Comparative Study of Influenza Vaccines in Adults, FLUVACS-year 4

Influenza Clinical Trial

— FLUVACS  

Official title:

Comparative Study of Influenza Vaccines in Adults, FLUVACS-year 4

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00538512
• Other study ID #: FLUVACS
• Status: Completed
• Phase: Phase 4
• First received: October 1, 2007
• Last updated: November 1, 2017
• Start date: September 2007
• Est. completion date: May 2008

Study information

• Verified date: November 2017
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1952
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 49 Years

Eligibility

Inclusion Criteria:

• Healthy adult men and women

• Age 18-49 years

• Who reside geographically close to one of the four study sites in Michigan

Exclusion Criteria:

• Persons with any of the health conditions for which the inactivated vaccine is recommended

• Persons for whom either vaccine is contraindicated

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• Fluzone
single dose licensed trivalent inactivated influenza vaccine (2007-08)
• Flumist
single dose licensed live-attenuated influenza vaccine Flumist (2007-08)

Other:
• Physiologic saline
single dose placebo administered as an intranasal spray or intramuscular injection

Locations

Country	Name	City	State
United States	University of Michigan School of Public Heatlh	Ann Arbor	Michigan
United States	Western Michigan University Health Services	Kalamazoo	Michigan
United States	Central Michigan University Health Services	Mount Pleasant	Michigan
United States	Eastern Michigan University Health Services	Ypsilanti	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

United States, 

References & Publications (4)

Monto 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. — View Citation

Monto 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. — View Citation

Ohmit 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Laboratory-confirmed (Culture and/or PCR) Symptomatic Influenza		one influenza season - 2007-2008
Secondary	Measure Immune Response Induced by the Vaccines and Identify Serologic Correlates of Immune Protection	Measure immune response induced by the vaccines. Response was defined as greater than or equal to 4 fold rise in antibody titers measured by hemagglutination inhibition (HAI), microneutralization (MN), or neuraminidase inhibition (NAI) assays between sera collected at the prevaccination visit and those collected at the postvaccination visit.	Time between prevaccination visit and postvaccination visit; typically about 30 days.
Secondary	Immune Response to Vaccination and Infection	Response was defined as greater than or equal to 4 fold rise in antibody titers measured by hemagglutination inhibition (HAI), microneutralization (MN), or neuraminidase inhibition (NAI) assays between sera collected at the postvaccination visit and those collected at the postseason visit.	Postvaccination to postseason visit; typically about 3 months.
Secondary	Identify Serologic Correlates of Immune Protection. Suggest Changing to: Number of Participants Demonstrating Postvaccination Seroconversion.	Identify serologic correlates of immune protection. Seroconversion is defined as either prevaccination titer of less than 8 and postvaccination titer of greater than or equal to 32 or prevaccination titer of greater than or equal to 8 and greater than or equal to 4 fold rise in strain specific hemagglutination-inhibition (HAI) antibody titer between prevaccination and postvaccination sera. Data is shown separately for cases (subjects with symptomatic influenza A laboratory confirmed by isolation in cell culture or identification in real-time polymerase chain reaction (PCR) assay) and non-cases (subjects without cell culture, real time PCR or serologic evidence of influenza infection).	Time between prevaccination and postvaccination, typically about 30 days.