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.

Influenza Disease Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00522067
• Other study ID #: V70P4
• Secondary ID: 2007-000964-26
• Status: Completed
• Phase: Phase 2
• First received: August 28, 2007
• Last updated: November 30, 2016
• Start date: June 2007
• Est. completion date: July 2007

Study information

• Verified date: January 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chronic Disease
• Influenza Disease
• Influenza, Human

Intervention

Biological:
• Adjuvanted influenza vaccine
Vaccination with MF 59 adjuvanted trivalent seasonal influenza vaccine

Locations

Country	Name	City	State
Italy	Azienda Sanitaria USL 7 di Siena	Siena

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Vaccines

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	To evaluate the safety of the administration of a single intramuscular(IM) injection of an inactivated, adjuvanted influenza vaccine, in at risk adult subjects.

External Links

•   Results for V70P4 from the Novartis Clinical Trials website