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

Mucoviscidosis Clinical Trial

Official title:

Survey on the Human Papilloma Virus Vaccination in Girls With Cystic Fibrosis Followed in Cystic Fibrosis (CF) Center in France

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03653377
• Other study ID #: 69HCL18_0144
• Secondary ID: 2018-A01314-51
• Status: Completed
• Start date: December 17, 2018
• Est. completion date: April 30, 2019

Study information

• Verified date: June 2021
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: April 30, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 9 Years to 18 Years

Eligibility

Inclusion Criteria:

• young girls aged 9 years or older

• patients with Cystic Fibrosis

• patients followed in a pediatric or mixed CF center in the France (Rhone-Alpes Auvergne Region and Ile de France Region)

• patients with parents who did not object to participation in the study

Exclusion Criteria:

-patients who refuse to answer to the self-administrated questionnaire

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis
• Mucoviscidosis
• Papilloma

Intervention

Other:
• Self administrated questionnaire
Questionnaires are distributed to patients with their parents during their visit to the CF center.

Locations

Country	Name	City	State
France	Service Mucoviscidose, Pneumologie	Bron
France	Hôpital d'Estaing	Clermont-Ferrand
France	Pôle Couple / Enfant	Grenoble
France	CRCM, Hôpital Robert Debré	Paris
France	CRCM, Hôpital Trousseau	Paris
France	CRCM, Institut Necker Enfants Malade	Paris
France	Centre de Ressources et de Compétences de la Mucoviscidose Adultes	Pierre-Bénite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HPV vaccination	The outcome measure is having HPV vaccination. This information is collected through a self-questionnaire, completed by the patients or their parents, during a visit to the CF center	Baseline