A Phase I Safety and Immunogenicity Study of Mix and Match of Licensed Flu Vaccine and Flumist
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
1 other identifier
interventional
56
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Sep 2005
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 30, 2005
CompletedFirst Posted
Study publicly available on registry
October 4, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2007
CompletedAugust 27, 2010
February 1, 2010
1.5 years
September 30, 2005
August 26, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
Safety assessment of each of the vaccines in combination vaccine.
Duration of study.
Secondary Outcomes (3)
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.
CMI
Blood sample taken on Day 0, Day 28 + 7, Day 60 +/- 4.
Post-dose 1 HAI (Hemagglutination Inhibition) antibody titers and viral shedding.
Day 3 to 5 post LAIV vaccination.
Study Arms (4)
Vaccine 1: TIV. Vaccine 2: TIV.
ACTIVE COMPARATORVaccine 1: TIV. Vaccine 2: TIV.
Vaccine 1: LAIV. Vaccine 2: TIV.
EXPERIMENTALVaccine 1: LAIV. Vaccine 2: TIV.
Vaccine 1: LAIV. Vaccine 2: LAIV.
EXPERIMENTALVaccine 1: LAIV. Vaccine 2: LAIV.
Vaccine 1: TIV. Vaccine 2: LAIV.
EXPERIMENTALVaccine 1: TIV. Vaccine 2: LAIV.
Interventions
Live attenuated influenza vaccine (LAIV) containing approximately 10\^7 TCID50 of each of the 3 influenza strains. 0.5 mL total dose volume administered intranasally via spray applicator (approximately 0.25 mL into each nostril). Administration of Flumist in children under 5 years of age is investigational.
Trivalent inactivated vaccine (TIV), licensed Fluzone preservative free pediatric dose, 0.25 mL administered intramuscularly to the anterolateral thigh muscle or deltoid muscle.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Saint Louis University
St Louis, Missouri, 63104, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Vanderbilt University
Nashville, Tennessee, 37232, United States
Related Publications (1)
Hoft DF, Babusis E, Worku S, Spencer CT, Lottenbach K, Truscott SM, Abate G, Sakala IG, Edwards KM, Creech CB, Gerber MA, Bernstein DI, Newman F, Graham I, Anderson EL, Belshe RB. Live and inactivated influenza vaccines induce similar humoral responses, but only live vaccines induce diverse T-cell responses in young children. J Infect Dis. 2011 Sep 15;204(6):845-53. doi: 10.1093/infdis/jir436. Epub 2011 Aug 15.
PMID: 21846636DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- NIH
Study Record Dates
First Submitted
September 30, 2005
First Posted
October 4, 2005
Study Start
September 1, 2005
Primary Completion
March 1, 2007
Study Completion
March 1, 2007
Last Updated
August 27, 2010
Record last verified: 2010-02