Immunogenicity and Safety of a 13-valent pneumococcal conjugate vaccine in paediatric oncology patients

This study will look at the effectiveness of the 13-valent pneumococcal conjugate vaccine (Prevenar 13 registered trademark) in children currently or recently receiving cancer treatment. Prevenar13 (registered trademark) has been part of the regular immunisation schedule for all children at 2, 4, and 6 months in Australia since 2011. Pneumococcal conjugate vaccines are known to be very effective in healthy children under 2 years in preventing severe bacterial infections caused by Streptococcus pneumoniae, such as meningitis, bloodstream infections, chest and ear infections. Currently the vaccine is only licensed in Australia for children under 5 years and adults over 50 years of age. It is expected that it will be licensed for older children soon. It is recommended by experts that older children up to the age of 18 years with a medical condition that lowers the body’s immune system be given a dose of the Prevenar 13 (registered trademark) vaccine. Who is it for? All children aged between 1 and 18 years with a diagnosis of cancer who are either receiving chemotherapy and/or radiotherapy, or have recently completed chemotherapy or radiotherapy within the last 12 months. Patients who have completed treatment and already given a booster dose of Prevenar 13 (registered trademark) are not eligible. Trial details You will be asked to sign a consent form permitting your child to take part in the study. You will be asked questions regarding your child’s diagnosis, treatment (current or past), previous immunisations received and any side effects experienced. We will ask for your permission to access the Australian Childhood Immunisation Registry (ACIR) database for details of the immunisations. We ask you to remain for at least 15 minutes after the vaccination for observation of your child to monitor for any side effects. This is routine practice for all immunisations. You will be given a 7 day symptom diary to record any side effects, including measuring the body temperature at least once in the evening, and any other time that the child feels warm or unwell. You will be asked to bring the diary back at the next appointment. We will take a blood sample (5 mL or 1 teaspoon) to measure the immune level against the bacteria and a nasal swab to see if the bacteria is carried in the nose. The blood sample may be taken at the same time when other treatment bloods are being taken (e.g. from the “port” or Broviac). We will give the Prevenar 13 (registered trademark) vaccine by an injection in the leg or the upper arm. When you return for your appointment one month later, we will take another blood sample (5 mL) and a nasal swab to compare. If your child is enrolling and being vaccinated whilst still on cancer treatment, another blood sample (5 mL) and a nasal swab will be taken 6 months after your child has completed treatment.