A phase III, randomized, controlled, observer-blind, single-center study to compare immunogenicity and safety of an MF59-adjuvanted inactivated subunit influenza vaccine (FLUAD™) to those of a nonadjuvanted inactivated subunit influenza vaccine, when administered to adults affected by chronic diseases

• Conditions: Influenza; MedDRA version: 18.1Level: PTClassification code 10022000Term: InfluenzaSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2006-005558-63-IT
• Lead Sponsor: ovartis Vaccines and Diagnostics S.r.l.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-24
• Last Update Posted: 11 April 2016

Recruitment & Eligibility

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

Inclusion Criteria

1. 18 to 60 years of age adult volunteers, mentally competent, willing and able to give written informed consent prior to study entry;
2. able to comply with all the study requirements;
3. suffering from at least one of these chronic diseases:
• moderate to severe hypertension
• moderate to severe congestive heart failure
• COPD or moderate to severe asthma
• moderate to severe hepatic or renal insufficiency
• arteriosclerotic disease or insulin dependent diabetes mellitus

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 330
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. hypersensitivity to ovalbumin, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the vaccine;
2. history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine;
3. 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 cortical steroid or cancer chemotherapy/radiotherapy) within 60 days prior to enrollment and for the full length of the study;
• receipt of immunostimulants;
• receipt of parenteral immunoglobulin preparation, blood products and/or plasma derivates within 3 months prior to enrollment and for the full length of the study;
• suspected or known HIV infection or HIV-related disease;
4. known or suspected history of drug or alcohol abuse;
5. women who were pregnant, or women able to bear children but not willing to practice acceptable contraception for the first 3 weeks of the duration of the trial;
6. within the 12 months prior to enrollment, the individual had:
• received more than one injection of influenza vaccine;
7. within the 6 months prior to enrollment, the individual had:
• laboratory confirmed influenza disease;
• received influenza vaccine;
8. within the 4 weeks prior to enrollment the individual had received:
• another vaccine;
• any investigational agent;
9. within the 7 days prior to enrollment, the individual had experienced:
• any acute disease;
• infections requiring systemic antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis was acceptable);
10. had experienced an acute exacerbation of a COPD within the 14 days prior to enrollment;
11. within the 3 days prior to enrollment, individuals had experienced:
• fever (i.e., body temperature = 38°C);
12. were taking part in another clinical study;
13. had 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