ANZCTR - Registration

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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]

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

Condition category

Condition code

Cancer

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]

Treatment: Drugs

Comparator / control treatment

N/A

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

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]

functional immune response to the 10vPCV measure by avidity and opsonphagocytosis assay (OPA)

Timepoint [1]

Secondary outcome [2]

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]

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

Sex

Both males and females

Can healthy volunteers participate?

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

1/06/2009

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

100

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council (NHMRC) Clinical Centre for Research Excellence (CCRE) in Childhood and Adolescent Immunisation

Address [1]

Department of General Medicine

5th Floor, AP1 Building

Murdoch Childrens Research Institute

Royal Children's Hospital

Flemington Road, Parkville VIC 3052

Country [1]

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]

Hospital

Name [1]

Royal Children's Hospital

Address [1]

Department of General Medicine

5th Floor, AP1 Building

Murdoch Childrens Research Institute

Royal Children's Hospital

Flemington Road, Parkville VIC 3052

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Children's Hospital (RCH) Human Research Ethics Committee

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

20/03/2009

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr Nigel Crawford

Address

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

Australia

Phone

+61 3 9345 4448

Fax

nigel.crawford@rch.org.au

Contact person for scientific queries

Name

Dr Nigel Crawford

Address

Country

Australia

Phone

+61 3 393455522

Fax

nigel.crawford@rch.org.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

Source	Title	Year of Publication	DOI
Embase	Pneumococcal conjugate vaccine administration during therapy for pediatric leukemia.	2015	https://dx.doi.org/10.1097/INF.0000000000000502

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically