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Study of a Pandemic Influenza...

Study of a Pandemic Influenza Vaccine in Elderly Participants

NCT ID: NCT00376402

Last Updated: 2016-07-19

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

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2007-06-30

Brief Summary

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The World Health Organisation has warned that an influenza pandemic is inevitable. The avian influenza H5N1 virus strain is one of the leading candidates to cause the next influenza pandemic. The elderly are likely to be a special target group for vaccination; therefore, this study will test the safety and immunogenicity of a H5N1 pandemic influenza vaccine in a healthy elderly population.

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Detailed Description

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Conditions

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Influenza

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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H5N1 Pandemic Influenza Vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Healthy male and female participants

Exclusion Criteria

* History of clinically significant medical conditions
* History of Guillain-Barre syndrome or active neurological disease
* Resident of nursing home or long-term care facility

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Seqirus

INDUSTRY

Sponsor Role lead

Responsible Party

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CSL Limited

Principal Investigators

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Peter Richmond, Dr

Role: PRINCIPAL_INVESTIGATOR

Princess Margaret Hospital for Children

Locations

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CMAX, a division of IDT Australia

Adelaide, South Australia, Australia

Site Status

Princess Margaret Hospital for Children

Perth, Western Australia, Australia

Site Status

Countries

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Australia

Other Identifiers

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CSLCT-PAN-05-24

Identifier Type: -

Identifier Source: org_study_id

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