Comparative Study of Influenza Vaccines in Adults, FLUVACS-year 4
FLUVACS
1 other identifier
interventional
1,952
1 country
4
Brief Summary
The purpose of this study is to evaluate the absolute (versus placebo) and relative (one vaccine compared to the other) efficacies of the live attenuated and inactivated influenza vaccines in preventing laboratory confirmed symptomatic influenza caused by circulating strains whether similar or dissimilar to strains included in the vaccines.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2007
Shorter than P25 for phase_4
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
October 1, 2007
CompletedFirst Posted
Study publicly available on registry
October 2, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2008
CompletedResults Posted
Study results publicly available
September 12, 2011
CompletedDecember 6, 2017
November 1, 2017
8 months
October 1, 2007
August 8, 2011
November 1, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Laboratory-confirmed (Culture and/or PCR) Symptomatic Influenza
one influenza season - 2007-2008
Secondary Outcomes (3)
Measure Immune Response Induced by the Vaccines and Identify Serologic Correlates of Immune Protection
Time between prevaccination visit and postvaccination visit; typically about 30 days.
Immune Response to Vaccination and Infection
Postvaccination to postseason visit; typically about 3 months.
Identify Serologic Correlates of Immune Protection. Suggest Changing to: Number of Participants Demonstrating Postvaccination Seroconversion.
Time between prevaccination and postvaccination, typically about 30 days.
Study Arms (3)
TIV
ACTIVE COMPARATORthe trivalent inactivated influenza vaccine - Fluzone, manufactured by Sanofi-Pasteur
LAIV
ACTIVE COMPARATORlive-attenuated influenza vaccine Flumist, manufactured by MedImmune
Placebo
PLACEBO COMPARATORPhysiologic saline administered as a nasal spray or intramuscular injection
Interventions
single dose placebo administered as an intranasal spray or intramuscular injection
Eligibility Criteria
You may qualify if:
- Healthy adult men and women
- Age 18-49 years
- Who reside geographically close to one of the four study sites in Michigan
You may not qualify if:
- Persons with any of the health conditions for which the inactivated vaccine is recommended
- Persons for whom either vaccine is contraindicated
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Michiganlead
- Sanofi Pasteur, a Sanofi Companycollaborator
Study Sites (4)
University of Michigan School of Public Heatlh
Ann Arbor, Michigan, 48109, United States
Western Michigan University Health Services
Kalamazoo, Michigan, 49008, 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 (6)
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: 17167134BACKGROUNDMonto AS, Ohmit SE, Petrie JG, Johnson E, Truscon R, Teich E, Rotthoff J, Boulton M, Victor JC. Comparative efficacy of inactivated and live attenuated influenza vaccines. N Engl J Med. 2009 Sep 24;361(13):1260-7. doi: 10.1056/NEJMoa0808652.
PMID: 19776407RESULTMonto AS, Petrie JG, Cross RT, Johnson E, Liu M, Zhong W, Levine M, Katz JM, Ohmit SE. Antibody to Influenza Virus Neuraminidase: An Independent Correlate of Protection. J Infect Dis. 2015 Oct 15;212(8):1191-9. doi: 10.1093/infdis/jiv195. Epub 2015 Apr 8.
PMID: 25858957RESULTOhmit SE, Petrie JG, Cross RT, Johnson E, Monto AS. Influenza hemagglutination-inhibition antibody titer as a correlate of vaccine-induced protection. J Infect Dis. 2011 Dec 15;204(12):1879-85. doi: 10.1093/infdis/jir661. Epub 2011 Oct 12.
PMID: 21998477RESULTGilbert PB, Fong Y, Juraska M, Carpp LN, Monto AS, Martin ET, Petrie JG. HAI and NAI titer correlates of inactivated and live attenuated influenza vaccine efficacy. BMC Infect Dis. 2019 May 22;19(1):453. doi: 10.1186/s12879-019-4049-5.
PMID: 31117986DERIVEDPetrie 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
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Arnold S. Monto, MD
- Organization
- University of Michigan School of Public Health
Study Officials
- PRINCIPAL INVESTIGATOR
Arnold S. Monto, MD
University of Michigan School of Public Health
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 1, 2007
First Posted
October 2, 2007
Study Start
September 1, 2007
Primary Completion
May 1, 2008
Study Completion
May 1, 2008
Last Updated
December 6, 2017
Results First Posted
September 12, 2011
Record last verified: 2017-11