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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00915187

Enrollment

130

Registered

2009-06-05

Start date

2009-10-31

Completion date

2010-02-28

Last updated

2011-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza

Keywords

Vaccination, influenza prevention

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).

Interventions

DRUGCCS/C

Adjuvant to influenza vaccine

BIOLOGICALInfluenza Vaccine

Influenza vaccine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

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

Design outcomes

Primary

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	Day 28 following vaccination

Secondary

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	Day 90 following vaccination

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026