Clinical Immunization Safety Assessment (CISA) Project: Pilot Study to Assess the Effect of Prophylactic Antipyretics on Immune Responses and Fever After IIV

Inclusion Criteria:

To be eligible for inclusion in the study the following enrollment criteria must be met:

1. The child must be 12 through 35 months of age.

2. The child must only need a single dose of IIV during the current season. (Children
only need 1 dose of vaccine in 2013-14 if they received a total of 2 or more doses of
seasonal vaccine since July 1, 2010. Children who did not receive a total of 2 or
more doses of seasonal vaccine since July 1, 2010 require 2 doses in 2013-14).[19]

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

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

5. 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:

Participants must not have any of the following:

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

2. 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.

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

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

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

6. History of liver disease.

7. Currently taking the blood thinning drug warfarin (Coumadin).

8. 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 vaccination in this study.
Concomitant vaccinations are not allowed.

9. 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
receipt of the influenza vaccine.

10. 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).

11. 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).

12. 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 IIV (this exclusion does not apply if the caretaker
indicates he/she might administer antipyretics after vaccination to reduce a fever).

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

14. 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).

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

16. 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.