Human Papillomavirus VaccineMC-HPVNCT06158802
Evaluation of Human Papillomavirus Vaccine Coverage in Girls and Young Women With Chronic Disease
An observational study of Human Papillomavirus Vaccine and Chronic Condition, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 20 years, women only
- Conditions the study is for
- Human Papillomavirus Vaccine, Chronic Condition
- What is being tested?
- Questionnaire
- Type of treatment
- Vaccines
- How many people
- 223 participants
- Where
- 2 sitesFrance
- Study dates
- 23 Jan 2024to 26 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 20 years
- Women only
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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
Show all 16Show fewer
- 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)
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre Médical Spécialisé de l'Enfant et de l'Adolescent (CMSEA)
Paris, 75011
Hôpital Necker-Enfants Malades
Paris, 75015
About this study
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.
Read the 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.
- Conditions
- Human Papillomavirus Vaccine, Chronic Condition
- Being tested
- Questionnaire
- Keywords
- Human papillomavirus vaccine, Young women with chronic condition, Vaccination coverage rate
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Chronic condition | Girls and young women between the ages of 11 and 20 suffering from chronic condition Receives: Other: Questionnaire | |
| Control | Girls and young women between the ages of 11 and 20 in good health Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunization coverage rate for human papillomavirus vaccine
Percentage of patients with or without a chronic illness who have received HPV vaccination (complete vaccination schedule).
Measured: Day 1
Secondary outcomes (4)
Intention of vaccination by human papillomavirus vaccine by the usual health professionals
Percentage of patients with or without a chronic illness who have been offered HPV vaccination.
Measured: Day 1
Category of health professionals offering vaccination by human papillomavirus vaccine
Patients with or without a chronic illness to whom vaccination has been offered/prescribed :
- Percentage of vaccination offered/prescribed by the general practitioner
- Vaccination percentage proposed/prescribed by the pediatrician,
- Vaccination percentage proposed/prescribed by the gynecologist,
- Percentage of vaccination proposed/prescribed by the specialist doctor,
- Percentage of vaccination offered/prescribed by another healthcare professional.
Measured: Day 1
Reasons for non-vaccination by human papillomavirus vaccine
Patients suffering from a chronic illness or not and not vaccinated:
- Percentage of patients not vaccinated due to fear/apprehension,
- Percentage of patients not vaccinated because they did not know this vaccine,
- Percentage of patients not vaccinated because they are against vaccination,
- Percentage of patients not vaccinated due to lack of time.
Measured: Day 1
Description of parameters that may impact vaccination coverage for human papillomavirus vaccine
Description of patients with or without a chronic illness and vaccinated or not against HPV
- Average age of patients at the time of inclusion,
- Socio-professional category of parents (father's and mother's profession),
- Average age at menarche,
- Assessment of risk behaviors (percentage of patients who smoke, percentage of patients who consume alcohol),
- Percentage of patients who have started their sexual life,
- Average age at first sexual intercourse,
- Percentage of patients followed by a pediatrician,
- Percentage of patients followed by a general practitioner,
- Percentage of patients followed by a gynecologist.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study start23 Jan 2024
- Primary completion26 Jun 2025
- Study completion26 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Human Papillomavirus VaccineStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 223 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Sabrina DA COSTA, MD, Principal investigator, Assistance Publique - Hôpitaux de ParisAlaa CHEIKHELARD, MD, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06158802
- Sponsor's protocol ID
- APHP210417
- Other IDs
- 2021-A02421-40
- Acronym
- MC-HPV
- Status last verified
- Nov 2025
- First submitted
- 24 Nov 2023
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 28928039Gras-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.
PubMed 28760611Hoffman 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.
PubMed 22831900
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Human Papillomavirus Vaccine Coverage in Girls and Young Women With Chronic Disease
- ClinicalTrials.gov ID
- NCT06158802
- Acronym / sponsor ID
- MC-HPV / APHP210417
- Conditions
- Human Papillomavirus Vaccine, Chronic Condition
- Keywords
- Human papillomavirus vaccine, Young women with chronic condition, Vaccination coverage rate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 23 Jan 2024 (actual)
- Primary completion
- 26 Jun 2025 (actual)
- Study completion
- 26 Jun 2025 (actual)
- First posted
- 6 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic condition | – | Other: QuestionnaireGirls and young women between the ages of 11 and 20 suffering from chronic condition |
| Control | – | Other: QuestionnaireGirls and young women between the ages of 11 and 20 in good health |
Who may qualify
- Ages
- 11 to 20 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (16 listed)
- 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) :
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireQuestionnaire 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. | Other | Chronic condition, Control |
Primary outcome
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).
4 secondary outcomes
Intention of vaccination by human papillomavirus vaccine by the usual health professionals
Time frame: Day 1
Category of health professionals offering vaccination by human papillomavirus vaccine
Time frame: Day 1
Reasons for non-vaccination by human papillomavirus vaccine
Time frame: Day 1
Description of parameters that may impact vaccination coverage for human papillomavirus vaccine
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Background: PubMed 28928039Hofstetter 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.
- Background: PubMed 28760611Gras-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.
- Background: PubMed 22831900Hoffman 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sabrina DA COSTA, MD principal investigator
Assistance Publique - Hôpitaux de Paris
Alaa CHEIKHELARD, MD study director
Assistance Publique - Hôpitaux de Paris
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Papillomavirus Vaccine and Chronic Condition, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunization coverage rate for human papillomavirus vaccine (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06158802, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.