FLU-VACS Comparative Study in Adults
Comparative Study of Influenza Vaccines in Adults - FLU-VACS
2 other identifiers
interventional
2,349
1 country
6
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Oct 2004
Typical duration for phase_4
6 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
October 1, 2004
CompletedFirst Submitted
Initial submission to the registry
August 19, 2005
CompletedFirst Posted
Study publicly available on registry
August 23, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2007
CompletedDecember 5, 2014
October 1, 2009
2.7 years
August 19, 2005
December 4, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The appearance among patients of symptomatic laboratory-confirmed influenza.
Influenza season Nov-Apr. Within 72 hours of illness onset throat swab specimens will be obtained from participants with influenza like illness (ILI).
Secondary Outcomes (1)
Any measurable increase in antibody titers, and the proportion with antibody levels considered protective.
Annual enrollment, post vaccination Oct-Jan, and post season Apr-May.
Study Arms (4)
Group 4: Placebo: Intramuscular
PLACEBO COMPARATORN=165 subjects administered placebo intramuscularly.
Group 3: Placebo: Nasal
PLACEBO COMPARATORN=165 subjects administered placebo intranasally.
Group 1: FluMist™
EXPERIMENTALN=825 subjects administered live attenuated vaccine intranasally.
Group 2: Fluzone®/Fluvirin
EXPERIMENTALN=825 subjects administered inactivated vaccine intramuscularly.
Interventions
Live-attenuated influenza vaccine; single annual dose administered as an intranasal spray.
Physiological saline administered as an intramuscular injection.
Inactivated influenza vaccine; single annual dose administered as an intramuscular injection..
Eligibility Criteria
You may qualify if:
- Persons must be adult men and women aged 18-49 years.
- Persons must be able and willing to provide informed consent.
- Persons must expect to reside in the study area during the entire study period and be interested in participating each year.
- Persons must be willing to receive the licensed live-attenuated vaccine (FluMist) or placebo given as a nasal spray, or the licensed inactivated influenza vaccine (Fluzone or Fluvirin) or placebo given as an intramuscular injection.
- Persons must be willing to provide multiple blood specimens collected by venipuncture each year they are in the study. During each of the first two years of study, blood specimens will be collected three times - at the enrollment visit (immediately prior to administration of vaccine or placebo), at the first follow-up visit 3-5 weeks later, and at the end of the influenza season visit (approximately 4-6 months later); during the third year of the study, blood specimens will be collected twice only, at visits before and after the influenza season.
- Persons must be willing to notify study personnel in the event of influenza-like illness, to provide information on illness symptoms, and to permit collection of a throat culture (swab) specimen for laboratory studies.
- Persons must be willing to not receive an influenza vaccine while participating - other than that (influenza vaccine or placebo) received as study medication.
You may not qualify if:
- Persons with any health condition for which the inactivated vaccine is recommended (Advisory Committee on Immunization Practices - ACIP) including: chronic diseases of the pulmonary or cardiovascular systems (including asthma); chronic metabolic diseases (including diabetes); renal dysfunction; hemoglobinopathies; immune deficiency disease (including HIV infection) or on-going immunosuppressive therapy.
- Persons who are currently pregnant, nursing mothers or planning a pregnancy within one month of vaccination.
- Persons with hypersensitivity to egg, egg protein, thimerosal (a preservative) or the antibiotic Gentamicin (also know as Garamycin).
- Persons who have had a prior serious reaction to influenza vaccine, or ever had Guillain-Barre syndrome.
- Persons who are living in a household with or have direction occupational contact with immunosuppressed individuals (including health care workers with direct patient contact).
- Persons who have received an influenza vaccine for the influenza season in which they are to be first enrolled or those who plan to receive an influenza vaccine during their participation in the study - other than that (influenza vaccine or placebo) received as study medication.
- Persons who have received any other vaccine within one week prior to enrollment (may delay enrollment).
- Persons who have had a respiratory illness or illness with fever within 3 days of study enrollment (may delay enrollment).
- Persons who are participating in another research study involving any study medications (medicines or vaccines).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Ann Arbor West
Ann Arbor, Michigan, 48103, United States
University of Michigan
Ann Arbor, Michigan, 48109-2029, United States
Western Michigan University Health Services
Kalamazoo, Michigan, 49008, United States
Livonia East
Livonia, Michigan, 48150, United States
Central Michigan University Health Services
Mount Pleasant, Michigan, 48859, United States
Eastern Michigan University Health Services
Ypsilanti, Michigan, 48197, United States
Related Publications (3)
Ohmit SE, Victor JC, Rotthoff JR, Teich ER, Truscon RK, Baum LL, Rangarajan B, Newton DW, Boulton ML, Monto AS. Prevention of antigenically drifted influenza by inactivated and live attenuated vaccines. N Engl J Med. 2006 Dec 14;355(24):2513-22. doi: 10.1056/NEJMoa061850.
PMID: 17167134RESULTOhmit SE, Victor JC, Teich ER, Truscon RK, Rotthoff JR, Newton DW, Campbell SA, Boulton ML, Monto AS. Prevention of symptomatic seasonal influenza in 2005-2006 by inactivated and live attenuated vaccines. J Infect Dis. 2008 Aug 1;198(3):312-7. doi: 10.1086/589885.
PMID: 18522501RESULTPetrie JG, Ohmit SE, Johnson E, Cross RT, Monto AS. Efficacy studies of influenza vaccines: effect of end points used and characteristics of vaccine failures. J Infect Dis. 2011 May 1;203(9):1309-15. doi: 10.1093/infdis/jir015. Epub 2011 Mar 4.
PMID: 21378375DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
Study Record Dates
First Submitted
August 19, 2005
First Posted
August 23, 2005
Study Start
October 1, 2004
Primary Completion
July 1, 2007
Study Completion
July 1, 2007
Last Updated
December 5, 2014
Record last verified: 2009-10