Influenza Clinical Trial
Official title:
Influenza Vaccines: Mix and Match of Trivalent Inactivated Influenza (TIV) and Live Attenuated Influenza Vaccine (LAIV), a Phase I Safety, Immunogenicity, and Viral Shedding Study
The purpose of this research is to compare the safety and ability to stimulate antibodies (part of the bodies proteins that fight infections) of two influenza (flu) vaccines given to children 12 to 35 months old. The two flu vaccines being compared are: trivalent inactivated influenza virus vaccine (TIV), a killed virus vaccine given as a shot licensed for use in children 6 months of age or older and live attenuated influenza vaccine (LAIV), a live (but weakened) virus vaccine licensed for children 5 years old and older given as a nose spray. The strains of the viruses have been weakened so that they do not cause typical influenza illness, but may allow the body to develop protection against the flu. LAIV vaccine is not licensed for children less than five years of age, therefore its use in this study is investigational. Participation is approximately 7 months in duration.
Status | Completed |
Enrollment | 56 |
Est. completion date | March 2007 |
Est. primary completion date | March 2007 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 12 Months to 35 Months |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio |
United States | Vanderbilt University | Nashville | Tennessee |
United States | Saint Louis University | St. Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
National Institute of Allergy and Infectious Diseases (NIAID) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assessment of post-dose 2 HAI (Hemagglutination Inhibition) antibodies to each of the 3 strains of influenza contained in the vaccine. | Blood sample taken on day 0, 28 + 7, day 60 +/- 4. | No | |
Primary | Safety assessment of each of the vaccines in combination vaccine. | Duration of study. | Yes | |
Secondary | Assessment of secretory IgA in nasal wash samples manifested after 1 or 2 doses of vaccine. | Nasal wash samples will be colllected on Days 0, 30, and 60. | No | |
Secondary | CMI | Blood sample taken on Day 0, Day 28 + 7, Day 60 +/- 4. | No | |
Secondary | Post-dose 1 HAI (Hemagglutination Inhibition) antibody titers and viral shedding. | Day 3 to 5 post LAIV vaccination. | No |
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