Trial Outcomes & Findings for Trial of High Dose vs. Standard Dose Influenza Vaccine in Inflammatory Bowel Disease Patients (NCT NCT02461758)
NCT ID: NCT02461758
Last Updated: 2019-10-02
Results Overview
Influenza vaccine antibody concentration will be measured in immunosuppressed IBD patients who receive high dose and standard of care dose influenza vaccine. Higher antibody concentrations are associated with better protection from infection.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
81 participants
Primary outcome timeframe
Pre-immunization and 2-4 weeks post immunization
Results posted on
2019-10-02
Participant Flow
Participant milestones
| Measure |
Control Group
A group of 20 healthy individuals without IBD, other chronic diseases, or immunosuppressive therapy will be enrolled. All healthy individuals will receive standard dose influenza vaccine SDIV.
|
Vedolizumab Group
A group of 20 patients who are currently on vedolizumab. All individuals in this group will receive SDIV
|
High Dose Influenza Vaccine (HDIV)
This arm will be a double blind randomized controlled trial of High dose influenza vaccine (HDIV) for IBD patients on TNF monotherapy.
40 patients will be enrolled and randomized in a 5:3 fashion to HDIV or SDIV. Randomization will generated by a random number generator and investigator will be blinded to randomization scheme.
|
Standard Dose Influenza Vaccine (SDIV)
This arm will be a double blind randomized controlled trial of standard dose influenza vaccine (SDIV) for IBD patients on TNF monotherapy.
40 patients will be enrolled and randomized in a 5:3 fashion to HDIV or SDIV. Randomization will generated by a random number generator and investigator will be blinded to randomization scheme.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
26
|
15
|
|
Overall Study
COMPLETED
|
20
|
19
|
25
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
0
|
Reasons for withdrawal
| Measure |
Control Group
A group of 20 healthy individuals without IBD, other chronic diseases, or immunosuppressive therapy will be enrolled. All healthy individuals will receive standard dose influenza vaccine SDIV.
|
Vedolizumab Group
A group of 20 patients who are currently on vedolizumab. All individuals in this group will receive SDIV
|
High Dose Influenza Vaccine (HDIV)
This arm will be a double blind randomized controlled trial of High dose influenza vaccine (HDIV) for IBD patients on TNF monotherapy.
40 patients will be enrolled and randomized in a 5:3 fashion to HDIV or SDIV. Randomization will generated by a random number generator and investigator will be blinded to randomization scheme.
|
Standard Dose Influenza Vaccine (SDIV)
This arm will be a double blind randomized controlled trial of standard dose influenza vaccine (SDIV) for IBD patients on TNF monotherapy.
40 patients will be enrolled and randomized in a 5:3 fashion to HDIV or SDIV. Randomization will generated by a random number generator and investigator will be blinded to randomization scheme.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
1
|
0
|
Baseline Characteristics
Trial of High Dose vs. Standard Dose Influenza Vaccine in Inflammatory Bowel Disease Patients
Baseline characteristics by cohort
| Measure |
Control Group
n=20 Participants
A group of 20 healthy individuals without IBD, other chronic diseases, or immunosuppressive therapy will be enrolled. All healthy individuals will receive standard dose influenza vaccine SDIV.
|
Vedolizumab Group
n=19 Participants
A group of 20 patients who are currently on vedolizumab. All individuals in this group will receive SDIV
|
High Dose Influenza Vaccine (HDIV)
n=25 Participants
This arm will be a double blind randomized controlled trial of high dose influenza vaccine (HDIV) for IBD patients on TNF monotherapy.
40 patients will be enrolled and randomized in a 5:3 fashion to HDIV or SDIV. Randomization will generated by a random number generator and investigator will be blinded to randomization scheme.
|
Standard Dose Influenza Vaccine (SDIV)
n=15 Participants
This arm will be a double blind randomized controlled trial of standard dose influenza vaccine (SDIV) for IBD patients on TNF monotherapy.
40 patients will be enrolled and randomized in a 5:3 fashion to HDIV or SDIV. Randomization will generated by a random number generator and investigator will be blinded to randomization scheme.
|
Total
n=79 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
40.35 years
STANDARD_DEVIATION 9.89 • n=5 Participants
|
36.57 years
STANDARD_DEVIATION 16.16 • n=7 Participants
|
34.96 years
STANDARD_DEVIATION 12.92 • n=5 Participants
|
39.35 years
STANDARD_DEVIATION 11.98 • n=4 Participants
|
37.81 years
STANDARD_DEVIATION 12.74 • n=21 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
36 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
43 Participants
n=21 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
|
|
Race (NIH/OMB)
Asian
|
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
|
|
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
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
77 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 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
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
19 participants
n=7 Participants
|
25 participants
n=5 Participants
|
15 participants
n=4 Participants
|
79 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Pre-immunization and 2-4 weeks post immunizationInfluenza vaccine antibody concentration will be measured in immunosuppressed IBD patients who receive high dose and standard of care dose influenza vaccine. Higher antibody concentrations are associated with better protection from infection.
Outcome measures
| Measure |
High Dose of Influenza Vaccine (HDIV) Group
n=25 Participants
This arm will be a double blind randomized controlled trial of high dose influenza vaccine (HDIV) for IBD patients on TNF monotherapy.
40 patients will be enrolled and randomized in a 5:3 fashion to HDIV or SDIV. Randomization will generated by a random number generator and investigator will be blinded to randomization scheme.
|
Standard Dose Influenza Vaccine (SDIV) Group
n=15 Participants
This arm will be a double blind randomized controlled trial of standard dose influenza vaccine (SDIV) for IBD patients on TNF monotherapy.
40 patients will be enrolled and randomized in a 5:3 fashion to HDIV or SDIV. Randomization will generated by a random number generator and investigator will be blinded to randomization scheme.
|
Vedolizumab Group
n=19 Participants
A group of 20 patients who are currently on vedolizumab. All individuals in this group will receive SDIV
|
Control Group
n=20 Participants
A group of 20 healthy individuals without IBD, other chronic diseases, or immunosuppressive therapy will be enrolled. All healthy individuals will receive standard dose influenza vaccine SDIV.
|
|---|---|---|---|---|
|
Measure Antibody Concentrations in Immunosuppressed IBD Patients Who Receive High Dose and Standard of Care Dose Influenza Vaccine
Influenza A H3N2, 2-4 weeks post immunization
|
160 Antibody Titer
Interval 80.0 to 320.0
|
80 Antibody Titer
Interval 40.0 to 160.0
|
320 Antibody Titer
Interval 160.0 to 320.0
|
160 Antibody Titer
Interval 160.0 to 160.0
|
|
Measure Antibody Concentrations in Immunosuppressed IBD Patients Who Receive High Dose and Standard of Care Dose Influenza Vaccine
Influenza B Victoria,Pre-immunization
|
10 Antibody Titer
Interval 10.0 to 20.0
|
10 Antibody Titer
Interval 10.0 to 20.0
|
20 Antibody Titer
Interval 10.0 to 20.0
|
20 Antibody Titer
Interval 20.0 to 35.0
|
|
Measure Antibody Concentrations in Immunosuppressed IBD Patients Who Receive High Dose and Standard of Care Dose Influenza Vaccine
Influenza A H1N1, pre-immunization
|
160 Antibody Titer
Interval 80.0 to 240.0
|
160 Antibody Titer
Interval 80.0 to 160.0
|
160 Antibody Titer
Interval 80.0 to 320.0
|
160 Antibody Titer
Interval 80.0 to 160.0
|
|
Measure Antibody Concentrations in Immunosuppressed IBD Patients Who Receive High Dose and Standard of Care Dose Influenza Vaccine
Influenza A H1N1, 2-4 weeks post immunization
|
320 Antibody Titer
Interval 150.0 to 320.0
|
160 Antibody Titer
Interval 80.0 to 320.0
|
320 Antibody Titer
Interval 160.0 to 640.0
|
320 Antibody Titer
Interval 160.0 to 320.0
|
|
Measure Antibody Concentrations in Immunosuppressed IBD Patients Who Receive High Dose and Standard of Care Dose Influenza Vaccine
Influenza A H3N2, Pre-immunization
|
80 Antibody Titer
Interval 40.0 to 160.0
|
40 Antibody Titer
Interval 20.0 to 40.0
|
80 Antibody Titer
Interval 80.0 to 160.0
|
80 Antibody Titer
Interval 40.0 to 80.0
|
|
Measure Antibody Concentrations in Immunosuppressed IBD Patients Who Receive High Dose and Standard of Care Dose Influenza Vaccine
Influenza B Victoria, 2-4 weeks post immunization
|
20 Antibody Titer
Interval 15.0 to 20.0
|
20 Antibody Titer
Interval 20.0 to 40.0
|
20 Antibody Titer
Interval 20.0 to 40.0
|
20 Antibody Titer
Interval 20.0 to 40.0
|
|
Measure Antibody Concentrations in Immunosuppressed IBD Patients Who Receive High Dose and Standard of Care Dose Influenza Vaccine
Influenza B Yamagata, Pre-immunization
|
10 Antibody Titer
Interval 10.0 to 20.0
|
10 Antibody Titer
Interval 10.0 to 20.0
|
20 Antibody Titer
Interval 10.0 to 40.0
|
20 Antibody Titer
Interval 10.0 to 35.0
|
|
Measure Antibody Concentrations in Immunosuppressed IBD Patients Who Receive High Dose and Standard of Care Dose Influenza Vaccine
Influenza B Yamagata, 2-4 weeks post immunization
|
10 Antibody Titer
Interval 10.0 to 20.0
|
20 Antibody Titer
Interval 10.0 to 20.0
|
40 Antibody Titer
Interval 20.0 to 40.0
|
20 Antibody Titer
Interval 13.0 to 40.0
|
SECONDARY outcome
Timeframe: 4 weeksVaccine response rates for influenza vaccines in patients with inflammatory bowel disease will be accessed by number of patients who has shown significant seroconversion. Seroconversion is defined as a four fold increase in antibody concentration from preimmunization to 4 weeks post immunization.
Outcome measures
| Measure |
High Dose of Influenza Vaccine (HDIV) Group
n=15 Participants
This arm will be a double blind randomized controlled trial of high dose influenza vaccine (HDIV) for IBD patients on TNF monotherapy.
40 patients will be enrolled and randomized in a 5:3 fashion to HDIV or SDIV. Randomization will generated by a random number generator and investigator will be blinded to randomization scheme.
|
Standard Dose Influenza Vaccine (SDIV) Group
n=25 Participants
This arm will be a double blind randomized controlled trial of standard dose influenza vaccine (SDIV) for IBD patients on TNF monotherapy.
40 patients will be enrolled and randomized in a 5:3 fashion to HDIV or SDIV. Randomization will generated by a random number generator and investigator will be blinded to randomization scheme.
|
Vedolizumab Group
n=19 Participants
A group of 20 patients who are currently on vedolizumab. All individuals in this group will receive SDIV
|
Control Group
n=20 Participants
A group of 20 healthy individuals without IBD, other chronic diseases, or immunosuppressive therapy will be enrolled. All healthy individuals will receive standard dose influenza vaccine SDIV.
|
|---|---|---|---|---|
|
Response Rate Against Influenza Vaccine in Patients With Inflammatory Bowel Disease: Number of Participants Positive for Seroconversion
Influenza A H1N1
|
1 participants
|
9 participants
|
4 participants
|
4 participants
|
|
Response Rate Against Influenza Vaccine in Patients With Inflammatory Bowel Disease: Number of Participants Positive for Seroconversion
Influenza A H3N2
|
6 participants
|
11 participants
|
7 participants
|
6 participants
|
|
Response Rate Against Influenza Vaccine in Patients With Inflammatory Bowel Disease: Number of Participants Positive for Seroconversion
Influenza B Victoria
|
1 participants
|
4 participants
|
2 participants
|
0 participants
|
|
Response Rate Against Influenza Vaccine in Patients With Inflammatory Bowel Disease: Number of Participants Positive for Seroconversion
Influenza B Yamagata
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Response Rate Against Influenza Vaccine in Patients With Inflammatory Bowel Disease: Number of Participants Positive for Seroconversion
At least one virus
|
7 participants
|
15 participants
|
9 participants
|
7 participants
|
|
Response Rate Against Influenza Vaccine in Patients With Inflammatory Bowel Disease: Number of Participants Positive for Seroconversion
At least two viruses
|
1 participants
|
7 participants
|
3 participants
|
3 participants
|
|
Response Rate Against Influenza Vaccine in Patients With Inflammatory Bowel Disease: Number of Participants Positive for Seroconversion
Three viruses
|
0 participants
|
2 participants
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 4 weeksSeroprotection is defined as an antibody concentration of at least 1:40 at 4 weeks post-immunization which confers protection from infection in about 50% of individuals
Outcome measures
| Measure |
High Dose of Influenza Vaccine (HDIV) Group
n=15 Participants
This arm will be a double blind randomized controlled trial of high dose influenza vaccine (HDIV) for IBD patients on TNF monotherapy.
40 patients will be enrolled and randomized in a 5:3 fashion to HDIV or SDIV. Randomization will generated by a random number generator and investigator will be blinded to randomization scheme.
|
Standard Dose Influenza Vaccine (SDIV) Group
n=25 Participants
This arm will be a double blind randomized controlled trial of standard dose influenza vaccine (SDIV) for IBD patients on TNF monotherapy.
40 patients will be enrolled and randomized in a 5:3 fashion to HDIV or SDIV. Randomization will generated by a random number generator and investigator will be blinded to randomization scheme.
|
Vedolizumab Group
n=19 Participants
A group of 20 patients who are currently on vedolizumab. All individuals in this group will receive SDIV
|
Control Group
n=20 Participants
A group of 20 healthy individuals without IBD, other chronic diseases, or immunosuppressive therapy will be enrolled. All healthy individuals will receive standard dose influenza vaccine SDIV.
|
|---|---|---|---|---|
|
Seroprotection: Number of Participants With Antibody Concentration at Least 1:40 at Week 4 Postimmunization
Influenza A H1N1
|
15 participants
|
25 participants
|
19 participants
|
20 participants
|
|
Seroprotection: Number of Participants With Antibody Concentration at Least 1:40 at Week 4 Postimmunization
Influenza A H3N2
|
15 participants
|
25 participants
|
19 participants
|
20 participants
|
|
Seroprotection: Number of Participants With Antibody Concentration at Least 1:40 at Week 4 Postimmunization
Influenza B Victoria
|
8 participants
|
6 participants
|
10 participants
|
10 participants
|
|
Seroprotection: Number of Participants With Antibody Concentration at Least 1:40 at Week 4 Postimmunization
Influenza B Yamagata
|
6 participants
|
6 participants
|
11 participants
|
8 participants
|
|
Seroprotection: Number of Participants With Antibody Concentration at Least 1:40 at Week 4 Postimmunization
At least one virus
|
15 participants
|
25 participants
|
19 participants
|
20 participants
|
|
Seroprotection: Number of Participants With Antibody Concentration at Least 1:40 at Week 4 Postimmunization
At least two virus
|
15 participants
|
25 participants
|
19 participants
|
20 participants
|
|
Seroprotection: Number of Participants With Antibody Concentration at Least 1:40 at Week 4 Postimmunization
Three viruses
|
8 participants
|
9 participants
|
13 participants
|
11 participants
|
SECONDARY outcome
Timeframe: 4 weeksSeroprotection is defined by the FDA as post-immunization concentration of 1:160 that confers protection from infection to 95% of the population.
Outcome measures
| Measure |
High Dose of Influenza Vaccine (HDIV) Group
n=15 Participants
This arm will be a double blind randomized controlled trial of high dose influenza vaccine (HDIV) for IBD patients on TNF monotherapy.
40 patients will be enrolled and randomized in a 5:3 fashion to HDIV or SDIV. Randomization will generated by a random number generator and investigator will be blinded to randomization scheme.
|
Standard Dose Influenza Vaccine (SDIV) Group
n=25 Participants
This arm will be a double blind randomized controlled trial of standard dose influenza vaccine (SDIV) for IBD patients on TNF monotherapy.
40 patients will be enrolled and randomized in a 5:3 fashion to HDIV or SDIV. Randomization will generated by a random number generator and investigator will be blinded to randomization scheme.
|
Vedolizumab Group
n=19 Participants
A group of 20 patients who are currently on vedolizumab. All individuals in this group will receive SDIV
|
Control Group
n=20 Participants
A group of 20 healthy individuals without IBD, other chronic diseases, or immunosuppressive therapy will be enrolled. All healthy individuals will receive standard dose influenza vaccine SDIV.
|
|---|---|---|---|---|
|
Seroprotection: Number of Participants With Antibody Titer of 160 at Week 4 Post-immunization
Influenza A H1N1
|
12 participants
|
24 participants
|
19 participants
|
18 participants
|
|
Seroprotection: Number of Participants With Antibody Titer of 160 at Week 4 Post-immunization
Influenza A H3N2
|
6 participants
|
21 participants
|
16 participants
|
17 participants
|
|
Seroprotection: Number of Participants With Antibody Titer of 160 at Week 4 Post-immunization
Influenza B Victoria
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Seroprotection: Number of Participants With Antibody Titer of 160 at Week 4 Post-immunization
Influenza B Yamagata
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Seroprotection: Number of Participants With Antibody Titer of 160 at Week 4 Post-immunization
At least one virus
|
13 participants
|
25 participants
|
19 participants
|
20 participants
|
|
Seroprotection: Number of Participants With Antibody Titer of 160 at Week 4 Post-immunization
At least two virus
|
5 participants
|
20 participants
|
16 participants
|
15 participants
|
|
Seroprotection: Number of Participants With Antibody Titer of 160 at Week 4 Post-immunization
Three viruses
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 6 months post-immunizationInfluenza vaccine antibody concentration will be measured in immunosuppressed IBD patients who receive high dose and standard of care dose influenza vaccine. Higher antibody concentrations are associated with better protection from infection.
Outcome measures
| Measure |
High Dose of Influenza Vaccine (HDIV) Group
n=25 Participants
This arm will be a double blind randomized controlled trial of high dose influenza vaccine (HDIV) for IBD patients on TNF monotherapy.
40 patients will be enrolled and randomized in a 5:3 fashion to HDIV or SDIV. Randomization will generated by a random number generator and investigator will be blinded to randomization scheme.
|
Standard Dose Influenza Vaccine (SDIV) Group
n=15 Participants
This arm will be a double blind randomized controlled trial of standard dose influenza vaccine (SDIV) for IBD patients on TNF monotherapy.
40 patients will be enrolled and randomized in a 5:3 fashion to HDIV or SDIV. Randomization will generated by a random number generator and investigator will be blinded to randomization scheme.
|
Vedolizumab Group
n=19 Participants
A group of 20 patients who are currently on vedolizumab. All individuals in this group will receive SDIV
|
Control Group
n=20 Participants
A group of 20 healthy individuals without IBD, other chronic diseases, or immunosuppressive therapy will be enrolled. All healthy individuals will receive standard dose influenza vaccine SDIV.
|
|---|---|---|---|---|
|
Measure Antibody Concentrations in Immunosuppressed IBD Patients Who Receive High Dose and Standard of Care Dose Influenza Vaccine
Influenza A H1N1, 6 months post immunization
|
160 Antibody Titer
Interval 80.0 to 320.0
|
160 Antibody Titer
Interval 80.0 to 320.0
|
160 Antibody Titer
Interval 160.0 to 320.0
|
160 Antibody Titer
Interval 80.0 to 320.0
|
|
Measure Antibody Concentrations in Immunosuppressed IBD Patients Who Receive High Dose and Standard of Care Dose Influenza Vaccine
Influenza A H3N2, 6 months post immunization
|
80 Antibody Titer
Interval 40.0 to 80.0
|
80 Antibody Titer
Interval 40.0 to 160.0
|
160 Antibody Titer
Interval 80.0 to 160.0
|
80 Antibody Titer
Interval 80.0 to 160.0
|
|
Measure Antibody Concentrations in Immunosuppressed IBD Patients Who Receive High Dose and Standard of Care Dose Influenza Vaccine
Influenza B Victoria, 6 months post immunization
|
20 Antibody Titer
Interval 10.0 to 20.0
|
20 Antibody Titer
Interval 18.0 to 40.0
|
40 Antibody Titer
Interval 20.0 to 40.0
|
20 Antibody Titer
Interval 20.0 to 40.0
|
|
Measure Antibody Concentrations in Immunosuppressed IBD Patients Who Receive High Dose and Standard of Care Dose Influenza Vaccine
Influenza B Yamagata, 6 months post immunization
|
20 Antibody Titer
Interval 10.0 to 20.0
|
20 Antibody Titer
Interval 10.0 to 20.0
|
20 Antibody Titer
Interval 20.0 to 40.0
|
20 Antibody Titer
Interval 20.0 to 40.0
|
Adverse Events
High Dose Influenza Vaccine (HDIV)
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Standard Dose Influenza Vaccine (SDIV)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
High Dose Influenza Vaccine (HDIV)
n=24 participants at risk；n=25 participants at risk
This arm will be a double blind randomized controlled trial of High dose influenza vaccine (HDIV) for IBD patients on TNF monotherapy.
40 patients will be enrolled and randomized in a 5:3 fashion to HDIV or SDIV. Randomization will generated by a random number generator and investigator will be blinded to randomization scheme.
|
Standard Dose Influenza Vaccine (SDIV)
n=15 participants at risk
This arm will be a double blind randomized controlled trial of standard dose influenza vaccine (SDIV) for IBD patients on TNF monotherapy.
40 patients will be enrolled and randomized in a 5:3 fashion to HDIV or SDIV. Randomization will generated by a random number generator and investigator will be blinded to randomization scheme.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Local reactions: Pain
|
41.7%
10/24 • Number of events 10 • Up to 7 days
AEs were recorded after administration of the vaccine from days 0-6 using the adverse event dairy. Adverse event data is reported for 24 participants in the HDIV arm as 1 participant did not submit the diary card for adverse event reporting. Adverse event are reported just for anti-TNF monotherapy group HDIV and SDIV since these were the primary outcome.No AEs were collected for vedolizumab group and control group as they were secondary outcomes which were dependent on primary outcomes.
|
26.7%
4/15 • Number of events 4 • Up to 7 days
AEs were recorded after administration of the vaccine from days 0-6 using the adverse event dairy. Adverse event data is reported for 24 participants in the HDIV arm as 1 participant did not submit the diary card for adverse event reporting. Adverse event are reported just for anti-TNF monotherapy group HDIV and SDIV since these were the primary outcome.No AEs were collected for vedolizumab group and control group as they were secondary outcomes which were dependent on primary outcomes.
|
|
Skin and subcutaneous tissue disorders
Local reaction: Redness
|
29.2%
7/24 • Number of events 7 • Up to 7 days
AEs were recorded after administration of the vaccine from days 0-6 using the adverse event dairy. Adverse event data is reported for 24 participants in the HDIV arm as 1 participant did not submit the diary card for adverse event reporting. Adverse event are reported just for anti-TNF monotherapy group HDIV and SDIV since these were the primary outcome.No AEs were collected for vedolizumab group and control group as they were secondary outcomes which were dependent on primary outcomes.
|
33.3%
5/15 • Number of events 5 • Up to 7 days
AEs were recorded after administration of the vaccine from days 0-6 using the adverse event dairy. Adverse event data is reported for 24 participants in the HDIV arm as 1 participant did not submit the diary card for adverse event reporting. Adverse event are reported just for anti-TNF monotherapy group HDIV and SDIV since these were the primary outcome.No AEs were collected for vedolizumab group and control group as they were secondary outcomes which were dependent on primary outcomes.
|
|
Skin and subcutaneous tissue disorders
Swelling
|
20.8%
5/24 • Number of events 5 • Up to 7 days
AEs were recorded after administration of the vaccine from days 0-6 using the adverse event dairy. Adverse event data is reported for 24 participants in the HDIV arm as 1 participant did not submit the diary card for adverse event reporting. Adverse event are reported just for anti-TNF monotherapy group HDIV and SDIV since these were the primary outcome.No AEs were collected for vedolizumab group and control group as they were secondary outcomes which were dependent on primary outcomes.
|
33.3%
5/15 • Number of events 5 • Up to 7 days
AEs were recorded after administration of the vaccine from days 0-6 using the adverse event dairy. Adverse event data is reported for 24 participants in the HDIV arm as 1 participant did not submit the diary card for adverse event reporting. Adverse event are reported just for anti-TNF monotherapy group HDIV and SDIV since these were the primary outcome.No AEs were collected for vedolizumab group and control group as they were secondary outcomes which were dependent on primary outcomes.
|
|
General disorders
fever
|
4.2%
1/24 • Number of events 1 • Up to 7 days
AEs were recorded after administration of the vaccine from days 0-6 using the adverse event dairy. Adverse event data is reported for 24 participants in the HDIV arm as 1 participant did not submit the diary card for adverse event reporting. Adverse event are reported just for anti-TNF monotherapy group HDIV and SDIV since these were the primary outcome.No AEs were collected for vedolizumab group and control group as they were secondary outcomes which were dependent on primary outcomes.
|
0.00%
0/15 • Up to 7 days
AEs were recorded after administration of the vaccine from days 0-6 using the adverse event dairy. Adverse event data is reported for 24 participants in the HDIV arm as 1 participant did not submit the diary card for adverse event reporting. Adverse event are reported just for anti-TNF monotherapy group HDIV and SDIV since these were the primary outcome.No AEs were collected for vedolizumab group and control group as they were secondary outcomes which were dependent on primary outcomes.
|
|
General disorders
Headache
|
37.5%
9/24 • Number of events 9 • Up to 7 days
AEs were recorded after administration of the vaccine from days 0-6 using the adverse event dairy. Adverse event data is reported for 24 participants in the HDIV arm as 1 participant did not submit the diary card for adverse event reporting. Adverse event are reported just for anti-TNF monotherapy group HDIV and SDIV since these were the primary outcome.No AEs were collected for vedolizumab group and control group as they were secondary outcomes which were dependent on primary outcomes.
|
33.3%
5/15 • Number of events 5 • Up to 7 days
AEs were recorded after administration of the vaccine from days 0-6 using the adverse event dairy. Adverse event data is reported for 24 participants in the HDIV arm as 1 participant did not submit the diary card for adverse event reporting. Adverse event are reported just for anti-TNF monotherapy group HDIV and SDIV since these were the primary outcome.No AEs were collected for vedolizumab group and control group as they were secondary outcomes which were dependent on primary outcomes.
|
|
General disorders
Muscle Aches
|
50.0%
12/24 • Number of events 12 • Up to 7 days
AEs were recorded after administration of the vaccine from days 0-6 using the adverse event dairy. Adverse event data is reported for 24 participants in the HDIV arm as 1 participant did not submit the diary card for adverse event reporting. Adverse event are reported just for anti-TNF monotherapy group HDIV and SDIV since these were the primary outcome.No AEs were collected for vedolizumab group and control group as they were secondary outcomes which were dependent on primary outcomes.
|
53.3%
8/15 • Number of events 8 • Up to 7 days
AEs were recorded after administration of the vaccine from days 0-6 using the adverse event dairy. Adverse event data is reported for 24 participants in the HDIV arm as 1 participant did not submit the diary card for adverse event reporting. Adverse event are reported just for anti-TNF monotherapy group HDIV and SDIV since these were the primary outcome.No AEs were collected for vedolizumab group and control group as they were secondary outcomes which were dependent on primary outcomes.
|
|
General disorders
Arthralgia
|
25.0%
6/24 • Number of events 6 • Up to 7 days
AEs were recorded after administration of the vaccine from days 0-6 using the adverse event dairy. Adverse event data is reported for 24 participants in the HDIV arm as 1 participant did not submit the diary card for adverse event reporting. Adverse event are reported just for anti-TNF monotherapy group HDIV and SDIV since these were the primary outcome.No AEs were collected for vedolizumab group and control group as they were secondary outcomes which were dependent on primary outcomes.
|
26.7%
4/15 • Number of events 4 • Up to 7 days
AEs were recorded after administration of the vaccine from days 0-6 using the adverse event dairy. Adverse event data is reported for 24 participants in the HDIV arm as 1 participant did not submit the diary card for adverse event reporting. Adverse event are reported just for anti-TNF monotherapy group HDIV and SDIV since these were the primary outcome.No AEs were collected for vedolizumab group and control group as they were secondary outcomes which were dependent on primary outcomes.
|
|
General disorders
Fatigue
|
54.2%
13/24 • Number of events 13 • Up to 7 days
AEs were recorded after administration of the vaccine from days 0-6 using the adverse event dairy. Adverse event data is reported for 24 participants in the HDIV arm as 1 participant did not submit the diary card for adverse event reporting. Adverse event are reported just for anti-TNF monotherapy group HDIV and SDIV since these were the primary outcome.No AEs were collected for vedolizumab group and control group as they were secondary outcomes which were dependent on primary outcomes.
|
46.7%
7/15 • Number of events 7 • Up to 7 days
AEs were recorded after administration of the vaccine from days 0-6 using the adverse event dairy. Adverse event data is reported for 24 participants in the HDIV arm as 1 participant did not submit the diary card for adverse event reporting. Adverse event are reported just for anti-TNF monotherapy group HDIV and SDIV since these were the primary outcome.No AEs were collected for vedolizumab group and control group as they were secondary outcomes which were dependent on primary outcomes.
|
Additional Information
FREDDY CALDERA, ASST PROFESSOR , GASTROENTEROLOGY
University of Wisconsin School of Medicine and Public Health
Phone: (608) 263-1995
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place