Fever After Simultaneous Versus Sequential Vaccination in Young Children

Exclusion Criteria

• •1. History of any seizure (including febrile seizure) in the child or a febrile seizure in a first degree relative
• •2. Has already completed influenza vaccination during the current season per ACIP recommendations
• •3. Receipt of more than 3 previous doses of DTaP
• •4. Received the 3rd dose of DTaP within 6 months of Visit 1
• •5. Receipt of more than 3 previous doses of PCV13
• •6. Received the 3rd dose of PCV13 within 8 weeks of Visit 1
• •7. History of a severe allergic reaction (e.g. anaphylaxis) to a previous dose of any influenza, diphtheria toxoid-, tetanus toxoid-, or pertussis-containing vaccine, or pneumococcal vaccine.
• •8. History of a severe allergic reaction (e.g., anaphylaxis) to any component (including egg protein) of any of the three vaccines used in this study; or a latex allergy.
• •9. History of Guillain-Barré syndrome within 6 weeks following a prior dose of influenza, DTaP, or tetanus toxoid containing vaccine
• •10. History of a progressive neurologic disorder
• •11. History of encephalopathy within 7 days of a previous pertussis-containing vaccine
• •12. History of collapse within 3 days after a prior dose of DTaP
• •13. Received any other licensed vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to Visit 1
• •14. Received an experimental/investigational agent (vaccine, drug, biologic, device, blood product, or medication) within 28 days prior to Visit 1, or expects to receive an experimental/investigational agent during the study period (up to 8 days after visit 2)
• •15. A moderate to severe acute illness within 72 hours of Visit 1
• •16. A reported temperature greater than or equal to 100.4°F (38.0°C) within 72 hours prior enrollment or a temperature (measured by temporal artery thermometer) greater than or equal to 100.4°F (38.0°C) at the time of enrollment
• •17. Receipt of an antipyretic medication (acetaminophen or ibuprofen) within 24 hours prior to enrollment
• •18. Parent(s)/LAR is planning to administer a prophylactic antipyretic or medication on the day of, and/or within 7 days following Visit 1 or Visit 2
• •19. Long term (at least 14 consecutive days) oral corticosteroids (prednisone 2 mg/kg/day or equivalent other glucocorticoid), any parenteral steroids, high-dose inhaled steroids (\>800 mcg/day of beclomethasone dipropionate or equivalent) or other immune-modifying drugs or immunosuppressants within the preceding 6 months prior to Visit 1
• •20. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and or their provider's routine physical examination
• •21. Has an active neoplastic disease, a history of any hematologic malignancy, current bleeding disorder, or taking anticoagulants.
• •22. Unable to receive an intramuscular injection in the thigh
• •23. Any condition deemed by the investigator to place the child at increased risk as a result of their participation in the study
• •24. Any child or grandchild of a study investigator or study team member