Prevalence-based Health and Economic Model of the Bivalent Versus the Quadrivalent Human Papillomavirus (HPV) Vaccine

Human Papillomavirus Infection Clinical Trial

Official title:

Additional Health and Economic Impact of the Bivalent Versus the Quadrivalent HPV Vaccine in Taiwan: Results of a Prevalence-based Model

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01702337
• Other study ID #: 114420
• Status: Completed
• Phase: N/A
• First received: September 27, 2012
• Last updated: October 4, 2012
• Start date: February 2010
• Est. completion date: February 2010

Study information

• Verified date: October 2012
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Food and Drug Administration, Department of Health
• Study type: Observational

Clinical Trial Summary

This study compares the health and economic impact of the bivalent HPV vaccine (HPV-1) and the quadrivalent HPV vaccine (HPV-2).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Female subjects vaccinated with either HPV-1 or HPV-2 vaccines in Taiwan (hypothetical group).

Exclusion Criteria:

Study Design

N/A

Related Conditions & MeSH terms

• Human Papillomavirus Infection
• Papillomavirus Infections

Intervention

Other:
• Prevalence-based model
Static prevalence-based model to estimate vaccine effect over a one-year period at a steady state (when all women are fully vaccinated).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

References & Publications (1)

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Annual number of lesions prevented by each vaccine		Over a one-year period	No
Primary	Lesion related total cost averted by each vaccine		Over a one-year period	No
Primary	Additional costs averted by HPV-1 vaccine compared to HPV-2 vaccine		Over a one-year period	No