Human Papillomavirus InfectionNCT01702337
Prevalence-based Health and Economic Model of the Bivalent Versus the Quadrivalent Human Papillomavirus (HPV) Vaccine
An observational study of Human Papillomavirus Infection, run by GlaxoSmithKline.
Trial summary
This study compares the health and economic impact of the bivalent HPV vaccine (HPV-1) and the quadrivalent HPV vaccine (HPV-2). Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Human Papillomavirus Infection
- What is being tested?
- Prevalence-based model
- Type of treatment
- Vaccines
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- Feb 2010to Feb 2010
- Phase
- Observational
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Hypothetical group of women vaccinated with either HPV-1 or HPV-2 vaccines in Taiwan.
Who may be able to join
- Female subjects vaccinated with either HPV-1 or HPV-2 vaccines in Taiwan (hypothetical group).
Who cannot join
- Not applicable.
About this study
Official title: Additional Health and Economic Impact of the Bivalent Versus the Quadrivalent HPV Vaccine in Taiwan: Results of a Prevalence-based Model
This study compares the health and economic impact of the bivalent HPV vaccine (HPV-1) and the quadrivalent HPV vaccine (HPV-2).
Read the detailed description
This study uses a prevalence-based model (by using efficacy data from each vaccine's respective trials and published cost data for Taiwan) which estimates the differences in lesions, genital warts, cervical cancer and costs from a healthcare payer's perspective prevented between HPV-1 and HPV-2 vaccines during one year (when all women are vaccinated). It also analyses costs from a societal perspective.
- Conditions
- Human Papillomavirus Infection
- Being tested
- Prevalence-based model
- Keywords
- Gardasil, Prevalence-model, Cervarix, economic, health
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prevalence-based modelOther
Static prevalence-based model to estimate vaccine effect over a one-year period at a steady state (when all women are fully vaccinated).
| Study group | Role | What they receive |
|---|---|---|
| HPV-1 Group | Hypothetical group of women vaccinated with HPV-1 vaccine in Taiwan. Receives: Other: Prevalence-based model | |
| HPV-2 Group | Hypothetical group of women vaccinated with HPV-2 vaccine in Taiwan. Receives: Other: Prevalence-based model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annual number of lesions prevented by each vaccine
Measured: Over a one-year period
Lesion related total cost averted by each vaccine
Measured: Over a one-year period
Additional costs averted by HPV-1 vaccine compared to HPV-2 vaccine
Measured: Over a one-year period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2012 (estimated)
- Study startFeb 2010
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Human Papillomavirus InfectionStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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
- Observational
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01702337
- Sponsor's protocol ID
- 114420
- Status last verified
- Oct 2012
- First submitted
- 27 Sep 2012
- Last updated
- 8 Oct 2012
- Results posted
- No
Publications
ADDITIONAL HEALTH AND ECONOMIC IMPACT OF THE BIVALENT VERSUS THE QUADRIVALENT HPV VACCINE IN TAIWAN: RESULTS OF A PREVALENCE-BASED MODEL, Ho. T.H., van Enckevort, P.J. & Demarteau, N. Poster presented at: ISPOR, 4th Asia-Pacific Conference, 5-7 September 2010, Phuket, Thailand.
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Additional Health and Economic Impact of the Bivalent Versus the Quadrivalent HPV Vaccine in Taiwan: Results of a Prevalence-based Model
- ClinicalTrials.gov ID
- NCT01702337
- Acronym / sponsor ID
- 114420
- Conditions
- Human Papillomavirus Infection
- Keywords
- Gardasil, Prevalence-model, Cervarix, economic, health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 8 Oct 2012 (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.
This study compares the health and economic impact of the bivalent HPV vaccine (HPV-1) and the quadrivalent HPV vaccine (HPV-2).
Detailed description
This study uses a prevalence-based model (by using efficacy data from each vaccine's respective trials and published cost data for Taiwan) which estimates the differences in lesions, genital warts, cervical cancer and costs from a healthcare payer's perspective prevented between HPV-1 and HPV-2 vaccines during one year (when all women are vaccinated). It also analyses costs from a societal perspective.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HPV-1 Group | – | Other: Prevalence-based modelHypothetical group of women vaccinated with HPV-1 vaccine in Taiwan. |
| HPV-2 Group | – | Other: Prevalence-based modelHypothetical group of women vaccinated with HPV-2 vaccine in Taiwan. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Hypothetical group of women vaccinated with either HPV-1 or HPV-2 vaccines in Taiwan.
Key inclusion criteria (1 listed)
- Female subjects vaccinated with either HPV-1 or HPV-2 vaccines in Taiwan (hypothetical group).
Key exclusion criteria (1 listed)
- Not applicable.
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 |
|---|---|---|
| Prevalence-based modelStatic prevalence-based model to estimate vaccine effect over a one-year period at a steady state (when all women are fully vaccinated). | Other | HPV-1 Group, HPV-2 Group |
Primary outcome
Annual number of lesions prevented by each vaccine
Time frame: Over a one-year period
Lesion related total cost averted by each vaccine
Time frame: Over a one-year period
Additional costs averted by HPV-1 vaccine compared to HPV-2 vaccine
Time frame: Over a one-year period
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 8 Oct 2012.
- BackgroundADDITIONAL HEALTH AND ECONOMIC IMPACT OF THE BIVALENT VERSUS THE QUADRIVALENT HPV VACCINE IN TAIWAN: RESULTS OF A PREVALENCE-BASED MODEL, Ho. T.H., van Enckevort, P.J. & Demarteau, N. Poster presented at: ISPOR, 4th Asia-Pacific Conference, 5-7 September 2010, Phuket, Thailand.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
An observational study of Human Papillomavirus Infection, run by GlaxoSmithKline.
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 1 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 8 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Annual number of lesions prevented by each vaccine (time frame: Over a one-year period). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01702337, which also lists 1 linked publication.
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 8 Oct 2012.