Page 5
|
|
Key inclusion criteria:
|
Term, well newborn infants. |
|
Update:
|
|
|
Reason:
|
|
|
Minimum Age:
|
1
Days
|
|
Update:
|
|
|
Reason:
|
|
|
Maximum Age:
|
2
Months
|
|
Update:
|
|
|
Reason:
|
|
|
Gender:
|
Both males and females |
|
Update:
|
|
|
Reason:
|
|
|
Healthy volunteers?
|
No |
|
Update:
|
|
|
Reason:
|
|
|
Key exclusion criteria:
|
Family history of immunodeficiencies. Mother with HIV. Mother with active TB. |
|
Update:
|
|
|
Reason:
|
|
Page 6
|
|
Study type: |
Interventional |
|
Update:
|
|
|
Reason:
|
|
|
Purpose of the study: |
Prevention |
|
Update:
|
|
|
Allocation to intervention: |
Randomised controlled trial |
|
Update:
|
|
|
Reason:
|
|
|
Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures): |
Consenting mothers/families in antenatal clinic. Randomisation of newborn infants to one of four groups at birth using seald opaque envelopes. |
|
Update:
|
|
|
Reason:
|
|
|
Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation): |
Stratified allocation using three broad ethnical groups: Parents originating form Africa, Indian Subcontinent, Asia. |
|
Update:
|
|
|
Reason:
|
|
|
Masking / blinding: |
Blinded (masking used) |
|
Update:
|
|
|
Reason:
|
|
|
Who is/are masked/blinded: |
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
|
|
Update:
|
|
|
Reason:
|
|
|
Assignment: |
Parallel |
|
Update:
|
|
|
Reason:
|
|
|
Other design features (specify): |
|
|
Update:
|
|
|
Reason:
|
|
|
Type of endpoint(s): |
Safety/efficacy |
|
Update:
|
|
|
Reason:
|
|
|
Update:
|
|
|
Reason:
|
|
|
Update:
|
|
|
Reason:
|
|
|
Update:
|
|
|
Reason:
|
|
|
Update:
|
|
|
Reason:
|
|
Page 7
|
|
Phase |
Not Applicable |
|
Update:
|
|
|
Reason:
|
|
|
Anticipated or actual date of first participant enrolement: |
26/04/2008 |
|
Update:
|
|
|
Reason:
|
|
|
Target sample size: |
256 |
|
Update:
|
|
|
Reason:
|
|
|
Recruitment status: |
Open to recruitment |
|
Update:
|
|
|
Reason:
|
|
Page 8
|
| Funding source 1: | Government funding body e.g. Australian Research Council |
| Name: | Murdoch Children's Research Institute |
| Address: | Flemington Rd
Parkville, VIC 3052 |
| Country: | Australia |
| Funding source 2: | University |
| Name: | Nossal Institute of Global Health |
| Address: | Faculty of Medicine, Dentistry and Health Sciences
The University of Melbourne
Victoria 3010 Australia |
| Country: | Australia |
| Funding source 3: | Government funding body e.g. Australian Research Council |
| Name: | Swiss National Science Foundation |
| Address: | Wildhainweg 3, POBox 8232, 3001 Berne |
| Country: | Switzerland |
| Funding source 4: | University |
| Name: | The University of Melbourne |
| Address: | Faculty of Medicine, Dentistry and Health Sciences
The University of Melbourne
Victoria 3010 Australia |
| Country: | Australia |
| Funding source 5: | Charities/Societies/Foundations |
| Name: | European Society for Paediatric Infectious Diseases |
| Address: | c/o Kenes International
Rue de Chantepoulet 1-3
P.O.Box 1726
CH-1211 Geneva 1
Telephone: +41 22 906 91 65
Fax: +41 22 732 2607 |
| Country: | Switzerland |
|
Primary sponsor: |
Hospital |
|
Update:
|
|
|
Reason:
|
|
|
Name: |
The Mercy Hospital for Women |
|
Update:
|
|
|
Reason:
|
|
|
Address: |
163 Studley Road, Heidelberg 3084, VIC |
|
Update:
|
|
|
Reason:
|
|
| Country:
|
Australia |
|
Update:
|
|
|
Reason:
|
|
| Secondary sponsor: | None |
| Name: | |
| Address: | |
| Country: | |
| Other collaborator: | |
Page 9
|
|
Has the study received approval from at least one ethics committee? |
Yes |
|
Update:
|
|
|
Reason:
|
|
| Ethics Committee name: | Human Research Ethics Committee, Mercy Hospital for Women |
| Address: | 163 Studley Road, Heidelberg 3084, VIC |
| Country: | Australia |
| Date of approval: | 7/12/2007 |
| HREC Number: | R07/16 |
| Countries of recruitment: | Australia |
|
Brief summary: |
This study is investigating the influence of vaccine strain and age at immunisation on the immune response in children to Bacille Calmette-Guérin (BCG) immunisation. The underlying hypothesis is that there is a measurable difference in the qualtitative and qualitative immune response which may be associated with differences in the level of protection |
|
Update:
|
|
|
Reason:
|
|
|
Trial website: |
|
|
Update:
|
|
|
Presentations / publication list: |
Ritz N, Hanekom, W, Robins-Browne R, Britton W, Curtis N. The influence of BCG vaccine strain on the immune response and protection against tuberculosis.
FEMS Microbiology Reviews 2008 in press. |
|
Update:
|
|
Page 10
|
|
Contact person for public queries
|
|
Name: |
Prof Nigel Curtis |
|
Update:
|
|
|
Reason:
|
|
|
Address: |
Royal Children's Hospital Melbourne
Flemington Road
Parkville 3052, VIC |
|
Update:
|
|
|
Reason:
|
|
|
Country: |
Australia |
|
Update:
|
|
|
Reason:
|
|
|
Tel: |
03 9345 6366 |
|
Update:
|
|
|
Reason:
|
|
|
Fax: |
|
|
Update:
|
|
|
Reason:
|
|
|
Email: |
nigel.curtis@rch.org.au |
|
Update:
|
|
|
Reason:
|
|
Contact person for scientific queries |
|
Name: |
Dr Nicole Ritz |
|
Update:
|
|
|
Reason:
|
|
|
Address: |
Royal Children's Hospital Melbourne
Flemington Road
Parkville 3052, VIC |
|
Update:
|
|
|
Reason:
|
|
|
Country: |
Australia |
|
Update:
|
|
|
Reason:
|
|
|
Tel: |
03 9345 4990 |
|
Update:
|
|
|
Reason:
|
|
|
Fax: |
|
|
Update:
|
|
|
Reason:
|
|
|
Email: |
nicole.ritz@rch.org.au |
|
Update:
|
|
|
Reason:
|
|
Contact person responsible for updating information |
|
Name: |
Dr Nicole Ritz |
|
Update:
|
|
|
Reason:
|
|
|
Address: |
Royal Children's Hospital Melbourne |
|
Update:
|
|
|
Reason:
|
|
|
Country: |
Australia |
|
Update:
|
|
|
Reason:
|
|
|
Tel: |
03 9345 6664 |
|
Update:
|
|
|
Reason:
|
|
|
Fax: |
|
|
Update:
|
|
|
Reason:
|
|
|
Email: |
nicole.ritz@rch.org.au |
|
Update:
|
|
|
Reason:
|
|
|
|
|
