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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00519064

Enrollment

361

Registered

2007-08-21

Start date

2006-11-30

Completion date

2007-05-31

Last updated

2016-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza Disease

Keywords

influenza, influenza vaccine, adjuvanted influenza vaccine, H5N1 influenza antigen

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.

Interventions

BIOLOGICALAdjuvanted influenza vaccine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026