NCT02837926

Brief Summary

The study aims to identify global and local determinants of HPV vaccine acceptability, HPV vaccine uptake and compliance as well as identify logistics and programmatic issues in each country to offer the HPV vaccine, as a potential cervical cancer prevention strategy, to mid-aged women attending screening.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
63

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2016

Typical duration for phase_4

Geographic Reach
1 country

1 active site

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

May 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 13, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 20, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

April 10, 2019

Status Verified

April 1, 2019

Enrollment Period

1.6 years

First QC Date

July 13, 2016

Last Update Submit

April 8, 2019

Conditions

Cervical Cancer

Outcome Measures

Primary Outcomes (1)

  • number of vaccinated patients

    up to 3 years

Study Arms (1)

women attending for cervical cancer screening

EXPERIMENTAL
Other: questionnaireBiological: Gardasil vaccineBiological: Cervarix®

Interventions

questionnaireOTHER
women attending for cervical cancer screening
Gardasil vaccineBIOLOGICAL
women attending for cervical cancer screening
Cervarix®BIOLOGICAL
women attending for cervical cancer screening

Eligibility Criteria

Age25 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • women within the age range of 25-45
  • attending cervical cancer screening

You may not qualify if:

  • previous history of HPV vaccine administration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Reims

Reims, 51092, France

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Surveys and QuestionnairesHuman Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18human papillomavirus vaccine, L1 type 16, 18

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthVaccines, CombinedVaccinesBiological ProductsComplex MixturesPapillomavirus VaccinesViral Vaccines

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2016

First Posted

July 20, 2016

Study Start

May 1, 2016

Primary Completion

December 1, 2017

Study Completion

June 1, 2018

Last Updated

April 10, 2019

Record last verified: 2019-04

Locations

FR(1)