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 - Full Text View

Sponsor:	Novartis
Collaborator:	Novartis Vaccines
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00519064

Purpose

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.

Condition	Intervention	Phase
Influenza Disease	Biological: Adjuvanted influenza vaccine	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Prevention
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

Resource links provided by NLM:

MedlinePlus related topics: Coping with Chronic Illness Flu

Drug Information available for: Fluvirin Influenza Vaccines

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

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 [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 [ Designated as safety issue: No ]
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 [ Designated as safety issue: No ]
To evaluate the safety of a single IM injection of the two influenza vaccines, when administered to adult subjects with underlying chronic disease(s). [ Designated as safety issue: Yes ]

Enrollment:	361
Study Start Date:	November 2006
Study Completion Date:	May 2007
Primary Completion Date:	December 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Arm 1	Biological: Adjuvanted influenza vaccine
Active Comparator: Arm 2	Biological: Adjuvanted influenza vaccine

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00519064

Sponsors and Collaborators

Novartis

Novartis Vaccines

Investigators

Study Chair:

Novartis Vaccines

More Information

No publications provided

Responsible Party:	Novartis Vaccines and Diagnostics
ClinicalTrials.gov Identifier:	NCT00519064 History of Changes
Other Study ID Numbers:	V70P3, 2006-005558-63
Study First Received:	August 20, 2007
Last Updated:	June 14, 2011
Health Authority:	Italy: Ministry of Health

Keywords provided by Novartis:

influenza
influenza vaccine
adjuvanted influenza vaccine
H5N1 influenza antigen

Additional relevant MeSH terms:

Chronic Disease
Influenza, Human
Disease Attributes
Pathologic Processes
Orthomyxoviridae Infections

RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on February 12, 2012