Fever After Simultaneous Versus Sequential Vaccination in Young Children

Inclusion criteria

• 12 through 16 months of age (i.e. from the 1-year birthday until the day before 17 months of age) at the time of vaccination
• Stable health as determined by investigator's clinical examination and assessment of child's medical history
• Has received all immunizations recommended by Advisory Committee for Immunization Practices (ACIP) during the first year of life with the exception of rotavirus and influenza vaccines.
• The parent(s)/ legally authorized representative(s) LAR(s) intend for the child to receive DTaP and PCV13 in addition to this season's IIV
• The parent(s)/LAR(s) must be willing and capable of providing permission for their child to participate through the written informed consent process
• The parent(s)/LAR(s) must be able to comply with the requirements of the protocol (e.g., completion of the memory aid (either electronic or paper diary), return for follow-up visits, respects intervals between the visits and have telephone access.
• The parent(s)/LAR(s) must be English speaking
• The parent(s)/LAR(s) 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

• History of any seizure (including febrile seizure) in the child or a febrile seizure in a first degree relative
• Has already completed influenza vaccination during the current season per ACIP recommendations
• Receipt of more than 3 previous doses of DTaP
• Received the 3rd dose of DTaP within 6 months of Visit 1
• Receipt of more than 3 previous doses of PCV13
• Received the 3rd dose of PCV13 within 8 weeks of Visit 1
• 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.
• 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.
• History of Guillain-Barré syndrome within 6 weeks following a prior dose of influenza, DTaP, or tetanus toxoid containing vaccine
• History of a progressive neurologic disorder
• History of encephalopathy within 7 days of a previous pertussis-containing vaccine
• History of collapse within 3 days after a prior dose of DTaP
• Received any other licensed vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to Visit 1
• 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)
• A moderate to severe acute illness within 72 hours of Visit 1
• 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
• Receipt of an antipyretic medication (acetaminophen or ibuprofen) within 24 hours prior to enrollment
• 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
• 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
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and or their provider's routine physical examination
• Has an active neoplastic disease, a history of any hematologic malignancy, current bleeding disorder, or taking anticoagulants.
• Unable to receive an intramuscular injection in the thigh
• Any condition deemed by the investigator to place the child at increased risk as a result of their participation in the study
• Any child or grandchild of a study investigator or study team member