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Trial registered on ANZCTR
Registration number
ACTRN12614000743662
Ethics application status
Approved
Date submitted
15/06/2014
Date registered
14/07/2014
Date last updated
14/07/2014
Type of registration
Retrospectively registered
Titles & IDs
Public title
A cohort study to examine the effect of 10-valent pneumococcal-Haemophilus influenzae protein D conjugate vaccine (PHiD-CV, Synflorix, Registered Trademark) on the frequency of non-typeable Haemophilus influenzae (NTHi) infection in the upper and lower airways of children
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Scientific title
Does prior immunization with PHiD-CV influence the frequency of NTHi detection in the upper and lower airways in children undergoing bronchoscopy?
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Secondary ID [1]
284049
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Nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Children at risk of chronic lung disease and undergoing bronchoscopy
291105
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non-typeable Haemophilus influenzae (NTHi) infection
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Condition category
Condition code
Respiratory
291448
291448
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0
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Other respiratory disorders / diseases
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Infection
292764
292764
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0
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Studies of infection and infectious agents
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
PHiD-CV given as per the Northern Territory infant immunization schedule. Child is not observed for any set period of time. Observation consist of the bronchoscopy alveolar lavage results at the time-point when the procedure is undertaken for clinical purposes and not for research purposes. Thus there is no time limit of the observation period as the bronchoscopy is undertaken when the paediatrician (not related to the study) deemed the procedure is necessary
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Intervention code [1]
288742
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Not applicable
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Comparator / control treatment
No PHiD-CV
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Control group
Active
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Outcomes
Primary outcome [1]
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Number of children with NTHi detected in the bronchoalveolar lavage at >=10E4 cfu/ml
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Assessment method [1]
291434
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Timepoint [1]
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At time of bronchoscopy. For subjects: at least one month post PHiD-CV immunisation.
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Secondary outcome [1]
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Number of children with NTHi detected in the nasopharyngeal swab
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Assessment method [1]
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Timepoint [1]
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At time of bronchoscopy
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Secondary outcome [2]
306762
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In subgroup where blood could be collected, secondary outcomes are cytokine levels from PBMC stimulation using PHA (Phytohemagglutanin) for adaptive responses (72 hours post stimulation)
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Assessment method [2]
306762
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Timepoint [2]
306762
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Bloods collected at time of bronchoscopy (uncontrolled)
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Secondary outcome [3]
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In subgroup where blood could be collected, secondary outcomes are cytokine levels from PBMC stimulation using LPS and Poly I:C for innate responses (24 hour post stimulation)
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Assessment method [3]
308897
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Timepoint [3]
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At time of blood collection opportunistically i.e like the bronchoscopy, the procedure is undertaken for clinical purposes and not for research purposes. Thus there is no time limit of the observation period as the bloods undertaken when the paediatrician (not related to the study) deemed the procedure is necessary
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Eligibility
Key inclusion criteria
Subjects: Children undergoing bronchoscopy who have had at least one PHiD-CV dose more than a month before bronchoscopy
Comparator: Children undergoing bronchoscopy who have not had any PHiD-CV dose (Brisbane and/or Darwin)
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Minimum age
1
Years
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Maximum age
19
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Previously enrolled
Cystic fibrosis
Immunodeficiency
Interstitial lung disease
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Study design
Purpose
Natural history
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Duration
Cross-sectional
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Selection
Defined population
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Timing
Both
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Statistical methods / analysis
Vaccine effectiveness will be calculated from the number children who have had PHiD-CV with clinically important levels of NTHi will be compared to those who have not had PHiD-CV with clinically important levels of NTHi.
Comparisons between groups will consist of subjects vs. total controls (Brisbane and NT children).
Subanalysis will be performed comparing subjects with
(a) NT controls only, and
(b) Brisbane contemporaneous controls
Total number of children in study is expected to be >300 which comprises of at least 79 children who have received at least one dose of PHiD-CV. Our main comparison will be between the cohort of NT children with and without PHiD-CV immunization. We currently have BAL data (2007-2010) from 80 children (who have not had PHiD-CV) in the NT and 50% of these children have NTHi in their BAL. We expect to collect BAL from a further children from NT who have had various number of PHiD-CV doses.
Assuming a 45% reduction in the proportion of children who have NTHi in their BAL post PHiD-CV, the study provides 88% power (5% level of significance), if we have a minimum of 221 children. However, we will continue to enroll children until the end of 2014 and expect an approximated sample size of 250 (children vaccinated with PHiD-CV and controls).
In the subgroup with blood available, cytokine profile from PBMC stimulation will be compared between groups using unpaired T-tests or Mann–Whitney U test
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
19/04/2011
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Actual
19/04/2011
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Date of last participant enrolment
Anticipated
31/12/2014
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
316
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NT,QLD
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Recruitment hospital [1]
2058
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Royal Darwin Hospital - Tiwi
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Recruitment hospital [2]
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Royal Children's Hospital - Herston
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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National Health and Medical Research Council
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Address [1]
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GPO Box 1421
Canberra ACT 2601
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Country [1]
288679
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Australia
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Funding source category [2]
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Commercial sector/Industry
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Name [2]
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GlaxoSmithKline
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Address [2]
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1061 Mountain Highway, Boronia, Victoria 3155
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Country [2]
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United Kingdom
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Funding source category [3]
288683
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Charities/Societies/Foundations
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Name [3]
288683
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Financial Markets Foundation for children (Grant 2011-019)
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Address [3]
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GPO Box 3655
Sydney NSW 2000
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Country [3]
288683
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Australia
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Primary sponsor type
University
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Name
Menzies School of Health Research, Charles Darwin University
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Address
PO Box 41096, Casuarina NT 0811, Australia
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Country
Australia
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Secondary sponsor category [1]
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Individual
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Name [1]
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Prof Anne Chang
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Address [1]
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Menzies School of Health Research
PO Box 41096, Casuarina NT 0811, Australia
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Country [1]
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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NT Department of Health & Community Services and Menzies School of Health Research
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Ethics committee address [1]
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PO Box 41096, Casuarina NT 0811, Australia
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
290529
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Approval date [1]
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03/10/2007
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Ethics approval number [1]
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07/63
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Ethics committee name [2]
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Royal Children's Hospital, Brisbane
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Ethics committee address [2]
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Herston Road, Herston, Queensland 4029
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Ethics committee country [2]
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Australia
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Date submitted for ethics approval [2]
290530
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Approval date [2]
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18/03/2008
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Ethics approval number [2]
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2003/017
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Summary
Brief summary
The aims of our study are to: 1. Determine the frequency of NTHi infection (defined by >10E4 cfu/ml BAL) in the lower airways of children who have received PHiD-CV; 2. Determine the frequency of NTHi carriage in the upper airways of children who have received PHiD-CV; and 3. Evaluate the influence of PHiD-CV on the systemic adaptive immunity to NTHi in`children with chronic suppurative lung disease.
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Trial website
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Trial related presentations / publications
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Public notes
Aim 3 will only be conducted in a subset of children. Data includes analysis of previously collected data (microbiology of the lower and upper airways)
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Contacts
Principal investigator
Name
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Prof Anne B Chang
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Address
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Qld Children's Respiratory Centre
Children's Health Services (Royal Children's Hospital)
Herston Rd
Herston
QLD 4029
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Country
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Australia
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Phone
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+61 7 3636 5270
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Gabrielle McCallum
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Address
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Menzies School of Health Research
Rocklands Road
Tiwi
NT
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Country
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Australia
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Phone
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+61 8 89228588
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Anne Chang
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Address
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Qld Children's Respiratory Centre
Children's Health Services (Royal Children's Hospital)
Herston Rd
Herston
QLD 4029
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Country
46100
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Australia
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Phone
46100
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+61 7 3636 5270
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Fax
46100
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Email
46100
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[email protected]
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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.
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