Trial Outcomes & Findings for Flublok or Fluzone With Advax-CpG55.2 or AF03 (NCT NCT03945825)
NCT ID: NCT03945825
Last Updated: 2025-10-14
Results Overview
Local adverse events (AEs) solicited on a memory aid provided to participants included Pain, Tenderness, Itching/Pruritus, Ecchymosis/Bruising (functional grade based on interference with daily activities), Ecchymosis/Bruising (any measured value \>0mm), Erythema/Redness (functional grade), Erythema/ Redness (any measured value \>0mm), Induration/Swelling (functional grade), and Induration/Swelling (any measured value \>0mm). Systemic AEs solicited on a memory aid provided to participants included Elevated Oral Temperature, Feverishness, Fatigue, Malaise, Myalgia, Arthralgia, Headache, and Nausea. Participants are considered reporting the local or systemic AE if they reported mild or greater severity at any time during the 8 days at or following the first vaccination.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
241 participants
Primary outcome timeframe
Day 1 through Day 8
Results posted on
2025-10-14
Participant Flow
Participants were healthy males and non-pregnant females aged 18 to 45 years old recruited from existing volunteer populations and from the communities at large around the clinical sites. Participants were enrolled between 18JUN2019 and 27AUG2019.
Participant milestones
| Measure |
Fluzone
0.5 mL of 2018/2019 Fluzone QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
Influenza Virus Quadrivalent Inactivated Vaccine: unadjuvanted 2018/2019 Fluzone QIV and 2019/2020 Fluzone QIV vaccines will be given with 90 days interval
|
Fluzone + AF03
0.5 mL of 2018/2019 Fluzone QIV + 0.25 mL of AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
AF03: A squalene-in-PBS emulsion stabilized by nonionic surfactants, sorbitan oleate and macrogol cetostearyl ether
Influenza Virus Quadrivalent Inactivated Vaccine: 2018/2019 Fluzone QIV and 2019/2020 Fluzone QIV vaccines will be given with 90 days interval
|
Fluzone + CpG55
0.5 mL of 2018/2019 Fluzone QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 mL 2019/2020 of Fluzone QIV intramuscular injection on Day 90.
Delta Inulin-CpG55.2 (referred to as CpG55): A combination adjuvant supplied as two separate components, Delta Inulin (Sypharma Pty Ltd.) and CpG55.2 (Nikko Denka Avecia and Sypharma Pty Ltd)
Influenza Virus Quadrivalent Inactivated Vaccine: 2018/2019 Fluzone QIV and 2019/2020 Fluzone QIV vaccines will be given with 90 days interval
|
Flublok
0.5 mL of 2018/2019 Flublok QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
Quadrivalent Recombinant Seasonal Influenza Vaccine: unadjuvanted 2018/2019 Flublok QIV and 2019/2020 Flublok QIV vaccines will be given with 90 days interval
|
Flublok + AF03
0.5 mL of 2018/2019 Flublok QIV + 0.25 mL AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
AF03: A squalene-in-PBS emulsion stabilized by nonionic surfactants, sorbitan oleate and macrogol cetostearyl ether
Quadrivalent Recombinant Seasonal Influenza Vaccine: 2018/2019 Flublok QIV and 2019/2020 Flublok QIV vaccines will be given with 90 days interval
|
Flublok + CpG55
0.5 mL of 2018/2019 Flublok QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
Delta Inulin-CpG55.2 (referred to as CpG55): A combination adjuvant supplied as two separate components, Delta Inulin (Sypharma Pty Ltd.) and CpG55.2 (Nikko Denka Avecia and Sypharma Pty Ltd)
Quadrivalent Recombinant Seasonal Influenza Vaccine: 2018/2019 Flublok QIV and 2019/2020 Flublok QIV vaccines will be given with 90 days interval
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
41
|
37
|
40
|
41
|
39
|
43
|
|
Overall Study
COMPLETED
|
39
|
32
|
39
|
39
|
36
|
40
|
|
Overall Study
NOT COMPLETED
|
2
|
5
|
1
|
2
|
3
|
3
|
Reasons for withdrawal
| Measure |
Fluzone
0.5 mL of 2018/2019 Fluzone QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
Influenza Virus Quadrivalent Inactivated Vaccine: unadjuvanted 2018/2019 Fluzone QIV and 2019/2020 Fluzone QIV vaccines will be given with 90 days interval
|
Fluzone + AF03
0.5 mL of 2018/2019 Fluzone QIV + 0.25 mL of AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
AF03: A squalene-in-PBS emulsion stabilized by nonionic surfactants, sorbitan oleate and macrogol cetostearyl ether
Influenza Virus Quadrivalent Inactivated Vaccine: 2018/2019 Fluzone QIV and 2019/2020 Fluzone QIV vaccines will be given with 90 days interval
|
Fluzone + CpG55
0.5 mL of 2018/2019 Fluzone QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 mL 2019/2020 of Fluzone QIV intramuscular injection on Day 90.
Delta Inulin-CpG55.2 (referred to as CpG55): A combination adjuvant supplied as two separate components, Delta Inulin (Sypharma Pty Ltd.) and CpG55.2 (Nikko Denka Avecia and Sypharma Pty Ltd)
Influenza Virus Quadrivalent Inactivated Vaccine: 2018/2019 Fluzone QIV and 2019/2020 Fluzone QIV vaccines will be given with 90 days interval
|
Flublok
0.5 mL of 2018/2019 Flublok QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
Quadrivalent Recombinant Seasonal Influenza Vaccine: unadjuvanted 2018/2019 Flublok QIV and 2019/2020 Flublok QIV vaccines will be given with 90 days interval
|
Flublok + AF03
0.5 mL of 2018/2019 Flublok QIV + 0.25 mL AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
AF03: A squalene-in-PBS emulsion stabilized by nonionic surfactants, sorbitan oleate and macrogol cetostearyl ether
Quadrivalent Recombinant Seasonal Influenza Vaccine: 2018/2019 Flublok QIV and 2019/2020 Flublok QIV vaccines will be given with 90 days interval
|
Flublok + CpG55
0.5 mL of 2018/2019 Flublok QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
Delta Inulin-CpG55.2 (referred to as CpG55): A combination adjuvant supplied as two separate components, Delta Inulin (Sypharma Pty Ltd.) and CpG55.2 (Nikko Denka Avecia and Sypharma Pty Ltd)
Quadrivalent Recombinant Seasonal Influenza Vaccine: 2018/2019 Flublok QIV and 2019/2020 Flublok QIV vaccines will be given with 90 days interval
|
|---|---|---|---|---|---|---|
|
Overall Study
Enrolled but treatment not administered
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
5
|
0
|
1
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
1
|
0
|
1
|
Baseline Characteristics
Flublok or Fluzone With Advax-CpG55.2 or AF03
Baseline characteristics by cohort
| Measure |
Fluzone
n=41 Participants
0.5 mL of 2018/2019 Fluzone QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Fluzone + AF03
n=37 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.25 mL of AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Fluzone + CpG55
n=40 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 mL of 2019/2020 of Fluzone QIV intramuscular injection on Day 90.
|
Flublok
n=41 Participants
0.5 mL of 2018/2019 Flublok QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
|
Flublok + AF03
n=39 Participants
0.5 mL of 2018/2019 Flublok QIV + 0.25 mL AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
|
Flublok + CpG55
n=43 Participants
0.5 mL of 2018/2019 Flublok QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
|
Total
n=241 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
41 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
39 Participants
n=21 Participants
|
43 Participants
n=8 Participants
|
241 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
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
|
|
Age, Continuous
|
30.7 years
STANDARD_DEVIATION 7.2 • n=5 Participants
|
29.6 years
STANDARD_DEVIATION 6.2 • n=7 Participants
|
28.2 years
STANDARD_DEVIATION 7.0 • n=5 Participants
|
30.2 years
STANDARD_DEVIATION 7.6 • n=4 Participants
|
29.7 years
STANDARD_DEVIATION 6.8 • n=21 Participants
|
28.7 years
STANDARD_DEVIATION 6.5 • n=8 Participants
|
29.5 years
STANDARD_DEVIATION 6.9 • n=8 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
26 Participants
n=8 Participants
|
152 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
17 Participants
n=8 Participants
|
89 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
23 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
40 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
40 Participants
n=8 Participants
|
217 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 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
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
22 Participants
n=8 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
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
30 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
34 Participants
n=8 Participants
|
177 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
9 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
41 participants
n=5 Participants
|
37 participants
n=7 Participants
|
40 participants
n=5 Participants
|
41 participants
n=4 Participants
|
39 participants
n=21 Participants
|
43 participants
n=8 Participants
|
241 participants
n=8 Participants
|
|
BMI
|
26.73 kg/m^2
STANDARD_DEVIATION 5.37 • n=5 Participants
|
26.87 kg/m^2
STANDARD_DEVIATION 6.29 • n=7 Participants
|
24.82 kg/m^2
STANDARD_DEVIATION 4.64 • n=5 Participants
|
26.91 kg/m^2
STANDARD_DEVIATION 6.55 • n=4 Participants
|
26.25 kg/m^2
STANDARD_DEVIATION 6.81 • n=21 Participants
|
25.79 kg/m^2
STANDARD_DEVIATION 5.67 • n=8 Participants
|
26.22 kg/m^2
STANDARD_DEVIATION 5.91 • n=8 Participants
|
|
Prior Seasonal Influenza Vaccination
Either 2017-2018 or 2018-2019
|
36 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
36 Participants
n=8 Participants
|
195 Participants
n=8 Participants
|
|
Prior Seasonal Influenza Vaccination
Neither 2017-2018 or 2018-2019
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
44 Participants
n=8 Participants
|
|
Prior Seasonal Influenza Vaccination
Unknown
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 8Population: The Safety Analysis population includes all participants who received the first study vaccination. Analyses for the safety population are based on vaccine actually received. One participant randomized to Flublok + AF03 group received Flublok due to a pharmacy error and is analyzed in the Flublok group.
Local adverse events (AEs) solicited on a memory aid provided to participants included Pain, Tenderness, Itching/Pruritus, Ecchymosis/Bruising (functional grade based on interference with daily activities), Ecchymosis/Bruising (any measured value \>0mm), Erythema/Redness (functional grade), Erythema/ Redness (any measured value \>0mm), Induration/Swelling (functional grade), and Induration/Swelling (any measured value \>0mm). Systemic AEs solicited on a memory aid provided to participants included Elevated Oral Temperature, Feverishness, Fatigue, Malaise, Myalgia, Arthralgia, Headache, and Nausea. Participants are considered reporting the local or systemic AE if they reported mild or greater severity at any time during the 8 days at or following the first vaccination.
Outcome measures
| Measure |
Fluzone + CpG55
n=40 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 2019/2020 of Fluzone QIV intramuscular injection on Day 90.
|
Fluzone
n=41 Participants
0.5 mL of 2018/2019 Fluzone QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Fluzone + AF03
n=37 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.25 mL of AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Flublok
n=42 Participants
0.5 mL of 2018/2019 Flublok QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + AF03
n=37 Participants
0.5 mL of 2018/2019 Flublok QIV + 0.25 mL AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + CpG55
n=43 Participants
0.5 mL of 2018/2019 Flublok QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
|
|---|---|---|---|---|---|---|
|
Number of Participants Reporting Local and Systemic Solicited Reactogenicity Events Post First Vaccination
Any Systemic Symptom
|
23 Participants
|
24 Participants
|
25 Participants
|
23 Participants
|
18 Participants
|
26 Participants
|
|
Number of Participants Reporting Local and Systemic Solicited Reactogenicity Events Post First Vaccination
Any Local Symptom
|
40 Participants
|
35 Participants
|
36 Participants
|
32 Participants
|
33 Participants
|
43 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 29Population: The Safety Analysis population includes all participants who received the first study vaccination. Analyses for the safety population are based on vaccine actually received. One participant randomized to Flublok + AF03 group received Flublok due to a pharmacy error and is analyzed in the Flublok group.
Adverse events were defined as any untoward medical occurrence in a participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Non-serious AEs were collected from participants at follow up visits through 28 days after the first study vaccination while serious adverse events (SAEs) were collected at follow up visits through approximately 12 months after the first study vaccination. Adverse events were MedDRA coded and are summarized by MedDRA System Organ Class (SOC).
Outcome measures
| Measure |
Fluzone + CpG55
n=40 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 2019/2020 of Fluzone QIV intramuscular injection on Day 90.
|
Fluzone
n=41 Participants
0.5 mL of 2018/2019 Fluzone QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Fluzone + AF03
n=37 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.25 mL of AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Flublok
n=42 Participants
0.5 mL of 2018/2019 Flublok QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + AF03
n=37 Participants
0.5 mL of 2018/2019 Flublok QIV + 0.25 mL AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + CpG55
n=43 Participants
0.5 mL of 2018/2019 Flublok QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
|
|---|---|---|---|---|---|---|
|
Number of Participants Reporting Serious and Non-serious Adverse Events (AE) Through Day 29
AEs
|
8 Participants
|
12 Participants
|
11 Participants
|
14 Participants
|
10 Participants
|
15 Participants
|
|
Number of Participants Reporting Serious and Non-serious Adverse Events (AE) Through Day 29
SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 365Population: The Safety Analysis population includes all participants who received the first study vaccination. Analyses for the safety population are based on vaccine actually received. One participant randomized to Flublok + AF03 group received Flublok due to a pharmacy error and is analyzed in the Flublok group.
SAEs included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required inpatient hospitalization or prolongation or a congenital anomaly/birth defect. All SAEs were reported from time of first study vaccination through approximately 12 months after the first study vaccination.
Outcome measures
| Measure |
Fluzone + CpG55
n=40 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 2019/2020 of Fluzone QIV intramuscular injection on Day 90.
|
Fluzone
n=41 Participants
0.5 mL of 2018/2019 Fluzone QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Fluzone + AF03
n=37 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.25 mL of AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Flublok
n=42 Participants
0.5 mL of 2018/2019 Flublok QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + AF03
n=37 Participants
0.5 mL of 2018/2019 Flublok QIV + 0.25 mL AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + CpG55
n=43 Participants
0.5 mL of 2018/2019 Flublok QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
|
|---|---|---|---|---|---|---|
|
Number of Participants Reporting Serious Adverse Events (SAEs)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 8Population: The Safety Analysis population includes all participants who received the first study vaccination. Analyses for the safety population are based on vaccine actually received. One participant randomized to Flublok + AF03 group received Flublok due to a pharmacy error and is analyzed in the Flublok group.
Laboratory parameters include white blood cells (WBC), hemoglobin, platelets, alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin, Gamma-Glutamyl Transferase (GGT), alkaline phosphatase (ALP), amylase, lipase, and creatinine. Thresholds for adverse events were considered WBC of 3.90 x10\^3/uL or lower or 10.60 x10\^3/uL or higher; hemoglobin 11.4 g/dL or lower (female) or 12.4 g/dL or lower (male); platelets 139 x10\^3/uL or below or 416 x10\^3/uL or greater when using EDTA tubes or platelets 124 x10\^3/uL or below or 550 x10\^3/uL or greater when using Citrate tubes; ALT 44 IU/L or greater (female) or 61 IU/L or greater (male); AST 37 IU/L or greater (female) or 44 IU/L or greater (male); bilirubin 1.30 mg/dL or greater; GGT 33 IU/L or greater (female) or 50 IU/L or greater (male); ALP 116 IU/L or greater; amylase 122 IU/L or greater; lipase 61 IU/L or greater; creatinine 1.1 mg/dL or greater (female) or 1.4 mg/dL or greater (male).
Outcome measures
| Measure |
Fluzone + CpG55
n=40 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 2019/2020 of Fluzone QIV intramuscular injection on Day 90.
|
Fluzone
n=41 Participants
0.5 mL of 2018/2019 Fluzone QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Fluzone + AF03
n=37 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.25 mL of AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Flublok
n=42 Participants
0.5 mL of 2018/2019 Flublok QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + AF03
n=37 Participants
0.5 mL of 2018/2019 Flublok QIV + 0.25 mL AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + CpG55
n=43 Participants
0.5 mL of 2018/2019 Flublok QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
|
|---|---|---|---|---|---|---|
|
Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination
WBCs
|
3 Participants
|
6 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination
Hemoglobin
|
2 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination
Platelets
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination
ALT
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination
AST
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination
Bilirubin
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination
GGT
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination
ALP
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination
Amylase
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination
Lipase
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Clinical Safety Laboratory Adverse Events (AEs) Post First Vaccination
Creatinine
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Day 1, Day 29Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood sample for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid HAI results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
Blood was collected for HAI assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at Day 1 and Day 29 post first study vaccination.
Outcome measures
| Measure |
Fluzone + CpG55
n=40 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 2019/2020 of Fluzone QIV intramuscular injection on Day 90.
|
Fluzone
n=41 Participants
0.5 mL of 2018/2019 Fluzone QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Fluzone + AF03
n=37 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.25 mL of AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Flublok
n=41 Participants
0.5 mL of 2018/2019 Flublok QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + AF03
n=38 Participants
0.5 mL of 2018/2019 Flublok QIV + 0.25 mL AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + CpG55
n=42 Participants
0.5 mL of 2018/2019 Flublok QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 1
|
96.8 titer
Interval 60.4 to 155.0
|
114.1 titer
Interval 72.7 to 179.1
|
193.0 titer
Interval 129.8 to 286.8
|
164.1 titer
Interval 106.4 to 253.0
|
129.7 titer
Interval 81.1 to 207.5
|
108.6 titer
Interval 74.2 to 158.9
|
|
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 1
|
120.2 titer
Interval 75.7 to 190.8
|
140.9 titer
Interval 88.5 to 224.6
|
149.8 titer
Interval 101.2 to 221.9
|
248.3 titer
Interval 156.0 to 395.2
|
107.1 titer
Interval 70.4 to 162.9
|
131.3 titer
Interval 90.6 to 190.2
|
|
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Michigan/45/2015 X-275 (H1N1) - Day 1
|
174.5 titer
Interval 108.2 to 281.2
|
242.1 titer
Interval 164.8 to 355.7
|
196.6 titer
Interval 139.2 to 277.6
|
296.6 titer
Interval 194.9 to 451.3
|
186.8 titer
Interval 117.1 to 298.2
|
237.8 titer
Interval 156.9 to 360.3
|
|
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Phuket/3073/2013 (B Yamagata lineage) - Day 1
|
489.3 titer
Interval 355.3 to 673.7
|
366.3 titer
Interval 262.9 to 510.4
|
478.7 titer
Interval 311.3 to 736.1
|
618.7 titer
Interval 397.9 to 962.2
|
331.9 titer
Interval 208.7 to 527.8
|
390.1 titer
Interval 296.2 to 513.7
|
|
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 29
|
340.5 titer
Interval 257.1 to 451.0
|
270.2 titer
Interval 195.9 to 372.8
|
538.2 titer
Interval 414.7 to 698.5
|
634.5 titer
Interval 478.4 to 841.4
|
516.0 titer
Interval 357.5 to 744.6
|
492.5 titer
Interval 359.4 to 674.8
|
|
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 29
|
349.7 titer
Interval 253.3 to 482.9
|
423.0 titer
Interval 323.1 to 553.7
|
456.9 titer
Interval 338.5 to 616.7
|
515.4 titer
Interval 355.0 to 748.3
|
416.0 titer
Interval 281.3 to 615.2
|
388.7 titer
Interval 278.7 to 542.1
|
|
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Michigan/45/2015 X-275 (H1N1) - Day 29
|
365.6 titer
Interval 259.8 to 514.5
|
488.3 titer
Interval 363.2 to 656.6
|
474.9 titer
Interval 354.3 to 636.4
|
680.0 titer
Interval 479.4 to 964.5
|
722.9 titer
Interval 516.0 to 1012.7
|
522.5 titer
Interval 371.6 to 734.6
|
|
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Phuket/3073/2013 (B Yamagata lineage) - Day 29
|
1081.1 titer
Interval 828.3 to 1411.2
|
952.2 titer
Interval 721.6 to 1256.5
|
1356.1 titer
Interval 1006.0 to 1828.1
|
1645.6 titer
Interval 1252.9 to 2161.4
|
1280.0 titer
Interval 969.6 to 1689.8
|
1280.0 titer
Interval 995.0 to 1646.6
|
PRIMARY outcome
Timeframe: Day 1, Day 29Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood sample for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid HAI results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
Blood was collected for HAI assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at Day 1 and Day 29 post first study vaccination and the ratio of these GMTs between adjuvanted and unadjuvanted study arms were calculated. Unadjuvanted Fluzone and Flublok study arms are considered as reference groups for the analysis of ratio of GMTs. Ratio of GMTs is defined as the ratio of the GMT from the adjuvanted group divided by the GMT from the corresponding unadjuvanted group.
Outcome measures
| Measure |
Fluzone + CpG55
n=38 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 2019/2020 of Fluzone QIV intramuscular injection on Day 90.
|
Fluzone
n=37 Participants
0.5 mL of 2018/2019 Fluzone QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Fluzone + AF03
n=40 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.25 mL of AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Flublok
n=42 Participants
0.5 mL of 2018/2019 Flublok QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + AF03
0.5 mL of 2018/2019 Flublok QIV + 0.25 mL AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + CpG55
0.5 mL of 2018/2019 Flublok QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
|
|---|---|---|---|---|---|---|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 1
|
0.8 ratio of GMT
Interval 0.4 to 1.5
|
1.7 ratio of GMT
Interval 0.9 to 3.1
|
0.8 ratio of GMT
Interval 0.4 to 1.6
|
0.7 ratio of GMT
Interval 0.4 to 1.2
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 1
|
0.4 ratio of GMT
Interval 0.2 to 0.8
|
1.1 ratio of GMT
Interval 0.6 to 1.9
|
0.9 ratio of GMT
Interval 0.4 to 1.6
|
0.5 ratio of GMT
Interval 0.3 to 0.9
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Michigan/45/2015 X-275 (H1N1) - Day 1
|
0.6 ratio of GMT
Interval 0.3 to 1.2
|
0.8 ratio of GMT
Interval 0.5 to 1.4
|
0.7 ratio of GMT
Interval 0.4 to 1.3
|
0.8 ratio of GMT
Interval 0.4 to 1.4
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms
B/Phuket/3073/2013 (B Yamagata lineage) - Day 1
|
0.5 ratio of GMT
Interval 0.3 to 1.0
|
1.3 ratio of GMT
Interval 0.8 to 2.2
|
1.3 ratio of GMT
Interval 0.8 to 2.1
|
0.6 ratio of GMT
Interval 0.4 to 1.1
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 29
|
0.8 ratio of GMT
Interval 0.5 to 1.3
|
2.0 ratio of GMT
Interval 1.3 to 3.0
|
1.3 ratio of GMT
Interval 0.8 to 1.9
|
0.8 ratio of GMT
Interval 0.5 to 1.2
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 29
|
0.8 ratio of GMT
Interval 0.5 to 1.4
|
1.1 ratio of GMT
Interval 0.7 to 1.6
|
0.8 ratio of GMT
Interval 0.5 to 1.3
|
0.8 ratio of GMT
Interval 0.5 to 1.2
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Michigan/45/2015 X-275 (H1N1) - Day 29
|
1.1 ratio of GMT
Interval 0.7 to 1.7
|
1.0 ratio of GMT
Interval 0.6 to 1.5
|
0.7 ratio of GMT
Interval 0.5 to 1.2
|
0.8 ratio of GMT
Interval 0.5 to 1.2
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms
B/Phuket/3073/2013 (B Yamagata lineage) - Day 29
|
0.8 ratio of GMT
Interval 0.5 to 1.1
|
1.4 ratio of GMT
Interval 1.0 to 2.1
|
1.1 ratio of GMT
Interval 0.8 to 1.7
|
0.8 ratio of GMT
Interval 0.5 to 1.1
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 29Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood sample for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid HAI results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
Blood was collected for HAI assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. HAI seroconversion was defined as either a pre-vaccination titer \< 1:10 and a post-vaccination titer \>= 1:40 or a pre-vaccination titer \>= 1:10 and a minimum four-fold rise in post-vaccination antibody titer.
Outcome measures
| Measure |
Fluzone + CpG55
n=39 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 2019/2020 of Fluzone QIV intramuscular injection on Day 90.
|
Fluzone
n=41 Participants
0.5 mL of 2018/2019 Fluzone QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Fluzone + AF03
n=36 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.25 mL of AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Flublok
n=40 Participants
0.5 mL of 2018/2019 Flublok QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + AF03
n=37 Participants
0.5 mL of 2018/2019 Flublok QIV + 0.25 mL AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + CpG55
n=41 Participants
0.5 mL of 2018/2019 Flublok QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2)
|
36 percentage of participants
Interval 21.0 to 53.0
|
27 percentage of participants
Interval 14.0 to 43.0
|
33 percentage of participants
Interval 19.0 to 51.0
|
45 percentage of participants
Interval 29.0 to 62.0
|
46 percentage of participants
Interval 29.0 to 63.0
|
56 percentage of participants
Interval 40.0 to 72.0
|
|
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Maryland/15/2016 BX-69A (B Victoria lineage)
|
31 percentage of participants
Interval 17.0 to 48.0
|
29 percentage of participants
Interval 16.0 to 46.0
|
36 percentage of participants
Interval 21.0 to 54.0
|
23 percentage of participants
Interval 11.0 to 38.0
|
41 percentage of participants
Interval 25.0 to 58.0
|
32 percentage of participants
Interval 18.0 to 48.0
|
|
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Michigan/45/2015 X-275 (H1N1)
|
18 percentage of participants
Interval 8.0 to 34.0
|
24 percentage of participants
Interval 12.0 to 40.0
|
19 percentage of participants
Interval 8.0 to 36.0
|
23 percentage of participants
Interval 11.0 to 38.0
|
46 percentage of participants
Interval 29.0 to 63.0
|
32 percentage of participants
Interval 18.0 to 48.0
|
|
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Phuket/3073/2013 (B Yamagata lineage)
|
23 percentage of participants
Interval 11.0 to 39.0
|
24 percentage of participants
Interval 12.0 to 40.0
|
25 percentage of participants
Interval 12.0 to 42.0
|
28 percentage of participants
Interval 15.0 to 44.0
|
30 percentage of participants
Interval 16.0 to 47.0
|
34 percentage of participants
Interval 20.0 to 51.0
|
PRIMARY outcome
Timeframe: Day 1, Day 29Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood sample for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid HAI results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
Blood was collected for HAI assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result.
Outcome measures
| Measure |
Fluzone + CpG55
n=40 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 2019/2020 of Fluzone QIV intramuscular injection on Day 90.
|
Fluzone
n=41 Participants
0.5 mL of 2018/2019 Fluzone QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Fluzone + AF03
n=37 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.25 mL of AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Flublok
n=41 Participants
0.5 mL of 2018/2019 Flublok QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + AF03
n=38 Participants
0.5 mL of 2018/2019 Flublok QIV + 0.25 mL AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + CpG55
n=42 Participants
0.5 mL of 2018/2019 Flublok QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Phuket/3073/2013 (B Yamagata lineage) - Day 29
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 90.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
|
Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 1
|
75 percentage of participants
Interval 59.0 to 87.0
|
85 percentage of participants
Interval 71.0 to 94.0
|
95 percentage of participants
Interval 82.0 to
Value is NA because it's \>99 but \<100
|
93 percentage of participants
Interval 80.0 to 98.0
|
76 percentage of participants
Interval 60.0 to 89.0
|
88 percentage of participants
Interval 74.0 to 96.0
|
|
Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 1
|
80 percentage of participants
Interval 64.0 to 91.0
|
80 percentage of participants
Interval 65.0 to 91.0
|
89 percentage of participants
Interval 75.0 to 97.0
|
90 percentage of participants
Interval 77.0 to 97.0
|
79 percentage of participants
Interval 63.0 to 90.0
|
90 percentage of participants
Interval 77.0 to 97.0
|
|
Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Michigan/45/2015 X-275 (H1N1) - Day 1
|
88 percentage of participants
Interval 73.0 to 96.0
|
93 percentage of participants
Interval 80.0 to 98.0
|
95 percentage of participants
Interval 82.0 to
Value is NA because it's \>99 but \<100
|
93 percentage of participants
Interval 80.0 to 98.0
|
89 percentage of participants
Interval 75.0 to 97.0
|
95 percentage of participants
Interval 84.0 to
Value is NA because it's \>99 but \<100
|
|
Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Phuket/3073/2013 (B Yamagata lineage) - Day 1
|
100 percentage of participants
Interval 91.0 to 100.0
|
98 percentage of participants
Interval 87.0 to
Value is NA because it's \>99 but \<100
|
95 percentage of participants
Interval 82.0 to
Value is NA because it's \>99 but \<100
|
95 percentage of participants
Interval 83.0 to
Value is NA because it's \>99 but \<100
|
92 percentage of participants
Interval 79.0 to 98.0
|
100 percentage of participants
Interval 92.0 to 100.0
|
|
Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 29
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 90.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
|
Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 29
|
97 percentage of participants
Interval 87.0 to
Value is NA because it's \>99 but \<100
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 90.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
97 percentage of participants
Interval 86.0 to
Value is NA because it's \>99 but \<100
|
100 percentage of participants
Interval 91.0 to 100.0
|
|
Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Michigan/45/2015 X-275 (H1N1) - Day 29
|
97 percentage of participants
Interval 87.0 to
Value is NA because it's \>99 but \<100
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 90.0 to 100.0
|
98 percentage of participants
Interval 87.0 to
Value is NA because it's \>99 but \<100
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
PRIMARY outcome
Timeframe: Day 29Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood sample for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid HAI results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
Blood was collected for HAI assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. Fold-rises from baseline were calculated as the Day 29 titer divided by the baseline titers for each participant. The geometric mean of these fold rises was then calculated to obtain the GMFR.
Outcome measures
| Measure |
Fluzone + CpG55
n=39 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 2019/2020 of Fluzone QIV intramuscular injection on Day 90.
|
Fluzone
n=41 Participants
0.5 mL of 2018/2019 Fluzone QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Fluzone + AF03
n=36 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.25 mL of AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Flublok
n=40 Participants
0.5 mL of 2018/2019 Flublok QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + AF03
n=37 Participants
0.5 mL of 2018/2019 Flublok QIV + 0.25 mL AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + CpG55
n=41 Participants
0.5 mL of 2018/2019 Flublok QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2)
|
3.6 fold rise
Interval 2.4 to 5.5
|
2.4 fold rise
Interval 1.6 to 3.6
|
2.6 fold rise
Interval 1.8 to 3.7
|
3.8 fold rise
Interval 2.5 to 5.7
|
3.8 fold rise
Interval 2.7 to 5.3
|
4.3 fold rise
Interval 2.9 to 6.3
|
|
Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Maryland/15/2016 BX-69A (B Victoria lineage)
|
2.9 fold rise
Interval 2.0 to 4.4
|
3.0 fold rise
Interval 2.0 to 4.5
|
3.2 fold rise
Interval 2.1 to 4.8
|
2.1 fold rise
Interval 1.5 to 2.7
|
3.7 fold rise
Interval 2.5 to 5.4
|
2.9 fold rise
Interval 2.1 to 4.0
|
|
Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Michigan/45/2015 X-275 (H1N1)
|
2.2 fold rise
Interval 1.5 to 3.2
|
2.0 fold rise
Interval 1.4 to 3.0
|
2.3 fold rise
Interval 1.5 to 3.5
|
2.1 fold rise
Interval 1.7 to 2.8
|
3.7 fold rise
Interval 2.4 to 5.8
|
2.1 fold rise
Interval 1.5 to 3.0
|
|
Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Phuket/3073/2013 (B Yamagata lineage)
|
2.3 fold rise
Interval 1.7 to 3.0
|
2.6 fold rise
Interval 1.9 to 3.6
|
2.7 fold rise
Interval 1.8 to 4.0
|
2.6 fold rise
Interval 1.9 to 3.7
|
4.0 fold rise
Interval 2.6 to 6.0
|
3.2 fold rise
Interval 2.4 to 4.2
|
PRIMARY outcome
Timeframe: Day 1, Day 29Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood sample for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid NAI results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
Blood was collected for NAI assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at Day 1 and Day 29 post first study vaccination.
Outcome measures
| Measure |
Fluzone + CpG55
n=40 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 2019/2020 of Fluzone QIV intramuscular injection on Day 90.
|
Fluzone
n=41 Participants
0.5 mL of 2018/2019 Fluzone QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Fluzone + AF03
n=37 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.25 mL of AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Flublok
n=41 Participants
0.5 mL of 2018/2019 Flublok QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + AF03
n=38 Participants
0.5 mL of 2018/2019 Flublok QIV + 0.25 mL AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + CpG55
n=42 Participants
0.5 mL of 2018/2019 Flublok QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 1
|
91.9 titer
Interval 60.3 to 140.1
|
123.1 titer
Interval 85.1 to 178.1
|
116.4 titer
Interval 82.3 to 164.5
|
140.9 titer
Interval 91.1 to 218.0
|
129.7 titer
Interval 92.5 to 181.8
|
105.9 titer
Interval 73.8 to 152.0
|
|
Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Colorado/06/2017 (B Victoria lineage) - Day 1
|
213.0 titer
Interval 160.3 to 282.9
|
178.6 titer
Interval 142.4 to 223.9
|
211.9 titer
Interval 156.5 to 286.9
|
256.9 titer
Interval 183.1 to 360.4
|
226.3 titer
Interval 170.3 to 300.6
|
166.7 titer
Interval 131.3 to 211.7
|
|
Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Michigan/45/2015 X-275 (H1N1) - Day 1
|
96.8 titer
Interval 63.7 to 147.0
|
118.0 titer
Interval 81.6 to 170.6
|
108.0 titer
Interval 75.4 to 154.7
|
143.3 titer
Interval 92.8 to 221.5
|
127.4 titer
Interval 89.8 to 180.7
|
100.8 titer
Interval 69.2 to 146.7
|
|
Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Phuket/3073/2013 (B Yamagata lineage) - Day 1
|
91.1 titer
Interval 72.5 to 114.5
|
63.1 titer
Interval 49.9 to 79.9
|
89.5 titer
Interval 69.6 to 115.1
|
88.5 titer
Interval 65.8 to 119.1
|
81.5 titer
Interval 62.8 to 105.7
|
66.7 titer
Interval 54.0 to 82.5
|
|
Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 29
|
224.3 titer
Interval 164.5 to 305.7
|
259.0 titer
Interval 197.1 to 340.5
|
293.4 titer
Interval 213.9 to 402.6
|
157.3 titer
Interval 105.7 to 234.0
|
129.0 titer
Interval 94.0 to 177.1
|
107.5 titer
Interval 74.7 to 154.8
|
|
Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Colorado/06/2017 (B Victoria lineage) - Day 29
|
464.8 titer
Interval 367.3 to 588.1
|
402.0 titer
Interval 333.4 to 484.8
|
538.2 titer
Interval 409.8 to 706.8
|
346.0 titer
Interval 258.6 to 462.8
|
243.9 titer
Interval 186.7 to 318.5
|
211.5 titer
Interval 167.6 to 266.8
|
|
Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Michigan/45/2015 X-275 (H1N1) - Day 29
|
216.4 titer
Interval 160.6 to 291.7
|
250.4 titer
Interval 191.5 to 327.5
|
264.0 titer
Interval 195.8 to 355.8
|
161.4 titer
Interval 111.1 to 234.5
|
129.0 titer
Interval 95.7 to 173.9
|
105.7 titer
Interval 73.0 to 153.3
|
|
Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Phuket/3073/2013 (B Yamagata lineage) - Day 29
|
143.8 titer
Interval 117.2 to 176.5
|
116.0 titer
Interval 98.2 to 137.1
|
188.5 titer
Interval 147.0 to 241.6
|
112.2 titer
Interval 87.8 to 143.3
|
92.1 titer
Interval 72.7 to 116.6
|
82.1 titer
Interval 66.9 to 100.6
|
PRIMARY outcome
Timeframe: Day 1, Day 29Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood sample for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid NAI results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
Blood was collected for NAI assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at Day 1 and Day 29 post first study vaccination and the ratio of these GMTs between adjuvanted and unadjuvanted study arms were calculated. Unadjuvanted Fluzone and Flublok study arms are considered as reference groups for the analysis of ratio of GMTs. Ratio of GMTs is defined as the ratio of the GMT from the adjuvanted group divided by the GMT from the corresponding unadjuvanted group.
Outcome measures
| Measure |
Fluzone + CpG55
n=38 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 2019/2020 of Fluzone QIV intramuscular injection on Day 90.
|
Fluzone
n=37 Participants
0.5 mL of 2018/2019 Fluzone QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Fluzone + AF03
n=40 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.25 mL of AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Flublok
n=42 Participants
0.5 mL of 2018/2019 Flublok QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + AF03
0.5 mL of 2018/2019 Flublok QIV + 0.25 mL AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + CpG55
0.5 mL of 2018/2019 Flublok QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
|
|---|---|---|---|---|---|---|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 1
|
0.9 ratio of GMT
Interval 0.5 to 1.6
|
0.9 ratio of GMT
Interval 0.6 to 1.6
|
0.7 ratio of GMT
Interval 0.4 to 1.3
|
0.8 ratio of GMT
Interval 0.4 to 1.3
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms
B/Colorado/06/2017 (B Victoria lineage) - Day 1
|
0.9 ratio of GMT
Interval 0.6 to 1.4
|
1.2 ratio of GMT
Interval 0.8 to 1.7
|
1.2 ratio of GMT
Interval 0.8 to 1.7
|
0.6 ratio of GMT
Interval 0.4 to 1.0
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Michigan/45/2015 X-275 (H1N1) - Day 1
|
0.9 ratio of GMT
Interval 0.5 to 1.5
|
0.9 ratio of GMT
Interval 0.6 to 1.5
|
0.8 ratio of GMT
Interval 0.5 to 1.4
|
0.7 ratio of GMT
Interval 0.4 to 1.2
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms
B/Phuket/3073/2013 (B Yamagata lineage) - Day 1
|
0.9 ratio of GMT
Interval 0.6 to 1.4
|
1.4 ratio of GMT
Interval 1.0 to 2.0
|
1.4 ratio of GMT
Interval 1.0 to 2.0
|
0.8 ratio of GMT
Interval 0.5 to 1.1
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 29
|
0.8 ratio of GMT
Interval 0.5 to 1.4
|
1.1 ratio of GMT
Interval 0.8 to 1.7
|
0.9 ratio of GMT
Interval 0.6 to 1.3
|
0.7 ratio of GMT
Interval 0.4 to 1.2
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms
B/Colorado/06/2017 (B Victoria lineage) - Day 29
|
0.7 ratio of GMT
Interval 0.5 to 1.0
|
1.3 ratio of GMT
Interval 1.0 to 1.9
|
1.2 ratio of GMT
Interval 0.9 to 1.6
|
0.6 ratio of GMT
Interval 0.4 to 0.9
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Michigan/45/2015 X-275 (H1N1) - Day 29
|
0.8 ratio of GMT
Interval 0.5 to 1.3
|
1.1 ratio of GMT
Interval 0.7 to 1.6
|
0.9 ratio of GMT
Interval 0.6 to 1.3
|
0.7 ratio of GMT
Interval 0.4 to 1.1
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms
B/Phuket/3073/2013 (B Yamagata lineage) - Day 29
|
0.8 ratio of GMT
Interval 0.6 to 1.1
|
1.6 ratio of GMT
Interval 1.2 to 2.2
|
1.2 ratio of GMT
Interval 1.0 to 1.6
|
0.7 ratio of GMT
Interval 0.5 to 1.0
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 29Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood sample for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid NAI results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
Blood was collected for NAI assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. NAI seroconversion was defined as \>4 four-fold rise in post-vaccination antibody titer at Day 29.
Outcome measures
| Measure |
Fluzone + CpG55
n=39 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 2019/2020 of Fluzone QIV intramuscular injection on Day 90.
|
Fluzone
n=41 Participants
0.5 mL of 2018/2019 Fluzone QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Fluzone + AF03
n=36 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.25 mL of AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Flublok
n=40 Participants
0.5 mL of 2018/2019 Flublok QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + AF03
n=37 Participants
0.5 mL of 2018/2019 Flublok QIV + 0.25 mL AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + CpG55
n=41 Participants
0.5 mL of 2018/2019 Flublok QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2)
|
36 percentage of participants
Interval 21.0 to 53.0
|
27 percentage of participants
Interval 14.0 to 43.0
|
36 percentage of participants
Interval 21.0 to 54.0
|
3 percentage of participants
Interval to 13.0
Value is NA because it's \>0 but \<1
|
0 percentage of participants
Interval 0.0 to 9.0
|
2 percentage of participants
Interval to 13.0
Value is NA because it's \>0 but \<1
|
|
Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Colorado/06/2017 (B Victoria lineage)
|
18 percentage of participants
Interval 8.0 to 34.0
|
27 percentage of participants
Interval 14.0 to 43.0
|
25 percentage of participants
Interval 12.0 to 42.0
|
0 percentage of participants
Interval 0.0 to 9.0
|
0 percentage of participants
Interval 0.0 to 9.0
|
5 percentage of participants
Interval to 17.0
Value is NA because it's \>0 but \<1
|
|
Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Michigan/45/2015 X-275 (H1N1)
|
36 percentage of participants
Interval 21.0 to 53.0
|
27 percentage of participants
Interval 14.0 to 43.0
|
31 percentage of participants
Interval 16.0 to 48.0
|
3 percentage of participants
Interval to 13.0
Value is NA because it's \>0 but \<1
|
0 percentage of participants
Interval 0.0 to 9.0
|
2 percentage of participants
Interval to 13.0
Value is NA because it's \>0 but \<1
|
|
Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Phuket/3073/2013 (B Yamagata lineage)
|
10 percentage of participants
Interval 3.0 to 24.0
|
20 percentage of participants
Interval 9.0 to 35.0
|
22 percentage of participants
Interval 10.0 to 39.0
|
3 percentage of participants
Interval to 13.0
Value is NA because it's \>0 but \<1
|
0 percentage of participants
Interval 0.0 to 9.0
|
2 percentage of participants
Interval to 13.0
Value is NA because it's \>0 but \<1
|
PRIMARY outcome
Timeframe: Day 29Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood sample for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid NAI results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
Blood was collected for NAI assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. Fold-rises from baseline were calculated as the Day 29 titer divided by the baseline titers for each participant. The geometric mean of these fold rises was then calculated to obtain the GMFR.
Outcome measures
| Measure |
Fluzone + CpG55
n=39 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 2019/2020 of Fluzone QIV intramuscular injection on Day 90.
|
Fluzone
n=41 Participants
0.5 mL of 2018/2019 Fluzone QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Fluzone + AF03
n=36 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.25 mL of AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Flublok
n=40 Participants
0.5 mL of 2018/2019 Flublok QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + AF03
n=37 Participants
0.5 mL of 2018/2019 Flublok QIV + 0.25 mL AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + CpG55
n=41 Participants
0.5 mL of 2018/2019 Flublok QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2)
|
2.6 fold rise
Interval 2.0 to 3.2
|
2.1 fold rise
Interval 1.6 to 2.7
|
2.5 fold rise
Interval 2.0 to 3.3
|
1.0 fold rise
Interval 0.9 to 1.2
|
1.0 fold rise
Interval 0.9 to 1.1
|
1.0 fold rise
Interval 0.9 to 1.3
|
|
Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Colorado/06/2017 (B Victoria lineage)
|
2.2 fold rise
Interval 1.8 to 2.7
|
2.3 fold rise
Interval 1.9 to 2.7
|
2.6 fold rise
Interval 2.0 to 3.3
|
1.2 fold rise
Interval 1.1 to 1.4
|
1.1 fold rise
Interval 1.0 to 1.2
|
1.2 fold rise
Interval 1.0 to 1.5
|
|
Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Michigan/45/2015 X-275 (H1N1)
|
2.4 fold rise
Interval 1.9 to 3.0
|
2.1 fold rise
Interval 1.7 to 2.7
|
2.5 fold rise
Interval 1.9 to 3.2
|
1.0 fold rise
Interval 0.9 to 1.2
|
1.0 fold rise
Interval 0.9 to 1.2
|
1.1 fold rise
Interval 0.9 to 1.3
|
|
Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Phuket/3073/2013 (B Yamagata lineage
|
1.6 fold rise
Interval 1.3 to 2.0
|
1.8 fold rise
Interval 1.5 to 2.3
|
2.1 fold rise
Interval 1.7 to 2.6
|
1.2 fold rise
Interval 1.0 to 1.3
|
1.2 fold rise
Interval 1.0 to 1.3
|
1.2 fold rise
Interval 1.0 to 1.4
|
PRIMARY outcome
Timeframe: Day 1, Day 29Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood sample for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid HAI results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
Blood was collected for Neut assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, but only one result which a geometric mean titer of the replicates was reported by the lab. The geometric mean titer was calculated for each study arm from the available results at Day 1 and Day 29 post first study vaccination.
Outcome measures
| Measure |
Fluzone + CpG55
n=40 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 2019/2020 of Fluzone QIV intramuscular injection on Day 90.
|
Fluzone
n=41 Participants
0.5 mL of 2018/2019 Fluzone QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Fluzone + AF03
n=37 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.25 mL of AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Flublok
n=41 Participants
0.5 mL of 2018/2019 Flublok QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + AF03
n=38 Participants
0.5 mL of 2018/2019 Flublok QIV + 0.25 mL AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + CpG55
n=42 Participants
0.5 mL of 2018/2019 Flublok QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 1
|
101.9 titer
Interval 75.5 to 137.6
|
106.8 titer
Interval 78.0 to 146.1
|
147.7 titer
Interval 111.1 to 196.3
|
151.6 titer
Interval 109.9 to 209.2
|
121.2 titer
Interval 87.6 to 167.7
|
118.5 titer
Interval 88.4 to 158.8
|
|
Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 1
|
94.0 titer
Interval 53.9 to 164.0
|
108.9 titer
Interval 63.1 to 187.9
|
113.4 titer
Interval 68.8 to 186.9
|
199.4 titer
Interval 115.0 to 345.9
|
81.9 titer
Interval 49.7 to 134.9
|
101.0 titer
Interval 65.3 to 156.4
|
|
Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Michigan/45/2015 X-275 (H1N1) - Day 1
|
2147.8 titer
Interval 1271.7 to 3627.5
|
3141.7 titer
Interval 2145.9 to 4599.4
|
2697.5 titer
Interval 1756.2 to 4143.2
|
3703.3 titer
Interval 2937.7 to 5719.6
|
2214.0 titer
Interval 1337.5 to 3664.9
|
2764.2 titer
Interval 1667.7 to 4581.7
|
|
Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Phuket/3073/2013 (B Yamagata lineage) - Day 1
|
630.3 titer
Interval 447.0 to 889.0
|
479.4 titer
Interval 320.1 to 717.9
|
577.8 titer
Interval 383.2 to 871.1
|
860.1 titer
Interval 562.1 to 1316.1
|
447.8 titer
Interval 281.3 to 712.9
|
539.2 titer
Interval 394.8 to 736.5
|
|
Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 29
|
456.5 titer
Interval 334.5 to 622.9
|
379.1 titer
Interval 285.4 to 503.4
|
671.9 titer
Interval 497.1 to 908.2
|
848.9 titer
Interval 667.6 to 1079.4
|
741.9 titer
Interval 536.1 to 1026.7
|
567.0 titer
Interval 422.5 to 760.9
|
|
Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 29
|
248.4 titer
Interval 169.4 to 364.3
|
302.2 titer
Interval 207.7 to 439.8
|
305.1 titer
Interval 219.1 to 424.9
|
463.3 titer
Interval 279.2 to 768.9
|
304.8 titer
Interval 188.2 to 493.7
|
291.6 titer
Interval 191.2 to 444.7
|
|
Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Michigan/45/2015 X-275 (H1N1) - Day 29
|
4455.8 titer
Interval 2877.2 to 6900.5
|
5639.5 titer
Interval 3958.0 to 8035.2
|
5435.2 titer
Interval 3627.9 to 8142.8
|
8539.5 titer
Interval 5785.7 to 12603.9
|
9197.6 titer
Interval 5941.1 to 14239.1
|
6021.9 titer
Interval 4138.3 to 8762.7
|
|
Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Phuket/3073/2013 (B Yamagata lineage) - Day 29
|
1152.1 titer
Interval 873.2 to 1520.1
|
1162.7 titer
Interval 860.0 to 1572.0
|
1437.4 titer
Interval 1053.1 to 1962.0
|
2053.5 titer
Interval 1509.7 to 2793.3
|
1473.1 titer
Interval 1049.7 to 2067.5
|
1291.7 titer
Interval 940.6 to 1774.0
|
PRIMARY outcome
Timeframe: Day 1, Day 29Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood sample for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid Neut results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
Blood was collected for Neut assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, but only one result which a geometric mean titer of the replicates was reported by the lab. The geometric mean titer was calculated for each study arm from the available results at Day 1 and Day 29 post first study vaccination and the ratio of these GMTs between adjuvanted and unadjuvanted study arms were calculated. Unadjuvanted Fluzone and Flublok study arms are considered as reference groups for the analysis of ratio of GMTs. Ratio of GMTs is defined as the ratio of the GMT from the adjuvanted group divided by the GMT from the corresponding unadjuvanted group.
Outcome measures
| Measure |
Fluzone + CpG55
n=38 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 2019/2020 of Fluzone QIV intramuscular injection on Day 90.
|
Fluzone
n=37 Participants
0.5 mL of 2018/2019 Fluzone QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Fluzone + AF03
n=40 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.25 mL of AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Flublok
n=42 Participants
0.5 mL of 2018/2019 Flublok QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + AF03
0.5 mL of 2018/2019 Flublok QIV + 0.25 mL AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + CpG55
0.5 mL of 2018/2019 Flublok QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
|
|---|---|---|---|---|---|---|
|
Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 1
|
0.8 ratio of GMT
Interval 0.5 to 1.3
|
1.4 ratio of GMT
Interval 0.9 to 2.1
|
1.0 ratio of GMT
Interval 0.6 to 1.5
|
0.8 ratio of GMT
Interval 0.5 to 1.2
|
—
|
—
|
|
Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 1
|
0.4 ratio of GMT
Interval 0.2 to 0.9
|
1.0 ratio of GMT
Interval 0.5 to 2.2
|
0.9 ratio of GMT
Interval 0.4 to 1.9
|
0.5 ratio of GMT
Interval 0.3 to 1.0
|
—
|
—
|
|
Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Michigan/45/2015 X-275 (H1N1) - Day 1
|
0.6 ratio of GMT
Interval 0.3 to 1.2
|
0.9 ratio of GMT
Interval 0.5 to 1.5
|
0.7 ratio of GMT
Interval 0.4 to 1.3
|
0.7 ratio of GMT
Interval 0.4 to 1.4
|
—
|
—
|
|
Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms
B/Phuket/3073/2013 (B Yamagata lineage) - Day 1
|
0.5 ratio of GMT
Interval 0.3 to 1.0
|
1.2 ratio of GMT
Interval 0.7 to 2.1
|
1.3 ratio of GMT
Interval 0.8 to 2.2
|
0.6 ratio of GMT
Interval 0.4 to 1.1
|
—
|
—
|
|
Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 29
|
0.9 ratio of GMT
Interval 0.6 to 1.3
|
1.8 ratio of GMT
Interval 1.2 to 2.7
|
1.2 ratio of GMT
Interval 0.8 to 1.8
|
0.7 ratio of GMT
Interval 0.5 to 1.0
|
—
|
—
|
|
Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 29
|
0.7 ratio of GMT
Interval 0.3 to 1.3
|
1.0 ratio of GMT
Interval 0.6 to 1.7
|
0.8 ratio of GMT
Interval 0.5 to 1.4
|
0.6 ratio of GMT
Interval 0.3 to 1.2
|
—
|
—
|
|
Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Michigan/45/2015 X-275 (H1N1) - Day 29
|
1.1 ratio of GMT
Interval 0.6 to 1.9
|
1.0 ratio of GMT
Interval 0.6 to 1.6
|
0.8 ratio of GMT
Interval 0.5 to 1.4
|
0.7 ratio of GMT
Interval 0.4 to 1.2
|
—
|
—
|
|
Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms
B/Phuket/3073/2013 (B Yamagata lineage) - Day 29
|
0.7 ratio of GMT
Interval 0.5 to 1.1
|
1.2 ratio of GMT
Interval 0.8 to 1.9
|
1.0 ratio of GMT
Interval 0.7 to 1.5
|
0.6 ratio of GMT
Interval 0.4 to 1.0
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 29Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood sample for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid Neut results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
Blood was collected for Neut assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, but only one result which a geometric mean titer of the replicates was reported by the lab. Neut seroconversion was defined as either a pre-vaccination titer \< 1:10 and a post-vaccination titer \>= 1:40 or a pre-vaccination titer \>= 1:10 and a minimum four-fold rise in post-vaccination antibody titer.
Outcome measures
| Measure |
Fluzone + CpG55
n=39 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 2019/2020 of Fluzone QIV intramuscular injection on Day 90.
|
Fluzone
n=41 Participants
0.5 mL of 2018/2019 Fluzone QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Fluzone + AF03
n=36 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.25 mL of AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Flublok
n=40 Participants
0.5 mL of 2018/2019 Flublok QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + AF03
n=37 Participants
0.5 mL of 2018/2019 Flublok QIV + 0.25 mL AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + CpG55
n=41 Participants
0.5 mL of 2018/2019 Flublok QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2)
|
38 percentage of participants
Interval 23.0 to 55.0
|
37 percentage of participants
Interval 22.0 to 53.0
|
42 percentage of participants
Interval 26.0 to 59.0
|
60 percentage of participants
Interval 43.0 to 75.0
|
65 percentage of participants
Interval 47.0 to 80.0
|
56 percentage of participants
Interval 40.0 to 72.0
|
|
Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Maryland/15/2016 BX-69A (B Victoria lineage)
|
28 percentage of participants
Interval 15.0 to 45.0
|
22 percentage of participants
Interval 11.0 to 38.0
|
19 percentage of participants
Interval 8.0 to 36.0
|
20 percentage of participants
Interval 9.0 to 36.0
|
30 percentage of participants
Interval 16.0 to 47.0
|
34 percentage of participants
Interval 20.0 to 51.0
|
|
Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Michigan/45/2015 X-275 (H1N1)
|
21 percentage of participants
Interval 9.0 to 36.0
|
15 percentage of participants
Interval 6.0 to 29.0
|
11 percentage of participants
Interval 3.0 to 26.0
|
20 percentage of participants
Interval 9.0 to 36.0
|
41 percentage of participants
Interval 25.0 to 58.0
|
20 percentage of participants
Interval 9.0 to 35.0
|
|
Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Phuket/3073/2013 (B Yamagata lineage)
|
18 percentage of participants
Interval 8.0 to 34.0
|
24 percentage of participants
Interval 12.0 to 40.0
|
14 percentage of participants
Interval 5.0 to 29.0
|
18 percentage of participants
Interval 7.0 to 33.0
|
30 percentage of participants
Interval 16.0 to 47.0
|
22 percentage of participants
Interval 11.0 to 38.0
|
PRIMARY outcome
Timeframe: Day 1, Day 29Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood sample for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid Neut results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
Blood was collected for Neut assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, but only one result which a geometric mean titer of the replicates was reported by the lab.
Outcome measures
| Measure |
Fluzone + CpG55
n=40 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 2019/2020 of Fluzone QIV intramuscular injection on Day 90.
|
Fluzone
n=41 Participants
0.5 mL of 2018/2019 Fluzone QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Fluzone + AF03
n=37 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.25 mL of AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Flublok
n=41 Participants
0.5 mL of 2018/2019 Flublok QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + AF03
n=38 Participants
0.5 mL of 2018/2019 Flublok QIV + 0.25 mL AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + CpG55
n=42 Participants
0.5 mL of 2018/2019 Flublok QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Phuket/3073/2013 (B Yamagata lineage) - Day 29
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 90.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
|
Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 1
|
75 percentage of participants
Interval 59.0 to 87.0
|
88 percentage of participants
Interval 74.0 to 96.0
|
95 percentage of participants
Interval 82.0 to
Value is NA because it's \>99 but \<100
|
90 percentage of participants
Interval 77.0 to 97.0
|
89 percentage of participants
Interval 75.0 to 97.0
|
90 percentage of participants
Interval 77.0 to 97.0
|
|
Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 1
|
68 percentage of participants
Interval 51.0 to 81.0
|
78 percentage of participants
Interval 62.0 to 89.0
|
78 percentage of participants
Interval 62.0 to 90.0
|
83 percentage of participants
Interval 68.0 to 93.0
|
71 percentage of participants
Interval 54.0 to 85.0
|
76 percentage of participants
Interval 61.0 to 88.0
|
|
Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Michigan/45/2015 X-275 (H1N1) - Day 1
|
98 percentage of participants
Interval 87.0 to
Value is NA because it's \>99 but \<100
|
100 percentage of participants
Interval 91.0 to 100.0
|
97 percentage of participants
Interval 86.0 to
Value is NA because it's \>99 but \<100
|
100 percentage of participants
Interval 91.0 to 100.0
|
97 percentage of participants
Interval 86.0 to
Value is NA because it's \>99 but \<100
|
98 percentage of participants
Interval 87.0 to
Value is NA because it's \>99 but \<100
|
|
Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Phuket/3073/2013 (B Yamagata lineage) - Day 1
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
97 percentage of participants
Interval 86.0 to
Value is NA because it's \>99 but \<100
|
95 percentage of participants
Interval 83.0 to
Value is NA because it's \>99 but \<100
|
92 percentage of participants
Interval 79.0 to 98.0
|
100 percentage of participants
Interval 92.0 to 100.0
|
|
Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 29
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 90.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
|
Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 29
|
95 percentage of participants
Interval 83.0 to
Value is NA because it's \>99 but \<100
|
95 percentage of participants
Interval 83.0 to
Value is NA because it's \>99 but \<100
|
97 percentage of participants
Interval 85.0 to
Value is NA because it's \>99 but \<100
|
90 percentage of participants
Interval 76.0 to 97.0
|
92 percentage of participants
Interval 78.0 to 98.0
|
95 percentage of participants
Interval 83.0 to
Value is NA because it's \>99 but \<100
|
|
Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Michigan/45/2015 X-275 (H1N1) - Day 29
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 90.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
PRIMARY outcome
Timeframe: Day 29Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood samples for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid Neut results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
Blood was collected for Neut assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, but only one result which a geometric mean titer of the replicates was reported by the lab. Fold-rises from baseline were calculated as the Day 29 titer divided by the baseline titers for each participant. The geometric mean of these fold rises was then calculated to obtain the GMFR.
Outcome measures
| Measure |
Fluzone + CpG55
n=39 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 2019/2020 of Fluzone QIV intramuscular injection on Day 90.
|
Fluzone
n=41 Participants
0.5 mL of 2018/2019 Fluzone QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Fluzone + AF03
n=36 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.25 mL of AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Flublok
n=40 Participants
0.5 mL of 2018/2019 Flublok QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + AF03
n=37 Participants
0.5 mL of 2018/2019 Flublok QIV + 0.25 mL AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + CpG55
n=41 Participants
0.5 mL of 2018/2019 Flublok QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2)
|
4.6 fold rise
Interval 3.2 to 6.7
|
3.6 fold rise
Interval 2.7 to 4.7
|
4.3 fold rise
Interval 3.1 to 6.1
|
5.5 fold rise
Interval 3.9 to 7.7
|
5.9 fold rise
Interval 4.6 to 7.5
|
4.6 fold rise
Interval 3.4 to 6.3
|
|
Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Maryland/15/2016 BX-69A (B Victoria lineage)
|
2.7 fold rise
Interval 1.6 to 4.3
|
2.8 fold rise
Interval 1.7 to 4.5
|
2.8 fold rise
Interval 1.6 to 4.8
|
2.3 fold rise
Interval 1.6 to 3.3
|
3.5 fold rise
Interval 2.4 to 5.3
|
2.8 fold rise
Interval 1.9 to 4.2
|
|
Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Michigan/45/2015 X-275 (H1N1)
|
2.2 fold rise
Interval 1.3 to 3.6
|
1.8 fold rise
Interval 1.1 to 2.8
|
1.9 fold rise
Interval 1.1 to 3.3
|
2.1 fold rise
Interval 1.6 to 2.8
|
4.2 fold rise
Interval 2.4 to 7.2
|
2.1 fold rise
Interval 1.4 to 3.2
|
|
Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Phuket/3073/2013 (B Yamagata lineage)
|
1.9 fold rise
Interval 1.4 to 2.6
|
2.4 fold rise
Interval 1.6 to 3.6
|
2.4 fold rise
Interval 1.6 to 3.6
|
2.4 fold rise
Interval 1.7 to 3.4
|
3.4 fold rise
Interval 2.0 to 5.5
|
2.3 fold rise
Interval 1.7 to 3.3
|
SECONDARY outcome
Timeframe: Day 1 through Day 365Population: The Safety Analysis population includes all participants who received study vaccination. Analyses for the safety population are based on vaccine actually received. One participant randomized to Flublok + AF03 group received Flublok due to a pharmacy error and is analyzed in the Flublok group.
Participants were queried at each visit for the occurrence of adverse events of special interest (AESIs) through approximately 12 months following the first study vaccination. AESIs include reports of tearing, dry mouth, and dry eyes.
Outcome measures
| Measure |
Fluzone + CpG55
n=40 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 2019/2020 of Fluzone QIV intramuscular injection on Day 90.
|
Fluzone
n=41 Participants
0.5 mL of 2018/2019 Fluzone QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Fluzone + AF03
n=37 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.25 mL of AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Flublok
n=42 Participants
0.5 mL of 2018/2019 Flublok QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + AF03
n=37 Participants
0.5 mL of 2018/2019 Flublok QIV + 0.25 mL AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + CpG55
n=43 Participants
0.5 mL of 2018/2019 Flublok QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
|
|---|---|---|---|---|---|---|
|
Number of Participants Reporting Protocol Specified Adverse Events of Special Interest (AESIs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 365Population: The Safety Analysis population includes all participants who received the first study vaccination. Analyses for the safety population are based on vaccine actually received. One participant randomized to Flublok + AF03 group received Flublok due to a pharmacy error and is analyzed in the Flublok group.
Participants were queried at each visit for the occurrence of medically-attended adverse events (MAAEs), including new-onset chronic medical conditions (NOCMCs) and potentially immune-mediated medical conditions (PIMMCs) through approximately 12 months following the first study vaccination.
Outcome measures
| Measure |
Fluzone + CpG55
n=40 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 2019/2020 of Fluzone QIV intramuscular injection on Day 90.
|
Fluzone
n=41 Participants
0.5 mL of 2018/2019 Fluzone QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Fluzone + AF03
n=37 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.25 mL of AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Flublok
n=42 Participants
0.5 mL of 2018/2019 Flublok QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + AF03
n=37 Participants
0.5 mL of 2018/2019 Flublok QIV + 0.25 mL AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + CpG55
n=43 Participants
0.5 mL of 2018/2019 Flublok QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
|
|---|---|---|---|---|---|---|
|
Number of Participants Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs)
MAAEs
|
7 Participants
|
9 Participants
|
13 Participants
|
8 Participants
|
7 Participants
|
10 Participants
|
|
Number of Participants Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs)
NOCMCs
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Medically-Attended Adverse Events (MAAEs), New-Onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-Mediated Medical Conditions (PIMMCs)
PIMMCs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 90 through Day 118Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood samples for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid HAI results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
Blood was collected for HAI assay which was conducted with the 2019/2020 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at Day 90 and Day 118 post first study vaccination.
Outcome measures
| Measure |
Fluzone + CpG55
n=40 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 2019/2020 of Fluzone QIV intramuscular injection on Day 90.
|
Fluzone
n=41 Participants
0.5 mL of 2018/2019 Fluzone QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Fluzone + AF03
n=37 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.25 mL of AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Flublok
n=41 Participants
0.5 mL of 2018/2019 Flublok QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + AF03
n=38 Participants
0.5 mL of 2018/2019 Flublok QIV + 0.25 mL AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + CpG55
n=42 Participants
0.5 mL of 2018/2019 Flublok QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118
|
255.7 titer
Interval 170.6 to 383.3
|
323.1 titer
Interval 235.1 to 443.9
|
281.8 titer
Interval 196.2 to 404.8
|
404.5 titer
Interval 255.1 to 641.4
|
320.0 titer
Interval 224.4 to 456.3
|
329.9 titer
Interval 233.6 to 465.9
|
|
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains
A/Brisbane/02/2018 IVR-190 (H1N1) - Day 90
|
234.7 titer
Interval 157.8 to 349.1
|
325.5 titer
Interval 242.9 to 436.0
|
326.2 titer
Interval 237.6 to 447.9
|
456.6 titer
Interval 314.7 to 662.4
|
408.2 titer
Interval 278.0 to 599.4
|
355.1 titer
Interval 246.5 to 511.4
|
|
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains
A/Brisbane/02/2018 IVR-190 (H1N1) - Day 118
|
269.1 titer
Interval 173.3 to 417.7
|
387.9 titer
Interval 281.0 to 535.6
|
367.6 titer
Interval 254.7 to 530.6
|
627.1 titer
Interval 430.9 to 912.7
|
509.8 titer
Interval 330.5 to 786.5
|
491.0 titer
Interval 343.5 to 701.9
|
|
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains
A/Kansas/14/2017 (H3N2) - Day 90
|
38.2 titer
Interval 25.8 to 56.6
|
33.8 titer
Interval 23.2 to 49.2
|
67.9 titer
Interval 44.6 to 103.4
|
69.4 titer
Interval 47.0 to 102.4
|
50.1 titer
Interval 32.5 to 77.2
|
62.2 titer
Interval 41.8 to 92.5
|
|
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains
A/Kansas/14/2017 (H3N2) - Day 118
|
274.6 titer
Interval 198.4 to 380.1
|
203.5 titer
Interval 132.1 to 313.6
|
213.6 titer
Interval 136.9 to 333.1
|
369.1 titer
Interval 238.5 to 571.2
|
254.9 titer
Interval 154.2 to 421.3
|
212.8 titer
Interval 135.9 to 333.5
|
|
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains
B/Phuket/3073/2013 (B Yamagata lineage) - Day 90
|
849.1 titer
Interval 644.1 to 1119.4
|
797.3 titer
Interval 595.9 to 1066.9
|
1129.4 titer
Interval 853.2 to 1495.2
|
1502.0 titer
Interval 1132.8 to 1991.7
|
1041.6 titer
Interval 747.5 to 1451.6
|
995.6 titer
Interval 752.0 to 1318.1
|
|
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains
B/Phuket/3073/2013 (B Yamagata lineage) - Day 118
|
792.8 titer
Interval 615.8 to 1020.6
|
665.1 titer
Interval 499.2 to 886.2
|
874.3 titer
Interval 647.1 to 1181.1
|
1228.9 titer
Interval 924.0 to 1634.4
|
905.1 titer
Interval 649.8 to 1260.7
|
1065.4 titer
Interval 836.2 to 1357.5
|
|
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90
|
245.6 titer
Interval 170.6 to 353.7
|
312.0 titer
Interval 231.6 to 420.3
|
339.0 titer
Interval 241.2 to 476.5
|
410.4 titer
Interval 270.4 to 622.8
|
323.0 titer
Interval 219.2 to 475.9
|
303.8 titer
Interval 215.8 to 427.6
|
SECONDARY outcome
Timeframe: Day 90 through Day 118Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood samples for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid HAI results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
Blood was collected for HAI assay which was conducted with the 2019/2020 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at Day 90 and Day 118 post first study vaccination and the ratio of these GMTs between adjuvanted and unadjuvanted study arms were calculated. Unadjuvanted Fluzone and Flublok study arms are considered as reference groups for the analysis of ratio of GMTs. Ratio of GMTs is defined as the ratio of the GMT from the adjuvanted group divided by the GMT from the corresponding unadjuvanted group.
Outcome measures
| Measure |
Fluzone + CpG55
n=38 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 2019/2020 of Fluzone QIV intramuscular injection on Day 90.
|
Fluzone
n=37 Participants
0.5 mL of 2018/2019 Fluzone QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Fluzone + AF03
n=40 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.25 mL of AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Flublok
n=42 Participants
0.5 mL of 2018/2019 Flublok QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + AF03
0.5 mL of 2018/2019 Flublok QIV + 0.25 mL AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + CpG55
0.5 mL of 2018/2019 Flublok QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
|
|---|---|---|---|---|---|---|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Brisbane/02/2018 IVR-190 (H1N1) - Day 90
|
0.9 ratio of GMT
Interval 0.5 to 1.5
|
1.0 ratio of GMT
Interval 0.7 to 1.5
|
0.7 ratio of GMT
Interval 0.4 to 1.2
|
0.8 ratio of GMT
Interval 0.5 to 1.3
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Brisbane/02/2018 IVR-190 (H1N1) - Day 118
|
0.8 ratio of GMT
Interval 0.5 to 1.4
|
0.9 ratio of GMT
Interval 0.6 to 1.5
|
0.7 ratio of GMT
Interval 0.4 to 1.2
|
0.8 ratio of GMT
Interval 0.5 to 1.3
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Kansas/14/2017 (H3N2) - Day 90
|
0.7 ratio of GMT
Interval 0.4 to 1.3
|
2.0 ratio of GMT
Interval 1.2 to 3.5
|
1.1 ratio of GMT
Interval 0.7 to 1.9
|
0.9 ratio of GMT
Interval 0.5 to 1.5
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Kansas/14/2017 (H3N2) - Day 118
|
0.7 ratio of GMT
Interval 0.4 to 1.3
|
1.0 ratio of GMT
Interval 0.6 to 1.9
|
1.3 ratio of GMT
Interval 0.8 to 2.3
|
0.6 ratio of GMT
Interval 0.3 to 1.1
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms
B/Phuket/3073/2013 (B Yamagata lineage) - Day 90
|
0.7 ratio of GMT
Interval 0.5 to 1.1
|
1.4 ratio of GMT
Interval 1.0 to 2.1
|
1.1 ratio of GMT
Interval 0.7 to 1.6
|
0.7 ratio of GMT
Interval 0.4 to 1.0
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms
B/Phuket/3073/2013 (B Yamagata lineage) - Day 118
|
0.7 ratio of GMT
Interval 0.5 to 1.1
|
1.3 ratio of GMT
Interval 0.9 to 2.0
|
1.2 ratio of GMT
Interval 0.8 to 1.7
|
0.9 ratio of GMT
Interval 0.6 to 1.3
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90
|
0.8 ratio of GMT
Interval 0.4 to 1.4
|
1.1 ratio of GMT
Interval 0.7 to 1.7
|
0.8 ratio of GMT
Interval 0.5 to 1.3
|
0.7 ratio of GMT
Interval 0.4 to 1.3
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118
|
0.8 ratio of GMT
Interval 0.4 to 1.4
|
0.9 ratio of GMT
Interval 0.5 to 1.4
|
0.8 ratio of GMT
Interval 0.5 to 1.3
|
0.8 ratio of GMT
Interval 0.5 to 1.4
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 118Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood samples for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid HAI results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
Blood was collected for HAI assay which was conducted with the 2019/2020 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. HAI seroconversion was defined as either a pre-second vaccination titer \< 1:10 and a post- second vaccination titer \>= 1:40 or a pre-second vaccination titer \>= 1:10 and a minimum four-fold rise in post-vaccination antibody titer.
Outcome measures
| Measure |
Fluzone + CpG55
n=34 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 2019/2020 of Fluzone QIV intramuscular injection on Day 90.
|
Fluzone
n=36 Participants
0.5 mL of 2018/2019 Fluzone QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Fluzone + AF03
n=30 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.25 mL of AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Flublok
n=34 Participants
0.5 mL of 2018/2019 Flublok QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + AF03
n=32 Participants
0.5 mL of 2018/2019 Flublok QIV + 0.25 mL AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + CpG55
n=34 Participants
0.5 mL of 2018/2019 Flublok QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains
A/Brisbane/02/2018 IVR-190 (H1N1)
|
0 percentage of participants
Interval 0.0 to 10.0
|
0 percentage of participants
Interval 0.0 to 10.0
|
0 percentage of participants
Interval 0.0 to 12.0
|
6 percentage of participants
Interval to 20.0
Value is NA because it is \>0 but \<1
|
0 percentage of participants
Interval 0.0 to 11.0
|
6 percentage of participants
Interval to 20.0
Value is NA because it is \>0 but \<1
|
|
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains
A/Kansas/14/2017 (H3N2)
|
74 percentage of participants
Interval 56.0 to 87.0
|
67 percentage of participants
Interval 49.0 to 81.0
|
43 percentage of participants
Interval 25.0 to 63.0
|
56 percentage of participants
Interval 38.0 to 73.0
|
53 percentage of participants
Interval 35.0 to 71.0
|
53 percentage of participants
Interval 35.0 to 70.0
|
|
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains
B/Phuket/3073/2013 (B Yamagata lineage)
|
0 percentage of participants
Interval 0.0 to 10.0
|
0 percentage of participants
Interval 0.0 to 10.0
|
0 percentage of participants
Interval 0.0 to 12.0
|
0 percentage of participants
Interval 0.0 to 10.0
|
0 percentage of participants
Interval 0.0 to 11.0
|
0 percentage of participants
Interval 0.0 to 10.0
|
|
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains
B/Maryland/15/2016 BX-69A (B Victoria lineage)
|
0 percentage of participants
Interval 0.0 to 10.0
|
0 percentage of participants
Interval 0.0 to 10.0
|
0 percentage of participants
Interval 0.0 to 12.0
|
0 percentage of participants
Interval 0.0 to 10.0
|
0 percentage of participants
Interval 0.0 to 11.0
|
0 percentage of participants
Interval 0.0 to 10.0
|
SECONDARY outcome
Timeframe: Day 90 through Day 118Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood samples for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid HAI results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
Blood was collected for HAI assay which was conducted with the 2019/2020 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result.
Outcome measures
| Measure |
Fluzone + CpG55
n=40 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 2019/2020 of Fluzone QIV intramuscular injection on Day 90.
|
Fluzone
n=41 Participants
0.5 mL of 2018/2019 Fluzone QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Fluzone + AF03
n=37 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.25 mL of AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Flublok
n=41 Participants
0.5 mL of 2018/2019 Flublok QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + AF03
n=38 Participants
0.5 mL of 2018/2019 Flublok QIV + 0.25 mL AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + CpG55
n=42 Participants
0.5 mL of 2018/2019 Flublok QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains
A/Brisbane/02/2018 IVR-190 (H1N1) - Day 90
|
92 percentage of participants
Interval 79.0 to 98.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 90.0 to 100.0
|
95 percentage of participants
Interval 83.0 to
Value is NA because it is \>99 but \<100
|
95 percentage of participants
Interval 82.0 to
Value is NA because it is \>99 but \<100
|
95 percentage of participants
Interval 83.0 to
Value is NA because it is \>99 but \<100
|
|
Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains
A/Brisbane/02/2018 IVR-190 (H1N1) - Day 118
|
91 percentage of participants
Interval 76.0 to 98.0
|
100 percentage of participants
Interval 90.0 to 100.0
|
100 percentage of participants
Interval 88.0 to 100.0
|
97 percentage of participants
Interval 85.0 to
Value is NA because it is \>99 but \<100
|
97 percentage of participants
Interval 84.0 to
Value is NA because it is \>99 but \<100
|
97 percentage of participants
Interval 85.0 to
Value is NA because it is \>99 but \<100
|
|
Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains
A/Kansas/14/2017 (H3N2) - Day 90
|
50 percentage of participants
Interval 33.0 to 67.0
|
41 percentage of participants
Interval 26.0 to 58.0
|
67 percentage of participants
Interval 49.0 to 81.0
|
77 percentage of participants
Interval 61.0 to 89.0
|
59 percentage of participants
Interval 42.0 to 75.0
|
73 percentage of participants
Interval 56.0 to 85.0
|
|
Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains
A/Kansas/14/2017 (H3N2) - Day 118
|
94 percentage of participants
Interval 80.0 to
Value is NA because it is \>99 but \<100
|
92 percentage of participants
Interval 78.0 to 98.0
|
93 percentage of participants
Interval 78.0 to
Value is NA because it is \>99 but \<100
|
100 percentage of participants
Interval 90.0 to 100.0
|
91 percentage of participants
Interval 75.0 to 98.0
|
94 percentage of participants
Interval 80.0 to
Value is NA because it is \>99 but \<100
|
|
Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains
B/Phuket/3073/2013 (B Yamagata lineage) - Day 90
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 90.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
|
Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains
B/Phuket/3073/2013 (B Yamagata lineage) - Day 118
|
100 percentage of participants
Interval 90.0 to 100.0
|
100 percentage of participants
Interval 90.0 to 100.0
|
100 percentage of participants
Interval 88.0 to 100.0
|
100 percentage of participants
Interval 90.0 to 100.0
|
100 percentage of participants
Interval 89.0 to 100.0
|
100 percentage of participants
Interval 90.0 to 100.0
|
|
Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90
|
97 percentage of participants
Interval 86.0 to
Value is NA because it is \>99 but \<100
|
98 percentage of participants
Interval 87.0 to
Value is NA because it is \>99 but \<100
|
100 percentage of participants
Interval 90.0 to 100.0
|
97 percentage of participants
Interval 87.0 to
Value is NA because it is \>99 but \<100
|
97 percentage of participants
Interval 86.0 to
Value is NA because it is \>99 but \<100
|
100 percentage of participants
Interval 91.0 to 100.0
|
|
Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118
|
97 percentage of participants
Interval 85.0 to
Value is NA because it is \>99 but \<100
|
100 percentage of participants
Interval 90.0 to 100.0
|
100 percentage of participants
Interval 88.0 to 100.0
|
100 percentage of participants
Interval 90.0 to 100.0
|
94 percentage of participants
Interval 79.0 to
Value is NA because it is \>99 but \<100
|
100 percentage of participants
Interval 90.0 to 100.0
|
SECONDARY outcome
Timeframe: Day 90 through Day 118Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood samples for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid HAI results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
Blood was collected for HAI assay which was conducted with the 2019/2020 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. Fold-rises at Day 118 were calculated as the Day 118 titer divided by the Day 90 titers for each participant. The geometric mean of these fold rises was then calculated to obtain the GMFR.
Outcome measures
| Measure |
Fluzone + CpG55
n=40 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 2019/2020 of Fluzone QIV intramuscular injection on Day 90.
|
Fluzone
n=41 Participants
0.5 mL of 2018/2019 Fluzone QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Fluzone + AF03
n=37 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.25 mL of AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Flublok
n=41 Participants
0.5 mL of 2018/2019 Flublok QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + AF03
n=38 Participants
0.5 mL of 2018/2019 Flublok QIV + 0.25 mL AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + CpG55
n=42 Participants
0.5 mL of 2018/2019 Flublok QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Fold Rise in Hemagglutination Inhibition (HAI) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains
A/Brisbane/02/2018 IVR-190 (H1N1)
|
1.2 fold rise
Interval 1.1 to 1.4
|
1.1 fold rise
Interval 1.0 to 1.2
|
1.1 fold rise
Interval 1.0 to 1.2
|
1.3 fold rise
Interval 1.1 to 1.6
|
1.3 fold rise
Interval 1.1 to 1.4
|
1.4 fold rise
Interval 1.2 to 1.7
|
|
Geometric Mean Fold Rise in Hemagglutination Inhibition (HAI) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains
A/Kansas/14/2017 (H3N2)
|
6.9 fold rise
Interval 4.7 to 10.0
|
7.1 fold rise
Interval 4.8 to 10.6
|
3.3 fold rise
Interval 2.3 to 4.6
|
5.4 fold rise
Interval 3.4 to 8.4
|
5.5 fold rise
Interval 3.4 to 8.7
|
3.6 fold rise
Interval 2.7 to 4.9
|
|
Geometric Mean Fold Rise in Hemagglutination Inhibition (HAI) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains
B/Phuket/3073/2013 (B Yamagata lineage)
|
1.0 fold rise
Interval 0.8 to 1.1
|
0.8 fold rise
Interval 0.8 to 0.9
|
0.8 fold rise
Interval 0.7 to 0.9
|
0.8 fold rise
Interval 0.7 to 1.0
|
0.9 fold rise
Interval 0.8 to 1.0
|
1.1 fold rise
Interval 0.9 to 1.3
|
|
Geometric Mean Fold Rise in Hemagglutination Inhibition (HAI) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains
B/Maryland/15/2016 BX-69A (B Victoria lineage)
|
1.0 fold rise
Interval 0.9 to 1.2
|
1.1 fold rise
Interval 0.9 to 1.2
|
0.9 fold rise
Interval 0.8 to 1.0
|
1.0 fold rise
Interval 0.9 to 1.1
|
1.0 fold rise
Interval 0.9 to 1.2
|
1.1 fold rise
Interval 1.0 to 1.3
|
SECONDARY outcome
Timeframe: Day 90 through Day 118Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood samples for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid NAI results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
Blood was collected for NAI assay which was conducted with the 2019/2020 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at Day 90 and Day 118 post first study vaccination.
Outcome measures
| Measure |
Fluzone + CpG55
n=40 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 2019/2020 of Fluzone QIV intramuscular injection on Day 90.
|
Fluzone
n=41 Participants
0.5 mL of 2018/2019 Fluzone QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Fluzone + AF03
n=37 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.25 mL of AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Flublok
0.5 mL of 2018/2019 Flublok QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + AF03
0.5 mL of 2018/2019 Flublok QIV + 0.25 mL AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + CpG55
0.5 mL of 2018/2019 Flublok QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms
A/Brisbane/02/2018 IVR-190 (H1N1) - Day 90
|
72.4 titer
Interval 50.1 to 104.5
|
90.1 titer
Interval 65.0 to 124.8
|
91.5 titer
Interval 65.8 to 127.3
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms
A/Brisbane/02/2018 IVR-190 (H1N1) - Day 118
|
79.2 titer
Interval 55.6 to 112.7
|
107.8 titer
Interval 76.8 to 151.3
|
111.8 titer
Interval 79.4 to 157.5
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms
A/Kansas/14/2017 (H3N2) - Day 90
|
36.5 titer
Interval 28.1 to 47.5
|
35.8 titer
Interval 28.9 to 44.5
|
49.0 titer
Interval 38.6 to 62.1
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms
A/Kansas/14/2017 (H3N2) - Day 118
|
45.7 titer
Interval 34.8 to 59.9
|
48.5 titer
Interval 38.2 to 61.6
|
51.0 titer
Interval 41.0 to 63.4
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms
B/Phuket/3073/2013 (B Yamagata lineage) - Day 90
|
137.0 titer
Interval 113.1 to 166.1
|
104.0 titer
Interval 86.2 to 125.4
|
156.9 titer
Interval 120.1 to 205.0
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms
B/Phuket/3073/2013 (B Yamagata lineage) - Day 118
|
150.5 titer
Interval 120.1 to 188.6
|
115.3 titer
Interval 97.5 to 136.4
|
158.2 titer
Interval 117.3 to 213.3
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms
B/Colorado/06/2017 (B Victoria lineage) - Day 90
|
294.8 titer
Interval 234.2 to 371.0
|
286.7 titer
Interval 241.4 to 340.5
|
391.7 titer
Interval 285.8 to 536.8
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms
B/Colorado/06/2017 (B Victoria lineage) - Day 118
|
400.4 titer
Interval 313.3 to 511.8
|
373.3 titer
Interval 305.9 to 455.5
|
474.0 titer
Interval 351.9 to 638.3
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 90 through Day 118Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood samples for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid NAI results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
Blood was collected for NAI assay which was conducted with the 2019/2020 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at Day 90 and Day 118 post first study vaccination and the ratio of these GMTs between adjuvanted and unadjuvanted study arms were calculated. The unadjuvanted Fluzone study arm is considered a reference group for the analysis of ratio of GMTs. Ratio of GMTs is defined as the ratio of the GMT from the adjuvanted group divided by the GMT from the corresponding unadjuvanted group.
Outcome measures
| Measure |
Fluzone + CpG55
0.5 mL of 2018/2019 Fluzone QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 2019/2020 of Fluzone QIV intramuscular injection on Day 90.
|
Fluzone
n=37 Participants
0.5 mL of 2018/2019 Fluzone QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Fluzone + AF03
n=40 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.25 mL of AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Flublok
0.5 mL of 2018/2019 Flublok QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + AF03
0.5 mL of 2018/2019 Flublok QIV + 0.25 mL AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + CpG55
0.5 mL of 2018/2019 Flublok QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
|
|---|---|---|---|---|---|---|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms for the Fluzone Study Arms
A/Brisbane/02/2018 IVR-190 (H1N1) - Day 90
|
—
|
1.0 ratio of GMT
Interval 0.6 to 1.6
|
0.8 ratio of GMT
Interval 0.5 to 1.3
|
—
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms for the Fluzone Study Arms
A/Brisbane/02/2018 IVR-190 (H1N1) - Day 118
|
—
|
1.0 ratio of GMT
Interval 0.6 to 1.7
|
0.7 ratio of GMT
Interval 0.5 to 1.2
|
—
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms for the Fluzone Study Arms
A/Kansas/14/2017 (H3N2) - Day 90
|
—
|
1.4 ratio of GMT
Interval 1.0 to 1.9
|
1.0 ratio of GMT
Interval 0.7 to 1.4
|
—
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms for the Fluzone Study Arms
A/Kansas/14/2017 (H3N2) - Day 118
|
—
|
1.1 ratio of GMT
Interval 0.8 to 1.4
|
0.9 ratio of GMT
Interval 0.7 to 1.3
|
—
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms for the Fluzone Study Arms
B/Phuket/3073/2013 (B Yamagata lineage) - Day 90
|
—
|
1.5 ratio of GMT
Interval 1.1 to 2.1
|
1.3 ratio of GMT
Interval 1.0 to 1.7
|
—
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms for the Fluzone Study Arms
B/Phuket/3073/2013 (B Yamagata lineage) - Day 118
|
—
|
1.4 ratio of GMT
Interval 1.0 to 1.9
|
1.3 ratio of GMT
Interval 1.0 to 1.7
|
—
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms for the Fluzone Study Arms
B/Colorado/06/2017 (B Victoria lineage) - Day 90
|
—
|
1.4 ratio of GMT
Interval 1.0 to 1.9
|
1.0 ratio of GMT
Interval 0.8 to 1.4
|
—
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms for the Fluzone Study Arms
B/Colorado/06/2017 (B Victoria lineage) - Day 118
|
—
|
1.3 ratio of GMT
Interval 0.9 to 1.8
|
1.1 ratio of GMT
Interval 0.8 to 1.5
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 118Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood samples for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid NAI results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
Blood was collected for NAI assay which was conducted with the 2019/2020 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. NAI seroconversion was defined as \>4 four-fold rise in post-vaccination antibody titer at Day 90 through Day 118.
Outcome measures
| Measure |
Fluzone + CpG55
n=34 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 2019/2020 of Fluzone QIV intramuscular injection on Day 90.
|
Fluzone
n=36 Participants
0.5 mL of 2018/2019 Fluzone QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Fluzone + AF03
n=30 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.25 mL of AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Flublok
0.5 mL of 2018/2019 Flublok QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + AF03
0.5 mL of 2018/2019 Flublok QIV + 0.25 mL AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + CpG55
0.5 mL of 2018/2019 Flublok QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms
A/Brisbane/02/2018 IVR-190 (H1N1)
|
0 percentage of participants
Interval 0.0 to 10.0
|
6 percentage of participants
Interval to 19.0
Value is NA because it is \>0 but \<1
|
0 percentage of participants
Interval 0.0 to 12.0
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms
A/Kansas/14/2017 (H3N2)
|
0 percentage of participants
Interval 0.0 to 10.0
|
8 percentage of participants
Interval 2.0 to 22.0
|
0 percentage of participants
Interval 0.0 to 12.0
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms
B/Phuket/3073/2013 (B Yamagata lineage)
|
0 percentage of participants
Interval 0.0 to 10.0
|
3 percentage of participants
Interval to 15.0
Value is NA because it is \>0 but \<1
|
0 percentage of participants
Interval 0.0 to 12.0
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms
B/Colorado/06/2017 (B Victoria lineage)
|
0 percentage of participants
Interval 0.0 to 10.0
|
8 percentage of participants
Interval 2.0 to 22.0
|
0 percentage of participants
Interval 0.0 to 12.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 118Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood samples for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid NAI results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
Blood was collected for NAI assay which was conducted with the 2019/2020 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. Fold-rises at Day 118 were calculated as the Day 118 titer divided by the Day 90 titers for each participant. The geometric mean of these fold rises was then calculated to obtain the GMFR.
Outcome measures
| Measure |
Fluzone + CpG55
n=34 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 2019/2020 of Fluzone QIV intramuscular injection on Day 90.
|
Fluzone
n=36 Participants
0.5 mL of 2018/2019 Fluzone QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Fluzone + AF03
n=30 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.25 mL of AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Flublok
0.5 mL of 2018/2019 Flublok QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + AF03
0.5 mL of 2018/2019 Flublok QIV + 0.25 mL AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + CpG55
0.5 mL of 2018/2019 Flublok QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms
A/Brisbane/02/2018 IVR-190 (H1N1)
|
1.2 Fold Rise
Interval 1.1 to 1.4
|
1.3 Fold Rise
Interval 1.1 to 1.5
|
1.2 Fold Rise
Interval 1.0 to 1.3
|
—
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms
A/Kansas/14/2017 (H3N2)
|
1.3 Fold Rise
Interval 1.1 to 1.5
|
1.4 Fold Rise
Interval 1.2 to 1.7
|
1.1 Fold Rise
Interval 1.0 to 1.2
|
—
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms
B/Phuket/3073/2013 (B Yamagata lineage)
|
1.1 Fold Rise
Interval 1.0 to 1.2
|
1.2 Fold Rise
Interval 1.0 to 1.3
|
1.0 Fold Rise
Interval 0.9 to 1.2
|
—
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms
B/Colorado/06/2017 (B Victoria lineage)
|
1.3 Fold Rise
Interval 1.2 to 1.5
|
1.3 Fold Rise
Interval 1.2 to 1.6
|
1.3 Fold Rise
Interval 1.2 to 1.5
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 90 through Day 118Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood samples for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid HAI results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
Blood was collected for Neut assay which was conducted with the 2019/2020 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, but only one result which a geometric mean titer of the replicates was reported by the lab. The geometric mean titer was calculated for each study arm from the available results at Day 90 and Day 118 post first study vaccination.
Outcome measures
| Measure |
Fluzone + CpG55
n=40 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 2019/2020 of Fluzone QIV intramuscular injection on Day 90.
|
Fluzone
n=41 Participants
0.5 mL of 2018/2019 Fluzone QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Fluzone + AF03
n=37 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.25 mL of AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Flublok
n=41 Participants
0.5 mL of 2018/2019 Flublok QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + AF03
n=38 Participants
0.5 mL of 2018/2019 Flublok QIV + 0.25 mL AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + CpG55
n=42 Participants
0.5 mL of 2018/2019 Flublok QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains
A/Brisbane/02/2018 IVR-190 (H1N1) - Day 90
|
2488.0 titer
Interval 1582.9 to 3910.7
|
3375.3 titer
Interval 2416.0 to 4715.5
|
3727.3 titer
Interval 2736.7 to 5076.5
|
4850.2 titer
Interval 3042.7 to 7731.4
|
5622.8 titer
Interval 3362.1 to 9403.6
|
3899.5 titer
Interval 2623.1 to 5796.9
|
|
Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains
A/Brisbane/02/2018 IVR-190 (H1N1) - Day 118
|
2895.1 titer
Interval 1881.9 to 4453.8
|
3891.7 titer
Interval 2737.9 to 5531.8
|
3613.3 titer
Interval 2494.4 to 5234.0
|
6618.8 titer
Interval 4313.1 to 10157.2
|
5654.7 titer
Interval 3513.2 to 9101.6
|
4983.6 titer
Interval 3408.9 to 7285.6
|
|
Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains
A/Kansas/14/2017 (H3N2) - Day 90
|
57.2 titer
Interval 45.0 to 72.7
|
50.7 titer
Interval 41.0 to 62.5
|
81.4 titer
Interval 63.0 to 105.3
|
90.7 titer
Interval 65.0 to 126.7
|
72.3 titer
Interval 56.8 to 92.2
|
79.1 titer
Interval 60.9 to 102.8
|
|
Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains
A/Kansas/14/2017 (H3N2) - Day 118
|
225.6 titer
Interval 173.2 to 293.9
|
238.1 titer
Interval 164.2 to 345.2
|
198.0 titer
Interval 140.0 to 280.2
|
396.6 titer
Interval 262.7 to 598.7
|
266.5 titer
Interval 178.4 to 398.2
|
251.9 titer
Interval 168.1 to 377.3
|
|
Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains
B/Phuket/3073/2013 (B Yamagata lineage) - Day 90
|
766.9 titer
Interval 541.3 to 1086.4
|
681.0 titer
Interval 490.3 to 945.9
|
909.3 titer
Interval 638.8 to 1294.5
|
1371.5 titer
Interval 981.9 to 1915.7
|
953.5 titer
Interval 638.6 to 1423.7
|
754.8 titer
Interval 533.9 to 1066.9
|
|
Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains
B/Phuket/3073/2013 (B Yamagata lineage) - Day 118
|
1086.9 titer
Interval 798.5 to 1479.6
|
1087.2 titer
Interval 762.1 to 1551.2
|
1031.7 titer
Interval 703.9 to 1512.2
|
1920.9 titer
Interval 1351.2 to 2730.8
|
1234.9 titer
Interval 710.6 to 2146.0
|
1284.8 titer
Interval 914.5 to 1805.0
|
|
Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90
|
178.3 titer
Interval 110.1 to 288.7
|
255.4 titer
Interval 173.2 to 376.7
|
235.4 titer
Interval 164.9 to 335.9
|
362.6 titer
Interval 208.1 to 632.0
|
234.1 titer
Interval 140.7 to 389.6
|
232.4 titer
Interval 151.2 to 357.3
|
|
Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118
|
151.5 titer
Interval 85.9 to 267.2
|
202.2 titer
Interval 127.2 to 321.4
|
180.7 titer
Interval 113.0 to 288.9
|
312.0 titer
Interval 160.1 to 607.8
|
212.1 titer
Interval 127.1 to 354.2
|
211.7 titer
Interval 136.9 to 327.2
|
SECONDARY outcome
Timeframe: Day 90 through Day 118Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood samples for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid Neut results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
Blood was collected for Neut assay which was conducted with the 2019/2020 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, but only one result which a geometric mean titer of the replicates was reported by the lab. The geometric mean titer was calculated for each study arm from the available results at Day 90 and Day 118 post first study vaccination and the ratio of these GMTs between adjuvanted and unadjuvanted study arms were calculated. Unadjuvanted Fluzone and Flublok study arms are considered as reference groups for the analysis of ratio of GMTs. Ratio of GMTs is defined as the ratio of the GMT from the adjuvanted group divided by the GMT from the corresponding unadjuvanted group.
Outcome measures
| Measure |
Fluzone + CpG55
n=38 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 2019/2020 of Fluzone QIV intramuscular injection on Day 90.
|
Fluzone
n=37 Participants
0.5 mL of 2018/2019 Fluzone QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Fluzone + AF03
n=40 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.25 mL of AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Flublok
n=42 Participants
0.5 mL of 2018/2019 Flublok QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + AF03
0.5 mL of 2018/2019 Flublok QIV + 0.25 mL AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + CpG55
0.5 mL of 2018/2019 Flublok QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
|
|---|---|---|---|---|---|---|
|
Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Brisbane/02/2018 IVR-190 (H1N1) - Day 90
|
1.2 ratio of GMT
Interval 0.6 to 2.3
|
1.1 ratio of GMT
Interval 0.7 to 1.7
|
0.7 ratio of GMT
Interval 0.4 to 1.3
|
0.8 ratio of GMT
Interval 0.4 to 1.5
|
—
|
—
|
|
Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Brisbane/02/2018 IVR-190 (H1N1) - Day 118
|
0.9 ratio of GMT
Interval 0.5 to 1.6
|
0.9 ratio of GMT
Interval 0.6 to 1.5
|
0.7 ratio of GMT
Interval 0.4 to 1.3
|
0.8 ratio of GMT
Interval 0.4 to 1.3
|
—
|
—
|
|
Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Kansas/14/2017 (H3N2) - Day 90
|
0.8 ratio of GMT
Interval 0.5 to 1.2
|
1.6 ratio of GMT
Interval 1.2 to 2.2
|
1.1 ratio of GMT
Interval 0.8 to 1.5
|
0.9 ratio of GMT
Interval 0.6 to 1.3
|
—
|
—
|
|
Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Kansas/14/2017 (H3N2) - Day 118
|
0.7 ratio of GMT
Interval 0.4 to 1.2
|
0.8 ratio of GMT
Interval 0.5 to 1.4
|
0.9 ratio of GMT
Interval 0.6 to 1.5
|
0.6 ratio of GMT
Interval 0.4 to 1.1
|
—
|
—
|
|
Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms
B/Phuket/3073/2013 (B Yamagata lineage) - Day 90
|
0.7 ratio of GMT
Interval 0.4 to 1.2
|
1.3 ratio of GMT
Interval 0.8 to 2.1
|
1.1 ratio of GMT
Interval 0.7 to 1.8
|
0.6 ratio of GMT
Interval 0.3 to 0.9
|
—
|
—
|
|
Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms
B/Phuket/3073/2013 (B Yamagata lineage) - Day 118
|
0.6 ratio of GMT
Interval 0.3 to 1.2
|
0.9 ratio of GMT
Interval 0.6 to 1.6
|
1.0 ratio of GMT
Interval 0.6 to 1.6
|
0.7 ratio of GMT
Interval 0.4 to 1.1
|
—
|
—
|
|
Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90
|
0.6 ratio of GMT
Interval 0.3 to 1.4
|
0.9 ratio of GMT
Interval 0.5 to 1.5
|
0.7 ratio of GMT
Interval 0.4 to 1.3
|
0.6 ratio of GMT
Interval 0.3 to 1.3
|
—
|
—
|
|
Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118
|
0.7 ratio of GMT
Interval 0.3 to 1.6
|
0.9 ratio of GMT
Interval 0.5 to 1.7
|
0.7 ratio of GMT
Interval 0.4 to 1.5
|
0.7 ratio of GMT
Interval 0.3 to 1.5
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 118Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood samples for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid Neut results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
Blood was collected for Neut assay which was conducted with the 2019/2020 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, but only one result which a geometric mean titer of the replicates was reported by the lab. Neut seroconversion was defined as either a pre-second vaccination titer \< 1:10 and a post-second vaccination titer \>= 1:40 or a pre-second vaccination titer \>= 1:10 and a minimum four-fold rise in post-vaccination antibody titer.
Outcome measures
| Measure |
Fluzone + CpG55
n=34 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 2019/2020 of Fluzone QIV intramuscular injection on Day 90.
|
Fluzone
n=36 Participants
0.5 mL of 2018/2019 Fluzone QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Fluzone + AF03
n=30 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.25 mL of AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Flublok
n=34 Participants
0.5 mL of 2018/2019 Flublok QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + AF03
n=32 Participants
0.5 mL of 2018/2019 Flublok QIV + 0.25 mL AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + CpG55
n=34 Participants
0.5 mL of 2018/2019 Flublok QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains
A/Brisbane/02/2018 IVR-190 (H1N1)
|
0 percentage of participants
Interval 0.0 to 10.0
|
0 percentage of participants
Interval 0.0 to 10.0
|
0 percentage of participants
Interval 0.0 to 12.0
|
9 percentage of participants
Interval 2.0 to 24.0
|
6 percentage of participants
Interval to 21.0
Value is NA because it is \>0 but \<1
|
3 percentage of participants
Interval to 15.0
Value is NA because it is \>0 but \<1
|
|
Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains
A/Kansas/14/2017 (H3N2)
|
44 percentage of participants
Interval 27.0 to 62.0
|
58 percentage of participants
Interval 41.0 to 74.0
|
30 percentage of participants
Interval 15.0 to 49.0
|
56 percentage of participants
Interval 38.0 to 73.0
|
38 percentage of participants
Interval 21.0 to 56.0
|
26 percentage of participants
Interval 13.0 to 44.0
|
|
Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains
B/Phuket/3073/2013 (B Yamagata lineage)
|
3 percentage of participants
Interval to 15.0
Value is NA because it is \>0 but \<1
|
8 percentage of participants
Interval 2.0 to 22.0
|
3 percentage of participants
Interval to 17.0
Value is NA because it is \>0 but \<1
|
0 percentage of participants
Interval 0.0 to 10.0
|
9 percentage of participants
Interval 2.0 to 25.0
|
12 percentage of participants
Interval 3.0 to 27.0
|
|
Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains
B/Maryland/15/2016 BX-69A (B Victoria lineage)
|
0 percentage of participants
Interval 0.0 to 10.0
|
3 percentage of participants
Interval to 15.0
Value is NA because it is \>0 but \<1
|
0 percentage of participants
Interval 0.0 to 12.0
|
0 percentage of participants
Interval 0.0 to 10.0
|
0 percentage of participants
Interval 0.0 to 11.0
|
0 percentage of participants
Interval 0.0 to 10.0
|
SECONDARY outcome
Timeframe: Day 118Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood samples for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid Neut results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
Blood was collected for Neut assay which was conducted with the 2019/2020 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, but only one result which a geometric mean titer of the replicates was reported by the lab. Fold-rises at Day 118 were calculated as the Day 118 titer divided by the Day 90 titers for each participant. The geometric mean of these fold rises was then calculated to obtain the GMFR.
Outcome measures
| Measure |
Fluzone + CpG55
n=34 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 2019/2020 of Fluzone QIV intramuscular injection on Day 90.
|
Fluzone
n=36 Participants
0.5 mL of 2018/2019 Fluzone QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Fluzone + AF03
n=30 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.25 mL of AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Flublok
n=34 Participants
0.5 mL of 2018/2019 Flublok QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + AF03
n=32 Participants
0.5 mL of 2018/2019 Flublok QIV + 0.25 mL AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + CpG55
n=34 Participants
0.5 mL of 2018/2019 Flublok QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains
A/Brisbane/02/2018 IVR-190 (H1N1)
|
1.3 Fold Rise
Interval 1.1 to 1.5
|
1.0 Fold Rise
Interval 0.9 to 1.2
|
1.0 Fold Rise
Interval 0.8 to 1.2
|
1.4 Fold Rise
Interval 1.0 to 1.9
|
1.1 Fold Rise
Interval 0.8 to 1.4
|
1.3 Fold Rise
Interval 1.1 to 1.6
|
|
Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains
A/Kansas/14/2017 (H3N2)
|
3.9 Fold Rise
Interval 2.9 to 5.2
|
5.1 Fold Rise
Interval 3.7 to 6.9
|
2.5 Fold Rise
Interval 1.9 to 3.3
|
4.5 Fold Rise
Interval 2.9 to 7.0
|
3.9 Fold Rise
Interval 2.7 to 5.6
|
3.1 Fold Rise
Interval 2.3 to 4.3
|
|
Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains
B/Phuket/3073/2013 (B Yamagata lineage)
|
1.5 Fold Rise
Interval 1.2 to 1.7
|
1.7 Fold Rise
Interval 1.3 to 2.2
|
1.2 Fold Rise
Interval 0.9 to 1.6
|
1.5 Fold Rise
Interval 1.3 to 1.8
|
1.3 Fold Rise
Interval 0.9 to 1.8
|
1.7 Fold Rise
Interval 1.4 to 2.0
|
|
Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2019/2020 Quadrivalent Influenza Vaccine (QIV) Strains
B/Maryland/15/2016 BX-69A (B Victoria lineage)
|
0.9 Fold Rise
Interval 0.7 to 1.0
|
0.8 Fold Rise
Interval 0.7 to 0.9
|
0.9 Fold Rise
Interval 0.7 to 1.0
|
0.9 Fold Rise
Interval 0.7 to 1.0
|
0.9 Fold Rise
Interval 0.8 to 1.1
|
0.9 Fold Rise
Interval 0.8 to 1.1
|
SECONDARY outcome
Timeframe: Day 8, Day 57, Day 90, Day 118Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood samples for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid HAI results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
Blood was collected for HAI assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at Day 8, Day 57, Day 90, and Day 118 Post first study vaccination.
Outcome measures
| Measure |
Fluzone + CpG55
n=40 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 2019/2020 of Fluzone QIV intramuscular injection on Day 90.
|
Fluzone
n=41 Participants
0.5 mL of 2018/2019 Fluzone QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Fluzone + AF03
n=37 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.25 mL of AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Flublok
n=41 Participants
0.5 mL of 2018/2019 Flublok QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + AF03
n=38 Participants
0.5 mL of 2018/2019 Flublok QIV + 0.25 mL AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + CpG55
n=42 Participants
0.5 mL of 2018/2019 Flublok QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 8
|
343.0 titer
Interval 256.2 to 459.2
|
296.6 titer
Interval 215.3 to 408.5
|
582.8 titer
Interval 421.4 to 805.9
|
398.7 titer
Interval 294.9 to 538.8
|
469.4 titer
Interval 314.4 to 700.6
|
347.5 titer
Interval 255.9 to 472.0
|
|
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 57
|
266.6 titer
Interval 184.4 to 385.5
|
248.9 titer
Interval 175.2 to 353.7
|
520.8 titer
Interval 386.2 to 702.3
|
602.3 titer
Interval 451.0 to 804.5
|
506.4 titer
Interval 354.6 to 723.1
|
408.9 titer
Interval 301.2 to 555.1
|
|
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 90
|
245.6 titer
Interval 169.1 to 356.7
|
224.4 titer
Interval 162.3 to 310.2
|
456.9 titer
Interval 338.1 to 617.5
|
565.1 titer
Interval 426.9 to 748.2
|
444.1 titer
Interval 314.1 to 628.1
|
383.9 titer
Interval 272.1 to 541.5
|
|
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 118
|
404.5 titer
Interval 264.2 to 619.4
|
320.0 titer
Interval 224.7 to 455.7
|
570.2 titer
Interval 409.2 to 794.5
|
962.2 titer
Interval 698.8 to 1324.9
|
839.0 titer
Interval 585.3 to 1202.7
|
554.9 titer
Interval 356.8 to 863.0
|
|
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 8
|
400.9 titer
Interval 290.8 to 552.6
|
441.2 titer
Interval 335.5 to 580.2
|
525.7 titer
Interval 389.4 to 709.8
|
480.1 titer
Interval 333.2 to 691.8
|
402.0 titer
Interval 278.4 to 580.3
|
344.7 titer
Interval 247.1 to 480.7
|
|
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 57
|
254.8 titer
Interval 177.6 to 365.3
|
322.8 titer
Interval 241.0 to 432.3
|
338.5 titer
Interval 243.7 to 470.2
|
422.2 titer
Interval 285.7 to 624.0
|
311.1 titer
Interval 216.9 to 446.3
|
286.7 titer
Interval 201.2 to 408.5
|
|
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90
|
245.6 titer
Interval 170.6 to 353.7
|
312.0 titer
Interval 231.6 to 420.3
|
339.0 titer
Interval 241.2 to 476.5
|
410.4 titer
Interval 270.4 to 622.8
|
323.0 titer
Interval 219.2 to 475.9
|
303.8 titer
Interval 215.8 to 427.6
|
|
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118
|
255.7 titer
Interval 170.6 to 383.3
|
323.1 titer
Interval 235.1 to 443.9
|
281.8 titer
Interval 196.2 to 404.8
|
404.5 titer
Interval 255.1 to 641.4
|
320.0 titer
Interval 224.4 to 456.3
|
329.9 titer
Interval 233.6 to 465.9
|
|
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Michigan/45/2015 X-275 (H1N1) - Day 8
|
472.6 titer
Interval 340.3 to 656.3
|
603.2 titer
Interval 442.7 to 821.9
|
561.3 titer
Interval 409.9 to 768.8
|
673.3 titer
Interval 476.6 to 951.2
|
701.1 titer
Interval 471.8 to 1041.9
|
542.6 titer
Interval 382.1 to 770.6
|
|
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Michigan/45/2015 X-275 (H1N1) - Day 57
|
440.3 titer
Interval 305.5 to 634.6
|
629.0 titer
Interval 472.5 to 837.4
|
582.8 titer
Interval 431.6 to 787.0
|
897.3 titer
Interval 648.4 to 1241.7
|
771.9 titer
Interval 527.9 to 1128.6
|
645.4 titer
Interval 460.9 to 903.8
|
|
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Michigan/45/2015 X-275 (H1N1) - Day 90
|
366.9 titer
Interval 252.9 to 532.4
|
526.9 titer
Interval 390.9 to 710.3
|
548.6 titer
Interval 401.8 to 749.1
|
757.7 titer
Interval 550.4 to 1043.2
|
689.8 titer
Interval 476.7 to 998.2
|
571.8 titer
Interval 401.5 to 814.3
|
|
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Michigan/45/2015 X-275 (H1N1) - Day 118
|
361.6 titer
Interval 242.1 to 540.3
|
586.9 titer
Interval 436.0 to 790.0
|
519.8 titer
Interval 351.0 to 770.0
|
868.9 titer
Interval 610.4 to 1237.0
|
697.9 titer
Interval 457.5 to 1064.6
|
715.9 titer
Interval 502.3 to 1020.4
|
|
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Phuket/3073/2013 (B Yamagata lineage) - Day 8
|
889.5 titer
Interval 727.8 to 1087.3
|
714.3 titer
Interval 553.7 to 921.6
|
1061.3 titer
Interval 844.2 to 1334.2
|
1045.0 titer
Interval 801.2 to 1363.0
|
1019.0 titer
Interval 794.5 to 1306.9
|
875.7 titer
Interval 690.0 to 1111.4
|
|
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Phuket/3073/2013 (B Yamagata lineage) - Day 57
|
740.6 titer
Interval 584.7 to 938.0
|
629.0 titer
Interval 478.4 to 827.1
|
905.1 titer
Interval 688.4 to 1190.1
|
1133.8 titer
Interval 887.1 to 1449.1
|
839.8 titer
Interval 617.7 to 1141.6
|
817.8 titer
Interval 638.6 to 1047.3
|
|
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Phuket/3073/2013 (B Yamagata lineage) - Day 90
|
849.1 titer
Interval 644.1 to 1119.4
|
797.3 titer
Interval 595.9 to 1066.9
|
1129.4 titer
Interval 853.2 to 1495.2
|
1502.0 titer
Interval 1132.8 to 1991.7
|
1041.6 titer
Interval 747.5 to 1451.6
|
995.6 titer
Interval 752.0 to 1318.1
|
|
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Phuket/3073/2013 (B Yamagata lineage) - Day 118
|
792.8 titer
Interval 615.8 to 1020.6
|
665.1 titer
Interval 499.2 to 886.2
|
874.3 titer
Interval 647.1 to 1181.1
|
1228.9 titer
Interval 924.0 to 1634.4
|
905.1 titer
Interval 649.8 to 1260.7
|
1065.4 titer
Interval 836.2 to 1357.5
|
SECONDARY outcome
Timeframe: Day 8, Day 57, Day 90, Day 118Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood samples for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid HAI results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
Blood was collected for HAI assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at Day 8, Day 57, Day 90, and Day 118 Post first study vaccination and the ratio of these GMTs between adjuvanted and unadjuvanted study arms were calculated. Unadjuvanted Fluzone and Flublok study arms are considered as reference groups for the analysis of ratio of GMTs. Ratio of GMTs is defined as the ratio of the GMT from the adjuvanted group divided by the GMT from the corresponding unadjuvanted group.
Outcome measures
| Measure |
Fluzone + CpG55
n=38 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 2019/2020 of Fluzone QIV intramuscular injection on Day 90.
|
Fluzone
n=37 Participants
0.5 mL of 2018/2019 Fluzone QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Fluzone + AF03
n=40 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.25 mL of AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Flublok
n=42 Participants
0.5 mL of 2018/2019 Flublok QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + AF03
0.5 mL of 2018/2019 Flublok QIV + 0.25 mL AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + CpG55
0.5 mL of 2018/2019 Flublok QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
|
|---|---|---|---|---|---|---|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Michigan/45/2015 X-275 (H1N1) - Day 8
|
1.0 ratio of GMT
Interval 0.6 to 1.7
|
0.9 ratio of GMT
Interval 0.6 to 1.4
|
0.8 ratio of GMT
Interval 0.5 to 1.2
|
0.8 ratio of GMT
Interval 0.5 to 1.3
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Michigan/45/2015 X-275 (H1N1) - Day 57
|
0.9 ratio of GMT
Interval 0.5 to 1.4
|
0.9 ratio of GMT
Interval 0.6 to 1.4
|
0.7 ratio of GMT
Interval 0.4 to 1.1
|
0.7 ratio of GMT
Interval 0.5 to 1.1
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Michigan/45/2015 X-275 (H1N1) - Day 90
|
0.9 ratio of GMT
Interval 0.6 to 1.5
|
1.0 ratio of GMT
Interval 0.7 to 1.6
|
0.7 ratio of GMT
Interval 0.4 to 1.1
|
0.8 ratio of GMT
Interval 0.5 to 1.2
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Michigan/45/2015 X-275 (H1N1) - Day 118
|
0.8 ratio of GMT
Interval 0.5 to 1.4
|
0.9 ratio of GMT
Interval 0.5 to 1.4
|
0.6 ratio of GMT
Interval 0.4 to 1.0
|
0.8 ratio of GMT
Interval 0.5 to 1.3
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms
B/Phuket/3073/2013 (B Yamagata lineage) - Day 8
|
1.0 ratio of GMT
Interval 0.7 to 1.4
|
1.5 ratio of GMT
Interval 1.1 to 2.1
|
1.2 ratio of GMT
Interval 0.9 to 1.7
|
0.8 ratio of GMT
Interval 0.6 to 1.2
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms
B/Phuket/3073/2013 (B Yamagata lineage) - Day 57
|
0.7 ratio of GMT
Interval 0.5 to 1.1
|
1.4 ratio of GMT
Interval 1.0 to 2.1
|
1.2 ratio of GMT
Interval 0.8 to 1.7
|
0.7 ratio of GMT
Interval 0.5 to 1.0
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms
B/Phuket/3073/2013 (B Yamagata lineage) - Day 90
|
0.7 ratio of GMT
Interval 0.5 to 1.1
|
1.4 ratio of GMT
Interval 1.0 to 2.1
|
1.1 ratio of GMT
Interval 0.7 to 1.6
|
0.7 ratio of GMT
Interval 0.4 to 1.0
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms
B/Phuket/3073/2013 (B Yamagata lineage) - Day 118
|
0.7 ratio of GMT
Interval 0.5 to 1.1
|
1.3 ratio of GMT
Interval 0.9 to 2.0
|
1.2 ratio of GMT
Interval 0.8 to 1.7
|
0.9 ratio of GMT
Interval 0.6 to 1.3
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 8
|
1.2 ratio of GMT
Interval 0.7 to 1.9
|
2.0 ratio of GMT
Interval 1.3 to 3.1
|
1.2 ratio of GMT
Interval 0.8 to 1.8
|
0.9 ratio of GMT
Interval 0.6 to 1.3
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 57
|
0.8 ratio of GMT
Interval 0.5 to 1.3
|
2.1 ratio of GMT
Interval 1.3 to 3.3
|
1.1 ratio of GMT
Interval 0.6 to 1.8
|
0.7 ratio of GMT
Interval 0.4 to 1.0
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 90
|
0.8 ratio of GMT
Interval 0.5 to 1.2
|
2.0 ratio of GMT
Interval 1.3 to 3.1
|
1.1 ratio of GMT
Interval 0.7 to 1.8
|
0.7 ratio of GMT
Interval 0.4 to 1.1
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 118
|
0.9 ratio of GMT
Interval 0.5 to 1.4
|
1.8 ratio of GMT
Interval 1.1 to 2.9
|
1.3 ratio of GMT
Interval 0.7 to 2.2
|
0.6 ratio of GMT
Interval 0.3 to 1.0
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 8
|
0.8 ratio of GMT
Interval 0.5 to 1.4
|
1.2 ratio of GMT
Interval 0.8 to 1.8
|
0.9 ratio of GMT
Interval 0.6 to 1.4
|
0.7 ratio of GMT
Interval 0.4 to 1.2
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 57
|
0.7 ratio of GMT
Interval 0.4 to 1.2
|
1.0 ratio of GMT
Interval 0.7 to 1.6
|
0.8 ratio of GMT
Interval 0.5 to 1.2
|
0.7 ratio of GMT
Interval 0.4 to 1.1
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90
|
0.8 ratio of GMT
Interval 0.4 to 1.4
|
1.1 ratio of GMT
Interval 0.7 to 1.7
|
0.8 ratio of GMT
Interval 0.5 to 1.3
|
0.7 ratio of GMT
Interval 0.4 to 1.3
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118
|
0.8 ratio of GMT
Interval 0.4 to 1.4
|
0.9 ratio of GMT
Interval 0.5 to 1.4
|
0.8 ratio of GMT
Interval 0.5 to 1.3
|
0.8 ratio of GMT
Interval 0.5 to 1.4
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 8, Day 57, Day 90, Day 118Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood samples for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid HAI results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
Blood was collected for HAI assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. HAI seroconversion was defined as either a pre-vaccination titer \< 1:10 and a post-vaccination titer \>= 1:40 or a pre-vaccination titer \>= 1:10 and a minimum four-fold rise in post-vaccination antibody titer.
Outcome measures
| Measure |
Fluzone + CpG55
n=40 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 2019/2020 of Fluzone QIV intramuscular injection on Day 90.
|
Fluzone
n=41 Participants
0.5 mL of 2018/2019 Fluzone QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Fluzone + AF03
n=37 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.25 mL of AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Flublok
n=41 Participants
0.5 mL of 2018/2019 Flublok QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + AF03
n=38 Participants
0.5 mL of 2018/2019 Flublok QIV + 0.25 mL AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + CpG55
n=42 Participants
0.5 mL of 2018/2019 Flublok QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 8
|
30 percentage of participants
Interval 17.0 to 47.0
|
27 percentage of participants
Interval 14.0 to 43.0
|
35 percentage of participants
Interval 20.0 to 53.0
|
29 percentage of participants
Interval 16.0 to 46.0
|
47 percentage of participants
Interval 31.0 to 64.0
|
43 percentage of participants
Interval 28.0 to 59.0
|
|
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 57
|
32 percentage of participants
Interval 18.0 to 49.0
|
25 percentage of participants
Interval 13.0 to 41.0
|
30 percentage of participants
Interval 16.0 to 47.0
|
43 percentage of participants
Interval 27.0 to 59.0
|
54 percentage of participants
Interval 37.0 to 71.0
|
44 percentage of participants
Interval 28.0 to 60.0
|
|
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 90
|
32 percentage of participants
Interval 18.0 to 49.0
|
24 percentage of participants
Interval 12.0 to 40.0
|
25 percentage of participants
Interval 12.0 to 42.0
|
41 percentage of participants
Interval 26.0 to 58.0
|
41 percentage of participants
Interval 25.0 to 58.0
|
43 percentage of participants
Interval 27.0 to 59.0
|
|
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 118
|
50 percentage of participants
Interval 32.0 to 68.0
|
42 percentage of participants
Interval 26.0 to 59.0
|
37 percentage of participants
Interval 20.0 to 56.0
|
71 percentage of participants
Interval 53.0 to 85.0
|
72 percentage of participants
Interval 53.0 to 86.0
|
56 percentage of participants
Interval 38.0 to 73.0
|
|
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 8
|
35 percentage of participants
Interval 21.0 to 52.0
|
27 percentage of participants
Interval 14.0 to 43.0
|
35 percentage of participants
Interval 20.0 to 53.0
|
22 percentage of participants
Interval 11.0 to 38.0
|
47 percentage of participants
Interval 31.0 to 64.0
|
26 percentage of participants
Interval 14.0 to 42.0
|
|
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 57
|
24 percentage of participants
Interval 11.0 to 40.0
|
20 percentage of participants
Interval 9.0 to 36.0
|
22 percentage of participants
Interval 10.0 to 38.0
|
15 percentage of participants
Interval 6.0 to 30.0
|
35 percentage of participants
Interval 20.0 to 53.0
|
22 percentage of participants
Interval 11.0 to 38.0
|
|
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90
|
24 percentage of participants
Interval 11.0 to 40.0
|
22 percentage of participants
Interval 11.0 to 38.0
|
22 percentage of participants
Interval 10.0 to 39.0
|
15 percentage of participants
Interval 6.0 to 31.0
|
35 percentage of participants
Interval 20.0 to 53.0
|
23 percentage of participants
Interval 11.0 to 38.0
|
|
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118
|
26 percentage of participants
Interval 13.0 to 44.0
|
22 percentage of participants
Interval 10.0 to 39.0
|
17 percentage of participants
Interval 6.0 to 35.0
|
15 percentage of participants
Interval 5.0 to 31.0
|
31 percentage of participants
Interval 16.0 to 50.0
|
29 percentage of participants
Interval 15.0 to 47.0
|
|
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Michigan/45/2015 X-275 (H1N1) - Day 8
|
23 percentage of participants
Interval 11.0 to 38.0
|
22 percentage of participants
Interval 11.0 to 38.0
|
19 percentage of participants
Interval 8.0 to 35.0
|
24 percentage of participants
Interval 12.0 to 40.0
|
39 percentage of participants
Interval 24.0 to 57.0
|
24 percentage of participants
Interval 12.0 to 39.0
|
|
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Michigan/45/2015 X-275 (H1N1) - Day 57
|
24 percentage of participants
Interval 11.0 to 40.0
|
23 percentage of participants
Interval 11.0 to 38.0
|
24 percentage of participants
Interval 12.0 to 41.0
|
33 percentage of participants
Interval 19.0 to 49.0
|
46 percentage of participants
Interval 29.0 to 63.0
|
24 percentage of participants
Interval 12.0 to 40.0
|
|
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Michigan/45/2015 X-275 (H1N1) - Day 90
|
16 percentage of participants
Interval 6.0 to 31.0
|
20 percentage of participants
Interval 9.0 to 35.0
|
17 percentage of participants
Interval 6.0 to 33.0
|
28 percentage of participants
Interval 15.0 to 45.0
|
38 percentage of participants
Interval 22.0 to 55.0
|
23 percentage of participants
Interval 11.0 to 38.0
|
|
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Michigan/45/2015 X-275 (H1N1) - Day 118
|
24 percentage of participants
Interval 11.0 to 41.0
|
22 percentage of participants
Interval 10.0 to 39.0
|
10 percentage of participants
Interval 2.0 to 27.0
|
32 percentage of participants
Interval 17.0 to 51.0
|
47 percentage of participants
Interval 29.0 to 65.0
|
44 percentage of participants
Interval 27.0 to 62.0
|
|
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Phuket/3073/2013 (B Yamagata lineage) - Day 8
|
20 percentage of participants
Interval 9.0 to 36.0
|
20 percentage of participants
Interval 9.0 to 35.0
|
16 percentage of participants
Interval 6.0 to 32.0
|
12 percentage of participants
Interval 4.0 to 26.0
|
29 percentage of participants
Interval 15.0 to 46.0
|
21 percentage of participants
Interval 10.0 to 37.0
|
|
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Phuket/3073/2013 (B Yamagata lineage) - Day 57
|
16 percentage of participants
Interval 6.0 to 31.0
|
15 percentage of participants
Interval 6.0 to 30.0
|
19 percentage of participants
Interval 8.0 to 35.0
|
18 percentage of participants
Interval 7.0 to 33.0
|
30 percentage of participants
Interval 16.0 to 47.0
|
22 percentage of participants
Interval 11.0 to 38.0
|
|
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Phuket/3073/2013 (B Yamagata lineage) - Day 90
|
13 percentage of participants
Interval 4.0 to 28.0
|
22 percentage of participants
Interval 11.0 to 38.0
|
14 percentage of participants
Interval 5.0 to 29.0
|
26 percentage of participants
Interval 13.0 to 42.0
|
27 percentage of participants
Interval 14.0 to 44.0
|
30 percentage of participants
Interval 17.0 to 47.0
|
|
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Phuket/3073/2013 (B Yamagata lineage) - Day 118
|
15 percentage of participants
Interval 5.0 to 31.0
|
17 percentage of participants
Interval 6.0 to 33.0
|
13 percentage of participants
Interval 4.0 to 31.0
|
15 percentage of participants
Interval 5.0 to 31.0
|
16 percentage of participants
Interval 5.0 to 33.0
|
35 percentage of participants
Interval 20.0 to 54.0
|
SECONDARY outcome
Timeframe: Day 8, Day 57, Day 90, Day 118Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood samples for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid HAI results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
Blood was collected for HAI assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result.
Outcome measures
| Measure |
Fluzone + CpG55
n=40 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 2019/2020 of Fluzone QIV intramuscular injection on Day 90.
|
Fluzone
n=41 Participants
0.5 mL of 2018/2019 Fluzone QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Fluzone + AF03
n=37 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.25 mL of AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Flublok
n=41 Participants
0.5 mL of 2018/2019 Flublok QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + AF03
n=38 Participants
0.5 mL of 2018/2019 Flublok QIV + 0.25 mL AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + CpG55
n=42 Participants
0.5 mL of 2018/2019 Flublok QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90
|
97 percentage of participants
Interval 86.0 to
Value is NA because it's \>99 but \<100
|
98 percentage of participants
Interval 87.0 to
Value is NA because it's \>99 but \<100
|
100 percentage of participants
Interval 90.0 to 100.0
|
97 percentage of participants
Interval 87.0 to
Value is NA because it's \>99 but \<100
|
97 percentage of participants
Interval 86.0 to
Value is NA because it's \>99 but \<100
|
100 percentage of participants
Interval 91.0 to 100.0
|
|
Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 8
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
97 percentage of participants
Interval 86.0 to
Value is NA because it's \>99 but \<100
|
100 percentage of participants
Interval 92.0 to 100.0
|
|
Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 57
|
97 percentage of participants
Interval 86.0 to
Value is NA because it's \>99 but \<100
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
|
Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 90
|
97 percentage of participants
Interval 86.0 to
Value is NA because it's \>99 but \<100
|
98 percentage of participants
Interval 87.0 to
Value is NA because it's \>99 but \<100
|
100 percentage of participants
Interval 90.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
98 percentage of participants
Interval 87.0 to
Value is NA because it's \>99 but \<100
|
|
Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 118
|
97 percentage of participants
Interval 85.0 to
Value is NA because it's \>99 but \<100
|
100 percentage of participants
Interval 90.0 to 100.0
|
100 percentage of participants
Interval 88.0 to 100.0
|
100 percentage of participants
Interval 90.0 to 100.0
|
100 percentage of participants
Interval 89.0 to 100.0
|
100 percentage of participants
Interval 90.0 to 100.0
|
|
Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 8
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
97 percentage of participants
Interval 86.0 to
Value is NA because it's \>99 but \<100
|
100 percentage of participants
Interval 92.0 to 100.0
|
|
Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 57
|
97 percentage of participants
Interval 86.0 to
Value is NA because it's \>99 but \<100
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
97 percentage of participants
Interval 86.0 to
Value is NA because it's \>99 but \<100
|
100 percentage of participants
Interval 91.0 to 100.0
|
|
Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118
|
97 percentage of participants
Interval 85.0 to
Value is NA because it's \>99 but \<100
|
100 percentage of participants
Interval 90.0 to 100.0
|
100 percentage of participants
Interval 88.0 to 100.0
|
100 percentage of participants
Interval 90.0 to 100.0
|
94 percentage of participants
Interval 79.0 to
Value is NA because it's \>99 but \<100
|
100 percentage of participants
Interval 90.0 to 100.0
|
|
Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Michigan/45/2015 X-275 (H1N1) - Day 57
|
95 percentage of participants
Interval 82.0 to
Value is NA because it's \>99 but \<100
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
97 percentage of participants
Interval 86.0 to
Value is NA because it's \>99 but \<100
|
98 percentage of participants
Interval 87.0 to
Value is NA because it's \>99 but \<100
|
|
Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Michigan/45/2015 X-275 (H1N1) - Day 90
|
95 percentage of participants
Interval 82.0 to
Value is NA because it's \>99 but \<100
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 90.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
97 percentage of participants
Interval 86.0 to
Value is NA because it's \>99 but \<100
|
98 percentage of participants
Interval 87.0 to
Value is NA because it's \>99 but \<100
|
|
Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Michigan/45/2015 X-275 (H1N1) - Day 8
|
98 percentage of participants
Interval 87.0 to
Value is NA because it's \>99 but \<100
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
97 percentage of participants
Interval 86.0 to
Value is NA because it's \>99 but \<100
|
98 percentage of participants
Interval 87.0 to
Value is NA because it's \>99 but \<100
|
|
Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Michigan/45/2015 X-275 (H1N1) - Day 118
|
94 percentage of participants
Interval 80.0 to
Value is NA because it's \>99 but \<100
|
100 percentage of participants
Interval 90.0 to 100.0
|
100 percentage of participants
Interval 88.0 to 100.0
|
100 percentage of participants
Interval 90.0 to 100.0
|
97 percentage of participants
Interval 84.0 to
Value is NA because it's \>99 but \<100
|
100 percentage of participants
Interval 90.0 to 100.0
|
|
Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Phuket/3073/2013 (B Yamagata lineage) - Day 118
|
100 percentage of participants
Interval 90.0 to 100.0
|
100 percentage of participants
Interval 90.0 to 100.0
|
100 percentage of participants
Interval 88.0 to 100.0
|
100 percentage of participants
Interval 90.0 to 100.0
|
100 percentage of participants
Interval 89.0 to 100.0
|
100 percentage of participants
Interval 90.0 to 100.0
|
|
Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Phuket/3073/2013 (B Yamagata lineage) - Day 8
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 92.0 to 100.0
|
|
Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Phuket/3073/2013 (B Yamagata lineage) - Day 57
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
|
Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Phuket/3073/2013 (B Yamagata lineage) - Day 90
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 90.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
SECONDARY outcome
Timeframe: Day 8, Day 57, Day 90, Day 118Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood samples for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid HAI results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
Blood was collected for HAI assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. Fold-rises from baseline were calculated as the Day 8 (or Day 57, Day 90, Day 118) titer divided by the baseline titers for each participant. The geometric mean of these fold rises was then calculated to obtain the GMFR.
Outcome measures
| Measure |
Fluzone + CpG55
n=40 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 2019/2020 of Fluzone QIV intramuscular injection on Day 90.
|
Fluzone
n=41 Participants
0.5 mL of 2018/2019 Fluzone QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Fluzone + AF03
n=37 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.25 mL of AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Flublok
n=41 Participants
0.5 mL of 2018/2019 Flublok QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + AF03
n=38 Participants
0.5 mL of 2018/2019 Flublok QIV + 0.25 mL AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + CpG55
n=42 Participants
0.5 mL of 2018/2019 Flublok QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 57
|
2.2 fold rise
Interval 1.5 to 3.2
|
2.2 fold rise
Interval 1.5 to 3.2
|
2.3 fold rise
Interval 1.5 to 3.3
|
1.7 fold rise
Interval 1.3 to 2.2
|
2.8 fold rise
Interval 2.0 to 4.0
|
2.1 fold rise
Interval 1.6 to 2.8
|
|
Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90
|
2.1 fold rise
Interval 1.5 to 2.9
|
2.2 fold rise
Interval 1.5 to 3.3
|
2.4 fold rise
Interval 1.6 to 3.5
|
1.7 fold rise
Interval 1.3 to 2.2
|
2.9 fold rise
Interval 2.1 to 4.1
|
2.3 fold rise
Interval 1.7 to 3.0
|
|
Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118
|
2.3 fold rise
Interval 1.7 to 3.1
|
2.3 fold rise
Interval 1.5 to 3.5
|
2.1 fold rise
Interval 1.4 to 3.2
|
1.6 fold rise
Interval 1.3 to 2.2
|
2.9 fold rise
Interval 2.0 to 4.2
|
2.6 fold rise
Interval 1.9 to 3.7
|
|
Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Phuket/3073/2013 (B Yamagata lineage) - Day 118
|
1.8 fold rise
Interval 1.4 to 2.4
|
1.8 fold rise
Interval 1.4 to 2.3
|
1.8 fold rise
Interval 1.1 to 2.7
|
2.0 fold rise
Interval 1.4 to 2.9
|
2.6 fold rise
Interval 1.7 to 3.9
|
2.8 fold rise
Interval 2.2 to 3.5
|
|
Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Michigan/45/2015 X-275 (H1N1) - Day 57
|
2.7 fold rise
Interval 1.9 to 3.9
|
2.4 fold rise
Interval 1.7 to 3.5
|
3.0 fold rise
Interval 1.9 to 4.6
|
2.8 fold rise
Interval 2.2 to 3.6
|
4.2 fold rise
Interval 2.9 to 6.3
|
2.6 fold rise
Interval 2.0 to 3.5
|
|
Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Michigan/45/2015 X-275 (H1N1) - Day 8
|
2.7 fold rise
Interval 1.8 to 4.2
|
2.5 fold rise
Interval 1.6 to 3.8
|
2.9 fold rise
Interval 1.9 to 4.4
|
2.3 fold rise
Interval 1.7 to 3.0
|
3.8 fold rise
Interval 2.4 to 5.8
|
2.3 fold rise
Interval 1.7 to 3.1
|
|
Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Phuket/3073/2013 (B Yamagata lineage) - Day 90
|
1.8 fold rise
Interval 1.4 to 2.3
|
2.2 fold rise
Interval 1.7 to 2.8
|
2.2 fold rise
Interval 1.5 to 3.3
|
2.5 fold rise
Interval 1.7 to 3.5
|
3.1 fold rise
Interval 2.0 to 4.7
|
2.5 fold rise
Interval 2.0 to 3.2
|
|
Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Michigan/45/2015 X-275 (H1N1) - Day 90
|
2.3 fold rise
Interval 1.6 to 3.2
|
2.2 fold rise
Interval 1.6 to 3.0
|
2.7 fold rise
Interval 1.8 to 4.1
|
2.4 fold rise
Interval 1.9 to 3.0
|
3.8 fold rise
Interval 2.5 to 5.7
|
2.4 fold rise
Interval 1.8 to 3.0
|
|
Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Michigan/45/2015 X-275 (H1N1) - Day 118
|
2.5 fold rise
Interval 1.8 to 3.6
|
2.2 fold rise
Interval 1.5 to 3.2
|
2.2 fold rise
Interval 1.4 to 3.7
|
2.7 fold rise
Interval 2.1 to 3.4
|
3.8 fold rise
Interval 2.5 to 5.7
|
3.0 fold rise
Interval 2.2 to 4.2
|
|
Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Phuket/3073/2013 (B Yamagata lineage) - Day 8
|
1.8 fold rise
Interval 1.4 to 2.3
|
1.9 fold rise
Interval 1.4 to 2.8
|
2.2 fold rise
Interval 1.6 to 3.1
|
1.7 fold rise
Interval 1.2 to 2.4
|
3.1 fold rise
Interval 2.0 to 4.8
|
2.2 fold rise
Interval 1.8 to 2.8
|
|
Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Phuket/3073/2013 (B Yamagata lineage) - Day 57
|
1.5 fold rise
Interval 1.1 to 2.1
|
1.7 fold rise
Interval 1.3 to 2.3
|
1.9 fold rise
Interval 1.3 to 2.8
|
1.8 fold rise
Interval 1.3 to 2.5
|
2.5 fold rise
Interval 1.6 to 3.9
|
2.1 fold rise
Interval 1.6 to 2.7
|
|
Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 8
|
3.5 fold rise
Interval 2.1 to 5.9
|
2.6 fold rise
Interval 1.7 to 3.9
|
3.0 fold rise
Interval 1.9 to 4.8
|
2.4 fold rise
Interval 1.8 to 3.3
|
3.6 fold rise
Interval 2.6 to 5.1
|
3.2 fold rise
Interval 2.2 to 4.6
|
|
Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 57
|
3.0 fold rise
Interval 2.0 to 4.5
|
2.2 fold rise
Interval 1.5 to 3.1
|
2.7 fold rise
Interval 1.8 to 4.0
|
3.6 fold rise
Interval 2.5 to 5.2
|
3.8 fold rise
Interval 2.7 to 5.3
|
3.6 fold rise
Interval 2.5 to 5.0
|
|
Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 8
|
3.3 fold rise
Interval 2.2 to 5.1
|
3.1 fold rise
Interval 2.0 to 5.0
|
3.5 fold rise
Interval 2.4 to 5.2
|
1.9 fold rise
Interval 1.5 to 2.5
|
3.8 fold rise
Interval 2.5 to 5.6
|
2.6 fold rise
Interval 1.9 to 3.6
|
|
Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 90
|
2.8 fold rise
Interval 1.9 to 4.1
|
2.0 fold rise
Interval 1.4 to 2.7
|
2.2 fold rise
Interval 1.6 to 3.1
|
3.4 fold rise
Interval 2.4 to 4.8
|
3.3 fold rise
Interval 2.4 to 4.6
|
3.3 fold rise
Interval 2.3 to 4.7
|
|
Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 118
|
5.0 fold rise
Interval 3.3 to 7.7
|
3.1 fold rise
Interval 2.2 to 4.5
|
2.8 fold rise
Interval 2.0 to 3.9
|
6.1 fold rise
Interval 4.2 to 8.8
|
6.7 fold rise
Interval 4.3 to 10.2
|
5.3 fold rise
Interval 3.7 to 7.7
|
SECONDARY outcome
Timeframe: Day 8, Day 57, Day 90, Day 118Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood samples for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid NAI results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
Blood was collected for NAI assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at Day 8, Day 57, Day 90, and Day 118 Post first study vaccination.
Outcome measures
| Measure |
Fluzone + CpG55
n=40 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 2019/2020 of Fluzone QIV intramuscular injection on Day 90.
|
Fluzone
n=41 Participants
0.5 mL of 2018/2019 Fluzone QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Fluzone + AF03
n=37 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.25 mL of AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Flublok
0.5 mL of 2018/2019 Flublok QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + AF03
0.5 mL of 2018/2019 Flublok QIV + 0.25 mL AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + CpG55
0.5 mL of 2018/2019 Flublok QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 8
|
394.0 titer
Interval 291.6 to 532.3
|
441.2 titer
Interval 330.9 to 588.3
|
501.7 titer
Interval 383.2 to 656.8
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 57
|
202.8 titer
Interval 145.2 to 283.3
|
262.2 titer
Interval 190.5 to 360.8
|
260.4 titer
Interval 195.3 to 347.2
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 90
|
148.7 titer
Interval 103.3 to 214.1
|
201.0 titer
Interval 143.3 to 282.0
|
201.6 titer
Interval 145.0 to 280.2
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 118
|
200.2 titer
Interval 144.3 to 277.8
|
258.9 titer
Interval 191.1 to 350.8
|
242.5 titer
Interval 170.2 to 345.5
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms
B/Colorado/06/2017 (B Victoria lineage) - Day 8
|
415.0 titer
Interval 326.7 to 527.1
|
385.4 titer
Interval 306.3 to 484.9
|
566.6 titer
Interval 432.0 to 743.2
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms
B/Colorado/06/2017 (B Victoria lineage) - Day 57
|
311.4 titer
Interval 243.8 to 397.7
|
309.1 titer
Interval 261.3 to 365.6
|
427.8 titer
Interval 313.8 to 583.3
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms
B/Colorado/06/2017 (B Victoria lineage) - Day 90
|
294.8 titer
Interval 234.2 to 371.0
|
286.7 titer
Interval 241.4 to 340.5
|
391.7 titer
Interval 285.8 to 536.8
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms
B/Colorado/06/2017 (B Victoria lineage) - Day 118
|
400.4 titer
Interval 313.3 to 511.8
|
373.3 titer
Interval 305.9 to 455.5
|
474.0 titer
Interval 351.9 to 638.3
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms
A/Michigan/45/2015 X-275 (H1N1) - Day 8
|
352.0 titer
Interval 265.0 to 467.6
|
398.7 titer
Interval 303.7 to 523.3
|
419.9 titer
Interval 318.0 to 554.4
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms
A/Michigan/45/2015 X-275 (H1N1) - Day 57
|
155.7 titer
Interval 113.5 to 213.5
|
218.6 titer
Interval 160.9 to 296.9
|
220.0 titer
Interval 161.6 to 299.5
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms
A/Michigan/45/2015 X-275 (H1N1) - Day 90
|
125.1 titer
Interval 89.7 to 174.5
|
189.5 titer
Interval 139.3 to 257.7
|
176.2 titer
Interval 127.9 to 242.7
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms
A/Michigan/45/2015 X-275 (H1N1) - Day 118
|
177.2 titer
Interval 126.8 to 247.6
|
261.4 titer
Interval 186.5 to 366.5
|
218.6 titer
Interval 156.0 to 306.2
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms
B/Phuket/3073/2013 (B Yamagata lineage) - Day 8
|
174.5 titer
Interval 143.5 to 212.2
|
137.4 titer
Interval 111.7 to 169.1
|
208.0 titer
Interval 164.2 to 263.5
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms
B/Phuket/3073/2013 (B Yamagata lineage) - Day 57
|
157.1 titer
Interval 126.5 to 195.1
|
117.1 titer
Interval 96.2 to 142.7
|
177.4 titer
Interval 140.3 to 224.1
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms
B/Phuket/3073/2013 (B Yamagata lineage) - Day 90
|
137.0 titer
Interval 113.1 to 166.1
|
104.0 titer
Interval 86.2 to 125.4
|
156.9 titer
Interval 120.1 to 205.0
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms
B/Phuket/3073/2013 (B Yamagata lineage) - Day 118
|
150.5 titer
Interval 120.1 to 188.6
|
115.3 titer
Interval 97.5 to 136.4
|
158.2 titer
Interval 117.3 to 213.3
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 8, Day 57, Day 90, Day 118Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood samples for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid NAI results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
Blood was collected for NAI assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at Day 8, Day 57, Day 90, and Day 118 Post first study vaccination and the ratio of these GMTs between adjuvanted and unadjuvanted study arms were calculated. The unadjuvanted Fluzone study arm is considered a reference group for the analysis of ratio of GMTs. Ratio of GMTs is defined as the ratio of the GMT from the adjuvanted group divided by the GMT from the corresponding unadjuvanted group.
Outcome measures
| Measure |
Fluzone + CpG55
0.5 mL of 2018/2019 Fluzone QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 2019/2020 of Fluzone QIV intramuscular injection on Day 90.
|
Fluzone
n=37 Participants
0.5 mL of 2018/2019 Fluzone QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Fluzone + AF03
n=40 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.25 mL of AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Flublok
0.5 mL of 2018/2019 Flublok QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + AF03
0.5 mL of 2018/2019 Flublok QIV + 0.25 mL AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + CpG55
0.5 mL of 2018/2019 Flublok QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
|
|---|---|---|---|---|---|---|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms for the Fluzone Study Arms
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 8
|
—
|
1.1 ratio of GMT
Interval 0.8 to 1.7
|
0.9 ratio of GMT
Interval 0.6 to 1.3
|
—
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms for the Fluzone Study Arms
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 57
|
—
|
1.0 ratio of GMT
Interval 0.7 to 1.5
|
0.8 ratio of GMT
Interval 0.5 to 1.2
|
—
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms for the Fluzone Study Arms
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 90
|
—
|
1.0 ratio of GMT
Interval 0.6 to 1.6
|
0.7 ratio of GMT
Interval 0.5 to 1.2
|
—
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms for the Fluzone Study Arms
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 118
|
—
|
0.9 ratio of GMT
Interval 0.6 to 1.5
|
0.8 ratio of GMT
Interval 0.5 to 1.2
|
—
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms for the Fluzone Study Arms
B/Colorado/06/2017 (B Victoria lineage) - Day 8
|
—
|
1.5 ratio of GMT
Interval 1.0 to 2.1
|
1.1 ratio of GMT
Interval 0.8 to 1.5
|
—
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms for the Fluzone Study Arms
B/Colorado/06/2017 (B Victoria lineage) - Day 57
|
—
|
1.4 ratio of GMT
Interval 1.0 to 2.0
|
1.0 ratio of GMT
Interval 0.8 to 1.3
|
—
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms for the Fluzone Study Arms
B/Colorado/06/2017 (B Victoria lineage) - Day 90
|
—
|
1.4 ratio of GMT
Interval 1.0 to 1.9
|
1.0 ratio of GMT
Interval 0.8 to 1.4
|
—
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms for the Fluzone Study Arms
B/Colorado/06/2017 (B Victoria lineage) - Day 118
|
—
|
1.3 ratio of GMT
Interval 0.9 to 1.8
|
1.1 ratio of GMT
Interval 0.8 to 1.5
|
—
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms for the Fluzone Study Arms
A/Michigan/45/2015 X-275 (H1N1) - Day 8
|
—
|
1.1 ratio of GMT
Interval 0.7 to 1.5
|
0.9 ratio of GMT
Interval 0.6 to 1.3
|
—
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms for the Fluzone Study Arms
A/Michigan/45/2015 X-275 (H1N1) - Day 57
|
—
|
1.0 ratio of GMT
Interval 0.7 to 1.5
|
0.7 ratio of GMT
Interval 0.5 to 1.1
|
—
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms for the Fluzone Study Arms
A/Michigan/45/2015 X-275 (H1N1) - Day 90
|
—
|
0.9 ratio of GMT
Interval 0.6 to 1.4
|
0.7 ratio of GMT
Interval 0.4 to 1.0
|
—
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms for the Fluzone Study Arms
A/Michigan/45/2015 X-275 (H1N1) - Day 118
|
—
|
0.8 ratio of GMT
Interval 0.5 to 1.3
|
0.7 ratio of GMT
Interval 0.4 to 1.1
|
—
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms for the Fluzone Study Arms
B/Phuket/3073/2013 (B Yamagata lineage) - Day 8
|
—
|
1.5 ratio of GMT
Interval 1.1 to 2.1
|
1.3 ratio of GMT
Interval 1.0 to 1.7
|
—
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms for the Fluzone Study Arms
B/Phuket/3073/2013 (B Yamagata lineage) - Day 57
|
—
|
1.5 ratio of GMT
Interval 1.1 to 2.0
|
1.3 ratio of GMT
Interval 1.0 to 1.8
|
—
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms for the Fluzone Study Arms
B/Phuket/3073/2013 (B Yamagata lineage) - Day 90
|
—
|
1.5 ratio of GMT
Interval 1.1 to 2.1
|
1.3 ratio of GMT
Interval 1.0 to 1.7
|
—
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms for the Fluzone Study Arms
B/Phuket/3073/2013 (B Yamagata lineage) - Day 118
|
—
|
1.4 ratio of GMT
Interval 1.0 to 1.9
|
1.3 ratio of GMT
Interval 1.0 to 1.7
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 8, Day 57, Day 90, Day 118Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood samples for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid NAI results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
Blood was collected for NAI assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. NAI seroconversion was defined as \>4 four-fold rise in post-vaccination antibody titer at Day 8, 57, 90, and 118.
Outcome measures
| Measure |
Fluzone + CpG55
n=40 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 2019/2020 of Fluzone QIV intramuscular injection on Day 90.
|
Fluzone
n=41 Participants
0.5 mL of 2018/2019 Fluzone QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Fluzone + AF03
n=37 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.25 mL of AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Flublok
0.5 mL of 2018/2019 Flublok QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + AF03
0.5 mL of 2018/2019 Flublok QIV + 0.25 mL AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + CpG55
0.5 mL of 2018/2019 Flublok QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 8
|
50 percentage of participants
Interval 34.0 to 66.0
|
49 percentage of participants
Interval 33.0 to 65.0
|
62 percentage of participants
Interval 45.0 to 78.0
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 57
|
24 percentage of participants
Interval 11.0 to 40.0
|
20 percentage of participants
Interval 9.0 to 36.0
|
22 percentage of participants
Interval 10.0 to 38.0
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 90
|
13 percentage of participants
Interval 4.0 to 28.0
|
12 percentage of participants
Interval 4.0 to 26.0
|
8 percentage of participants
Interval 2.0 to 22.0
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 118
|
32 percentage of participants
Interval 17.0 to 51.0
|
28 percentage of participants
Interval 14.0 to 45.0
|
23 percentage of participants
Interval 10.0 to 42.0
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms
B/Colorado/06/2017 (B Victoria lineage) - Day 8
|
13 percentage of participants
Interval 4.0 to 27.0
|
20 percentage of participants
Interval 9.0 to 35.0
|
30 percentage of participants
Interval 16.0 to 47.0
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms
B/Colorado/06/2017 (B Victoria lineage) - Day 57
|
8 percentage of participants
Interval 2.0 to 21.0
|
18 percentage of participants
Interval 7.0 to 33.0
|
16 percentage of participants
Interval 6.0 to 32.0
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms
B/Colorado/06/2017 (B Victoria lineage) - Day 90
|
5 percentage of participants
Interval to 18.0
Value is NA because it's \>0 but \<1
|
10 percentage of participants
Interval 3.0 to 23.0
|
8 percentage of participants
Interval 2.0 to 22.0
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms
B/Colorado/06/2017 (B Victoria lineage) - Day 118
|
9 percentage of participants
Interval 2.0 to 24.0
|
19 percentage of participants
Interval 8.0 to 36.0
|
20 percentage of participants
Interval 8.0 to 39.0
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms
A/Michigan/45/2015 X-275 (H1N1) - Day 8
|
50 percentage of participants
Interval 34.0 to 66.0
|
46 percentage of participants
Interval 31.0 to 63.0
|
57 percentage of participants
Interval 39.0 to 73.0
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms
A/Michigan/45/2015 X-275 (H1N1) - Day 57
|
11 percentage of participants
Interval 3.0 to 25.0
|
15 percentage of participants
Interval 6.0 to 30.0
|
22 percentage of participants
Interval 10.0 to 38.0
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms
A/Michigan/45/2015 X-275 (H1N1) - Day 90
|
3 percentage of participants
Interval to 14.0
Value is NA because it's \>0 but \<1
|
10 percentage of participants
Interval 3.0 to 23.0
|
11 percentage of participants
Interval 3.0 to 26.0
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms
A/Michigan/45/2015 X-275 (H1N1) - Day 118
|
24 percentage of participants
Interval 11.0 to 41.0
|
25 percentage of participants
Interval 12.0 to 42.0
|
13 percentage of participants
Interval 4.0 to 31.0
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms
B/Phuket/3073/2013 (B Yamagata lineage) - Day 8
|
20 percentage of participants
Interval 9.0 to 36.0
|
27 percentage of participants
Interval 14.0 to 43.0
|
30 percentage of participants
Interval 16.0 to 47.0
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms
B/Phuket/3073/2013 (B Yamagata lineage) - Day 57
|
8 percentage of participants
Interval 2.0 to 21.0
|
18 percentage of participants
Interval 7.0 to 33.0
|
16 percentage of participants
Interval 6.0 to 32.0
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms
B/Phuket/3073/2013 (B Yamagata lineage) - Day 90
|
5 percentage of participants
Interval to 18.0
Value is NA because it's \>0 but \<1
|
12 percentage of participants
Interval 4.0 to 26.0
|
11 percentage of participants
Interval 3.0 to 26.0
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms
B/Phuket/3073/2013 (B Yamagata lineage) - Day 118
|
6 percentage of participants
Interval to 20.0
Value is NA because it's \>0 but \<1
|
17 percentage of participants
Interval 6.0 to 33.0
|
10 percentage of participants
Interval 2.0 to 27.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 8, Day 57, Day 90, Day 118Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood samples for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid NAI results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
Blood was collected for NAI assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. Fold-rises from baseline were calculated as the Day 8 (or Day 57, Day 90, Day 118) titer divided by the baseline titers for each participant. The geometric mean of these fold rises was then calculated to obtain the GMFR.
Outcome measures
| Measure |
Fluzone + CpG55
n=40 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 2019/2020 of Fluzone QIV intramuscular injection on Day 90.
|
Fluzone
n=41 Participants
0.5 mL of 2018/2019 Fluzone QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Fluzone + AF03
n=37 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.25 mL of AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Flublok
0.5 mL of 2018/2019 Flublok QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + AF03
0.5 mL of 2018/2019 Flublok QIV + 0.25 mL AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + CpG55
0.5 mL of 2018/2019 Flublok QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 8
|
4.3 fold rise
Interval 3.2 to 5.8
|
3.6 fold rise
Interval 2.6 to 4.9
|
4.3 fold rise
Interval 3.3 to 5.7
|
—
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 57
|
2.4 fold rise
Interval 1.9 to 3.0
|
2.0 fold rise
Interval 1.7 to 2.4
|
2.2 fold rise
Interval 1.8 to 2.8
|
—
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 90
|
1.8 fold rise
Interval 1.5 to 2.1
|
1.6 fold rise
Interval 1.4 to 1.9
|
1.7 fold rise
Interval 1.4 to 2.1
|
—
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 118
|
2.7 fold rise
Interval 2.2 to 3.4
|
2.2 fold rise
Interval 1.7 to 2.7
|
2.1 fold rise
Interval 1.6 to 2.8
|
—
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms
B/Colorado/06/2017 (B Victoria lineage) - Day 8
|
1.9 fold rise
Interval 1.5 to 2.5
|
2.2 fold rise
Interval 1.7 to 2.8
|
2.7 fold rise
Interval 2.0 to 3.6
|
—
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms
B/Colorado/06/2017 (B Victoria lineage) - Day 57
|
1.5 fold rise
Interval 1.3 to 1.8
|
1.8 fold rise
Interval 1.5 to 2.1
|
2.0 fold rise
Interval 1.6 to 2.6
|
—
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms
B/Colorado/06/2017 (B Victoria lineage) - Day 90
|
1.5 fold rise
Interval 1.2 to 1.8
|
1.6 fold rise
Interval 1.3 to 1.9
|
1.9 fold rise
Interval 1.5 to 2.4
|
—
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms
B/Colorado/06/2017 (B Victoria lineage) - Day 118
|
2.0 fold rise
Interval 1.6 to 2.3
|
2.2 fold rise
Interval 1.8 to 2.7
|
2.5 fold rise
Interval 1.9 to 3.3
|
—
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms
A/Michigan/45/2015 X-275 (H1N1) - Day 8
|
3.6 fold rise
Interval 2.7 to 4.9
|
3.4 fold rise
Interval 2.6 to 4.5
|
3.9 fold rise
Interval 2.8 to 5.3
|
—
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms
A/Michigan/45/2015 X-275 (H1N1) - Day 57
|
1.8 fold rise
Interval 1.4 to 2.2
|
1.8 fold rise
Interval 1.5 to 2.1
|
2.0 fold rise
Interval 1.6 to 2.6
|
—
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms
A/Michigan/45/2015 X-275 (H1N1) - Day 90
|
1.4 fold rise
Interval 1.2 to 1.7
|
1.6 fold rise
Interval 1.4 to 1.9
|
1.6 fold rise
Interval 1.2 to 2.0
|
—
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms
A/Michigan/45/2015 X-275 (H1N1) - Day 118
|
2.2 fold rise
Interval 1.8 to 2.8
|
2.4 fold rise
Interval 1.9 to 2.9
|
2.0 fold rise
Interval 1.5 to 2.6
|
—
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms
B/Phuket/3073/2013 (B Yamagata lineage) - Day 8
|
1.9 fold rise
Interval 1.5 to 2.4
|
2.2 fold rise
Interval 1.6 to 3.0
|
2.3 fold rise
Interval 1.8 to 2.9
|
—
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms
B/Phuket/3073/2013 (B Yamagata lineage) - Day 57
|
1.7 fold rise
Interval 1.5 to 2.1
|
1.8 fold rise
Interval 1.5 to 2.3
|
2.0 fold rise
Interval 1.6 to 2.5
|
—
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms
B/Phuket/3073/2013 (B Yamagata lineage) - Day 90
|
1.5 fold rise
Interval 1.3 to 1.8
|
1.6 fold rise
Interval 1.3 to 2.0
|
1.7 fold rise
Interval 1.4 to 2.2
|
—
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains for the Fluzone Study Arms
B/Phuket/3073/2013 (B Yamagata lineage) - Day 118
|
1.7 fold rise
Interval 1.4 to 2.0
|
1.9 fold rise
Interval 1.5 to 2.5
|
1.7 fold rise
Interval 1.3 to 2.2
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 8, Day 57, Day 90, Day 118Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood sample for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid Neut results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
Blood was collected for Neut assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, but only one result which is a geometric mean titer of the replicates was reported by the lab. The geometric mean titer was calculated for each study arm from the available results at Day 8, Day 57, Day 90, and Day 118 Post first study vaccination.
Outcome measures
| Measure |
Fluzone + CpG55
n=40 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 2019/2020 of Fluzone QIV intramuscular injection on Day 90.
|
Fluzone
n=41 Participants
0.5 mL of 2018/2019 Fluzone QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Fluzone + AF03
n=37 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.25 mL of AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Flublok
n=41 Participants
0.5 mL of 2018/2019 Flublok QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + AF03
n=38 Participants
0.5 mL of 2018/2019 Flublok QIV + 0.25 mL AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + CpG55
n=42 Participants
0.5 mL of 2018/2019 Flublok QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 8
|
154.0 titer
Interval 113.7 to 208.6
|
140.6 titer
Interval 106.7 to 185.4
|
271.9 titer
Interval 201.0 to 367.9
|
168.8 titer
Interval 129.9 to 219.5
|
210.6 titer
Interval 149.7 to 296.3
|
148.5 titer
Interval 111.9 to 196.9
|
|
Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 57
|
195.6 titer
Interval 142.1 to 269.1
|
150.2 titer
Interval 114.2 to 197.5
|
312.9 titer
Interval 243.1 to 402.6
|
354.4 titer
Interval 264.8 to 474.5
|
309.0 titer
Interval 219.9 to 434.1
|
259.3 titer
Interval 189.4 to 355.0
|
|
Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 90
|
152.8 titer
Interval 107.1 to 217.9
|
132.1 titer
Interval 102.0 to 171.1
|
244.2 titer
Interval 177.7 to 335.6
|
273.4 titer
Interval 185.7 to 402.6
|
265.7 titer
Interval 184.9 to 381.8
|
202.7 titer
Interval 144.5 to 284.3
|
|
Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 118
|
224.1 titer
Interval 156.4 to 321.3
|
161.8 titer
Interval 113.5 to 230.7
|
257.6 titer
Interval 188.3 to 352.4
|
446.6 titer
Interval 300.1 to 664.6
|
409.5 titer
Interval 286.6 to 585.1
|
276.8 titer
Interval 178.2 to 430.0
|
|
Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 8
|
261.6 titer
Interval 165.7 to 413.0
|
309.6 titer
Interval 203.4 to 471.4
|
333.9 titer
Interval 223.3 to 499.3
|
369.0 titer
Interval 227.9 to 597.7
|
243.2 titer
Interval 148.5 to 398.4
|
255.4 titer
Interval 169.9 to 383.8
|
|
Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 57
|
232.1 titer
Interval 147.8 to 364.6
|
365.7 titer
Interval 238.0 to 561.8
|
358.1 titer
Interval 231.2 to 554.8
|
439.5 titer
Interval 255.9 to 755.0
|
300.2 titer
Interval 178.1 to 506.3
|
306.0 titer
Interval 198.5 to 471.7
|
|
Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90
|
178.3 titer
Interval 110.1 to 288.7
|
255.4 titer
Interval 173.2 to 376.7
|
235.4 titer
Interval 164.9 to 335.9
|
362.6 titer
Interval 208.1 to 632.0
|
234.1 titer
Interval 140.7 to 389.6
|
232.4 titer
Interval 151.2 to 357.3
|
|
Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118
|
151.5 titer
Interval 85.9 to 267.2
|
202.2 titer
Interval 127.2 to 321.4
|
180.7 titer
Interval 113.0 to 288.9
|
312.0 titer
Interval 160.1 to 607.8
|
212.1 titer
Interval 127.1 to 354.2
|
211.7 titer
Interval 136.9 to 327.2
|
|
Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Michigan/45/2015 X-275 (H1N1) - Day 8
|
5604.4 titer
Interval 3894.9 to 8064.2
|
6824.7 titer
Interval 5245.8 to 8878.7
|
7795.4 titer
Interval 5275.0 to 11520.0
|
6666.4 titer
Interval 4657.5 to 9541.7
|
8444.6 titer
Interval 5590.8 to 12755.0
|
5925.2 titer
Interval 4184.9 to 8389.3
|
|
Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Michigan/45/2015 X-275 (H1N1) - Day 57
|
3335.0 titer
Interval 2194.5 to 5068.3
|
3437.4 titer
Interval 2218.8 to 5325.2
|
4437.2 titer
Interval 3179.4 to 6192.8
|
8293.9 titer
Interval 5358.8 to 12836.6
|
6502.7 titer
Interval 4251.4 to 9946.1
|
5791.6 titer
Interval 3915.1 to 8567.5
|
|
Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Michigan/45/2015 X-275 (H1N1) - Day 90
|
3255.1 titer
Interval 2163.5 to 4897.5
|
4623.9 titer
Interval 3377.1 to 6331.0
|
4965.3 titer
Interval 3475.0 to 7094.9
|
6518.8 titer
Interval 4528.7 to 9383.4
|
6113.7 titer
Interval 4061.6 to 9202.6
|
4837.8 titer
Interval 3410.7 to 6862.1
|
|
Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Michigan/45/2015 X-275 (H1N1) - Day 118
|
3153.9 titer
Interval 2145.3 to 4636.8
|
5094.4 titer
Interval 3714.6 to 6986.7
|
5393.5 titer
Interval 3578.0 to 8130.2
|
8037.0 titer
Interval 5516.3 to 11709.7
|
6631.4 titer
Interval 4338.9 to 10135.2
|
6168.6 titer
Interval 4323.8 to 8800.5
|
|
Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Phuket/3073/2013 (B Yamagata lineage) - Day 8
|
1095.1 titer
Interval 817.4 to 1467.1
|
1126.1 titer
Interval 727.4 to 1743.5
|
1049.1 titer
Interval 645.4 to 1705.3
|
1515.8 titer
Interval 1031.0 to 2228.7
|
1154.5 titer
Interval 747.1 to 1784.0
|
824.8 titer
Interval 495.5 to 1372.9
|
|
Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Phuket/3073/2013 (B Yamagata lineage) - Day 57
|
1037.6 titer
Interval 759.5 to 1417.5
|
859.6 titer
Interval 592.8 to 1246.6
|
1225.3 titer
Interval 851.4 to 1763.2
|
1959.7 titer
Interval 1398.2 to 2746.6
|
1243.1 titer
Interval 834.1 to 1852.8
|
1173.0 titer
Interval 816.8 to 1684.5
|
|
Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Phuket/3073/2013 (B Yamagata lineage) - Day 90
|
766.9 titer
Interval 541.3 to 1086.4
|
681.0 titer
Interval 490.3 to 945.9
|
909.3 titer
Interval 638.8 to 1294.5
|
1371.5 titer
Interval 981.9 to 1915.7
|
953.5 titer
Interval 638.6 to 1423.7
|
754.8 titer
Interval 533.9 to 1066.9
|
|
Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Phuket/3073/2013 (B Yamagata lineage) - Day 118
|
1086.9 titer
Interval 798.5 to 1479.6
|
1087.2 titer
Interval 762.1 to 1551.2
|
1031.7 titer
Interval 703.9 to 1512.2
|
1920.9 titer
Interval 1351.2 to 2730.8
|
1234.9 titer
Interval 710.6 to 2146.0
|
1284.8 titer
Interval 914.5 to 1805.0
|
SECONDARY outcome
Timeframe: Day 8, Day 57, Day 90, Day 118Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood sample for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid Neut results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
Blood was collected for Neut assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, but only one result which is a geometric mean titer of the replicates was reported by the lab. The geometric mean titer was calculated for each study arm from the available results at Day 8, Day 57, Day 90, and Day 118 Post first study vaccination and the ratio of these GMTs between adjuvanted and unadjuvanted study arms were calculated. Unadjuvanted Fluzone and Flublok study arms are considered as reference groups for the analysis of ratio of GMTs. Ratio of GMTs is defined as the ratio of the GMT from the adjuvanted group divided by the GMT from the corresponding unadjuvanted group.
Outcome measures
| Measure |
Fluzone + CpG55
n=38 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 2019/2020 of Fluzone QIV intramuscular injection on Day 90.
|
Fluzone
n=37 Participants
0.5 mL of 2018/2019 Fluzone QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Fluzone + AF03
n=40 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.25 mL of AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Flublok
n=42 Participants
0.5 mL of 2018/2019 Flublok QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + AF03
0.5 mL of 2018/2019 Flublok QIV + 0.25 mL AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + CpG55
0.5 mL of 2018/2019 Flublok QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
|
|---|---|---|---|---|---|---|
|
Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 8
|
1.2 ratio of GMT
Interval 0.8 to 1.9
|
1.9 ratio of GMT
Interval 1.3 to 2.9
|
1.1 ratio of GMT
Interval 0.7 to 1.6
|
0.9 ratio of GMT
Interval 0.6 to 1.3
|
—
|
—
|
|
Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 57
|
0.9 ratio of GMT
Interval 0.6 to 1.4
|
2.1 ratio of GMT
Interval 1.4 to 3.0
|
1.3 ratio of GMT
Interval 0.9 to 2.0
|
0.7 ratio of GMT
Interval 0.5 to 1.1
|
—
|
—
|
|
Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 90
|
1.0 ratio of GMT
Interval 0.6 to 1.6
|
1.8 ratio of GMT
Interval 1.2 to 2.8
|
1.2 ratio of GMT
Interval 0.8 to 1.8
|
0.7 ratio of GMT
Interval 0.4 to 1.2
|
—
|
—
|
|
Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 118
|
0.9 ratio of GMT
Interval 0.5 to 1.5
|
1.6 ratio of GMT
Interval 1.0 to 2.5
|
1.4 ratio of GMT
Interval 0.8 to 2.3
|
0.6 ratio of GMT
Interval 0.3 to 1.1
|
—
|
—
|
|
Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 8
|
0.7 ratio of GMT
Interval 0.3 to 1.3
|
1.1 ratio of GMT
Interval 0.6 to 1.9
|
0.8 ratio of GMT
Interval 0.5 to 1.6
|
0.7 ratio of GMT
Interval 0.4 to 1.3
|
—
|
—
|
|
Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 57
|
0.7 ratio of GMT
Interval 0.3 to 1.4
|
1.0 ratio of GMT
Interval 0.5 to 1.8
|
0.6 ratio of GMT
Interval 0.3 to 1.2
|
0.7 ratio of GMT
Interval 0.4 to 1.4
|
—
|
—
|
|
Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90
|
0.6 ratio of GMT
Interval 0.3 to 1.4
|
0.9 ratio of GMT
Interval 0.5 to 1.5
|
0.7 ratio of GMT
Interval 0.4 to 1.3
|
0.6 ratio of GMT
Interval 0.3 to 1.3
|
—
|
—
|
|
Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118
|
0.7 ratio of GMT
Interval 0.3 to 1.6
|
0.9 ratio of GMT
Interval 0.5 to 1.7
|
0.7 ratio of GMT
Interval 0.4 to 1.5
|
0.7 ratio of GMT
Interval 0.3 to 1.5
|
—
|
—
|
|
Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Michigan/45/2015 X-275 (H1N1) - Day 8
|
1.3 ratio of GMT
Interval 0.7 to 2.2
|
1.1 ratio of GMT
Interval 0.7 to 1.8
|
0.8 ratio of GMT
Interval 0.5 to 1.3
|
0.9 ratio of GMT
Interval 0.5 to 1.5
|
—
|
—
|
|
Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Michigan/45/2015 X-275 (H1N1) - Day 57
|
0.8 ratio of GMT
Interval 0.4 to 1.4
|
1.3 ratio of GMT
Interval 0.8 to 2.2
|
1.0 ratio of GMT
Interval 0.5 to 1.8
|
0.7 ratio of GMT
Interval 0.4 to 1.2
|
—
|
—
|
|
Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Michigan/45/2015 X-275 (H1N1) - Day 90
|
0.9 ratio of GMT
Interval 0.5 to 1.6
|
1.1 ratio of GMT
Interval 0.7 to 1.7
|
0.7 ratio of GMT
Interval 0.4 to 1.2
|
0.7 ratio of GMT
Interval 0.5 to 1.2
|
—
|
—
|
|
Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Michigan/45/2015 X-275 (H1N1) - Day 118
|
0.8 ratio of GMT
Interval 0.5 to 1.4
|
1.1 ratio of GMT
Interval 0.6 to 1.8
|
0.6 ratio of GMT
Interval 0.4 to 1.0
|
0.8 ratio of GMT
Interval 0.5 to 1.3
|
—
|
—
|
|
Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms
B/Phuket/3073/2013 (B Yamagata lineage) - Day 8
|
0.8 ratio of GMT
Interval 0.4 to 1.3
|
0.9 ratio of GMT
Interval 0.5 to 1.8
|
1.0 ratio of GMT
Interval 0.6 to 1.6
|
0.5 ratio of GMT
Interval 0.3 to 1.0
|
—
|
—
|
|
Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms
B/Phuket/3073/2013 (B Yamagata lineage) - Day 57
|
0.6 ratio of GMT
Interval 0.4 to 1.1
|
1.4 ratio of GMT
Interval 0.9 to 2.4
|
1.2 ratio of GMT
Interval 0.7 to 1.9
|
0.6 ratio of GMT
Interval 0.4 to 1.0
|
—
|
—
|
|
Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms
B/Phuket/3073/2013 (B Yamagata lineage) - Day 90
|
0.7 ratio of GMT
Interval 0.4 to 1.2
|
1.3 ratio of GMT
Interval 0.8 to 2.1
|
1.1 ratio of GMT
Interval 0.7 to 1.8
|
0.6 ratio of GMT
Interval 0.3 to 0.9
|
—
|
—
|
|
Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains Between Adjuvanted and Unadjuvanted Study Arms
B/Phuket/3073/2013 (B Yamagata lineage) - Day 118
|
0.6 ratio of GMT
Interval 0.3 to 1.2
|
0.9 ratio of GMT
Interval 0.6 to 1.6
|
1.0 ratio of GMT
Interval 0.6 to 1.6
|
0.7 ratio of GMT
Interval 0.4 to 1.1
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 8, Day 57, Day 90, Day 118Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood sample for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid Neut results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
Blood was collected for Neut assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, but only one result which is a geometric mean titer of the replicates was reported by the lab. Neut seroconversion was defined as either a pre-vaccination titer \< 1:10 and a post-vaccination titer \>= 1:40 or a pre-vaccination titer \>= 1:10 and a minimum four-fold rise in post-vaccination antibody titer.
Outcome measures
| Measure |
Fluzone + CpG55
n=40 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 2019/2020 of Fluzone QIV intramuscular injection on Day 90.
|
Fluzone
n=41 Participants
0.5 mL of 2018/2019 Fluzone QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Fluzone + AF03
n=37 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.25 mL of AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Flublok
n=41 Participants
0.5 mL of 2018/2019 Flublok QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + AF03
n=38 Participants
0.5 mL of 2018/2019 Flublok QIV + 0.25 mL AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + CpG55
n=42 Participants
0.5 mL of 2018/2019 Flublok QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 8
|
20 percentage of participants
Interval 9.0 to 36.0
|
10 percentage of participants
Interval 3.0 to 23.0
|
16 percentage of participants
Interval 6.0 to 32.0
|
15 percentage of participants
Interval 6.0 to 29.0
|
11 percentage of participants
Interval 3.0 to 25.0
|
7 percentage of participants
Interval 1.0 to 19.0
|
|
Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 57
|
18 percentage of participants
Interval 8.0 to 34.0
|
10 percentage of participants
Interval 3.0 to 24.0
|
22 percentage of participants
Interval 10.0 to 38.0
|
38 percentage of participants
Interval 23.0 to 54.0
|
27 percentage of participants
Interval 14.0 to 44.0
|
24 percentage of participants
Interval 12.0 to 40.0
|
|
Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 90
|
13 percentage of participants
Interval 4.0 to 28.0
|
12 percentage of participants
Interval 4.0 to 26.0
|
11 percentage of participants
Interval 3.0 to 26.0
|
23 percentage of participants
Interval 11.0 to 39.0
|
22 percentage of participants
Interval 10.0 to 38.0
|
10 percentage of participants
Interval 3.0 to 24.0
|
|
Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 118
|
24 percentage of participants
Interval 11.0 to 41.0
|
14 percentage of participants
Interval 5.0 to 29.0
|
10 percentage of participants
Interval 2.0 to 27.0
|
32 percentage of participants
Interval 17.0 to 51.0
|
38 percentage of participants
Interval 21.0 to 56.0
|
24 percentage of participants
Interval 11.0 to 41.0
|
|
Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 8
|
30 percentage of participants
Interval 17.0 to 47.0
|
15 percentage of participants
Interval 6.0 to 29.0
|
24 percentage of participants
Interval 12.0 to 41.0
|
15 percentage of participants
Interval 6.0 to 29.0
|
34 percentage of participants
Interval 20.0 to 51.0
|
31 percentage of participants
Interval 18.0 to 47.0
|
|
Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 57
|
32 percentage of participants
Interval 18.0 to 49.0
|
25 percentage of participants
Interval 13.0 to 41.0
|
27 percentage of participants
Interval 14.0 to 44.0
|
25 percentage of participants
Interval 13.0 to 41.0
|
35 percentage of participants
Interval 20.0 to 53.0
|
34 percentage of participants
Interval 20.0 to 51.0
|
|
Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90
|
18 percentage of participants
Interval 8.0 to 34.0
|
17 percentage of participants
Interval 7.0 to 32.0
|
19 percentage of participants
Interval 8.0 to 36.0
|
13 percentage of participants
Interval 4.0 to 27.0
|
30 percentage of participants
Interval 16.0 to 47.0
|
25 percentage of participants
Interval 13.0 to 41.0
|
|
Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118
|
18 percentage of participants
Interval 7.0 to 35.0
|
14 percentage of participants
Interval 5.0 to 29.0
|
17 percentage of participants
Interval 6.0 to 35.0
|
9 percentage of participants
Interval 2.0 to 24.0
|
28 percentage of participants
Interval 14.0 to 47.0
|
26 percentage of participants
Interval 13.0 to 44.0
|
|
Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Michigan/45/2015 X-275 (H1N1) - Day 8
|
20 percentage of participants
Interval 9.0 to 36.0
|
17 percentage of participants
Interval 7.0 to 32.0
|
24 percentage of participants
Interval 12.0 to 41.0
|
20 percentage of participants
Interval 9.0 to 35.0
|
37 percentage of participants
Interval 22.0 to 54.0
|
24 percentage of participants
Interval 12.0 to 39.0
|
|
Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Michigan/45/2015 X-275 (H1N1) - Day 57
|
8 percentage of participants
Interval 2.0 to 21.0
|
13 percentage of participants
Interval 4.0 to 27.0
|
11 percentage of participants
Interval 3.0 to 25.0
|
23 percentage of participants
Interval 11.0 to 38.0
|
27 percentage of participants
Interval 14.0 to 44.0
|
17 percentage of participants
Interval 7.0 to 32.0
|
|
Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Michigan/45/2015 X-275 (H1N1) - Day 90
|
11 percentage of participants
Interval 3.0 to 25.0
|
12 percentage of participants
Interval 4.0 to 26.0
|
11 percentage of participants
Interval 3.0 to 26.0
|
8 percentage of participants
Interval 2.0 to 21.0
|
30 percentage of participants
Interval 16.0 to 47.0
|
13 percentage of participants
Interval 4.0 to 27.0
|
|
Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Michigan/45/2015 X-275 (H1N1) - Day 118
|
18 percentage of participants
Interval 7.0 to 35.0
|
11 percentage of participants
Interval 3.0 to 26.0
|
10 percentage of participants
Interval 2.0 to 27.0
|
18 percentage of participants
Interval 7.0 to 35.0
|
31 percentage of participants
Interval 16.0 to 50.0
|
21 percentage of participants
Interval 9.0 to 38.0
|
|
Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Phuket/3073/2013 (B Yamagata lineage) - Day 8
|
23 percentage of participants
Interval 11.0 to 38.0
|
32 percentage of participants
Interval 18.0 to 48.0
|
11 percentage of participants
Interval 3.0 to 25.0
|
24 percentage of participants
Interval 12.0 to 40.0
|
24 percentage of participants
Interval 11.0 to 40.0
|
19 percentage of participants
Interval 9.0 to 34.0
|
|
Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Phuket/3073/2013 (B Yamagata lineage) - Day 57
|
21 percentage of participants
Interval 10.0 to 37.0
|
28 percentage of participants
Interval 15.0 to 44.0
|
16 percentage of participants
Interval 6.0 to 32.0
|
18 percentage of participants
Interval 7.0 to 33.0
|
22 percentage of participants
Interval 10.0 to 38.0
|
27 percentage of participants
Interval 14.0 to 43.0
|
|
Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Phuket/3073/2013 (B Yamagata lineage) - Day 90
|
8 percentage of participants
Interval 2.0 to 21.0
|
15 percentage of participants
Interval 6.0 to 29.0
|
11 percentage of participants
Interval 3.0 to 26.0
|
15 percentage of participants
Interval 6.0 to 31.0
|
22 percentage of participants
Interval 10.0 to 38.0
|
15 percentage of participants
Interval 6.0 to 30.0
|
|
Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Phuket/3073/2013 (B Yamagata lineage) - Day 118
|
18 percentage of participants
Interval 7.0 to 35.0
|
22 percentage of participants
Interval 10.0 to 39.0
|
13 percentage of participants
Interval 4.0 to 31.0
|
18 percentage of participants
Interval 7.0 to 35.0
|
16 percentage of participants
Interval 5.0 to 33.0
|
21 percentage of participants
Interval 9.0 to 38.0
|
SECONDARY outcome
Timeframe: Day 8, Day 57, Day 90, Day 118Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood sample for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid Neut results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
Blood was collected for Neut assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, but only one result which is a geometric mean titer of the replicates was reported by the lab.
Outcome measures
| Measure |
Fluzone + CpG55
n=40 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 2019/2020 of Fluzone QIV intramuscular injection on Day 90.
|
Fluzone
n=41 Participants
0.5 mL of 2018/2019 Fluzone QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Fluzone + AF03
n=37 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.25 mL of AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Flublok
n=41 Participants
0.5 mL of 2018/2019 Flublok QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + AF03
n=38 Participants
0.5 mL of 2018/2019 Flublok QIV + 0.25 mL AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + CpG55
n=42 Participants
0.5 mL of 2018/2019 Flublok QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 8
|
95 percentage of participants
Interval 83.0 to
Value is NA because it's \>99 but \<100
|
95 percentage of participants
Interval 83.0 to
Value is NA because it's \>99 but \<100
|
100 percentage of participants
Interval 91.0 to 100.0
|
95 percentage of participants
Interval 83.0 to
Value is NA because it's \>99 but \<100
|
95 percentage of participants
Interval 82.0 to
Value is NA because it's \>99 but \<100
|
93 percentage of participants
Interval 81.0 to 99.0
|
|
Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 57
|
97 percentage of participants
Interval 86.0 to
Value is NA because it's \>99 but \<100
|
98 percentage of participants
Interval 87.0 to
Value is NA because it's \>99 but \<100
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
|
Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 90
|
89 percentage of participants
Interval 75.0 to 97.0
|
95 percentage of participants
Interval 83.0 to
Value is NA because it's \>99 but \<100
|
100 percentage of participants
Interval 90.0 to 100.0
|
97 percentage of participants
Interval 87.0 to
Value is NA because it's \>99 but \<100
|
95 percentage of participants
Interval 82.0 to
Value is NA because it's \>99 but \<100
|
93 percentage of participants
Interval 80.0 to 98.0
|
|
Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 118
|
97 percentage of participants
Interval 85.0 to
Value is NA because it's \>99 but \<100
|
94 percentage of participants
Interval 81.0 to
Value is NA because it's \>99 but \<100
|
100 percentage of participants
Interval 88.0 to 100.0
|
100 percentage of participants
Interval 90.0 to 100.0
|
97 percentage of participants
Interval 84.0 to
Value is NA because it's \>99 but \<100
|
97 percentage of participants
Interval 85.0 to
Value is NA because it's \>99 but \<100
|
|
Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 8
|
90 percentage of participants
Interval 76.0 to 97.0
|
93 percentage of participants
Interval 80.0 to 98.0
|
97 percentage of participants
Interval 86.0 to
Value is NA because it's \>99 but \<100
|
95 percentage of participants
Interval 83.0 to
Value is NA because it's \>99 but \<100
|
87 percentage of participants
Interval 72.0 to 96.0
|
98 percentage of participants
Interval 87.0 to
Value is NA because it's \>99 but \<100
|
|
Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 57
|
95 percentage of participants
Interval 82.0 to
Value is NA because it's \>99 but \<100
|
95 percentage of participants
Interval 83.0 to
Value is NA because it's \>99 but \<100
|
100 percentage of participants
Interval 91.0 to 100.0
|
90 percentage of participants
Interval 76.0 to 97.0
|
89 percentage of participants
Interval 75.0 to 97.0
|
98 percentage of participants
Interval 87.0 to
Value is NA because it's \>99 but \<100
|
|
Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90
|
82 percentage of participants
Interval 66.0 to 92.0
|
95 percentage of participants
Interval 83.0 to
Value is NA because it's \>99 but \<100
|
100 percentage of participants
Interval 90.0 to 100.0
|
87 percentage of participants
Interval 73.0 to 96.0
|
89 percentage of participants
Interval 75.0 to 97.0
|
93 percentage of participants
Interval 80.0 to 98.0
|
|
Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118
|
71 percentage of participants
Interval 53.0 to 85.0
|
89 percentage of participants
Interval 74.0 to 97.0
|
90 percentage of participants
Interval 73.0 to 98.0
|
85 percentage of participants
Interval 69.0 to 95.0
|
91 percentage of participants
Interval 75.0 to 98.0
|
94 percentage of participants
Interval 80.0 to
Value is NA because it's \>99 but \<100
|
|
Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Michigan/45/2015 X-275 (H1N1) - Day 8
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 92.0 to 100.0
|
|
Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Michigan/45/2015 X-275 (H1N1) - Day 57
|
100 percentage of participants
Interval 91.0 to 100.0
|
98 percentage of participants
Interval 87.0 to
Value is NA because it's \>99 but \<100
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
|
Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Michigan/45/2015 X-275 (H1N1) - Day 90
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 90.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
|
Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Michigan/45/2015 X-275 (H1N1) - Day 118
|
100 percentage of participants
Interval 90.0 to 100.0
|
100 percentage of participants
Interval 90.0 to 100.0
|
100 percentage of participants
Interval 88.0 to 100.0
|
100 percentage of participants
Interval 90.0 to 100.0
|
100 percentage of participants
Interval 89.0 to 100.0
|
100 percentage of participants
Interval 90.0 to 100.0
|
|
Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Phuket/3073/2013 (B Yamagata lineage) - Day 8
|
100 percentage of participants
Interval 91.0 to 100.0
|
98 percentage of participants
Interval 87.0 to
Value is NA because it's \>99 but \<100
|
97 percentage of participants
Interval 86.0 to
Value is NA because it's \>99 but \<100
|
100 percentage of participants
Interval 91.0 to 100.0
|
97 percentage of participants
Interval 86.0 to
Value is NA because it's \>99 but \<100
|
95 percentage of participants
Interval 84.0 to
Value is NA because it's \>99 but \<100
|
|
Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Phuket/3073/2013 (B Yamagata lineage) - Day 57
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
|
Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Phuket/3073/2013 (B Yamagata lineage) - Day 90
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 90.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
|
Percentage of Participants With Neutralizing (Neut) Titer of 1:40 or Greater Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Phuket/3073/2013 (B Yamagata lineage) - Day 118
|
100 percentage of participants
Interval 90.0 to 100.0
|
100 percentage of participants
Interval 90.0 to 100.0
|
100 percentage of participants
Interval 88.0 to 100.0
|
100 percentage of participants
Interval 90.0 to 100.0
|
97 percentage of participants
Interval 84.0 to
Value is NA because it's \>99 but \<100
|
100 percentage of participants
Interval 90.0 to 100.0
|
SECONDARY outcome
Timeframe: Day 8, Day 57, Day 90, Day 118Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood sample for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid Neut results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
Blood was collected for Neut assay which was conducted with the 2018/2019 QIV viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, but only one result which a geometric mean titer of the replicates was reported by the lab. Fold-rises from baseline were calculated as the Day 8 (or Day 57, Day 90, Day 118) titer divided by the baseline titers for each participant. The geometric mean of these fold rises was then calculated to obtain the GMFR.
Outcome measures
| Measure |
Fluzone + CpG55
n=40 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 2019/2020 of Fluzone QIV intramuscular injection on Day 90.
|
Fluzone
n=41 Participants
0.5 mL of 2018/2019 Fluzone QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Fluzone + AF03
n=37 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.25 mL of AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Flublok
n=41 Participants
0.5 mL of 2018/2019 Flublok QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + AF03
n=38 Participants
0.5 mL of 2018/2019 Flublok QIV + 0.25 mL AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + CpG55
n=42 Participants
0.5 mL of 2018/2019 Flublok QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Phuket/3073/2013 (B Yamagata lineage) - Day 90
|
1.2 fold rise
Interval 0.9 to 1.7
|
1.4 fold rise
Interval 1.0 to 1.9
|
1.5 fold rise
Interval 1.0 to 2.3
|
1.6 fold rise
Interval 1.1 to 2.3
|
2.1 fold rise
Interval 1.3 to 3.4
|
1.4 fold rise
Interval 1.0 to 2.0
|
|
Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Phuket/3073/2013 (B Yamagata lineage) - Day 118
|
1.9 fold rise
Interval 1.3 to 2.6
|
2.2 fold rise
Interval 1.5 to 3.3
|
1.7 fold rise
Interval 1.0 to 2.8
|
2.3 fold rise
Interval 1.6 to 3.3
|
2.4 fold rise
Interval 1.5 to 4.1
|
2.6 fold rise
Interval 1.9 to 3.5
|
|
Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 8
|
1.5 fold rise
Interval 1.1 to 2.1
|
1.3 fold rise
Interval 1.0 to 1.8
|
1.8 fold rise
Interval 1.3 to 2.6
|
1.1 fold rise
Interval 0.8 to 1.5
|
1.7 fold rise
Interval 1.3 to 2.3
|
1.3 fold rise
Interval 0.9 to 1.7
|
|
Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 57
|
2.0 fold rise
Interval 1.4 to 2.9
|
1.4 fold rise
Interval 1.1 to 1.8
|
2.1 fold rise
Interval 1.5 to 2.9
|
2.3 fold rise
Interval 1.7 to 3.1
|
2.5 fold rise
Interval 1.9 to 3.3
|
2.1 fold rise
Interval 1.5 to 2.9
|
|
Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 90
|
1.6 fold rise
Interval 1.2 to 2.2
|
1.2 fold rise
Interval 0.9 to 1.6
|
1.6 fold rise
Interval 1.1 to 2.2
|
1.8 fold rise
Interval 1.3 to 2.5
|
2.1 fold rise
Interval 1.5 to 3.0
|
1.7 fold rise
Interval 1.2 to 2.2
|
|
Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) - Day 118
|
2.4 fold rise
Interval 1.7 to 3.5
|
1.7 fold rise
Interval 1.3 to 2.2
|
1.7 fold rise
Interval 1.3 to 2.3
|
3.0 fold rise
Interval 2.3 to 4.1
|
3.5 fold rise
Interval 2.5 to 4.9
|
2.4 fold rise
Interval 1.8 to 3.3
|
|
Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 8
|
2.8 fold rise
Interval 1.6 to 4.9
|
2.8 fold rise
Interval 1.6 to 5.0
|
2.9 fold rise
Interval 1.8 to 4.9
|
1.9 fold rise
Interval 1.3 to 2.6
|
3.0 fold rise
Interval 1.9 to 4.5
|
2.5 fold rise
Interval 1.8 to 3.6
|
|
Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 57
|
2.5 fold rise
Interval 1.6 to 4.0
|
3.2 fold rise
Interval 1.9 to 5.3
|
3.2 fold rise
Interval 1.7 to 5.8
|
2.2 fold rise
Interval 1.5 to 3.2
|
3.6 fold rise
Interval 2.2 to 5.7
|
2.9 fold rise
Interval 2.0 to 4.4
|
|
Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 90
|
2.0 fold rise
Interval 1.3 to 2.9
|
2.3 fold rise
Interval 1.6 to 3.5
|
2.1 fold rise
Interval 1.3 to 3.6
|
1.8 fold rise
Interval 1.3 to 2.5
|
2.8 fold rise
Interval 1.9 to 4.0
|
2.3 fold rise
Interval 1.6 to 3.2
|
|
Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Maryland/15/2016 BX-69A (B Victoria lineage) - Day 118
|
1.7 fold rise
Interval 1.1 to 2.8
|
1.8 fold rise
Interval 1.2 to 2.9
|
1.7 fold rise
Interval 0.9 to 3.2
|
1.5 fold rise
Interval 1.1 to 2.1
|
2.5 fold rise
Interval 1.6 to 3.8
|
2.2 fold rise
Interval 1.4 to 3.4
|
|
Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Michigan/45/2015 X-275 (H1N1) - Day 8
|
2.6 fold rise
Interval 1.6 to 4.4
|
2.2 fold rise
Interval 1.4 to 3.4
|
2.9 fold rise
Interval 1.7 to 4.8
|
1.8 fold rise
Interval 1.3 to 2.4
|
3.8 fold rise
Interval 2.3 to 6.2
|
2.1 fold rise
Interval 1.5 to 3.1
|
|
Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Michigan/45/2015 X-275 (H1N1) - Day 57
|
1.7 fold rise
Interval 1.0 to 2.7
|
1.0 fold rise
Interval 0.6 to 1.6
|
1.6 fold rise
Interval 1.0 to 2.8
|
2.1 fold rise
Interval 1.5 to 2.9
|
3.0 fold rise
Interval 1.9 to 4.8
|
2.0 fold rise
Interval 1.4 to 3.1
|
|
Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Michigan/45/2015 X-275 (H1N1) - Day 90
|
1.6 fold rise
Interval 1.0 to 2.6
|
1.5 fold rise
Interval 1.0 to 2.2
|
1.7 fold rise
Interval 1.1 to 2.9
|
1.6 fold rise
Interval 1.3 to 2.1
|
2.9 fold rise
Interval 1.8 to 4.4
|
1.7 fold rise
Interval 1.2 to 2.5
|
|
Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
A/Michigan/45/2015 X-275 (H1N1) - Day 118
|
1.8 fold rise
Interval 1.1 to 2.9
|
1.5 fold rise
Interval 1.0 to 2.2
|
1.7 fold rise
Interval 0.9 to 3.2
|
2.0 fold rise
Interval 1.5 to 2.6
|
3.0 fold rise
Interval 1.8 to 4.9
|
2.3 fold rise
Interval 1.6 to 3.5
|
|
Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Phuket/3073/2013 (B Yamagata lineage) - Day 8
|
1.7 fold rise
Interval 1.2 to 2.4
|
2.3 fold rise
Interval 1.4 to 4.0
|
1.8 fold rise
Interval 1.2 to 2.9
|
1.8 fold rise
Interval 1.2 to 2.6
|
2.6 fold rise
Interval 1.6 to 4.3
|
1.5 fold rise
Interval 0.9 to 2.5
|
|
Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against the 2018/2019 Quadrivalent Influenza Vaccine (QIV) Strains
B/Phuket/3073/2013 (B Yamagata lineage) - Day 57
|
1.6 fold rise
Interval 1.1 to 2.4
|
1.8 fold rise
Interval 1.2 to 2.6
|
2.1 fold rise
Interval 1.3 to 3.4
|
2.2 fold rise
Interval 1.6 to 3.1
|
2.7 fold rise
Interval 1.7 to 4.3
|
2.1 fold rise
Interval 1.4 to 3.1
|
SECONDARY outcome
Timeframe: Day 1, Day 8, Day 29, Day 57, Day 90, Day 118Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood samples for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid HAI results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
Blood was collected for HAI assay which was conducted with the heterologous H1 and H3 influenza viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at Day 1, Day 8, Day 29, Day 57, Day 90, and Day 118 post first study vaccination.
Outcome measures
| Measure |
Fluzone + CpG55
n=40 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 2019/2020 of Fluzone QIV intramuscular injection on Day 90.
|
Fluzone
n=41 Participants
0.5 mL of 2018/2019 Fluzone QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Fluzone + AF03
n=37 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.25 mL of AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Flublok
n=41 Participants
0.5 mL of 2018/2019 Flublok QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + AF03
n=38 Participants
0.5 mL of 2018/2019 Flublok QIV + 0.25 mL AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + CpG55
n=42 Participants
0.5 mL of 2018/2019 Flublok QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains
A/Shandonglaicheng/1763/2016 [H3N2] - Day 1
|
70.3 titer
Interval 44.2 to 111.6
|
59.5 titer
Interval 39.7 to 89.3
|
113.1 titer
Interval 71.1 to 180.0
|
87.8 titer
Interval 53.7 to 143.5
|
78.6 titer
Interval 49.2 to 125.4
|
63.5 titer
Interval 41.2 to 97.8
|
|
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains
A/Shandonglaicheng/1763/2016 [H3N2] - Day 8
|
296.0 titer
Interval 210.3 to 416.6
|
189.5 titer
Interval 138.6 to 259.0
|
440.0 titer
Interval 307.1 to 630.5
|
261.2 titer
Interval 176.8 to 386.1
|
357.0 titer
Interval 223.6 to 570.0
|
299.6 titer
Interval 209.6 to 428.2
|
|
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains
A/Shandonglaicheng/1763/2016 [H3N2] - Day 29
|
282.6 titer
Interval 195.5 to 408.5
|
184.7 titer
Interval 126.9 to 269.0
|
415.0 titer
Interval 299.9 to 574.3
|
400.9 titer
Interval 272.9 to 588.8
|
440.0 titer
Interval 279.1 to 693.7
|
366.3 titer
Interval 249.2 to 538.4
|
|
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains
A/Shandonglaicheng/1763/2016 [H3N2] - Day 57
|
167.5 titer
Interval 113.0 to 248.1
|
116.1 titer
Interval 78.6 to 171.5
|
272.9 titer
Interval 193.9 to 384.1
|
314.5 titer
Interval 212.0 to 466.6
|
317.0 titer
Interval 204.6 to 491.2
|
281.9 titer
Interval 194.6 to 408.4
|
|
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains
A/Shandonglaicheng/1763/2016 [H3N2] - Day 90
|
155.7 titer
Interval 102.6 to 236.3
|
112.2 titer
Interval 75.4 to 167.0
|
264.0 titer
Interval 182.7 to 381.4
|
272.7 titer
Interval 179.6 to 414.1
|
288.7 titer
Interval 182.3 to 457.1
|
244.6 titer
Interval 163.5 to 365.9
|
|
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains
A/Shandonglaicheng/1763/2016 [H3N2] - Day 118
|
291.9 titer
Interval 197.3 to 432.0
|
215.6 titer
Interval 137.9 to 337.1
|
351.0 titer
Interval 232.5 to 529.9
|
583.9 titer
Interval 360.2 to 946.5
|
580.6 titer
Interval 362.1 to 930.8
|
388.4 titer
Interval 246.3 to 612.5
|
|
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains
A/Aksaray/4048/2016 [H3N2] - Day 57
|
188.5 titer
Interval 131.5 to 270.2
|
146.7 titer
Interval 102.2 to 210.7
|
338.5 titer
Interval 250.4 to 457.6
|
407.9 titer
Interval 303.0 to 549.0
|
423.8 titer
Interval 299.4 to 600.0
|
366.3 titer
Interval 269.9 to 497.2
|
|
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains
A/Aksaray/4048/2016 [H3N2] - Day 1
|
76.6 titer
Interval 48.8 to 120.4
|
72.9 titer
Interval 48.1 to 110.6
|
141.7 titer
Interval 87.1 to 230.3
|
112.2 titer
Interval 72.3 to 174.1
|
80.0 titer
Interval 50.7 to 126.2
|
87.6 titer
Interval 60.5 to 126.8
|
|
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains
A/Aksaray/4048/2016 [H3N2] - Day 8
|
259.9 titer
Interval 188.5 to 358.4
|
178.6 titer
Interval 133.9 to 238.1
|
452.5 titer
Interval 337.9 to 606.1
|
314.6 titer
Interval 230.5 to 429.5
|
394.7 titer
Interval 264.7 to 588.5
|
339.0 titer
Interval 251.7 to 456.7
|
|
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains
A/Aksaray/4048/2016 [H3N2] - Day 29
|
222.3 titer
Interval 157.8 to 313.2
|
174.1 titer
Interval 124.2 to 244.1
|
415.0 titer
Interval 298.8 to 576.4
|
433.4 titer
Interval 326.5 to 575.2
|
456.8 titer
Interval 322.1 to 647.8
|
402.0 titer
Interval 295.2 to 547.6
|
|
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains
A/Aksaray/4048/2016 [H3N2] - Day 90
|
157.1 titer
Interval 104.7 to 235.8
|
140.9 titer
Interval 95.5 to 207.9
|
299.1 titer
Interval 212.8 to 420.6
|
331.6 titer
Interval 241.6 to 455.0
|
323.0 titer
Interval 222.9 to 468.1
|
293.4 titer
Interval 214.1 to 402.2
|
|
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains
A/Aksaray/4048/2016 [H3N2] - Day 118
|
438.9 titer
Interval 300.0 to 642.1
|
320.0 titer
Interval 226.8 to 451.6
|
496.4 titer
Interval 336.9 to 731.2
|
877.8 titer
Interval 610.8 to 1261.5
|
812.2 titer
Interval 548.2 to 1203.4
|
578.0 titer
Interval 394.5 to 846.7
|
|
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains
A/Kenya/105/2017 [H3N2] - Day 1
|
67.3 titer
Interval 42.7 to 106.1
|
63.7 titer
Interval 44.3 to 91.6
|
123.1 titer
Interval 79.5 to 190.5
|
105.7 titer
Interval 71.6 to 156.1
|
69.8 titer
Interval 44.7 to 108.9
|
78.0 titer
Interval 56.6 to 107.6
|
|
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains
A/Kenya/105/2017 [H3N2] - Day 8
|
251.1 titer
Interval 184.4 to 341.8
|
184.7 titer
Interval 140.7 to 242.6
|
483.2 titer
Interval 349.8 to 667.6
|
312.0 titer
Interval 233.7 to 416.4
|
405.6 titer
Interval 273.8 to 600.9
|
374.3 titer
Interval 281.9 to 497.0
|
|
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains
A/Kenya/105/2017 [H3N2] - Day 29
|
311.6 titer
Interval 225.0 to 431.4
|
265.7 titer
Interval 186.9 to 377.8
|
646.2 titer
Interval 472.1 to 884.6
|
656.9 titer
Interval 480.9 to 897.3
|
709.5 titer
Interval 494.9 to 1017.1
|
650.9 titer
Interval 494.7 to 856.5
|
|
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains
A/Kenya/105/2017 [H3N2] - Day 57
|
216.2 titer
Interval 153.0 to 305.4
|
182.2 titer
Interval 132.9 to 249.7
|
435.9 titer
Interval 311.3 to 610.4
|
452.5 titer
Interval 339.2 to 603.8
|
416.0 titer
Interval 302.6 to 571.7
|
405.5 titer
Interval 309.0 to 532.1
|
|
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains
A/Kenya/105/2017 [H3N2] - Day 90
|
226.3 titer
Interval 156.5 to 327.2
|
202.7 titer
Interval 141.1 to 291.3
|
508.0 titer
Interval 357.5 to 721.7
|
545.4 titer
Interval 404.8 to 734.9
|
516.0 titer
Interval 365.8 to 727.7
|
460.5 titer
Interval 335.9 to 631.2
|
|
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains
A/Kenya/105/2017 [H3N2] - Day 118
|
301.0 titer
Interval 204.3 to 443.5
|
269.1 titer
Interval 191.2 to 378.7
|
417.4 titer
Interval 275.4 to 632.6
|
784.7 titer
Interval 546.9 to 1126.0
|
661.1 titer
Interval 445.1 to 982.0
|
543.7 titer
Interval 372.1 to 794.4
|
|
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains
A/Louisiana/13/2017 [H3N2] - Day 1
|
29.8 titer
Interval 19.6 to 45.4
|
29.8 titer
Interval 20.7 to 42.8
|
61.5 titer
Interval 38.4 to 98.6
|
43.5 titer
Interval 28.8 to 65.8
|
33.0 titer
Interval 23.0 to 47.4
|
34.8 titer
Interval 25.0 to 48.4
|
|
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains
A/Louisiana/13/2017 [H3N2] - Day 8
|
121.3 titer
Interval 85.8 to 171.4
|
103.1 titer
Interval 74.2 to 143.1
|
248.5 titer
Interval 168.5 to 366.5
|
130.6 titer
Interval 94.3 to 181.0
|
148.7 titer
Interval 100.1 to 220.9
|
117.9 titer
Interval 83.2 to 167.0
|
|
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains
A/Louisiana/13/2017 [H3N2] - Day 29
|
129.3 titer
Interval 90.5 to 184.7
|
113.1 titer
Interval 80.3 to 159.5
|
271.7 titer
Interval 188.0 to 392.6
|
226.3 titer
Interval 160.7 to 318.6
|
196.6 titer
Interval 133.3 to 290.0
|
180.1 titer
Interval 125.1 to 259.2
|
|
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains
A/Louisiana/13/2017 [H3N2] - Day 57
|
86.8 titer
Interval 58.7 to 128.6
|
74.6 titer
Interval 53.1 to 104.8
|
169.2 titer
Interval 115.9 to 247.2
|
177.5 titer
Interval 128.0 to 246.3
|
132.7 titer
Interval 89.1 to 197.5
|
127.4 titer
Interval 89.8 to 180.5
|
|
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains
A/Louisiana/13/2017 [H3N2] - Day 90
|
77.1 titer
Interval 51.5 to 115.4
|
72.3 titer
Interval 50.9 to 102.7
|
163.1 titer
Interval 107.8 to 246.7
|
176.4 titer
Interval 124.7 to 249.5
|
129.0 titer
Interval 84.6 to 196.6
|
124.5 titer
Interval 86.1 to 180.0
|
|
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains
A/Louisiana/13/2017 [H3N2] - Day 118
|
253.1 titer
Interval 168.2 to 381.0
|
256.4 titer
Interval 174.2 to 377.5
|
278.6 titer
Interval 178.3 to 435.4
|
673.5 titer
Interval 445.3 to 1018.6
|
521.0 titer
Interval 334.9 to 810.5
|
365.3 titer
Interval 239.0 to 558.4
|
|
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains
A/Michigan/84/2016 [H3N2] - Day 1
|
62.8 titer
Interval 44.4 to 88.8
|
82.1 titer
Interval 59.7 to 112.7
|
98.3 titer
Interval 67.6 to 143.0
|
98.0 titer
Interval 69.8 to 137.5
|
58.1 titer
Interval 41.0 to 82.4
|
74.9 titer
Interval 54.8 to 102.3
|
|
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains
A/Michigan/84/2016 [H3N2] - Day 8
|
96.8 titer
Interval 72.2 to 129.8
|
115.1 titer
Interval 89.1 to 148.5
|
169.2 titer
Interval 120.6 to 237.4
|
129.5 titer
Interval 91.8 to 182.7
|
100.5 titer
Interval 68.7 to 147.0
|
106.8 titer
Interval 76.0 to 150.0
|
|
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains
A/Michigan/84/2016 [H3N2] - Day 29
|
94.7 titer
Interval 68.5 to 130.9
|
124.2 titer
Interval 94.8 to 162.7
|
152.5 titer
Interval 105.7 to 220.0
|
168.5 titer
Interval 119.0 to 238.8
|
108.0 titer
Interval 71.8 to 162.3
|
121.1 titer
Interval 85.0 to 172.4
|
|
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains
A/Michigan/84/2016 [H3N2] - Day 57
|
75.7 titer
Interval 54.4 to 105.4
|
95.1 titer
Interval 70.5 to 128.4
|
131.4 titer
Interval 92.0 to 187.8
|
154.5 titer
Interval 108.1 to 221.0
|
81.5 titer
Interval 53.3 to 124.6
|
106.6 titer
Interval 74.1 to 153.4
|
|
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains
A/Michigan/84/2016 [H3N2] - Day 90
|
79.3 titer
Interval 56.0 to 112.3
|
99.7 titer
Interval 73.2 to 135.8
|
137.2 titer
Interval 95.0 to 198.0
|
162.9 titer
Interval 113.8 to 233.2
|
78.5 titer
Interval 51.8 to 119.1
|
111.2 titer
Interval 74.2 to 166.5
|
|
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains
A/Michigan/84/2016 [H3N2] - Day 118
|
121.5 titer
Interval 83.7 to 176.4
|
129.5 titer
Interval 93.9 to 178.5
|
183.8 titer
Interval 122.3 to 276.2
|
323.3 titer
Interval 231.3 to 451.8
|
153.2 titer
Interval 97.5 to 240.8
|
180.8 titer
Interval 118.8 to 275.2
|
SECONDARY outcome
Timeframe: Day 1, Day 8, Day 29, Day 57, Day 90, Day 118Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood samples for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid HAI results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
Blood was collected for HAI assay which was conducted with the heterologous H1 and H3 influenza viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at Day 1, Day 8, Day 29, Day 57, Day 90, and Day 118 post first study vaccination and the ratio of these GMTs between adjuvanted and unadjuvanted study arms was calculated. Unadjuvanted Fluzone and Flublok study arms are considered as reference groups for the analysis of ratio of GMTs. Ratio of GMTs is defined as the ratio of the GMT from the adjuvanted group divided by the GMT from the corresponding unadjuvanted group.
Outcome measures
| Measure |
Fluzone + CpG55
n=38 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 2019/2020 of Fluzone QIV intramuscular injection on Day 90.
|
Fluzone
n=37 Participants
0.5 mL of 2018/2019 Fluzone QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Fluzone + AF03
n=40 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.25 mL of AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Flublok
n=42 Participants
0.5 mL of 2018/2019 Flublok QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + AF03
0.5 mL of 2018/2019 Flublok QIV + 0.25 mL AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + CpG55
0.5 mL of 2018/2019 Flublok QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
|
|---|---|---|---|---|---|---|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Michigan/84/2016 [H3N2] - Day 57
|
0.5 ratio of GMT
Interval 0.3 to 0.9
|
1.4 ratio of GMT
Interval 0.9 to 2.2
|
0.8 ratio of GMT
Interval 0.5 to 1.2
|
0.7 ratio of GMT
Interval 0.4 to 1.1
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Shandonglaicheng/1763/2016 [H3N2] - Day 1
|
0.9 ratio of GMT
Interval 0.5 to 1.7
|
1.9 ratio of GMT
Interval 1.0 to 3.5
|
1.2 ratio of GMT
Interval 0.6 to 2.2
|
0.7 ratio of GMT
Interval 0.4 to 1.4
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Shandonglaicheng/1763/2016 [H3N2] - Day 8
|
1.4 ratio of GMT
Interval 0.7 to 2.5
|
2.3 ratio of GMT
Interval 1.5 to 3.7
|
1.6 ratio of GMT
Interval 1.0 to 2.5
|
1.1 ratio of GMT
Interval 0.7 to 1.9
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Shandonglaicheng/1763/2016 [H3N2] - Day 29
|
1.1 ratio of GMT
Interval 0.6 to 2.0
|
2.2 ratio of GMT
Interval 1.4 to 3.7
|
1.5 ratio of GMT
Interval 0.9 to 2.6
|
0.9 ratio of GMT
Interval 0.5 to 1.6
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Shandonglaicheng/1763/2016 [H3N2] - Day 57
|
1.0 ratio of GMT
Interval 0.6 to 1.8
|
2.4 ratio of GMT
Interval 1.4 to 3.9
|
1.4 ratio of GMT
Interval 0.8 to 2.5
|
0.9 ratio of GMT
Interval 0.5 to 1.5
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Shandonglaicheng/1763/2016 [H3N2] - Day 90
|
1.1 ratio of GMT
Interval 0.6 to 2.0
|
2.4 ratio of GMT
Interval 1.4 to 4.0
|
1.4 ratio of GMT
Interval 0.8 to 2.4
|
0.9 ratio of GMT
Interval 0.5 to 1.6
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Shandonglaicheng/1763/2016 [H3N2] - Day 118
|
1.0 ratio of GMT
Interval 0.5 to 1.9
|
1.6 ratio of GMT
Interval 0.9 to 3.0
|
1.4 ratio of GMT
Interval 0.8 to 2.4
|
0.7 ratio of GMT
Interval 0.3 to 1.3
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Aksaray/4048/2016 [H3N2] - Day 1
|
0.7 ratio of GMT
Interval 0.4 to 1.3
|
1.9 ratio of GMT
Interval 1.0 to 3.6
|
1.1 ratio of GMT
Interval 0.6 to 1.9
|
0.8 ratio of GMT
Interval 0.4 to 1.4
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Aksaray/4048/2016 [H3N2] - Day 8
|
1.3 ratio of GMT
Interval 0.8 to 2.1
|
2.5 ratio of GMT
Interval 1.7 to 3.8
|
1.5 ratio of GMT
Interval 1.0 to 2.2
|
1.1 ratio of GMT
Interval 0.7 to 1.6
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Aksaray/4048/2016 [H3N2] - Day 29
|
1.1 ratio of GMT
Interval 0.7 to 1.6
|
2.4 ratio of GMT
Interval 1.5 to 3.8
|
1.3 ratio of GMT
Interval 0.8 to 2.1
|
0.9 ratio of GMT
Interval 0.6 to 1.4
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Aksaray/4048/2016 [H3N2] - Day 57
|
1.0 ratio of GMT
Interval 0.7 to 1.6
|
2.3 ratio of GMT
Interval 1.5 to 3.7
|
1.3 ratio of GMT
Interval 0.8 to 2.1
|
0.9 ratio of GMT
Interval 0.6 to 1.4
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Aksaray/4048/2016 [H3N2] - Day 90
|
1.0 ratio of GMT
Interval 0.6 to 1.6
|
2.1 ratio of GMT
Interval 1.3 to 3.5
|
1.1 ratio of GMT
Interval 0.6 to 1.9
|
0.9 ratio of GMT
Interval 0.6 to 1.4
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Aksaray/4048/2016 [H3N2] - Day 118
|
0.9 ratio of GMT
Interval 0.5 to 1.6
|
1.6 ratio of GMT
Interval 0.9 to 2.6
|
1.4 ratio of GMT
Interval 0.8 to 2.3
|
0.7 ratio of GMT
Interval 0.4 to 1.1
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Kenya/105/2017 [H3N2] - Day 1
|
0.7 ratio of GMT
Interval 0.4 to 1.2
|
1.9 ratio of GMT
Interval 1.1 to 3.4
|
1.1 ratio of GMT
Interval 0.6 to 1.9
|
0.7 ratio of GMT
Interval 0.4 to 1.2
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Kenya/105/2017 [H3N2] - Day 8
|
1.3 ratio of GMT
Interval 0.8 to 2.1
|
2.6 ratio of GMT
Interval 1.7 to 4.0
|
1.4 ratio of GMT
Interval 0.9 to 2.0
|
1.2 ratio of GMT
Interval 0.8 to 1.8
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Kenya/105/2017 [H3N2] - Day 29
|
1.1 ratio of GMT
Interval 0.7 to 1.7
|
2.4 ratio of GMT
Interval 1.5 to 3.9
|
1.2 ratio of GMT
Interval 0.7 to 1.9
|
1.0 ratio of GMT
Interval 0.7 to 1.5
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Kenya/105/2017 [H3N2] - Day 57
|
0.9 ratio of GMT
Interval 0.6 to 1.4
|
2.4 ratio of GMT
Interval 1.5 to 3.8
|
1.2 ratio of GMT
Interval 0.7 to 1.9
|
0.9 ratio of GMT
Interval 0.6 to 1.3
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Kenya/105/2017 [H3N2] - Day 90
|
0.9 ratio of GMT
Interval 0.6 to 1.5
|
2.5 ratio of GMT
Interval 1.5 to 4.1
|
1.1 ratio of GMT
Interval 0.7 to 1.9
|
0.8 ratio of GMT
Interval 0.6 to 1.3
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Kenya/105/2017 [H3N2] - Day 118
|
0.8 ratio of GMT
Interval 0.5 to 1.4
|
1.6 ratio of GMT
Interval 0.9 to 2.6
|
1.1 ratio of GMT
Interval 0.7 to 1.9
|
0.7 ratio of GMT
Interval 0.4 to 1.2
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Louisiana/13/2017 [H3N2] - Day 1
|
0.8 ratio of GMT
Interval 0.4 to 1.3
|
2.1 ratio of GMT
Interval 1.2 to 3.7
|
1.0 ratio of GMT
Interval 0.6 to 1.7
|
0.8 ratio of GMT
Interval 0.5 to 1.3
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Louisiana/13/2017 [H3N2] - Day 8
|
1.1 ratio of GMT
Interval 0.7 to 1.9
|
2.4 ratio of GMT
Interval 1.5 to 4.0
|
1.2 ratio of GMT
Interval 0.7 to 1.9
|
0.9 ratio of GMT
Interval 0.6 to 1.4
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Louisiana/13/2017 [H3N2] - Day 29
|
0.9 ratio of GMT
Interval 0.5 to 1.4
|
2.4 ratio of GMT
Interval 1.5 to 3.9
|
1.1 ratio of GMT
Interval 0.7 to 1.9
|
0.8 ratio of GMT
Interval 0.5 to 1.3
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Louisiana/13/2017 [H3N2] - Day 57
|
0.7 ratio of GMT
Interval 0.4 to 1.2
|
2.3 ratio of GMT
Interval 1.4 to 3.7
|
1.2 ratio of GMT
Interval 0.7 to 1.9
|
0.7 ratio of GMT
Interval 0.4 to 1.1
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Louisiana/13/2017 [H3N2] - Day 90
|
0.7 ratio of GMT
Interval 0.4 to 1.3
|
2.3 ratio of GMT
Interval 1.3 to 3.8
|
1.1 ratio of GMT
Interval 0.6 to 1.8
|
0.7 ratio of GMT
Interval 0.4 to 1.2
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Louisiana/13/2017 [H3N2] - Day 118
|
0.8 ratio of GMT
Interval 0.4 to 1.4
|
1.1 ratio of GMT
Interval 0.6 to 1.9
|
1.0 ratio of GMT
Interval 0.6 to 1.7
|
0.5 ratio of GMT
Interval 0.3 to 1.0
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Michigan/84/2016 [H3N2] - Day 1
|
0.6 ratio of GMT
Interval 0.4 to 1.0
|
1.2 ratio of GMT
Interval 0.7 to 1.9
|
0.8 ratio of GMT
Interval 0.5 to 1.2
|
0.8 ratio of GMT
Interval 0.5 to 1.2
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Michigan/84/2016 [H3N2] - Day 8
|
0.8 ratio of GMT
Interval 0.5 to 1.3
|
1.5 ratio of GMT
Interval 1.0 to 2.2
|
0.8 ratio of GMT
Interval 0.6 to 1.2
|
0.8 ratio of GMT
Interval 0.5 to 1.3
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Michigan/84/2016 [H3N2] - Day 29
|
0.6 ratio of GMT
Interval 0.4 to 1.1
|
1.2 ratio of GMT
Interval 0.8 to 1.9
|
0.8 ratio of GMT
Interval 0.5 to 1.2
|
0.7 ratio of GMT
Interval 0.4 to 1.2
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Michigan/84/2016 [H3N2] - Day 90
|
0.5 ratio of GMT
Interval 0.3 to 0.8
|
1.4 ratio of GMT
Interval 0.9 to 2.2
|
0.8 ratio of GMT
Interval 0.5 to 1.3
|
0.7 ratio of GMT
Interval 0.4 to 1.2
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Michigan/84/2016 [H3N2] - Day 118
|
0.5 ratio of GMT
Interval 0.3 to 0.8
|
1.4 ratio of GMT
Interval 0.9 to 2.4
|
0.9 ratio of GMT
Interval 0.6 to 1.5
|
0.6 ratio of GMT
Interval 0.3 to 0.9
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 8, Day 29, Day 57, Day 90, Day 118Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood samples for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid HAI results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
Blood was collected for HAI assay which was conducted with the heterologous H1 and H3 influenza viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. HAI seroconversion was defined as either a pre-vaccination titer \< 1:10 and a post-vaccination titer \>= 1:40 or a pre-vaccination titer \>= 1:10 and a minimum four-fold rise in post-vaccination antibody titer.
Outcome measures
| Measure |
Fluzone + CpG55
n=40 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 2019/2020 of Fluzone QIV intramuscular injection on Day 90.
|
Fluzone
n=41 Participants
0.5 mL of 2018/2019 Fluzone QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Fluzone + AF03
n=37 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.25 mL of AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Flublok
n=41 Participants
0.5 mL of 2018/2019 Flublok QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + AF03
n=38 Participants
0.5 mL of 2018/2019 Flublok QIV + 0.25 mL AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + CpG55
n=42 Participants
0.5 mL of 2018/2019 Flublok QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains
A/Michigan/84/2016 [H3N2] - Day 29
|
8 percentage of participants
Interval 2.0 to 21.0
|
5 percentage of participants
Interval to 17.0
Value is NA because it's \>0 but \<1
|
8 percentage of participants
Interval 2.0 to 22.0
|
10 percentage of participants
Interval 3.0 to 24.0
|
16 percentage of participants
Interval 6.0 to 32.0
|
12 percentage of participants
Interval 4.0 to 26.0
|
|
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains
A/Shandonglaicheng/1763/2016 [H3N2] - Day 8
|
33 percentage of participants
Interval 19.0 to 49.0
|
44 percentage of participants
Interval 28.0 to 60.0
|
38 percentage of participants
Interval 22.0 to 55.0
|
27 percentage of participants
Interval 14.0 to 43.0
|
50 percentage of participants
Interval 33.0 to 67.0
|
48 percentage of participants
Interval 32.0 to 64.0
|
|
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains
A/Aksaray/4048/2016 [H3N2] - Day 8
|
30 percentage of participants
Interval 17.0 to 47.0
|
27 percentage of participants
Interval 14.0 to 43.0
|
30 percentage of participants
Interval 16.0 to 47.0
|
29 percentage of participants
Interval 16.0 to 46.0
|
47 percentage of participants
Interval 31.0 to 64.0
|
40 percentage of participants
Interval 26.0 to 57.0
|
|
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains
A/Kenya/105/2017 [H3N2] - Day 8
|
35 percentage of participants
Interval 21.0 to 52.0
|
32 percentage of participants
Interval 18.0 to 48.0
|
38 percentage of participants
Interval 22.0 to 55.0
|
32 percentage of participants
Interval 18.0 to 48.0
|
58 percentage of participants
Interval 41.0 to 74.0
|
57 percentage of participants
Interval 41.0 to 72.0
|
|
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains
A/Louisiana/13/2017 [H3N2] - Day 8
|
45 percentage of participants
Interval 29.0 to 62.0
|
39 percentage of participants
Interval 24.0 to 55.0
|
41 percentage of participants
Interval 25.0 to 58.0
|
29 percentage of participants
Interval 16.0 to 46.0
|
47 percentage of participants
Interval 31.0 to 64.0
|
40 percentage of participants
Interval 26.0 to 57.0
|
|
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains
A/Michigan/84/2016 [H3N2] - Day 8
|
10 percentage of participants
Interval 3.0 to 24.0
|
10 percentage of participants
Interval 3.0 to 23.0
|
11 percentage of participants
Interval 3.0 to 25.0
|
5 percentage of participants
Interval to 17.0
Value is NA because it's \>0 but \<1
|
11 percentage of participants
Interval 3.0 to 25.0
|
7 percentage of participants
Interval 1.0 to 19.0
|
|
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains
A/Shandonglaicheng/1763/2016 [H3N2] - Day 29
|
36 percentage of participants
Interval 21.0 to 53.0
|
37 percentage of participants
Interval 22.0 to 53.0
|
31 percentage of participants
Interval 16.0 to 48.0
|
55 percentage of participants
Interval 38.0 to 71.0
|
57 percentage of participants
Interval 39.0 to 73.0
|
63 percentage of participants
Interval 47.0 to 78.0
|
|
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains
A/Aksaray/4048/2016 [H3N2] - Day 29
|
31 percentage of participants
Interval 17.0 to 48.0
|
27 percentage of participants
Interval 14.0 to 43.0
|
31 percentage of participants
Interval 16.0 to 48.0
|
48 percentage of participants
Interval 32.0 to 64.0
|
57 percentage of participants
Interval 39.0 to 73.0
|
59 percentage of participants
Interval 42.0 to 74.0
|
|
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains
A/Kenya/105/2017 [H3N2] - Day 29
|
51 percentage of participants
Interval 35.0 to 68.0
|
51 percentage of participants
Interval 35.0 to 67.0
|
56 percentage of participants
Interval 38.0 to 72.0
|
65 percentage of participants
Interval 48.0 to 79.0
|
78 percentage of participants
Interval 62.0 to 90.0
|
78 percentage of participants
Interval 62.0 to 89.0
|
|
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains
A/Louisiana/13/2017 [H3N2] - Day 29
|
56 percentage of participants
Interval 40.0 to 72.0
|
41 percentage of participants
Interval 26.0 to 58.0
|
53 percentage of participants
Interval 35.0 to 70.0
|
53 percentage of participants
Interval 36.0 to 68.0
|
73 percentage of participants
Interval 56.0 to 86.0
|
59 percentage of participants
Interval 42.0 to 74.0
|
|
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains
A/Shandonglaicheng/1763/2016 [H3N2] - Day 57
|
26 percentage of participants
Interval 13.0 to 43.0
|
18 percentage of participants
Interval 7.0 to 33.0
|
24 percentage of participants
Interval 12.0 to 41.0
|
40 percentage of participants
Interval 25.0 to 57.0
|
49 percentage of participants
Interval 32.0 to 66.0
|
46 percentage of participants
Interval 31.0 to 63.0
|
|
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains
A/Aksaray/4048/2016 [H3N2] - Day 57
|
29 percentage of participants
Interval 15.0 to 46.0
|
23 percentage of participants
Interval 11.0 to 38.0
|
27 percentage of participants
Interval 14.0 to 44.0
|
40 percentage of participants
Interval 25.0 to 57.0
|
57 percentage of participants
Interval 39.0 to 73.0
|
51 percentage of participants
Interval 35.0 to 67.0
|
|
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains
A/Kenya/105/2017 [H3N2] - Day 57
|
39 percentage of participants
Interval 24.0 to 57.0
|
23 percentage of participants
Interval 11.0 to 38.0
|
35 percentage of participants
Interval 20.0 to 53.0
|
50 percentage of participants
Interval 34.0 to 66.0
|
62 percentage of participants
Interval 45.0 to 78.0
|
66 percentage of participants
Interval 49.0 to 80.0
|
|
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains
A/Louisiana/13/2017 [H3N2] - Day 57
|
32 percentage of participants
Interval 18.0 to 49.0
|
25 percentage of participants
Interval 13.0 to 41.0
|
30 percentage of participants
Interval 16.0 to 47.0
|
45 percentage of participants
Interval 29.0 to 62.0
|
46 percentage of participants
Interval 29.0 to 63.0
|
44 percentage of participants
Interval 28.0 to 60.0
|
|
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains
A/Michigan/84/2016 [H3N2] - Day 57
|
5 percentage of participants
Interval to 18.0
Value is NA because it's \>0 but \<1
|
3 percentage of participants
Interval to 13.0
Value is NA because it's \>0 but \<1
|
8 percentage of participants
Interval 2.0 to 22.0
|
8 percentage of participants
Interval 2.0 to 20.0
|
11 percentage of participants
Interval 3.0 to 25.0
|
10 percentage of participants
Interval 3.0 to 23.0
|
|
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains
A/Louisiana/13/2017 [H3N2] - Day 90
|
24 percentage of participants
Interval 11.0 to 40.0
|
27 percentage of participants
Interval 14.0 to 43.0
|
22 percentage of participants
Interval 10.0 to 39.0
|
46 percentage of participants
Interval 30.0 to 63.0
|
43 percentage of participants
Interval 27.0 to 61.0
|
48 percentage of participants
Interval 32.0 to 64.0
|
|
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains
A/Shandonglaicheng/1763/2016 [H3N2] - Day 90
|
24 percentage of participants
Interval 11.0 to 40.0
|
20 percentage of participants
Interval 9.0 to 35.0
|
19 percentage of participants
Interval 8.0 to 36.0
|
38 percentage of participants
Interval 23.0 to 55.0
|
38 percentage of participants
Interval 22.0 to 55.0
|
45 percentage of participants
Interval 29.0 to 62.0
|
|
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains
A/Aksaray/4048/2016 [H3N2] - Day 90
|
24 percentage of participants
Interval 11.0 to 40.0
|
20 percentage of participants
Interval 9.0 to 35.0
|
19 percentage of participants
Interval 8.0 to 36.0
|
38 percentage of participants
Interval 23.0 to 55.0
|
41 percentage of participants
Interval 25.0 to 58.0
|
45 percentage of participants
Interval 29.0 to 62.0
|
|
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains
A/Kenya/105/2017 [H3N2] - Day 90
|
39 percentage of participants
Interval 24.0 to 57.0
|
34 percentage of participants
Interval 20.0 to 51.0
|
36 percentage of participants
Interval 21.0 to 54.0
|
59 percentage of participants
Interval 42.0 to 74.0
|
62 percentage of participants
Interval 45.0 to 78.0
|
65 percentage of participants
Interval 48.0 to 79.0
|
|
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains
A/Michigan/84/2016 [H3N2] - Day 90
|
5 percentage of participants
Interval to 18.0
Value is NA because it's \>0 but \<1
|
2 percentage of participants
Interval to 13.0
Value is NA because it's \>0 but \<1
|
6 percentage of participants
Interval to 19.0
Value is NA because it's \>0 but \<1
|
8 percentage of participants
Interval 2.0 to 21.0
|
14 percentage of participants
Interval 5.0 to 29.0
|
13 percentage of participants
Interval 4.0 to 27.0
|
|
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains
A/Shandonglaicheng/1763/2016 [H3N2] - Day 118
|
47 percentage of participants
Interval 30.0 to 65.0
|
53 percentage of participants
Interval 35.0 to 70.0
|
33 percentage of participants
Interval 17.0 to 53.0
|
71 percentage of participants
Interval 53.0 to 85.0
|
69 percentage of participants
Interval 50.0 to 84.0
|
79 percentage of participants
Interval 62.0 to 91.0
|
|
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains
A/Aksaray/4048/2016 [H3N2] - Day 118
|
62 percentage of participants
Interval 44.0 to 78.0
|
58 percentage of participants
Interval 41.0 to 74.0
|
37 percentage of participants
Interval 20.0 to 56.0
|
79 percentage of participants
Interval 62.0 to 91.0
|
75 percentage of participants
Interval 57.0 to 89.0
|
76 percentage of participants
Interval 59.0 to 89.0
|
|
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains
A/Kenya/105/2017 [H3N2] - Day 118
|
62 percentage of participants
Interval 44.0 to 78.0
|
56 percentage of participants
Interval 38.0 to 72.0
|
30 percentage of participants
Interval 15.0 to 49.0
|
74 percentage of participants
Interval 56.0 to 87.0
|
88 percentage of participants
Interval 71.0 to 96.0
|
82 percentage of participants
Interval 65.0 to 93.0
|
|
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains
A/Louisiana/13/2017 [H3N2] - Day 118
|
82 percentage of participants
Interval 65.0 to 93.0
|
78 percentage of participants
Interval 61.0 to 90.0
|
47 percentage of participants
Interval 28.0 to 66.0
|
85 percentage of participants
Interval 69.0 to 95.0
|
91 percentage of participants
Interval 75.0 to 98.0
|
91 percentage of participants
Interval 76.0 to 98.0
|
|
Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains
A/Michigan/84/2016 [H3N2] - Day 118
|
15 percentage of participants
Interval 5.0 to 31.0
|
11 percentage of participants
Interval 3.0 to 26.0
|
13 percentage of participants
Interval 4.0 to 31.0
|
38 percentage of participants
Interval 22.0 to 56.0
|
38 percentage of participants
Interval 21.0 to 56.0
|
26 percentage of participants
Interval 13.0 to 44.0
|
SECONDARY outcome
Timeframe: Day 1, Day 8, Day 29, Day 57, Day 90, Day 118Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood samples for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid HAI results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
Blood was collected for HAI assay which was conducted with the heterologous H1 and H3 influenza viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result.
Outcome measures
| Measure |
Fluzone + CpG55
n=40 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 2019/2020 of Fluzone QIV intramuscular injection on Day 90.
|
Fluzone
n=41 Participants
0.5 mL of 2018/2019 Fluzone QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Fluzone + AF03
n=37 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.25 mL of AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Flublok
n=41 Participants
0.5 mL of 2018/2019 Flublok QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + AF03
n=38 Participants
0.5 mL of 2018/2019 Flublok QIV + 0.25 mL AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + CpG55
n=42 Participants
0.5 mL of 2018/2019 Flublok QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains
A/Shandonglaicheng/1763/2016 [H3N2] - Day 29
|
97 percentage of participants
Interval 87.0 to
Value is NA because it's \>99 but \<100
|
95 percentage of participants
Interval 83.0 to
Value is NA because it's \>99 but \<100
|
100 percentage of participants
Interval 90.0 to 100.0
|
98 percentage of participants
Interval 87.0 to
Value is NA because it's \>99 but \<100
|
95 percentage of participants
Interval 82.0 to
Value is NA because it's \>99 but \<100
|
98 percentage of participants
Interval 87.0 to
Value is NA because it's \>99 but \<100
|
|
Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains
A/Shandonglaicheng/1763/2016 [H3N2] - Day 1
|
73 percentage of participants
Interval 56.0 to 85.0
|
78 percentage of participants
Interval 62.0 to 89.0
|
78 percentage of participants
Interval 62.0 to 90.0
|
71 percentage of participants
Interval 54.0 to 84.0
|
71 percentage of participants
Interval 54.0 to 85.0
|
69 percentage of participants
Interval 53.0 to 82.0
|
|
Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains
A/Aksaray/4048/2016 [H3N2] - Day 1
|
70 percentage of participants
Interval 53.0 to 83.0
|
78 percentage of participants
Interval 62.0 to 89.0
|
81 percentage of participants
Interval 65.0 to 92.0
|
80 percentage of participants
Interval 65.0 to 91.0
|
71 percentage of participants
Interval 54.0 to 85.0
|
81 percentage of participants
Interval 66.0 to 91.0
|
|
Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains
A/Kenya/105/2017 [H3N2] - Day 1
|
70 percentage of participants
Interval 53.0 to 83.0
|
78 percentage of participants
Interval 62.0 to 89.0
|
86 percentage of participants
Interval 71.0 to 95.0
|
90 percentage of participants
Interval 77.0 to 97.0
|
74 percentage of participants
Interval 57.0 to 87.0
|
86 percentage of participants
Interval 71.0 to 95.0
|
|
Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains
A/Louisiana/13/2017 [H3N2] - Day 1
|
43 percentage of participants
Interval 27.0 to 59.0
|
54 percentage of participants
Interval 37.0 to 69.0
|
68 percentage of participants
Interval 50.0 to 82.0
|
56 percentage of participants
Interval 40.0 to 72.0
|
47 percentage of participants
Interval 31.0 to 64.0
|
52 percentage of participants
Interval 36.0 to 68.0
|
|
Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains
A/Aksaray/4048/2016 [H3N2] - Day 29
|
97 percentage of participants
Interval 87.0 to
Value is NA because it's \>99 but \<100
|
95 percentage of participants
Interval 83.0 to
Value is NA because it's \>99 but \<100
|
100 percentage of participants
Interval 90.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
|
Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains
A/Michigan/84/2016 [H3N2] - Day 1
|
68 percentage of participants
Interval 51.0 to 81.0
|
78 percentage of participants
Interval 62.0 to 89.0
|
81 percentage of participants
Interval 65.0 to 92.0
|
80 percentage of participants
Interval 65.0 to 91.0
|
66 percentage of participants
Interval 49.0 to 80.0
|
83 percentage of participants
Interval 69.0 to 93.0
|
|
Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains
A/Shandonglaicheng/1763/2016 [H3N2] - Day 8
|
100 percentage of participants
Interval 91.0 to 100.0
|
98 percentage of participants
Interval 87.0 to
Value is NA because it's \>99 but \<100
|
100 percentage of participants
Interval 91.0 to 100.0
|
93 percentage of participants
Interval 80.0 to 98.0
|
92 percentage of participants
Interval 79.0 to 98.0
|
100 percentage of participants
Interval 92.0 to 100.0
|
|
Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains
A/Aksaray/4048/2016 [H3N2] - Day 8
|
98 percentage of participants
Interval 87.0 to
Value is NA because it's \>99 but \<100
|
98 percentage of participants
Interval 87.0 to
Value is NA because it's \>99 but \<100
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
97 percentage of participants
Interval 86.0 to
Value is NA because it's \>99 but \<100
|
100 percentage of participants
Interval 92.0 to 100.0
|
|
Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains
A/Kenya/105/2017 [H3N2] - Day 8
|
98 percentage of participants
Interval 87.0 to
Value is NA because it's \>99 but \<100
|
98 percentage of participants
Interval 87.0 to
Value is NA because it's \>99 but \<100
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
97 percentage of participants
Interval 86.0 to
Value is NA because it's \>99 but \<100
|
100 percentage of participants
Interval 92.0 to 100.0
|
|
Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains
A/Louisiana/13/2017 [H3N2] - Day 8
|
88 percentage of participants
Interval 73.0 to 96.0
|
88 percentage of participants
Interval 74.0 to 96.0
|
95 percentage of participants
Interval 82.0 to
Value is NA because it's \>99 but \<100
|
88 percentage of participants
Interval 74.0 to 96.0
|
89 percentage of participants
Interval 75.0 to 97.0
|
86 percentage of participants
Interval 71.0 to 95.0
|
|
Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains
A/Michigan/84/2016 [H3N2] - Day 8
|
93 percentage of participants
Interval 80.0 to 98.0
|
93 percentage of participants
Interval 80.0 to 98.0
|
92 percentage of participants
Interval 78.0 to 98.0
|
88 percentage of participants
Interval 74.0 to 96.0
|
79 percentage of participants
Interval 63.0 to 90.0
|
93 percentage of participants
Interval 81.0 to 99.0
|
|
Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains
A/Kenya/105/2017 [H3N2] - Day 29
|
100 percentage of participants
Interval 91.0 to 100.0
|
98 percentage of participants
Interval 87.0 to
Value is NA because it's \>99 but \<100
|
100 percentage of participants
Interval 90.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
|
Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains
A/Louisiana/13/2017 [H3N2] - Day 29
|
95 percentage of participants
Interval 83.0 to
Value is NA because it's \>99 but \<100
|
90 percentage of participants
Interval 77.0 to 97.0
|
97 percentage of participants
Interval 85.0 to
Value is NA because it's \>99 but \<100
|
95 percentage of participants
Interval 83.0 to
Value is NA because it's \>99 but \<100
|
97 percentage of participants
Interval 86.0 to
Value is NA because it's \>99 but \<100
|
95 percentage of participants
Interval 83.0 to
Value is NA because it's \>99 but \<100
|
|
Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains
A/Michigan/84/2016 [H3N2] - Day 29
|
87 percentage of participants
Interval 73.0 to 96.0
|
98 percentage of participants
Interval 87.0 to
Value is NA because it's \>99 but \<100
|
94 percentage of participants
Interval 81.0 to
Value is NA because it's \>99 but \<100
|
90 percentage of participants
Interval 76.0 to 97.0
|
78 percentage of participants
Interval 62.0 to 90.0
|
90 percentage of participants
Interval 77.0 to 97.0
|
|
Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains
A/Shandonglaicheng/1763/2016 [H3N2] - Day 57
|
92 percentage of participants
Interval 79.0 to 98.0
|
83 percentage of participants
Interval 67.0 to 93.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
95 percentage of participants
Interval 83.0 to
Value is NA because it's \>99 but \<100
|
95 percentage of participants
Interval 82.0 to
Value is NA because it's \>99 but \<100
|
95 percentage of participants
Interval 83.0 to
Value is NA because it's \>99 but \<100
|
|
Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains
A/Aksaray/4048/2016 [H3N2] - Day 57
|
97 percentage of participants
Interval 86.0 to
Value is NA because it's \>99 but \<100
|
90 percentage of participants
Interval 76.0 to 97.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
97 percentage of participants
Interval 86.0 to
Value is NA because it's \>99 but \<100
|
100 percentage of participants
Interval 91.0 to 100.0
|
|
Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains
A/Kenya/105/2017 [H3N2] - Day 57
|
95 percentage of participants
Interval 82.0 to
Value is NA because it's \>99 but \<100
|
95 percentage of participants
Interval 83.0 to
Value is NA because it's \>99 but \<100
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
|
Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains
A/Louisiana/13/2017 [H3N2] - Day 57
|
82 percentage of participants
Interval 66.0 to 92.0
|
78 percentage of participants
Interval 62.0 to 89.0
|
95 percentage of participants
Interval 82.0 to
Value is NA because it's \>99 but \<100
|
95 percentage of participants
Interval 83.0 to
Value is NA because it's \>99 but \<100
|
92 percentage of participants
Interval 78.0 to 98.0
|
90 percentage of participants
Interval 77.0 to 97.0
|
|
Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains
A/Michigan/84/2016 [H3N2] - Day 57
|
82 percentage of participants
Interval 66.0 to 92.0
|
83 percentage of participants
Interval 67.0 to 93.0
|
89 percentage of participants
Interval 75.0 to 97.0
|
88 percentage of participants
Interval 73.0 to 96.0
|
76 percentage of participants
Interval 59.0 to 88.0
|
88 percentage of participants
Interval 74.0 to 96.0
|
|
Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains
A/Shandonglaicheng/1763/2016 [H3N2] - Day 90
|
92 percentage of participants
Interval 79.0 to 98.0
|
85 percentage of participants
Interval 71.0 to 94.0
|
100 percentage of participants
Interval 90.0 to 100.0
|
97 percentage of participants
Interval 87.0 to
Value is NA because it's \>99 but \<100
|
95 percentage of participants
Interval 82.0 to
Value is NA because it's \>99 but \<100
|
95 percentage of participants
Interval 83.0 to
Value is NA because it's \>99 but \<100
|
|
Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains
A/Aksaray/4048/2016 [H3N2] - Day 90
|
92 percentage of participants
Interval 79.0 to 98.0
|
90 percentage of participants
Interval 77.0 to 97.0
|
100 percentage of participants
Interval 90.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
97 percentage of participants
Interval 86.0 to
Value is NA because it's \>99 but \<100
|
100 percentage of participants
Interval 91.0 to 100.0
|
|
Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains
A/Kenya/105/2017 [H3N2] - Day 90
|
95 percentage of participants
Interval 82.0 to
Value is NA because it's \>99 but \<100
|
95 percentage of participants
Interval 83.0 to
Value is NA because it's \>99 but \<100
|
100 percentage of participants
Interval 90.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
100 percentage of participants
Interval 91.0 to 100.0
|
|
Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains
A/Louisiana/13/2017 [H3N2] - Day 90
|
74 percentage of participants
Interval 57.0 to 87.0
|
78 percentage of participants
Interval 62.0 to 89.0
|
94 percentage of participants
Interval 81.0 to
Value is NA because it's \>99 but \<100
|
97 percentage of participants
Interval 87.0 to
Value is NA because it's \>99 but \<100
|
89 percentage of participants
Interval 75.0 to 97.0
|
93 percentage of participants
Interval 80.0 to 98.0
|
|
Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains
A/Michigan/84/2016 [H3N2] - Day 90
|
79 percentage of participants
Interval 63.0 to 90.0
|
83 percentage of participants
Interval 68.0 to 93.0
|
89 percentage of participants
Interval 74.0 to 97.0
|
95 percentage of participants
Interval 83.0 to
Value is NA because it's \>99 but \<100
|
76 percentage of participants
Interval 59.0 to 88.0
|
85 percentage of participants
Interval 70.0 to 94.0
|
|
Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains
A/Shandonglaicheng/1763/2016 [H3N2] - Day 118
|
94 percentage of participants
Interval 80.0 to
Value is NA because it's \>99 but \<100
|
94 percentage of participants
Interval 81.0 to
Value is NA because it's \>99 but \<100
|
100 percentage of participants
Interval 88.0 to 100.0
|
100 percentage of participants
Interval 90.0 to 100.0
|
97 percentage of participants
Interval 84.0 to
Value is NA because it's \>99 but \<100
|
100 percentage of participants
Interval 90.0 to 100.0
|
|
Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains
A/Aksaray/4048/2016 [H3N2] - Day 118
|
94 percentage of participants
Interval 80.0 to
Value is NA because it's \>99 but \<100
|
100 percentage of participants
Interval 90.0 to 100.0
|
100 percentage of participants
Interval 88.0 to 100.0
|
100 percentage of participants
Interval 90.0 to 100.0
|
100 percentage of participants
Interval 89.0 to 100.0
|
100 percentage of participants
Interval 90.0 to 100.0
|
|
Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains
A/Kenya/105/2017 [H3N2] - Day 118
|
97 percentage of participants
Interval 85.0 to
Value is NA because it's \>99 but \<100
|
100 percentage of participants
Interval 90.0 to 100.0
|
100 percentage of participants
Interval 88.0 to 100.0
|
100 percentage of participants
Interval 90.0 to 100.0
|
100 percentage of participants
Interval 89.0 to 100.0
|
100 percentage of participants
Interval 90.0 to 100.0
|
|
Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains
A/Louisiana/13/2017 [H3N2] - Day 118
|
94 percentage of participants
Interval 80.0 to
Value is NA because it's \>99 but \<100
|
97 percentage of participants
Interval 85.0 to
Value is NA because it's \>99 but \<100
|
97 percentage of participants
Interval 83.0 to
Value is NA because it's \>99 but \<100
|
100 percentage of participants
Interval 90.0 to 100.0
|
97 percentage of participants
Interval 84.0 to
Value is NA because it's \>99 but \<100
|
100 percentage of participants
Interval 90.0 to 100.0
|
|
Percentage of Participants With Hemagglutination Inhibition (HAI) Titer of 1:40 or Greater Against Heterologous H1 and H3 Influenza Strains
A/Michigan/84/2016 [H3N2] - Day 118
|
88 percentage of participants
Interval 73.0 to 97.0
|
94 percentage of participants
Interval 81.0 to
Value is NA because it's \>99 but \<100
|
93 percentage of participants
Interval 78.0 to
Value is NA because it's \>99 but \<100
|
97 percentage of participants
Interval 85.0 to
Value is NA because it's \>99 but \<100
|
84 percentage of participants
Interval 67.0 to 95.0
|
91 percentage of participants
Interval 76.0 to 98.0
|
SECONDARY outcome
Timeframe: Day 8, Day 29, Day 57, Day 90, Day 118Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood samples for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid HAI results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
Blood was collected for HAI assay which was conducted with the heterologous H1 and H3 influenza viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. Fold-rises from baseline were calculated as the Day 8 (or Day 29, Day 57, Day 90, Day 118) titer divided by the baseline titers for each participant. The geometric mean of these fold rises was then calculated to obtain the GMFR.
Outcome measures
| Measure |
Fluzone + CpG55
n=40 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 2019/2020 of Fluzone QIV intramuscular injection on Day 90.
|
Fluzone
n=41 Participants
0.5 mL of 2018/2019 Fluzone QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Fluzone + AF03
n=37 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.25 mL of AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Flublok
n=41 Participants
0.5 mL of 2018/2019 Flublok QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + AF03
n=38 Participants
0.5 mL of 2018/2019 Flublok QIV + 0.25 mL AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + CpG55
n=42 Participants
0.5 mL of 2018/2019 Flublok QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains
A/Shandonglaicheng/1763/2016 [H3N2] - Day 8
|
4.2 fold rise
Interval 2.6 to 6.8
|
3.2 fold rise
Interval 2.2 to 4.6
|
3.9 fold rise
Interval 2.5 to 6.0
|
3.0 fold rise
Interval 2.1 to 4.3
|
4.5 fold rise
Interval 2.9 to 7.1
|
4.7 fold rise
Interval 3.1 to 7.2
|
|
Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains
A/Aksaray/4048/2016 [H3N2] - Day 8
|
3.4 fold rise
Interval 2.2 to 5.2
|
2.4 fold rise
Interval 1.8 to 3.4
|
3.2 fold rise
Interval 2.1 to 5.0
|
2.8 fold rise
Interval 2.0 to 4.0
|
4.9 fold rise
Interval 3.2 to 7.7
|
3.9 fold rise
Interval 2.7 to 5.5
|
|
Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains
A/Kenya/105/2017 [H3N2] - Day 8
|
3.7 fold rise
Interval 2.4 to 5.7
|
2.9 fold rise
Interval 2.1 to 4.1
|
3.9 fold rise
Interval 2.6 to 6.0
|
3.0 fold rise
Interval 2.1 to 4.1
|
5.8 fold rise
Interval 3.8 to 9.0
|
4.8 fold rise
Interval 3.4 to 6.7
|
|
Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains
A/Louisiana/13/2017 [H3N2] - Day 8
|
4.1 fold rise
Interval 2.8 to 5.9
|
3.5 fold rise
Interval 2.5 to 4.8
|
4.0 fold rise
Interval 2.8 to 5.8
|
3.0 fold rise
Interval 2.2 to 4.1
|
4.5 fold rise
Interval 3.2 to 6.4
|
3.4 fold rise
Interval 2.4 to 4.7
|
|
Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains
A/Michigan/84/2016 [H3N2] - Day 8
|
1.5 fold rise
Interval 1.3 to 1.9
|
1.4 fold rise
Interval 1.2 to 1.7
|
1.7 fold rise
Interval 1.4 to 2.1
|
1.3 fold rise
Interval 1.1 to 1.5
|
1.7 fold rise
Interval 1.3 to 2.4
|
1.4 fold rise
Interval 1.2 to 1.7
|
|
Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains
A/Shandonglaicheng/1763/2016 [H3N2] - Day 29
|
4.2 fold rise
Interval 2.7 to 6.6
|
3.1 fold rise
Interval 2.2 to 4.5
|
3.4 fold rise
Interval 2.2 to 5.2
|
4.6 fold rise
Interval 3.1 to 6.7
|
5.2 fold rise
Interval 3.6 to 7.6
|
5.5 fold rise
Interval 3.7 to 8.3
|
|
Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains
A/Aksaray/4048/2016 [H3N2] - Day 29
|
3.1 fold rise
Interval 2.1 to 4.5
|
2.4 fold rise
Interval 1.7 to 3.3
|
2.7 fold rise
Interval 1.8 to 4.0
|
3.8 fold rise
Interval 2.6 to 5.5
|
5.3 fold rise
Interval 3.5 to 8.0
|
4.4 fold rise
Interval 3.0 to 6.5
|
|
Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains
A/Kenya/105/2017 [H3N2] - Day 29
|
4.9 fold rise
Interval 3.3 to 7.1
|
4.2 fold rise
Interval 2.9 to 5.9
|
4.8 fold rise
Interval 3.2 to 7.2
|
6.1 fold rise
Interval 4.2 to 8.8
|
9.5 fold rise
Interval 6.2 to 14.5
|
8.1 fold rise
Interval 5.8 to 11.2
|
|
Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains
A/Louisiana/13/2017 [H3N2] - Day 29
|
4.6 fold rise
Interval 3.4 to 6.3
|
3.8 fold rise
Interval 2.8 to 5.1
|
4.2 fold rise
Interval 3.0 to 5.9
|
5.0 fold rise
Interval 3.6 to 7.0
|
5.7 fold rise
Interval 4.1 to 7.8
|
5.1 fold rise
Interval 3.6 to 7.3
|
|
Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains
A/Michigan/84/2016 [H3N2] - Day 29
|
1.5 fold rise
Interval 1.3 to 1.7
|
1.5 fold rise
Interval 1.3 to 1.8
|
1.6 fold rise
Interval 1.3 to 1.9
|
1.7 fold rise
Interval 1.3 to 2.1
|
1.8 fold rise
Interval 1.3 to 2.4
|
1.6 fold rise
Interval 1.3 to 2.0
|
|
Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains
A/Shandonglaicheng/1763/2016 [H3N2] - Day 57
|
2.6 fold rise
Interval 1.7 to 4.0
|
2.0 fold rise
Interval 1.4 to 2.8
|
2.4 fold rise
Interval 1.6 to 3.5
|
3.6 fold rise
Interval 2.5 to 5.1
|
3.9 fold rise
Interval 2.7 to 5.6
|
4.2 fold rise
Interval 2.9 to 6.3
|
|
Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains
A/Aksaray/4048/2016 [H3N2] - Day 57
|
2.7 fold rise
Interval 1.9 to 3.9
|
2.0 fold rise
Interval 1.5 to 2.8
|
2.4 fold rise
Interval 1.6 to 3.6
|
3.6 fold rise
Interval 2.5 to 5.1
|
5.1 fold rise
Interval 3.3 to 7.6
|
4.0 fold rise
Interval 2.8 to 5.6
|
|
Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains
A/Kenya/105/2017 [H3N2] - Day 57
|
3.6 fold rise
Interval 2.5 to 5.1
|
2.9 fold rise
Interval 2.2 to 3.9
|
3.5 fold rise
Interval 2.5 to 5.0
|
4.2 fold rise
Interval 3.0 to 5.9
|
5.8 fold rise
Interval 3.9 to 8.6
|
5.0 fold rise
Interval 3.7 to 6.9
|
|
Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains
A/Louisiana/13/2017 [H3N2] - Day 57
|
3.3 fold rise
Interval 2.4 to 4.5
|
2.6 fold rise
Interval 2.0 to 3.4
|
2.8 fold rise
Interval 2.0 to 3.8
|
3.9 fold rise
Interval 3.0 to 5.2
|
4.0 fold rise
Interval 3.0 to 5.3
|
3.6 fold rise
Interval 2.7 to 4.9
|
|
Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains
A/Michigan/84/2016 [H3N2] - Day 57
|
1.2 fold rise
Interval 1.1 to 1.4
|
1.2 fold rise
Interval 1.0 to 1.3
|
1.3 fold rise
Interval 1.1 to 1.7
|
1.5 fold rise
Interval 1.2 to 1.9
|
1.4 fold rise
Interval 1.1 to 1.8
|
1.4 fold rise
Interval 1.1 to 1.8
|
|
Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains
A/Shandonglaicheng/1763/2016 [H3N2] - Day 90
|
2.4 fold rise
Interval 1.7 to 3.5
|
1.9 fold rise
Interval 1.4 to 2.5
|
2.1 fold rise
Interval 1.5 to 3.1
|
3.1 fold rise
Interval 2.3 to 4.4
|
3.5 fold rise
Interval 2.5 to 5.1
|
3.6 fold rise
Interval 2.5 to 5.3
|
|
Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains
A/Aksaray/4048/2016 [H3N2] - Day 90
|
2.3 fold rise
Interval 1.6 to 3.2
|
1.9 fold rise
Interval 1.5 to 2.6
|
1.9 fold rise
Interval 1.4 to 2.7
|
2.9 fold rise
Interval 2.1 to 4.0
|
3.9 fold rise
Interval 2.6 to 5.7
|
3.2 fold rise
Interval 2.3 to 4.4
|
|
Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains
A/Kenya/105/2017 [H3N2] - Day 90
|
3.8 fold rise
Interval 2.6 to 5.4
|
3.2 fold rise
Interval 2.4 to 4.2
|
3.8 fold rise
Interval 2.6 to 5.4
|
5.1 fold rise
Interval 3.6 to 7.1
|
7.1 fold rise
Interval 4.8 to 10.6
|
5.7 fold rise
Interval 4.1 to 7.9
|
|
Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains
A/Louisiana/13/2017 [H3N2] - Day 90
|
2.9 fold rise
Interval 2.2 to 3.9
|
2.4 fold rise
Interval 1.9 to 3.1
|
2.5 fold rise
Interval 1.9 to 3.4
|
3.8 fold rise
Interval 2.9 to 4.8
|
3.9 fold rise
Interval 2.9 to 5.2
|
3.5 fold rise
Interval 2.5 to 4.8
|
|
Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains
A/Michigan/84/2016 [H3N2] - Day 90
|
1.3 fold rise
Interval 1.1 to 1.5
|
1.2 fold rise
Interval 1.1 to 1.4
|
1.4 fold rise
Interval 1.2 to 1.7
|
1.6 fold rise
Interval 1.3 to 1.9
|
1.4 fold rise
Interval 1.1 to 1.7
|
1.5 fold rise
Interval 1.2 to 1.9
|
|
Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains
A/Shandonglaicheng/1763/2016 [H3N2] - Day 118
|
4.9 fold rise
Interval 3.2 to 7.3
|
4.1 fold rise
Interval 2.9 to 5.9
|
2.8 fold rise
Interval 1.9 to 4.1
|
6.8 fold rise
Interval 4.3 to 10.7
|
8.1 fold rise
Interval 5.1 to 12.9
|
6.6 fold rise
Interval 4.5 to 9.6
|
|
Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains
A/Aksaray/4048/2016 [H3N2] - Day 118
|
6.5 fold rise
Interval 4.3 to 9.8
|
5.1 fold rise
Interval 3.5 to 7.4
|
3.1 fold rise
Interval 2.2 to 4.5
|
8.1 fold rise
Interval 5.4 to 12.0
|
11.0 fold rise
Interval 6.6 to 18.1
|
6.9 fold rise
Interval 4.9 to 9.6
|
|
Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains
A/Kenya/105/2017 [H3N2] - Day 118
|
5.2 fold rise
Interval 3.4 to 7.8
|
4.8 fold rise
Interval 3.4 to 6.9
|
3.1 fold rise
Interval 2.2 to 4.2
|
7.8 fold rise
Interval 5.1 to 12.0
|
10.4 fold rise
Interval 6.8 to 15.9
|
7.5 fold rise
Interval 5.4 to 10.6
|
|
Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains
A/Louisiana/13/2017 [H3N2] - Day 118
|
9.7 fold rise
Interval 6.5 to 14.6
|
9.8 fold rise
Interval 6.2 to 15.5
|
4.1 fold rise
Interval 2.8 to 6.0
|
15.5 fold rise
Interval 9.5 to 25.4
|
16.5 fold rise
Interval 10.2 to 26.7
|
11.1 fold rise
Interval 7.7 to 15.9
|
|
Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition (HAI) Titers Against Heterologous H1 and H3 Influenza Strains
A/Michigan/84/2016 [H3N2] - Day 118
|
2.0 fold rise
Interval 1.6 to 2.4
|
1.7 fold rise
Interval 1.4 to 2.0
|
1.6 fold rise
Interval 1.3 to 2.1
|
2.9 fold rise
Interval 2.2 to 3.7
|
2.8 fold rise
Interval 1.9 to 4.0
|
2.4 fold rise
Interval 1.9 to 3.0
|
SECONDARY outcome
Timeframe: Day 1, Day 8, Day 29, Day 57, Day 90, Day 118Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood samples for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid NAI results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
Blood was collected for NAI assay which was conducted with the heterologous N1 and N2 NA viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at Day 1, Day 8, Day 29, Day 57, Day 90, and Day 118 Post first study vaccination.
Outcome measures
| Measure |
Fluzone + CpG55
n=40 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 2019/2020 of Fluzone QIV intramuscular injection on Day 90.
|
Fluzone
n=41 Participants
0.5 mL of 2018/2019 Fluzone QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Fluzone + AF03
n=37 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.25 mL of AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Flublok
0.5 mL of 2018/2019 Flublok QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + AF03
0.5 mL of 2018/2019 Flublok QIV + 0.25 mL AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + CpG55
0.5 mL of 2018/2019 Flublok QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Townsville/51/2016 H6N2 - Day 1
|
14.5 titer
Interval 10.7 to 19.6
|
16.6 titer
Interval 12.8 to 21.5
|
20.2 titer
Interval 15.5 to 26.3
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Townsville/51/2016 H6N2 - Day 8
|
35.1 titer
Interval 27.8 to 44.4
|
34.1 titer
Interval 27.3 to 42.5
|
49.6 titer
Interval 39.8 to 61.8
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Townsville/51/2016 H6N2 - Day 29
|
23.3 titer
Interval 17.6 to 30.7
|
21.9 titer
Interval 17.8 to 27.1
|
35.6 titer
Interval 27.5 to 46.1
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Townsville/51/2016 H6N2 - Day 57
|
24.2 titer
Interval 17.9 to 32.7
|
26.2 titer
Interval 20.7 to 33.1
|
37.1 titer
Interval 29.0 to 47.4
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Townsville/51/2016 H6N2 - Day 90
|
24.0 titer
Interval 17.4 to 33.1
|
22.7 titer
Interval 17.9 to 28.8
|
34.6 titer
Interval 25.9 to 46.2
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Townsville/51/2016 H6N2 - Day 118
|
29.5 titer
Interval 21.3 to 40.8
|
32.4 titer
Interval 24.7 to 42.4
|
39.1 titer
Interval 29.3 to 52.1
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Cameroon/9766/2017 H6N1 - Day 1
|
40.0 titer
Interval 26.7 to 59.8
|
48.2 titer
Interval 33.0 to 70.4
|
47.3 titer
Interval 33.5 to 67.0
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Cameroon/9766/2017 H6N1 - Day 8
|
91.1 titer
Interval 66.5 to 124.7
|
104.0 titer
Interval 79.2 to 136.5
|
117.5 titer
Interval 91.0 to 151.6
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Cameroon/9766/2017 H6N1 - Day 29
|
68.2 titer
Interval 49.9 to 93.1
|
80.7 titer
Interval 60.4 to 107.8
|
95.1 titer
Interval 69.6 to 130.1
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Cameroon/9766/2017 H6N1 - Day 57
|
53.6 titer
Interval 37.0 to 77.6
|
76.6 titer
Interval 55.3 to 106.1
|
76.3 titer
Interval 55.2 to 105.6
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Cameroon/9766/2017 H6N1 - Day 90
|
48.9 titer
Interval 33.9 to 70.4
|
69.3 titer
Interval 49.7 to 96.6
|
66.6 titer
Interval 47.0 to 94.5
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Cameroon/9766/2017 H6N1 - Day 118
|
62.0 titer
Interval 42.9 to 89.6
|
83.1 titer
Interval 58.2 to 118.8
|
81.9 titer
Interval 56.1 to 119.5
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Hubeiwujiagang/SWL310/2013 - Day 1
|
92.7 titer
Interval 60.6 to 141.7
|
108.5 titer
Interval 73.7 to 159.7
|
105.0 titer
Interval 74.1 to 148.6
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Hubeiwujiagang/SWL310/2013 - Day 8
|
167.1 titer
Interval 120.8 to 231.1
|
197.7 titer
Interval 147.4 to 265.0
|
191.2 titer
Interval 141.7 to 257.8
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Hubeiwujiagang/SWL310/2013 - Day 29
|
128.1 titer
Interval 91.0 to 180.4
|
143.3 titer
Interval 104.2 to 197.3
|
161.5 titer
Interval 112.3 to 232.4
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Hubeiwujiagang/SWL310/2013 - Day 57
|
117.3 titer
Interval 80.0 to 172.7
|
144.2 titer
Interval 103.7 to 200.5
|
151.3 titer
Interval 105.8 to 216.3
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Hubeiwujiagang/SWL310/2013 - Day 90
|
113.1 titer
Interval 76.9 to 166.5
|
139.8 titer
Interval 99.2 to 196.8
|
145.3 titer
Interval 100.2 to 210.7
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Hubeiwujiagang/SWL310/2013 - Day 118
|
130.5 titer
Interval 90.0 to 189.3
|
141.2 titer
Interval 98.8 to 201.7
|
160.0 titer
Interval 108.1 to 236.8
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Oman/5532/2017 H6N1 - Day 1
|
31.7 titer
Interval 20.9 to 48.0
|
37.7 titer
Interval 26.4 to 53.9
|
35.1 titer
Interval 25.1 to 49.0
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Oman/5532/2017 H6N1 - Day 8
|
75.3 titer
Interval 55.8 to 101.5
|
80.7 titer
Interval 59.6 to 109.2
|
100.2 titer
Interval 75.3 to 133.3
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Oman/5532/2017 H6N1 - Day 29
|
54.1 titer
Interval 39.5 to 74.1
|
65.9 titer
Interval 49.7 to 87.3
|
74.8 titer
Interval 55.4 to 101.0
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Oman/5532/2017 H6N1 - Day 57
|
48.4 titer
Interval 33.0 to 71.2
|
63.3 titer
Interval 45.8 to 87.6
|
62.1 titer
Interval 44.2 to 87.4
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Oman/5532/2017 H6N1 - Day 90
|
40.4 titer
Interval 27.7 to 58.9
|
57.5 titer
Interval 40.1 to 82.6
|
53.9 titer
Interval 38.1 to 76.3
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Oman/5532/2017 H6N1 - Day 118
|
54.9 titer
Interval 38.0 to 79.2
|
72.7 titer
Interval 51.1 to 103.3
|
70.5 titer
Interval 47.6 to 104.2
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Aksaray/4048/2016 H6N2 - Day 1
|
28.5 titer
Interval 19.3 to 42.2
|
33.2 titer
Interval 23.7 to 46.5
|
45.2 titer
Interval 32.7 to 62.4
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Aksaray/4048/2016 H6N2 - Day 8
|
81.4 titer
Interval 62.4 to 106.2
|
72.9 titer
Interval 57.1 to 93.1
|
117.5 titer
Interval 93.9 to 147.0
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Aksaray/4048/2016 H6N2 - Day 29
|
62.9 titer
Interval 47.2 to 84.0
|
59.5 titer
Interval 47.2 to 75.1
|
102.8 titer
Interval 79.6 to 132.6
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Aksaray/4048/2016 H6N2 - Day 57
|
56.6 titer
Interval 40.6 to 78.7
|
51.9 titer
Interval 39.6 to 67.9
|
90.4 titer
Interval 70.9 to 115.1
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Aksaray/4048/2016 H6N2 - Day 90
|
63.1 titer
Interval 43.8 to 90.8
|
60.0 titer
Interval 45.2 to 79.7
|
96.1 titer
Interval 74.8 to 123.3
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Aksaray/4048/2016 H6N2 - Day 118
|
68.0 titer
Interval 48.4 to 95.3
|
69.9 titer
Interval 52.3 to 93.5
|
91.9 titer
Interval 69.4 to 121.8
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Louisiana/13/2017 H6N2 - Day 1
|
126.6 titer
Interval 86.8 to 184.7
|
124.2 titer
Interval 94.1 to 163.8
|
154.1 titer
Interval 109.9 to 216.0
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Louisiana/13/2017 H6N2 - Day 8
|
216.7 titer
Interval 161.8 to 290.1
|
181.6 titer
Interval 137.6 to 239.7
|
317.0 titer
Interval 247.9 to 405.4
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Louisiana/13/2017 H6N2 - Day 29
|
201.6 titer
Interval 149.2 to 272.4
|
181.6 titer
Interval 140.7 to 234.4
|
305.0 titer
Interval 230.0 to 404.3
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Louisiana/13/2017 H6N2 - Day 57
|
183.5 titer
Interval 131.6 to 225.8
|
153.2 titer
Interval 117.4 to 199.9
|
250.8 titer
Interval 188.1 to 334.6
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Louisiana/13/2017 H6N2 - Day 90
|
157.1 titer
Interval 113.3 to 217.8
|
144.6 titer
Interval 111.8 to 186.9
|
215.6 titer
Interval 162.7 to 285.9
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Louisiana/13/2017 H6N2 - Day 118
|
212.8 titer
Interval 142.8 to 317.2
|
167.9 titer
Interval 127.2 to 221.6
|
266.0 titer
Interval 198.3 to 356.8
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1, Day 8, Day 29, Day 57, Day 90, Day 118Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood samples for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid NAI results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
Blood was collected for NAI assay which was conducted with the heterologous N1 and N2 NA viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at Day 1, Day 8, Day 29, Day 57, Day 90, and Day 118 Post first study vaccination and the ratio of these GMTs between adjuvanted and unadjuvanted study arms were calculated. The unadjuvanted Fluzone study arm is considered a reference group for the analysis of ratio of GMTs. Ratio of GMTs is defined as the ratio of the GMT from the adjuvanted group divided by the GMT from the corresponding unadjuvanted group.
Outcome measures
| Measure |
Fluzone + CpG55
0.5 mL of 2018/2019 Fluzone QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 2019/2020 of Fluzone QIV intramuscular injection on Day 90.
|
Fluzone
n=37 Participants
0.5 mL of 2018/2019 Fluzone QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Fluzone + AF03
n=40 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.25 mL of AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Flublok
0.5 mL of 2018/2019 Flublok QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + AF03
0.5 mL of 2018/2019 Flublok QIV + 0.25 mL AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + CpG55
0.5 mL of 2018/2019 Flublok QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
|
|---|---|---|---|---|---|---|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens Between Adjuvanted and Unadjuvanted Study Arms for the Fluzone Study Arms
A/Louisiana/13/2017 H6N2 - Day 29
|
—
|
1.7 ratio of GMT
Interval 1.2 to 2.4
|
1.1 ratio of GMT
Interval 0.8 to 1.6
|
—
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens Between Adjuvanted and Unadjuvanted Study Arms for the Fluzone Study Arms
A/Townsville/51/2016 H6N2 - Day 1
|
—
|
1.2 ratio of GMT
Interval 0.8 to 1.7
|
0.9 ratio of GMT
Interval 0.6 to 1.3
|
—
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens Between Adjuvanted and Unadjuvanted Study Arms for the Fluzone Study Arms
A/Cameroon/9766/2017 H6N1 - Day 1
|
—
|
1.0 ratio of GMT
Interval 0.6 to 1.6
|
0.8 ratio of GMT
Interval 0.5 to 1.4
|
—
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens Between Adjuvanted and Unadjuvanted Study Arms for the Fluzone Study Arms
A/Hubeiwujiagang/SWL310/2013 - Day 1
|
—
|
1.0 ratio of GMT
Interval 0.6 to 1.6
|
0.9 ratio of GMT
Interval 0.5 to 1.5
|
—
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens Between Adjuvanted and Unadjuvanted Study Arms for the Fluzone Study Arms
A/Oman/5532/2017 H6N1 - Day 1
|
—
|
0.9 ratio of GMT
Interval 0.6 to 1.5
|
0.8 ratio of GMT
Interval 0.5 to 1.4
|
—
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens Between Adjuvanted and Unadjuvanted Study Arms for the Fluzone Study Arms
A/Aksaray/4048/2016 H6N2 - Day 1
|
—
|
1.4 ratio of GMT
Interval 0.9 to 2.2
|
0.9 ratio of GMT
Interval 0.5 to 1.4
|
—
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens Between Adjuvanted and Unadjuvanted Study Arms for the Fluzone Study Arms
A/Townsville/51/2016 H6N2 - Day 8
|
—
|
1.5 ratio of GMT
Interval 1.1 to 2.0
|
1.0 ratio of GMT
Interval 0.8 to 1.4
|
—
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens Between Adjuvanted and Unadjuvanted Study Arms for the Fluzone Study Arms
A/Cameroon/9766/2017 H6N1 - Day 8
|
—
|
1.1 ratio of GMT
Interval 0.8 to 1.6
|
0.9 ratio of GMT
Interval 0.6 to 1.3
|
—
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens Between Adjuvanted and Unadjuvanted Study Arms for the Fluzone Study Arms
A/Hubeiwujiagang/SWL310/2013 - Day 8
|
—
|
1.0 ratio of GMT
Interval 0.6 to 1.5
|
0.8 ratio of GMT
Interval 0.5 to 1.3
|
—
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens Between Adjuvanted and Unadjuvanted Study Arms for the Fluzone Study Arms
A/Oman/5532/2017 H6N1 - Day 8
|
—
|
1.2 ratio of GMT
Interval 0.8 to 1.9
|
0.9 ratio of GMT
Interval 0.6 to 1.4
|
—
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens Between Adjuvanted and Unadjuvanted Study Arms for the Fluzone Study Arms
A/Aksaray/4048/2016 H6N2 - Day 8
|
—
|
1.6 ratio of GMT
Interval 1.2 to 2.2
|
1.1 ratio of GMT
Interval 0.8 to 1.6
|
—
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens Between Adjuvanted and Unadjuvanted Study Arms for the Fluzone Study Arms
A/Townsville/51/2016 H6N2 - Day 29
|
—
|
1.6 ratio of GMT
Interval 1.2 to 2.3
|
1.1 ratio of GMT
Interval 0.8 to 1.5
|
—
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens Between Adjuvanted and Unadjuvanted Study Arms for the Fluzone Study Arms
A/Cameroon/9766/2017 H6N1 - Day 29
|
—
|
1.2 ratio of GMT
Interval 0.8 to 1.8
|
0.8 ratio of GMT
Interval 0.6 to 1.3
|
—
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens Between Adjuvanted and Unadjuvanted Study Arms for the Fluzone Study Arms
A/Hubeiwujiagang/SWL310/2013 - Day 29
|
—
|
1.1 ratio of GMT
Interval 0.7 to 1.8
|
0.9 ratio of GMT
Interval 0.6 to 1.4
|
—
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens Between Adjuvanted and Unadjuvanted Study Arms for the Fluzone Study Arms
A/Oman/5532/2017 H6N1 - Day 29
|
—
|
1.1 ratio of GMT
Interval 0.8 to 1.7
|
0.8 ratio of GMT
Interval 0.5 to 1.2
|
—
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens Between Adjuvanted and Unadjuvanted Study Arms for the Fluzone Study Arms
A/Aksaray/4048/2016 H6N2 - Day 29
|
—
|
1.7 ratio of GMT
Interval 1.2 to 2.4
|
1.1 ratio of GMT
Interval 0.7 to 1.5
|
—
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens Between Adjuvanted and Unadjuvanted Study Arms for the Fluzone Study Arms
A/Townsville/51/2016 H6N2 - Day 57
|
—
|
1.4 ratio of GMT
Interval 1.0 to 2.0
|
0.9 ratio of GMT
Interval 0.6 to 1.3
|
—
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens Between Adjuvanted and Unadjuvanted Study Arms for the Fluzone Study Arms
A/Cameroon/9766/2017 H6N1 - Day 57
|
—
|
1.0 ratio of GMT
Interval 0.6 to 1.6
|
0.7 ratio of GMT
Interval 0.4 to 1.1
|
—
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens Between Adjuvanted and Unadjuvanted Study Arms for the Fluzone Study Arms
A/Hubeiwujiagang/SWL310/2013 - Day 57
|
—
|
1.0 ratio of GMT
Interval 0.7 to 1.7
|
0.8 ratio of GMT
Interval 0.5 to 1.3
|
—
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens Between Adjuvanted and Unadjuvanted Study Arms for the Fluzone Study Arms
A/Oman/5532/2017 H6N1 - Day 57
|
—
|
1.0 ratio of GMT
Interval 0.6 to 1.6
|
0.8 ratio of GMT
Interval 0.5 to 1.3
|
—
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens Between Adjuvanted and Unadjuvanted Study Arms for the Fluzone Study Arms
A/Aksaray/4048/2016 H6N2 - Day 57
|
—
|
1.7 ratio of GMT
Interval 1.2 to 2.5
|
1.1 ratio of GMT
Interval 0.7 to 1.7
|
—
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens Between Adjuvanted and Unadjuvanted Study Arms for the Fluzone Study Arms
A/Townsville/51/2016 H6N2 - Day 90
|
—
|
1.5 ratio of GMT
Interval 1.1 to 2.2
|
1.1 ratio of GMT
Interval 0.7 to 1.6
|
—
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens Between Adjuvanted and Unadjuvanted Study Arms for the Fluzone Study Arms
A/Cameroon/9766/2017 H6N1 - Day 90
|
—
|
1.0 ratio of GMT
Interval 0.6 to 1.5
|
0.7 ratio of GMT
Interval 0.4 to 1.1
|
—
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens Between Adjuvanted and Unadjuvanted Study Arms for the Fluzone Study Arms
A/Hubeiwujiagang/SWL310/2013 - Day 90
|
—
|
1.0 ratio of GMT
Interval 0.6 to 1.7
|
0.8 ratio of GMT
Interval 0.5 to 1.3
|
—
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens Between Adjuvanted and Unadjuvanted Study Arms for the Fluzone Study Arms
A/Oman/5532/2017 H6N1 - Day 90
|
—
|
0.9 ratio of GMT
Interval 0.6 to 1.5
|
0.7 ratio of GMT
Interval 0.4 to 1.2
|
—
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens Between Adjuvanted and Unadjuvanted Study Arms for the Fluzone Study Arms
A/Aksaray/4048/2016 H6N2 - Day 90
|
—
|
1.6 ratio of GMT
Interval 1.1 to 2.3
|
1.1 ratio of GMT
Interval 0.7 to 1.7
|
—
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens Between Adjuvanted and Unadjuvanted Study Arms for the Fluzone Study Arms
A/Townsville/51/2016 H6N2 - Day 118
|
—
|
1.2 ratio of GMT
Interval 0.8 to 1.8
|
0.9 ratio of GMT
Interval 0.6 to 1.4
|
—
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens Between Adjuvanted and Unadjuvanted Study Arms for the Fluzone Study Arms
A/Cameroon/9766/2017 H6N1 - Day 118
|
—
|
1.0 ratio of GMT
Interval 0.6 to 1.6
|
0.7 ratio of GMT
Interval 0.5 to 1.2
|
—
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens Between Adjuvanted and Unadjuvanted Study Arms for the Fluzone Study Arms
A/Hubeiwujiagang/SWL310/2013 - Day 118
|
—
|
1.1 ratio of GMT
Interval 0.7 to 1.9
|
0.9 ratio of GMT
Interval 0.6 to 1.5
|
—
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens Between Adjuvanted and Unadjuvanted Study Arms for the Fluzone Study Arms
A/Oman/5532/2017 H6N1 - Day 118
|
—
|
1.0 ratio of GMT
Interval 0.6 to 1.6
|
0.8 ratio of GMT
Interval 0.5 to 1.2
|
—
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens Between Adjuvanted and Unadjuvanted Study Arms for the Fluzone Study Arms
A/Aksaray/4048/2016 H6N2 - Day 118
|
—
|
1.3 ratio of GMT
Interval 0.9 to 2.0
|
1.0 ratio of GMT
Interval 0.6 to 1.5
|
—
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens Between Adjuvanted and Unadjuvanted Study Arms for the Fluzone Study Arms
A/Louisiana/13/2017 H6N2 - Day 1
|
—
|
1.2 ratio of GMT
Interval 0.8 to 1.9
|
1.0 ratio of GMT
Interval 0.6 to 1.6
|
—
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens Between Adjuvanted and Unadjuvanted Study Arms for the Fluzone Study Arms
A/Louisiana/13/2017 H6N2 - Day 8
|
—
|
1.7 ratio of GMT
Interval 1.2 to 2.5
|
1.2 ratio of GMT
Interval 0.8 to 1.8
|
—
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens Between Adjuvanted and Unadjuvanted Study Arms for the Fluzone Study Arms
A/Louisiana/13/2017 H6N2 - Day 57
|
—
|
1.6 ratio of GMT
Interval 1.1 to 2.4
|
1.2 ratio of GMT
Interval 0.8 to 1.8
|
—
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens Between Adjuvanted and Unadjuvanted Study Arms for the Fluzone Study Arms
A/Louisiana/13/2017 H6N2 - Day 90
|
—
|
1.5 ratio of GMT
Interval 1.0 to 2.2
|
1.1 ratio of GMT
Interval 0.7 to 1.6
|
—
|
—
|
—
|
|
Ratio of Geometric Mean Titers (GMTs) of Serum Neuraminidase Inhibition (NAI) Against Heterologous N1 and N2 Neuraminidase (NA) Antigens Between Adjuvanted and Unadjuvanted Study Arms for the Fluzone Study Arms
A/Louisiana/13/2017 H6N2 - Day 118
|
—
|
1.6 ratio of GMT
Interval 1.1 to 2.4
|
1.3 ratio of GMT
Interval 0.8 to 2.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 8, Day 29, Day 57, Day 90, Day 118Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood samples for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid NAI results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
Blood was collected for NAI assay which was conducted with the heterologous N1 and N2 NA viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. NAI seroconversion was defined as \>4 four-fold rise in post-vaccination antibody titer at Day 8, 29, 57, 90, and 118.
Outcome measures
| Measure |
Fluzone + CpG55
n=40 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 2019/2020 of Fluzone QIV intramuscular injection on Day 90.
|
Fluzone
n=41 Participants
0.5 mL of 2018/2019 Fluzone QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Fluzone + AF03
n=37 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.25 mL of AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Flublok
0.5 mL of 2018/2019 Flublok QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + AF03
0.5 mL of 2018/2019 Flublok QIV + 0.25 mL AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + CpG55
0.5 mL of 2018/2019 Flublok QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Townsville/51/2016 H6N2 - Day 8
|
25 percentage of participants
Interval 13.0 to 41.0
|
17 percentage of participants
Interval 7.0 to 32.0
|
27 percentage of participants
Interval 14.0 to 44.0
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Cameroon/9766/2017 H6N1 - Day 8
|
38 percentage of participants
Interval 23.0 to 54.0
|
24 percentage of participants
Interval 12.0 to 40.0
|
32 percentage of participants
Interval 18.0 to 50.0
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Hubeiwujiagang/SWL310/2013 - Day 8
|
18 percentage of participants
Interval 7.0 to 33.0
|
17 percentage of participants
Interval 7.0 to 32.0
|
14 percentage of participants
Interval 5.0 to 29.0
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Oman/5532/2017 H6N1 - Day 8
|
28 percentage of participants
Interval 15.0 to 44.0
|
27 percentage of participants
Interval 14.0 to 43.0
|
41 percentage of participants
Interval 25.0 to 58.0
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Aksaray/4048/2016 H6N2 - Day 8
|
38 percentage of participants
Interval 23.0 to 54.0
|
29 percentage of participants
Interval 16.0 to 46.0
|
38 percentage of participants
Interval 22.0 to 55.0
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Louisiana/13/2017 H6N2 - Day 8
|
10 percentage of participants
Interval 3.0 to 24.0
|
10 percentage of participants
Interval 3.0 to 23.0
|
27 percentage of participants
Interval 14.0 to 44.0
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Townsville/51/2016 H6N2 - Day 29
|
5 percentage of participants
Interval to 17.0
Value is NA because it's \>0 but \<1
|
10 percentage of participants
Interval 3.0 to 23.0
|
14 percentage of participants
Interval 5.0 to 29.0
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Cameroon/9766/2017 H6N1 - Day 29
|
18 percentage of participants
Interval 8.0 to 34.0
|
15 percentage of participants
Interval 6.0 to 29.0
|
22 percentage of participants
Interval 10.0 to 39.0
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Hubeiwujiagang/SWL310/2013 - Day 29
|
3 percentage of participants
Interval to 13.0
Value is NA because it's \>0 but \<1
|
5 percentage of participants
Interval to 17.0
Value is NA because it's \>0 but \<1
|
14 percentage of participants
Interval 5.0 to 29.0
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Oman/5532/2017 H6N1 - Day 29
|
18 percentage of participants
Interval 8.0 to 34.0
|
17 percentage of participants
Interval 7.0 to 32.0
|
19 percentage of participants
Interval 8.0 to 36.0
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Aksaray/4048/2016 H6N2 - Day 29
|
33 percentage of participants
Interval 19.0 to 50.0
|
17 percentage of participants
Interval 7.0 to 32.0
|
25 percentage of participants
Interval 12.0 to 42.0
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Louisiana/13/2017 H6N2 - Day 29
|
13 percentage of participants
Interval 4.0 to 27.0
|
7 percentage of participants
Interval 2.0 to 20.0
|
19 percentage of participants
Interval 8.0 to 36.0
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Townsville/51/2016 H6N2 - Day 57
|
5 percentage of participants
Interval to 18.0
Value is NA because it's \>0 but \<1
|
8 percentage of participants
Interval 2.0 to 20.0
|
11 percentage of participants
Interval 3.0 to 25.0
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Cameroon/9766/2017 H6N1 - Day 57
|
5 percentage of participants
Interval to 18.0
Value is NA because it's \>0 but \<1
|
8 percentage of participants
Interval 2.0 to 20.0
|
11 percentage of participants
Interval 3.0 to 25.0
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Hubeiwujiagang/SWL310/2013 - Day 57
|
3 percentage of participants
Interval to 14.0
Value is NA because it's \>0 but \<1
|
0 percentage of participants
Interval 0.0 to 9.0
|
8 percentage of participants
Interval 2.0 to 22.0
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Oman/5532/2017 H6N1 - Day 57
|
11 percentage of participants
Interval 3.0 to 25.0
|
13 percentage of participants
Interval 4.0 to 27.0
|
8 percentage of participants
Interval 2.0 to 22.0
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Aksaray/4048/2016 H6N2 - Day 57
|
18 percentage of participants
Interval 8.0 to 34.0
|
5 percentage of participants
Interval to 17.0
Value is NA because it's \>0 but \<1
|
19 percentage of participants
Interval 8.0 to 35.0
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Louisiana/13/2017 H6N2 - Day 57
|
8 percentage of participants
Interval 2.0 to 21.0
|
3 percentage of participants
Interval to 13.0
Value is NA because it's \>0 but \<1
|
11 percentage of participants
Interval 3.0 to 25.0
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Townsville/51/2016 H6N2 - Day 90
|
5 percentage of participants
Interval to 18.0
Value is NA because it's \>0 but \<1
|
2 percentage of participants
Interval to 13.0
Value is NA because it's \>0 but \<1
|
6 percentage of participants
Interval to 19.0
Value is NA because it's \>0 but \<1
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Cameroon/9766/2017 H6N1 - Day 90
|
3 percentage of participants
Interval to 14.0
Value is NA because it's \>0 but \<1
|
5 percentage of participants
Interval to 17.0
Value is NA because it's \>0 but \<1
|
11 percentage of participants
Interval 3.0 to 26.0
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Hubeiwujiagang/SWL310/2013 - Day 90
|
3 percentage of participants
Interval to 14.0
Value is NA because it's \>0 but \<1
|
5 percentage of participants
Interval to 17.0
Value is NA because it's \>0 but \<1
|
11 percentage of participants
Interval 3.0 to 26.0
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Oman/5532/2017 H6N1 - Day 90
|
5 percentage of participants
Interval to 18.0
Value is NA because it's \>0 but \<1
|
10 percentage of participants
Interval 3.0 to 23.0
|
6 percentage of participants
Interval to 19.0
Value is NA because it's \>0 but \<1
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Aksaray/4048/2016 H6N2 - Day 90
|
24 percentage of participants
Interval 11.0 to 40.0
|
7 percentage of participants
Interval 2.0 to 20.0
|
17 percentage of participants
Interval 6.0 to 33.0
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Louisiana/13/2017 H6N2 - Day 90
|
3 percentage of participants
Interval to 14.0
Value is NA because it's \>0 but \<1
|
2 percentage of participants
Interval to 13.0
Value is NA because it's \>0 but \<1
|
6 percentage of participants
Interval to 19.0
Value is NA because it's \>0 but \<1
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Townsville/51/2016 H6N2 - Day 118
|
18 percentage of participants
Interval 7.0 to 35.0
|
22 percentage of participants
Interval 10.0 to 39.0
|
10 percentage of participants
Interval 2.0 to 27.0
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Cameroon/9766/2017 H6N1 - Day 118
|
15 percentage of participants
Interval 5.0 to 31.0
|
8 percentage of participants
Interval 2.0 to 22.0
|
13 percentage of participants
Interval 4.0 to 31.0
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Hubeiwujiagang/SWL310/2013 - Day 118
|
15 percentage of participants
Interval 5.0 to 31.0
|
11 percentage of participants
Interval 3.0 to 26.0
|
10 percentage of participants
Interval 2.0 to 27.0
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Oman/5532/2017 H6N1 - Day 118
|
18 percentage of participants
Interval 7.0 to 35.0
|
19 percentage of participants
Interval 8.0 to 36.0
|
17 percentage of participants
Interval 6.0 to 35.0
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Aksaray/4048/2016 H6N2 - Day 118
|
32 percentage of participants
Interval 17.0 to 51.0
|
25 percentage of participants
Interval 12.0 to 42.0
|
17 percentage of participants
Interval 6.0 to 35.0
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Neuraminidase Inhibition (NAI) Titer Seroconversion Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Louisiana/13/2017 H6N2 - Day 118
|
18 percentage of participants
Interval 7.0 to 35.0
|
8 percentage of participants
Interval 2.0 to 22.0
|
10 percentage of participants
Interval 2.0 to 27.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 8, Day 29, Day 57, Day 90, Day 118Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood samples for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid NAI results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
Blood was collected for NAI assay which was conducted with the heterologous N1 and N2 NA viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, and the geometric mean of the replicate results of each antigen was calculated as that sample's result. Fold-rises from baseline were calculated as the Day 8 (or Day 29, Day 57, Day 90, Day 118) titer divided by the baseline titers for each participant. The geometric mean of these fold rises was then calculated to obtain the GMFR.
Outcome measures
| Measure |
Fluzone + CpG55
n=40 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 2019/2020 of Fluzone QIV intramuscular injection on Day 90.
|
Fluzone
n=41 Participants
0.5 mL of 2018/2019 Fluzone QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Fluzone + AF03
n=37 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.25 mL of AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Flublok
0.5 mL of 2018/2019 Flublok QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + AF03
0.5 mL of 2018/2019 Flublok QIV + 0.25 mL AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + CpG55
0.5 mL of 2018/2019 Flublok QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Townsville/51/2016 H6N2 - Day 8
|
2.4 fold rise
Interval 2.0 to 2.9
|
2.1 fold rise
Interval 1.7 to 2.4
|
2.5 fold rise
Interval 2.0 to 3.1
|
—
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Cameroon/9766/2017 H6N1 - Day 8
|
2.3 fold rise
Interval 1.8 to 3.0
|
2.2 fold rise
Interval 1.7 to 2.8
|
2.5 fold rise
Interval 2.0 to 3.1
|
—
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Hubeiwujiagang/SWL310/2013 - Day 8
|
1.8 fold rise
Interval 1.5 to 2.2
|
1.8 fold rise
Interval 1.5 to 2.3
|
1.8 fold rise
Interval 1.5 to 2.2
|
—
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Oman/5532/2017 H6N1 - Day 8
|
2.4 fold rise
Interval 1.8 to 3.1
|
2.1 fold rise
Interval 1.6 to 2.8
|
2.9 fold rise
Interval 2.3 to 3.6
|
—
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Aksaray/4048/2016 H6N2 - Day 8
|
2.9 fold rise
Interval 2.3 to 3.6
|
2.2 fold rise
Interval 1.8 to 2.7
|
2.6 fold rise
Interval 2.0 to 3.4
|
—
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Louisiana/13/2017 H6N2 - Day 8
|
1.7 fold rise
Interval 1.4 to 2.1
|
1.5 fold rise
Interval 1.2 to 1.8
|
2.1 fold rise
Interval 1.6 to 2.7
|
—
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Townsville/51/2016 H6N2 - Day 29
|
1.6 fold rise
Interval 1.4 to 1.9
|
1.3 fold rise
Interval 1.1 to 1.5
|
1.7 fold rise
Interval 1.4 to 2.1
|
—
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Cameroon/9766/2017 H6N1 - Day 29
|
1.8 fold rise
Interval 1.5 to 2.2
|
1.7 fold rise
Interval 1.4 to 2.1
|
2.0 fold rise
Interval 1.6 to 2.5
|
—
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Hubeiwujiagang/SWL310/2013 - Day 29
|
1.5 fold rise
Interval 1.3 to 1.7
|
1.3 fold rise
Interval 1.1 to 1.5
|
1.6 fold rise
Interval 1.3 to 1.9
|
—
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Oman/5532/2017 H6N1 - Day 29
|
1.8 fold rise
Interval 1.5 to 2.2
|
1.7 fold rise
Interval 1.4 to 2.1
|
2.1 fold rise
Interval 1.8 to 2.6
|
—
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Aksaray/4048/2016 H6N2 - Day 29
|
2.3 fold rise
Interval 1.9 to 2.8
|
1.8 fold rise
Interval 1.5 to 2.1
|
2.2 fold rise
Interval 1.7 to 2.7
|
—
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Louisiana/13/2017 H6N2 - Day 29
|
1.6 fold rise
Interval 1.4 to 1.9
|
1.5 fold rise
Interval 1.3 to 1.7
|
1.9 fold rise
Interval 1.5 to 2.4
|
—
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Townsville/51/2016 H6N2 - Day 57
|
1.7 fold rise
Interval 1.5 to 2.0
|
1.6 fold rise
Interval 1.4 to 1.9
|
1.8 fold rise
Interval 1.5 to 2.2
|
—
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Cameroon/9766/2017 H6N1 - Day 57
|
1.5 fold rise
Interval 1.2 to 1.7
|
1.5 fold rise
Interval 1.3 to 1.8
|
1.6 fold rise
Interval 1.3 to 1.9
|
—
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Hubeiwujiagang/SWL310/2013 - Day 57
|
1.4 fold rise
Interval 1.2 to 1.6
|
1.3 fold rise
Interval 1.1 to 1.5
|
1.4 fold rise
Interval 1.2 to 1.7
|
—
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Oman/5532/2017 H6N1 - Day 57
|
1.7 fold rise
Interval 1.4 to 2.0
|
1.6 fold rise
Interval 1.4 to 1.9
|
1.8 fold rise
Interval 1.5 to 2.1
|
—
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Aksaray/4048/2016 H6N2 - Day 57
|
2.0 fold rise
Interval 1.7 to 2.3
|
1.6 fold rise
Interval 1.4 to 1.8
|
2.0 fold rise
Interval 1.6 to 2.5
|
—
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Louisiana/13/2017 H6N2 - Day 57
|
1.5 fold rise
Interval 1.3 to 1.8
|
1.3 fold rise
Interval 1.1 to 1.5
|
1.6 fold rise
Interval 1.3 to 2.0
|
—
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Townsville/51/2016 H6N2 - Day 90
|
1.7 fold rise
Interval 1.5 to 1.9
|
1.4 fold rise
Interval 1.2 to 1.5
|
1.6 fold rise
Interval 1.4 to 1.9
|
—
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Cameroon/9766/2017 H6N1 - Day 90
|
1.3 fold rise
Interval 1.1 to 1.5
|
1.4 fold rise
Interval 1.2 to 1.7
|
1.4 fold rise
Interval 1.2 to 1.7
|
—
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Hubeiwujiagang/SWL310/2013 - Day 90
|
1.3 fold rise
Interval 1.2 to 1.5
|
1.3 fold rise
Interval 1.1 to 1.5
|
1.4 fold rise
Interval 1.2 to 1.7
|
—
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Oman/5532/2017 H6N1 - Day 90
|
1.4 fold rise
Interval 1.2 to 1.6
|
1.5 fold rise
Interval 1.3 to 1.8
|
1.5 fold rise
Interval 1.3 to 1.8
|
—
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Aksaray/4048/2016 H6N2 - Day 90
|
2.2 fold rise
Interval 1.9 to 2.6
|
1.8 fold rise
Interval 1.6 to 2.0
|
2.0 fold rise
Interval 1.6 to 2.5
|
—
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Louisiana/13/2017 H6N2 - Day 90
|
1.3 fold rise
Interval 1.1 to 1.5
|
1.2 fold rise
Interval 1.0 to 1.3
|
1.3 fold rise
Interval 1.1 to 1.7
|
—
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Townsville/51/2016 H6N2 - Day 118
|
2.1 fold rise
Interval 1.8 to 2.5
|
2.1 fold rise
Interval 1.7 to 2.7
|
2.0 fold rise
Interval 1.6 to 2.4
|
—
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Cameroon/9766/2017 H6N1 - Day 118
|
2.0 fold rise
Interval 1.7 to 2.4
|
1.8 fold rise
Interval 1.5 to 2.3
|
1.7 fold rise
Interval 1.3 to 2.1
|
—
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Hubeiwujiagang/SWL310/2013 - Day 118
|
1.7 fold rise
Interval 1.4 to 2.1
|
1.4 fold rise
Interval 1.1 to 1.7
|
1.6 fold rise
Interval 1.2 to 2.0
|
—
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Oman/5532/2017 H6N1 - Day 118
|
2.2 fold rise
Interval 1.8 to 2.7
|
2.0 fold rise
Interval 1.6 to 2.5
|
2.0 fold rise
Interval 1.6 to 2.5
|
—
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Aksaray/4048/2016 H6N2 - Day 118
|
2.4 fold rise
Interval 1.9 to 3.0
|
2.4 fold rise
Interval 1.9 to 2.9
|
2.0 fold rise
Interval 1.6 to 2.6
|
—
|
—
|
—
|
|
Geometric Mean Fold Rise (GMFR) in Neuraminidase Inhibition (NAI) Titers Against Heterologous N1 and N2 Neuraminidase (NA) Antigens for the Fluzone Study Arms
A/Louisiana/13/2017 H6N2 - Day 118
|
1.7 fold rise
Interval 1.4 to 2.1
|
1.5 fold rise
Interval 1.2 to 1.9
|
1.7 fold rise
Interval 1.4 to 2.2
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1, Day 8, Day 29, Day 57, Day 90, Day 118Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood samples for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid Neut results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
Blood was collected for Neut assay which was conducted with the heterologous H1 and H3 influenza viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, but only one result which a geometric mean titer of the replicates was reported by the lab. The geometric mean titer was calculated for each study arm from the available results at Day 1, Day 8, Day 29, Day 57, Day 90, and Day 118 Post first study vaccination.
Outcome measures
| Measure |
Fluzone + CpG55
n=40 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 2019/2020 of Fluzone QIV intramuscular injection on Day 90.
|
Fluzone
n=41 Participants
0.5 mL of 2018/2019 Fluzone QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Fluzone + AF03
n=37 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.25 mL of AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Flublok
n=41 Participants
0.5 mL of 2018/2019 Flublok QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + AF03
n=38 Participants
0.5 mL of 2018/2019 Flublok QIV + 0.25 mL AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + CpG55
n=42 Participants
0.5 mL of 2018/2019 Flublok QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains
A/Shandonglaicheng/1763/2016 [H3N2] - Day 1
|
348.3 titer
Interval 204.3 to 593.9
|
293.5 titer
Interval 177.4 to 485.3
|
535.4 titer
Interval 308.2 to 930.0
|
412.1 titer
Interval 240.7 to 705.3
|
388.6 titer
Interval 219.7 to 687.4
|
307.9 titer
Interval 189.9 to 499.4
|
|
Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains
A/Aksaray/4048/2016 [H3N2] - Day 1
|
40.5 titer
Interval 32.0 to 51.3
|
34.2 titer
Interval 27.9 to 42.0
|
46.7 titer
Interval 34.5 to 63.3
|
47.1 titer
Interval 36.3 to 61.2
|
40.3 titer
Interval 32.6 to 49.9
|
40.9 titer
Interval 33.1 to 50.6
|
|
Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains
A/Kenya/105/2017 [H3N2] - Day 1
|
218.7 titer
Interval 162.1 to 295.1
|
183.2 titer
Interval 135.0 to 248.5
|
294.8 titer
Interval 212.0 to 410.0
|
226.8 titer
Interval 171.6 to 299.8
|
232.4 titer
Interval 174.5 to 309.5
|
217.9 titer
Interval 170.6 to 278.3
|
|
Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains
A/Michigan/84/2016 [H3N2] - Day 1
|
616.3 titer
Interval 438.6 to 866.0
|
858.5 titer
Interval 602.9 to 1222.5
|
852.9 titer
Interval 590.6 to 1231.8
|
736.5 titer
Interval 520.1 to 1042.8
|
667.0 titer
Interval 483.7 to 919.9
|
624.2 titer
Interval 455.1 to 856.2
|
|
Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains
A/Shandonglaicheng/1763/2016 [H3N2] - Day 8
|
1656.1 titer
Interval 1098.6 to 2496.5
|
830.8 titer
Interval 534.9 to 1290.4
|
2284.7 titer
Interval 1470.2 to 3550.6
|
1212.0 titer
Interval 783.0 to 1876.0
|
1795.8 titer
Interval 1069.5 to 3015.4
|
1425.2 titer
Interval 913.7 to 2222.9
|
|
Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains
A/Aksaray/4048/2016 [H3N2] - Day 8
|
65.8 titer
Interval 46.4 to 93.2
|
45.4 titer
Interval 33.8 to 61.0
|
101.3 titer
Interval 71.1 to 144.4
|
88.2 titer
Interval 64.1 to 121.5
|
121.5 titer
Interval 81.1 to 182.2
|
86.9 titer
Interval 60.8 to 124.0
|
|
Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains
A/Kenya/105/2017 [H3N2] - Day 8
|
312.8 titer
Interval 231.4 to 422.9
|
267.6 titer
Interval 191.5 to 374.1
|
486.9 titer
Interval 362.5 to 654.0
|
431.4 titer
Interval 332.7 to 559.6
|
559.0 titer
Interval 377.8 to 827.1
|
505.9 titer
Interval 384.6 to 665.2
|
|
Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains
A/Michigan/84/2016 [H3N2] - Day 8
|
1088.9 titer
Interval 833.9 to 1421.9
|
1237.6 titer
Interval 972.5 to 1574.9
|
1798.5 titer
Interval 1329.9 to 2432.3
|
1051.7 titer
Interval 802.0 to 1379.2
|
852.0 titer
Interval 591.9 to 1226.5
|
882.3 titer
Interval 652.2 to 1193.5
|
|
Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains
A/Shandonglaicheng/1763/2016 [H3N2] - Day 29
|
1416.0 titer
Interval 928.8 to 2158.7
|
819.1 titer
Interval 531.4 to 1262.6
|
2083.9 titer
Interval 1428.1 to 3041.0
|
1940.2 titer
Interval 1267.2 to 2970.8
|
2359.5 titer
Interval 1437.0 to 3874.2
|
1922.4 titer
Interval 1287.1 to 2871.3
|
|
Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains
A/Aksaray/4048/2016 [H3N2] - Day 29
|
48.9 titer
Interval 40.2 to 59.6
|
43.3 titer
Interval 35.1 to 53.5
|
70.9 titer
Interval 53.4 to 94.0
|
82.0 titer
Interval 63.0 to 106.7
|
107.0 titer
Interval 73.8 to 155.1
|
81.4 titer
Interval 59.0 to 112.4
|
|
Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains
A/Kenya/105/2017 [H3N2] - Day 29
|
421.4 titer
Interval 303.5 to 585.2
|
344.4 titer
Interval 247.5 to 479.3
|
698.1 titer
Interval 498.6 to 977.6
|
821.9 titer
Interval 618.7 to 1091.7
|
983.9 titer
Interval 672.0 to 1440.4
|
790.8 titer
Interval 597.1 to 1047.2
|
|
Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains
A/Michigan/84/2016 [H3N2] - Day 29
|
1032.4 titer
Interval 782.2 to 1362.6
|
1232.8 titer
Interval 936.8 to 1622.3
|
1541.8 titer
Interval 1141.7 to 2082.1
|
1424.0 titer
Interval 1017.3 to 1993.5
|
1020.1 titer
Interval 669.5 to 1554.2
|
1054.4 titer
Interval 724.7 to 1534.0
|
|
Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains
A/Shandonglaicheng/1763/2016 [H3N2] - Day 57
|
720.2 titer
Interval 448.3 to 1157.0
|
396.0 titer
Interval 245.2 to 639.7
|
1000.2 titer
Interval 630.6 to 1586.5
|
1086.0 titer
Interval 692.4 to 1703.1
|
1208.6 titer
Interval 710.9 to 2054.8
|
1032.9 titer
Interval 659.4 to 1618.0
|
|
Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains
A/Aksaray/4048/2016 [H3N2] - Day 57
|
61.8 titer
Interval 42.4 to 90.0
|
53.7 titer
Interval 36.9 to 78.0
|
117.6 titer
Interval 83.2 to 166.2
|
151.8 titer
Interval 111.0 to 207.6
|
156.5 titer
Interval 110.1 to 222.5
|
140.0 titer
Interval 101.3 to 193.4
|
|
Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains
A/Kenya/105/2017 [H3N2] - Day 57
|
283.7 titer
Interval 187.6 to 429.0
|
237.7 titer
Interval 168.6 to 335.2
|
469.4 titer
Interval 338.5 to 650.9
|
634.0 titer
Interval 467.3 to 860.1
|
688.0 titer
Interval 478.2 to 989.7
|
517.7 titer
Interval 364.7 to 735.1
|
|
Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains
A/Michigan/84/2016 [H3N2] - Day 57
|
946.6 titer
Interval 701.5 to 1277.2
|
1071.2 titer
Interval 844.9 to 1358.2
|
1602.1 titer
Interval 1174.2 to 2186.0
|
1533.4 titer
Interval 1127.0 to 2086.4
|
904.9 titer
Interval 631.5 to 1296.8
|
1158.3 titer
Interval 829.3 to 1617.9
|
|
Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains
A/Shandonglaicheng/1763/2016 [H3N2] - Day 90
|
946.6 titer
Interval 567.5 to 1579.1
|
556.7 titer
Interval 338.1 to 916.8
|
1501.0 titer
Interval 927.7 to 2316.6
|
1331.6 titer
Interval 812.5 to 2182.4
|
1563.9 titer
Interval 898.7 to 2721.5
|
1268.5 titer
Interval 799.6 to 2012.6
|
|
Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains
A/Aksaray/4048/2016 [H3N2] - Day 90
|
64.7 titer
Interval 44.7 to 93.6
|
62.4 titer
Interval 41.3 to 94.2
|
111.0 titer
Interval 77.1 to 159.6
|
149.1 titer
Interval 110.6 to 201.0
|
147.2 titer
Interval 104.2 to 208.0
|
129.6 titer
Interval 91.8 to 183.1
|
|
Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains
A/Kenya/105/2017 [H3N2] - Day 90
|
200.1 titer
Interval 130.8 to 306.1
|
151.6 titer
Interval 107.9 to 212.9
|
315.4 titer
Interval 220.1 to 452.1
|
431.5 titer
Interval 300.0 to 620.7
|
444.3 titer
Interval 297.7 to 663.0
|
385.5 titer
Interval 270.5 to 549.4
|
|
Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains
A/Michigan/84/2016 [H3N2] - Day 90
|
778.8 titer
Interval 576.1 to 1052.8
|
841.2 titer
Interval 627.1 to 1128.5
|
1268.8 titer
Interval 907.6 to 1773.7
|
1297.0 titer
Interval 905.5 to 1857.7
|
733.5 titer
Interval 488.2 to 1102.1
|
905.2 titer
Interval 611.5 to 1340.1
|
|
Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains
A/Shandonglaicheng/1763/2016 [H3N2] - Day 118
|
1631.8 titer
Interval 995.5 to 2674.9
|
1128.1 titer
Interval 631.8 to 2014.4
|
1723.8 titer
Interval 1046.1 to 2840.8
|
2739.4 titer
Interval 1472.3 to 5096.9
|
3672.3 titer
Interval 2051.3 to 6574.1
|
2233.2 titer
Interval 1295.2 to 3850.4
|
|
Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains
A/Aksaray/4048/2016 [H3N2] - Day 118
|
150.1 titer
Interval 103.6 to 217.3
|
94.6 titer
Interval 66.8 to 134.1
|
139.0 titer
Interval 89.9 to 215.1
|
326.1 titer
Interval 213.5 to 498.3
|
296.5 titer
Interval 200.9 to 437.6
|
241.3 titer
Interval 149.0 to 390.9
|
|
Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains
A/Kenya/105/2017 [H3N2] - Day 118
|
369.1 titer
Interval 235.3 to 538.0
|
300.7 titer
Interval 210.5 to 429.5
|
400.6 titer
Interval 253.2 to 633.8
|
936.6 titer
Interval 636.7 to 1377.7
|
965.5 titer
Interval 623.9 to 1494.3
|
733.9 titer
Interval 478.8 to 1125.0
|
|
Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains
A/Michigan/84/2016 [H3N2] - Day 118
|
1487.2 titer
Interval 1108.4 to 1996.6
|
1382.3 titer
Interval 1083.1 to 1764.2
|
1785.2 titer
Interval 1201.1 to 2653.4
|
2572.0 titer
Interval 1842.0 to 3591.3
|
1537.3 titer
Interval 1005.4 to 2350.7
|
1641.9 titer
Interval 1095.4 to 2461.0
|
SECONDARY outcome
Timeframe: Day 1, Day 8, Day 29, Day 57, Day 90, Day 118Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood samples for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid Neut results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
Blood was collected for Neut assay which was conducted with the heterologous H1 and H3 influenza viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, but only one result which a geometric mean titer of the replicates was reported by the lab. The geometric mean titer was calculated for each study arm from the available results at Day 1, Day 8, Day 29, Day 57, Day 90, and Day 118 Post first study vaccination and the ratio of these GMTs between adjuvanted and unadjuvanted study arms were calculated. Unadjuvanted Fluzone and Flublok study arms are considered as reference groups for the analysis of ratio of GMTs. Ratio of GMTs is defined as the ratio of the GMT from the adjuvanted group divided by the GMT from the corresponding unadjuvanted group.
Outcome measures
| Measure |
Fluzone + CpG55
n=38 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 2019/2020 of Fluzone QIV intramuscular injection on Day 90.
|
Fluzone
n=37 Participants
0.5 mL of 2018/2019 Fluzone QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Fluzone + AF03
n=40 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.25 mL of AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Flublok
n=42 Participants
0.5 mL of 2018/2019 Flublok QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + AF03
0.5 mL of 2018/2019 Flublok QIV + 0.25 mL AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + CpG55
0.5 mL of 2018/2019 Flublok QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
|
|---|---|---|---|---|---|---|
|
Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Shandonglaicheng/1763/2016 [H3N2] - Day 1
|
0.9 ratio of GMT
Interval 0.4 to 2.0
|
1.8 ratio of GMT
Interval 0.9 to 3.8
|
1.2 ratio of GMT
Interval 0.6 to 2.4
|
0.7 ratio of GMT
Interval 0.4 to 1.5
|
—
|
—
|
|
Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Aksaray/4048/2016 [H3N2] - Day 1
|
0.9 ratio of GMT
Interval 0.6 to 1.2
|
1.4 ratio of GMT
Interval 1.0 to 2.0
|
1.2 ratio of GMT
Interval 0.9 to 1.6
|
0.9 ratio of GMT
Interval 0.6 to 1.2
|
—
|
—
|
|
Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Kenya/105/2017 [H3N2] - Day 1
|
1.0 ratio of GMT
Interval 0.7 to 1.5
|
1.6 ratio of GMT
Interval 1.0 to 2.5
|
1.2 ratio of GMT
Interval 0.8 to 1.8
|
1.0 ratio of GMT
Interval 0.7 to 1.4
|
—
|
—
|
|
Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Michigan/84/2016 [H3N2] - Day 1
|
0.9 ratio of GMT
Interval 0.6 to 1.4
|
1.0 ratio of GMT
Interval 0.6 to 1.6
|
0.7 ratio of GMT
Interval 0.4 to 1.2
|
0.8 ratio of GMT
Interval 0.5 to 1.3
|
—
|
—
|
|
Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Shandonglaicheng/1763/2016 [H3N2] - Day 8
|
1.5 ratio of GMT
Interval 0.8 to 2.9
|
2.7 ratio of GMT
Interval 1.5 to 5.1
|
2.0 ratio of GMT
Interval 1.1 to 3.6
|
1.2 ratio of GMT
Interval 0.6 to 2.2
|
—
|
—
|
|
Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Aksaray/4048/2016 [H3N2] - Day 8
|
1.4 ratio of GMT
Interval 0.8 to 2.3
|
2.2 ratio of GMT
Interval 1.4 to 3.5
|
1.4 ratio of GMT
Interval 0.9 to 2.3
|
1.0 ratio of GMT
Interval 0.6 to 1.6
|
—
|
—
|
|
Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Kenya/105/2017 [H3N2] - Day 8
|
1.3 ratio of GMT
Interval 0.8 to 2.1
|
1.8 ratio of GMT
Interval 1.2 to 2.8
|
1.2 ratio of GMT
Interval 0.8 to 1.8
|
1.2 ratio of GMT
Interval 0.8 to 1.7
|
—
|
—
|
|
Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Michigan/84/2016 [H3N2] - Day 8
|
0.8 ratio of GMT
Interval 0.5 to 1.3
|
1.5 ratio of GMT
Interval 1.0 to 2.1
|
0.9 ratio of GMT
Interval 0.6 to 1.3
|
0.8 ratio of GMT
Interval 0.6 to 1.3
|
—
|
—
|
|
Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Shandonglaicheng/1763/2016 [H3N2] - Day 29
|
1.2 ratio of GMT
Interval 0.6 to 2.3
|
2.5 ratio of GMT
Interval 1.4 to 4.5
|
1.7 ratio of GMT
Interval 1.0 to 3.1
|
1.0 ratio of GMT
Interval 0.6 to 1.8
|
—
|
—
|
|
Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Aksaray/4048/2016 [H3N2] - Day 29
|
1.3 ratio of GMT
Interval 0.8 to 2.0
|
1.6 ratio of GMT
Interval 1.2 to 2.3
|
1.1 ratio of GMT
Interval 0.8 to 1.5
|
1.0 ratio of GMT
Interval 0.7 to 1.5
|
—
|
—
|
|
Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Kenya/105/2017 [H3N2] - Day 29
|
1.2 ratio of GMT
Interval 0.7 to 1.9
|
2.0 ratio of GMT
Interval 1.3 to 3.2
|
1.2 ratio of GMT
Interval 0.8 to 1.9
|
1.0 ratio of GMT
Interval 0.6 to 1.4
|
—
|
—
|
|
Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Michigan/84/2016 [H3N2] - Day 29
|
0.7 ratio of GMT
Interval 0.4 to 1.2
|
1.3 ratio of GMT
Interval 0.8 to 1.9
|
0.8 ratio of GMT
Interval 0.6 to 1.2
|
0.7 ratio of GMT
Interval 0.5 to 1.2
|
—
|
—
|
|
Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Shandonglaicheng/1763/2016 [H3N2] - Day 57
|
1.1 ratio of GMT
Interval 0.6 to 2.2
|
2.5 ratio of GMT
Interval 1.3 to 4.9
|
1.8 ratio of GMT
Interval 0.9 to 3.5
|
1.0 ratio of GMT
Interval 0.5 to 1.8
|
—
|
—
|
|
Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Aksaray/4048/2016 [H3N2] - Day 57
|
1.0 ratio of GMT
Interval 0.6 to 1.6
|
2.2 ratio of GMT
Interval 1.3 to 3.6
|
1.2 ratio of GMT
Interval 0.7 to 1.9
|
0.9 ratio of GMT
Interval 0.6 to 1.4
|
—
|
—
|
|
Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Kenya/105/2017 [H3N2] - Day 57
|
1.1 ratio of GMT
Interval 0.7 to 1.7
|
2.0 ratio of GMT
Interval 1.2 to 3.1
|
1.2 ratio of GMT
Interval 0.7 to 2.0
|
0.8 ratio of GMT
Interval 0.5 to 1.3
|
—
|
—
|
|
Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Michigan/84/2016 [H3N2] - Day 57
|
0.6 ratio of GMT
Interval 0.4 to 0.9
|
1.5 ratio of GMT
Interval 1.0 to 2.2
|
0.9 ratio of GMT
Interval 0.6 to 1.3
|
0.8 ratio of GMT
Interval 0.5 to 1.2
|
—
|
—
|
|
Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Shandonglaicheng/1763/2016 [H3N2] - Day 90
|
1.2 ratio of GMT
Interval 0.6 to 2.4
|
2.7 ratio of GMT
Interval 1.4 to 5.2
|
1.7 ratio of GMT
Interval 0.8 to 3.4
|
1.0 ratio of GMT
Interval 0.5 to 1.9
|
—
|
—
|
|
Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Aksaray/4048/2016 [H3N2] - Day 90
|
1.0 ratio of GMT
Interval 0.6 to 1.5
|
1.8 ratio of GMT
Interval 1.0 to 3.1
|
1.0 ratio of GMT
Interval 0.6 to 1.8
|
0.9 ratio of GMT
Interval 0.6 to 1.4
|
—
|
—
|
|
Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Kenya/105/2017 [H3N2] - Day 90
|
1.0 ratio of GMT
Interval 0.6 to 1.8
|
2.1 ratio of GMT
Interval 1.3 to 3.4
|
1.3 ratio of GMT
Interval 0.8 to 2.3
|
0.9 ratio of GMT
Interval 0.5 to 1.5
|
—
|
—
|
|
Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Michigan/84/2016 [H3N2] - Day 90
|
0.6 ratio of GMT
Interval 0.3 to 1.0
|
1.5 ratio of GMT
Interval 1.0 to 2.3
|
0.9 ratio of GMT
Interval 0.6 to 1.4
|
0.7 ratio of GMT
Interval 0.4 to 1.2
|
—
|
—
|
|
Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Shandonglaicheng/1763/2016 [H3N2] - Day 118
|
1.3 ratio of GMT
Interval 0.6 to 3.1
|
1.5 ratio of GMT
Interval 0.7 to 3.2
|
1.4 ratio of GMT
Interval 0.7 to 3.1
|
0.8 ratio of GMT
Interval 0.4 to 1.8
|
—
|
—
|
|
Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Aksaray/4048/2016 [H3N2] - Day 118
|
0.9 ratio of GMT
Interval 0.5 to 1.6
|
1.5 ratio of GMT
Interval 0.8 to 2.5
|
1.6 ratio of GMT
Interval 1.0 to 2.6
|
0.7 ratio of GMT
Interval 0.4 to 1.4
|
—
|
—
|
|
Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Kenya/105/2017 [H3N2] - Day 118
|
1.0 ratio of GMT
Interval 0.6 to 1.8
|
1.3 ratio of GMT
Interval 0.8 to 2.4
|
1.2 ratio of GMT
Interval 0.7 to 2.0
|
0.8 ratio of GMT
Interval 0.4 to 1.4
|
—
|
—
|
|
Ratio of Serum Neutralizing (Neut) Geometric Mean Titers (GMT) Against Heterologous H1 and H3 Influenza Strains Between Adjuvanted and Unadjuvanted Study Arms
A/Michigan/84/2016 [H3N2] - Day 118
|
0.6 ratio of GMT
Interval 0.4 to 1.0
|
1.3 ratio of GMT
Interval 0.8 to 2.0
|
1.1 ratio of GMT
Interval 0.7 to 1.6
|
0.6 ratio of GMT
Interval 0.4 to 1.1
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 8, Day 29, Day 57, Day 90, Day 118Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood samples for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid Neut results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
Blood was collected for Neut assay which was conducted with the heterologous H1 and H3 influenza viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, but only one result which a geometric mean titer of the replicates was reported by the lab. Neut seroconversion was defined as either a pre-vaccination titer \< 1:10 and a post-vaccination titer \>= 1:40 or a pre-vaccination titer \>= 1:10 and a minimum four-fold rise in post-vaccination antibody titer.
Outcome measures
| Measure |
Fluzone + CpG55
n=40 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 2019/2020 of Fluzone QIV intramuscular injection on Day 90.
|
Fluzone
n=41 Participants
0.5 mL of 2018/2019 Fluzone QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Fluzone + AF03
n=37 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.25 mL of AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Flublok
n=41 Participants
0.5 mL of 2018/2019 Flublok QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + AF03
n=38 Participants
0.5 mL of 2018/2019 Flublok QIV + 0.25 mL AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + CpG55
n=42 Participants
0.5 mL of 2018/2019 Flublok QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains
A/Shandonglaicheng/1763/2016 [H3N2] - Day 8
|
33 percentage of participants
Interval 19.0 to 49.0
|
24 percentage of participants
Interval 12.0 to 40.0
|
32 percentage of participants
Interval 18.0 to 50.0
|
27 percentage of participants
Interval 14.0 to 43.0
|
42 percentage of participants
Interval 26.0 to 59.0
|
45 percentage of participants
Interval 30.0 to 61.0
|
|
Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains
A/Aksaray/4048/2016 [H3N2] - Day 8
|
13 percentage of participants
Interval 4.0 to 27.0
|
7 percentage of participants
Interval 2.0 to 20.0
|
16 percentage of participants
Interval 6.0 to 32.0
|
20 percentage of participants
Interval 9.0 to 35.0
|
34 percentage of participants
Interval 20.0 to 51.0
|
21 percentage of participants
Interval 10.0 to 37.0
|
|
Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains
A/Kenya/105/2017 [H3N2] - Day 8
|
15 percentage of participants
Interval 6.0 to 30.0
|
12 percentage of participants
Interval 4.0 to 26.0
|
16 percentage of participants
Interval 6.0 to 32.0
|
15 percentage of participants
Interval 6.0 to 29.0
|
24 percentage of participants
Interval 11.0 to 40.0
|
24 percentage of participants
Interval 12.0 to 39.0
|
|
Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains
A/Michigan/84/2016 [H3N2] - Day 8
|
13 percentage of participants
Interval 4.0 to 27.0
|
12 percentage of participants
Interval 4.0 to 26.0
|
19 percentage of participants
Interval 8.0 to 35.0
|
10 percentage of participants
Interval 3.0 to 23.0
|
8 percentage of participants
Interval 2.0 to 21.0
|
12 percentage of participants
Interval 4.0 to 26.0
|
|
Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains
A/Shandonglaicheng/1763/2016 [H3N2] - Day 29
|
31 percentage of participants
Interval 17.0 to 48.0
|
34 percentage of participants
Interval 20.0 to 51.0
|
33 percentage of participants
Interval 19.0 to 51.0
|
55 percentage of participants
Interval 38.0 to 71.0
|
51 percentage of participants
Interval 34.0 to 68.0
|
49 percentage of participants
Interval 33.0 to 65.0
|
|
Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains
A/Aksaray/4048/2016 [H3N2] - Day 29
|
5 percentage of participants
Interval to 17.0
Value is NA because it's \>0 but \<1
|
7 percentage of participants
Interval 2.0 to 20.0
|
11 percentage of participants
Interval 3.0 to 26.0
|
10 percentage of participants
Interval 3.0 to 24.0
|
24 percentage of participants
Interval 12.0 to 41.0
|
17 percentage of participants
Interval 7.0 to 32.0
|
|
Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains
A/Kenya/105/2017 [H3N2] - Day 29
|
21 percentage of participants
Interval 9.0 to 36.0
|
15 percentage of participants
Interval 6.0 to 29.0
|
22 percentage of participants
Interval 10.0 to 39.0
|
35 percentage of participants
Interval 21.0 to 52.0
|
43 percentage of participants
Interval 27.0 to 61.0
|
39 percentage of participants
Interval 24.0 to 55.0
|
|
Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains
A/Michigan/84/2016 [H3N2] - Day 29
|
10 percentage of participants
Interval 3.0 to 24.0
|
12 percentage of participants
Interval 4.0 to 26.0
|
17 percentage of participants
Interval 6.0 to 33.0
|
15 percentage of participants
Interval 6.0 to 30.0
|
11 percentage of participants
Interval 3.0 to 25.0
|
12 percentage of participants
Interval 4.0 to 26.0
|
|
Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains
A/Shandonglaicheng/1763/2016 [H3N2] - Day 57
|
26 percentage of participants
Interval 13.0 to 43.0
|
15 percentage of participants
Interval 6.0 to 30.0
|
16 percentage of participants
Interval 6.0 to 32.0
|
33 percentage of participants
Interval 19.0 to 49.0
|
35 percentage of participants
Interval 20.0 to 53.0
|
32 percentage of participants
Interval 18.0 to 48.0
|
|
Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains
A/Aksaray/4048/2016 [H3N2] - Day 57
|
11 percentage of participants
Interval 3.0 to 25.0
|
13 percentage of participants
Interval 4.0 to 27.0
|
14 percentage of participants
Interval 5.0 to 29.0
|
38 percentage of participants
Interval 23.0 to 54.0
|
49 percentage of participants
Interval 32.0 to 66.0
|
37 percentage of participants
Interval 22.0 to 53.0
|
|
Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains
A/Kenya/105/2017 [H3N2] - Day 57
|
16 percentage of participants
Interval 6.0 to 31.0
|
8 percentage of participants
Interval 2.0 to 20.0
|
19 percentage of participants
Interval 8.0 to 35.0
|
30 percentage of participants
Interval 17.0 to 47.0
|
32 percentage of participants
Interval 18.0 to 50.0
|
29 percentage of participants
Interval 16.0 to 46.0
|
|
Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains
A/Michigan/84/2016 [H3N2] - Day 57
|
3 percentage of participants
Interval to 14.0
Value is NA because it's \>0 but \<1
|
13 percentage of participants
Interval 4.0 to 27.0
|
16 percentage of participants
Interval 6.0 to 32.0
|
13 percentage of participants
Interval 4.0 to 27.0
|
8 percentage of participants
Interval 2.0 to 22.0
|
12 percentage of participants
Interval 4.0 to 26.0
|
|
Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains
A/Shandonglaicheng/1763/2016 [H3N2] - Day 90
|
24 percentage of participants
Interval 11.0 to 40.0
|
20 percentage of participants
Interval 9.0 to 35.0
|
25 percentage of participants
Interval 12.0 to 42.0
|
33 percentage of participants
Interval 19.0 to 50.0
|
41 percentage of participants
Interval 25.0 to 58.0
|
40 percentage of participants
Interval 25.0 to 57.0
|
|
Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains
A/Aksaray/4048/2016 [H3N2] - Day 90
|
11 percentage of participants
Interval 3.0 to 25.0
|
17 percentage of participants
Interval 7.0 to 32.0
|
17 percentage of participants
Interval 6.0 to 33.0
|
33 percentage of participants
Interval 19.0 to 50.0
|
49 percentage of participants
Interval 32.0 to 66.0
|
30 percentage of participants
Interval 17.0 to 47.0
|
|
Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains
A/Kenya/105/2017 [H3N2] - Day 90
|
8 percentage of participants
Interval 2.0 to 21.0
|
5 percentage of participants
Interval to 17.0
Value is NA because it's \>0 but \<1
|
8 percentage of participants
Interval 2.0 to 22.0
|
18 percentage of participants
Interval 8.0 to 34.0
|
22 percentage of participants
Interval 10.0 to 38.0
|
18 percentage of participants
Interval 7.0 to 33.0
|
|
Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains
A/Michigan/84/2016 [H3N2] - Day 90
|
3 percentage of participants
Interval to 14.0
Value is NA because it's \>0 but \<1
|
0 percentage of participants
Interval 0.0 to 9.0
|
8 percentage of participants
Interval 2.0 to 22.0
|
10 percentage of participants
Interval 3.0 to 24.0
|
8 percentage of participants
Interval 2.0 to 22.0
|
8 percentage of participants
Interval 2.0 to 20.0
|
|
Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains
A/Shandonglaicheng/1763/2016 [H3N2] - Day 118
|
44 percentage of participants
Interval 27.0 to 62.0
|
47 percentage of participants
Interval 30.0 to 65.0
|
33 percentage of participants
Interval 17.0 to 53.0
|
56 percentage of participants
Interval 38.0 to 73.0
|
72 percentage of participants
Interval 53.0 to 86.0
|
68 percentage of participants
Interval 49.0 to 83.0
|
|
Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains
A/Aksaray/4048/2016 [H3N2] - Day 118
|
35 percentage of participants
Interval 20.0 to 54.0
|
33 percentage of participants
Interval 19.0 to 51.0
|
27 percentage of participants
Interval 12.0 to 46.0
|
79 percentage of participants
Interval 62.0 to 91.0
|
69 percentage of participants
Interval 50.0 to 84.0
|
62 percentage of participants
Interval 44.0 to 78.0
|
|
Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains
A/Kenya/105/2017 [H3N2] - Day 118
|
21 percentage of participants
Interval 9.0 to 38.0
|
19 percentage of participants
Interval 8.0 to 36.0
|
10 percentage of participants
Interval 2.0 to 27.0
|
44 percentage of participants
Interval 27.0 to 62.0
|
44 percentage of participants
Interval 26.0 to 62.0
|
38 percentage of participants
Interval 22.0 to 56.0
|
|
Percentage of Participants Achieving Neutralizing (Neut) Titer Seroconversion Against Heterologous H1 and H3 Influenza Strains
A/Michigan/84/2016 [H3N2] - Day 118
|
18 percentage of participants
Interval 7.0 to 35.0
|
19 percentage of participants
Interval 8.0 to 36.0
|
17 percentage of participants
Interval 6.0 to 35.0
|
32 percentage of participants
Interval 17.0 to 51.0
|
22 percentage of participants
Interval 9.0 to 40.0
|
35 percentage of participants
Interval 20.0 to 54.0
|
SECONDARY outcome
Timeframe: Day 8, Day 29, Day 57, Day 90, Day 118Population: The modified intent-to-treat (mITT) population includes all randomized participants who received the first study vaccination and contributed at least one post-first study vaccination venous blood samples for immunogenicity testing (HAI, NAI or Neut antibody assays) for which valid Neut results were reported. For analyses using the mITT population, participants were grouped based on randomized study arm.
Blood was collected for Neut assay which was conducted with the heterologous H1 and H3 influenza viruses as the antigens. Each sample was tested twice per antigen per the laboratory's standard operating procedure, but only one result which a geometric mean titer of the replicates was reported by the lab. Fold-rises from baseline were calculated as the Day 8 (or Day 29, Day 57, Day 90, Day 118) titer divided by the baseline titers for each participant. The geometric mean of these fold rises was then calculated to obtain the GMFR.
Outcome measures
| Measure |
Fluzone + CpG55
n=40 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 2019/2020 of Fluzone QIV intramuscular injection on Day 90.
|
Fluzone
n=41 Participants
0.5 mL of 2018/2019 Fluzone QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Fluzone + AF03
n=37 Participants
0.5 mL of 2018/2019 Fluzone QIV + 0.25 mL of AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Flublok
n=41 Participants
0.5 mL of 2018/2019 Flublok QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + AF03
n=38 Participants
0.5 mL of 2018/2019 Flublok QIV + 0.25 mL AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + CpG55
n=42 Participants
0.5 mL of 2018/2019 Flublok QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains
A/Shandonglaicheng/1763/2016 [H3N2] - Day 8
|
4.8 fold rise
Interval 2.9 to 7.7
|
2.8 fold rise
Interval 1.8 to 4.4
|
4.3 fold rise
Interval 2.6 to 7.0
|
2.9 fold rise
Interval 2.0 to 4.3
|
4.6 fold rise
Interval 2.8 to 7.7
|
4.6 fold rise
Interval 2.8 to 7.7
|
|
Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains
A/Aksaray/4048/2016 [H3N2] - Day 8
|
1.6 fold rise
Interval 1.2 to 2.2
|
1.3 fold rise
Interval 1.0 to 1.7
|
2.2 fold rise
Interval 1.6 to 3.0
|
1.9 fold rise
Interval 1.4 to 2.5
|
3.0 fold rise
Interval 2.1 to 4.3
|
2.1 fold rise
Interval 1.5 to 3.0
|
|
Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains
A/Kenya/105/2017 [H3N2] - Day 8
|
1.4 fold rise
Interval 1.1 to 1.9
|
1.5 fold rise
Interval 1.1 to 2.0
|
1.7 fold rise
Interval 1.2 to 2.3
|
1.9 fold rise
Interval 1.5 to 2.5
|
2.4 fold rise
Interval 1.7 to 3.5
|
2.3 fold rise
Interval 1.7 to 3.1
|
|
Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains
A/Michigan/84/2016 [H3N2] - Day 8
|
1.8 fold rise
Interval 1.3 to 2.3
|
1.4 fold rise
Interval 1.1 to 1.9
|
2.1 fold rise
Interval 1.5 to 2.9
|
1.4 fold rise
Interval 1.2 to 1.8
|
1.3 fold rise
Interval 1.0 to 1.7
|
1.4 fold rise
Interval 1.1 to 1.8
|
|
Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains
A/Shandonglaicheng/1763/2016 [H3N2] - Day 29
|
4.3 fold rise
Interval 2.6 to 7.1
|
2.8 fold rise
Interval 1.8 to 4.3
|
3.4 fold rise
Interval 2.1 to 5.5
|
4.7 fold rise
Interval 3.1 to 7.2
|
5.5 fold rise
Interval 3.5 to 8.5
|
5.9 fold rise
Interval 3.6 to 9.7
|
|
Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains
A/Aksaray/4048/2016 [H3N2] - Day 29
|
1.2 fold rise
Interval 1.0 to 1.5
|
1.3 fold rise
Interval 1.0 to 1.5
|
1.5 fold rise
Interval 1.1 to 2.0
|
1.7 fold rise
Interval 1.3 to 2.3
|
2.6 fold rise
Interval 1.8 to 3.7
|
2.0 fold rise
Interval 1.4 to 2.8
|
|
Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains
A/Kenya/105/2017 [H3N2] - Day 29
|
1.9 fold rise
Interval 1.4 to 2.7
|
1.9 fold rise
Interval 1.4 to 2.5
|
2.3 fold rise
Interval 1.6 to 3.2
|
3.6 fold rise
Interval 2.6 to 4.8
|
4.1 fold rise
Interval 2.9 to 5.8
|
3.5 fold rise
Interval 2.6 to 4.8
|
|
Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains
A/Michigan/84/2016 [H3N2] - Day 29
|
1.6 fold rise
Interval 1.4 to 1.9
|
1.4 fold rise
Interval 1.1 to 1.8
|
1.8 fold rise
Interval 1.3 to 2.3
|
1.9 fold rise
Interval 1.4 to 2.5
|
1.5 fold rise
Interval 1.2 to 1.9
|
1.7 fold rise
Interval 1.3 to 2.2
|
|
Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains
A/Shandonglaicheng/1763/2016 [H3N2] - Day 57
|
2.3 fold rise
Interval 1.4 to 3.6
|
1.4 fold rise
Interval 0.9 to 2.1
|
1.9 fold rise
Interval 1.2 to 2.9
|
2.6 fold rise
Interval 1.8 to 3.9
|
3.0 fold rise
Interval 1.9 to 4.7
|
3.2 fold rise
Interval 2.0 to 5.2
|
|
Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains
A/Aksaray/4048/2016 [H3N2] - Day 57
|
1.6 fold rise
Interval 1.2 to 2.1
|
1.6 fold rise
Interval 1.2 to 2.1
|
2.5 fold rise
Interval 1.9 to 3.4
|
3.2 fold rise
Interval 2.4 to 4.2
|
3.8 fold rise
Interval 2.7 to 5.2
|
3.4 fold rise
Interval 2.4 to 4.7
|
|
Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains
A/Kenya/105/2017 [H3N2] - Day 57
|
1.3 fold rise
Interval 0.9 to 1.9
|
1.3 fold rise
Interval 1.0 to 1.8
|
1.6 fold rise
Interval 1.1 to 2.3
|
2.7 fold rise
Interval 2.0 to 3.7
|
2.9 fold rise
Interval 2.2 to 3.9
|
2.3 fold rise
Interval 1.6 to 3.3
|
|
Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains
A/Michigan/84/2016 [H3N2] - Day 57
|
1.5 fold rise
Interval 1.3 to 1.8
|
1.3 fold rise
Interval 1.0 to 1.6
|
1.9 fold rise
Interval 1.4 to 2.5
|
2.0 fold rise
Interval 1.5 to 2.6
|
1.4 fold rise
Interval 1.1 to 1.7
|
1.8 fold rise
Interval 1.4 to 2.4
|
|
Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains
A/Shandonglaicheng/1763/2016 [H3N2] - Day 90
|
3.0 fold rise
Interval 2.0 to 4.6
|
1.9 fold rise
Interval 1.3 to 2.7
|
2.5 fold rise
Interval 1.5 to 4.0
|
3.3 fold rise
Interval 2.3 to 4.8
|
3.8 fold rise
Interval 2.4 to 6.0
|
3.8 fold rise
Interval 2.4 to 6.1
|
|
Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains
A/Aksaray/4048/2016 [H3N2] - Day 90
|
1.6 fold rise
Interval 1.3 to 2.1
|
1.8 fold rise
Interval 1.3 to 2.5
|
2.3 fold rise
Interval 1.8 to 3.0
|
3.1 fold rise
Interval 2.4 to 4.1
|
3.5 fold rise
Interval 2.6 to 4.8
|
3.1 fold rise
Interval 2.3 to 4.3
|
|
Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains
A/Kenya/105/2017 [H3N2] - Day 90
|
0.9 fold rise
Interval 0.7 to 1.3
|
0.8 fold rise
Interval 0.6 to 1.1
|
1.0 fold rise
Interval 0.7 to 1.4
|
1.9 fold rise
Interval 1.4 to 2.6
|
1.9 fold rise
Interval 1.3 to 2.7
|
1.7 fold rise
Interval 1.3 to 2.3
|
|
Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains
A/Michigan/84/2016 [H3N2] - Day 90
|
1.3 fold rise
Interval 1.0 to 1.5
|
1.0 fold rise
Interval 0.8 to 1.2
|
1.5 fold rise
Interval 1.1 to 1.9
|
1.7 fold rise
Interval 1.3 to 2.2
|
1.1 fold rise
Interval 0.8 to 1.4
|
1.4 fold rise
Interval 1.1 to 1.9
|
|
Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains
A/Shandonglaicheng/1763/2016 [H3N2] - Day 118
|
5.7 fold rise
Interval 3.5 to 9.4
|
4.6 fold rise
Interval 2.9 to 7.3
|
2.8 fold rise
Interval 1.8 to 4.3
|
6.8 fold rise
Interval 4.2 to 11.0
|
9.9 fold rise
Interval 5.8 to 16.8
|
7.8 fold rise
Interval 4.7 to 12.8
|
|
Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains
A/Aksaray/4048/2016 [H3N2] - Day 118
|
3.7 fold rise
Interval 2.6 to 5.3
|
3.0 fold rise
Interval 2.2 to 4.1
|
2.9 fold rise
Interval 2.0 to 4.1
|
6.9 fold rise
Interval 4.8 to 9.9
|
7.3 fold rise
Interval 5.0 to 10.6
|
6.1 fold rise
Interval 4.0 to 9.5
|
|
Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains
A/Kenya/105/2017 [H3N2] - Day 118
|
1.8 fold rise
Interval 1.3 to 2.4
|
1.8 fold rise
Interval 1.3 to 2.6
|
1.2 fold rise
Interval 0.9 to 1.7
|
4.2 fold rise
Interval 3.0 to 6.0
|
4.2 fold rise
Interval 2.9 to 6.2
|
3.5 fold rise
Interval 2.5 to 4.9
|
|
Geometric Mean Fold Rise (GMFR) in Neutralizing (Neut) Titers Against Heterologous H1 and H3 Influenza Strains
A/Michigan/84/2016 [H3N2] - Day 118
|
2.4 fold rise
Interval 1.9 to 3.0
|
1.7 fold rise
Interval 1.3 to 2.3
|
1.8 fold rise
Interval 1.4 to 2.3
|
3.2 fold rise
Interval 2.3 to 4.3
|
2.3 fold rise
Interval 1.7 to 3.1
|
2.6 fold rise
Interval 1.9 to 3.7
|
Adverse Events
Fluzone
Serious events: 0 serious events
Other events: 37 other events
Deaths: 0 deaths
Fluzone + AF03
Serious events: 1 serious events
Other events: 36 other events
Deaths: 0 deaths
Fluzone + CpG55
Serious events: 0 serious events
Other events: 40 other events
Deaths: 0 deaths
Flublok
Serious events: 0 serious events
Other events: 36 other events
Deaths: 0 deaths
Flublok + AF03
Serious events: 0 serious events
Other events: 34 other events
Deaths: 0 deaths
Flublok + CpG55
Serious events: 1 serious events
Other events: 43 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fluzone
n=41 participants at risk
0.5 mL of 2018/2019 Fluzone QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Fluzone + AF03
n=37 participants at risk
0.5 mL of 2018/2019 Fluzone QIV + 0.25 mL of AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Fluzone + CpG55
n=40 participants at risk
0.5 mL of 2018/2019 Fluzone QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 2019/2020 of Fluzone QIV intramuscular injection on Day 90.
|
Flublok
n=42 participants at risk
0.5 mL of 2018/2019 Flublok QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + AF03
n=37 participants at risk
0.5 mL of 2018/2019 Flublok QIV + 0.25 mL AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + CpG55
n=43 participants at risk
0.5 mL of 2018/2019 Flublok QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
|
|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Chronic Left Knee Pain
|
0.00%
0/41 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
0.00%
0/37 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
0.00%
0/40 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
0.00%
0/42 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
0.00%
0/37 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
2.3%
1/43 • Number of events 1 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
|
Infections and infestations
Clostridium Difficile Colitis
|
0.00%
0/41 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
2.7%
1/37 • Number of events 1 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
0.00%
0/40 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
0.00%
0/42 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
0.00%
0/37 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
0.00%
0/43 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
Other adverse events
| Measure |
Fluzone
n=41 participants at risk
0.5 mL of 2018/2019 Fluzone QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Fluzone + AF03
n=37 participants at risk
0.5 mL of 2018/2019 Fluzone QIV + 0.25 mL of AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Fluzone QIV intramuscular injection on Day 90.
|
Fluzone + CpG55
n=40 participants at risk
0.5 mL of 2018/2019 Fluzone QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 2019/2020 of Fluzone QIV intramuscular injection on Day 90.
|
Flublok
n=42 participants at risk
0.5 mL of 2018/2019 Flublok QIV intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + AF03
n=37 participants at risk
0.5 mL of 2018/2019 Flublok QIV + 0.25 mL AF03 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
One participant randomized to the Flublok + AF03 arm received Flublok due to a pharmacy error and is analyzed in the Flublok group for safety-related analyses.
|
Flublok + CpG55
n=43 participants at risk
0.5 mL of 2018/2019 Flublok QIV + 0.5 mL of Delta Inulin-CpG55.2 (admixed with vaccine) intramuscular injection on Day 1 and 0.5 ml of 2019/2020 Flublok QIV intramuscular injection on Day 90.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
2.4%
1/41 • Number of events 1 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
8.1%
3/37 • Number of events 3 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
0.00%
0/40 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
2.4%
1/42 • Number of events 1 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
5.4%
2/37 • Number of events 2 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
0.00%
0/43 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
|
Gastrointestinal disorders
Nausea
|
4.9%
2/41 • Number of events 2 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
8.1%
3/37 • Number of events 3 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
7.5%
3/40 • Number of events 3 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
11.9%
5/42 • Number of events 5 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
13.5%
5/37 • Number of events 5 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
14.0%
6/43 • Number of events 6 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
|
General disorders
Fatigue
|
31.7%
13/41 • Number of events 13 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
43.2%
16/37 • Number of events 16 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
35.0%
14/40 • Number of events 14 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
31.0%
13/42 • Number of events 13 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
37.8%
14/37 • Number of events 14 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
34.9%
15/43 • Number of events 15 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
|
General disorders
Influenza like illness
|
0.00%
0/41 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
0.00%
0/37 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
5.0%
2/40 • Number of events 2 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
2.4%
1/42 • Number of events 1 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
0.00%
0/37 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
0.00%
0/43 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
|
General disorders
Malaise
|
22.0%
9/41 • Number of events 9 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
29.7%
11/37 • Number of events 11 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
20.0%
8/40 • Number of events 8 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
14.3%
6/42 • Number of events 6 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
21.6%
8/37 • Number of events 8 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
11.6%
5/43 • Number of events 5 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
|
General disorders
Pyrexia
|
7.3%
3/41 • Number of events 3 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
10.8%
4/37 • Number of events 4 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
15.0%
6/40 • Number of events 6 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
11.9%
5/42 • Number of events 5 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
13.5%
5/37 • Number of events 5 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
9.3%
4/43 • Number of events 4 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
|
General disorders
Vaccination site bruising
|
4.9%
2/41 • Number of events 2 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
8.1%
3/37 • Number of events 3 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
2.5%
1/40 • Number of events 1 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
4.8%
2/42 • Number of events 2 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
0.00%
0/37 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
9.3%
4/43 • Number of events 4 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
|
General disorders
Vaccination site erythema
|
19.5%
8/41 • Number of events 8 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
24.3%
9/37 • Number of events 9 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
40.0%
16/40 • Number of events 16 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
14.3%
6/42 • Number of events 6 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
18.9%
7/37 • Number of events 7 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
27.9%
12/43 • Number of events 12 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
|
General disorders
Vaccination site induration
|
29.3%
12/41 • Number of events 12 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
10.8%
4/37 • Number of events 4 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
32.5%
13/40 • Number of events 13 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
14.3%
6/42 • Number of events 6 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
16.2%
6/37 • Number of events 6 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
30.2%
13/43 • Number of events 13 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
|
General disorders
Vaccination site pain
|
29.3%
12/41 • Number of events 12 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
59.5%
22/37 • Number of events 22 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
65.0%
26/40 • Number of events 26 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
16.7%
7/42 • Number of events 7 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
56.8%
21/37 • Number of events 21 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
62.8%
27/43 • Number of events 27 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
|
General disorders
Vaccination site pain (tenderness)
|
70.7%
29/41 • Number of events 29 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
94.6%
35/37 • Number of events 35 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
95.0%
38/40 • Number of events 38 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
71.4%
30/42 • Number of events 30 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
81.1%
30/37 • Number of events 30 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
95.3%
41/43 • Number of events 41 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
|
General disorders
Vaccination site pruritus
|
2.4%
1/41 • Number of events 1 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
2.7%
1/37 • Number of events 1 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
2.5%
1/40 • Number of events 1 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
2.4%
1/42 • Number of events 1 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
2.7%
1/37 • Number of events 1 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
7.0%
3/43 • Number of events 3 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/41 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
5.4%
2/37 • Number of events 2 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
0.00%
0/40 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
0.00%
0/42 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
0.00%
0/37 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
2.3%
1/43 • Number of events 1 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/41 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
2.7%
1/37 • Number of events 1 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
2.5%
1/40 • Number of events 1 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
2.4%
1/42 • Number of events 1 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
10.8%
4/37 • Number of events 4 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
0.00%
0/43 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
|
Infections and infestations
Urinary tract infection
|
2.4%
1/41 • Number of events 1 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
5.4%
2/37 • Number of events 2 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
2.5%
1/40 • Number of events 2 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
0.00%
0/42 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
2.7%
1/37 • Number of events 1 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
0.00%
0/43 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/41 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
2.7%
1/37 • Number of events 2 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
0.00%
0/40 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
2.4%
1/42 • Number of events 1 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
5.4%
2/37 • Number of events 2 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
2.3%
1/43 • Number of events 2 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
|
Investigations
Haemoglobin decreased
|
2.4%
1/41 • Number of events 1 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
2.7%
1/37 • Number of events 1 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
5.0%
2/40 • Number of events 3 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
9.5%
4/42 • Number of events 6 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
0.00%
0/37 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
0.00%
0/43 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
|
Investigations
Platelet count increased
|
0.00%
0/41 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
0.00%
0/37 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
0.00%
0/40 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
9.5%
4/42 • Number of events 8 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
0.00%
0/37 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
0.00%
0/43 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
|
Investigations
White blood cell count decreased
|
14.6%
6/41 • Number of events 6 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
8.1%
3/37 • Number of events 3 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
7.5%
3/40 • Number of events 3 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
4.8%
2/42 • Number of events 2 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
8.1%
3/37 • Number of events 3 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
0.00%
0/43 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.9%
2/41 • Number of events 2 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
13.5%
5/37 • Number of events 5 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
2.5%
1/40 • Number of events 1 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
7.1%
3/42 • Number of events 3 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
2.7%
1/37 • Number of events 1 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
4.7%
2/43 • Number of events 2 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
26.8%
11/41 • Number of events 11 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
40.5%
15/37 • Number of events 15 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
30.0%
12/40 • Number of events 12 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
14.3%
6/42 • Number of events 6 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
24.3%
9/37 • Number of events 9 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
25.6%
11/43 • Number of events 11 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
|
Nervous system disorders
Headache
|
26.8%
11/41 • Number of events 12 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
56.8%
21/37 • Number of events 21 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
25.0%
10/40 • Number of events 10 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
31.0%
13/42 • Number of events 13 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
29.7%
11/37 • Number of events 11 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
23.3%
10/43 • Number of events 10 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/41 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
2.7%
1/37 • Number of events 1 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
0.00%
0/40 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
0.00%
0/42 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
0.00%
0/37 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
7.0%
3/43 • Number of events 3 • Serious Adverse Events (SAEs), AESIs (including protocol-specified AESIs, MAAEs, NOCMCs and PIMMCs) were collected from the time of first study vaccination through approximately 12 months following first study vaccination. Solicited Adverse Events (AEs) and clinical safety laboratory AEs were collected from the time of first study vaccination through Day 7. Non-serious, unsolicited AEs were collected from the time of first study vaccination through approximately Day 29.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration, edema, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
|
Additional Information
Patricia Winokur, MD
University of Iowa Carver College of Medicine
Phone: 319-384-1735
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60