Do NSAIDS or Executing Exercise Decrease Local Erythema, Site Swelling & Pain After INoculation

NACompletedINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

September 30, 2016

Primary Completion Date

December 31, 2018

Study Completion Date

December 31, 2018

Conditions
Immune System and Related Disorders
Interventions
DRUG

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.

BEHAVIORAL

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.

DRUG

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.

Trial Locations (2)

28310

Womack Army Medical Center, Fort Bragg

20889-5600

Walter Reed National Military Medical Center, Bethesda

All Listed Sponsors
collaborator

United States Department of Defense

FED

lead

Womack Army Medical Center

FED

NCT02807623 - Do NSAIDS or Executing Exercise Decrease Local Erythema, Site Swelling & Pain After INoculation | Biotech Hunter | Biotech Hunter