Condition category
Infections and Infestations
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Contact information



Primary contact

Dr Juliet Gray


Contact details

Southampton University Hospitals NHS Trust
Tremona Road
SO16 6YD
United Kingdom

Additional identifiers

EudraCT number

2009-011587-11 number

Protocol/serial number


Study information

Scientific title

Investigating the clinical use of 13-valent pneumococcal conjugate vaccine (Prevenar) in childhood acute lymphoblastic leukaemia: a multicentre non-randomised interventional treatment trial


PCV (Pneumococcal Conjugate Vaccine)

Study hypothesis

he main aim of this study is to produce evidence on which to base a vaccination guideline that will reduce the incidence of pneumococcal infection in children with acute leukoblastic leukaemia (ALL). This will be achieved by examining the efficacy of 13 valent conjugate pneumococcal vaccination (13vPCV) immunisation in this population. Our hypothesis is that 13vPCV will be sufficiently immunogenic to generate protective anti-pneumococcal immunity in children with ALL whilst they are receiving maintenance therapy and are most at risk of infection. However, it is possible that vaccination of children during treatment will not be effective due to the immunosuppressive effects of chemotherapy. Therefore vaccination with 13vPCV will also be tested in children at the end of their treatment and 6 months after completion of treatment. The earliest of these time points at which 13vPCV is found to achieve protective immunity will be adopted as the final recommendation for all children with ALL, in order to provide protection for as long as possible during and after their leukaemia therapy.

The main study question is therefore to identify the earliest time point that children with ALL can be effectively vaccinated with 13vPCV. In order to answer this, the study primary objective is to establish if 13vPCV can achieve protective levels of anti-pneumococcal antibodies:
1. During maintenance therapy
2. At the end of chemotherapy treatment
3. Six months after completion of treatment

Ethics approval

Southampton and South West Hampshire REC, Committee B, 11/02/2010, ref: 09/HO504/112

Study design

Multicentre non-randomised interventional treatment trial

Primary study design


Secondary study design

Non randomised study

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Topic: Medicines for Children Research Network; Subtopic: All Diagnoses; Disease: All Diseases


PCV-13 vaccine, single 0.5 ml dose of vaccine to each study participant.

Follow up length: 12 months
Study entry: other
Details: non-random allocation to treatment group, depending on current timepoint in ALL treatment

Intervention type



Phase IV

Drug names

Primary outcome measures

Serum concentrations of IgG anti-capsular polysaccharide antibodies to pneumococcal serotypes, measured at 0, 1 and 12 months post-immunisation

Secondary outcome measures

1. Nasopharyngeal carriage of pneumococcal sp (including serotpye and MLST), measured at 0 and 12 months post-immunisation
2. Opsonophagocytosis assay (OPA) against two pneumococcal serotypes, measured at 0, 1 and 12 months post-immunisation
3. Peripheral blood lymphocyte subsets, measured at 0 and 12 months post-immunisation
4. Serum concentrations of total immunoglobulins and IgG subclasses, measured at 0 and 1 months post-immunisation

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

1. Aged 2 to 18 years (inclusive), either sex
2. ALL confirmed by immunophenotyping at diagnosis
3. Currently receiving maintenance therapy as per UKALL 2003 treatment protocol, or treatment as per UKALL 2003 protocol completed within last 6 months
4. Informed consent of parent/guardian (+/- patient)

Participant type


Age group




Target number of participants

Planned sample size: 120; UK sample size: 120

Participant exclusion criteria

1. Concomitant acquired or congenital immunodeficiency
2. Concomitant immunosuppressive medication within previous 3 months, other than maintenance chemotherapy as per UKALL 2003 protocol
3. Previous severe or anaphylactic reaction to PCV
4. Previous severe or anaphylactic reaction to diphtheria toxoid
5. Children with a contraindication to receipt of any vaccine or a specific vaccine as stated in the Department of Health Green Book on immunisation (DOH, 2006)
6. Pregnancy or lactation

Routine immunisation with PCV7 prior to ALL therapy is not an exclusion criteria

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Southampton University Hospitals NHS Trust
SO16 6YD
United Kingdom

Sponsor information


Southampton University Hospitals NHS Trust (UK)

Sponsor details

Tremona Road
SO16 6YD
United Kingdom

Sponsor type

Hospital/treatment centre



Funder type


Funder name

National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) Programme (ref: PB-PG-1207-15250)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

26/11/2015: no publications found on PubMed.