PCV immunisation for children with leukaemia

Phase 1

• Conditions: Childhood Acute Lymphoblastic Leukaemia; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2009-011587-11-GB
• Lead Sponsor: niversity Hospital Southampton NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-10-18
• Study Completion: 2015-11-20
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 118

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

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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified