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Trial registered on ANZCTR


Registration number
ACTRN12611000872932
Ethics application status
Approved
Date submitted
15/08/2011
Date registered
16/08/2011
Date last updated
31/03/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Retrospective safety survey of 2011 seasonal influenza vaccine (Fluarix Registered Trademark (R)) in New Zealand (NZ) children aged 6 months to 8 years
Scientific title
Retrospective safety survey of 2011 seasonal influenza vaccine (Fluarix (R)) in NZ children aged 6 months to 8 years
Secondary ID [1] 262828 0
nil
Universal Trial Number (UTN)
U1111-1123-7246
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Febrile and other reactions following vaccination of children with the 2011 seasonal influenza vaccine manufactured by GSK (Fluarix). 270552 0
Condition category
Condition code
Inflammatory and Immune System 270713 270713 0 0
Normal development and function of the immune system
Public Health 270727 270727 0 0
Epidemiology

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study aims to survey 400 parents for their recall of febrile and other reactions following their child’s vaccination with the 2011 seasonal influenza vaccine manufactured by GSK (Fluarix).
This will be a retrospective telephone survey of parents of infants and children, who received 2011 Fluarix influenza vaccine, and will be conducted by the practice nurses, in the general practice who administered the vaccine to the infants or children.
Recruitment is expected to take 2 months, or until 400 survey have been received which ever is the first.
Intervention code [1] 269181 0
Not applicable
Comparator / control treatment
Uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 269425 0
The primary objective of this study will be to determine the rates of febrile events in young children aged 6 months to 8 years inclusive within 24 hours of receipt of any dose of 2011 Fluarix (2011 seasonal influenza vaccine manufactured by GSK).
Parental recall to questions on the survey instrument will be recorded
Recall of fever (Yes/No) if yes did the fever occur between 1-4 hrs, 5-8 hrs, 9-24 hrs or after 24hrs
Was the childs temperature measured (Yes/No) if yes what was the measured temperature. Fever, endogenous elevation of at least one measured body temperature of 38C
Were there any other reactions (Yes/No) These will be coded as myalgia, arthralgia, malaise and headache etc.
Was anti-fever medicine given (Yes/No) if yes was it given before or after vaccination
Did you need to call or see a doctor (Yes/No) if yes who, where and why
Timepoint [1] 269425 0
30/09/2011, at the end of the study once all data is collected
Secondary outcome [1] 287606 0
Evaluate the reactogenicity of Fluarix, in young children aged 6 months to 8 years inclusive, associated with febrile AEs after any dose. Descriptive statistics will describe all baseline variables and key outcome variables and paired t-tests used to evaluate per person changes in temperature (temperatures will be characterised by reporting of mean, median and ranges). Incidence rates for febrile AEs will be further characterised by assessment of severity (by temperature grades of febrile AEs (38C, 39C and 40C), whether the febrile AE was medically attended, and any associated seizures (according to Brighton Collaboration seizure definitions). Patterns of febrile AEs with associated symptoms in other organ systems will also be characterised by incidence rates, with exploration of the associated severity of fever by major symptom clusters.
Timepoint [1] 287606 0
30/09/2011,at the end of the study once all data is collected
Secondary outcome [2] 287628 0
Identify any confirmed febrile convulsions (observed and conforming to Brighton Collaboration definitions for level one, two or three diagnosis.)
Timepoint [2] 287628 0
30/09/2011 at the end of the study once all data is collected
Secondary outcome [3] 287629 0
Evaluate all cases that include fever and at least one other symptom and follow up to allow further clarification and classification by a Clinician. The Clinician will confirm the events via Medical records, parental discussion and or attending Medical practitioner.
Timepoint [3] 287629 0
30/10/2011 after data is collected and analysis has been completed

Eligibility
Key inclusion criteria
All infants and children aged 6 months to 8 years inclusive receiving seasonal influenza vaccine during the study period.
Minimum age
6 Months
Maximum age
8 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Parents or caregivers unable to speak conversational English or unavailable by telephone.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 3787 0
New Zealand
State/province [1] 3787 0

Funding & Sponsors
Funding source category [1] 269653 0
Commercial sector/Industry
Name [1] 269653 0
GlaxoSmithKline Australia Pty. Ltd
Address [1] 269653 0
1061 Mountain Highway, Boronia, Victoria 3155
Country [1] 269653 0
Australia
Primary sponsor type
University
Name
Auckland Uniservices Ltd, for the Immunisation Advisory Centre, Department of General Practice & Primary Health Care, School of Population Health, Univeristy of Auckland
Address
Private Bag 92019
Glen Innes
Auckland
New Zealand 1142
Country
New Zealand
Secondary sponsor category [1] 266686 0
None
Name [1] 266686 0
Address [1] 266686 0
Country [1] 266686 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269600 0
Multi-region Ethics Committee
Ethics committee address [1] 269600 0
PO Box 5013
1 the Terrace
Wellington 6011
Ethics committee country [1] 269600 0
New Zealand
Date submitted for ethics approval [1] 269600 0
Approval date [1] 269600 0
29/06/2011
Ethics approval number [1] 269600 0
MEC/10/037/EXP

Summary
Brief summary
This study of children who received 2011 influenza vaccine, is to ensure that the safety profile of this year’s vaccine is within expectations. The aim is to survey 250 parents of children aged 6 months to five years inclusive and 150 parents of children aged six years to eight years inclusive, who received the 2011 influenza vaccine. To determine the rates of febrile events in young children aged 6 months to 8 years inclusive within 24 hours of receipt of any dose of 2011 Fluarix (R)
Trial website
Trial related presentations / publications
Febrile events including convulsions following the administration of four brands of 2010 and 2011 inactivated seasonal influenza vaccine in NZ infants and children: The importance of routine active safety surveillance Vaccine Petousis-Harris H, Poole T, Turner N, Reynolds G:2012 vol:30 iss:33 pg:4945 -4952
Public notes

Contacts
Principal investigator
Name 33014 0
Dr Helen Petousis-Harris
Address 33014 0
Immunisation Advisory Centre, Research and Vaccinology, Department of General Practice, School of Population Health University of Auckland Private Bag 92019 Auckland 1142
Country 33014 0
New Zealand
Phone 33014 0
+64 9 9232078 extn 82078
Fax 33014 0
Email 33014 0
h.petousis-harris@auckland.ac.nz
Contact person for public queries
Name 16261 0
Mrs Tracey Poole
Address 16261 0
Immunisation Advisory Centre, Research and Vaccinology, Department of General Practice, School of Population Health University of Auckland Private Bag 92019 Auckland 1142
Country 16261 0
New Zealand
Phone 16261 0
64 9 9232078 extn 83806
Fax 16261 0
64 9 3737030
Email 16261 0
t.poole@auckland.ac.nz
Contact person for scientific queries
Name 7189 0
Dr Helen Petousis-Harris Bsc, PGDipSc
Address 7189 0
University of Auckland
Immunisation Advisory Centre
School of Population Health
Private Bag 92019
Auckland 1142
Country 7189 0
New Zealand
Phone 7189 0
64 9 9232078 extn 82078
Fax 7189 0
649 373 7030
Email 7189 0
h.petousis-harris@auckland.ac.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary