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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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The purpose of this clinical investigation is to evaluate the efficacy and immunologic effects of a non-pharmacological exercise intervention (push-ups) compared to an oral NSAID (ibuprofen) and an oral placebo to decrease local injection site inflammation symptoms of delayed pain, erythema, and edema and any impact on serologic antibody immune response after influenza vaccine receipt.
The study will evaluate the efficacy and immunologic effects of a non-pharmacological exercise intervention (push-ups) compared to an oral NSAID (ibuprofen) and a blinded oral placebo to decrease local injection site inflammation symptoms of delayed pain, erythema, and edema and any impact on serologic antibody immune response after influenza vaccine receipt. A healthy military cohort will be randomly assigned to either perform push-ups consistent with their army physical fitness score, or to take a blinded oral medication which will be an NSAID (ibuprofen) or an oral placebo. The study will require three visits for assessment: on the day of vaccine receipt, 48-72 hours later and 21 -28 days later. The assessment visits will include injection site inspection, an injection site photograph, completion of symptom diaries and a validated pain scale and a laboratory blood specimen at the first and third visit to measure antibody level changes. The exercise participants will also be required to provide 1-2 fingerstick blood samples to evaluate for lactate, which is a byproduct of anaerobic exercise to measure if level of exercise effort achieved anaerobic metabolism. The study will evaluate if either of the interventions impacted perceived delayed pain, physical signs of inflammation or antibody response as measured by serology.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ibuprofen | Experimental | 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. |
|
| Placebo | Placebo Comparator | 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. |
|
| Compound Exercise of Push-ups | Experimental | Randomized study participants assigned to Group C will perform an exercise intervention of push-ups immediately after influenza vaccine receipt. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibuprofen | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Level of Pain | 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). | baseline, 48-72 hours and at 21-28 days ( 3 points ) |
| Measure | Description | Time Frame |
|---|---|---|
| Serologic Response - A/California/7/2009 | Baseline lab specimen (visit 1, day 0, before immunization) and repeated between 21-28 days (visit 3) after immunization to measure serologic response | Day 0 and between 21-28 days (2 points) |
| Serologic Response - A/Hong Kong / 4801/2014 |
| Measure | Description | Time Frame |
|---|---|---|
| Lactate | 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. |
Inclusion Criteria:
Must:
Exclusion Criteria:
Must Not:
Have already received influenza vaccine for the current season.
Have received any type of vaccine in the previous 72 hours.
Be on a medical profile resulting in current profile exemption from Physical Training of Upper 2 or Upper 3. (Upper extremity injury or illness)
Have preexisting symptoms of injury or infection or other local symptoms that would interfere with site assessment.
Be pregnant.
Have a history of allergy, intolerance, stomach bleeding or other medical exclusion for ibuprofen.
Have a history of stroke or coronary artery disease, such as uncontrolled high blood pressure or abnormal heart beat.
Has taken any topical or oral pain medications from the following medication classes in the past 24 hours prior to the start of the study: oral acetaminophen, opioids, tramadol, nonsteroidal anti-inflammatory drug (NSAID) or acetylsalicylic acid (ASA) or topical pain relievers or counterirritants of menthol, methyl salicylate, camphor menthols, and capsaicins.
Have any chronic or acute illness or treatment causing immunological suppression such as current oral steroid therapy, malignancy or chemotherapy or lung disease. (not including controlled asthma)
Currently participating in any other study
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| Name | Affiliation | Role |
|---|---|---|
| Laurie A. Housel, MSN,FNP | Defense Health Agency Immunization Healthcare Branch | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Walter Reed National Military Medical Center | Bethesda | Maryland | 20889-5600 | United States | ||
| Womack Army Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8594118 | Background | Abbott K, Fowler-Kerry S. The use of a topical refrigerant anesthetic to reduce injection pain in children. J Pain Symptom Manage. 1995 Nov;10(8):584-90. doi: 10.1016/0885-3924(95)00086-0. | |
| 24501164 | Background | Abuelkheir M, Alsourani D, Al-Eyadhy A, Temsah MH, Meo SA, Alzamil F. EMLA(R) cream: a pain-relieving strategy for childhood vaccination. J Int Med Res. 2014 Apr;42(2):329-36. doi: 10.1177/0300060513509473. Epub 2014 Feb 5. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Level of Pain | 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). | Posted | Mean | Standard Deviation | units on a scale | baseline, 48-72 hours and at 21-28 days ( 3 points ) |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| dysmenhorrhea | Reproductive system and breast disorders | ICD-10 | Systematic Assessment | Subject c/o lower abdominal pain after taking drug dose #3; seen clinically. Subject was unblinded and determined to have taken placebo and not study related, other than didn't take usual ibuprofen for menstrual cramps due to study participation. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Laurie Housel | Defense Health Agency Immunization Healthcare Division South Atlantic Region Vaccine Safety hub | 910-432-4015 | laurie.a.housel.civ@mail.mil |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 1, 2018 | May 20, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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|
|
| Compound Exercise of Push-ups | Behavioral | 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. |
|
|
| oral placebo | Drug | 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. |
|
|
Baseline lab specimen (visit 1, day 0, before immunization) and repeated between 21-28 days (visit 3) after immunization to measure serologic response |
| Day 0 and between 21-28 days (2 points) |
| Serologic Response - B/Phuket/3073/2013 | Baseline lab specimen (visit 1, day 0, before immunization) and repeated between 21-28 days (visit 3) after immunization to measure serologic response | Day 0 and between 21-28 days (2 points) |
| Serologic Response - B/Brisbane/60/2008 | Baseline lab specimen (visit 1, day 0, before immunization) and repeated between 21-28 days (visit 3) after immunization to measure serologic response | Day 0 and between 21-28 days (2 points) |
| Participants With Erythema | Reddening of the skin at vaccination site reported as the total number of participants with erythema over the duration of the study. | baseline, 48- 72 hours, 21-28 days (3 points) |
| Participants With Edema | Swelling at vaccination site | baseline, 48-72 hours, and 21- 28 days (3 points) |
| Immediately prior to Influenza vaccine and 3-8 minutes after Influenza vaccine was administered and after push-ups were completed. |
| Fort Bragg |
| North Carolina |
| 28310 |
| United States |
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| 21098067 | Background | Taddio A, Appleton M, Bortolussi R, Chambers C, Dubey V, Halperin S, Hanrahan A, Ipp M, Lockett D, MacDonald N, Midmer D, Mousmanis P, Palda V, Pielak K, Riddell RP, Rieder M, Scott J, Shah V. Reducing the pain of childhood vaccination: an evidence-based clinical practice guideline (summary). CMAJ. 2010 Dec 14;182(18):1989-95. doi: 10.1503/cmaj.092048. Epub 2010 Nov 22. No abstract available. |
| 19781434 | Background | Taddio A, Chambers CT, Halperin SA, Ipp M, Lockett D, Rieder MJ, Shah V. Inadequate pain management during routine childhood immunizations: the nerve of it. Clin Ther. 2009;31 Suppl 2:S152-67. doi: 10.1016/j.clinthera.2009.07.022. |
| 19781436 | Background | Taddio A, Ilersich AL, Ipp M, Kikuta A, Shah V; HELPinKIDS Team. Physical interventions and injection techniques for reducing injection pain during routine childhood immunizations: systematic review of randomized controlled trials and quasi-randomized controlled trials. Clin Ther. 2009;31 Suppl 2:S48-76. doi: 10.1016/j.clinthera.2009.07.024. |
| 20121985 | Background | Woods JA, Keylock KT, Lowder T, Vieira VJ, Zelkovich W, Dumich S, Colantuano K, Lyons K, Leifheit K, Cook M, Chapman-Novakofski K, McAuley E. Cardiovascular exercise training extends influenza vaccine seroprotection in sedentary older adults: the immune function intervention trial. J Am Geriatr Soc. 2009 Dec;57(12):2183-91. doi: 10.1111/j.1532-5415.2009.02563.x. |
| 18661769 | Background | Yalcin SS, Gumus A, Yurdakok K. Prophylactic use of acetaminophen in children vaccinated with diphtheria-tetanus-pertussis. World J Pediatr. 2008 May;4(2):127-9. doi: 10.1007/s12519-008-0025-7. |
| Background | Afluria US Package Insert for 2015-2016. 2015. bioCSL version 44. Retrieved from http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM263239.pdf |
| Background | Defense Health Agency (2004). Clinical guidelines for managing adverse events after vaccination. Defense Health Agency Immunization Health Care Branch. US Army Medical Command, Falls Church, VA. |
| Background | Díez-Domingo, J., Planelles, M., Baldó, J., Ballester, A., Núñez, F., Jubert, A., & Dominguez-Granados, R. (1998). Ibuprofen prophylaxis for adverse reactions to diphtheria-tetanus-pertussis vaccination: a randomized trial. Current Therapeutic Research, 59(8), 579-588. |
| Background | Fluarix US Package Insert. 2014. GlaxoSmithKline. |
| Background | Fluzone US Package Insert. June 2014. Sanofi Pasteur, Inc. |
| Background | Flublock US Package Insert. October 2014. Protein Sciences Corporation |
| Background | Flucelvax US Package Insert. March 2014. Novartis Vaccines and Diagnostics, Inc. |
| Background | Flulavel US Package Insert. May 2014. GlaxoSmithKline. |
| Background | Fluvirin US Package Insert. April 2014. Novartis Vaccines and Diagnostics, Inc. |
| Background | Hayat, H., Khan, Parwez S. & Hayat, G. (2011). The effect of prophylactic paracetamol administration on adverse reactions following DTP vaccination. Eastern Journal of Medicine 16, 258-260. |
| 10573666 | Background | Schuler PB, Lloyd LK, Leblanc PA, Clapp TA, Abadie BR, Collins RK. The effect of physical activity and fitness on specific antibody production in college students. J Sports Med Phys Fitness. 1999 Sep;39(3):233-9. |
| 14748456 | Background | Whitham M, Blannin AK. The effect of exercise training on the kinetics of the antibody response to influenza vaccination. J Sports Sci. 2003 Dec;21(12):991-1000. doi: 10.1080/0264041031000140464. |
| incomplete blood draw |
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| BG001 | 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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. |
| OG002 | 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. |
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| Secondary | Serologic Response - A/California/7/2009 | Baseline lab specimen (visit 1, day 0, before immunization) and repeated between 21-28 days (visit 3) after immunization to measure serologic response | Posted | Mean | Standard Deviation | Titer | Day 0 and between 21-28 days (2 points) |
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| Secondary | Serologic Response - A/Hong Kong / 4801/2014 | Baseline lab specimen (visit 1, day 0, before immunization) and repeated between 21-28 days (visit 3) after immunization to measure serologic response | Posted | Mean | Standard Deviation | Titer | Day 0 and between 21-28 days (2 points) |
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| Secondary | Serologic Response - B/Phuket/3073/2013 | Baseline lab specimen (visit 1, day 0, before immunization) and repeated between 21-28 days (visit 3) after immunization to measure serologic response | Posted | Mean | Standard Deviation | Titer | Day 0 and between 21-28 days (2 points) |
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| Secondary | Serologic Response - B/Brisbane/60/2008 | Baseline lab specimen (visit 1, day 0, before immunization) and repeated between 21-28 days (visit 3) after immunization to measure serologic response | Posted | Mean | Standard Deviation | Titer | Day 0 and between 21-28 days (2 points) |
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| Secondary | Participants With Erythema | Reddening of the skin at vaccination site reported as the total number of participants with erythema over the duration of the study. | 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. | Posted | Count of Participants | Participants | baseline, 48- 72 hours, 21-28 days (3 points) |
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| Secondary | Participants With Edema | Swelling at vaccination site | 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. | Posted | Count of Participants | Participants | baseline, 48-72 hours, and 21- 28 days (3 points) |
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| Other Pre-specified | Lactate | 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. | Posted | Mean | 95% Confidence Interval | mmol/L | Immediately prior to Influenza vaccine and 3-8 minutes after Influenza vaccine was administered and after push-ups were completed. |
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| 0 |
| 98 |
| 0 |
| 98 |
| 0 |
| 98 |
| EG001 | 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. | 0 | 100 | 0 | 100 | 1 | 100 |
| EG002 | 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. | 0 | 102 | 0 | 102 | 0 | 102 |
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| D002241 |
| Carbohydrates |
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