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Safety and Immunogenicity Study of Intramuscular CCS/C-adjuvanted Influenza Vaccine in Elderly

NCT00915187 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2011-10-19

No results posted yet for this study

Summary

To examine the safety and immunogenicity of two formulation of liposomal adjuvant / delivery system (VaxiSomeTM=CCS-Cholesterol \[CCS/C\]), combined with commercial influenza vaccine in an elderly healthy population when given once intramuscularly (IM).

Conditions

Interventions

DRUG

CCS/C

Adjuvant to influenza vaccine

BIOLOGICAL

Influenza Vaccine

Influenza vaccine

Sponsors & Collaborators

  • NasVax Ltd

    lead INDUSTRY

Principal Investigators

  • Yoseph Caraco, MD · Clinical Pharmacology Unit, Division of Medicine, Hadassah University Hospital Jerusalem, Israel

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2009-12-31
Completion
2010-02-28

Countries

  • Israel

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00915187 on ClinicalTrials.gov