NCT01702337

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2010

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

September 27, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 8, 2012

Completed
Last Updated

October 8, 2012

Status Verified

October 1, 2012

Enrollment Period

Same day

First QC Date

September 27, 2012

Last Update Submit

October 4, 2012

Conditions

Human Papillomavirus Infection

Keywords

GardasilPrevalence-modelCervarixeconomichealth

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

HPV-1 Group

Hypothetical group of women vaccinated with HPV-1 vaccine in Taiwan.

Other: Prevalence-based model

HPV-2 Group

Hypothetical group of women vaccinated with HPV-2 vaccine in Taiwan.

Other: Prevalence-based model

Interventions

Prevalence-based modelOTHER

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

HPV-1 GroupHPV-2 Group

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Not applicable.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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.

    BACKGROUND

MeSH Terms

Conditions

Papillomavirus Infections

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
observational
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2012

First Posted

October 8, 2012

Study Start

February 1, 2010

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

October 8, 2012

Record last verified: 2012-10