Safety and Immunogenicity of Two Doses, Administered Three Weeks Apart, of Two(Surface Antigen Adjuvanted With MF59C.1) Influenza Vaccines in Non-Elderly Adult and Elderly Subjects

March 12, 2007 updated by: Novartis

A Phase II, Randomized, Controlled, Observer-Blind, Multi-Center Study to Evaluate Safety and Immunogenicity of Two Doses, Administered Three Weeks Apart, of Two (Surface Antigen Adjuvanted With MF59C.1) Influenza Vaccines Containing 7.5 mg or 15 mg of H5N1 Influenza Antigen, in Non-Elderly Adult and Elderly Subjects

The present study aims to evaluate safety and immunogenicity of two doses, administered three weeks apart, of two influenza vaccines containing 7.5 micrograms or 15 micrograms of H5N1 influenza antigen, in non-elderly adult and elderly subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

520

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Chieti, Italy, 66100
        • G. d'Annunzio University
      • Genoa, Italy, 16129
        • Department of Health Sciences
      • Lanciano, Italy, 66034
        • ASL Lanciano-Vasto
      • Siena, Italy, 53100
        • University Hospital of Siena

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male and female volunteers 18 years of age or older

Exclusion Criteria:

  • any auto-immune disease or other serious acute, chronic or progressive disease
  • hypersensitivity to eggs, 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.
  • within the past 7 days, they have experienced: any acute disease, infections requiring systemic antibiotic or antiviral therapy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
CPMP criteria for evaluation of flu vaccines e.g. Seroprotection, GMT's and Seroconversion rate at day 0 and day 22 and day 43 following vaccination

Secondary Outcome Measures

Outcome Measure
Solicited Local and Systemic Reactions Within 6 Days Following Each Vaccination And Adverse Events Thought the Study.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Collaborators

Novartis Vaccines

Investigators

  • Principal Investigator: Drug Information Services, Novartis Vaccines & Diagnostics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Study Registration Dates

First Submitted

April 4, 2006

First Submitted That Met QC Criteria

April 4, 2006

First Posted (Estimate)

April 6, 2006

Study Record Updates

Last Update Posted (Estimate)

March 13, 2007

Last Update Submitted That Met QC Criteria

March 12, 2007

Last Verified

March 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V87P1
  • Eudract:2005-005871-14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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