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

Completed

• Conditions: Human Papillomavirus Infection
• Interventions: Other: Prevalence-based model

• Registration Number: NCT01702337
• Lead Sponsor: GlaxoSmithKline

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.

Study Timeline

• Study Start: 2010-02
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Study First Submitted: 2012-09-27
• Status Verified: 2012-10
• Study First Submitted QC: 2012-10-04
• Last Update Submitted: 2012-10-04
• Study First Posted: 2012-10-08
• Last Update Posted: 2012-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1

Inclusion Criteria

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

Exclusion Criteria

• Not applicable.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HPV-2 Group	Prevalence-based model	Hypothetical group of women vaccinated with HPV-2 vaccine in Taiwan.
HPV-1 Group	Prevalence-based model	Hypothetical group of women vaccinated with HPV-1 vaccine in Taiwan.

Primary Outcome Measures

Name	Time	Method
Annual number of lesions prevented by each vaccine	Over a one-year period
Lesion related total cost averted by each vaccine	Over a one-year period
Additional costs averted by HPV-1 vaccine compared to HPV-2 vaccine	Over a one-year period