NCT00863096

Brief Summary

Public Health Research Institute (PHRI) is carrying out a 15 month research and advocacy project with the goals of generating critical data on acceptability, identifying determinants and facilitators of HPV vaccine uptake in adolescent girls; and investigating physicians' attitudes to identify predictors of intention to recommend immunization in Mysore, India.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2009

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

March 16, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 17, 2009

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2009

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

March 3, 2011

Status Verified

March 1, 2009

Enrollment Period

1 year

First QC Date

March 16, 2009

Last Update Submit

March 2, 2011

Conditions

Human Papilloma Virus-Related Carcinoma

Keywords

HPVacceptability

Outcome Measures

Primary Outcomes (1)

  • Acceptability of HPV vaccine

    One year

Study Arms (1)

Gardasil

Biological: Gardasil

Interventions

GardasilBIOLOGICAL

HPV vaccine

Also known as: HPV vaccine
Gardasil

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Young women who participated in the formative study on acceptability of HPV vaccine in Mysore, India

You may qualify if:

  • Potential participants must have at least one daughter between 8 and 14 years of age
  • Be a decision maker for the welfare of a girl aged 8-14 years
  • Be able to understand and give informed consent
  • Be able to speak Kannada

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Public Health Research Institute, India

Mysore, Karnataka, 560021, India

Location

MeSH Terms

Interventions

Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18Papillomavirus Vaccines

Intervention Hierarchy (Ancestors)

Vaccines, CombinedVaccinesBiological ProductsComplex MixturesViral Vaccines

Study Officials

  • Purnima Madhivanan Madhivanan, MD, PhD

    Public Health Research Institute, India

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 16, 2009

First Posted

March 17, 2009

Study Start

June 1, 2009

Primary Completion

June 1, 2010

Study Completion

December 1, 2010

Last Updated

March 3, 2011

Record last verified: 2009-03

Locations

IN(1)