Immunogenicity, Safety and Tolerability of Two Doses of FLUAD-H5N1 Influenza Vaccine in Adult and Elderly Subjects

April 23, 2008 updated by: Novartis

A Phase III, Randomized, Controlled, Observer-Blind, Multicenter Study to Evaluate the Immunogenicity, Safety and Tolerability of Two Doses of FLUAD-H5N1 Influenza Vaccine in Adult and Elderly Subjects

This study is designed to evaluate the immunogenicity, safety and tolerability of 2 doses of FLUAD-H5N1 vaccine compared to 2 doses of trivalent, interpandemic FLUAD, each administered 3 weeks apart.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

4400

Phase

  • Phase 3

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

  • Poland
      • Kraków, Poland, 30-969
        • Centrum Badan Farmakologii Klinicznej monipol

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

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy Subjects 18 years of age who signed the informed consent

Exclusion Criteria:

  • Receipt of another investigational agent within 4 weeks
  • Receipt of influenza vaccination for current season 2006/2007.
  • any acute disease or infection, history of neurological symptoms or signs, known or suspected impairment of immune function, any serious disease, bleeding diathesis
  • fever (defined as axillary temperature ³38.0°C) within 3 days (prior to Visit 1)
  • Pregnant or breastfeeding or females of childbearing potential who refuse to use an acceptable method of birth control
  • Surgery planned during the study period
  • Hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the study vaccine
  • Receipt of another vaccine within 3 weeks prior to Visit 1 or planned vaccination within 3 weeks following the last study vaccination
  • History of (or current) drug or alcohol abuse
  • Any condition, which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives.

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: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Adverse event rate

Secondary Outcome Measures

Outcome Measure
Seroconversion and seroprotection after two doses of H5N1 vaccine

Collaborators and Investigators

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

Sponsor

Novartis

Collaborators

Novartis Vaccines

Investigators

  • Study Chair: Novartis Vaccines and Diagnostics GmbH & Co KG Novartis, Novartis Vaccines and Diagnostics GmbH & Co KG., Germany

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

January 1, 2007

Study Registration Dates

First Submitted

February 12, 2007

First Submitted That Met QC Criteria

February 12, 2007

First Posted (Estimate)

February 13, 2007

Study Record Updates

Last Update Posted (Estimate)

April 24, 2008

Last Update Submitted That Met QC Criteria

April 23, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V87P4
  • 2006-005428-18

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.

Clinical Trials on Influenza

Clinical Trials on Pandemic influenza vaccine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belarus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe