Please note that the ANZCTR website will be unavailable from 6pm until 6.30pm (AEST) on Monday 22nd July for website maintenance. Please be sure to log out of the system in order to avoid any loss of data. Thank you and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
Gender
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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
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
Address [1] 286749 0
Level 1, 68 Hay street, Subiaco Western Australia 6008
Country [1] 286749 0
Australia
Funding source category [2] 286750 0
Hospital
Name [2] 286750 0
PMH Telethon Fellowship
Address [2] 286750 0
Roberts Rd, Subiaco 6008 WA
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
Princess Margaret Hospital for Children
Roberts Road Subiaco WA 6008
GPO Box D184 Perth WA 6840
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
This study will look at the effectiveness of the 13-valent pneumococcal conjugate vaccine (Prevenar 13 registered trademark) in children currently or recently receiving cancer treatment. Prevenar13 (registered trademark) has been part of the regular immunisation schedule for all children at 2, 4, and 6 months in Australia since 2011. Pneumococcal conjugate vaccines are known to be very effective in healthy children under 2 years in preventing severe bacterial infections caused by Streptococcus pneumoniae, such as meningitis, bloodstream infections, chest and ear infections.

Currently the vaccine is only licensed in Australia for children under 5 years and adults over 50 years of age. It is expected that it will be licensed for older children soon. It is recommended by experts that older children up to the age of 18 years with a medical condition that lowers the body’s immune system be given a dose of the Prevenar 13 (registered trademark) vaccine.

Who is it for?
All children aged between 1 and 18 years with a diagnosis of cancer who are either receiving chemotherapy and/or radiotherapy, or have recently completed chemotherapy or radiotherapy within the last 12 months. Patients who have completed treatment and already given a booster dose of Prevenar 13 (registered trademark) are not eligible.

Trial details
You will be asked to sign a consent form permitting your child to take part in the study. You will be asked questions regarding your child’s diagnosis, treatment (current or past), previous immunisations received and any side effects experienced. We will ask for your permission to access the Australian Childhood Immunisation Registry (ACIR) database for details of the immunisations.

We ask you to remain for at least 15 minutes after the vaccination for observation of your child to monitor for any side effects. This is routine practice for all immunisations. You will be given a 7 day symptom diary to record any side effects, including measuring the body temperature at least once in the evening, and any other time that the child feels warm or unwell. You will be asked to bring the diary back at the next appointment.

We will take a blood sample (5 mL or 1 teaspoon) to measure the immune level against the bacteria and a nasal swab to see if the bacteria is carried in the nose. The blood sample may be taken at the same time when other treatment bloods are being taken (e.g. from the “port” or Broviac).

We will give the Prevenar 13 (registered trademark) vaccine by an injection in the leg or the upper arm. When you return for your appointment one month later, we will take another blood sample (5 mL) and a nasal swab to compare.

If your child is enrolling and being vaccinated whilst still on cancer treatment, another blood sample (5 mL) and a nasal swab will be taken 6 months after your child has completed treatment.
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
Te-Yu.Hung@health.wa.gov.au
Contact person for public queries
Name 37843 0
Dr 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
Te-Yu.Hung@health.wa.gov.au
Contact person for scientific queries
Name 37844 0
Dr 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
Te-Yu.Hung@health.wa.gov.au

No information has been provided regarding IPD availability
Summary results
No Results