Children Vaccination From 11 to 14 Years Old

Vaccination Refusal Clinical Trial

— QUALIOPIVAC  

Official title:

Qualitative Study Evaluating Opinions Regarding HPV Vaccinnation in Boys' Parents Aged From 11 to 14 Years Old

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04871243
• Other study ID #: 2021-A00660-41
• Secondary ID: CHES N°21/01
• Status: Completed
• Start date: May 1, 2021
• Est. completion date: February 11, 2022

Study information

• Verified date: April 2022
• Source: Centre Hospitalier Eure-Seine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The human papilloma virus infection is the most frequent sexually transmitted infection around the world. In the vast majority of cases, these are inapparent infections that disappear spontaneously. In some cases, the HPV infection persists and can generate anogenital warts or cancer.

In France, the papillomavirus is responsible for 6000 new cases of cancer/year with several possible localizations : cervical, anal, penile, oropharyngeal, vulvar or vaginal. Among them, 4580 new cases of cancer/year occur in women, and half of them are diagnosis of cervical cancer. A quarter of cancers caused by papillomavirus occur in men.

In France, the commercialization of anti-HPV vaccine in 2007 was addressed only to girls, in order to gain a group immunity that would therefore protect the boys. This vaccination did not achieve the cover immunization target that were announced: the objective was fixed at 60% of vaccination coverage and at the end of 2018, only 24% was achieved on the complete vaccination schedule. In December 2019, the French National Authority for Health recommended the anti-HPV vaccinations in girls and boys.

Description:

This qualitative study evaluates parents' opinion regarding the vaccination and the HPV. Parent's eligible to participate in this study are those with boys between 11 and 14 years old.

The anti-HPV vaccination is perceived favorably in 38% of parents, but 42% of parents are undecided.

The investigators would like to evaluate qualitatively the opinions and the obstacles in this vaccination, using interviews in parents of boys aged between 11 and 14 years old.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: February 11, 2022
• Est. primary completion date: February 11, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• parents having boys between 11 and 14 years old, followed-up by a general practitioner that participate in the study

• signed inform consent form

Exclusion Criteria:

• language barrier that could prevent the understanding or formulation of opinions during the interview

Related Conditions & MeSH terms

• Vaccination Refusal

Intervention

Other:
• Qualitative Interview
Individual semi-structured interviews

Locations

Country	Name	City	State
France	CH Eure-Seine	Évreux

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Eure-Seine

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of knowledge and understanding of papillomavirus and opinions related to anti-HPV vaccination		4 months
Secondary	Concept identification to ameliorate the vaccination coverage by overcoming the obstacles		4 months