NCT00311480

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
520

participants targeted

Target at P75+ for phase_2

Geographic Reach
1 country

4 active sites

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

March 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 4, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 6, 2006

Completed
Last Updated

March 13, 2007

Status Verified

March 1, 2007

First QC Date

April 4, 2006

Last Update Submit

March 12, 2007

Conditions

Pandemic Influenza Disease

Keywords

influenzapandemic influenzainfluenza vaccineadjuvanted influenza vaccine

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

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

Interventions

Influenza vaccine surface antigen adjuvanted with MF59BIOLOGICAL

Eligibility Criteria

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

You may qualify if:

  • Male and female volunteers 18 years of age or older

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

G. D'Annunzio University

Chieti, 66100, Italy

Location

Department of Health Sciences

Genoa, 16129, Italy

Location

ASL Lanciano-Vasto

Lanciano, 66034, Italy

Location

University Hospital of Siena

Siena, 53100, Italy

Location

Related Publications (1)

  • Banzhoff A, Gasparini R, Laghi-Pasini F, Staniscia T, Durando P, Montomoli E, Capecchi PL, di Giovanni P, Sticchi L, Gentile C, Hilbert A, Brauer V, Tilman S, Podda A. MF59-adjuvanted H5N1 vaccine induces immunologic memory and heterotypic antibody responses in non-elderly and elderly adults. PLoS One. 2009;4(2):e4384. doi: 10.1371/journal.pone.0004384. Epub 2009 Feb 6.

    PMID: 19197383DERIVED

MeSH Terms

Conditions

Influenza, Human

Interventions

MF59 oil emulsion

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Drug Information Services

    Novartis Vaccines & Diagnostics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 4, 2006

First Posted

April 6, 2006

Study Start

March 1, 2006

Last Updated

March 13, 2007

Record last verified: 2007-03

Locations

IT(4)