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

NCT ID: NCT00915187

Last Updated: 2011-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-02-28

Brief Summary

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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).

Detailed Description

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Conditions

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Influenza

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Control

Group Type ACTIVE_COMPARATOR

Influenza Vaccine

Intervention Type BIOLOGICAL

Influenza vaccine

CCS/C (Adjuvant Formulation)

Group Type EXPERIMENTAL

CCS/C

Intervention Type DRUG

Adjuvant to influenza vaccine

Interventions

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CCS/C

Adjuvant to influenza vaccine

Intervention Type DRUG

Influenza Vaccine

Influenza vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* 65 years of age or older, mentally competent, willing and able to give written informed consent prior to study entry, male or female;
* able to comply with all the study requirements;
* in stable good health as determined by medical history; physical examination; clinical judgment of the investigator.
* Have adequate renal function (renal clearance of at \> 30ml/min)
* Have normal liver function (hepatic transaminases \[ALT and AST\] \< 43 U/L)
* Have hemoglobin \> 11.5 g/L

Exclusion Criteria

* Any serious chronic or acute disease (in the judgment of the investigator) including but not limited to: cancer, except for localized skin cancer;
* Advanced congestive heart failure; Acute exacerbation of Chronic obstructive pulmonary disease (COPD); Autoimmune disease, Acute or progressive hepatic disease; Acute or progressive renal disease with a renal clearance of at \< 30ml/min ; Severe neurological or psychiatric disorder; History of Guillain Barré syndrome; Severe asthma.
* Clinically significant symptoms of neurological disease; untreated hypertension; increased liver enzymes.
* History of any anaphylactic reaction and/or serious allergic reaction following a vaccination
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NasVax Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yoseph Caraco, MD

Role: PRINCIPAL_INVESTIGATOR

Clinical Pharmacology Unit, Division of Medicine, Hadassah University Hospital Jerusalem, Israel

Locations

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Clinical Pharmacology Unit, Division of Medicine, Hadassah University Hospital

Jerusalem, , Israel

Site Status

Countries

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Israel

Other Identifiers

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NX09-4

Identifier Type: -

Identifier Source: org_study_id