Immunogenicity and Safety of an Adjuvanted Inactivated Subunit Influenza Vaccine to Those of a Non-Adjuvanted Inactivated Subunit Influenza Vaccine, When Administered to Adults Affected by Chronic Diseases

Condition(s) targeted: Influenza Disease

Intervention: Adjuvanted influenza vaccine (Biological)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis Vaccines, Study Chair, Affiliation: Novartis Vaccines

This phase III is designed to confirm the previous trial results evaluating the safety, clinical tolerability and immunogenicity of the 2006-2007 formulation of Novartis Vaccines' adjuvanted influenza vaccine and subunit influenza vaccine in adults with underlying chronic diseases.

Official title: A Phase III, Randomized, Controlled, Observer-Blind, Single-Center Study to Compare Immunogenicity and Safety of an Adjuvanted Inactivated Subunit Influenza Vaccine to Those of a Non-Adjuvanted Inactivated Subunit Influenza Vaccine, When Administered to Adults Affected by Chronic Diseases

Study design: Prevention, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Compare the immunog. of a single IM inj. of an adj. inactivated subunit flu vaccine vs. inactivated subunit virus flu vaccine, with regards to A/H3N2 antigen, when administered to adults with underlying chronic disease, as measured by HI test at day 22

Secondary outcome:

Compare the immunogenicity of an IM injection of an adj. inactivated subunit flu vaccine vs. inactivated subunit virus flu vaccine, with regards to B antigen, when administered to adults with underlying chronic disease, as measured by HI test at day 22

Evaluate the immunog. of a single IM inj. of an adj. inactivated subunit flu vaccine vs. inactivated subunit virus flu vaccine, with regards to A/H1N1 antigen, when administered to adults with underlying chronic disease, as measured by HI test at day 22

To evaluate the safety of a single IM injection of the two influenza vaccines, when administered to adult subjects with underlying chronic disease(s).

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 18 to 60 years of age adult volunteers, mentally competent, willing and able to give

written informed consent prior to study entry, suffering from at least one of these chronic diseases: moderate to severe hypertension, moderate to severe congestive heart failure, chronic obstructive pulmonary disease (COPD) or moderate to severe asthma, moderate to severe hepatic or renal insufficiency, arteriosclerotic disease or insulin dependent diabetes mellitus

Exclusion Criteria:

- Hypersensitivity to ovalbumin, chicken protein, chicken feathers, influenza viral

protein, neomycin or polymyxin or any other component of the vaccine;

- History of neurological symptoms or signs, or anaphylactic shock following

administration of any vaccine;

- Known or suspected impairment/ alteration of immune function;

- Any condition which might interfere with the evaluation of the study objectives

Starting date: November 2006
Last updated: August 20, 2007