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NCT03675256

The KEN SHE Study on HPV-vaccine Efficacy

KENya Single-dose HPV-vaccine Efficacy - The KEN-SHE Study
University of Washington·Phase 4·ClinicalTrials.gov·biologicalNot yet recruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Papillomavirus Infections
Drug/Device/Intervention
immediate Gardasil 9, delayed MenVeo vaccine
Study type
Interventional
Intervention type
biological
Sponsor & location
Primary sponsor
University of Washington
Location
Thika,Kisumu,Nairobi, Kenya
Timeline & enrollment
Phase
Phase 4
Start date
Dec 19, 2018
End date
Nov 15, 2022
Enrollment
2275 participants
Primary outcome

Persistent HPV 16/18 infection across arms,Persistent HPV 16/18/21/33/45/52/58 infection across arms

Summary

Study Description
 
 The KEN SHE Study aims to identify effective cervical cancer prevention strategies. Cervical
 cancer is caused by an infection with Human Papillomavirus, also called HPV. In Kenya, about
 2,500 women die from this condition each year. The study is conducted by Kenya Medical
 Research Institute (KEMRI) sites, based in Kisumu, Thika and Nairobi and the University of
 Washington, Seattle, USA.
 
 The purpose of this study is to learn whether a single dose of the HPV vaccine prevents HPV
 infection among adolescents and young women. Using a single dose will lower the cost of
 providing HPV vaccination (compared to two doses) and will make it possible for more women to
 receive the vaccination and be protected from cervical cancer.
 
 The study will involve approximately 15 clinic visits over a period of 37 months. All visits
 will involve blood draws and many will involve pelvic swabs. Participants will receive an
 FDA-approved HPV vaccine and a meningococcal vaccine.

ICD-10 classifications
Papillomavirus as the cause of diseases classified to other chaptersPapovavirus infection, unspecified sitePapilloedema, unspecifiedViral infection, unspecifiedParvovirus as the cause of diseases classified to other chapters
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT03675256
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT03675256 through Pure Global AI's free database. This Phase 4 trial is sponsored by University of Washington and is currently Not yet recruiting. The study focuses on Papillomavirus Infections. Target enrollment is 2275 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.