Trial Outcomes & Findings for Standard-dose Versus High-dose Flu Vaccine in Solid Organ Transplant. (NCT NCT01808456)
NCT ID: NCT01808456
Last Updated: 2022-07-22
Results Overview
Evaluation of local and systemic reactions, use of analgesics or antipyretics.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
62 participants
Primary outcome timeframe
Day 1 and weeks 1, 4, and 12
Results posted on
2022-07-22
Participant Flow
Participant milestones
| Measure |
SD-IIV3
Standard-dose trivalent (SD-IIV3) flu vaccine
|
HD-IIV3
high dose trivalent flu vaccine recipients
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
32
|
|
Overall Study
COMPLETED
|
26
|
30
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Standard-dose Versus High-dose Flu Vaccine in Solid Organ Transplant.
Baseline characteristics by cohort
| Measure |
SD-IIV3
n=30 Participants
Standard-dose trivalent (SD-IIV3) seasonal influenza vaccine
|
HD-IIV3
n=32 Participants
high-dose trivalent (HD-IIV3) seasonal influenza vaccine
|
Total
n=62 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
|
27 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Age, Continuous
|
54.9 years
n=5 Participants
|
56.6 years
n=7 Participants
|
55.7 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 and weeks 1, 4, and 12Evaluation of local and systemic reactions, use of analgesics or antipyretics.
Outcome measures
| Measure |
High Dose Flu Vaccine
n=32 Participants
influenza trivalent inactive vaccine high dose. IM (intramuscular) injection one time administration
influenza trivalent inactive vaccine high dose: one time IM injection of high dose influenza vaccine to measure immunogenicity, safety, and efficacy in organ transplant recipients
|
Flu Vaccine
n=30 Participants
influenza trivalent inactive vaccine IM injection one time administration
influenza trivalent inactive vaccine: one time IM injection of standard influenza vaccine to measure immunogenicity, safety, and efficacy in organ transplant recipients
|
|---|---|---|
|
Number of Patients With Local Site Reactions
|
2 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Week 1, 4, and 12Number of patients and percentage of subjects achieving hemagglutination inhibition (HI) titer≥40
Outcome measures
| Measure |
High Dose Flu Vaccine
n=30 Participants
influenza trivalent inactive vaccine high dose. IM (intramuscular) injection one time administration
influenza trivalent inactive vaccine high dose: one time IM injection of high dose influenza vaccine to measure immunogenicity, safety, and efficacy in organ transplant recipients
|
Flu Vaccine
n=32 Participants
influenza trivalent inactive vaccine IM injection one time administration
influenza trivalent inactive vaccine: one time IM injection of standard influenza vaccine to measure immunogenicity, safety, and efficacy in organ transplant recipients
|
|---|---|---|
|
Measurement of Strain-specific Hemagglutination Inhibition (HI) Antibody Titers
week 1
|
14 Participants
|
19 Participants
|
|
Measurement of Strain-specific Hemagglutination Inhibition (HI) Antibody Titers
Week 4
|
16 Participants
|
23 Participants
|
|
Measurement of Strain-specific Hemagglutination Inhibition (HI) Antibody Titers
Week 12
|
15 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: day 1 - 3 monthsAll-cause outpatient/Emergency department visits during study follow-up (other than pre-specified post transplant follow-up visits).
Outcome measures
| Measure |
High Dose Flu Vaccine
n=32 Participants
influenza trivalent inactive vaccine high dose. IM (intramuscular) injection one time administration
influenza trivalent inactive vaccine high dose: one time IM injection of high dose influenza vaccine to measure immunogenicity, safety, and efficacy in organ transplant recipients
|
Flu Vaccine
n=30 Participants
influenza trivalent inactive vaccine IM injection one time administration
influenza trivalent inactive vaccine: one time IM injection of standard influenza vaccine to measure immunogenicity, safety, and efficacy in organ transplant recipients
|
|---|---|---|
|
All Cause ED Visits/Unscheduled Clinic Visits
|
30 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: Week 4 and Week 12Population: Analysis performed only for participants between ages of 18 and 65.
Number and percentage of subjects in each group achieving seroconversion (at least 4-fold increase in titers from baseline) for each any strain at weeks 4 and 12
Outcome measures
| Measure |
High Dose Flu Vaccine
n=27 Participants
influenza trivalent inactive vaccine high dose. IM (intramuscular) injection one time administration
influenza trivalent inactive vaccine high dose: one time IM injection of high dose influenza vaccine to measure immunogenicity, safety, and efficacy in organ transplant recipients
|
Flu Vaccine
n=26 Participants
influenza trivalent inactive vaccine IM injection one time administration
influenza trivalent inactive vaccine: one time IM injection of standard influenza vaccine to measure immunogenicity, safety, and efficacy in organ transplant recipients
|
|---|---|---|
|
Number and Percentage of Subjects in Each Group Achieving Seroconversion for Each Strain
week 4
|
7 Participants
|
6 Participants
|
|
Number and Percentage of Subjects in Each Group Achieving Seroconversion for Each Strain
week 12
|
7 Participants
|
7 Participants
|
Adverse Events
SD-IIV3
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
HD-IIV3
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
SD-IIV3
n=30 participants at risk
The safety and immunogenicity of seasonal influenza vaccination using Standard-dose trivalent (SD-IIV3) in recipients of solid organ transplants who were at least 30 days after transplantation via a randomized blinded study.
|
HD-IIV3
n=32 participants at risk
The safety and immunogenicity of seasonal influenza vaccination using high-dose trivalent (HD-IIV3) in recipients of solid organ transplants who were at least 30 days after transplantation via a randomized blinded study.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
local pain
|
43.3%
13/30
|
40.6%
13/32
|
|
General disorders
redness
|
26.7%
8/30
|
37.5%
12/32
|
|
General disorders
swelling
|
43.3%
13/30
|
43.8%
14/32
|
|
General disorders
fever
|
33.3%
10/30
|
31.2%
10/32
|
|
General disorders
headache
|
30.0%
9/30
|
28.1%
9/32
|
|
General disorders
fatigue
|
23.3%
7/30
|
34.4%
11/32
|
|
General disorders
nausea, vomiting, diarrhea
|
16.7%
5/30
|
28.1%
9/32
|
|
General disorders
myalgia
|
33.3%
10/30
|
28.1%
9/32
|
|
General disorders
arthralgia
|
33.3%
10/30
|
25.0%
8/32
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place