Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000240640
Ethics application status
Approved
Date submitted
18/02/2014
Date registered
6/03/2014
Date last updated
27/03/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Influenza Specific Immunity After Vaccination in Recipients of Haematopoietic Stem Cell Transplantation Compared to Healthy Controls
Scientific title
A Prospective Study to Evaluate the Immunogenicity and Efficacy of Inactivated Trivalent Influenza Vaccine in Children (> or = 6 months to < or =18 years of age) who have Undergone Allogeneic or Autologous Haematopoietic Stem Cell Transplant compared to Aged Matched Controls
Secondary ID [1] 284123 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Influenza Vaccine HSCT study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Haematopoietic Stem Cell Transplant patients
 291202 0
cancer
 291245 0
haematological malignancy
 291246 0
Autologous or allogeneic 291247 0
Influenza 291248 0
Condition category
Condition code
Cancer 291539 291539 0 0
Any cancer
Infection 291590 291590 0 0
Other infectious diseases
Inflammatory and Immune System 291591 291591 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Trivalent Inactivated Influenza Vaccine 6 months to 2 years post transplant as per immunisation guidelines. Two doses of influenza vaccine at least 4 weeks apart are recommended for all HSCT recipients receiving influenza vaccine for the first time, with the 1st dose given as early as 6 months post transplant. This is given intramuscularly.
Intervention code [1] 288814 0
Prevention
Comparator / control treatment
comparing immunogenecity to healthy controls who will be given the vaccination as per the Australian immunisation guidelines. This means that children who are influenza vaccine naive and under 10 years of age will have two doses and the others will have one dose of the vaccine given intramuscularly.
Control group
Active

Outcomes
Primary outcome [1] 291505 0
To measure influenza specific Haemagglutinin Inhibition [HI] antibody levels by standarised method at WHO Collaborating Centre for Reference and Research on Influenza
Timepoint [1] 291505 0
for one dose, prevaccinetion and between 4 to 8 weeks post dose.
For two doses, prevaccination and between 4 to 8 weeks post each dose.
Secondary outcome [1] 306918 0
To identify the frequency and severity of microbiologically confirmed influenza illness in HSCT patients who received TIV during that influenza season. This is assessed by asking the patients to contact staff if they have an influenza like illness. If they fulfil the criteria, then they come in for medical assessment and nasal swab looking for respiratory viruses by IF +/_ PCR. If positive for influenza, the swab will be sent to WHO Collaborating Centre for Reference and Research on Influenza for specific strain typing to assess vaccine failure versus strain mismatch.
Timepoint [1] 306918 0
Any time from enrolment to end of the influenza season (End of nov of enrolment year)

Eligibility
Key inclusion criteria
1.Age greater than or equal to 6 months to less than or equal to 18 years of age at time of vaccination and have undergone HSCT
2.HSCT recipients who are more than 6 months upto 2 years post transplant
Minimum age
6 Months
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.Known contraindication to influenza vaccine as defined in the National Health and Medical Research Council (NHMRC) Immunisation Handbook (10th ed.)
2.Receipt of an inappropriate dose of influenza vaccine for age of child during the current year

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
23/05/2013
Actual
23/05/2013
Date of last participant enrolment
Anticipated
30/08/2015
Actual
12/05/2016
Date of last data collection
Anticipated
Actual
19/03/2017
Sample size
Target
150
Accrual to date
Final
131
Recruitment in Australia
Recruitment state(s)
QLD,SA,WA,VIC
Recruitment hospital [1] 2113 0
Princess Margaret Hospital - Subiaco
Recruitment hospital [2] 2114 0
The Royal Childrens Hospital - Parkville
Recruitment hospital [3] 2115 0
Royal Children's Hospital - Herston
Recruitment hospital [4] 7731 0
Womens and Childrens Hospital - North Adelaide
Recruitment postcode(s) [1] 7806 0
3052 - Parkville
Recruitment postcode(s) [2] 7807 0
4029 - Royal Brisbane Hospital
Recruitment postcode(s) [3] 15655 0
5006 - North Adelaide
Recruitment postcode(s) [4] 7805 0
6008 - Subiaco

Funding & Sponsors
Funding source category [1] 288753 0
Commercial sector/Industry
Name [1] 288753 0
Pfizer Australia
Country [1] 288753 0
Australia
Funding source category [2] 288755 0
Charities/Societies/Foundations
Name [2] 288755 0
Princess Margaret Hospital foundation
Country [2] 288755 0
Australia
Primary sponsor type
Hospital
Name
Princess Margaret Hospital for children
Address
Roberts Road
Subiaco WA 6008
Country
Australia
Secondary sponsor category [1] 287451 0
None
Name [1] 287451 0
Address [1] 287451 0
Country [1] 287451 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290593 0
princess margaret Hospital HREC
Ethics committee address [1] 290593 0
Roberts road
Subiaco WA 6008
Ethics committee country [1] 290593 0
Australia
Date submitted for ethics approval [1] 290593 0
Approval date [1] 290593 0
30/07/2013
Ethics approval number [1] 290593 0
1988/EP
Ethics committee name [2] 290594 0
QLD Children’s Health Services (RCH), HREC
Ethics committee address [2] 290594 0
Level 3, Foundation Building
Royal Children’s Hospital
Herston Road
HERSTON QLD 4029
Ethics committee country [2] 290594 0
Date submitted for ethics approval [2] 290594 0
Approval date [2] 290594 0
04/12/2012
Ethics approval number [2] 290594 0
HREC/12/QRCH/213
Ethics committee name [3] 297294 0
Women and Childrens Hospital HREC
Ethics committee address [3] 297294 0
Level 2, Samuel Way Building, 72 King William Road, North Adelaide, South Australia 5006
Ethics committee country [3] 297294 0
Australia
Date submitted for ethics approval [3] 297294 0
10/02/2015
Approval date [3] 297294 0
23/03/2015
Ethics approval number [3] 297294 0
HREC/15/WCHN/19

Summary
Brief summary
This study is looking at whether children who have had a bone marrow transplant produce protective antibodies after the flu vaccine. We will compare this to healthy children, and also look at how many children get the flu despite being vaccinated.

Who is it for?
You or your child may be eligible to join this study if you/they are aged between 6 months to 18 years, and have undergone haematopoietic stem cell transplant 6 months to 2 years ago.

Study details
Bone marrow transplant (BMT) patients have significant problems with their immune system. The rate of problems caused by the flu (influenza) is particularly high in these patients. Vaccination is the main way to prevent the flu and the problems it causes. Vaccination of children and adolescents may not only protect the children themselves, but may also significantly decrease the rate of transmission and consequently, the knock-on effects in the general population. There are many studies in adults that have looked at the immune response of the flu vaccine in patients post transplant. Response rates are poor and whilst the response improves over time with recovery of their immune system, it rarely reaches that of healthy controls. The rates reported are between 9-40%. The studies that have been done are small. There are limitations to these studies and importantly, there is minimal amount of data for children. To our knowledge, there have been no studies conducted looking at the immune response to the flu vaccine in children alone. In this study all participants will receive the influenza vaccine as per immunisation guidelines. After each vaccine dose (1-2 doses may be administered), participants will undergo a blood test to evaluate influenza specific antibody levels. Participants will also be monitored from enrolment to the end of the influenza season (end of November of enrolment year) in order to identify frequency and severity of influenza infection.


Trial website
None
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 46350 0
Dr Rishi Kotecha
Address 46350 0
Princess Margaret Hospital For children
Roberts Road,
SUBIACO
WA 6008
Country 46350 0
Australia
Phone 46350 0
+61893408222
Fax 46350 0
+61 8 9340 8402
Email 46350 0
rishi.kotecha@health.wa.gov.au
Contact person for public queries
Name 46351 0
Dr Ushma Wadia
Address 46351 0
Princess Margaret Hospital For children
Roberts Road,
SUBIACO
WA 6008
Country 46351 0
Australia
Phone 46351 0
+61 8 93408222
Fax 46351 0
+61 8 9340 8402
Email 46351 0
ushma.wadia@health.wa.gov.au
Contact person for scientific queries
Name 46352 0
Dr Ushma Wadia
Address 46352 0
Princess Margaret Hospital For children
Roberts Road,
SUBIACO
WA 6008
Country 46352 0
Australia
Phone 46352 0
+61 8 93408222
Fax 46352 0
Email 46352 0
ushma.wadia@health.wa.gov.au

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
SourceTitleYear of PublicationDOI
EmbaseImmunogenicity of the inactivated influenza vaccine in children who have undergone allogeneic haematopoietic stem cell transplant.2020https://dx.doi.org/10.1038/s41409-019-0728-5
N.B. These documents automatically identified may not have been verified by the study sponsor.