Trial Outcomes & Findings for Do NSAIDS or Executing Exercise Decrease Local Erythema, Site Swelling & Pain After INoculation (NCT NCT02807623)
NCT ID: NCT02807623
Last Updated: 2020-11-27
Results Overview
Level of Pain will be measured by validated pain scale, using a scale of 0 ( best, no pain) to 10 (worst, as bad as imaginable, completely interferes).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
300 participants
Primary outcome timeframe
baseline, 48-72 hours and at 21-28 days ( 3 points )
Results posted on
2020-11-27
Participant Flow
A total of 315 active-duty US Military Service Members due to receive injectable influenza vaccine (IIV) were recruited via flyers or verbal briefing from the Fort Bragg, North Carolina 82'nd Airborne Soldier Readiness Center and Walter Reed National Military Medical Center between 9/19/2016 and 11/6/2018.
Of these 315 subjects, 15 were excluded due to the following reasons: 4 did not meet inclusion criteria, 2 declined to participate, and 9 are identified as other reasons. 300 were randomized to 1 of 3 arms. However, only 233 of the 300 returned for follow-up visits. Thus results are based on data from those 233 participants with completed data.
Participant milestones
| Measure |
Ibuprofen
Randomized and double blinded study participants assigned to Group A intervention will receive an oral NSAID of ibuprofen 800 mgs three times a day for 48 hours.
Ibuprofen: The participants will take their first dose of the study drug immediately after influenza vaccine receipt. The medication will be blinded and dispensed by a research pharmacist. The participants will receive instructions on the dosing, frequency and a recommendation to take with food or milk and will be provided a snack with their first dose.
|
Placebo
Randomized and double blinded study participants assigned to Group B intervention will receive an oral placebo three times a day for 48 hours starting immediately after influenza vaccine receipt.
oral placebo: The participants will take their first dose of the study drug immediately after influenza vaccine receipt. The medication will be blinded and dispensed by a research pharmacist. The participants will receive instructions on the dosing, frequency and a recommendation to take with food or milk and will be provided a snack with their first dose.
|
Compound Exercise of Push-ups
Randomized study participants assigned to Group C will perform an exercise intervention of push-ups immediately after influenza vaccine receipt.
Compound Exercise of Push-ups: The participants will perform an exercise intervention of push-ups as immediately as possible but no more than 15 minutes after influenza vaccine receipt. The number of pushups performed will be at least 80% of the participants last Army Physical Fitness Test (APFT) score in one session. The number of pushups will be recorded. A baseline lactate fingerstick blood specimen will be collected with either the serology sample (if possible) or from the hand opposite the vaccine receipt arm prior to performing pushups and a second finger stick sample within 3-8 minutes, but no more than 15 minutes after vaccine receipt.
|
|---|---|---|---|
|
Overall Study
STARTED
|
98
|
100
|
102
|
|
Overall Study
COMPLETED
|
75
|
79
|
79
|
|
Overall Study
NOT COMPLETED
|
23
|
21
|
23
|
Reasons for withdrawal
| Measure |
Ibuprofen
Randomized and double blinded study participants assigned to Group A intervention will receive an oral NSAID of ibuprofen 800 mgs three times a day for 48 hours.
Ibuprofen: The participants will take their first dose of the study drug immediately after influenza vaccine receipt. The medication will be blinded and dispensed by a research pharmacist. The participants will receive instructions on the dosing, frequency and a recommendation to take with food or milk and will be provided a snack with their first dose.
|
Placebo
Randomized and double blinded study participants assigned to Group B intervention will receive an oral placebo three times a day for 48 hours starting immediately after influenza vaccine receipt.
oral placebo: The participants will take their first dose of the study drug immediately after influenza vaccine receipt. The medication will be blinded and dispensed by a research pharmacist. The participants will receive instructions on the dosing, frequency and a recommendation to take with food or milk and will be provided a snack with their first dose.
|
Compound Exercise of Push-ups
Randomized study participants assigned to Group C will perform an exercise intervention of push-ups immediately after influenza vaccine receipt.
Compound Exercise of Push-ups: The participants will perform an exercise intervention of push-ups as immediately as possible but no more than 15 minutes after influenza vaccine receipt. The number of pushups performed will be at least 80% of the participants last Army Physical Fitness Test (APFT) score in one session. The number of pushups will be recorded. A baseline lactate fingerstick blood specimen will be collected with either the serology sample (if possible) or from the hand opposite the vaccine receipt arm prior to performing pushups and a second finger stick sample within 3-8 minutes, but no more than 15 minutes after vaccine receipt.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
23
|
18
|
22
|
|
Overall Study
Drug intolerance
|
0
|
1
|
0
|
|
Overall Study
incomplete blood draw
|
0
|
2
|
1
|
Baseline Characteristics
Do NSAIDS or Executing Exercise Decrease Local Erythema, Site Swelling & Pain After INoculation
Baseline characteristics by cohort
| Measure |
Ibuprofen
n=75 Participants
Randomized and double blinded study participants assigned to Group A intervention will receive an oral NSAID of ibuprofen 800 mgs three times a day for 48 hours.
Ibuprofen: The participants will take their first dose of the study drug immediately after influenza vaccine receipt. The medication will be blinded and dispensed by a research pharmacist. The participants will receive instructions on the dosing, frequency and a recommendation to take with food or milk and will be provided a snack with their first dose.
|
Placebo
n=81 Participants
Randomized and double blinded study participants assigned to Group B intervention will receive an oral placebo three times a day for 48 hours starting immediately after influenza vaccine receipt.
oral placebo: The participants will take their first dose of the study drug immediately after influenza vaccine receipt. The medication will be blinded and dispensed by a research pharmacist. The participants will receive instructions on the dosing, frequency and a recommendation to take with food or milk and will be provided a snack with their first dose.
|
Compound Exercise of Push-ups
n=77 Participants
Randomized study participants assigned to Group C will perform an exercise intervention of push-ups immediately after influenza vaccine receipt.
Compound Exercise of Push-ups: The participants will perform an exercise intervention of push-ups as immediately as possible but no more than 15 minutes after influenza vaccine receipt. The number of pushups performed will be at least 80% of the participants last Army Physical Fitness Test (APFT) score in one session. The number of pushups will be recorded. A baseline lactate fingerstick blood specimen will be collected with either the serology sample (if possible) or from the hand opposite the vaccine receipt arm prior to performing pushups and a second finger stick sample within 3-8 minutes, but no more than 15 minutes after vaccine receipt.
|
Total
n=233 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
75 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
233 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
26.13 years
STANDARD_DEVIATION 6.119 • n=5 Participants
|
25.33 years
STANDARD_DEVIATION 5.239 • n=7 Participants
|
25.95 years
STANDARD_DEVIATION 5.426 • n=5 Participants
|
25.79 years
STANDARD_DEVIATION 5.583 • n=4 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
64 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
195 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
48 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
162 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
18 Participants
n=4 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
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 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
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
117 Participants
n=4 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
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
27 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
71 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
75 participants
n=5 Participants
|
81 participants
n=7 Participants
|
77 participants
n=5 Participants
|
233 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: baseline, 48-72 hours and at 21-28 days ( 3 points )Level of Pain will be measured by validated pain scale, using a scale of 0 ( best, no pain) to 10 (worst, as bad as imaginable, completely interferes).
Outcome measures
| Measure |
Ibuprofen
n=75 Participants
Randomized and double blinded study participants assigned to Group A intervention will receive an oral NSAID of ibuprofen 800 mgs three times a day for 48 hours.
Ibuprofen: The participants will take their first dose of the study drug immediately after influenza vaccine receipt. The medication will be blinded and dispensed by a research pharmacist. The participants will receive instructions on the dosing, frequency and a recommendation to take with food or milk and will be provided a snack with their first dose.
|
Placebo
n=80 Participants
Randomized and double blinded study participants assigned to Group B intervention will receive an oral placebo three times a day for 48 hours starting immediately after influenza vaccine receipt.
oral placebo: The participants will take their first dose of the study drug immediately after influenza vaccine receipt. The medication will be blinded and dispensed by a research pharmacist. The participants will receive instructions on the dosing, frequency and a recommendation to take with food or milk and will be provided a snack with their first dose.
|
Compound Exercise of Push-ups
n=78 Participants
Randomized study participants assigned to Group C will perform an exercise intervention of push-ups immediately after influenza vaccine receipt.
Compound Exercise of Push-ups: The participants will perform an exercise intervention of push-ups as immediately as possible but no more than 15 minutes after influenza vaccine receipt. The number of pushups performed will be at least 80% of the participants last Army Physical Fitness Test (APFT) score in one session. The number of pushups will be recorded. A baseline lactate fingerstick blood specimen will be collected with either the serology sample (if possible) or from the hand opposite the vaccine receipt arm prior to performing pushups and a second finger stick sample within 3-8 minutes, but no more than 15 minutes after vaccine receipt.
|
|---|---|---|---|
|
Level of Pain
Visit 1
|
.39 units on a scale
Standard Deviation 1.384
|
.19 units on a scale
Standard Deviation .713
|
.14 units on a scale
Standard Deviation .639
|
|
Level of Pain
Visit 2
|
.56 units on a scale
Standard Deviation 1.626
|
.22 units on a scale
Standard Deviation .741
|
.19 units on a scale
Standard Deviation .650
|
|
Level of Pain
Visit 3
|
.28 units on a scale
Standard Deviation 1.122
|
.06 units on a scale
Standard Deviation 0.401
|
.13 units on a scale
Standard Deviation .745
|
SECONDARY outcome
Timeframe: Day 0 and between 21-28 days (2 points)Baseline lab specimen (visit 1, day 0, before immunization) and repeated between 21-28 days (visit 3) after immunization to measure serologic response
Outcome measures
| Measure |
Ibuprofen
n=32 Participants
Randomized and double blinded study participants assigned to Group A intervention will receive an oral NSAID of ibuprofen 800 mgs three times a day for 48 hours.
Ibuprofen: The participants will take their first dose of the study drug immediately after influenza vaccine receipt. The medication will be blinded and dispensed by a research pharmacist. The participants will receive instructions on the dosing, frequency and a recommendation to take with food or milk and will be provided a snack with their first dose.
|
Placebo
n=32 Participants
Randomized and double blinded study participants assigned to Group B intervention will receive an oral placebo three times a day for 48 hours starting immediately after influenza vaccine receipt.
oral placebo: The participants will take their first dose of the study drug immediately after influenza vaccine receipt. The medication will be blinded and dispensed by a research pharmacist. The participants will receive instructions on the dosing, frequency and a recommendation to take with food or milk and will be provided a snack with their first dose.
|
Compound Exercise of Push-ups
n=45 Participants
Randomized study participants assigned to Group C will perform an exercise intervention of push-ups immediately after influenza vaccine receipt.
Compound Exercise of Push-ups: The participants will perform an exercise intervention of push-ups as immediately as possible but no more than 15 minutes after influenza vaccine receipt. The number of pushups performed will be at least 80% of the participants last Army Physical Fitness Test (APFT) score in one session. The number of pushups will be recorded. A baseline lactate fingerstick blood specimen will be collected with either the serology sample (if possible) or from the hand opposite the vaccine receipt arm prior to performing pushups and a second finger stick sample within 3-8 minutes, but no more than 15 minutes after vaccine receipt.
|
|---|---|---|---|
|
Serologic Response - A/California/7/2009
Baseline (day 0, visit 1)
|
216.75 Titer
Standard Deviation 182.072
|
171.00 Titer
Standard Deviation 105.970
|
214.80 Titer
Standard Deviation 171.742
|
|
Serologic Response - A/California/7/2009
Followup (between 21-28 days, visit 3)
|
343.03 Titer
Standard Deviation 216.797
|
239.25 Titer
Standard Deviation 120.223
|
345.09 Titer
Standard Deviation 217.495
|
SECONDARY outcome
Timeframe: Day 0 and between 21-28 days (2 points)Baseline lab specimen (visit 1, day 0, before immunization) and repeated between 21-28 days (visit 3) after immunization to measure serologic response
Outcome measures
| Measure |
Ibuprofen
n=32 Participants
Randomized and double blinded study participants assigned to Group A intervention will receive an oral NSAID of ibuprofen 800 mgs three times a day for 48 hours.
Ibuprofen: The participants will take their first dose of the study drug immediately after influenza vaccine receipt. The medication will be blinded and dispensed by a research pharmacist. The participants will receive instructions on the dosing, frequency and a recommendation to take with food or milk and will be provided a snack with their first dose.
|
Placebo
n=32 Participants
Randomized and double blinded study participants assigned to Group B intervention will receive an oral placebo three times a day for 48 hours starting immediately after influenza vaccine receipt.
oral placebo: The participants will take their first dose of the study drug immediately after influenza vaccine receipt. The medication will be blinded and dispensed by a research pharmacist. The participants will receive instructions on the dosing, frequency and a recommendation to take with food or milk and will be provided a snack with their first dose.
|
Compound Exercise of Push-ups
n=45 Participants
Randomized study participants assigned to Group C will perform an exercise intervention of push-ups immediately after influenza vaccine receipt.
Compound Exercise of Push-ups: The participants will perform an exercise intervention of push-ups as immediately as possible but no more than 15 minutes after influenza vaccine receipt. The number of pushups performed will be at least 80% of the participants last Army Physical Fitness Test (APFT) score in one session. The number of pushups will be recorded. A baseline lactate fingerstick blood specimen will be collected with either the serology sample (if possible) or from the hand opposite the vaccine receipt arm prior to performing pushups and a second finger stick sample within 3-8 minutes, but no more than 15 minutes after vaccine receipt.
|
|---|---|---|---|
|
Serologic Response - A/Hong Kong / 4801/2014
Baseline (day 0, visit 1)
|
221.09 Titer
Standard Deviation 263.64
|
177.78 Titer
Standard Deviation 165.489
|
149.22 Titer
Standard Deviation 146.387
|
|
Serologic Response - A/Hong Kong / 4801/2014
Followup (between 21-28 days, visit 3)
|
296.66 Titer
Standard Deviation 299.001
|
243.13 Titer
Standard Deviation 203.461
|
232.58 Titer
Standard Deviation 176.394
|
SECONDARY outcome
Timeframe: Day 0 and between 21-28 days (2 points)Baseline lab specimen (visit 1, day 0, before immunization) and repeated between 21-28 days (visit 3) after immunization to measure serologic response
Outcome measures
| Measure |
Ibuprofen
n=32 Participants
Randomized and double blinded study participants assigned to Group A intervention will receive an oral NSAID of ibuprofen 800 mgs three times a day for 48 hours.
Ibuprofen: The participants will take their first dose of the study drug immediately after influenza vaccine receipt. The medication will be blinded and dispensed by a research pharmacist. The participants will receive instructions on the dosing, frequency and a recommendation to take with food or milk and will be provided a snack with their first dose.
|
Placebo
n=32 Participants
Randomized and double blinded study participants assigned to Group B intervention will receive an oral placebo three times a day for 48 hours starting immediately after influenza vaccine receipt.
oral placebo: The participants will take their first dose of the study drug immediately after influenza vaccine receipt. The medication will be blinded and dispensed by a research pharmacist. The participants will receive instructions on the dosing, frequency and a recommendation to take with food or milk and will be provided a snack with their first dose.
|
Compound Exercise of Push-ups
n=45 Participants
Randomized study participants assigned to Group C will perform an exercise intervention of push-ups immediately after influenza vaccine receipt.
Compound Exercise of Push-ups: The participants will perform an exercise intervention of push-ups as immediately as possible but no more than 15 minutes after influenza vaccine receipt. The number of pushups performed will be at least 80% of the participants last Army Physical Fitness Test (APFT) score in one session. The number of pushups will be recorded. A baseline lactate fingerstick blood specimen will be collected with either the serology sample (if possible) or from the hand opposite the vaccine receipt arm prior to performing pushups and a second finger stick sample within 3-8 minutes, but no more than 15 minutes after vaccine receipt.
|
|---|---|---|---|
|
Serologic Response - B/Phuket/3073/2013
Baseline (day 0, visit 1)
|
36.69 Titer
Standard Deviation 44.586
|
40.16 Titer
Standard Deviation 60.321
|
32.89 Titer
Standard Deviation 33.857
|
|
Serologic Response - B/Phuket/3073/2013
Followup (between 21-28 days, visit 3)
|
44.78 Titer
Standard Deviation 43.773
|
47.34 Titer
Standard Deviation 58.976
|
49.07 Titer
Standard Deviation 39.578
|
SECONDARY outcome
Timeframe: Day 0 and between 21-28 days (2 points)Baseline lab specimen (visit 1, day 0, before immunization) and repeated between 21-28 days (visit 3) after immunization to measure serologic response
Outcome measures
| Measure |
Ibuprofen
n=32 Participants
Randomized and double blinded study participants assigned to Group A intervention will receive an oral NSAID of ibuprofen 800 mgs three times a day for 48 hours.
Ibuprofen: The participants will take their first dose of the study drug immediately after influenza vaccine receipt. The medication will be blinded and dispensed by a research pharmacist. The participants will receive instructions on the dosing, frequency and a recommendation to take with food or milk and will be provided a snack with their first dose.
|
Placebo
n=32 Participants
Randomized and double blinded study participants assigned to Group B intervention will receive an oral placebo three times a day for 48 hours starting immediately after influenza vaccine receipt.
oral placebo: The participants will take their first dose of the study drug immediately after influenza vaccine receipt. The medication will be blinded and dispensed by a research pharmacist. The participants will receive instructions on the dosing, frequency and a recommendation to take with food or milk and will be provided a snack with their first dose.
|
Compound Exercise of Push-ups
n=45 Participants
Randomized study participants assigned to Group C will perform an exercise intervention of push-ups immediately after influenza vaccine receipt.
Compound Exercise of Push-ups: The participants will perform an exercise intervention of push-ups as immediately as possible but no more than 15 minutes after influenza vaccine receipt. The number of pushups performed will be at least 80% of the participants last Army Physical Fitness Test (APFT) score in one session. The number of pushups will be recorded. A baseline lactate fingerstick blood specimen will be collected with either the serology sample (if possible) or from the hand opposite the vaccine receipt arm prior to performing pushups and a second finger stick sample within 3-8 minutes, but no more than 15 minutes after vaccine receipt.
|
|---|---|---|---|
|
Serologic Response - B/Brisbane/60/2008
Baseline (day 0, visit 1)
|
26.09 Titer
Standard Deviation 31.308
|
17.41 Titer
Standard Deviation 12.271
|
26.00 Titer
Standard Deviation 35.833
|
|
Serologic Response - B/Brisbane/60/2008
Followup (between 21-28 days, visit 3)
|
34.09 Titer
Standard Deviation 29.977
|
25.47 Titer
Standard Deviation 18.30
|
41.02 Titer
Standard Deviation 39.199
|
SECONDARY outcome
Timeframe: baseline, 48- 72 hours, 21-28 days (3 points)Population: Statistical analysis of participants with erythema post-vaccination was not performed due to no cases of erythema reported by participants or observed by research staff.
Reddening of the skin at vaccination site reported as the total number of participants with erythema over the duration of the study.
Outcome measures
| Measure |
Ibuprofen
n=233 Participants
Randomized and double blinded study participants assigned to Group A intervention will receive an oral NSAID of ibuprofen 800 mgs three times a day for 48 hours.
Ibuprofen: The participants will take their first dose of the study drug immediately after influenza vaccine receipt. The medication will be blinded and dispensed by a research pharmacist. The participants will receive instructions on the dosing, frequency and a recommendation to take with food or milk and will be provided a snack with their first dose.
|
Placebo
n=233 Participants
Randomized and double blinded study participants assigned to Group B intervention will receive an oral placebo three times a day for 48 hours starting immediately after influenza vaccine receipt.
oral placebo: The participants will take their first dose of the study drug immediately after influenza vaccine receipt. The medication will be blinded and dispensed by a research pharmacist. The participants will receive instructions on the dosing, frequency and a recommendation to take with food or milk and will be provided a snack with their first dose.
|
Compound Exercise of Push-ups
n=233 Participants
Randomized study participants assigned to Group C will perform an exercise intervention of push-ups immediately after influenza vaccine receipt.
Compound Exercise of Push-ups: The participants will perform an exercise intervention of push-ups as immediately as possible but no more than 15 minutes after influenza vaccine receipt. The number of pushups performed will be at least 80% of the participants last Army Physical Fitness Test (APFT) score in one session. The number of pushups will be recorded. A baseline lactate fingerstick blood specimen will be collected with either the serology sample (if possible) or from the hand opposite the vaccine receipt arm prior to performing pushups and a second finger stick sample within 3-8 minutes, but no more than 15 minutes after vaccine receipt.
|
|---|---|---|---|
|
Participants With Erythema
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: baseline, 48-72 hours, and 21- 28 days (3 points)Population: Statistical analysis of participants with edema post-vaccination was not performed due to no cases of edema reported by participants or observed by research staff.
Swelling at vaccination site
Outcome measures
| Measure |
Ibuprofen
n=233 Participants
Randomized and double blinded study participants assigned to Group A intervention will receive an oral NSAID of ibuprofen 800 mgs three times a day for 48 hours.
Ibuprofen: The participants will take their first dose of the study drug immediately after influenza vaccine receipt. The medication will be blinded and dispensed by a research pharmacist. The participants will receive instructions on the dosing, frequency and a recommendation to take with food or milk and will be provided a snack with their first dose.
|
Placebo
n=233 Participants
Randomized and double blinded study participants assigned to Group B intervention will receive an oral placebo three times a day for 48 hours starting immediately after influenza vaccine receipt.
oral placebo: The participants will take their first dose of the study drug immediately after influenza vaccine receipt. The medication will be blinded and dispensed by a research pharmacist. The participants will receive instructions on the dosing, frequency and a recommendation to take with food or milk and will be provided a snack with their first dose.
|
Compound Exercise of Push-ups
n=233 Participants
Randomized study participants assigned to Group C will perform an exercise intervention of push-ups immediately after influenza vaccine receipt.
Compound Exercise of Push-ups: The participants will perform an exercise intervention of push-ups as immediately as possible but no more than 15 minutes after influenza vaccine receipt. The number of pushups performed will be at least 80% of the participants last Army Physical Fitness Test (APFT) score in one session. The number of pushups will be recorded. A baseline lactate fingerstick blood specimen will be collected with either the serology sample (if possible) or from the hand opposite the vaccine receipt arm prior to performing pushups and a second finger stick sample within 3-8 minutes, but no more than 15 minutes after vaccine receipt.
|
|---|---|---|---|
|
Participants With Edema
|
0 Participants
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Immediately prior to Influenza vaccine and 3-8 minutes after Influenza vaccine was administered and after push-ups were completed.A Lactate meter was used to test the exercise group for lactate readings. Two lactate tests was performed for the exercise group at Visit 1, both pre and post Influenza vaccination. The first lactate reading was taken after the blood draw.The second lactate reading was obtained from a fingerstick from the hand opposite to the vaccination arm, ideally within 3-8 minutes after the study subject completes pushups.
Outcome measures
| Measure |
Ibuprofen
n=77 Participants
Randomized and double blinded study participants assigned to Group A intervention will receive an oral NSAID of ibuprofen 800 mgs three times a day for 48 hours.
Ibuprofen: The participants will take their first dose of the study drug immediately after influenza vaccine receipt. The medication will be blinded and dispensed by a research pharmacist. The participants will receive instructions on the dosing, frequency and a recommendation to take with food or milk and will be provided a snack with their first dose.
|
Placebo
Randomized and double blinded study participants assigned to Group B intervention will receive an oral placebo three times a day for 48 hours starting immediately after influenza vaccine receipt.
oral placebo: The participants will take their first dose of the study drug immediately after influenza vaccine receipt. The medication will be blinded and dispensed by a research pharmacist. The participants will receive instructions on the dosing, frequency and a recommendation to take with food or milk and will be provided a snack with their first dose.
|
Compound Exercise of Push-ups
Randomized study participants assigned to Group C will perform an exercise intervention of push-ups immediately after influenza vaccine receipt.
Compound Exercise of Push-ups: The participants will perform an exercise intervention of push-ups as immediately as possible but no more than 15 minutes after influenza vaccine receipt. The number of pushups performed will be at least 80% of the participants last Army Physical Fitness Test (APFT) score in one session. The number of pushups will be recorded. A baseline lactate fingerstick blood specimen will be collected with either the serology sample (if possible) or from the hand opposite the vaccine receipt arm prior to performing pushups and a second finger stick sample within 3-8 minutes, but no more than 15 minutes after vaccine receipt.
|
|---|---|---|---|
|
Lactate
Lactate before pushups
|
1.51 mmol/L
Interval 1.27 to 1.75
|
—
|
—
|
|
Lactate
Lactate after pushups
|
7.69 mmol/L
Interval 7.11 to 8.27
|
—
|
—
|
Adverse Events
Ibuprofen
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Compound Exercise of Push-ups
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ibuprofen
n=98 participants at risk
Randomized and double blinded study participants assigned to Group A intervention will receive an oral NSAID of ibuprofen 800 mgs three times a day for 48 hours.
Ibuprofen: The participants will take their first dose of the study drug immediately after influenza vaccine receipt. The medication will be blinded and dispensed by a research pharmacist. The participants will receive instructions on the dosing, frequency and a recommendation to take with food or milk and will be provided a snack with their first dose.
|
Placebo
n=100 participants at risk
Randomized and double blinded study participants assigned to Group B intervention will receive an oral placebo three times a day for 48 hours starting immediately after influenza vaccine receipt.
oral placebo: The participants will take their first dose of the study drug immediately after influenza vaccine receipt. The medication will be blinded and dispensed by a research pharmacist. The participants will receive instructions on the dosing, frequency and a recommendation to take with food or milk and will be provided a snack with their first dose.
|
Compound Exercise of Push-ups
n=102 participants at risk
Randomized study participants assigned to Group C will perform an exercise intervention of push-ups immediately after influenza vaccine receipt.
Compound Exercise of Push-ups: The participants will perform an exercise intervention of push-ups as immediately as possible but no more than 15 minutes after influenza vaccine receipt. The number of pushups performed will be at least 80% of the participants last Army Physical Fitness Test (APFT) score in one session. The number of pushups will be recorded. A baseline lactate fingerstick blood specimen will be collected with either the serology sample (if possible) or from the hand opposite the vaccine receipt arm prior to performing pushups and a second finger stick sample within 3-8 minutes, but no more than 15 minutes after vaccine receipt.
|
|---|---|---|---|
|
Reproductive system and breast disorders
dysmenhorrhea
|
0.00%
0/98 • Adverse event data was collected for each study participant beginning the day of enrollment and throughout the completion of the study at visit three day 21-28.
|
1.0%
1/100 • Number of events 1 • Adverse event data was collected for each study participant beginning the day of enrollment and throughout the completion of the study at visit three day 21-28.
|
0.00%
0/102 • Adverse event data was collected for each study participant beginning the day of enrollment and throughout the completion of the study at visit three day 21-28.
|
Additional Information
Laurie Housel
Defense Health Agency Immunization Healthcare Division South Atlantic Region Vaccine Safety hub
Phone: 910-432-4015
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place