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NCT00197301 Clinical Trial

Liposomal Based Intranasal Influenza Vaccine:Safety and Efficacy

Influenza Clinical Trial

Official title:
Phase 1 Study to Examine the Safety and Efficacy of a Novel Liposomal Based Intranasal Influenza Vaccine

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00197301
Other study ID # 16-05.08.05-HMO-CTIL
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received September 12, 2005
Last updated November 6, 2006
Start date October 2005
Est. completion date April 2006

Study information
Verified date September 2005
Source Hadassah Medical Organization
Contact n/a
Is FDA regulated No
Health authority Israel: Israeli Health Ministry Pharmaceutical Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date April 2006
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 20 Years to 95 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Biological:
• Vaccination

Locations
Country Name City State
Israel Hadassah Medical Organization Jerusalem

Sponsors (1)
Lead Sponsor Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Seroprotection
Secondary Antibody levels
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