- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01702337
Prevalence-based Health and Economic Model of the Bivalent Versus the Quadrivalent Human Papillomavirus (HPV) Vaccine
October 4, 2012 updated by: GlaxoSmithKline
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Hypothetical group of women vaccinated with either HPV-1 or HPV-2 vaccines in Taiwan.
Description
Inclusion Criteria:
- Female subjects vaccinated with either HPV-1 or HPV-2 vaccines in Taiwan (hypothetical group).
Exclusion Criteria:
- Not applicable.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
HPV-1 Group
Hypothetical group of women vaccinated with HPV-1 vaccine in Taiwan.
|
Static prevalence-based model to estimate vaccine effect over a one-year period at a steady state (when all women are fully vaccinated).
|
|
HPV-2 Group
Hypothetical group of women vaccinated with HPV-2 vaccine in Taiwan.
|
Static prevalence-based model to estimate vaccine effect over a one-year period at a steady state (when all women are fully vaccinated).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Annual number of lesions prevented by each vaccine
Time Frame: Over a one-year period
|
Over a one-year period
|
|
Lesion related total cost averted by each vaccine
Time Frame: Over a one-year period
|
Over a one-year period
|
|
Additional costs averted by HPV-1 vaccine compared to HPV-2 vaccine
Time Frame: Over a one-year period
|
Over a one-year period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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 record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2010
Primary Completion (Actual)
February 1, 2010
Study Completion (Actual)
February 1, 2010
Study Registration Dates
First Submitted
September 27, 2012
First Submitted That Met QC Criteria
October 4, 2012
First Posted (Estimate)
October 8, 2012
Study Record Updates
Last Update Posted (Estimate)
October 8, 2012
Last Update Submitted That Met QC Criteria
October 4, 2012
Last Verified
October 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 114420
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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