ANZCTR - Registration

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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]

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

Condition category

Condition code

Cancer

Children's - Brain

Cancer

Children's - Leukaemia & Lymphoma

Cancer

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]

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]

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]

1 month post vaccination

Primary outcome [2]

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]

1 month post vaccination

Secondary outcome [1]

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]

1 month post vaccination

Secondary outcome [2]

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]

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?

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)

Recruitment hospital [1]

Princess Margaret Hospital - Subiaco

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Princess Margaret Hospital Foundation

Address [1]

Level 1, 68 Hay street, Subiaco Western Australia 6008

Country [1]

Australia

Funding source category [2]

Hospital

Name [2]

PMH Telethon Fellowship

Address [2]

Roberts Rd, Subiaco 6008 WA

Country [2]

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]

Individual

Name [1]

Dr Peter Richmond

Address [1]

Princess Margaret Hospital for Children
Roberts Rd Subiaco WA 6008

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Princess Margaret Hospital for Children Ethics Committee

Ethics committee address [1]

Princess Margaret Hospital for Children
Roberts Road Subiaco WA 6008
GPO Box D184 Perth WA 6840

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

06/12/2012

Approval date [1]

04/02/2013

Ethics approval number [1]

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

Dr Te-Yu Hung

Address

Princess Margaret Hospital for Children
Roberts Rd
Subiaco WA 6008

Country

Australia

Phone

+61 8 9340 8222

Fax

Te-Yu.Hung@health.wa.gov.au

Contact person for public queries

Name

Te-Yu Hung

Address

Princess Margaret Hospital for Children
Roberts Rd
Subiaco WA 6008

Country

Australia

Phone

+61 8 9340 8222

Fax

Te-Yu.Hung@health.wa.gov.au

Contact person for scientific queries

Name

Te-Yu Hung

Address

Princess Margaret Hospital for Children
Roberts Rd
Subiaco WA 6008

Country

Australia

Phone

+61 8 9340 8222

Fax

Te-Yu.Hung@health.wa.gov.au

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

Source	Title	Year of Publication	DOI
Embase	Immunogenicity and safety of single-dose, 13-valent pneumococcal conjugate vaccine in pediatric and adolescent oncology patients.	2017	https://dx.doi.org/10.1002/cncr.30764

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically