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Human Papilloma Virus Vaccination in Girls With Cystic Fibrosis (VACCIN-HPV-MUC2)

NCT03653377 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 81

Last updated 2021-06-18

No results posted yet for this study

Summary

Background The main risk factor for cervical cancer is the infection by human papillomavirus (HPV). Vaccination against HPV, offered to all girls aged 11 to 14 is an effective method of prevention against cervical pathology. Despite this, vaccination coverage against HPV remains low in France. A proportion of women with cystic fibrosis may be involved in transplantation, a factor associated with a higher risk of HPV carriage and cervical pathology. An over-risk of cervical pathology would also be present in women with non-transplanted cystic fibrosis. Particular attention to vaccination should therefore be included in this population.

Objectives of the study The main objective of the study is to estimate the frequency of HPV vaccination in young girls with CF over 9 years and followed in a pediatric CF center.

The secondary objectives are to know:

* The type of vaccine used (bivalent / quadrivalent / nonavalent)
* The proportion of vaccinated girls with respect of the vaccination schedule (number of injections / spacing between doses)
* Reasons for non-use of vaccination

Study design The study will last 12 months. It is a cross-sectional, non-interventional, multicenter conducted by self-administered questionnaire.

Population

* young girls aged 9 years or older with Cystic fibrosis
* Followed in a pediatric or mixed CF center in the France (Rhone-Alpes Auvergne Region and Ile de France Region)
* With parents who did not object to participation in the study

Number of subject: 62 patients

Expected results

* Knowledge of HPV vaccination coverage in young girls with CF.
* Sensitization of patients, their parents and health professionals to HPV vaccination. Understand the barriers and reasons for refusing vaccination to promote actions to improve immunization coverage.

Conditions

  • Mucoviscidosis

Interventions

OTHER

Self administrated questionnaire

Questionnaires are distributed to patients with their parents during their visit to the CF center.

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Principal Investigators

  • Christine ROUSSET-JABLONSKI, MD · Hospices Civils de Lyon

Eligibility

Min Age
9 Years
Max Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-17
Primary Completion
2019-04-30
Completion
2019-04-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03653377 on ClinicalTrials.gov