World Health Organization site
Skip Navigation Links

Main
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ANZCTR
Last refreshed on: 13 January 2020
Main ID:  ACTRN12614001193662
Date of registration: 13/11/2014
Prospective Registration: No
Primary sponsor: Murdoch Childrens Research Institute
Public title: Investigating the association between timing of routine childhood vaccinations and food allergy
Scientific title: In 1 year old children, is there an association between early versus delayed routine childhood immunisations and subsequent challenge proven food allergy at 1 year of age?
Date of first enrolment: 31/10/2014
Target sample size: 4858
Recruitment status: Completed
URL:  https://anzctr.org.au/ACTRN12614001193662.aspx
Study type:  Observational
Study design:  Purpose: Natural history;Duration: Cross-sectional;Selection: Defined population;Timing: Retrospective;  
Phase:  Not Applicable
Countries of recruitment
Australia
Contacts
Name: Dr Nicholas Kiraly   
Address:  Gastro and Food Allergy Murdoch Childrens Research Institute Royal Children's Hospital 50 Flemington Rd Parkville VIC 3052 Australia
Telephone: +61393455522
Email: nicholas.kiraly@mcri.edu.au
Affiliation: 
Name: Dr Nicholas Kiraly   
Address:  Gastro and Food Allergy Murdoch Childrens Research Institute Royal Children's Hospital 50 Flemington Rd Parkville VIC 3052 Australia
Telephone: +61393455522
Email: nicholas.kiraly@mcri.edu.au
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria: Previously enrolled in the HealthNuts cohort, a large population based study of childhood food allergy in Melbourne, Australia. Briefly, healthy one-year old children were recruited at immunisation contacts and invited to participate.
Exclusion criteria: Refused consent to access Australian Childhood Immunisation Register data

Age minimum: 1 Years
Age maximum: 1 Years
Gender: Both males and females
Health Condition(s) or Problem(s) studied
Public Health - Epidemiology
Food allergy;Atopic sensitisation;
Food allergy
Atopic sensitisation
Inflammatory and Immune System - Allergies
Intervention(s)
Timing of immunisations delivered at routine immunisation contacts. Data is being collected from the Australian Childhood Immunisation Register which record all childhood vaccination contacts. Date of all childhood immunisations received in the first 18 months of life will be obtained from this register.
Primary Outcome(s)
Challenge proven food allergy. Children in the HealthNuts cohort were enrolled at immunisation contacts at 1 year of age and invited to undergo skin prick testing. Those with a positive skin prick test were invited to undergo oral food challenge. Hence children who were sensitised to a particular allergen were tested with the gold standard oral food challenge soon after turning one year of age. A description of the formal food challenges and assessment of outcomes has been described (Osbourne et al. 2010 Clinical & Experimental Allergy, 40, 1516–1522)[At 1 year of age]
Atopic sensitisation defined as a positive skin prick test to any food allergen at the time of enrolment into the HealthNuts cohort (skin prick testing protocol described in Osbourne et al. 2010 Clinical & Experimental Allergy, 40, 1516–1522)[At 1 year of age]
Secondary Outcome(s)
Wheeze: parent reported wheeze in the first year of life[At 1 year of age]
Eczema, defined as parental report of eczema diagnosis requiring treatment in the first year of life or eczematous rash observed by nurse at the time of recruitment into the HealthNuts cohort[At 1 year of age]
Use of eczema medication, assessed by parental report at the time of recruitment into the HealthNuts cohort[At 1 year of age]
Bronchiolitis admissions: parent reported admissions to hospital with bronchiolitis in the first year of life[before 1 year of age]
Secondary ID(s)
None
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date:
Contact:
Human Research Ethics Committee
Results
Results available:
Date Posted:
Date Completed:
URL:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history