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

Primary Purpose

Influenza

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Fluzone
Flumist
Physiologic saline
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza focused on measuring Influenza, Live attenuated influenza vaccine, Inactivated influenza vaccine, Vaccine Efficacy

Eligibility Criteria

18 Years - 49 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Michigan School of Public Heatlh
  • Western Michigan University Health Services
  • Central Michigan University Health Services
  • Eastern Michigan University Health Services

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

TIV

LAIV

Placebo

Arm Description

the trivalent inactivated influenza vaccine - Fluzone, manufactured by Sanofi-Pasteur

live-attenuated influenza vaccine Flumist, manufactured by MedImmune

Physiologic saline administered as a nasal spray or intramuscular injection

Outcomes

Primary Outcome Measures

Laboratory-confirmed (Culture and/or PCR) Symptomatic Influenza

Secondary Outcome Measures

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.
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.
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).

Full Information

First Posted
October 1, 2007
Last Updated
November 1, 2017
Sponsor
University of Michigan
Collaborators
Sanofi Pasteur, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT00538512
Brief Title
Comparative Study of Influenza Vaccines in Adults, FLUVACS-year 4
Acronym
FLUVACS
Official Title
Comparative Study of Influenza Vaccines in Adults, FLUVACS-year 4
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
Sanofi Pasteur, a Sanofi Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Influenza, Live attenuated influenza vaccine, Inactivated influenza vaccine, Vaccine Efficacy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
1952 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TIV
Arm Type
Active Comparator
Arm Description
the trivalent inactivated influenza vaccine - Fluzone, manufactured by Sanofi-Pasteur
Arm Title
LAIV
Arm Type
Active Comparator
Arm Description
live-attenuated influenza vaccine Flumist, manufactured by MedImmune
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Physiologic saline administered as a nasal spray or intramuscular injection
Intervention Type
Biological
Intervention Name(s)
Fluzone
Intervention Description
single dose licensed trivalent inactivated influenza vaccine (2007-08)
Intervention Type
Biological
Intervention Name(s)
Flumist
Intervention Description
single dose licensed live-attenuated influenza vaccine Flumist (2007-08)
Intervention Type
Other
Intervention Name(s)
Physiologic saline
Intervention Description
single dose placebo administered as an intranasal spray or intramuscular injection
Primary Outcome Measure Information:
Title
Laboratory-confirmed (Culture and/or PCR) Symptomatic Influenza
Time Frame
one influenza season - 2007-2008
Secondary Outcome Measure Information:
Title
Measure Immune Response Induced by the Vaccines and Identify Serologic Correlates of Immune Protection
Description
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 Frame
Time between prevaccination visit and postvaccination visit; typically about 30 days.
Title
Immune Response to Vaccination and Infection
Description
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.
Time Frame
Postvaccination to postseason visit; typically about 3 months.
Title
Identify Serologic Correlates of Immune Protection. Suggest Changing to: Number of Participants Demonstrating Postvaccination Seroconversion.
Description
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 Frame
Time between prevaccination and postvaccination, typically about 30 days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arnold S. Monto, MD
Organizational Affiliation
University of Michigan School of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan School of Public Heatlh
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Western Michigan University Health Services
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49008
Country
United States
Facility Name
Central Michigan University Health Services
City
Mount Pleasant
State/Province
Michigan
ZIP/Postal Code
48859
Country
United States
Facility Name
Eastern Michigan University Health Services
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17167134
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. doi: 10.1056/NEJMoa061850.
Results Reference
background
PubMed Identifier
19776407
Citation
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.
Results Reference
result
PubMed Identifier
25858957
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.
Results Reference
result
PubMed Identifier
21998477
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.
Results Reference
result
PubMed Identifier
31117986
Citation
Gilbert 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.
Results Reference
derived
PubMed Identifier
21378375
Citation
Petrie 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.
Results Reference
derived

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

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