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Safety and Immunogenicity of Two Adjuvanted and One Non-adjuvanted H5N1 Influenza Vaccine in Adults

NCT ID: NCT00382187

Last Updated: 2016-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2008-01-31

Brief Summary

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The present study aims to evaluate safety and immunogenicity of two doses, administered three weeks apart, and a 6 month booster dose, of two influenza vaccines containing 7.5 micrograms or 15 micrograms of H5N1 influenza antigen, and of a non-adjuvanted influenza vaccine containing 15 micrograms of H5N1 influenza antigen, in adults

Detailed Description

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Conditions

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Influenza

Keywords

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influenza pandemic influenza influenza vaccine adjuvanted influenza vaccine H5N1 influenza antigen MF59 Pandemic influenza disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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MF59 adjuvant H5N1 influenza vaccine 7.5 micrograms

Group Type EXPERIMENTAL

MF59 adjuvanted H5N1 influenza vaccine

Intervention Type BIOLOGICAL

* MF59 adjuvanted (H5N1) influenza vaccine (Vietnam strain) containing 7.5 mg or 15 mg of H5N1
* non-adjuvanted influenza vaccine containing 15 ug of H5N1

MF59 adjuvant H5N1 influenza vaccine 15 micrograms

Group Type EXPERIMENTAL

MF59 adjuvanted H5N1 influenza vaccine

Intervention Type BIOLOGICAL

* MF59 adjuvanted (H5N1) influenza vaccine (Vietnam strain) containing 7.5 mg or 15 mg of H5N1
* non-adjuvanted influenza vaccine containing 15 ug of H5N1

non-adjuvanted influenza vaccine 15 micrograms of H5N1 antigen

Group Type EXPERIMENTAL

MF59 adjuvanted H5N1 influenza vaccine

Intervention Type BIOLOGICAL

* MF59 adjuvanted (H5N1) influenza vaccine (Vietnam strain) containing 7.5 mg or 15 mg of H5N1
* non-adjuvanted influenza vaccine containing 15 ug of H5N1

Interventions

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MF59 adjuvanted H5N1 influenza vaccine

* MF59 adjuvanted (H5N1) influenza vaccine (Vietnam strain) containing 7.5 mg or 15 mg of H5N1
* non-adjuvanted influenza vaccine containing 15 ug of H5N1

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Male and female volunteers 18-60 years of age

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 or infections requiring systemic antibiotic or antiviral therapy
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Novartis Vaccines

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Vaccines - Information Services

Role: STUDY_CHAIR

Novartis

Locations

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Presidio Distrettuale N. 8, Azienda USL 7 di Siena, Via Savina Petrilli, 3

Siena, Siena, Italy

Site Status

Countries

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Italy

References

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Galli G, Medini D, Borgogni E, Zedda L, Bardelli M, Malzone C, Nuti S, Tavarini S, Sammicheli C, Hilbert AK, Brauer V, Banzhoff A, Rappuoli R, Del Giudice G, Castellino F. Adjuvanted H5N1 vaccine induces early CD4+ T cell response that predicts long-term persistence of protective antibody levels. Proc Natl Acad Sci U S A. 2009 Mar 10;106(10):3877-82. doi: 10.1073/pnas.0813390106. Epub 2009 Feb 23.

Reference Type RESULT
PMID: 19237568 (View on PubMed)

Other Identifiers

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Eudract number 2006-004063-66

Identifier Type: -

Identifier Source: secondary_id

V87P2

Identifier Type: -

Identifier Source: org_study_id