A Phase II, Randomized, Controlled, Observer-blind, Single-Center Study to Evaluate Safety and Immunogenicity of Two Doses, Administered Three Weeks Apart, and a Six Month Booster Dose of Two FLUAD-like Surface Antigen Adjuvanted with MF59C.1 Influenza Vaccines Containing 7.5 mg or 15 mg of A/H5N1 Influenza Antigen and of a Non-adjuvanted Influenza Vaccine Containing 15 mg of A/H5N1 Influenza Antigen, in Adults - ND

Active, not recruiting

• Conditions: Active influenza profilaxis pandemic strain; MedDRA version: 8.1Level: LLTClassification code 10022000Term: Influenza

• Registration Number: EUCTR2006-004063-66-IT
• Lead Sponsor: CHIRO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11-10
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

18 to 60 years of age, mentally competent, willing and able to give written informed consent prior to study entry; 2.able to comply with all the study requirements 3.in general good health as determined by medical history physical examination clinical judgment of the investigator
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

they have any serious disease such as cancer except for benign or localized skin cancer and non metastatic prostate cancer not presently treated with chemotherapy autoimmune disease including rheumatoid arthritis advanced arteriosclerotic disease or complicated diabetes mellitus chronic obstructive pulmonary disease COPD that requires oxygen therapy acute or progressive hepatic disease acute or progressive renal disease congestive heart failure 2. they are hypersensitive to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or kanamicin or any other component of the vaccine; 3. they have a history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine 4. they have a known or suspected or have a high risk of developing impairment/ alteration of immune function excluding that normally associated with advanced age resulting, for example, from receipt of immunosuppressive therapy any parenteral or oral corticosteroid or cancer chemotherapy/radiotherapy within the past 60 days and for the full length of the study receipt of immunostimulants receipt of parenteral immunoglobulin preparation, blood products and/or plasma derivates within the past 3 months suspected or known HIV infection or HIV-related disease 5.women who are pregnant, or women able to bear children but not willing to practice acceptable contraception for the duration of the trial 382 days ; 6.within the past 4 weeks they have received another vaccine any investigational agent 7.within the past 7 days, they have experienced any acute disease infections requiring systemic antibiotic or antiviral therapy chronic antibiotic therapy for urinary tract prophylaxis is acceptable 8.within the past 3 days, they have experienced fever i.e., axillary temperature 8805; 38 C ; 9.they are taking part in another clinical study; 10.they have surgery planned during the study period 11.they have any anemia, hypotension or any other medical condition which at the investigator s discretion could constitute a contraindication to the blood sampling foreseen by the study protocol 12.they have any condition, which, in the opinion of the investigator, might interfere with the evaluation of the study objective.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified