Trial Outcomes & Findings for Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Patients ≥65 Years (NCT NCT03233217)
NCT ID: NCT03233217
Last Updated: 2022-04-04
Results Overview
An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of symptom and/or onset post-vaccination. Unsolicited AEs includes both serious and non-serious unsolicited AEs. A serious adverse event is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event. All participants were observed for 30 minutes after vaccination, and any unsolicited AEs occurred during that time were recorded as immediate unsolicited AEs in the CRB.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
175 participants
Primary outcome timeframe
Within 30 minutes after vaccination
Results posted on
2022-04-04
Participant Flow
Study participants were enrolled from 15 September 2017 to 26 October 2017 at 2 centers in Japan.
10 participants were randomized 1:1 to receive either QIV-HD by intramuscular (IM) route or QIV-HD by subcutaneous (SC) route (Cohort 1). After review of local and systemic AEs for 7 days post-vaccination in Cohort 1, remaining 165 participants were randomized 1:1:1 to receive QIV-HD by IM route, QIV-HD by SC route, or QIV-SD by SC route (Cohort 2)
Participant milestones
| Measure |
Cohort 1: QIV-HD by IM
Participants were randomized to receive a single 0.7-milliliter (mL) injection of high-dose Quadrivalent influenza vaccine (QIV-HD) by IM route on Day 0.
|
Cohort 1: QIV-HD by SC
Participants were randomized to receive a single 0.7 mL injection of QIV-HD by SC route on Day 0.
|
Cohort 2: QIV-HD by IM
Participants were randomized to receive a single 0.7 mL injection of QIV-HD by IM route on Day 0.
|
Cohort 2: QIV-HD by SC
Participants were randomized to receive a single 0.7 mL injection of QIV-HD by SC route on Day 0.
|
Cohort 2: QIV-SD by SC
Participants were randomized to receive a single 0.5 mL injection of standard-dose Quadrivalent influenza vaccine (QIV-SD) by SC route on Day 0.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
55
|
55
|
55
|
|
Overall Study
Safety Analysis Set (SafAS)
|
5
|
5
|
55
|
55
|
55
|
|
Overall Study
Per-protocol Analysis Set (PPAS)
|
5
|
5
|
55
|
55
|
54
|
|
Overall Study
COMPLETED
|
5
|
5
|
55
|
55
|
55
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Patients ≥65 Years
Baseline characteristics by cohort
| Measure |
Cohort 1: QIV-HD by IM
n=5 Participants
Participants were randomized to receive a single 0.7 mL injection of QIV-HD by IM route on Day 0.
|
Cohort 1: QIV-HD by SC
n=5 Participants
Participants were randomized to receive a single 0.7 mL injection of QIV-HD by SC route on Day 0.
|
Cohort 2: QIV-HD by IM
n=55 Participants
Participants were randomized to receive a single 0.7 mL injection of QIV-HD by IM route on Day 0.
|
Cohort 2: QIV-HD by SC
n=55 Participants
Participants were randomized to receive a single 0.7 mL injection of QIV-HD by SC route on Day 0.
|
Cohort 2: QIV-SD by SC
n=55 Participants
Participants were randomized to receive a single 0.5 mL injection of QIV-SD by SC route on Day 0.
|
Total
n=175 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
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=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
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=10 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
55 Participants
n=4 Participants
|
55 Participants
n=21 Participants
|
175 Participants
n=10 Participants
|
|
Age, Continuous
|
70.8 years
STANDARD_DEVIATION 2.0 • n=5 Participants
|
70.8 years
STANDARD_DEVIATION 2.3 • n=7 Participants
|
70.1 years
STANDARD_DEVIATION 3.7 • n=5 Participants
|
70.5 years
STANDARD_DEVIATION 3.6 • n=4 Participants
|
69.9 years
STANDARD_DEVIATION 3.8 • n=21 Participants
|
70.2 years
STANDARD_DEVIATION 3.6 • n=10 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
80 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
95 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
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=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
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=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
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=10 Participants
|
PRIMARY outcome
Timeframe: Within 30 minutes after vaccinationPopulation: The safety analysis was performed on SafAS which included participants who received study vaccine and analyzed according to the vaccine they actually received. Data for this outcome measure was planned to be collected and analyzed for combined population of Cohort 1 and Cohort 2 participants who received QIV-HD (QIV-HD by IM and QIV-HD by SC).
An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of symptom and/or onset post-vaccination. Unsolicited AEs includes both serious and non-serious unsolicited AEs. A serious adverse event is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event. All participants were observed for 30 minutes after vaccination, and any unsolicited AEs occurred during that time were recorded as immediate unsolicited AEs in the CRB.
Outcome measures
| Measure |
Cohort 1 and 2: QIV-HD by IM
n=60 Participants
Participants were randomized to receive a single 0.7 mL injection of QIV-HD by IM route on Day 0.
|
Cohort 1 and 2: QIV-HD by SC
n=60 Participants
Participants were randomized to receive a single 0.7 mL injection of QIV-HD by SC route on Day 0.
|
Cohort 2: QIV-SD by SC
n=55 Participants
Participants were randomized to receive a single 0.5 mL injection of QIV-SD by SC route on Day 0.
|
|---|---|---|---|
|
Number of Participants With Immediate Unsolicited Adverse Events (AE) After Vaccination
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Within 7 days after vaccinationPopulation: The safety analysis was performed on SafAS which included participants who received study vaccine and analyzed according to the vaccine they actually received. Data for this outcome measure was planned to be collected and analyzed for combined population for Cohort 1 and Cohort 2 participants who received QIV-HD (QIV-HD by IM and QIV-HD by SC).
A solicited reaction was an adverse reaction observed and reported under the conditions (symptom and onset) prelisted (i.e., solicited) in the CRB and considered as related to the administered vaccination. Solicited injection site reactions: pain, erythema, swelling, induration, and bruising. Solicited systemic reactions: fever, headache, malaise, myalgia, and shivering.
Outcome measures
| Measure |
Cohort 1 and 2: QIV-HD by IM
n=60 Participants
Participants were randomized to receive a single 0.7 mL injection of QIV-HD by IM route on Day 0.
|
Cohort 1 and 2: QIV-HD by SC
n=60 Participants
Participants were randomized to receive a single 0.7 mL injection of QIV-HD by SC route on Day 0.
|
Cohort 2: QIV-SD by SC
n=55 Participants
Participants were randomized to receive a single 0.5 mL injection of QIV-SD by SC route on Day 0.
|
|---|---|---|---|
|
Number of Participants With Solicited Injection Site and Systemic Reactions
Injection site pain
|
18 Participants
|
27 Participants
|
15 Participants
|
|
Number of Participants With Solicited Injection Site and Systemic Reactions
Injection site erythema
|
11 Participants
|
19 Participants
|
11 Participants
|
|
Number of Participants With Solicited Injection Site and Systemic Reactions
Injection site swelling
|
9 Participants
|
17 Participants
|
13 Participants
|
|
Number of Participants With Solicited Injection Site and Systemic Reactions
Injection site induration
|
2 Participants
|
7 Participants
|
2 Participants
|
|
Number of Participants With Solicited Injection Site and Systemic Reactions
Injection site bruising
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Injection Site and Systemic Reactions
Fever
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Solicited Injection Site and Systemic Reactions
Headache
|
3 Participants
|
8 Participants
|
1 Participants
|
|
Number of Participants With Solicited Injection Site and Systemic Reactions
Malaise
|
1 Participants
|
4 Participants
|
3 Participants
|
|
Number of Participants With Solicited Injection Site and Systemic Reactions
Myalgia
|
9 Participants
|
16 Participants
|
7 Participants
|
|
Number of Participants With Solicited Injection Site and Systemic Reactions
Shivering
|
0 Participants
|
2 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Within 28 days after vaccinationPopulation: The safety analysis was performed on SafAS which included participants who received study vaccine and analyzed according to the vaccine they actually received. Data for this outcome measure was planned to be collected and analyzed for combined population of Cohort 1 and Cohort 2 participants who received QIV-HD (QIV-HD by IM and QIV-HD by SC).
An unsolicited AE was an observed AE that does not fulfill the conditions prelisted in the CRB in terms of symptom and/or onset post-vaccination. Unsolicited AEs included both serious and non-serious unsolicited AEs. A serious adverse event is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.
Outcome measures
| Measure |
Cohort 1 and 2: QIV-HD by IM
n=60 Participants
Participants were randomized to receive a single 0.7 mL injection of QIV-HD by IM route on Day 0.
|
Cohort 1 and 2: QIV-HD by SC
n=60 Participants
Participants were randomized to receive a single 0.7 mL injection of QIV-HD by SC route on Day 0.
|
Cohort 2: QIV-SD by SC
n=55 Participants
Participants were randomized to receive a single 0.5 mL injection of QIV-SD by SC route on Day 0.
|
|---|---|---|---|
|
Number of Participants With Unsolicited Adverse Events After Vaccination
|
4 Participants
|
4 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: Up to 6 months after vaccinationPopulation: The safety analysis was performed on SafAS which included participants who received study vaccine and analyzed according to the vaccine they actually received. Data for this outcome measure was planned to be collected and analyzed for combined population of Cohort 1 and Cohort 2 participants who received QIV-HD (QIV-HD by IM and QIV-HD by SC).
An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.
Outcome measures
| Measure |
Cohort 1 and 2: QIV-HD by IM
n=60 Participants
Participants were randomized to receive a single 0.7 mL injection of QIV-HD by IM route on Day 0.
|
Cohort 1 and 2: QIV-HD by SC
n=60 Participants
Participants were randomized to receive a single 0.7 mL injection of QIV-HD by SC route on Day 0.
|
Cohort 2: QIV-SD by SC
n=55 Participants
Participants were randomized to receive a single 0.5 mL injection of QIV-SD by SC route on Day 0.
|
|---|---|---|---|
|
Number of Participant With Serious Adverse Events (SAEs) After Vaccination
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 0 (pre-vaccination) and Day 28 (post-vaccination)Population: Analyzed on PPAS which included all participants who received at least 1 dose of study vaccine, and had post-vaccination blood sample HAI result for at least 1 strain, with no protocol deviations. Here, 'number analyzed' = participants with available data for each category. Data for this outcome measure was not planned to be analyzed for Cohort 1.
GMT of anti-influenza antibodies strains (A1, A1-like, A2, A2-like, B1, B2, B2-like) were measured using a hemagglutination inhibition (HAI) assay.
Outcome measures
| Measure |
Cohort 1 and 2: QIV-HD by IM
n=55 Participants
Participants were randomized to receive a single 0.7 mL injection of QIV-HD by IM route on Day 0.
|
Cohort 1 and 2: QIV-HD by SC
n=55 Participants
Participants were randomized to receive a single 0.7 mL injection of QIV-HD by SC route on Day 0.
|
Cohort 2: QIV-SD by SC
n=54 Participants
Participants were randomized to receive a single 0.5 mL injection of QIV-SD by SC route on Day 0.
|
|---|---|---|---|
|
Cohort 2: Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD
B1: Day 28
|
877.0 titers (1/dilution)
Interval 632.9 to 1215.3
|
628.0 titers (1/dilution)
Interval 475.4 to 829.6
|
336.9 titers (1/dilution)
Interval 263.7 to 430.3
|
|
Cohort 2: Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD
A1: Day 0
|
44.5 titers (1/dilution)
Interval 29.4 to 67.5
|
59.5 titers (1/dilution)
Interval 39.7 to 89.2
|
41.0 titers (1/dilution)
Interval 27.7 to 60.8
|
|
Cohort 2: Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD
A1-like: Day 0
|
46.2 titers (1/dilution)
Interval 35.4 to 60.4
|
56.2 titers (1/dilution)
Interval 43.0 to 73.5
|
42.1 titers (1/dilution)
Interval 32.8 to 54.1
|
|
Cohort 2: Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD
A2: Day 0
|
62.6 titers (1/dilution)
Interval 39.9 to 98.1
|
101.0 titers (1/dilution)
Interval 66.9 to 152.6
|
83.7 titers (1/dilution)
Interval 53.9 to 129.9
|
|
Cohort 2: Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD
A2-like: Day 0
|
76.1 titers (1/dilution)
Interval 49.6 to 116.7
|
107.6 titers (1/dilution)
Interval 71.4 to 162.1
|
91.0 titers (1/dilution)
Interval 57.7 to 143.3
|
|
Cohort 2: Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD
B1: Day 0
|
116.8 titers (1/dilution)
Interval 83.2 to 163.9
|
134.1 titers (1/dilution)
Interval 92.2 to 195.0
|
108.2 titers (1/dilution)
Interval 79.5 to 147.1
|
|
Cohort 2: Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD
B2: Day 0
|
76.1 titers (1/dilution)
Interval 49.9 to 115.9
|
109.6 titers (1/dilution)
Interval 73.4 to 163.8
|
97.6 titers (1/dilution)
Interval 69.6 to 137.0
|
|
Cohort 2: Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD
B2-like: Day 0
|
32.7 titers (1/dilution)
Interval 22.9 to 46.7
|
47.1 titers (1/dilution)
Interval 32.8 to 67.6
|
41.6 titers (1/dilution)
Interval 31.4 to 55.1
|
|
Cohort 2: Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD
A1: Day 28
|
712.4 titers (1/dilution)
Interval 509.7 to 995.7
|
550.2 titers (1/dilution)
Interval 402.2 to 752.5
|
269.1 titers (1/dilution)
Interval 181.5 to 399.0
|
|
Cohort 2: Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD
A1-like: Day 28
|
427.6 titers (1/dilution)
Interval 309.1 to 591.5
|
356.2 titers (1/dilution)
Interval 260.0 to 488.0
|
216.3 titers (1/dilution)
Interval 157.4 to 297.3
|
|
Cohort 2: Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD
A2: Day 28
|
1059.5 titers (1/dilution)
Interval 759.5 to 1478.0
|
839.2 titers (1/dilution)
Interval 617.7 to 1140.0
|
405.8 titers (1/dilution)
Interval 270.5 to 608.6
|
|
Cohort 2: Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD
A2-like: Day 28
|
940.0 titers (1/dilution)
Interval 664.3 to 1330.1
|
797.9 titers (1/dilution)
Interval 586.8 to 1084.9
|
402.3 titers (1/dilution)
Interval 263.0 to 615.4
|
|
Cohort 2: Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD
B2: Day 28
|
813.2 titers (1/dilution)
Interval 603.0 to 1096.5
|
758.7 titers (1/dilution)
Interval 589.5 to 976.5
|
281.5 titers (1/dilution)
Interval 217.0 to 365.0
|
|
Cohort 2: Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD
B2-like: Day 28
|
269.9 titers (1/dilution)
Interval 199.4 to 365.4
|
261.6 titers (1/dilution)
Interval 201.1 to 340.2
|
111.0 titers (1/dilution)
Interval 87.6 to 140.7
|
SECONDARY outcome
Timeframe: Day 0 (pre-vaccination) and Day 28 (post-vaccination)Population: The analysis was performed on PPAS which included all participants who received at least 1 dose of study vaccine, and had post-vaccination blood sample HAI result for at least 1 strain, with no protocol deviations. Data for this outcome measure was not planned to be analyzed for Cohort 1.
GMT of anti-influenza antibodies strains (A1, A1-like, A2, A2-like, B1, B2, B2-like) were measured using an HAI assay. GMTRs were calculated as the ratio of GMTs post vaccination and pre-vaccination.
Outcome measures
| Measure |
Cohort 1 and 2: QIV-HD by IM
n=55 Participants
Participants were randomized to receive a single 0.7 mL injection of QIV-HD by IM route on Day 0.
|
Cohort 1 and 2: QIV-HD by SC
n=55 Participants
Participants were randomized to receive a single 0.7 mL injection of QIV-HD by SC route on Day 0.
|
Cohort 2: QIV-SD by SC
n=54 Participants
Participants were randomized to receive a single 0.5 mL injection of QIV-SD by SC route on Day 0.
|
|---|---|---|---|
|
Cohort 2: Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD
A1: Day 28/Day 0
|
16.00 ratio
Interval 10.19 to 25.11
|
9.25 ratio
Interval 6.11 to 14.0
|
6.56 ratio
Interval 4.36 to 9.86
|
|
Cohort 2: Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD
A1-like: Day 28/Day 0
|
9.25 ratio
Interval 6.67 to 12.82
|
6.34 ratio
Interval 4.79 to 8.38
|
5.13 ratio
Interval 3.67 to 7.17
|
|
Cohort 2: Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD
A2: Day 28/Day 0
|
16.93 ratio
Interval 10.99 to 26.1
|
8.31 ratio
Interval 5.54 to 12.46
|
4.85 ratio
Interval 3.08 to 7.63
|
|
Cohort 2: Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD
A2-like: Day 28/Day 0
|
12.36 ratio
Interval 8.03 to 19.01
|
7.42 ratio
Interval 4.98 to 11.05
|
4.56 ratio
Interval 2.89 to 7.19
|
|
Cohort 2: Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD
B1: Day 28/Day 0
|
7.51 ratio
Interval 4.93 to 11.45
|
4.68 ratio
Interval 3.34 to 6.56
|
3.11 ratio
Interval 2.29 to 4.24
|
|
Cohort 2: Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD
B2: Day 28/Day 0
|
10.69 ratio
Interval 7.05 to 16.21
|
6.92 ratio
Interval 4.79 to 9.99
|
2.88 ratio
Interval 2.08 to 3.99
|
|
Cohort 2: Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD
B2-like: Day 28/Day 0
|
8.26 ratio
Interval 5.74 to 11.89
|
5.55 ratio
Interval 3.97 to 7.76
|
2.67 ratio
Interval 2.0 to 3.57
|
SECONDARY outcome
Timeframe: Day 28 (post-vaccination)Population: Analyzed on PPAS which included all participants who received at least 1 dose of study vaccine, and had post-vaccination blood sample HAI result for at least 1 strain, with no protocol deviations. Here, 'number analyzed' = participants with available data for each category. Data for this outcome measure was not planned to be analyzed for Cohort 1.
Anti-influenza antibodies were measured by using the HAI assay for the strains A1, A1-like, A2, A2-like, B1, B2, and B2-like. Seroconversion was defined as either a HAI titer lesser than (\<) 10 (1/dilution) at Day 0 and post-vaccination titer greater than or equal to (\>=) 40 (1/dilution) at Day 28, or HAI titer \>=10 (1/dilution) at Day 0 and a \>=4-fold increase in HAI titer (1/dilution) at Day 28.
Outcome measures
| Measure |
Cohort 1 and 2: QIV-HD by IM
n=55 Participants
Participants were randomized to receive a single 0.7 mL injection of QIV-HD by IM route on Day 0.
|
Cohort 1 and 2: QIV-HD by SC
n=55 Participants
Participants were randomized to receive a single 0.7 mL injection of QIV-HD by SC route on Day 0.
|
Cohort 2: QIV-SD by SC
n=54 Participants
Participants were randomized to receive a single 0.5 mL injection of QIV-SD by SC route on Day 0.
|
|---|---|---|---|
|
Cohort 2: Percentage of Participants Achieving Seroconversion Against Antigens Following Vaccination With QIV-HD or QIV-SD
A1
|
74.5 percentage of participants
Interval 61.0 to 85.3
|
67.3 percentage of participants
Interval 53.3 to 79.3
|
55.6 percentage of participants
Interval 41.4 to 69.1
|
|
Cohort 2: Percentage of Participants Achieving Seroconversion Against Antigens Following Vaccination With QIV-HD or QIV-SD
A1-like
|
74.5 percentage of participants
Interval 61.0 to 85.3
|
69.1 percentage of participants
Interval 55.2 to 80.9
|
56.6 percentage of participants
Interval 42.3 to 70.2
|
|
Cohort 2: Percentage of Participants Achieving Seroconversion Against Antigens Following Vaccination With QIV-HD or QIV-SD
A2
|
85.5 percentage of participants
Interval 73.3 to 93.5
|
63.6 percentage of participants
Interval 49.6 to 76.2
|
42.6 percentage of participants
Interval 29.2 to 56.8
|
|
Cohort 2: Percentage of Participants Achieving Seroconversion Against Antigens Following Vaccination With QIV-HD or QIV-SD
A2-like
|
74.5 percentage of participants
Interval 61.0 to 85.3
|
58.2 percentage of participants
Interval 44.1 to 71.3
|
43.4 percentage of participants
Interval 29.8 to 57.7
|
|
Cohort 2: Percentage of Participants Achieving Seroconversion Against Antigens Following Vaccination With QIV-HD or QIV-SD
B1
|
58.2 percentage of participants
Interval 44.1 to 71.3
|
47.3 percentage of participants
Interval 33.7 to 61.2
|
37.0 percentage of participants
Interval 24.3 to 51.3
|
|
Cohort 2: Percentage of Participants Achieving Seroconversion Against Antigens Following Vaccination With QIV-HD or QIV-SD
B2
|
65.5 percentage of participants
Interval 51.4 to 77.8
|
63.6 percentage of participants
Interval 49.6 to 76.2
|
33.3 percentage of participants
Interval 21.1 to 47.5
|
|
Cohort 2: Percentage of Participants Achieving Seroconversion Against Antigens Following Vaccination With QIV-HD or QIV-SD
B2-like
|
67.3 percentage of participants
Interval 53.3 to 79.3
|
60.0 percentage of participants
Interval 45.9 to 73.0
|
33.3 percentage of participants
Interval 21.1 to 47.5
|
SECONDARY outcome
Timeframe: Day 0 (pre-vaccination) and Day 28 (post-vaccination)Population: Analyzed on PPAS which included all participants who received at least 1 dose of study vaccine, and had post-vaccination blood sample HAI result for at least 1 strain, with no protocol deviations. Here, 'number analyzed' = participants with available data for each category. Data for this outcome measure was not planned to be analyzed for Cohort 1.
Anti-influenza antibodies were measured by using the HAI assay for the strains A1, A1-like, A2, A2-like, B1, B2, and B2-like. Seroprotection was defined as a HAI titer \>=40 (1/dilution) at Day 0 and Day 28.
Outcome measures
| Measure |
Cohort 1 and 2: QIV-HD by IM
n=55 Participants
Participants were randomized to receive a single 0.7 mL injection of QIV-HD by IM route on Day 0.
|
Cohort 1 and 2: QIV-HD by SC
n=55 Participants
Participants were randomized to receive a single 0.7 mL injection of QIV-HD by SC route on Day 0.
|
Cohort 2: QIV-SD by SC
n=54 Participants
Participants were randomized to receive a single 0.5 mL injection of QIV-SD by SC route on Day 0.
|
|---|---|---|---|
|
Cohort 2: Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With QIV-HD or QIV-SD
A1: Day 0
|
60.0 percentage of participants
Interval 45.9 to 73.0
|
65.5 percentage of participants
Interval 51.4 to 77.8
|
53.7 percentage of participants
Interval 39.6 to 67.4
|
|
Cohort 2: Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With QIV-HD or QIV-SD
A1-like: Day 0
|
58.2 percentage of participants
Interval 44.1 to 71.3
|
60.0 percentage of participants
Interval 45.9 to 73.0
|
54.7 percentage of participants
Interval 40.4 to 68.4
|
|
Cohort 2: Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With QIV-HD or QIV-SD
A2: Day 0
|
63.6 percentage of participants
Interval 49.6 to 76.2
|
83.6 percentage of participants
Interval 71.2 to 92.2
|
68.5 percentage of participants
Interval 54.4 to 80.5
|
|
Cohort 2: Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With QIV-HD or QIV-SD
A2-like: Day 0
|
65.5 percentage of participants
Interval 51.4 to 77.8
|
81.8 percentage of participants
Interval 69.1 to 90.9
|
70.4 percentage of participants
Interval 56.4 to 82.0
|
|
Cohort 2: Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With QIV-HD or QIV-SD
B1: Day 0
|
76.4 percentage of participants
Interval 63.0 to 86.8
|
87.3 percentage of participants
Interval 75.5 to 94.7
|
81.5 percentage of participants
Interval 68.6 to 90.7
|
|
Cohort 2: Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With QIV-HD or QIV-SD
B2: Day 0
|
67.3 percentage of participants
Interval 53.3 to 79.3
|
78.2 percentage of participants
Interval 65.0 to 88.2
|
79.6 percentage of participants
Interval 66.5 to 89.4
|
|
Cohort 2: Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With QIV-HD or QIV-SD
B2-like: Day 0
|
49.1 percentage of participants
Interval 35.4 to 62.9
|
52.7 percentage of participants
Interval 38.8 to 66.3
|
57.4 percentage of participants
Interval 43.2 to 70.8
|
|
Cohort 2: Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With QIV-HD or QIV-SD
A1: Day 28
|
98.2 percentage of participants
Interval 90.3 to 100.0
|
100 percentage of participants
Interval 93.5 to 100.0
|
92.6 percentage of participants
Interval 82.1 to 97.9
|
|
Cohort 2: Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With QIV-HD or QIV-SD
A1-like: Day 28
|
98.2 percentage of participants
Interval 90.3 to 100.0
|
100 percentage of participants
Interval 93.5 to 100.0
|
98.1 percentage of participants
Interval 90.1 to 100.0
|
|
Cohort 2: Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With QIV-HD or QIV-SD
A2: Day 28
|
100 percentage of participants
Interval 93.5 to 100.0
|
100 percentage of participants
Interval 93.5 to 100.0
|
96.3 percentage of participants
Interval 87.3 to 99.5
|
|
Cohort 2: Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With QIV-HD or QIV-SD
A2-like: day 28
|
100 percentage of participants
Interval 93.5 to 100.0
|
100 percentage of participants
Interval 93.5 to 100.0
|
96.2 percentage of participants
Interval 87.0 to 99.5
|
|
Cohort 2: Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With QIV-HD or QIV-SD
B1: Day 28
|
98.2 percentage of participants
Interval 90.3 to 100.0
|
100 percentage of participants
Interval 93.5 to 100.0
|
98.1 percentage of participants
Interval 90.1 to 100.0
|
|
Cohort 2: Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With QIV-HD or QIV-SD
B2: Day 28
|
98.2 percentage of participants
Interval 90.3 to 100.0
|
100 percentage of participants
Interval 93.5 to 100.0
|
98.1 percentage of participants
Interval 90.1 to 100.0
|
|
Cohort 2: Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With QIV-HD or QIV-SD
B2-like: Day 28
|
98.2 percentage of participants
Interval 90.3 to 100.0
|
100 percentage of participants
Interval 93.5 to 100.0
|
94.4 percentage of participants
Interval 84.6 to 98.8
|
Adverse Events
Cohort 1 and 2: QIV-HD by IM
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 1 and 2: QIV-HD by SC
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 2: QIV-SD by SC
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1 and 2: QIV-HD by IM
n=60 participants at risk
Participants were randomized to receive a single 0.7 mL injection of QIV-HD by IM route on Day 0.
|
Cohort 1 and 2: QIV-HD by SC
n=60 participants at risk
Participants were randomized to receive a single 0.7 mL injection of QIV-HD by SC route on Day 0.
|
Cohort 2: QIV-SD by SC
n=55 participants at risk
Participants were randomized to receive a single 0.5 mL injection of QIV-SD by SC route on Day 0.
|
|---|---|---|---|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.00%
0/60 • Adverse event (AE) data was collected from Day 0 (post-vaccination) up to Day 28 after vaccination. Solicited Reaction (SR) data were collected up to Day 7 after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 28 days after vaccination).
Analyzed on SafAS. SR: an AE prelisted in CRB and considered related to vaccination. SR was therefore an adverse reaction observed and reported under conditions (symptom and onset) prelisted in CRB. An unsolicited AE: an observed AE that did not fulfill conditions prelisted in CRB in terms of symptom and/or onset post-vaccination. AE data were planned to be collected and analyzed for the combined population of Cohort 1 and Cohort 2 participants who received QIV-HD (QIV-HD by IM and QIV-HD by SC)
|
0.00%
0/60 • Adverse event (AE) data was collected from Day 0 (post-vaccination) up to Day 28 after vaccination. Solicited Reaction (SR) data were collected up to Day 7 after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 28 days after vaccination).
Analyzed on SafAS. SR: an AE prelisted in CRB and considered related to vaccination. SR was therefore an adverse reaction observed and reported under conditions (symptom and onset) prelisted in CRB. An unsolicited AE: an observed AE that did not fulfill conditions prelisted in CRB in terms of symptom and/or onset post-vaccination. AE data were planned to be collected and analyzed for the combined population of Cohort 1 and Cohort 2 participants who received QIV-HD (QIV-HD by IM and QIV-HD by SC)
|
1.8%
1/55 • Adverse event (AE) data was collected from Day 0 (post-vaccination) up to Day 28 after vaccination. Solicited Reaction (SR) data were collected up to Day 7 after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 28 days after vaccination).
Analyzed on SafAS. SR: an AE prelisted in CRB and considered related to vaccination. SR was therefore an adverse reaction observed and reported under conditions (symptom and onset) prelisted in CRB. An unsolicited AE: an observed AE that did not fulfill conditions prelisted in CRB in terms of symptom and/or onset post-vaccination. AE data were planned to be collected and analyzed for the combined population of Cohort 1 and Cohort 2 participants who received QIV-HD (QIV-HD by IM and QIV-HD by SC)
|
Other adverse events
| Measure |
Cohort 1 and 2: QIV-HD by IM
n=60 participants at risk
Participants were randomized to receive a single 0.7 mL injection of QIV-HD by IM route on Day 0.
|
Cohort 1 and 2: QIV-HD by SC
n=60 participants at risk
Participants were randomized to receive a single 0.7 mL injection of QIV-HD by SC route on Day 0.
|
Cohort 2: QIV-SD by SC
n=55 participants at risk
Participants were randomized to receive a single 0.5 mL injection of QIV-SD by SC route on Day 0.
|
|---|---|---|---|
|
Infections and infestations
Cystitis
|
1.7%
1/60 • Adverse event (AE) data was collected from Day 0 (post-vaccination) up to Day 28 after vaccination. Solicited Reaction (SR) data were collected up to Day 7 after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 28 days after vaccination).
Analyzed on SafAS. SR: an AE prelisted in CRB and considered related to vaccination. SR was therefore an adverse reaction observed and reported under conditions (symptom and onset) prelisted in CRB. An unsolicited AE: an observed AE that did not fulfill conditions prelisted in CRB in terms of symptom and/or onset post-vaccination. AE data were planned to be collected and analyzed for the combined population of Cohort 1 and Cohort 2 participants who received QIV-HD (QIV-HD by IM and QIV-HD by SC)
|
0.00%
0/60 • Adverse event (AE) data was collected from Day 0 (post-vaccination) up to Day 28 after vaccination. Solicited Reaction (SR) data were collected up to Day 7 after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 28 days after vaccination).
Analyzed on SafAS. SR: an AE prelisted in CRB and considered related to vaccination. SR was therefore an adverse reaction observed and reported under conditions (symptom and onset) prelisted in CRB. An unsolicited AE: an observed AE that did not fulfill conditions prelisted in CRB in terms of symptom and/or onset post-vaccination. AE data were planned to be collected and analyzed for the combined population of Cohort 1 and Cohort 2 participants who received QIV-HD (QIV-HD by IM and QIV-HD by SC)
|
0.00%
0/55 • Adverse event (AE) data was collected from Day 0 (post-vaccination) up to Day 28 after vaccination. Solicited Reaction (SR) data were collected up to Day 7 after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 28 days after vaccination).
Analyzed on SafAS. SR: an AE prelisted in CRB and considered related to vaccination. SR was therefore an adverse reaction observed and reported under conditions (symptom and onset) prelisted in CRB. An unsolicited AE: an observed AE that did not fulfill conditions prelisted in CRB in terms of symptom and/or onset post-vaccination. AE data were planned to be collected and analyzed for the combined population of Cohort 1 and Cohort 2 participants who received QIV-HD (QIV-HD by IM and QIV-HD by SC)
|
|
Infections and infestations
Laryngitis
|
1.7%
1/60 • Adverse event (AE) data was collected from Day 0 (post-vaccination) up to Day 28 after vaccination. Solicited Reaction (SR) data were collected up to Day 7 after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 28 days after vaccination).
Analyzed on SafAS. SR: an AE prelisted in CRB and considered related to vaccination. SR was therefore an adverse reaction observed and reported under conditions (symptom and onset) prelisted in CRB. An unsolicited AE: an observed AE that did not fulfill conditions prelisted in CRB in terms of symptom and/or onset post-vaccination. AE data were planned to be collected and analyzed for the combined population of Cohort 1 and Cohort 2 participants who received QIV-HD (QIV-HD by IM and QIV-HD by SC)
|
0.00%
0/60 • Adverse event (AE) data was collected from Day 0 (post-vaccination) up to Day 28 after vaccination. Solicited Reaction (SR) data were collected up to Day 7 after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 28 days after vaccination).
Analyzed on SafAS. SR: an AE prelisted in CRB and considered related to vaccination. SR was therefore an adverse reaction observed and reported under conditions (symptom and onset) prelisted in CRB. An unsolicited AE: an observed AE that did not fulfill conditions prelisted in CRB in terms of symptom and/or onset post-vaccination. AE data were planned to be collected and analyzed for the combined population of Cohort 1 and Cohort 2 participants who received QIV-HD (QIV-HD by IM and QIV-HD by SC)
|
0.00%
0/55 • Adverse event (AE) data was collected from Day 0 (post-vaccination) up to Day 28 after vaccination. Solicited Reaction (SR) data were collected up to Day 7 after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 28 days after vaccination).
Analyzed on SafAS. SR: an AE prelisted in CRB and considered related to vaccination. SR was therefore an adverse reaction observed and reported under conditions (symptom and onset) prelisted in CRB. An unsolicited AE: an observed AE that did not fulfill conditions prelisted in CRB in terms of symptom and/or onset post-vaccination. AE data were planned to be collected and analyzed for the combined population of Cohort 1 and Cohort 2 participants who received QIV-HD (QIV-HD by IM and QIV-HD by SC)
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/60 • Adverse event (AE) data was collected from Day 0 (post-vaccination) up to Day 28 after vaccination. Solicited Reaction (SR) data were collected up to Day 7 after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 28 days after vaccination).
Analyzed on SafAS. SR: an AE prelisted in CRB and considered related to vaccination. SR was therefore an adverse reaction observed and reported under conditions (symptom and onset) prelisted in CRB. An unsolicited AE: an observed AE that did not fulfill conditions prelisted in CRB in terms of symptom and/or onset post-vaccination. AE data were planned to be collected and analyzed for the combined population of Cohort 1 and Cohort 2 participants who received QIV-HD (QIV-HD by IM and QIV-HD by SC)
|
3.3%
2/60 • Adverse event (AE) data was collected from Day 0 (post-vaccination) up to Day 28 after vaccination. Solicited Reaction (SR) data were collected up to Day 7 after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 28 days after vaccination).
Analyzed on SafAS. SR: an AE prelisted in CRB and considered related to vaccination. SR was therefore an adverse reaction observed and reported under conditions (symptom and onset) prelisted in CRB. An unsolicited AE: an observed AE that did not fulfill conditions prelisted in CRB in terms of symptom and/or onset post-vaccination. AE data were planned to be collected and analyzed for the combined population of Cohort 1 and Cohort 2 participants who received QIV-HD (QIV-HD by IM and QIV-HD by SC)
|
3.6%
2/55 • Adverse event (AE) data was collected from Day 0 (post-vaccination) up to Day 28 after vaccination. Solicited Reaction (SR) data were collected up to Day 7 after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 28 days after vaccination).
Analyzed on SafAS. SR: an AE prelisted in CRB and considered related to vaccination. SR was therefore an adverse reaction observed and reported under conditions (symptom and onset) prelisted in CRB. An unsolicited AE: an observed AE that did not fulfill conditions prelisted in CRB in terms of symptom and/or onset post-vaccination. AE data were planned to be collected and analyzed for the combined population of Cohort 1 and Cohort 2 participants who received QIV-HD (QIV-HD by IM and QIV-HD by SC)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
|
0.00%
0/60 • Adverse event (AE) data was collected from Day 0 (post-vaccination) up to Day 28 after vaccination. Solicited Reaction (SR) data were collected up to Day 7 after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 28 days after vaccination).
Analyzed on SafAS. SR: an AE prelisted in CRB and considered related to vaccination. SR was therefore an adverse reaction observed and reported under conditions (symptom and onset) prelisted in CRB. An unsolicited AE: an observed AE that did not fulfill conditions prelisted in CRB in terms of symptom and/or onset post-vaccination. AE data were planned to be collected and analyzed for the combined population of Cohort 1 and Cohort 2 participants who received QIV-HD (QIV-HD by IM and QIV-HD by SC)
|
0.00%
0/60 • Adverse event (AE) data was collected from Day 0 (post-vaccination) up to Day 28 after vaccination. Solicited Reaction (SR) data were collected up to Day 7 after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 28 days after vaccination).
Analyzed on SafAS. SR: an AE prelisted in CRB and considered related to vaccination. SR was therefore an adverse reaction observed and reported under conditions (symptom and onset) prelisted in CRB. An unsolicited AE: an observed AE that did not fulfill conditions prelisted in CRB in terms of symptom and/or onset post-vaccination. AE data were planned to be collected and analyzed for the combined population of Cohort 1 and Cohort 2 participants who received QIV-HD (QIV-HD by IM and QIV-HD by SC)
|
1.8%
1/55 • Adverse event (AE) data was collected from Day 0 (post-vaccination) up to Day 28 after vaccination. Solicited Reaction (SR) data were collected up to Day 7 after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 28 days after vaccination).
Analyzed on SafAS. SR: an AE prelisted in CRB and considered related to vaccination. SR was therefore an adverse reaction observed and reported under conditions (symptom and onset) prelisted in CRB. An unsolicited AE: an observed AE that did not fulfill conditions prelisted in CRB in terms of symptom and/or onset post-vaccination. AE data were planned to be collected and analyzed for the combined population of Cohort 1 and Cohort 2 participants who received QIV-HD (QIV-HD by IM and QIV-HD by SC)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/60 • Adverse event (AE) data was collected from Day 0 (post-vaccination) up to Day 28 after vaccination. Solicited Reaction (SR) data were collected up to Day 7 after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 28 days after vaccination).
Analyzed on SafAS. SR: an AE prelisted in CRB and considered related to vaccination. SR was therefore an adverse reaction observed and reported under conditions (symptom and onset) prelisted in CRB. An unsolicited AE: an observed AE that did not fulfill conditions prelisted in CRB in terms of symptom and/or onset post-vaccination. AE data were planned to be collected and analyzed for the combined population of Cohort 1 and Cohort 2 participants who received QIV-HD (QIV-HD by IM and QIV-HD by SC)
|
0.00%
0/60 • Adverse event (AE) data was collected from Day 0 (post-vaccination) up to Day 28 after vaccination. Solicited Reaction (SR) data were collected up to Day 7 after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 28 days after vaccination).
Analyzed on SafAS. SR: an AE prelisted in CRB and considered related to vaccination. SR was therefore an adverse reaction observed and reported under conditions (symptom and onset) prelisted in CRB. An unsolicited AE: an observed AE that did not fulfill conditions prelisted in CRB in terms of symptom and/or onset post-vaccination. AE data were planned to be collected and analyzed for the combined population of Cohort 1 and Cohort 2 participants who received QIV-HD (QIV-HD by IM and QIV-HD by SC)
|
3.6%
2/55 • Adverse event (AE) data was collected from Day 0 (post-vaccination) up to Day 28 after vaccination. Solicited Reaction (SR) data were collected up to Day 7 after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 28 days after vaccination).
Analyzed on SafAS. SR: an AE prelisted in CRB and considered related to vaccination. SR was therefore an adverse reaction observed and reported under conditions (symptom and onset) prelisted in CRB. An unsolicited AE: an observed AE that did not fulfill conditions prelisted in CRB in terms of symptom and/or onset post-vaccination. AE data were planned to be collected and analyzed for the combined population of Cohort 1 and Cohort 2 participants who received QIV-HD (QIV-HD by IM and QIV-HD by SC)
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/60 • Adverse event (AE) data was collected from Day 0 (post-vaccination) up to Day 28 after vaccination. Solicited Reaction (SR) data were collected up to Day 7 after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 28 days after vaccination).
Analyzed on SafAS. SR: an AE prelisted in CRB and considered related to vaccination. SR was therefore an adverse reaction observed and reported under conditions (symptom and onset) prelisted in CRB. An unsolicited AE: an observed AE that did not fulfill conditions prelisted in CRB in terms of symptom and/or onset post-vaccination. AE data were planned to be collected and analyzed for the combined population of Cohort 1 and Cohort 2 participants who received QIV-HD (QIV-HD by IM and QIV-HD by SC)
|
0.00%
0/60 • Adverse event (AE) data was collected from Day 0 (post-vaccination) up to Day 28 after vaccination. Solicited Reaction (SR) data were collected up to Day 7 after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 28 days after vaccination).
Analyzed on SafAS. SR: an AE prelisted in CRB and considered related to vaccination. SR was therefore an adverse reaction observed and reported under conditions (symptom and onset) prelisted in CRB. An unsolicited AE: an observed AE that did not fulfill conditions prelisted in CRB in terms of symptom and/or onset post-vaccination. AE data were planned to be collected and analyzed for the combined population of Cohort 1 and Cohort 2 participants who received QIV-HD (QIV-HD by IM and QIV-HD by SC)
|
1.8%
1/55 • Adverse event (AE) data was collected from Day 0 (post-vaccination) up to Day 28 after vaccination. Solicited Reaction (SR) data were collected up to Day 7 after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 28 days after vaccination).
Analyzed on SafAS. SR: an AE prelisted in CRB and considered related to vaccination. SR was therefore an adverse reaction observed and reported under conditions (symptom and onset) prelisted in CRB. An unsolicited AE: an observed AE that did not fulfill conditions prelisted in CRB in terms of symptom and/or onset post-vaccination. AE data were planned to be collected and analyzed for the combined population of Cohort 1 and Cohort 2 participants who received QIV-HD (QIV-HD by IM and QIV-HD by SC)
|
|
Gastrointestinal disorders
Faeces soft
|
0.00%
0/60 • Adverse event (AE) data was collected from Day 0 (post-vaccination) up to Day 28 after vaccination. Solicited Reaction (SR) data were collected up to Day 7 after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 28 days after vaccination).
Analyzed on SafAS. SR: an AE prelisted in CRB and considered related to vaccination. SR was therefore an adverse reaction observed and reported under conditions (symptom and onset) prelisted in CRB. An unsolicited AE: an observed AE that did not fulfill conditions prelisted in CRB in terms of symptom and/or onset post-vaccination. AE data were planned to be collected and analyzed for the combined population of Cohort 1 and Cohort 2 participants who received QIV-HD (QIV-HD by IM and QIV-HD by SC)
|
0.00%
0/60 • Adverse event (AE) data was collected from Day 0 (post-vaccination) up to Day 28 after vaccination. Solicited Reaction (SR) data were collected up to Day 7 after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 28 days after vaccination).
Analyzed on SafAS. SR: an AE prelisted in CRB and considered related to vaccination. SR was therefore an adverse reaction observed and reported under conditions (symptom and onset) prelisted in CRB. An unsolicited AE: an observed AE that did not fulfill conditions prelisted in CRB in terms of symptom and/or onset post-vaccination. AE data were planned to be collected and analyzed for the combined population of Cohort 1 and Cohort 2 participants who received QIV-HD (QIV-HD by IM and QIV-HD by SC)
|
1.8%
1/55 • Adverse event (AE) data was collected from Day 0 (post-vaccination) up to Day 28 after vaccination. Solicited Reaction (SR) data were collected up to Day 7 after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 28 days after vaccination).
Analyzed on SafAS. SR: an AE prelisted in CRB and considered related to vaccination. SR was therefore an adverse reaction observed and reported under conditions (symptom and onset) prelisted in CRB. An unsolicited AE: an observed AE that did not fulfill conditions prelisted in CRB in terms of symptom and/or onset post-vaccination. AE data were planned to be collected and analyzed for the combined population of Cohort 1 and Cohort 2 participants who received QIV-HD (QIV-HD by IM and QIV-HD by SC)
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.7%
1/60 • Adverse event (AE) data was collected from Day 0 (post-vaccination) up to Day 28 after vaccination. Solicited Reaction (SR) data were collected up to Day 7 after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 28 days after vaccination).
Analyzed on SafAS. SR: an AE prelisted in CRB and considered related to vaccination. SR was therefore an adverse reaction observed and reported under conditions (symptom and onset) prelisted in CRB. An unsolicited AE: an observed AE that did not fulfill conditions prelisted in CRB in terms of symptom and/or onset post-vaccination. AE data were planned to be collected and analyzed for the combined population of Cohort 1 and Cohort 2 participants who received QIV-HD (QIV-HD by IM and QIV-HD by SC)
|
0.00%
0/60 • Adverse event (AE) data was collected from Day 0 (post-vaccination) up to Day 28 after vaccination. Solicited Reaction (SR) data were collected up to Day 7 after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 28 days after vaccination).
Analyzed on SafAS. SR: an AE prelisted in CRB and considered related to vaccination. SR was therefore an adverse reaction observed and reported under conditions (symptom and onset) prelisted in CRB. An unsolicited AE: an observed AE that did not fulfill conditions prelisted in CRB in terms of symptom and/or onset post-vaccination. AE data were planned to be collected and analyzed for the combined population of Cohort 1 and Cohort 2 participants who received QIV-HD (QIV-HD by IM and QIV-HD by SC)
|
0.00%
0/55 • Adverse event (AE) data was collected from Day 0 (post-vaccination) up to Day 28 after vaccination. Solicited Reaction (SR) data were collected up to Day 7 after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 28 days after vaccination).
Analyzed on SafAS. SR: an AE prelisted in CRB and considered related to vaccination. SR was therefore an adverse reaction observed and reported under conditions (symptom and onset) prelisted in CRB. An unsolicited AE: an observed AE that did not fulfill conditions prelisted in CRB in terms of symptom and/or onset post-vaccination. AE data were planned to be collected and analyzed for the combined population of Cohort 1 and Cohort 2 participants who received QIV-HD (QIV-HD by IM and QIV-HD by SC)
|
|
General disorders
Injection site pruritus
|
1.7%
1/60 • Adverse event (AE) data was collected from Day 0 (post-vaccination) up to Day 28 after vaccination. Solicited Reaction (SR) data were collected up to Day 7 after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 28 days after vaccination).
Analyzed on SafAS. SR: an AE prelisted in CRB and considered related to vaccination. SR was therefore an adverse reaction observed and reported under conditions (symptom and onset) prelisted in CRB. An unsolicited AE: an observed AE that did not fulfill conditions prelisted in CRB in terms of symptom and/or onset post-vaccination. AE data were planned to be collected and analyzed for the combined population of Cohort 1 and Cohort 2 participants who received QIV-HD (QIV-HD by IM and QIV-HD by SC)
|
5.0%
3/60 • Adverse event (AE) data was collected from Day 0 (post-vaccination) up to Day 28 after vaccination. Solicited Reaction (SR) data were collected up to Day 7 after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 28 days after vaccination).
Analyzed on SafAS. SR: an AE prelisted in CRB and considered related to vaccination. SR was therefore an adverse reaction observed and reported under conditions (symptom and onset) prelisted in CRB. An unsolicited AE: an observed AE that did not fulfill conditions prelisted in CRB in terms of symptom and/or onset post-vaccination. AE data were planned to be collected and analyzed for the combined population of Cohort 1 and Cohort 2 participants who received QIV-HD (QIV-HD by IM and QIV-HD by SC)
|
1.8%
1/55 • Adverse event (AE) data was collected from Day 0 (post-vaccination) up to Day 28 after vaccination. Solicited Reaction (SR) data were collected up to Day 7 after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 28 days after vaccination).
Analyzed on SafAS. SR: an AE prelisted in CRB and considered related to vaccination. SR was therefore an adverse reaction observed and reported under conditions (symptom and onset) prelisted in CRB. An unsolicited AE: an observed AE that did not fulfill conditions prelisted in CRB in terms of symptom and/or onset post-vaccination. AE data were planned to be collected and analyzed for the combined population of Cohort 1 and Cohort 2 participants who received QIV-HD (QIV-HD by IM and QIV-HD by SC)
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
- Publication restrictions are in place
Restriction type: OTHER