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COMPLETED
NCT03979014
PHASE3

Nonavalent Prophylactic HPV Vaccine (GARDASIL9) After Local Conservative Treatment for Cervical Intra-epithelial Neoplasia

Sponsor: Imperial College London

View on ClinicalTrials.gov

Summary

The researchers involved in this new study are interested in whether giving a HPV vaccine to women at the same time as conisation can lead to a greater rate of HPV clearance compared to conisation on its own, and a result reduce the occurrence of further infection and high grade CIN. The study will do this by using a specific HPV vaccine called Gardasil 9™ which protects against 9 types of HPV infection (types 6, 11, 16, 18, 31, 33, 45, 52 and 58).

Official title: Nonavalent Prophylactic HPV Vaccine (GARDASIL9) After Local Conservative Treatment for Cervical Intra-epithelial Neoplasia: a Randomised Controlled Trial - The NOVEL Trial

Key Details

Gender

FEMALE

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

1099

Start Date

2019-11-01

Completion Date

2025-09-05

Last Updated

2026-05-06

Healthy Volunteers

No

Conditions

Interventions

BIOLOGICAL

Gardasill 9™ vaccine

3 doses of Gardasill 9™ vaccine 0.5 ml administered 3 times at 0, 2 and 6 month

Locations (13)

Helsinki University Hospital

Helsinki, Finland

Tampere University Hospital

Tampere, Finland

Regionhälsan Masthugget Clinic of Obstetrics and Gynecology

Gothenburg, Sweden

Sahlgrenska University Hospital

Gothenburg, Sweden

Frölunda Specialist Hospital Gynecology Clinic

Västra Frölunda, Sweden

St James's University Hospital, Leeds

Leeds, England, United Kingdom

Guy's and St Thomas' NHS Foundation Trust

London, England, United Kingdom

West Middlesex University Hospital

London, England, United Kingdom

St. Mary's Hospital - Manchester University NHS Foundation Trust

Manchester, England, United Kingdom

Whittington Health NHS Trust

Middlesex, England, United Kingdom

Nottingham University Hospitals NHS Trust

Nottingham, England, United Kingdom

Royal Preston Hospital - Lancashire Teaching Hospitals NHS Trust

Fulwood, Preston, United Kingdom

St Mary's Hospital - Imperial College Healthcare NHS Trust

London, United Kingdom