Skip to main content
OpenTrials
Completed

NCT Number: NCT00538512

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Michigan School of Public Heatlh, Ann Arbor, Michigan, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluzone

Biological

single dose licensed trivalent inactivated influenza vaccine (2007-08)

FluMist

Biological

single dose licensed live-attenuated influenza vaccine Flumist (2007-08)

Physiologic saline

Other

single dose placebo administered as an intranasal spray or intramuscular injection

Primary outcomes

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

    Time frame: one influenza season - 2007-2008

Secondary outcomes

  1. Measure Immune Response Induced by the Vaccines and Identify Serologic Correlates of Immune Protection

    Time frame: Time between prevaccination visit and postvaccination visit; typically about 30 days.

    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.

  2. Immune Response to Vaccination and Infection

    Time frame: Postvaccination to postseason visit; typically about 3 months.

    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.

  3. Identify Serologic Correlates of Immune Protection. Suggest Changing to: Number of Participants Demonstrating Postvaccination Seroconversion.

    Time frame: Time between prevaccination and postvaccination, typically about 30 days.

    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).

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Sanofi Pasteur, a Sanofi Company

Registry information

Acronym: FLUVACS

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Oct 2, 2007
Registry last updated
Dec 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.