NCT00434733

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,400

participants targeted

Target at P75+ for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 12, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 13, 2007

Completed
Last Updated

April 24, 2008

Status Verified

April 1, 2008

First QC Date

February 12, 2007

Last Update Submit

April 23, 2008

Conditions

Influenza

Keywords

Influenza H5N1, pandemic

Outcome Measures

Primary Outcomes (1)

  • Adverse event rate

Secondary Outcomes (1)

  • Seroconversion and seroprotection after two doses of H5N1 vaccine

Interventions

Pandemic influenza vaccineBIOLOGICAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centrum Badań Farmakologii Klinicznej monipol

Krakow, 30-969, Poland

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Novartis Vaccines and Diagnostics GmbH & Co KG Novartis

    Novartis Vaccines and Diagnostics GmbH & Co KG., Germany

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 12, 2007

First Posted

February 13, 2007

Study Start

January 1, 2007

Last Updated

April 24, 2008

Record last verified: 2008-04

Locations

PL(1)