Childhood Acute Lymphoblastic Leukaemia
Conditions
Interventions
Trade Name: Prevenar-13
Product Name: Prevenar-13
Product Code: N/A
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: P
Sponsors
University Hospital Southampton NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria: i) Age 2 to 18 years (inclusive) ii) ALL confirmed by immunophenotyping at diagnosis iii) Currently receiving maintenance therapy as per UKALL 2003 treatment protocol, or treatment as per UKALL 2003 protocol (iincluding interim guidelines) completed within last 6 months iv) Informed consent of parent/guardian (+/- patient) Are the trial subjects under 18? yes Number of subjects for this age range: 120 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria: i) Concomitant acquired or congenital immunodeficiency ii) Concomitant immunosuppressive medication within previous 3 months, other than maintenance chemotherapy as per UKALL 2003 protocol iii) Previous severe or anaphylactic reaction to PCV iv) Previous severe or anaphylactic reaction to diphtheria toxoid v) Previous immunisation with PCV13 v) Children with a contraindication to receipt of any vaccine or a specific vaccine as stated in the Department of Health Green Book on immunization (DOH, 2006)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The principal research question is whether immunisation with a pneumococcal vaccine (13vPCV) can be used to protect children with Acute Lymphoblastic Leukaemia from pneumococcal infection. It will seek to identify the earliest time-point in treatment that children can be effectively vaccinated in order to protect children from this infection for as long as possible, when they are most at risk of infection. Specifically, it will investigate whether protective pneumococcal immunity can be achieved by immunising with 13vPCV: a) during leukaemia treatment (during maintenance chemotherapy)? b) at the end of leukaemia treatment? c) 6 months after completion of leukaemia treatment? ; Secondary Objective: Secondary objectives of the study are: 1. To establish if the side effcts of a pneumococcal vaccine (13vPCV)are tolerable and acceptable in children with Acute Lymphoblastic Leukaemia (ALL). 2. To document any cases of pneumococcal infection in the study population 3. To document how many children carry different pneumococcal types in this population. This is important to ensure that the different types of pneumococcal contained in the vaccine are appropriate for the population. 4. To describe the effects on the immune system of current ALL chemotherapy treatment. ; Primary end point(s): The primary outcome measure will be the percentage of children who have protective levels of anti-pneumococcal antibodies (as defined by WHO) 1 month post-13vPCV immunisation. ;Timepoint(s) of evaluation of this end point: 0, 1 and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): i) immune status (lymphocyte subsets and immunoglubulin subclasses) in children receiving treatment for ALL ii) Pneumococcal serotype carriage in children receiving treatment for ALL ;Timepoint(s) of evaluation of this end point: 0,1 and 12 months | — |
Countries
United Kingdom
Contacts
Public ContactElizabeth Dixon, Trials Mana
University of Southampton CTU
Outcome results
None listed