Status:
COMPLETED
The Effect of Prophylactic Antipyretics on Immune Responses and Fever After 2014-2015 and 2015-2016 Inactivated Influenza Vaccine
Lead Sponsor:
Duke University
Collaborating Sponsors:
Centers for Disease Control and Prevention
Conditions:
Fever
Eligibility:
All Genders
6-47 years
Phase:
NA
Brief Summary
This study aims to conduct a double-blind, placebo-controlled study to assess the effect of prophylactic antipyretics on the immune responses and rates of fever after inactivated influenza vaccine (II...
Eligibility Criteria
Inclusion
- The child must be 6 through 47 months of age.
- The child must weigh 5.4 kilograms.
- The child must be receiving IIV this season.
- If the child is two years of age or older and needs two doses of influenza vaccine this season the parent/guardian intends for the child to receive IIV for the second dose.
- The parent/guardian must be willing and capable of providing written informed consent for the child.
- The parent/guardian must be available for follow-up and must at minimum have telephone access.
- The parent/guardian must agree to sign a medical release for the child so that study personnel may obtain medical information about the child's health (if needed).
Exclusion
- History of receipt of current year's licensed influenza vaccine.
- Planned receipt of the live attenuated nasally administered influenza vaccine this year
- History of a severe allergic reaction (e.g. anaphylaxis) to any component of influenza vaccine, including egg protein, formaldehyde, octylphenol ethoxylate, gelatin, or thimerosal if using thimerosal containing vaccine.
- History of a severe allergic reaction (e.g. anaphylaxis) following a prior dose of influenza vaccine.
- History of an allergic reaction following acetaminophen or ingredients in the acetaminophen product.
- History of an allergic reaction following ibuprofen or ingredients in the ibuprofen product.
- History of an allergic reaction following aspirin or other pain reliever or fever reducer.
- History of liver disease.
- Currently taking the blood thinning drug warfarin (Coumadin) or other blood thinners.
- History of recent or planned heart surgery within the past 3 months or next 3 months.
- History of stomach ulcer or bleeding problem.
- Currently already routinely taking prescription or nonprescription non-steroidal anti-inflammatory drugs or NSAIDs (aspirin, ibuprofen, naproxen, or others)
- Received any other licensed vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to vaccination in this study or expects to receive a licensed vaccine during the 28 days following the last influenza vaccination in this study. Concomitant vaccinations are not allowed.
- Routine immunizations are delayed or will be delayed by not being able to receive a concomitantly administered vaccine or a needed vaccine in the 28 days following the last influenza vaccination in this study.
- Received an experimental/investigational agent (vaccine, drug, biologic, device, blood product, or medication) within 28 days prior to vaccination in this study, or expects to receive an experimental/investigational agent within the follow-up time period (28 days after the last vaccination in this study).
- A moderate to severe acute illness and/or a reported temperature greater than or equal to 100.0°F (37.8°C) within 72 hours prior to first dose of IIV or an axillary temperature greater than or equal to 100.0°F (37.8°C) at the time of enrollment. (This may result in a temporary delay of vaccination. For those needing a second dose of IIV, a moderate to severe acute illness and/or a reported temperature greater than or equal to 100.0°F (37.8°C) within 72 hours prior to second dose of IIV may result in a temporary delay of vaccination).
- Receipt of an antipyretic medication (acetaminophen or ibuprofen) within 72 hours prior to the first dose of IIV (This may result in a temporary delay of vaccination) or is already planning to administer a prophylactic antipyretic medication on the day of and the day following any dose of IIV (this exclusion does not apply if the caretaker indicates he/she might administer antipyretics after vaccination to reduce a fever).
- Immunosuppression as a result of an underlying illness or treatment, or use of anti-cancer chemotherapy or radiation therapy within the preceding 36 months.
- Long term (at least 14 days of prednisone 2 mg/kg/day or equivalent other glucocorticoid), any parenteral steroids, high-dose inhaled steroids (\>800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding 6 months (topical and nasal steroids are allowed).
- History of Guillain-Barré syndrome within 6 weeks of a prior dose of influenza vaccine.
- Has any condition that would, in the opinion of the site investigator, place the participant at an unacceptable risk of injury or render the participant unable to meet the requirements of the protocol.
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT02212990
Start Date
September 1 2014
End Date
March 1 2016
Last Update
February 7 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Duke University Health System
Durham, North Carolina, United States, 27710