QUALIOPIVAC: Children Vaccination From 11 to 14 Years Old

Sponsor

Centre Hospitalier Eure-Seine (Other)

Overall Status

Completed

CT.gov ID

NCT04871243

Collaborator

(none)

Enrollment

Location

9.4

Actual Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Vaccination Refusal Opinions	Other: Qualitative Interview

Detailed 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.

Study Design

Study Type:

Observational

Actual Enrollment :

18 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

May 1, 2021

Actual Primary Completion Date :

Feb 11, 2022

Actual Study Completion Date :

Feb 11, 2022

Outcome Measures

Primary Outcome Measures

Evaluation of knowledge and understanding of papillomavirus and opinions related to anti-HPV vaccination [4 months]

Secondary Outcome Measures

Concept identification to ameliorate the vaccination coverage by overcoming the obstacles [4 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CH Eure-Seine	Évreux		France	27015

Sponsors and Collaborators

Centre Hospitalier Eure-Seine

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Eure-Seine

ClinicalTrials.gov Identifier:

NCT04871243

Other Study ID Numbers:

2021-A00660-41
CHES N°21/01

First Posted:

May 4, 2021

Last Update Posted:

Apr 22, 2022

Last Verified:

Apr 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Centre Hospitalier Eure-Seine

human papilloma virus

vaccination

Study Results

No Results Posted as of Apr 22, 2022