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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01702337
First received: September 27, 2012
Last updated: October 4, 2012
Last verified: October 2012
  Purpose

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


Condition Intervention
Human Papillomavirus Infection
Other: Prevalence-based model

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

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Annual number of lesions prevented by each vaccine [ Time Frame: Over a one-year period ] [ Designated as safety issue: No ]
  • Lesion related total cost averted by each vaccine [ Time Frame: Over a one-year period ] [ Designated as safety issue: No ]
  • Additional costs averted by HPV-1 vaccine compared to HPV-2 vaccine [ Time Frame: Over a one-year period ] [ Designated as safety issue: No ]

Enrollment: 1
Study Start Date: February 2010
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
HPV-1 Group
Hypothetical group of women vaccinated with HPV-1 vaccine in Taiwan.
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).
HPV-2 Group
Hypothetical group of women vaccinated with HPV-2 vaccine in Taiwan.
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).

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Hypothetical group of women vaccinated with either HPV-1 or HPV-2 vaccines in Taiwan.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Not applicable.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01702337

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01702337     History of Changes
Other Study ID Numbers: 114420
Study First Received: September 27, 2012
Last Updated: October 4, 2012
Health Authority: Taiwan: Food and Drug Administration, Department of Health

Keywords provided by GlaxoSmithKline:
Gardasil
Prevalence-model
Cervarix
economic
health

Additional relevant MeSH terms:
Warts
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Tumor Virus Infections
Neoplasms
Skin Diseases, Infectious
Skin Diseases

ClinicalTrials.gov processed this record on April 16, 2014