Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000619448
Ethics application status
Approved
Date submitted
13/11/2007
Date registered
30/11/2007
Date last updated
30/11/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Burden of Influenza in Children under 5 years Admitted to the Children Hospital at Westmead 2006
Scientific title
The Burden of Influenza in Children under 5 years Admitted to the Children Hospital at Westmead 2006
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Influenza in children under 5 years. 2543 0
Condition category
Condition code
Infection 2643 2643 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Observational study; no intervention. The incidence of influenza hospitalisation in children under 5 years during the period June to October 2006.
Intervention code [1] 2275 0
Early detection / Screening
Comparator / control treatment
Observational study, no comparator
Control group
Uncontrolled

Outcomes
Primary outcome [1] 3553 0
Influenza.
Timepoint [1] 3553 0
One year.
Secondary outcome [1] 5951 0
Parental time off work.
Secondary infection.
Timepoint [1] 5951 0
One year.

Eligibility
Key inclusion criteria
Children under 5 years
Temp > 37.8
Hospital admission
Respiratory symptoms
Minimum age
7 Days
Maximum age
5 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Respiratory symptoms more than 15 days duration.
Children who did not leave hospital since birth.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
275
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 494 0
2145

Funding & Sponsors
Funding source category [1] 2788 0
Commercial sector/Industry
Name [1] 2788 0
Sanofi Pasteur
Country [1] 2788 0
Australia
Primary sponsor type
Individual
Name
Mary Iskander
Address
National Centre for Immunisation, Research and Surveillance
The Children Hospital at Westmead
Corner of Hawkesbury and Hainsworth Street
Westmead NSW 2145
Country
Australia
Secondary sponsor category [1] 2518 0
Hospital
Name [1] 2518 0
Department of Infectious Diseases and Microbiology
Address [1] 2518 0
The Children Hospital at Westmead
Corner of Hawkesbury and Hainsworth Street
Westmead NSW 2145
Country [1] 2518 0
Australia
Other collaborator category [1] 86 0
Hospital
Name [1] 86 0
Department of Virology
Address [1] 86 0
Westmead Hospital
Country [1] 86 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4706 0
The Children Hospital at Westmead Ethics Committee
Ethics committee address [1] 4706 0
The Children Hospital at Westmead
Corner of Hawkesbury and Hainsworth Street
Westmead NSW 2145
Ethics committee country [1] 4706 0
Australia
Date submitted for ethics approval [1] 4706 0
Approval date [1] 4706 0
05/07/2006
Ethics approval number [1] 4706 0

Summary
Brief summary
The aim of the study is to prospectively measure the morbidity in children under 5 years of age hospitalised with influenza as well as the indirect burden on their families during one influenza season. This enhanced surveillance data will serve to accurately assess the cost effectiveness of influenza vaccination in young children.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28178 0
Address 28178 0
Country 28178 0
Phone 28178 0
Fax 28178 0
Email 28178 0
Contact person for public queries
Name 11335 0
Mary Iskander
Address 11335 0
National Centre for Immunisation, Research and Surveillance
The Children Hospital at Westmead
Corner of Hawkesbury Road and Hainsworth Street
Westmead NSW 2145
Country 11335 0
Australia
Phone 11335 0
+61 2 98450122
Fax 11335 0
+61 2 98451418
Email 11335 0
[email protected]
Contact person for scientific queries
Name 2263 0
Mary Iskander
Address 2263 0
National Centre for Immunisation, Research and Surveillance
The Children Hospital at Westmead
Corner of Hawkesbury Road and Hainsworth Street
Westmead NSW 2145
Country 2263 0
Australia
Phone 2263 0
+61 2 98450122
Fax 2263 0
+61 2 98451418
Email 2263 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.