Cervical CancerPhase 3HPVNCT00964210
Protecting Young Special Risk Females From Cervical Cancer Through Human Papilloma Virus (HPV) Vaccination
A Phase 3 study testing Licensed quadrivalent HPV vaccine, Gardasil in people with Cervical Cancer, run by Murdoch Childrens Research Institute at 1 site in Australia.
Trial summary
A research project is currently being undertaken looking at Human Papilloma Virus (HPV) vaccination in special risk groups. It aims to see if young women with a chronic illness respond well to the HPV vaccine or whether they may require additional doses to ensure protective immunity. Read more about this study
- Who is it for?
- Ages 12 to 26 years, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Licensed quadrivalent HPV vaccine, Gardasil
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- 240 participants
- Where
- 1 siteAustralia
- Study dates
- Mar 2008to Apr 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 26 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Females aged 12-26 years
- Have been diagnosed by a specialist with one of the six chronic medical conditions described:
- Paediatric Rheumatological Disease
- Inflammatory Bowel Disease
- Acute Lymphoblastic Leukaemia
- Solid Organ Transplant Recipients (kidney and liver)
- Chronic Renal Disease
- Bone Marrow Transplant
Who cannot join
- Previous immunisation with HPV vaccine Recognised contraindication to the receipt of the vaccine e.g. anaphylaxis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Non Controlled Study of Immunogenicity of Human Papilloma Virus (HPV) Vaccine in Groups at Special Risk of Poor Vaccine Result
A research project is currently being undertaken looking at Human Papilloma Virus (HPV) vaccination in special risk groups. It aims to see if young women with a chronic illness respond well to the HPV vaccine or whether they may require additional doses to ensure protective immunity. The four valent HPV vaccine protects against HPV types 16 \& 18, cervical cancer and HPV types 6 \& 11, anogenital warts.
The six special risk groups include:
Read more
Paediatric Rheumatological Disease Inflammatory Bowel Disease Acute Lymphoblastic Leukaemia Solid Organ Transplant Recipients (kidney and liver) Chronic Renal Disease Bone Marrow Transplants This immunity is measured by antibody levels of the HPV types, which requires a single blood test one month after the final dose of HPV vaccine.
This is compared to healthy controls using antibody response to HPV vaccine. This will assess directly whether these special risk groups respond as well to the HPV vaccine.
- Conditions
- Cervical Cancer
- Being tested
- Licensed quadrivalent HPV vaccine, Gardasil
- Keywords
- Juvenile Idiopathic Arthritis, Inflammatory Bowel Disease, Acute Lymphoblastic Leukemia, Chronic Renal Disease, Solid Organ Transplant
- Medical subject headings
- Uterine Cervical Neoplasms, Arthritis, Juvenile, Inflammatory Bowel Diseases, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Licensed quadrivalent HPV vaccine, GardasilDrug
The dose of the four valent (4v) HPV vaccine is 0.5ml administered by intramuscular (IM)injection. The recommended schedule is 0, 2 and 6 months.
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the HPV vaccine immunogenicity in females 12-26 years with six special risk groups at one month post the third and final HPV vaccination. Blood analysis taken at one month post third and final HPV vaccine to assess immunogenicity.
Measured: One Month post HPV vaccination
Secondary outcomes (1)
Describe the safety of the HPV vaccine in the six study groups using self reports and liaison with treating sub specialist team.
Measured: One month post third HPV vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2009 (estimated)
- Study startMar 2008
- Primary completionDec 2010
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Murdoch Childrens Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Murdoch Childrens Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Brockhoff Foundation Australia, Shepherd Foundation Australia
- Investigators
- Jim Buttery, Principal investigator, NHMRC CCRE in Childhood and Adolescent Immunisation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00964210
- Sponsor's protocol ID
- RCH CA27091
- Acronym
- HPV
- Status last verified
- Aug 2009
- First submitted
- 21 Aug 2009
- Last updated
- 15 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Non Controlled Study of Immunogenicity of Human Papilloma Virus (HPV) Vaccine in Groups at Special Risk of Poor Vaccine Result
- ClinicalTrials.gov ID
- NCT00964210
- Acronym / sponsor ID
- HPV / RCH CA27091
- Conditions
- Cervical Cancer
- Keywords
- Juvenile Idiopathic Arthritis, Inflammatory Bowel Disease, Acute Lymphoblastic Leukemia, Chronic Renal Disease, Solid Organ Transplant
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Murdoch Childrens Research InstituteUniversity, hospital or other
- Collaborators
- Brockhoff Foundation Australia, Shepherd Foundation Australia
- Study start
- Mar 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 24 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A research project is currently being undertaken looking at Human Papilloma Virus (HPV) vaccination in special risk groups. It aims to see if young women with a chronic illness respond well to the HPV vaccine or whether they may require additional doses to ensure protective immunity. The four valent HPV vaccine protects against HPV types 16 \& 18, cervical cancer and HPV types 6 \& 11, anogenital warts.
The six special risk groups include:
Paediatric Rheumatological Disease Inflammatory Bowel Disease Acute Lymphoblastic Leukaemia Solid Organ Transplant Recipients (kidney and liver) Chronic Renal Disease Bone Marrow Transplants This immunity is measured by antibody levels of the HPV types, which requires a single blood test one month after the final dose of HPV vaccine.
This is compared to healthy controls using antibody response to HPV vaccine. This will assess directly whether these special risk groups respond as well to the HPV vaccine.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 12 to 26 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Females aged 12-26 years
- Have been diagnosed by a specialist with one of the six chronic medical conditions described:
Key exclusion criteria (1 listed)
- Previous immunisation with HPV vaccine Recognised contraindication to the receipt of the vaccine e.g. anaphylaxis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Licensed quadrivalent HPV vaccine, GardasilThe dose of the four valent (4v) HPV vaccine is 0.5ml administered by intramuscular (IM)injection. The recommended schedule is 0, 2 and 6 months. | Drug | – |
Primary outcome
Determine the HPV vaccine immunogenicity in females 12-26 years with six special risk groups at one month post the third and final HPV vaccination. Blood analysis taken at one month post third and final HPV vaccine to assess immunogenicity.
Time frame: One Month post HPV vaccination
1 secondary outcome
Describe the safety of the HPV vaccine in the six study groups using self reports and liaison with treating sub specialist team.
Time frame: One month post third HPV vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jim Buttery principal investigator
NHMRC CCRE in Childhood and Adolescent Immunisation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Licensed quadrivalent HPV vaccine, Gardasil in people with Cervical Cancer, run by Murdoch Childrens Research Institute at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the HPV vaccine immunogenicity in females 12-26 years with six special risk groups at one month post the third and final HPV vaccination. Blood analysis taken at one month post third and final HPV vaccine to assess immunogenicity. (time frame: One Month post HPV vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2011.