NCT03979014CompletedPhase 3
Nonavalent Prophylactic HPV Vaccine (GARDASIL9) After Local Conservative Treatment for Cervical Intra-epithelial Neoplasia
Nonavalent Prophylactic HPV Vaccine (GARDASIL9) After Local Conservative Treatment for Cervical Intra-epithelial Neoplasia: a Randomised Controlled Trial - The NOVEL Trial
Source: ClinicalTrials.gov · Last updated 6 May 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 1099 (actual)
- First submitted
- 4 Jun 2019
- Start date
- 1 Nov 2019
- Primary completion date
- 5 Sept 2025
- Lead sponsor
- Imperial College London
- Diseases
- Cervical cancer
- NCT number
- NCT03979014
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 1099
- From 1 Nov 2019 to the primary completion date, 5 Sept 2025
- 13 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of other investigational/non-registered product within 30 days preceding the 1st vaccine dose
- Previous vaccination against HPV
Other illness
- Cancer or autoimmune disease under treatment. Patients who have a history of cancer or autoimmune disease but are not currently being treated for the condition will be included
- Any confirmed or suspected immunosuppressive condition, including HIV infection
- History of allergic disease or any neurologic disorders likely to interact with study vaccination
- Acute febrile disease at enrolment (will be postponed)
Other
- Patients who meet any of the following exclusion criteria will not be eligible for this study:
- Continuous administration of immunosuppressants
- Pregnant women or women intending to get pregnant during the next 6 months (if pregnant during follow-up, remaining doses will be delayed until after delivery)
Who the study is looking for
- Patients who meet all of the following inclusion criteria will be considered eligible for this study:
- Female (18-55y) attending for local treatment for presumed CIN2 (cytological and colposcopy impression) OR presumed CIN3 (cytological and colposcopy impression) OR presumed cGIN/AIS (cytological and colposcopy impression) OR biopsy-confirmed CIN2 OR biopsy-confirmed CIN3 OR biopsy-confirmed CGIN/AIS
- Written informed consent obtained from the subject prior to enrolment
- Free of other relevant health problems as established by medical history and clinical examination, e.g. immunosuppression
- Patients who the investigator believes can and will comply with the protocol requirements (e.g. attendance at clinic appointments and return for follow-up visits)
Age in the registry: 18 years to 55 years · Sex: Female · Does not accept healthy volunteers
Sites (13)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Helsinki University Hospital Coordinator of this site? Confirm its status | Helsinki | Finland | Unknown status |
| Tampere University Hospital Coordinator of this site? Confirm its status | Tampere | Finland | Unknown status |
| Royal Preston Hospital - Lancashire Teaching Hospitals NHS Trust Coordinator of this site? Confirm its status | Fulwood | United Kingdom | Unknown status |
| St James's University Hospital, Leeds Coordinator of this site? Confirm its status | Leeds | United Kingdom | Unknown status |
| St Mary's Hospital - Imperial College Healthcare NHS Trust Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| West Middlesex University Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Guy's and St Thomas' NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| St. Mary's Hospital - Manchester University NHS Foundation Trust Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
| Whittington Health NHS Trust Coordinator of this site? Confirm its status | Middlesex | United Kingdom | Unknown status |
| Nottingham University Hospitals NHS Trust Coordinator of this site? Confirm its status | Nottingham | United Kingdom | Unknown status |
| Regionhälsan Masthugget Clinic of Obstetrics and Gynecology Coordinator of this site? Confirm its status | Gothenburg | Sweden | Unknown status |
| Sahlgrenska University Hospital Coordinator of this site? Confirm its status | Gothenburg | Sweden | Unknown status |
| Frölunda Specialist Hospital Gynecology Clinic Coordinator of this site? Confirm its status | Västra Frölunda | Sweden | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.