A Phase I Safety and Immunogenicity Study of Mix and Match of Licensed Flu Vaccine and Flumist
Influenza
About this trial
This is an interventional prevention trial for Influenza focused on measuring influenza, vaccine, TIV, LAIV, booster, children
Eligibility Criteria
Inclusion Criteria: Twelve to 35 months of age at enrollment. Minimum weight of 8 kg. In good health, as determined by parent/guardian verbal medical history and physical examination by clinical investigator. Parent/guardian available by telephone for safety data collection through 6 months post-dose 2. Ability of parent/guardian to understand and comply with the requirements of the protocol. Signed informed consent document and Health Insurance Portability and Accountability Act (HIPAA) authorization by the parent/guardian prior to performance of any study procedures. Exclusion Criteria: History of hypersensitivity to any component of LAIV or TIV, including egg or egg products. History of hypersensitivity to gentamicin. Known or suspected immune deficiency diseases or immunosuppressed or have altered or compromised immune status as a consequence of treatment with immunosuppressive therapies. Known close contact with a severely immunocompromised person, such as someone currently in isolation secondary to a bone marrow transplantation (LAIV recipients should avoid close contact with severely immunocompromised individuals for at least 7 days after vaccination). History of chronic underlying medical conditions such as chronic disorders of the cardiovascular and pulmonary systems, chronic metabolic diseases (including diabetes), renal dysfunction, or hemoglobinopathies. History of Guillain-Barré syndrome. History of asthma or reactive airways disease. Acute febrile (>99.6 degrees Fahrenheit axillary) and/or respiratory illness, within the 72 hours prior to enrollment. Use of aspirin or aspirin containing products in the month prior to enrollment or anticipated use during the study. Administration of any intranasal medication within 2 weeks prior to enrollment or expected receipt during this study. Previous receipt of an influenza vaccine. Administration of any live virus vaccine within 4 weeks prior to enrollment or (other than study vaccine) planned receipt of another live virus vaccine before completion of the 2 weeks after the last vaccination in this study* Administration of any inactivated vaccine within 2 weeks prior to enrollment or planned receipt of another inactivated vaccine before 2 weeks after the last vaccination in this study* Participation in another investigational trial or administration of any investigational drug within 1 month prior to enrollment or during this study. Any condition that in the opinion of the investigator would interfere with the interpretation or evaluation of the vaccine. Routine immunizations can be resumed after the memory aid period following dose 2.
Sites / Locations
- Saint Louis University
- Cincinnati Children's Hospital Medical Center
- Vanderbilt University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Experimental
Experimental
Experimental
Vaccine 1: TIV. Vaccine 2: TIV.
Vaccine 1: LAIV. Vaccine 2: TIV.
Vaccine 1: LAIV. Vaccine 2: LAIV.
Vaccine 1: TIV. Vaccine 2: LAIV.
Vaccine 1: TIV. Vaccine 2: TIV.
Vaccine 1: LAIV. Vaccine 2: TIV.
Vaccine 1: LAIV. Vaccine 2: LAIV.
Vaccine 1: TIV. Vaccine 2: LAIV.