Trial Outcomes & Findings for High vs. Standard Dose Flu Vaccine in Adult Stem Cell Transplant Recipients (NCT NCT03179761)
NCT ID: NCT03179761
Last Updated: 2024-12-04
Results Overview
Point estimates and 95% confidence intervals for proportion of subjects achieving seroprotection (≥1:40 HAI titer) and seroconversion (4-fold or greater rise in HAI titers from visit 1) for Influenza A antigens.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
124 participants
Primary outcome timeframe
Visit 1 titers (baseline) were measured on day 0; visit 2 titers were measured 28-42 days after visit 1; visit 3 titers were measured 28-42 days after visit 2; and visit 4 titers were measured 138-222 days after visit 2.
Results posted on
2024-12-04
Participant Flow
A total of 138 adults were targeted with the expectation of a 20% drop out rate, as described in Section C17 in the protocol. We were able to enroll 124 subjects with a 15% dropout rate between Visit 1 and Visit 4.
Participant milestones
| Measure |
Group I (HD-TIV)
Patients received HD-TIV intramuscularly once at baseline (day 0) and again between 28-42 days later.
Trivalent Influenza Vaccine: High Dose Trivalent Influenza Vaccine given intramuscularly
Laboratory Biomarker Analysis: Correlative studies
|
Group 2 (SD-QIV)
Patients received SD-QIV intramuscularly once at baseline (day 0) and again between 28-42 days later.
Quadrivalent Inactivated Influenza Vaccine: Standard Dose Quadrivalent Influenza Vaccine given intramuscularly
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
64
|
|
Overall Study
Visit 1
|
60
|
64
|
|
Overall Study
Visit 2
|
59
|
59
|
|
Overall Study
Visit 3
|
59
|
59
|
|
Overall Study
Visit 4
|
54
|
51
|
|
Overall Study
Visit 1 Repeat
|
23
|
20
|
|
Overall Study
Visit 2 Repeat
|
21
|
20
|
|
Overall Study
Visit 3 Repeat
|
19
|
20
|
|
Overall Study
Visit 4 Repeat
|
12
|
12
|
|
Overall Study
COMPLETED
|
54
|
51
|
|
Overall Study
NOT COMPLETED
|
6
|
13
|
Reasons for withdrawal
| Measure |
Group I (HD-TIV)
Patients received HD-TIV intramuscularly once at baseline (day 0) and again between 28-42 days later.
Trivalent Influenza Vaccine: High Dose Trivalent Influenza Vaccine given intramuscularly
Laboratory Biomarker Analysis: Correlative studies
|
Group 2 (SD-QIV)
Patients received SD-QIV intramuscularly once at baseline (day 0) and again between 28-42 days later.
Quadrivalent Inactivated Influenza Vaccine: Standard Dose Quadrivalent Influenza Vaccine given intramuscularly
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|---|
|
Overall Study
Death
|
2
|
5
|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
4
|
|
Overall Study
Investigator Request
|
0
|
2
|
Baseline Characteristics
High vs. Standard Dose Flu Vaccine in Adult Stem Cell Transplant Recipients
Baseline characteristics by cohort
| Measure |
Group I (HD-TIV)
n=60 Participants
Patients received HD-TIV intramuscularly once at baseline (day 0) and again between 28-42 days later.
Trivalent Influenza Vaccine: High Dose Trivalent Influenza Vaccine given intramuscularly
Laboratory Biomarker Analysis: Correlative studies
|
Group 2 (SD-QIV)
n=64 Participants
Patients received SD-QIV intramuscularly once at baseline (day 0) and again between 28-42 days later.
Quadrivalent Inactivated Influenza Vaccine: Standard Dose Quadrivalent Influenza Vaccine given intramuscularly
Laboratory Biomarker Analysis: Correlative studies
|
Total
n=124 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
|
|
Age, Categorical
Between 18 and 65 years
|
53 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Age, Continuous
|
52.657 years
n=5 Participants
|
59.986 years
n=7 Participants
|
57.815 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
58 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
51 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
111 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
60 participants
n=5 Participants
|
64 participants
n=7 Participants
|
124 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Visit 1 titers (baseline) were measured on day 0; visit 2 titers were measured 28-42 days after visit 1; visit 3 titers were measured 28-42 days after visit 2; and visit 4 titers were measured 138-222 days after visit 2.Population: The number analyzed for each row represents the number of participants that completed the indicated visit and had a recorded HAI titer for the indicated antigen and visit.
Point estimates and 95% confidence intervals for proportion of subjects achieving seroprotection (≥1:40 HAI titer) and seroconversion (4-fold or greater rise in HAI titers from visit 1) for Influenza A antigens.
Outcome measures
| Measure |
Group I (HD-TIV)
n=60 Participants
Patients received HD-TIV intramuscularly once at baseline (day 0) and again between 28-42 days later.
Trivalent Influenza Vaccine: High Dose Trivalent Influenza Vaccine given intramuscularly
Laboratory Biomarker Analysis: Correlative studies
|
Group 2 (SD-QIV)
n=64 Participants
Patients received SD-QIV intramuscularly once at baseline (day 0) and again between 28-42 days later.
Quadrivalent Inactivated Influenza Vaccine: Standard Dose Quadrivalent Influenza Vaccine given intramuscularly
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|---|
|
HD-TIV Compared With SD-QIV (Influenza A) - Immunogenicity
A/H1N1 Visit 2 GMT ≥1:40
|
0.62 proportion of participants
Interval 0.49 to 0.73
|
0.59 proportion of participants
Interval 0.46 to 0.7
|
|
HD-TIV Compared With SD-QIV (Influenza A) - Immunogenicity
A/H1N1 Visit 2 GMFR ≥ 4-Fold Rise
|
0.23 proportion of participants
Interval 0.14 to 0.35
|
0.25 proportion of participants
Interval 0.16 to 0.37
|
|
HD-TIV Compared With SD-QIV (Influenza A) - Immunogenicity
A/H1N1 Visit 3 GMT ≥1:40
|
0.75 proportion of participants
Interval 0.63 to 0.84
|
0.73 proportion of participants
Interval 0.61 to 0.84
|
|
HD-TIV Compared With SD-QIV (Influenza A) - Immunogenicity
A/H1N1 Visit 4 GMT ≥1:40
|
0.66 proportion of participants
Interval 0.53 to 0.78
|
0.65 proportion of participants
Interval 0.51 to 0.78
|
|
HD-TIV Compared With SD-QIV (Influenza A) - Immunogenicity
A/H1N1 Visit 4 GMFR ≥ 4-Fold Rise
|
0.34 proportion of participants
Interval 0.22 to 0.47
|
0.35 proportion of participants
Interval 0.22 to 0.49
|
|
HD-TIV Compared With SD-QIV (Influenza A) - Immunogenicity
A/H3N2 Visit 2 GMT ≥1:40
|
0.65 proportion of participants
Interval 0.52 to 0.76
|
0.60 proportion of participants
Interval 0.48 to 0.72
|
|
HD-TIV Compared With SD-QIV (Influenza A) - Immunogenicity
A/H3N2 Visit 2 GMFR ≥ 4-Fold Rise
|
0.32 proportion of participants
Interval 0.21 to 0.44
|
0.19 proportion of participants
Interval 0.11 to 0.3
|
|
HD-TIV Compared With SD-QIV (Influenza A) - Immunogenicity
A/H3N2 Visit 3 GMT ≥1:40
|
0.78 proportion of participants
Interval 0.66 to 0.87
|
0.73 proportion of participants
Interval 0.61 to 0.84
|
|
HD-TIV Compared With SD-QIV (Influenza A) - Immunogenicity
A/H3N2 Visit 3 GMFR ≥ 4-Fold Rise
|
0.49 proportion of participants
Interval 0.37 to 0.62
|
0.38 proportion of participants
Interval 0.26 to 0.51
|
|
HD-TIV Compared With SD-QIV (Influenza A) - Immunogenicity
A/H3N2 Visit 4 GMT ≥1:40
|
0.66 proportion of participants
Interval 0.53 to 0.78
|
0.49 proportion of participants
Interval 0.35 to 0.63
|
|
HD-TIV Compared With SD-QIV (Influenza A) - Immunogenicity
A/H3N2 Visit 4 GMFR ≥ 4-Fold Rise
|
0.40 proportion of participants
Interval 0.27 to 0.53
|
0.27 proportion of participants
Interval 0.16 to 0.4
|
|
HD-TIV Compared With SD-QIV (Influenza A) - Immunogenicity
A/H1N1 Visit 3 GMFR ≥ 4-Fold Rise
|
0.41 proportion of participants
Interval 0.29 to 0.53
|
0.39 proportion of participants
Interval 0.27 to 0.52
|
SECONDARY outcome
Timeframe: Visit 1 titers (baseline) were measured on day 0; visit 2 titers were measured 28-42 days after visit 1; visit 3 titers were measured 28-42 days after visit 2; and visit 4 titers were measured 138-222 days after visit 2.Population: The number analyzed for each row represents the number of participants that completed the indicated visit and had a recorded HAI titer for the indicated antigen and visit.
Point estimates and 95% confidence intervals for proportion of subjects achieving seroprotection (≥1:40 HAI titer) and seroconversion (4-fold or greater rise in HAI titers from visit 1) for Influenza B antigens.
Outcome measures
| Measure |
Group I (HD-TIV)
n=60 Participants
Patients received HD-TIV intramuscularly once at baseline (day 0) and again between 28-42 days later.
Trivalent Influenza Vaccine: High Dose Trivalent Influenza Vaccine given intramuscularly
Laboratory Biomarker Analysis: Correlative studies
|
Group 2 (SD-QIV)
n=64 Participants
Patients received SD-QIV intramuscularly once at baseline (day 0) and again between 28-42 days later.
Quadrivalent Inactivated Influenza Vaccine: Standard Dose Quadrivalent Influenza Vaccine given intramuscularly
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|---|
|
HD-TIV Compared With SD-QIV (Influenza B) - Immunogenicity
B/Victoria Visit 2 GMT ≥1:40
|
0.73 proportion of participants
Interval 0.61 to 0.83
|
0.79 proportion of participants
Interval 0.68 to 0.88
|
|
HD-TIV Compared With SD-QIV (Influenza B) - Immunogenicity
B/Victoria Visit 2 GMFR ≥ 4-Fold Rise
|
0.25 proportion of participants
Interval 0.15 to 0.37
|
0.17 proportion of participants
Interval 0.09 to 0.28
|
|
HD-TIV Compared With SD-QIV (Influenza B) - Immunogenicity
B/Victoria Visit 3 GMT ≥1:40
|
0.92 proportion of participants
Interval 0.83 to 0.97
|
0.86 proportion of participants
Interval 0.75 to 0.93
|
|
HD-TIV Compared With SD-QIV (Influenza B) - Immunogenicity
B/Victoria Visit 3 GMFR ≥ 4-Fold Rise
|
0.44 proportion of participants
Interval 0.32 to 0.57
|
0.29 proportion of participants
Interval 0.18 to 0.41
|
|
HD-TIV Compared With SD-QIV (Influenza B) - Immunogenicity
B/Victoria Visit 4 GMT ≥1:40
|
0.83 proportion of participants
Interval 0.71 to 0.91
|
0.73 proportion of participants
Interval 0.6 to 0.84
|
|
HD-TIV Compared With SD-QIV (Influenza B) - Immunogenicity
B/Victoria Visit 4 GMFR ≥ 4-Fold Rise
|
0.34 proportion of participants
Interval 0.22 to 0.47
|
0.18 proportion of participants
Interval 0.09 to 0.31
|
|
HD-TIV Compared With SD-QIV (Influenza B) - Immunogenicity
B/Yamagata Visit 2 GMFR ≥ 4-Fold Rise
|
0.07 proportion of participants
Interval 0.02 to 0.15
|
0.22 proportion of participants
Interval 0.13 to 0.33
|
|
HD-TIV Compared With SD-QIV (Influenza B) - Immunogenicity
B/Yamagata Visit 3 GMT ≥1:40
|
0.80 proportion of participants
Interval 0.68 to 0.89
|
0.88 proportion of participants
Interval 0.77 to 0.94
|
|
HD-TIV Compared With SD-QIV (Influenza B) - Immunogenicity
B/Yamagata Visit 3 GMFR ≥ 4-Fold Rise
|
0.10 proportion of participants
Interval 0.04 to 0.2
|
0.27 proportion of participants
Interval 0.16 to 0.39
|
|
HD-TIV Compared With SD-QIV (Influenza B) - Immunogenicity
B/Yamagata Visit 4 GMT ≥1:40
|
0.64 proportion of participants
Interval 0.51 to 0.76
|
0.84 proportion of participants
Interval 0.72 to 0.92
|
|
HD-TIV Compared With SD-QIV (Influenza B) - Immunogenicity
B/Yamagata Visit 4 GMFR ≥ 4-Fold Rise
|
0.09 proportion of participants
Interval 0.03 to 0.19
|
0.22 proportion of participants
Interval 0.12 to 0.35
|
|
HD-TIV Compared With SD-QIV (Influenza B) - Immunogenicity
B/Yamagata Visit 2 GMT ≥1:40
|
0.72 proportion of participants
Interval 0.6 to 0.82
|
0.87 proportion of participants
Interval 0.78 to 0.94
|
SECONDARY outcome
Timeframe: Adverse events were recorded for 7 days following each vaccination or until resolution, up to study conclusion.Population: The number of subjects analyzed for Vaccine 1 represents the number of subjects who attended Visit 1 and received the first vaccine. The number of subjects analyzed for Vaccine 2 represents the number of subjects who attended Visit 2 and received the second vaccine.
The proportion of subjects in each group experiencing at least one solicited AE with 95% posterior credible intervals, separated by vaccine number and adverse event type. AEs were assessed by clinicians using Tables 4 and 5 within section C16 of the protocol. Solicited injection site AEs included: pain, tenderness, erythema/redness, and swelling/induration. The diameter of any erythema/redness and swelling/induration was measured to evaluate "redness size" and "swelling size."
Outcome measures
| Measure |
Group I (HD-TIV)
n=60 Participants
Patients received HD-TIV intramuscularly once at baseline (day 0) and again between 28-42 days later.
Trivalent Influenza Vaccine: High Dose Trivalent Influenza Vaccine given intramuscularly
Laboratory Biomarker Analysis: Correlative studies
|
Group 2 (SD-QIV)
n=64 Participants
Patients received SD-QIV intramuscularly once at baseline (day 0) and again between 28-42 days later.
Quadrivalent Inactivated Influenza Vaccine: Standard Dose Quadrivalent Influenza Vaccine given intramuscularly
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|---|
|
Solicited Local Injection Site Adverse Events
Vaccine 1 - Pain
|
0.250 proportion of participants
Interval 0.147 to 0.379
|
0.156 proportion of participants
Interval 0.078 to 0.269
|
|
Solicited Local Injection Site Adverse Events
Vaccine 2 - Pain
|
0.254 proportion of participants
Interval 0.15 to 0.384
|
0.169 proportion of participants
Interval 0.084 to 0.29
|
|
Solicited Local Injection Site Adverse Events
Vaccine 2 - Tenderness
|
0.458 proportion of participants
Interval 0.327 to 0.592
|
0.288 proportion of participants
Interval 0.178 to 0.421
|
|
Solicited Local Injection Site Adverse Events
Vaccine 2 - Redness size
|
0.102 proportion of participants
Interval 0.038 to 0.208
|
0.000 proportion of participants
Interval 0.0 to 0.061
|
|
Solicited Local Injection Site Adverse Events
Vaccine 1 - Swelling
|
0.117 proportion of participants
Interval 0.048 to 0.226
|
0.094 proportion of participants
Interval 0.035 to 0.193
|
|
Solicited Local Injection Site Adverse Events
Vaccine 1 - Swelling size
|
0.100 proportion of participants
Interval 0.038 to 0.205
|
0.063 proportion of participants
Interval 0.017 to 0.152
|
|
Solicited Local Injection Site Adverse Events
Vaccine 2 - Swelling
|
0.136 proportion of participants
Interval 0.06 to 0.25
|
0.102 proportion of participants
Interval 0.038 to 0.208
|
|
Solicited Local Injection Site Adverse Events
Vaccine 2 - Swelling size
|
0.119 proportion of participants
Interval 0.049 to 0.229
|
0.034 proportion of participants
Interval 0.004 to 0.117
|
|
Solicited Local Injection Site Adverse Events
Vaccine 1 - Tenderness
|
0.383 proportion of participants
Interval 0.261 to 0.518
|
0.297 proportion of participants
Interval 0.189 to 0.424
|
|
Solicited Local Injection Site Adverse Events
Vaccine 1 - Redness size
|
0.067 proportion of participants
Interval 0.018 to 0.162
|
0.047 proportion of participants
Interval 0.01 to 0.131
|
SECONDARY outcome
Timeframe: Adverse events were recorded for 7 days following each vaccination or until resolution, up to study conclusion.Population: The number of subjects analyzed for Vaccine 1 represents the number of subjects who attended Visit 1 and received the first vaccine. The number of subjects analyzed for Vaccine 2 represents the number of subjects who attended Visit 2 and received the second vaccine.
The proportion of subjects in each group experiencing at least one solicited AE with 95% posterior credible intervals, separated by vaccine number and adverse event type. AEs were assessed by clinicians using Tables 4 and 5 within section C16 of the protocol. Solicited systemic AEs included: fevers, fatigue/malaise, headache, nausea, body ache/myalgia, generally activity, and vomiting.
Outcome measures
| Measure |
Group I (HD-TIV)
n=60 Participants
Patients received HD-TIV intramuscularly once at baseline (day 0) and again between 28-42 days later.
Trivalent Influenza Vaccine: High Dose Trivalent Influenza Vaccine given intramuscularly
Laboratory Biomarker Analysis: Correlative studies
|
Group 2 (SD-QIV)
n=64 Participants
Patients received SD-QIV intramuscularly once at baseline (day 0) and again between 28-42 days later.
Quadrivalent Inactivated Influenza Vaccine: Standard Dose Quadrivalent Influenza Vaccine given intramuscularly
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|---|
|
Solicited Systemic Adverse Events
Vaccine 1 - Nausea
|
0.083 proportion of participants
Interval 0.028 to 0.184
|
0.172 proportion of participants
Interval 0.089 to 0.287
|
|
Solicited Systemic Adverse Events
Vaccine 1 - Myalgia
|
0.200 proportion of participants
Interval 0.108 to 0.323
|
0.172 proportion of participants
Interval 0.089 to 0.287
|
|
Solicited Systemic Adverse Events
Vaccine 1 - General Activity
|
0.300 proportion of participants
Interval 0.188 to 0.432
|
0.297 proportion of participants
Interval 0.189 to 0.424
|
|
Solicited Systemic Adverse Events
Vaccine 1 - Vomiting
|
0.017 proportion of participants
Interval 0.0 to 0.089
|
0.063 proportion of participants
Interval 0.017 to 0.152
|
|
Solicited Systemic Adverse Events
Vaccine 2 - Fever
|
0.034 proportion of participants
Interval 0.004 to 0.117
|
0.068 proportion of participants
Interval 0.019 to 0.165
|
|
Solicited Systemic Adverse Events
Vaccine 2 - Fatigue
|
0.254 proportion of participants
Interval 0.15 to 0.384
|
0.254 proportion of participants
Interval 0.15 to 0.384
|
|
Solicited Systemic Adverse Events
Vaccine 2 - Headache
|
0.203 proportion of participants
Interval 0.11 to 0.328
|
0.203 proportion of participants
Interval 0.11 to 0.328
|
|
Solicited Systemic Adverse Events
Vaccine 2 - Nausea
|
0.119 proportion of participants
Interval 0.049 to 0.229
|
0.186 proportion of participants
Interval 0.097 to 0.309
|
|
Solicited Systemic Adverse Events
Vaccine 2 - Myalgia
|
0.153 proportion of participants
Interval 0.072 to 0.27
|
0.153 proportion of participants
Interval 0.072 to 0.27
|
|
Solicited Systemic Adverse Events
Vaccine 2 - General Activity
|
0.305 proportion of participants
Interval 0.192 to 0.439
|
0.220 proportion of participants
Interval 0.123 to 0.347
|
|
Solicited Systemic Adverse Events
Vaccine 2 - Vomiting
|
0.000 proportion of participants
Interval 0.0 to 0.061
|
0.017 proportion of participants
Interval 0.0 to 0.091
|
|
Solicited Systemic Adverse Events
Vaccine 1 - Fever
|
0.033 proportion of participants
Interval 0.004 to 0.115
|
0.031 proportion of participants
Interval 0.004 to 0.108
|
|
Solicited Systemic Adverse Events
Vaccine 1 - Fatigue
|
0.350 proportion of participants
Interval 0.231 to 0.484
|
0.313 proportion of participants
Interval 0.202 to 0.441
|
|
Solicited Systemic Adverse Events
Vaccine 1 - Headache
|
0.267 proportion of participants
Interval 0.161 to 0.397
|
0.188 proportion of participants
Interval 0.101 to 0.305
|
SECONDARY outcome
Timeframe: Nasal swabs were collected at each study visit or within 48 hours if a subject presented with influenza-like symptoms throughout the duration of the study.The percentage of breakthrough flu in vaccinated participants, separated by treatment group.
Outcome measures
| Measure |
Group I (HD-TIV)
n=60 Participants
Patients received HD-TIV intramuscularly once at baseline (day 0) and again between 28-42 days later.
Trivalent Influenza Vaccine: High Dose Trivalent Influenza Vaccine given intramuscularly
Laboratory Biomarker Analysis: Correlative studies
|
Group 2 (SD-QIV)
n=64 Participants
Patients received SD-QIV intramuscularly once at baseline (day 0) and again between 28-42 days later.
Quadrivalent Inactivated Influenza Vaccine: Standard Dose Quadrivalent Influenza Vaccine given intramuscularly
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|---|
|
Percentage of Individuals in Each Group That Test Positive for Influenza by PCR
|
5 Participants
|
2 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Visit 1 cell counts (baseline) were measured on day 0; visit 2 cell counts were measured 28-42 days after visit 1; visit 3 cell counts were measured 28-42 days after visit 2; and visit 4 cell counts were measured 138-222 days after visit 2.The total number of B cells will be measured prior to each vaccination and compared to each group.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Visit 1 cell counts (baseline) were measured on day 0; visit 2 cell counts were measured 28-42 days after visit 1; visit 3 cell counts were measured 28-42 days after visit 2; and visit 4 cell counts were measured 138-222 days after visit 2.The total number of T cells will be measured prior to each vaccination and compared to each group.
Outcome measures
Outcome data not reported
Adverse Events
Group I (HD-TIV)
Serious events: 4 serious events
Other events: 45 other events
Deaths: 2 deaths
Group 2 (SD-QIV)
Serious events: 0 serious events
Other events: 45 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Group I (HD-TIV)
n=60 participants at risk
Patients received HD-TIV intramuscularly once at baseline (day 0) and again between 28-42 days later.
Trivalent Influenza Vaccine: High Dose Trivalent Influenza Vaccine given intramuscularly
Laboratory Biomarker Analysis: Correlative studies
|
Group 2 (SD-QIV)
n=64 participants at risk
Patients received SD-QIV intramuscularly once at baseline (day 0) and again between 28-42 days later.
Quadrivalent Inactivated Influenza Vaccine: Standard Dose Quadrivalent Influenza Vaccine given intramuscularly
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
1.7%
1/60 • Number of events 1 • AEs and SAEs were collected for 7 days following each vaccination (up to day 7 for vaccine 1 and up to day 35-49 for vaccine 2). Events were followed until resolution, up to study conclusion.
|
0.00%
0/64 • AEs and SAEs were collected for 7 days following each vaccination (up to day 7 for vaccine 1 and up to day 35-49 for vaccine 2). Events were followed until resolution, up to study conclusion.
|
|
Gastrointestinal disorders
Diarrhea
|
1.7%
1/60 • Number of events 1 • AEs and SAEs were collected for 7 days following each vaccination (up to day 7 for vaccine 1 and up to day 35-49 for vaccine 2). Events were followed until resolution, up to study conclusion.
|
0.00%
0/64 • AEs and SAEs were collected for 7 days following each vaccination (up to day 7 for vaccine 1 and up to day 35-49 for vaccine 2). Events were followed until resolution, up to study conclusion.
|
|
Cardiac disorders
Atrial fibrillation
|
1.7%
1/60 • Number of events 1 • AEs and SAEs were collected for 7 days following each vaccination (up to day 7 for vaccine 1 and up to day 35-49 for vaccine 2). Events were followed until resolution, up to study conclusion.
|
0.00%
0/64 • AEs and SAEs were collected for 7 days following each vaccination (up to day 7 for vaccine 1 and up to day 35-49 for vaccine 2). Events were followed until resolution, up to study conclusion.
|
|
Infections and infestations
Viral illness
|
1.7%
1/60 • Number of events 1 • AEs and SAEs were collected for 7 days following each vaccination (up to day 7 for vaccine 1 and up to day 35-49 for vaccine 2). Events were followed until resolution, up to study conclusion.
|
0.00%
0/64 • AEs and SAEs were collected for 7 days following each vaccination (up to day 7 for vaccine 1 and up to day 35-49 for vaccine 2). Events were followed until resolution, up to study conclusion.
|
Other adverse events
| Measure |
Group I (HD-TIV)
n=60 participants at risk
Patients received HD-TIV intramuscularly once at baseline (day 0) and again between 28-42 days later.
Trivalent Influenza Vaccine: High Dose Trivalent Influenza Vaccine given intramuscularly
Laboratory Biomarker Analysis: Correlative studies
|
Group 2 (SD-QIV)
n=64 participants at risk
Patients received SD-QIV intramuscularly once at baseline (day 0) and again between 28-42 days later.
Quadrivalent Inactivated Influenza Vaccine: Standard Dose Quadrivalent Influenza Vaccine given intramuscularly
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|---|
|
General disorders
Fever
|
6.7%
4/60 • Number of events 4 • AEs and SAEs were collected for 7 days following each vaccination (up to day 7 for vaccine 1 and up to day 35-49 for vaccine 2). Events were followed until resolution, up to study conclusion.
|
9.4%
6/64 • Number of events 6 • AEs and SAEs were collected for 7 days following each vaccination (up to day 7 for vaccine 1 and up to day 35-49 for vaccine 2). Events were followed until resolution, up to study conclusion.
|
|
General disorders
Fatigue
|
40.0%
24/60 • Number of events 24 • AEs and SAEs were collected for 7 days following each vaccination (up to day 7 for vaccine 1 and up to day 35-49 for vaccine 2). Events were followed until resolution, up to study conclusion.
|
35.9%
23/64 • Number of events 23 • AEs and SAEs were collected for 7 days following each vaccination (up to day 7 for vaccine 1 and up to day 35-49 for vaccine 2). Events were followed until resolution, up to study conclusion.
|
|
General disorders
Headache
|
30.0%
18/60 • Number of events 18 • AEs and SAEs were collected for 7 days following each vaccination (up to day 7 for vaccine 1 and up to day 35-49 for vaccine 2). Events were followed until resolution, up to study conclusion.
|
31.2%
20/64 • Number of events 20 • AEs and SAEs were collected for 7 days following each vaccination (up to day 7 for vaccine 1 and up to day 35-49 for vaccine 2). Events were followed until resolution, up to study conclusion.
|
|
General disorders
Nausea
|
16.7%
10/60 • Number of events 10 • AEs and SAEs were collected for 7 days following each vaccination (up to day 7 for vaccine 1 and up to day 35-49 for vaccine 2). Events were followed until resolution, up to study conclusion.
|
25.0%
16/64 • Number of events 16 • AEs and SAEs were collected for 7 days following each vaccination (up to day 7 for vaccine 1 and up to day 35-49 for vaccine 2). Events were followed until resolution, up to study conclusion.
|
|
General disorders
Myalgia/ Body aches
|
25.0%
15/60 • Number of events 15 • AEs and SAEs were collected for 7 days following each vaccination (up to day 7 for vaccine 1 and up to day 35-49 for vaccine 2). Events were followed until resolution, up to study conclusion.
|
28.1%
18/64 • Number of events 18 • AEs and SAEs were collected for 7 days following each vaccination (up to day 7 for vaccine 1 and up to day 35-49 for vaccine 2). Events were followed until resolution, up to study conclusion.
|
|
General disorders
Decreased general activity
|
43.3%
26/60 • Number of events 26 • AEs and SAEs were collected for 7 days following each vaccination (up to day 7 for vaccine 1 and up to day 35-49 for vaccine 2). Events were followed until resolution, up to study conclusion.
|
39.1%
25/64 • Number of events 25 • AEs and SAEs were collected for 7 days following each vaccination (up to day 7 for vaccine 1 and up to day 35-49 for vaccine 2). Events were followed until resolution, up to study conclusion.
|
|
General disorders
Vomiting
|
1.7%
1/60 • Number of events 1 • AEs and SAEs were collected for 7 days following each vaccination (up to day 7 for vaccine 1 and up to day 35-49 for vaccine 2). Events were followed until resolution, up to study conclusion.
|
7.8%
5/64 • Number of events 5 • AEs and SAEs were collected for 7 days following each vaccination (up to day 7 for vaccine 1 and up to day 35-49 for vaccine 2). Events were followed until resolution, up to study conclusion.
|
|
General disorders
Pain
|
35.0%
21/60 • Number of events 21 • AEs and SAEs were collected for 7 days following each vaccination (up to day 7 for vaccine 1 and up to day 35-49 for vaccine 2). Events were followed until resolution, up to study conclusion.
|
23.4%
15/64 • Number of events 15 • AEs and SAEs were collected for 7 days following each vaccination (up to day 7 for vaccine 1 and up to day 35-49 for vaccine 2). Events were followed until resolution, up to study conclusion.
|
|
General disorders
Tenderness
|
55.0%
33/60 • Number of events 33 • AEs and SAEs were collected for 7 days following each vaccination (up to day 7 for vaccine 1 and up to day 35-49 for vaccine 2). Events were followed until resolution, up to study conclusion.
|
35.9%
23/64 • Number of events 23 • AEs and SAEs were collected for 7 days following each vaccination (up to day 7 for vaccine 1 and up to day 35-49 for vaccine 2). Events were followed until resolution, up to study conclusion.
|
|
Skin and subcutaneous tissue disorders
Swelling
|
18.3%
11/60 • Number of events 11 • AEs and SAEs were collected for 7 days following each vaccination (up to day 7 for vaccine 1 and up to day 35-49 for vaccine 2). Events were followed until resolution, up to study conclusion.
|
14.1%
9/64 • Number of events 9 • AEs and SAEs were collected for 7 days following each vaccination (up to day 7 for vaccine 1 and up to day 35-49 for vaccine 2). Events were followed until resolution, up to study conclusion.
|
|
Skin and subcutaneous tissue disorders
Redness/ Erythema
|
13.3%
8/60 • Number of events 8 • AEs and SAEs were collected for 7 days following each vaccination (up to day 7 for vaccine 1 and up to day 35-49 for vaccine 2). Events were followed until resolution, up to study conclusion.
|
4.7%
3/64 • Number of events 3 • AEs and SAEs were collected for 7 days following each vaccination (up to day 7 for vaccine 1 and up to day 35-49 for vaccine 2). Events were followed until resolution, up to study conclusion.
|
Additional Information
Natasha Halasa, MD, MPH
Vanderbilt-Ingram Cancer Center
Phone: 800-811-8480
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place