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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00231907 |
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Date of registration:
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30/09/2005 |
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Primary sponsor: |
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Public title:
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A Phase I Safety and Immunogenicity Study of Mix and Match of Licensed Flu Vaccine and Flumist
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Scientific title:
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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 |
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Date of first enrolment:
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September 2005 |
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Target sample size:
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56 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00231907 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention
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Countries of recruitment
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United States
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Key inclusion & exclusion criteria
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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.
Age minimum:
12 Months
Age maximum:
35 Months
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Influenza
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Intervention(s)
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Biological: FluMist
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Biological: Fluzone
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Primary Outcome(s)
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Assessment of post-dose 2 HAI (Hemagglutination Inhibition) antibodies to each of the 3 strains of influenza contained in the vaccine.
[Time Frame: Blood sample taken on day 0, 28 + 7, day 60 +/- 4.]
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Safety assessment of each of the vaccines in combination vaccine.
[Time Frame: Duration of study.]
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Secondary Outcome(s)
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Assessment of secretory IgA in nasal wash samples manifested after 1 or 2 doses of vaccine.
[Time Frame: Nasal wash samples will be colllected on Days 0, 30, and 60.]
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CMI
[Time Frame: Blood sample taken on Day 0, Day 28 + 7, Day 60 +/- 4.]
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Post-dose 1 HAI (Hemagglutination Inhibition) antibody titers and viral shedding.
[Time Frame: Day 3 to 5 post LAIV vaccination.]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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