ActivePhase 3ACTRN12609000515291

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.


Sponsor

NHMRC CCRE in Childhood and Adolescent Immunisation

Enrollment

100 participants

Start Date

Jun 1, 2009

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 0 YearssMax Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests a vaccination strategy to protect children and adolescents being treated for leukaemia from a serious lung infection called invasive pneumococcal disease. Because cancer treatment weakens the immune system, researchers want to find the best time and way to vaccinate these young patients.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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, Synf

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.


Locations(1)

Australia

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ACTRN12609000515291