Clinical trial NCT00519064: 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
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza Disease
Keywords: influenza
influenza vaccine
adjuvanted influenza vaccine
H5N1 influenza antigen
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-08-21
Enrollment: 361
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Compare immunogenicity 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 outcomes:
measure: Compare 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
measure: Evaluate 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
measure: To evaluate the safety of a single IM injection of the two influenza vaccines, when administered to adult subjects with underlying chronic disease(s).
Other outcomes:
Locations:
city: Mira, Via Nazionale 48
country: Italy
facility: Azienda ULSS 13 di Mirano
state: Venezia
Study officials:
affiliation: Novartis Vaccines
name: Novartis Vaccines
role: STUDY_CHAIR
References:
citation: Black S, Della Cioppa G, Malfroot A, Nacci P, Nicolay U, Pellegrini M, Sokal E, Vertruyen A. Safety of MF59-adjuvanted versus non-adjuvanted influenza vaccines in children and adolescents: an integrated analysis. Vaccine. 2010 Oct 21;28(45):7331-6. doi: 10.1016/j.vaccine.2010.08.075. Epub 2010 Sep 15.