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

NCT ID: NCT06158802

Last Updated: 2025-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

223 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-23

Study Completion Date

2025-06-26

Brief Summary

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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

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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.

Conditions

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Human Papillomavirus Vaccine Chronic Condition

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Chronic condition

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

Questionnaire

Intervention Type 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.

Control

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

Questionnaire

Intervention Type 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.

Interventions

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Questionnaire

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.

Intervention Type OTHER

Eligibility Criteria

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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
* Sickle
* 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)
Minimum Eligible Age

11 Years

Maximum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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URC-CIC Paris Descartes Necker Cochin

OTHER

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sabrina DA COSTA, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Alaa CHEIKHELARD, MD

Role: STUDY_DIRECTOR

Assistance Publique - Hôpitaux de Paris

Locations

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

Paris, , France

Site Status

Hôpital Necker-Enfants Malades

Paris, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 28928039 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28760611 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22831900 (View on PubMed)

Other Identifiers

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2021-A02421-40

Identifier Type: OTHER

Identifier Source: secondary_id

APHP210417

Identifier Type: -

Identifier Source: org_study_id

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