The Effect of Prophylactic Antipyretics on Immune Responses and Fever After 2014-2015 and 2015-2016 Inactivated Influenza Vaccine

Inclusion Criteria:

1. The child must be 6 through 47 months of age.

2. The child must weigh 5.4 kilograms.

3. The child must be receiving IIV this season.

4. 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.

5. The parent/guardian must be willing and capable of providing written informed consent
for the child.

6. The parent/guardian must be available for follow-up and must at minimum have telephone
access.

7. 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 Criteria:

1. History of receipt of current year's licensed influenza vaccine.

2. Planned receipt of the live attenuated nasally administered influenza vaccine this
year

3. 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.

4. History of a severe allergic reaction (e.g. anaphylaxis) following a prior dose of
influenza vaccine.

5. History of an allergic reaction following acetaminophen or ingredients in the
acetaminophen product.

6. History of an allergic reaction following ibuprofen or ingredients in the ibuprofen
product.

7. History of an allergic reaction following aspirin or other pain reliever or fever
reducer.

8. History of liver disease.

9. Currently taking the blood thinning drug warfarin (Coumadin) or other blood thinners.

10. History of recent or planned heart surgery within the past 3 months or next 3 months.

11. History of stomach ulcer or bleeding problem.

12. Currently already routinely taking prescription or nonprescription non-steroidal
anti-inflammatory drugs or NSAIDs (aspirin, ibuprofen, naproxen, or others)

13. 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.

14. 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.

15. 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).

16. 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).

17. 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).

18. Immunosuppression as a result of an underlying illness or treatment, or use of
anti-cancer chemotherapy or radiation therapy within the preceding 36 months.

19. 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).

20. History of Guillain-Barré syndrome within 6 weeks of a prior dose of influenza
vaccine.

21. 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.