Preventing Invasive Pneumococcal Disease in Children & Adolescents with Leukaemia

Assessing the immunogenicity of pneumococcal vaccination given as sson as possible after diagnsosis to children and adolescents with leukaemia.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000515291

Acronym

PreventIPD

Enrollment

100

Registered

2009-06-29

Start date

2009-06-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Prevention

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

0 to 18 Years

Healthy volunteers

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

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.

Outcome results