Support Annual Strain Update, Safety and Immunogenicity of an Inactivated, Adjuvanted Influenza Vaccine, Formulation 2007-2008, When Administered to Subjects 18-64 Years Affected by Chronic Diseases.

This phase II, open label, is designed as a seasonal study to support annual strain update evaluating the safety, clinical tolerability and immunogenicity of the 2007-2008 formulation of Novartis Vaccines' adjuvanted, subunit influenza vaccine in adults with underlying chronic diseases

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Key information

Conditions

Influenza Disease Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Azienda Sanitaria USL 7 di Siena

Siena, 53100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

18 to 64 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: hypertension, heart disease, chronic obstructive pulmonary disease (COPD) or asthma, hepatic or renal insufficiency, arteriosclerotic disease or insulin dependent diabetes mellitus

Exclusion criteria

Hypersensitivity to ovalbumin, chicken protein, chicken feathers, influenza viral protein, kanamycin and neomycin sulphate 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;
Having received within the past 12 months more than one injection of influenza vaccine
Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives

Treatment and study plan

Adjuvanted Influenza Vaccine

Biological

Vaccination with MF 59 adjuvanted trivalent seasonal influenza vaccine

Primary outcomes

Evaluate the antibody response to each flu vacc. antigen, measured by SRH at 21-day post-vacc. in at risk adults in compliance with the requirements of the EU recommendations for the evaluation of the immunog. for a new formulation of a licensed flu vacc
To evaluate the safety of the administration of a single intramuscular(IM) injection of an inactivated, adjuvanted influenza vaccine, in at risk adult subjects.

Sponsors and collaborators

Lead sponsor

Novartis Vaccines

Industry

Registry information

Official study title

A Phase II, Open Label, Uncontrolled, Multi-Center Study to Support Annual Strain Update and to Evaluate Safety and Immunogenicity of a Surface Antigen, Inactivated, Adjuvanted Influenza Vaccine, Formulation 2007-2008, When Administered to Subjects Aged 18-64 Years Affected by Chronic Diseases

Important dates

Study start: 2007
Primary completion: 2007
Study completion: 2007
First posted: Aug 29, 2007
Registry last updated: Dec 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed