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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02490007




Registration number
NCT02490007
Ethics application status
Date submitted
30/06/2015
Date registered
3/07/2015

Titles & IDs
Public title
Pertussis Immunisation and Food Allergy
Scientific title
Case-control Study of the Association Between Pertussis Vaccination in Infancy and the Risk of IgE-mediated Food Allergy
Secondary ID [1] 0 0
CVID/2015-02
Universal Trial Number (UTN)
Trial acronym
PIFA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Food Allergy 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Inflammatory and Immune System 0 0 0 0
Allergies

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Allergy Cases - All participants appear on the Australian Childhood Immunisation Register (ACIR) and have received their first pertussis vaccination before the age of 16 weeks. They will have been born during the period of change over from whole cell pertussis vaccine to acellular pertussis vaccine (1997-1999). Allergy case participants have all attended allergy clinics associated with tertiary teaching hospitals. They have confirmed IgE-mediated food allergy as defined by the case description and as ascertained by their medical records.

Controls - All participants appear on the Australian Childhood Immunisation Register (ACIR) and have received their first pertussis vaccination before the age of 16 weeks. They will have been born during the period of change over from whole cell pertussis vaccine to acellular pertussis vaccine (1997-1999).
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Diagnosis of IgE-mediated food allergy
Timepoint [1] 0 0
birth-15 years
Secondary outcome [1] 0 0
Diagnosis of IgE-mediated food allergy
Timepoint [1] 0 0
birth-15 years
Secondary outcome [2] 0 0
Diagnosis of IgE-mediated food allergy
Timepoint [2] 0 0
birth-15 years

Eligibility
Key inclusion criteria
Eligibility Criteria

1. All cases and controls must be registered on ACIR as having had a first dose of any pertussis containing vaccine before age 16 weeks and during the period of time in which the transition between aP and wP vaccine occurred; birth dates within 1st Janurary 1997 and 31st December 1999 depending on the jurisdiction.

Case Inclusion Criteria- Cases will be considered to have IgE-mediated food allergy on the basis of

1. a documented history of consistent clinical symptoms following ingestion of an implicated food, and
2. evidence of sensitisation to that food via either positive skin-prick test or elevated specific IgE to the implicated food, with onset after the first pertussis-containing vaccine but before age 15 years.

IgE-mediated food allergy is defined as BOTH:

1. The clinical notes or clinical letter arising from the allergy consult must explicitly document the presence of one or more of the following features. Onset of at least one these features must be within 1 hour of ingestion of suspected food where this can reasonably inferred from statements such as "immediate", "within x mins" where x is <60:

* urticaria
* angioedema
* emesis
* vocal hoarseness
* persistent cough
* wheeze
* stridor
* collapse
* hypotension

AND
2. Documented evidence of allergic sensitisation to the implicated food through EITHER:

* specific IgE positive (serum specific IgE >0.35KU/l) to suspected food ), OR
* positive skin prick test (wheal diameter >3mm) against suspected food (SPT) Evidence of sensitisation must be at the time of consultation or the 6 months after the clinical encounter for the case to meet definition.
Minimum age
14 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion Criteria- none

Study design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2018
Sample size
Target
Accrual to date
Final
508
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Princess Margaret Childrens Hospital - Subiaco
Recruitment postcode(s) [1] 0 0
6009 - Subiaco

Funding & Sponsors
Primary sponsor type
Other
Name
Telethon Kids Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Princess Margaret Hospital for Children
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Royal Children's Hospital
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Government body
Name [3] 0 0
Women's and Children's Hospital, Australia
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Sydney Children's Hospitals Network
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
National Health and Medical Research Council, Australia
Address [5] 0 0
Country [5] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Thomas Snelling, BMBS PhD
Address 0 0
Telethon Kids Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02490007