Liposomal Based Intranasal Influenza Vaccine:Safety and Efficacy
Primary Purpose
Influenza
Status
Completed
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
Vaccination
Sponsored by
About this trial
This is an interventional prevention trial for Influenza focused on measuring Intranasal vaccination, Influenza
Eligibility Criteria
Inclusion Criteria:Healthy young(20-45years old) and elderly(65-95 years old) volunteers - Exclusion Criteria:Known allergy to eggs and to the flu vaccine, pregnant and breast feeding women, chronic viral carriers, recently hospitalized persons -
Sites / Locations
- Hadassah Medical Organization
Outcomes
Primary Outcome Measures
Seroprotection
Secondary Outcome Measures
Antibody levels
Full Information
NCT ID
NCT00197301
First Posted
September 12, 2005
Last Updated
November 6, 2006
Sponsor
Hadassah Medical Organization
1. Study Identification
Unique Protocol Identification Number
NCT00197301
Brief Title
Liposomal Based Intranasal Influenza Vaccine:Safety and Efficacy
Official Title
Phase 1 Study to Examine the Safety and Efficacy of a Novel Liposomal Based Intranasal Influenza Vaccine
Study Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Hadassah Medical Organization
4. Oversight
5. Study Description
Brief Summary
Influnza vaccination is highly recommended over the age of 50,but is only 50% efficatious among the elderly. A Vaccine given as a nasal spray may improve compliance and local immunity.Liposomes are lipid particles that may serve as carriers for the vaccine and together they enhance the local immune response in mice when given as nasal spray.This study aims to examine the safety and nasal and humoral responses to the nasal vaccine compared to the commercial muscular vaccine.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Intranasal vaccination, Influenza
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
200 (false)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
Vaccination
Primary Outcome Measure Information:
Title
Seroprotection
Secondary Outcome Measure Information:
Title
Antibody levels
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:Healthy young(20-45years old) and elderly(65-95 years old) volunteers -
Exclusion Criteria:Known allergy to eggs and to the flu vaccine, pregnant and breast feeding women, chronic viral carriers, recently hospitalized persons
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arie Ben Yehuda, M.D.
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Study Director
Facility Information:
Facility Name
Hadassah Medical Organization
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Liposomal Based Intranasal Influenza Vaccine:Safety and Efficacy
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