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

NCT06158802 | Completed

• 2 other identifiers: APHP2104172021-A02421-40
• Study Type: observational
• Target: 223
• Locations: 1 country
• Sites: 2

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.

Conditions

Human Papillomavirus Vaccine; Chronic Condition

Keywords

Human papillomavirus vaccine; Young women with chronic condition; Vaccination coverage rate

Outcome Measures

Primary Outcomes (1)

• Immunization coverage rate for human papillomavirus vaccine

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

  Day 1

Secondary Outcomes (4)

• Intention of vaccination by human papillomavirus vaccine by the usual health professionals

  Day 1

• Category of health professionals offering vaccination by human papillomavirus vaccine

  Day 1

• Reasons for non-vaccination by human papillomavirus vaccine

  Day 1

• Description of parameters that may impact vaccination coverage for human papillomavirus vaccine

  Day 1

Study Arms (2)

Chronic condition

Girls and young women between the ages of 11 and 20 suffering from chronic condition

Other: Questionnaire

Control

Girls and young women between the ages of 11 and 20 in good health

Other: Questionnaire

Interventions

Questionnaire OTHER

Questionnaire on human papillomavirus vaccine status of girls and young women and modalities of the vaccination or reason of the non-vaccination. The questionnaire is completed by the patient.

Chronic condition; Control

Eligibility Criteria

• Age: 11 Years - 20 Years
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged from 11 to 20 to cover the recommended age window for HPV vaccination, ie between 11 and 14 years old, with the possibility of catching up between 15 and 19 years of age (Public Health France, 2019). "Chronic condition" group: type 1 diabetes, metabolic diseases, immuno-hematological diseases, cystic fibrosis, sickle cell disease, kidney transplant, heart disease and inflammatory bowel disease, rare anorectal and pelvic malformations. Recruitment at the Necker-Enfants Malades Hospital and at the Specialized Medical Center for Children and Adolescents in Paris. "Control" group: patients in good health. Recruitment at the Specialized Medical Center for Children and Adolescents in Paris.

You may qualify if:

• 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
• Sickle
• Kidney transplant
• Heart Disease
• Inflammatory bowel diseases
• Rare anorectal and pelvic anomalies
• Live in France

You may not qualify if:

• 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)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (2)

Centre Médical Spécialisé de l'Enfant et de l'Adolescent (CMSEA)

Paris, 75011, France

Location

Hôpital Necker-Enfants Malades

Paris, 75015, France

Location

Related Publications (3)

• Hofstetter AM, Camargo S, Natarajan K, Rosenthal SL, Stockwell MS. Vaccination Coverage of Adolescents With Chronic Medical Conditions. Am J Prev Med. 2017 Nov;53(5):680-688. doi: 10.1016/j.amepre.2017.07.017. Epub 2017 Sep 18.

  PMID: 28928039 BACKGROUND

• Gras-Le Guen C, Legrand A, Caquard M, Micaelli X, Picherot G, Lacroix S, Volteau C, Launay E. Chronically ill adolescents are also incompletely vaccinated: A cross-sectional study in France. Vaccine. 2017 Aug 24;35(36):4707-4712. doi: 10.1016/j.vaccine.2017.07.042. Epub 2017 Jul 29.

  PMID: 28760611 BACKGROUND

• Hoffman L, Okcu MF, Dreyer ZE, Suzawa H, Bryant R, Middleman AB. Human papillomavirus vaccination in female pediatric cancer survivors. J Pediatr Adolesc Gynecol. 2012 Oct;25(5):305-7. doi: 10.1016/j.jpag.2012.05.004. Epub 2012 Jul 24.

  PMID: 22831900 BACKGROUND

MeSH Terms

Conditions

Chronic Disease

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Sabrina DA COSTA, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

• Alaa CHEIKHELARD, MD

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2023
• First Posted: December 6, 2023
• Study Start: January 23, 2024
• Primary Completion: June 26, 2025
• Study Completion: June 26, 2025
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)