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Phase II Study of Pandemic Influenza Vaccine

NCT ID: NCT00320346

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

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2006-09-30

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 the leading candidate to cause the next influenza pandemic. This study will test the safety and immunogenicity of a H5N1 Pandemic Influenza Vaccine in healthy adults. The Study will also assess Lot to Lot consistency of the Pandemic Influenza Vaccine.

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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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Pandemic Influenza Vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Healthy Adults

Exclusion Criteria

* Previous vaccination with an influenza Vaccine containing the H5N1 strain
* History of clinically significant medical conditions
* History of Guillian-Barre Syndrome or active Neurological disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 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

Murdoch Childrens Research Institute

Melbourne, Victoria, Australia

Site Status

Princess Margaret Hospital for Children

Perth, Western Australia, Australia

Site Status

Countries

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Australia

References

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Nolan TM, Richmond PC, Skeljo MV, Pearce G, Hartel G, Formica NT, Hoschler K, Bennet J, Ryan D, Papanaoum K, Basser RL, Zambon MC. Phase I and II randomised trials of the safety and immunogenicity of a prototype adjuvanted inactivated split-virus influenza A (H5N1) vaccine in healthy adults. Vaccine. 2008 Aug 5;26(33):4160-7. doi: 10.1016/j.vaccine.2008.05.077. Epub 2008 Jun 13.

Reference Type DERIVED
PMID: 18599164 (View on PubMed)

Other Identifiers

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CSLCT-PAN-05-18

Identifier Type: -

Identifier Source: org_study_id

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