Influenza Vaccine Feasibility Study in Children With Persistent Asthma

• Status: Completed
• Trial end date: 2017-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed to note whether a larger safety study using quadrivalent live attenuated influenza vaccine (LAIV4) versus quadrivalent inactivated influenza vaccine (IIV4)(FLUARIX®), would be feasible in children with persistent asthma. Half of the patients in this study will receive the FLUARIX® influenza vaccine, while the other half will receive a cell cultured quadrivalent inactivated influenza vaccine (ccIIV4)(Flucelvax®) being used as a surrogate for LAIV4.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanderbilt University; Vanderbilt University Medical Center
• Collaborators: Centers for Disease Control and Prevention; Children's Hospital Medical Center, Cincinnati; Duke University

Criteria

Inclusion Criteria:

• Children between 5-11 years of age, inclusive, at enrollment.

• Participant must have a current diagnosis of persistent asthma.

• Parent/legal guardian must provide written informed consent and subject must provide assent as appropriate for age prior to initiation of study procedures and according to local Institutional Review Board (IRB) requirement.

• Parent/legal guardian and subject must be willing and able to comply with planned study procedures and be available for all study visits.

• Children aged 5-8 years must have received at least 2 doses of seasonal trivalent or quadrivalent influenza vaccine prior to the current influenza season. Children 9-11 years must have received at least 1 dose of seasonal trivalent or quadrivalent influenza vaccine prior to the current influenza season.

• Is in good health, other than their asthma, as determined by medical history and targeted physical examination based on medical history.

• English or Spanish literate.

• Intention of being available for entire study period and complete all relevant study procedures, including follow-up phone calls and collection of information.

Exclusion Criteria:

• Acute illness and/or a reported oral temperature of ≥ 100.4°F within 72 hours prior to enrollment (this may result in a temporary delay of vaccination.

• Use of antipyretic medication during the preceding 24 hours that might mask a fever (temporary deferral).

• History of a severe allergic reaction (e.g., anaphylaxis) to any component of study influenza vaccines or a known allergy to eggs.

• Receipt of any licensed vaccine within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to vaccination or planned receipt of any licensed vaccine within 42 days after vaccination.

• Receipt of current year's licensed influenza vaccine.

• Received an investigational agent (licensed or unlicensed vaccine, drug, biologic, device, blood product, or medication) in the 28 days prior to enrollment or planned receipt before 42 days after vaccination.

• Has immunosuppression as a result of an underlying illness or treatment, or use of anticancer chemotherapy or radiation therapy within the preceding 36 months.

• Has taken ≥ 20mg/day of prednisone or its equivalent, for 14 days or more within the past 28 days.

• Has know active neoplasm or a history of any hematologic malignancy.

• Has had a previous exacerbation of their asthma symptoms requiring systemic steroids within the prior 28 days, or has had a life-threatening exacerbation of asthma in the past two years (e.g. hypoxic seizure, mechanical ventilation).

• History of Guillian-Barre syndrome within 6 weeks of previous influenza vaccination.

• Has any condition that, in the opinion of the investigator, would interfere with the evaluation of the responses or would place the participant at unacceptable risk of injury.

• Has any diagnosis, current or past, of schizophrenia, bipolar disease, or other major psychiatric disorder.

• Currently taking aspirin or aspirin-containing products.