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OpenTrials
Completed

NCT Number: NCT00915187

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

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).

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Clinical Pharmacology Unit, Division of Medicine, Hadassah University Hospital

Jerusalem, 91120, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CCS/C

Drug

Adjuvant to influenza vaccine

influenza vaccine

Biological

Influenza vaccine

Primary outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

NasVax Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2009
Study completion
2010
First posted
Jun 5, 2009
Registry last updated
Oct 19, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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