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The University of Southampton
Southampton Clinical Trials Unit

PCV 13 in ALL Trial

Trial Name

PCV 13 in ALL Trial - Investigating the clinical use of 13-valent pneumococcal conjugate vaccine (PCV13, Prevenar-13) in childhood Acute Lymphoblastic Leukaemia 

Description

Non-randomised, open-label study examining the efficacy of PCV13 (Prevenar-13) in children at three time points during/after Acute Lymphoblastic Leukaemia (ALL) treatment:

i) during maintenance chemotherapy, 6 months from last intensive chemotherapy (Study group 1)
ii) at the end of treatment (Study group 2)
iii) 6 months after completion of treatment (Study group 3) 

Objectives

Primary Objective:

The primary objective is to establish whether immunisation with PCV13 (Prevenar-13TM) can achieve protective levels of anti-pneumococcal antibodies in children:

  1. Receiving maintenance chemotherapy for Acute Lymphoblastic Leukaemia
  2. At the end of treatment for Acute Lymphoblastic Leukaemia
  3. 6 months after completion of treatment for Acute Lymphoblastic Leukaemia

Secondary Objectives:

Design

Multicentre non-randomised interventional treatment trial 

Status

Complete

Population

120 children (40 per study group) who are receiving, or who recently completed, treatment for acute lymphoblastic leukaemia. Age 2-18 years 

Contact Details

All Trial enquiries should be addressed to ctu@soton.ac.uk

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