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Trial registered on ANZCTR


Registration number
ACTRN12611001036909
Ethics application status
Approved
Date submitted
25/02/2009
Date registered
30/09/2011
Date last updated
30/09/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Prevention and immunisation of cervical cancer amongst school girls in Vanuatu
Scientific title
A sustainable program for prevention of Cervical Cancer in school girls in Vanuatu
Secondary ID [1] 273126 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cervical cancer 4386 0
Condition category
Condition code
Cancer 4633 4633 0 0
Cervical (cervix)

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
A series of 1 hour long focus groups will be conducted in 10 participating villages, by the district nurses in English and Bislami to ascertain the beliefs of vaccination and cervical cancer immunisation program amongst government officials, parents and 10-12 year old school girls . The findings from the sessions will be used to lay the vaccination program in Vanuatu. Hence these sessions happen prior to the 3 shots of vaccine.
1000 school girls will be educated about cervical cancer and immunised intravenously with 3 doses of Cervarix (0.5 ml per dose) by a dedicated nurse across 10 villages. HPV antibody levels will be measured 3 months after the final dose of the vaccine delivered to a 0,2.5,6 month schedule. The collected sera will then be tested in a WHO lab.
Intervention code [1] 4118 0
Not applicable
Comparator / control treatment
none
Control group
Uncontrolled

Outcomes
Primary outcome [1] 5503 0
Uptake of HPV vaccination: percentage of 10-12 year old girls recruited in the study.
Timepoint [1] 5503 0
one year
Secondary outcome [1] 9266 0
Personal card record systems. This is to verify that the participants return back for the 3 shots of vaccine within the nominated time period.
Timepoint [1] 9266 0
one year
Secondary outcome [2] 294287 0
Relationship of age and nutrition with the immune responses to HPV infection. Sera collected pre and post immunisation, together with the participant personal information such as weight and height will be used to assess this information.
Timepoint [2] 294287 0
one year
Secondary outcome [3] 294288 0
HPV antibody test for the vaccine using ELISA assay. The assay demonstrates the presence of type specific IgG antibody present in the sera post immunisation. All participants immunised with Cervarix should demonstrate the presence of HPV 16 and HPV 18 antibodies.
Timepoint [3] 294288 0
6 months

Eligibility
Key inclusion criteria
age 9 - 12 years old school girls
Minimum age
9 Years
Maximum age
12 Years
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. younger than 9 and older than 12 women
2. who currently receive any immunology modifier meditation.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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 outside Australia
Country [1] 1602 0
Vanuatu
State/province [1] 1602 0
Port Vila

Funding & Sponsors
Funding source category [1] 4562 0
Commercial sector/Industry
Name [1] 4562 0
GlaxoSmithKline Biologicals
Address [1] 4562 0
1061 Mountain Hwy (PO Box 168)
Boronia VIC 3155
Country [1] 4562 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
St Lucia, Brisbane
QLD - 4067
Country
Australia
Secondary sponsor category [1] 4116 0
Individual
Name [1] 4116 0
Prof Ian Frazer
Address [1] 4116 0
Translational Research Institute Pty Ltd.
20 Cornwall Street
Wooloongabba
QLD - 4102
Country [1] 4116 0
Australia
Other collaborator category [1] 583 0
Individual
Name [1] 583 0
Dr Margaret McAdam
Address [1] 583 0
Wesley Hospital
451, Coronation drive
Auchenflower
QLD - 4066
Country [1] 583 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6611 0
University of Queensland Human Ethics Committee
Ethics committee address [1] 6611 0
The University of Queensland
Cumbrae-Stewart Building
Research Road
Brisbane Qld 4072
Ethics committee country [1] 6611 0
Australia
Date submitted for ethics approval [1] 6611 0
26/11/2008
Approval date [1] 6611 0
14/01/2009
Ethics approval number [1] 6611 0
2008002173

Summary
Brief summary
Engagement of the Ni-Vanuatu women will enable effective delivery of Cervarix vaccine to a cohort of 10-12 year old school girls. Efficient monitoring and follow up will lead to the prevention of cervical cancer in Vanuatu.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29325 0
Address 29325 0
Country 29325 0
Phone 29325 0
Fax 29325 0
Email 29325 0
Contact person for public queries
Name 12572 0
Dr Margaret McAdam
Address 12572 0
Wesley Hospital,
451, Coronation Drive
Auchenflower
QLD - 4066.
Country 12572 0
Australia
Phone 12572 0
+61 419622326
Fax 12572 0
Email 12572 0
mcadamia@bigpond.net.au
Contact person for scientific queries
Name 3500 0
Prof Ian Frazer
Address 3500 0
Translational Research Institute Pty Ltd.
20 Cornwall Street,
Wooloongabba
QLD - 4102
Country 3500 0
Australia
Phone 3500 0
+61 7 3346 1905
Fax 3500 0
+61 7 3346 1732
Email 3500 0
ian.frazer@tri.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary