A Phase 4 interventional study of Gardasil 9, 9-Valent Intramuscular Suspension in Papilloma Viral Infection, sponsored by Centre Hospitalier Universitaire de la Réunion. Completed at 1 site in France. Open to participants aged 9 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-02.
Sponsored by Centre Hospitalier Universitaire de la Réunion · Phase 4, Interventional, and Prevention
Cervical cancer (CCU) is the fourth most common cancer in women worldwide. In Reunion island, CCU is the third leading cause of cancer in women (standardized incidence rate on the world population (TIS) in 2013 of 10.3 / 100,000) and is the eighth deadliest cancer with a rate standardized mortality of 4.8 / 100,000, almost three times higher than in mainland France where it was 1.7 / 100,000 in 2018.
CCU results from infection with the human papillomavirus (HPV), which is the most common sexually transmitted viral infection.
CCU prevention is mainly based on cervical smear screening and anti HPV vaccination (VHPV) which has demonstrated its effectiveness on the prevalence of HPV carriage, but also on incidence of condyloma or intermediate grade dysplasia. Since HPV is mainly transmitted sexually, it is important to vaccinate before the start of sex.
In Reunion island, the HPV vaccination coverage rate is the lowest in France, estimated by Public Health France at 8.1% among girls aged 16 years in 2018, while the already low national average was established 23.7%.
Thus, in view of the epidemiological situation in Reunion island (high incidence and mortality for the CCU, very low VHPV coverage rate), we thought it would be interesting to study the impact of a health promotion program sex and prevention of sexually transmitted infections (STIs) including papillomavirus-related pathologies, with a program to promote HPV vaccination among young students in middle school.
914 studies on the registry are indexed under Virus Diseases; 110 are open to participants now.
This study's enrollment of 355 is above the median of 102 across 604 interventional studies indexed under Virus Diseases.
Browse Virus Diseases studies →Centre Hospitalier Universitaire de la Réunion is the lead sponsor of 137 studies on the registry; 35 are open to participants now.
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Exclusion Criteria:
Drug: Gardasil 9, 9-Valent Intramuscular Suspension
access to HPV vaccination near the college in a health bus
Change the vaccination rate in girls
Number of girls having completed a complete vaccination schedule. Hypothesis: the intervention under study should increase the rate of vaccinated
Time frame: 9 month
increase the vaccination rate in all student
number of student having completed a complete vaccination schedule
Time frame: 9 month
increase the vaccination rate in all student
number of student having completed a incomplete vaccination schedule
Time frame: 9 month
Plan to share: No
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Universitaire de la Réunion