Prevalence-based Health and Economic Model of the Bivalent Versus the Quadrivalent Human Papillomavirus (HPV) Vaccine
Primary Purpose
Human Papillomavirus Infection
Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Prevalence-based model
Sponsored by
About this trial
This is an observational trial for Human Papillomavirus Infection focused on measuring Gardasil, Prevalence-model, Cervarix, economic, health
Eligibility Criteria
Inclusion Criteria:
- Female subjects vaccinated with either HPV-1 or HPV-2 vaccines in Taiwan (hypothetical group).
Exclusion Criteria:
- Not applicable.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Arm Label
HPV-1 Group
HPV-2 Group
Arm Description
Hypothetical group of women vaccinated with HPV-1 vaccine in Taiwan.
Hypothetical group of women vaccinated with HPV-2 vaccine in Taiwan.
Outcomes
Primary Outcome Measures
Annual number of lesions prevented by each vaccine
Lesion related total cost averted by each vaccine
Additional costs averted by HPV-1 vaccine compared to HPV-2 vaccine
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01702337
Brief Title
Prevalence-based Health and Economic Model of the Bivalent Versus the Quadrivalent Human Papillomavirus (HPV) Vaccine
Official Title
Additional Health and Economic Impact of the Bivalent Versus the Quadrivalent HPV Vaccine in Taiwan: Results of a Prevalence-based Model
Study Type
Observational
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Papillomavirus Infection
Keywords
Gardasil, Prevalence-model, Cervarix, economic, health
7. Study Design
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HPV-1 Group
Arm Description
Hypothetical group of women vaccinated with HPV-1 vaccine in Taiwan.
Arm Title
HPV-2 Group
Arm Description
Hypothetical group of women vaccinated with HPV-2 vaccine in Taiwan.
Intervention Type
Other
Intervention Name(s)
Prevalence-based model
Intervention Description
Static prevalence-based model to estimate vaccine effect over a one-year period at a steady state (when all women are fully vaccinated).
Primary Outcome Measure Information:
Title
Annual number of lesions prevented by each vaccine
Time Frame
Over a one-year period
Title
Lesion related total cost averted by each vaccine
Time Frame
Over a one-year period
Title
Additional costs averted by HPV-1 vaccine compared to HPV-2 vaccine
Time Frame
Over a one-year period
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Female subjects vaccinated with either HPV-1 or HPV-2 vaccines in Taiwan (hypothetical group).
Exclusion Criteria:
Not applicable.
Study Population Description
Hypothetical group of women vaccinated with either HPV-1 or HPV-2 vaccines in Taiwan.
Sampling Method
Non-Probability Sample
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
Citation
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.
Results Reference
background
Learn more about this trial
Prevalence-based Health and Economic Model of the Bivalent Versus the Quadrivalent Human Papillomavirus (HPV) Vaccine
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