Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Liposomal Based Intranasal Influenza Vaccine:Safety and Efficacy

This study has been completed.
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00197301
First received: September 12, 2005
Last updated: November 6, 2006
Last verified: September 2005

September 12, 2005
November 6, 2006
October 2005
Not Provided
Seroprotection
Same as current
Complete list of historical versions of study NCT00197301 on ClinicalTrials.gov Archive Site
Antibody levels
Same as current
Not Provided
Not Provided
 
Liposomal Based Intranasal Influenza Vaccine:Safety and Efficacy
Phase 1 Study to Examine the Safety and Efficacy of a Novel Liposomal Based Intranasal Influenza Vaccine

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Prevention
Influenza
Biological: Vaccination
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
April 2006
Not Provided

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

-

Both
20 Years to 95 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00197301
16-05.08.05-HMO-CTIL
Not Provided
Not Provided
Hadassah Medical Organization
Not Provided
Study Director: Arie Ben Yehuda, M.D. Hadassah Medical Organization
Hadassah Medical Organization
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP