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

Phase 2

Recruiting

• Conditions: paediatric malignancy; Cancer - Children's - Brain; Cancer - Children's - Leukaemia & Lymphoma; Cancer - Children's - Other

• Registration Number: ACTRN12613000264785
• Lead Sponsor: Te-Yu Hung

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-03-06
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

patients with haematological and solid organ malignancies at Princess Margaret Hospital for Children and currently receiving chemotherapy and/or radiotherapy, or those who have completed chemotherapy or radiotherapy within the last 12 months and have not yet received a PCV 13 booster.

Exclusion Criteria

previous anaphylaxis to Prevenar 13 or any vaccine component, received intravenous immunoglobulin in the 3 months prior to administration of vaccination, and patient with asplenia or conditions known to be associated with hyposplenia.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determine the percentage of participants who achieve protective vaccine type serotype specific serum IgG antibody levels (>0.35 microgram/mL) following single dose administration of PCV13. (5 mL of venous blood will be taken). Method: microsphere based flow-cytometric assay.[1 month post vaccination];Determine the percentage of participants who achieve protective vaccine type serotype specific opsonophagocytic assay titre >1:8 following single dose administration of PCV13. 5 mL of venous blood will be taken for serum, from which the multiplex opsonophagocytic assay is performed.[1 month post vaccination]

Secondary Outcome Measures

Name	Time	Method
Determine change in serotype-specific nasopharyngeal colonisation rate of Streptococcus pneumoniae following single dose of PCV 13. A nasopharyngeal swab will be taken and bacterial cultures performed. Bacterial identification, serotyping and antibiotic sensitivity will be tested.[1 month post vaccination];Determine persistence of antibody levels and OPA titres in patients receiving PCV13 booster vaccination during cancer treatment, by measuring serum levels of IgG antibody and opsonophagocytic assay. A 5 mL venous blood sample will be taken.[6 months post end of treatment.]