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

Study Overview
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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).

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

Conditions
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Influenza

Intervention / Treatment
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* Drug: CCS/C
* Biological: Influenza Vaccine


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |  | Day 28 following vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |  | Day 90 following vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vaccination, influenza prevention