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Trial registered on ANZCTR


Registration number
ACTRN12610000319077
Ethics application status
Approved
Date submitted
16/04/2010
Date registered
20/04/2010
Date last updated
7/12/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Paediatric Influenza Vaccine Outcome Trial (PIVOT)
Scientific title
Social, economic and Health Benefits of Vaccinating Children aged 6 months to 48 months against Influenza. Paediatric Influenza Vaccine Outcome Trial (PIVOT)
Secondary ID [1] 251632 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Influenza 257194 0
influenza infection during winter season 257195 0
Condition category
Condition code
Infection 257338 257338 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An randomised controlled trial of trivalent inactivated influenza vaccine (Registered Trademark: VAXIGRIP Junior, Sanofi Pasteur; administered via intramuscular injection. 0.5ml used for subjects just turned 3 years of age whereas 0.25ml will be used for under 3 years of age), using Hepatitis A vaccine (HAV, Registered Trademark: VAQTA Paediatric, CSL, 25 units of virus protein) as the control at a ratio of 1:1. Frequency of administration would be either once or twice depending on subjects’ previous vaccination. The approximate duration between each vaccine Vaccination would 4 weeks. Will start from April to July.
Intervention code [1] 256325 0
Other interventions
Intervention code [2] 256340 0
Prevention
Comparator / control treatment
influenza vaccine recipients and non-recipients
Control group
Active

Outcomes
Primary outcome [1] 258233 0
1. To determine the social, economic, and health impact of influenza prevention in preschool children attending day care centres (DCC) during two consecutive influenza seasons through interviewing participants parents.
Timepoint [1] 258233 0
Subjects will be followed up every two weeks during the influenza season which will start from June and continue until the end of Septemebr.
Primary outcome [2] 258234 0
2. to determine the efficacy and effectiveness of influenza vaccine in preventing laboratory proven influenza and influenza like illness ( ILI) in preschool children attending DCC in Sydney metropolitan area during two consecutive influenza seasons. This will be through nasal swabs
Timepoint [2] 258234 0
Subjects will be followed up during the influenza season ( June to September) and when they report an influenza like symptom (ILI). Subjects will will be swabed ( nasal) for testing and interviewed at 2 and 4 weeks after the onset of ILI.
Primary outcome [3] 258235 0
3. To explore parental and day care staff attitudes and knowledge about influenza prevention. this will be done through interviews
Timepoint [3] 258235 0
Subjects will be followed up in day care centres and be interviewed at any time from June to September.
Secondary outcome [1] 263923 0
Nil
Timepoint [1] 263923 0
Nil

Eligibility
Key inclusion criteria
Male or female aged greater than or equal to 6 months to <48months at 1st march 2011; who will comply with the requirements of the protocol (e.g. completion of the diaries, return for the follow-up visit). The parent’s/guardian’s ability to understand English is sufficient not to impede the ability to give properly informed consent
Minimum age
6 Months
Maximum age
48 Months
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Systemic hypersensitivity to egg proteins, chicken proteins, or any of the vaccine components for the vaccine group. Unstable chronic illness; Known history of Guillain-Barre Syndrome; Plans to enter another clinical trial, or receive an investigational product after receiving vaccine for this trial any time before 31 October 2010; Thrombocytopenia or bleeding disorder and History of psychiatric disorders in the parent/guardian providing consent

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint(s)
Efficacy
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 in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256827 0
Government body
Name [1] 256827 0
Australian Research Council
Address [1] 256827 0
Australian Research Council
GPO Box 2702
Canberra ACT 2601
Country [1] 256827 0
Australia
Funding source category [2] 256829 0
University
Name [2] 256829 0
The University of Sydney
Address [2] 256829 0
The University of Sydney
NSW 2006
Australia
Country [2] 256829 0
Australia
Primary sponsor type
Government body
Name
Australian Research Council
Address
Australian Research Council
GPO Box 2702
Canberra ACT 2601
Country
Australia
Secondary sponsor category [1] 256105 0
None
Name [1] 256105 0
Address [1] 256105 0
Country [1] 256105 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258844 0
Royal Alexandra Hospital for Children at Westmead
Ethics committee address [1] 258844 0
The children's Hospital at Westmead
Cnr of Hawksbury Rd and Hainsworth St
Westmead NSW 2145
Australia
Ethics committee country [1] 258844 0
Australia
Date submitted for ethics approval [1] 258844 0
01/03/2006
Approval date [1] 258844 0
01/06/2006
Ethics approval number [1] 258844 0
2007/017

Summary
Brief summary
Influenza is a viral illness that causes much social disruption. It causes serious complications in young children including hospitalisation. Children in child care settings are more likely to be infected. Influenza vaccination can help prevent influenza in adults but data are lacking in young children. This study will determine both direct child benefits (protection, continuity of day care) and indirect benefits of influenza vaccination in reduced work absence (staff, parents), illness in the extended family. The study also measures the social and economic impact of influenza vaccination.
Trial website
VacTrial@chw.edu.au
w: www.ncirs.edu.au
Trial related presentations / publications
Journal article:
1. Iskander M, Kesson AM, Dwyer D, Rost L, Pym M, Wang H, McCaskill M, Booy R. The burden of influenza in children under 5 years admitted to The Children’s Hospital at Westmead in the winter of 2006. Journal of Paediatrics and Child Health. 2010 in press.
2. Lester-Smith D, Zurynski Y, Booy R, Festa M, Kesson A, Elliott E. THE BURDEN OF CHILDHOOD INFLUENZA IN A TERTIARY PAEDIATRIC SETTING. CDI 2009
3. Leask J, Chow, M, King C, Booy R. Caregivers’ intentions regarding influenza H1N1 vaccine for their children. Submitted to MJA March, 2010
4. Mary ISKANDER, Monica M LAHRA, Jiehui YIN (Kevin), Stephen B LAMBERT, Michael D NISSEN, Jennifer MURPHY, Laura ROST, Theo P SLOOTS, Robert BOOY. A Pilot Study of Influenza Vaccine Effectiveness in Urban Australian Children attending Childcare. For submission to J Paed Child Health.
Conference:
1. King C. Parents attitudes to influenza and influenza vaccination. Postgraduate student conference. Discipline of Paediatrics and Child Health, University of Sydney. August 2009.
2. King C and Leask J. Parents of children attending childcare – beliefs about seasonal and H1N1 influenza. Submitted to PHAA National Immunisation Conference, March 2010
3. Leask J, Chow M, King C, Booy R. Caregivers’ intentions regarding seasonal influenza and H1N1 vaccines for their children. Submitted to PHAA National Immunisation Conference, March 2010
Public notes

Contacts
Principal investigator
Name 31063 0
Address 31063 0
Country 31063 0
Phone 31063 0
Fax 31063 0
Email 31063 0
Contact person for public queries
Name 14310 0
Jiehui Kevin Yin
Address 14310 0
National Centre for Immunisation Research and Surveillance of vaccine preventable diseases.
The children's Hospital at Westmead
Cnr of Hawksbury Rd and Hainsworth St
Westmead NSW 2145
Country 14310 0
Australia
Phone 14310 0
+612 9845 1232
Fax 14310 0
+612 98451418
Email 14310 0
kevin.yin@health.nsw.gov.au
Contact person for scientific queries
Name 5238 0
Prof Robert Booy
Address 5238 0
National Centre for Immunisation Research and Surveillance of vaccine preventable diseases.
The children's Hospital at Westmead
Cnr of Hawksbury Rd and Hainsworth St
Westmead NSW 2145
Country 5238 0
Australia
Phone 5238 0
+612 98451433
Fax 5238 0
+612 98451418
Email 5238 0
VacTrial@chw.edu.au

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