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Safety and Immunogenicity of a Booster Dose of -H5N1 Influenza Vaccine

NCT ID: NCT00561184

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

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2008-06-30

Brief Summary

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To assess persistence of antibody titers 17-18 months after primary immunization with two 0.5mL intramuscular (IM) doses of H5N1 influenza vaccine containing H5N1 influenza antigen, as measured by Hemagglutination Inhibition (HI), Single Radial Hemolysis (SRH), and Microneutralization (MN) test

Detailed Description

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Conditions

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Avian Influenza

Keywords

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H5N1 Pandemic

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

H5N1 influenza vaccine

Intervention Type BIOLOGICAL

One 0.5 ml booster injection 12 months after the second injection, of influenza vaccine containing 7.5 micrograms of H5N1 influenza antigen

2

Group Type EXPERIMENTAL

H5N1 influenza vaccine

Intervention Type BIOLOGICAL

One 0.5 ml booster injection 12 months after the second injection, of influenza vaccine containing 15.0 micrograms of H5N1 influenza antigen

Interventions

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H5N1 influenza vaccine

One 0.5 ml booster injection 12 months after the second injection, of influenza vaccine containing 7.5 micrograms of H5N1 influenza antigen

Intervention Type BIOLOGICAL

H5N1 influenza vaccine

One 0.5 ml booster injection 12 months after the second injection, of influenza vaccine containing 15.0 micrograms of H5N1 influenza antigen

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Healthy subjects who previously participated in study V87P1, but did not receive the booster dose on day 202

Exclusion Criteria

* Pregnant or breastfeeding
* Receipt of another vaccine or any investigational agent within the past 4 weeks
* Surgery planned during the study period
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

Role: STUDY_CHAIR

Novartis Vaccines

Locations

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Dipartimento di Medicina e Scienze dell'Invecchiamento, Università G. D'Annunzio, Via dei Vestini

Chieti, , Italy

Site Status

01: Dipartimento di Scienze della Salute, Sezione Igiene e Medicina Preventiva, Università di Genova

Genova, , Italy

Site Status

03: Ufficio di Igiene e Sanità Pubblica di Lanciano, ASL Lanciano -Vasto, Via Spaventa, 37,

Lanciano, , Italy

Site Status

Countries

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Italy

References

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Fragapane E, Gasparini R, Schioppa F, Laghi-Pasini F, Montomoli E, Banzhoff A. A heterologous MF59-adjuvanted H5N1 prepandemic influenza booster vaccine induces a robust, cross-reactive immune response in adults and the elderly. Clin Vaccine Immunol. 2010 Nov;17(11):1817-9. doi: 10.1128/CVI.00461-09. Epub 2010 Sep 1.

Reference Type RESULT
PMID: 20810680 (View on PubMed)

Other Identifiers

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2007-000165-38

Identifier Type: -

Identifier Source: secondary_id

V87P1E1

Identifier Type: -

Identifier Source: org_study_id