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

October 18, 2011 updated by: NasVax Ltd

A Phase II Safety and Immunogenicity Study of Intramuscular CCS/C-adjuvanted Influenza Vaccine in Elderly, a Double-blind Randomized, Controlled Single Center Study

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel, 91120
        • Clinical Pharmacology Unit, Division of Medicine, Hadassah University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
Biological: Influenza Vaccine
Influenza vaccine
Experimental: CCS/C (Adjuvant Formulation)
Drug: CCS/C
Adjuvant to influenza vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Immunogenicity will be evaluated according to the CHMP criteria for evaluation of flu vaccines, i.e., Seroprotection, Geometric Mean Ratios, and Seroconversion rate
Time Frame: Day 28 following vaccination
Day 28 following vaccination

Secondary Outcome Measures

Outcome Measure
Time Frame
Immunogenicity will be evaluated according to the CHMP criteria for evaluation of flu vaccines, i.e., Seroprotection, Geometric Mean Ratios, and Seroconversion rate
Time Frame: Day 90 following vaccination
Day 90 following vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NasVax Ltd

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

June 3, 2009

First Submitted That Met QC Criteria

June 3, 2009

First Posted (Estimate)

June 5, 2009

Study Record Updates

Last Update Posted (Estimate)

October 19, 2011

Last Update Submitted That Met QC Criteria

October 18, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NX09-4

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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