Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000264785
Ethics application status
Approved
Date submitted
15/02/2013
Date registered
6/03/2013
Date last updated
1/08/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Immunogenicity and Safety of a 13-valent pneumococcal conjugate vaccine in paediatric oncology patients
Scientific title
Immunogenicity and Safety of a 13-valent pneumococcal conjugate vaccine in paediatric oncology patients
Secondary ID [1] 281951 0
none here
Universal Trial Number (UTN)
U1111-1139-5120
Trial acronym
PCVPON1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
paediatric malignancy 288381 0
Condition category
Condition code
Cancer 288723 288723 0 0
Children's - Brain
Cancer 288724 288724 0 0
Children's - Leukaemia & Lymphoma
Cancer 288725 288725 0 0
Children's - Other

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All patients will receive a pre-vaccination blood sample and a nasal swab. All patients will then be administered single dose of 13-valent pneumococcal conjugate vaccine, 0.5 mL intramuscular injection. All patients will then have a post-vaccination blood sample and a nasal swab 1 month later.
Intervention code [1] 286526 0
Treatment: Drugs
Comparator / control treatment
Comparator treatment being studied is the immunogenicity of the pneumococcal conjugate vaccine (13-valent) being given to oncology children on immunosuppressive treatment. All patients will be administered single dose of 13-valent pneumococcal conjugate vaccine, 0.5 mL intramuscular injection.

There is a active control group of oncology children who had completed treatment within 12 months. This is not a "true" control group, since the current standard practice are to administer vaccinations when 6 months after treatment completion.

Therefore, both comparator groups will be compared to historical control groups, who are healthy infants with previous PCV7 given single dose of PCV13 (reference: Silfverdal SA et al Vaccine. 2013 Feb 18;31(9):1284-92.).
Control group
Active

Outcomes
Primary outcome [1] 288889 0
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.
Timepoint [1] 288889 0
1 month post vaccination
Primary outcome [2] 288890 0
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.
Timepoint [2] 288890 0
1 month post vaccination
Secondary outcome [1] 301247 0
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.
Timepoint [1] 301247 0
1 month post vaccination
Secondary outcome [2] 301248 0
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.
Timepoint [2] 301248 0
6 months post end of treatment.

Eligibility
Key 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.
Minimum age
1 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
6/03/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 602 0
Princess Margaret Hospital - Subiaco

Funding & Sponsors
Funding source category [1] 286749 0
Charities/Societies/Foundations
Name [1] 286749 0
Princess Margaret Hospital Foundation
Country [1] 286749 0
Australia
Funding source category [2] 286750 0
Hospital
Name [2] 286750 0
PMH Telethon Fellowship
Country [2] 286750 0
Australia
Primary sponsor type
Individual
Name
Te-Yu Hung
Address
Princess Margaret Hospital for Children
Roberts Rd
Subiaco WA 6008
Country
Australia
Secondary sponsor category [1] 285530 0
Individual
Name [1] 285530 0
Dr Peter Richmond
Address [1] 285530 0
Princess Margaret Hospital for Children
Roberts Rd Subiaco WA 6008
Country [1] 285530 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288820 0
Princess Margaret Hospital for Children Ethics Committee
Ethics committee address [1] 288820 0
Ethics committee country [1] 288820 0
Australia
Date submitted for ethics approval [1] 288820 0
06/12/2012
Approval date [1] 288820 0
04/02/2013
Ethics approval number [1] 288820 0
2072/EP

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37842 0
Dr Te-Yu Hung
Address 37842 0
Princess Margaret Hospital for Children
Roberts Rd
Subiaco WA 6008
Country 37842 0
Australia
Phone 37842 0
+61 8 9340 8222
Fax 37842 0
Email 37842 0
[email protected]
Contact person for public queries
Name 37843 0
Te-Yu Hung
Address 37843 0
Princess Margaret Hospital for Children
Roberts Rd
Subiaco WA 6008
Country 37843 0
Australia
Phone 37843 0
+61 8 9340 8222
Fax 37843 0
Email 37843 0
[email protected]
Contact person for scientific queries
Name 37844 0
Te-Yu Hung
Address 37844 0
Princess Margaret Hospital for Children
Roberts Rd
Subiaco WA 6008
Country 37844 0
Australia
Phone 37844 0
+61 8 9340 8222
Fax 37844 0
Email 37844 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseImmunogenicity and safety of single-dose, 13-valent pneumococcal conjugate vaccine in pediatric and adolescent oncology patients.2017https://dx.doi.org/10.1002/cncr.30764
N.B. These documents automatically identified may not have been verified by the study sponsor.