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

NCT03653377 | Completed

• 2 other identifiers: 69HCL18_01442018-A01314-51
• Study Type: observational
• Target: 81
• Locations: 1 country
• Sites: 7

Brief 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

Keywords

mucoviscidosis; Human Papilloma Virus; Vaccination; Young girl

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Patients with self-administered questionnaire

Other: Self administrated questionnaire

Interventions

Self administrated questionnaire OTHER

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

Patients with self-administered questionnaire

Eligibility Criteria

• Age: 9 Years - 18 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Cohort of minor girls with cystic fibrosis older than 9 years, followed in a pediatric Mucoviscidosis Resource and Competence Center (MRCC).

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (7)

Service Mucoviscidose, Pneumologie

Bron, France

Location

Hôpital d'Estaing

Clermont-Ferrand, France

Location

Pôle Couple / Enfant

Grenoble, France

Location

CRCM, Hôpital Robert Debré

Paris, France

Location

CRCM, Hôpital Trousseau

Paris, France

Location

CRCM, Institut Necker Enfants Malade

Paris, France

Location

Centre de Ressources et de Compétences de la Mucoviscidose Adultes

Pierre-Bénite, France

Location

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Christine ROUSSET-JABLONSKI, MD

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2018
• First Posted: August 31, 2018
• Study Start: December 17, 2018
• Primary Completion: April 30, 2019
• Study Completion: April 30, 2019
• Last Updated: June 18, 2021

Record last verified: 2021-06

Locations

FR (7)