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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014