events 1 • 6 Month
|
0.00%
0/40 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/37 • 6 Month
|
0.00%
0/41 • 6 Month
|
0.00%
0/41 • 6 Month
|
0.00%
0/81 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/40 • 6 Month
|
0.00%
0/40 • 6 Month
|
0.00%
0/41 • 6 Month
|
5.1%
2/39 • Number of events 2 • 6 Month
|
0.00%
0/40 • 6 Month
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/80 • 6 Month
|
0.00%
0/40 • 6 Month
|
0.00%
0/39 • 6 Month
|
5.4%
2/37 • Number of events 2 • 6 Month
|
0.00%
0/41 • 6 Month
|
2.4%
1/41 • Number of events 1 • 6 Month
|
1.2%
1/81 • Number of events 1 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/40 • 6 Month
|
0.00%
0/40 • 6 Month
|
0.00%
0/41 • 6 Month
|
0.00%
0/39 • 6 Month
|
2.5%
1/40 • Number of events 1 • 6 Month
|
|
Infections and infestations
Gastroenteritis
|
2.5%
2/80 • Number of events 2 • 6 Month
|
0.00%
0/40 • 6 Month
|
0.00%
0/39 • 6 Month
|
5.4%
2/37 • Number of events 2 • 6 Month
|
0.00%
0/41 • 6 Month
|
0.00%
0/41 • 6 Month
|
1.2%
1/81 • Number of events 1 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/40 • 6 Month
|
0.00%
0/40 • 6 Month
|
0.00%
0/41 • 6 Month
|
0.00%
0/39 • 6 Month
|
2.5%
1/40 • Number of events 1 • 6 Month
|
|
Infections and infestations
Rhinitis
|
0.00%
0/80 • 6 Month
|
0.00%
0/40 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/37 • 6 Month
|
0.00%
0/41 • 6 Month
|
0.00%
0/41 • 6 Month
|
0.00%
0/81 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/40 • 6 Month
|
0.00%
0/40 • 6 Month
|
2.4%
1/41 • Number of events 1 • 6 Month
|
5.1%
2/39 • Number of events 2 • 6 Month
|
0.00%
0/40 • 6 Month
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/80 • 6 Month
|
2.5%
1/40 • Number of events 1 • 6 Month
|
2.6%
1/39 • Number of events 1 • 6 Month
|
2.7%
1/37 • Number of events 1 • 6 Month
|
2.4%
1/41 • Number of events 1 • 6 Month
|
0.00%
0/41 • 6 Month
|
2.5%
2/81 • Number of events 2 • 6 Month
|
5.1%
2/39 • Number of events 2 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/40 • 6 Month
|
0.00%
0/40 • 6 Month
|
0.00%
0/41 • 6 Month
|
2.6%
1/39 • Number of events 2 • 6 Month
|
0.00%
0/40 • 6 Month
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/80 • 6 Month
|
0.00%
0/40 • 6 Month
|
0.00%
0/39 • 6 Month
|
5.4%
2/37 • Number of events 2 • 6 Month
|
0.00%
0/41 • 6 Month
|
0.00%
0/41 • 6 Month
|
0.00%
0/81 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/40 • 6 Month
|
0.00%
0/40 • 6 Month
|
0.00%
0/41 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/40 • 6 Month
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/80 • 6 Month
|
0.00%
0/40 • 6 Month
|
7.7%
3/39 • Number of events 3 • 6 Month
|
2.7%
1/37 • Number of events 1 • 6 Month
|
0.00%
0/41 • 6 Month
|
2.4%
1/41 • Number of events 1 • 6 Month
|
0.00%
0/81 • 6 Month
|
0.00%
0/39 • 6 Month
|
2.6%
1/39 • Number of events 1 • 6 Month
|
0.00%
0/40 • 6 Month
|
0.00%
0/40 • 6 Month
|
2.4%
1/41 • Number of events 1 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/40 • 6 Month
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.5%
2/80 • Number of events 2 • 6 Month
|
2.5%
1/40 • Number of events 1 • 6 Month
|
5.1%
2/39 • Number of events 2 • 6 Month
|
2.7%
1/37 • Number of events 1 • 6 Month
|
0.00%
0/41 • 6 Month
|
4.9%
2/41 • Number of events 2 • 6 Month
|
3.7%
3/81 • Number of events 3 • 6 Month
|
0.00%
0/39 • 6 Month
|
5.1%
2/39 • Number of events 4 • 6 Month
|
0.00%
0/40 • 6 Month
|
0.00%
0/40 • 6 Month
|
4.9%
2/41 • Number of events 2 • 6 Month
|
0.00%
0/39 • 6 Month
|
2.5%
1/40 • Number of events 1 • 6 Month
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.2%
1/80 • Number of events 3 • 6 Month
|
2.5%
1/40 • Number of events 1 • 6 Month
|
2.6%
1/39 • Number of events 1 • 6 Month
|
5.4%
2/37 • Number of events 2 • 6 Month
|
2.4%
1/41 • Number of events 1 • 6 Month
|
2.4%
1/41 • Number of events 1 • 6 Month
|
2.5%
2/81 • Number of events 2 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/39 • 6 Month
|
2.5%
1/40 • Number of events 1 • 6 Month
|
0.00%
0/40 • 6 Month
|
0.00%
0/41 • 6 Month
|
0.00%
0/39 • 6 Month
|
2.5%
1/40 • Number of events 1 • 6 Month
|
|
Nervous system disorders
Headache
|
2.5%
2/80 • Number of events 2 • 6 Month
|
7.5%
3/40 • Number of events 3 • 6 Month
|
7.7%
3/39 • Number of events 3 • 6 Month
|
5.4%
2/37 • Number of events 2 • 6 Month
|
9.8%
4/41 • Number of events 4 • 6 Month
|
7.3%
3/41 • Number of events 3 • 6 Month
|
8.6%
7/81 • Number of events 7 • 6 Month
|
2.6%
1/39 • Number of events 1 • 6 Month
|
10.3%
4/39 • Number of events 4 • 6 Month
|
2.5%
1/40 • Number of events 1 • 6 Month
|
10.0%
4/40 • Number of events 4 • 6 Month
|
0.00%
0/41 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/40 • 6 Month
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/80 • 6 Month
|
0.00%
0/40 • 6 Month
|
5.1%
2/39 • Number of events 2 • 6 Month
|
0.00%
0/37 • 6 Month
|
2.4%
1/41 • Number of events 2 • 6 Month
|
0.00%
0/41 • 6 Month
|
3.7%
3/81 • Number of events 3 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/39 • 6 Month
|
0.00%
0/40 • 6 Month
|
0.00%
0/40 • 6 Month
|
9.8%
4/41 • Number of events 4 • 6 Month
|
2.6%
1/39 • Number of events 1 • 6 Month
|
0.00%
0/40 • 6 Month
|
Additional Information
Novavax Customer Service Center
Novavax Inc.
Phone: 1-844-Novavax (668-2829)
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Principal Investigators are NOT employed by the organization sponsoring the study. There IS an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
- Publication restrictions are in place
Restriction type: OTHER