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Trial registered on ANZCTR


Registration number
ACTRN12617001086358
Ethics application status
Approved
Date submitted
4/07/2017
Date registered
26/07/2017
Date last updated
4/08/2023
Date data sharing statement initially provided
3/03/2022
Date results provided
4/08/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A study on the influence of obesity on the protection after influenza vaccination in children aged 9-17 years.
Scientific title
A prospective pilot study investigating the impact of obesity on seroprotection after influenza vaccination in children aged 9-17 years.
Secondary ID [1] 292230 0
None
Universal Trial Number (UTN)
U1111-1198-7227
Trial acronym
FluTe
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity in children and adolescents 303725 0
Response to influenza vaccination 304151 0
Condition category
Condition code
Inflammatory and Immune System 303098 303098 0 0
Normal development and function of the immune system
Inflammatory and Immune System 303099 303099 0 0
Other inflammatory or immune system disorders
Diet and Nutrition 303485 303485 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a pilot case control study to study the effect, if any, of obesity, on the immune response to the annual licensed quadrivalent influenza vaccination in Australian children aged 9-17 years.
Cases - 25 obese children (BMI >=95th percentile for age and gender) aged 9-17 years.
Controls - 25 non-obese children (BMI 5th - <95th percentile for age and gender) aged 9-17 years.
The dose of the influenza vaccine is 0.5 ml administered as a single dose IM injection. All vaccines will be administered by a qualified and experienced practitioners (medical officer or registered nurse) within the unit, according to current vaccination guidelines.
All participants will have bloods samples collected by the recruiting medical officer before vaccination and at the follow-up visits at 1 and 6 months after vaccination.
Intervention code [1] 298391 0
Prevention
Comparator / control treatment
The control group consists of non-obese children (BMI 5th - <95th percentile for age and gender) aged 9-17 years.
All participants, cases and control, will receive the same intervention
Control group
Active

Outcomes
Primary outcome [1] 302558 0
The count and proportion in the case and control groups with seroprotective Haemagglutination Inhibition Assay (HIA) titres (>=40) at 1 and 6 months post vaccination.
Timepoint [1] 302558 0
At baseline, 1 month and 6 months after influenza vaccination.



Primary outcome [2] 302561 0
Proportion in the case and control groups who achieve a four-fold rise in Haemagglutination Inhibition Assay (HIA) titres after influenza vaccination.
Timepoint [2] 302561 0
Comparison of the baseline with the 1 month and 6 month post-vaccination results.
Secondary outcome [1] 336373 0
Geometric mean Haemagglutination Inhibition Assay titres in the case and control groups.
Timepoint [1] 336373 0
Comparison of the baseline with the 1 month and 6 month post-vaccination results.
Secondary outcome [2] 337249 0
Mean geometric increase in Haemagglutination Inhibition Assay (HIA) titres in the case and control groups.
Timepoint [2] 337249 0
Comparison of the baseline with the 1 month and 6 month post-vaccination results.

Eligibility
Key inclusion criteria

All participants must satisfy ALL the following criteria at study entry:
1. Participants are healthy children aged between 9-17 years at the time of enrolment.
2. Participants who, in the opinion of the study staff, can and will comply with the requirements of the protocol (eg return for follow-up visits, blood collection).
3. Participants who can provide assent and have a parent willing to provide consent.

Additional criteria specific to cases and controls include:
Cases - Obese children (BMI >=95th percentile for age and gender) aged 9-17 years. Total number to be enrolled is 25 cases.
Controls - Non-obese children (BMI 5th - <95th percentile for age and gender) aged 9-17 years. Total number to be enrolled is 25 controls.
Minimum age
9 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Presence of any of the following criteria will exclude the subject from receipt of influenza vaccination as part of the study:
1. History of serious medical conditions (eg cardiac, respiratory, renal, hepatic disorders, diabetes mellitus requiring treatment with insulin).
2. Any syndromal and/or endocrinological causes for obesity.
3. History of seasonal influenza vaccination within the last six months prior to enrolment.
4. History of any immunosuppressive condition (eg HIV infection) or on immunosuppressing medication.
5. Any contraindication to influenza immunisation according to the Australian Immunisation Handbook.
6. Anaphylaxis following a previous dose of any influenza vaccine
7. Anaphylaxis following any vaccine component.
8. History of egg allergy.
9. History of Guillain Barre syndrome.
10. Bleeding diathesis or condition associated with prolonged bleeding that may contraindicate intramuscular injection or blood draw.
11. Any major illness that, in the investigator’s judgment, will substantially increase the risk associated with the subject’s participation in the study, or interfere with the evaluation of the study objectives.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
This is a prospective clinical pilot study to assess the impact of obesity on the immune response to influenza vaccination in Australian children aged 9-17 years. A total of 50 children, which will include 25 non-obese (BMI 5th - <95th percentile for age and gender) and 25 obese (BMI >=95th percentile for age and gender) children, aged 9-17 years of age (N=50), will be recruited for the pilot study phase. The data from this pilot study will be used as the basis to plan subsequent larger studies which will undergo a peer review process.

Primary outcomes: Influenza specific antibody concentrations and haemagglutination inhibition assay (HIA) titres will be measured on blood samples from all three time-points following vaccination (0, 1 month and 6 months post-vaccination). A HIA titre of 1:40 is the established level of protection for influenza vaccination. Serum antibody concentrations will be log transformed to provide geometric mean concentrations (GMC).

To examine the primary objective, continuous and categorical evaluations of immune response will be assessed between obese and non-obese cohorts. The percentage of participants within each group (obese or non-obese) with protective HIA titres will be evaluated using logistic regression models, with effects expressed as odds ratios with 95% CIs. Both unadjusted and adjusted analyses will be performed, with adjustment for biologically plausible potential confounders. Basic demographic data and other information collected will be correlated with GMC results for the obese and non-obese groups to identify the impact that the various data collected about participants, has on the immune response to influenza vaccination.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/04/2018
Actual
4/07/2019
Date of last participant enrolment
Anticipated
30/06/2018
Actual
8/10/2020
Date of last data collection
Anticipated
31/12/2018
Actual
23/08/2021
Sample size
Target
50
Accrual to date
Final
44
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 8471 0
Womens and Childrens Hospital - North Adelaide
Recruitment postcode(s) [1] 16554 0
5006 - North Adelaide

Funding & Sponsors
Funding source category [1] 296778 0
Hospital
Name [1] 296778 0
Women's and Children's Hospital Foundation, MS McLeod Research Fund
Country [1] 296778 0
Australia
Primary sponsor type
Hospital
Name
Women's and Children's Hospital
Address
72 King William Road,
North Adelaide,
South Australia 5006
Country
Australia
Secondary sponsor category [1] 295759 0
None
Name [1] 295759 0
Address [1] 295759 0
Country [1] 295759 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298003 0
Women's and Children's Health Network (WCHN) Human Research Ethics Committee's (HREC)
Ethics committee address [1] 298003 0
Ethics committee country [1] 298003 0
Australia
Date submitted for ethics approval [1] 298003 0
23/05/2017
Approval date [1] 298003 0
15/09/2017
Ethics approval number [1] 298003 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2426 2426 0 0
/AnzctrAttachments/373160-hrec approval letter.pdf (Ethics approval)

Contacts
Principal investigator
Name 75698 0
Prof Helen Marshall
Address 75698 0
Women's and Children's Health Network,
Department of Paediatrics,
Level 2, Clarence Rieger Building
72 King William Road,
North Adelaide,
SA 5006
Country 75698 0
Australia
Phone 75698 0
+61 8 81618115
Fax 75698 0
+61 8 81617031
Email 75698 0
helen.marshall@adelaide.edu.au
Contact person for public queries
Name 75699 0
Michelle Clarke
Address 75699 0
Women's and Children's Health Network,
Department of Paediatrics,
Level 2, Clarence Rieger Building
72 King William Road,
North Adelaide,
SA 5006
Country 75699 0
Australia
Phone 75699 0
+61 8 81618115
Fax 75699 0
+61 8 81617031
Email 75699 0
michelle.clarke@adelaide.edu.au
Contact person for scientific queries
Name 75700 0
Helen Marshall
Address 75700 0
Women's and Children's Health Network,
Department of Paediatrics,
Level 2, Clarence Rieger Building
72 King William Road,
North Adelaide,
SA 5006
Country 75700 0
Australia
Phone 75700 0
+61 8 81618115
Fax 75700 0
+61 8 81617031
Email 75700 0
helen.marshall@adelaide.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Deidentified IPD and data dictionaries will be available following approval from the WCHN data custodian.
When will data be available (start and end dates)?
Dec 2021- Dec 2022
Available to whom?
Requests will be reviewed and approval sought from WCHN to share
Available for what types of analyses?
Requests will be reviewed and approval sought from WCHN to share
How or where can data be obtained?
email request to Helen Marshall (helen.marshall@adelaide.edu.au)


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.