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Clinical Trials/NCT06158802
NCT06158802CompletedNot Applicable

Evaluation of Human Papillomavirus Vaccine Coverage in Girls and Young Women With Chronic Disease

Assistance Publique - Hôpitaux de Paris2 sites in 1 country223 target enrollmentStarted: January 23, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
223
Locations
2
Primary Endpoint
Immunization coverage rate for human papillomavirus vaccine

Study Overview

Brief Summary

The main objective of the study is to determine the vaccination coverage rate for human papillomavirus in adolescents aged 11 to 20 with chronic disease and treated at the Necker-Enfants Malades Hospital, compared to a population witnessed adolescent girls aged 11 to 20 years without chronic disease.

Detailed Description

Girls and young women with chronic condition are at higher risk for infections that can be prevented by vaccination. Human papillomavirus infection is very common, one of the three most common in the general population. A vaccine exists to significantly prevent this infection and its complications.

In France, it is advisable to vaccinate girls and boys from the age of 9 years and as soon as possible in the case of acquired immunodeficiency since these patients are more likely to be suffering from cancer induced by the human papillomavirus.

In France, the overall rate of vaccination coverage for girls is 21%, which is significantly lower than in several other industrialized countries.

The vaccination coverage rate for human papillomavirus in patients with chronic diseases may be even lower.

The main objective of the study is to determine the vaccination coverage rate for human papillomavirus in adolescents aged 11 to 20 with chronic condition and treated at the Necker-Enfants Malades Hospital, compared to a population witnessed adolescent girls aged 11 to 20 years without chronic disease.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
11 Years to 20 Years (Child, Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Information and non-opposition of major patients and holders of parental authority of minor patients and minor patients
  • Girls and young women aged 11 to 20
  • To be followed at the Necker-Enfants Malades Hospital ("chronic condition" group)
  • To be followed at the Specialized Medical Center for Children and Adolescents ("control" group)
  • Have a chronic condition ("chronic condition" group) :
  • Diabetes type 1
  • Metabolic diseases
  • Patients followed in immuno-hematology
  • Cystic Fibrosis
  • Kidney transplant
  • Heart Disease
  • Inflammatory bowel diseases
  • Rare anorectal and pelvic anomalies
  • Live in France
  • Comprehension of the French language (oral and written)

Exclusion Criteria

  • Have a contraindication to the HPV vaccine - Gardasil 9 (Vidal Hoptimal, 2018)
  • Have a contraindication to the HPV vaccine - Gardasil (Vidal Hopitmal, 2018)
  • Have a contraindication to HPV vaccine - Cervarix (Vidal Hoptimal, 2018)

Outcomes

Primary Outcomes

Immunization coverage rate for human papillomavirus vaccine

Time Frame: Day 1

Percentage of patients with or without a chronic illness who have received HPV vaccination (complete vaccination schedule).

Secondary Outcomes

  • Description of parameters that may impact vaccination coverage for human papillomavirus vaccine(Day 1)
  • Intention of vaccination by human papillomavirus vaccine by the usual health professionals(Day 1)
  • Reasons for non-vaccination by human papillomavirus vaccine(Day 1)
  • Category of health professionals offering vaccination by human papillomavirus vaccine(Day 1)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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