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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00133523 |
The purpose of this study is to compare 2 licensed flu vaccines to each other and to placebo (inactive substance). The study will be conducted among healthy adult participants aged 18-49 years and is expected to last 3 years. During year 1, participants will be assigned to receive 1 of the 2 licensed flu vaccines or placebo, given as either nasal spray (live-attenuated vaccine or placebo) or injection (inactivated vaccine or placebo). Participants will receive the same assigned vaccine or placebo during year 2. During year 3, participants will be followed, but will not receive flu vaccine. Each year blood samples will be collected before and 1 month after each vaccination and at the end of each flu season in order to measure how the body responds to the vaccine and how well participants were protected from the flu. During the flu season, participants with flu-like illness will provide information on symptoms and provide a throat swab to test for virus identification.
Condition | Intervention | Phase |
Influenza |
Biological: FluMist Drug: Placebo (spray) Drug: Placebo (injection) Biological: Fluzone/Fluvirin |
Phase IV |
MedlinePlus related topics: | Flu |
Drug Information available for: | Sodium chloride Influenza Vaccines Fluvirin |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Comparative Study of Influenza Vaccines in Adults FLU-VACS |
Enrollment: | 2349 |
Study Start Date: | October 2004 |
Study Completion Date: | July 2007 |
Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
N=825 subjects administered live attenuated vaccine intranasally.
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Biological: FluMist
Live-attenuated influenza vaccine; single annual dose administered as an intranasal spray.
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4: Placebo Comparator
N=165 subjects administered placebo intramuscularly.
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Drug: Placebo (injection)
Physiological saline administered as an intramuscular injection.
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3: Placebo Comparator
N=165 subjects administered placebo intranasally.
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Drug: Placebo (spray)
Normal allantoic fluid administered annually as an internasal spray.
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2: Experimental
N=825 subjects administered inactivated vaccine intramuscularly.
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Biological: Fluzone/Fluvirin
Inactivated influenza vaccine; single annual dose administered as an intramuscular injection.
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Influenza occurs on an annual basis, producing significant mortality in most years, mainly in those with underlying conditions and those at extremes of age. This study is a placebo-controlled trial to examine efficacies of the live attenuated and inactivated influenza vaccines, and immune correlates of protection; the study will take place in Michigan over a three year period, and will target adults aged 18-49 years. Both vaccine preparations are licensed for this age group. In the first year, participants will be randomly assigned to receive one of the two licensed vaccines or placebo. In the second year, participant receipt of vaccine (updated according to national recommendations) or placebo will continue as assigned in the first year for returning participants, and new enrollees will be randomly assigned to intervention. In the third year, when duration of immunity will be evaluated, no interventions will be given. In all study years, blood specimens for serologic studies and specimens for virus identification will be collected and a number of laboratory studies will be performed so that it will be possible to achieve the study's objectives. The primary annual study outcome for efficacy is the proportion of subjects with laboratory-confirmed symptomatic influenza A or B illness, defined as influenza virus isolated in tissue culture from a throat swab obtained from a participant during an episode of illness meeting the influenza case definition that is confirmed as influenza by fluorescent antibody or polymerase chain reaction (PCR) techniques; or serologic confirmation of influenza infection in a participant with an episode of illness meeting the influenza case definition, specifically a 4-fold rise in hemagglutinin inhibition assay (HAI) antibody titer to a circulating influenza strain between post-vaccination (pre-season) and post-season paired sera. The influenza case definition is illness with at least one respiratory symptom (cough or nasal congestion) and at least one constitutional symptom (fever or feverishness, chills or body aches). Subjects will be evaluated for serious adverse events throughout each annual study period. Annually, the proportion of participants with local reactions during the first seven days or any adverse reactions during the first thirty days after vaccine receipt will be compared with recipients of placebo.
Ages Eligible for Study: | 18 Years to 49 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Michigan | |||||
University of Michigan | |||||
Ann Arbor, Michigan, United States, 48109-2029 | |||||
Ann Arbor West | |||||
Ann Arbor, Michigan, United States, 48103 | |||||
Livonia East | |||||
Livonia, Michigan, United States, 48150 | |||||
Western Michigan University Health Services | |||||
Kalamazoo, Michigan, United States, 49008 | |||||
Eastern Michigan University Health Services | |||||
Ypsilanti, Michigan, United States, 48197 | |||||
Central Michigan University Health Services | |||||
Mt. Pleasant, Michigan, United States, 48859 |
Responsible Party: | HHS/NIAID/DMID ( Robert Johnson ) |
Study ID Numbers: | 04-060, IRBMed# 2004-0334 |
First Received: | August 19, 2005 |
Last Updated: | October 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00133523 |
Health Authority: | United States: Federal Government; United States: Food and Drug Administration; United States: Institutional Review Board |
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