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

Influenza Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00915187
• Other study ID #: NX09-4
• Status: Completed
• Phase: Phase 2
• First received: June 3, 2009
• Last updated: October 18, 2011
• Start date: October 2009
• Est. completion date: February 2010

Study information

• Verified date: October 2011
• Source: NasVax Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: February 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Drug:
• CCS/C
Adjuvant to influenza vaccine

Biological:
• Influenza Vaccine
Influenza vaccine

Locations

Country	Name	City	State
Israel	Clinical Pharmacology Unit, Division of Medicine, Hadassah University Hospital	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
NasVax Ltd

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No