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Study of a Pandemic Influenza Vaccine in Children

NCT ID: NCT00370864

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

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2007-07-31

Brief Summary

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

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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 children aged greater or equal to 6 months to less than 9 years
* Normal gestation period

Exclusion Criteria

* History of clinically significant medical conditions
* History of Guillain Barre syndrome or active neurological disease
Minimum Eligible Age

6 Months

Maximum Eligible Age

8 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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Terry M Nolan, Prof

Role: PRINCIPAL_INVESTIGATOR

Murdoch Childrens Research Institute

Locations

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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 T, Richmond PC, Formica NT, Hoschler K, Skeljo MV, Stoney T, McVernon J, Hartel G, Sawlwin DC, Bennet J, Ryan D, Basser RL, Zambon MC. Safety and immunogenicity of a prototype adjuvanted inactivated split-virus influenza A (H5N1) vaccine in infants and children. Vaccine. 2008 Nov 25;26(50):6383-91. doi: 10.1016/j.vaccine.2008.08.046. Epub 2008 Sep 16.

Reference Type DERIVED
PMID: 18801398 (View on PubMed)

Other Identifiers

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CSLCT-PAN-05-17

Identifier Type: -

Identifier Source: org_study_id

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