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.

NCT00522067 | Completed Phase 2

• 2 other identifiers: V70P42007-000964-26
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Influenza Disease

Keywords

influenza; influenza vaccine; adjuvanted influenza vaccine; subunit influenza vaccine; surface antigen

Outcome Measures

Primary Outcomes (2)

• 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.

Study Arms (1)

Arm 1

EXPERIMENTAL

FLUAD

Biological: Adjuvanted influenza vaccine

Interventions

Adjuvanted influenza vaccine BIOLOGICAL

Vaccination with MF 59 adjuvanted trivalent seasonal influenza vaccine

Arm 1

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Vaccines: lead

Study Sites (1)

Azienda Sanitaria USL 7 di Siena

Siena, 53100, Italy

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Novartis Vaccines

  Novartis Vaccines

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2007
• First Posted: August 29, 2007
• Study Start: June 1, 2007
• Primary Completion: July 1, 2007
• Study Completion: July 1, 2007
• Last Updated: December 1, 2016

Record last verified: 2012-01

Locations

IT (1)