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

Primary Purpose

Influenza

Status

Completed

Phase

Phase 2

Locations

Israel

Study Type

Interventional

Intervention

CCS/C

Influenza Vaccine

About this trial

This is an interventional prevention trial for Influenza focused on measuring Vaccination, influenza prevention

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Clinical Pharmacology Unit, Division of Medicine, Hadassah University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control

CCS/C (Adjuvant Formulation)

Arm Description

Outcomes

Primary Outcome Measures

Immunogenicity will be evaluated according to the CHMP criteria for evaluation of flu vaccines, i.e., Seroprotection, Geometric Mean Ratios, and Seroconversion rate

Secondary Outcome Measures

Immunogenicity will be evaluated according to the CHMP criteria for evaluation of flu vaccines, i.e., Seroprotection, Geometric Mean Ratios, and Seroconversion rate

Full Information

NCT ID

NCT00915187

First Posted

June 3, 2009

Last Updated

October 18, 2011

Sponsor

NasVax Ltd

1. Study Identification

Unique Protocol Identification Number

NCT00915187

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2011

Overall Recruitment Status

Completed

Study Start Date

October 2009 (undefined)

Primary Completion Date

December 2009 (Actual)

Study Completion Date

February 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

NasVax Ltd

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza

Keywords

Vaccination, influenza prevention

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

130 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

Active Comparator

Arm Title

CCS/C (Adjuvant Formulation)

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

CCS/C

Intervention Description

Adjuvant to influenza vaccine

Intervention Type

Biological

Intervention Name(s)

Influenza Vaccine

Intervention Description

Influenza vaccine

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yoseph Caraco, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

Clinical Pharmacology Unit, Division of Medicine, Hadassah University Hospital

City

Jerusalem

ZIP/Postal Code

91120

Country

Israel

12. IPD Sharing Statement

Learn more about this trial

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

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