- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06158802
Evaluation of Human Papillomavirus Vaccine Coverage in Girls and Young Women With Chronic Disease (MC-HPV)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Hélène Morel
- Phone Number: +33 1 71 19 63 46
- Email: helene.morel@aphp.fr
Study Contact Backup
- Name: Sabrina DA COSTA, MD
- Phone Number: +33 1 44 49 48 04
- Email: sabrina.dacosta@aphp.fr
Study Locations
-
-
-
Paris, France, 75015
- Recruiting
- Hôpital Necker-Enfants Malades
-
Contact:
- Sabrina DA COSTA, MD
- Phone Number: +33 1 44 49 48 04
- Email: sabrina.dacosta@aphp.fr
-
Sub-Investigator:
- Magali Viaud, MSc
-
Paris, France, 75011
- Recruiting
- Centre Médical Spécialisé de l'Enfant et de l'Adolescent (CMSEA)
-
Contact:
- Alaa CHEIKHELARD, MD
- Phone Number: +33 1 44 49 48 04
- Email: alaa.cheikhelard@aphp.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
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.
Description
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)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Chronic condition
Girls and young women between the ages of 11 and 20 suffering from chronic condition
|
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 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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intention of vaccination by human papillomavirus vaccine by the usual health professionals
Time Frame: Day 1
|
Percentage of patients with or without a chronic illness who have been offered HPV vaccination.
|
Day 1
|
Category of health professionals offering vaccination by human papillomavirus vaccine
Time Frame: Day 1
|
Patients with or without a chronic illness to whom vaccination has been offered/prescribed :
|
Day 1
|
Reasons for non-vaccination by human papillomavirus vaccine
Time Frame: Day 1
|
Patients suffering from a chronic illness or not and not vaccinated:
|
Day 1
|
Description of parameters that may impact vaccination coverage for human papillomavirus vaccine
Time Frame: Day 1
|
Description of patients with or without a chronic illness and vaccinated or not against HPV
|
Day 1
|
Collaborators and Investigators
Investigators
- Principal Investigator: Sabrina DA COSTA, MD, Assistance Publique - Hôpitaux de Paris
- Study Director: Alaa CHEIKHELARD, MD, Assistance Publique - Hôpitaux de Paris
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- APHP210417
- 2021-A02421-40 (Other Identifier: IDRCB number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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