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Trial registered on ANZCTR


Registration number
ACTRN12609000515291
Ethics application status
Approved
Date submitted
27/02/2009
Date registered
29/06/2009
Date last updated
6/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Preventing Invasive Pneumococcal Disease in Children & Adolescents with Leukaemia
Scientific title
Assessing the immunogenicity of pneumococcal vaccination given as sson as possible after diagnsosis to children and adolescents with leukaemia.
Secondary ID [1] 253124 0
PreventIPD
Universal Trial Number (UTN)
Trial acronym
PreventIPD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Immunogenicity of pneumococcal vaccination in children and adolescents newly diagnosed with Leukaemia, with the aim to protect them from invasive pneumococcal disease 3967 0
Condition category
Condition code
Cancer 4164 4164 0 0
Leukaemia - Acute leukaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A new 10-valent conjugate pneumococcal vaccine (10vPCV- Synflorix(Registered Trademark)) is now available as an intervention. Like the old intervention, a 7-valent conjugate pneumococcal vaccine, Synflorix is given 0.5ml intramuscular (IM). There are two groups in the study: Group 1: 1 dose of 10vPCV for those children & adolescents who completed their primary 7vPCV course (3 doses) Group 2: 3 doses of 10vPCV 2 months apart for all other children & adolescents diagnosed with leukaemia.
Intervention code [1] 3686 0
Treatment: Drugs
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 5059 0
The primary study end point is a blood test measuring serologic response (defined as detection of titres > 0.35 microgram/mL measured by serotype specific enzyme-linked immunosorbent assay (ELISA) to at least 3 pneumococcal serotypes) to primary immunisation, or, in patients exhibiting protective antibody levels prior to first vaccination, a greater than 2-fold increase from baseline antibody concentration.
Timepoint [1] 5059 0
Group 1: 1 month post the single 10vPCV vaccine dose Group 2: 1 month post the third 10vPCV vaccine dose There are two different time points reflect those receining a booster (group 1); compared to those receiving a primary course (group 2)
Secondary outcome [1] 8511 0
functional immune response to the 10vPCV measure by avidity and opsonphagocytosis assay (OPA)
Timepoint [1] 8511 0
Group 1: 1 month post the single 10vPCV vaccine dose Group 2: 1 month post the third 10vPCV vaccine dose There are two different time points reflect those receining a booster (group 1); compared to those receiving a primary course (group 2)
Secondary outcome [2] 244549 0
Safety of the vaccine with a particular focus on tolerability in the older age group (10-18 years) for which 10vPCV is currently not licensed
Timepoint [2] 244549 0
Throughout the study- a safety diary is to be kept by the patient/guardian for 5 days post each vaccine dose.

On day 5 post each vaccine dose the patient will be contacted by the researchers to complete a complementary safety data log of any reactions. The patient/family will also be able to contact the study team at any point if they have any concerns.

Eligibility
Key inclusion criteria
All children receiving therapy for Leukaemia (Acute Lymphoblastic Leukaemia (ALL) or Acute Myeloblastic leukaemia (AML)) will potentially be eligible for inclusion. Diagnoses are confirmed histopathologically according to national and international guidelines
Minimum age
0 Years
Maximum age
18 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria will include those children who suffer a relapse or have a Bone Marrow Transplant. If a study subject relapses following commencement of the study they will be excluded from further participation. Patients will not be vaccinated until their blood count is satisfactory: platelets>/= 50 x109/L and neutrophils>/=500 x 106/L. Recent immunoglobulin (within last 9 months) or previous severe adverse reaction to vaccinations will also be exclusion criteria as per the Australian Immunisation guidelines.

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 3
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4154 0
Government body
Name [1] 4154 0
National Health and Medical Research Council (NHMRC) Clinical Centre for Research Excellence (CCRE) in Childhood and Adolescent Immunisation
Address [1] 4154 0
Department of General Medicine

5th Floor, AP1 Building

Murdoch Childrens Research Institute

Royal Children's Hospital

Flemington Road, Parkville VIC 3052
Country [1] 4154 0
Australia
Primary sponsor type
Government body
Name
NHMRC CCRE in Childhood and Adolescent Immunisation
Address
Department of General Medicine

5th Floor, AP1 Building

Murdoch Childrens Research Institute

Royal Children's Hospital

Flemington Road, Parkville VIC 3052
Country
Australia
Secondary sponsor category [1] 3735 0
Hospital
Name [1] 3735 0
Royal Children's Hospital
Address [1] 3735 0
Department of General Medicine

5th Floor, AP1 Building

Murdoch Childrens Research Institute

Royal Children's Hospital

Flemington Road, Parkville VIC 3052
Country [1] 3735 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6217 0
Royal Children's Hospital (RCH) Human Research Ethics Committee
Ethics committee address [1] 6217 0
Ethics committee country [1] 6217 0
Australia
Date submitted for ethics approval [1] 6217 0
Approval date [1] 6217 0
20/03/2009
Ethics approval number [1] 6217 0
28146A

Summary
Brief summary
Children receiving cancer therapy are at an increased risk of illness and death due to Invasive Pneumococcal Disease (IPD), caused by the bacteria Streptococcus pneumoniae. This study aims to determine the immune response in the blood (immunogenicity) of pneumococcal vaccination given as soon as possible after diagnosis in children and adolescents with leukaemia.

A 10-valent conjugate pneumococcal vaccine (10vPCV), marketed as Synflorix(Registered Trademark), came onto the National Immunisation Program in 2009. The latest Australian Immunisation Guidelines (9th edition) recommend that those who develop haematological malignancies, such as leukaemia, have pneumococcal vaccine boosters according to their age. It is recommended that the pneumococcal vaccines be given as early as possible after diagnosis and ideally before chemotherapy and/or radiotherapy is started.

This study aims to protect leukaemia patients from IPD as soon as possible after diagnosis. The study patients will be divided into two groups:

Group 1: 1 dose of 10vPCV vaccine for those children & adolescents who have already completed their childhood primary pneumococcal conjugate vaccine course (3 doses)
Group 2: 3 doses of 10vPCV vaccine 2 months apart for all other children & adolescents

The endpoint is a blood test 1 month after each dose. That is Group 1 is assessed once and Group 2 is assessed 3 times. The blood test is to determine if the participants have responded as well as healthy subjects to at least 5 of the 10 serotypes in the Synflorix(Registered Trademark) 10vPCV vaccine.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29121 0
Address 29121 0
Country 29121 0
Phone 29121 0
Fax 29121 0
Email 29121 0
Contact person for public queries
Name 12278 0
Dr Nigel Crawford
Address 12278 0
NHMRC CCRE in Childhood and Adolescent Immunisation

Department of General Medicine

5th Floor, AP1 Building

Murdoch Childrens Research Institute

Royal Children's Hospital

Flemington Road, Parkville VIC 3052
Country 12278 0
Australia
Phone 12278 0
+61 3 9345 4448
Fax 12278 0
Email 12278 0
nigel.crawford@rch.org.au
Contact person for scientific queries
Name 3206 0
Dr Nigel Crawford
Address 3206 0
NHMRC CCRE in Childhood and Adolescent Immunisation

Department of General Medicine

5th Floor, AP1 Building

Murdoch Childrens Research Institute

Royal Children's Hospital

Flemington Road, Parkville VIC 3052
Country 3206 0
Australia
Phone 3206 0
+61 3 393455522
Fax 3206 0
Email 3206 0
nigel.crawford@rch.org.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary