Cervical CancerPhase 4NCT01544478
V501 Safety and Efficacy Study in Japanese Women Aged 16 to 26 Years (V501-110)
A Phase 4 study testing V501 in people with Cervical Cancer and Cervical Intraepithelial Neoplasia, run by Merck Sharp & Dohme LLC.
Trial summary
This study evaluated the long-term safety of quadrivalent Human Papillomavirus (HPV) types 6, 11, 16, 18 vaccine and its effectiveness in the prevention of cervical intraepithelial neoplasia (CIN), adenocarcinoma in situ, and cervical cancer related to HPV in Japanese women. Read more about this study
- Who is it for?
- Ages 16 to 26 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer, Cervical Intraepithelial Neoplasia, Adenocarcinoma in Situ
- What is being tested?
- V501
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,030 participants
- Where
- No sites listed yet
- Study dates
- 25 Nov 2011to 27 Aug 2016
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 26 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy Japanese females
- Not pregnant at Screening and agree to use effective contraception through Month 7 of the study
- Lifetime history of 0 to 4 male or female sexual partners
- No oral temperature ≥37.5 centigrade within 24 hours prior to injection
Who cannot join
- Received a marketed HPV vaccine
- Prior abnormal Papanicolaou smear (PAP) or biopsy showing CIN
- Known history of positive test for HPV
- Known history of genital warts
- Received immune globulin or blood products within 6 months prior to first injection or plan to receive any through Month 7 of the study
- History of splenectomy, known immune disorders, or receiving immunosuppressives
- Immunocompromised or diagnosed as having human immunodeficiency virus (HIV)
About this study
Official title: A Phase IV Open-Label, Descriptive Study to Evaluate the Safety and Effectiveness on the Incidence of HPV 6, 11, 16 and 18 Related CIN 2/3 or Worse of the Quadrivalent HPV (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine in 16- to 26-Year-Old Japanese Women
This study evaluated the long-term safety of quadrivalent Human Papillomavirus (HPV) types 6, 11, 16, 18 vaccine and its effectiveness in the prevention of cervical intraepithelial neoplasia (CIN), adenocarcinoma in situ, and cervical cancer related to HPV in Japanese women.
- Being tested
- V501
- Medical subject headings
- Uterine Cervical Neoplasms, Uterine Cervical Dysplasia, Adenocarcinoma in Situ
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V501Biological
Also called Gardasil™
HPV types 6, 11, 16, and 18 vaccine 0.5 mL by intramuscular injection at Day 1, Month 2, and Month 6
| Study group | Role | What they receive |
|---|---|---|
| V501 | Experimental | Participants received a 0.5-mL vaccination of V501 by intramuscular injection on Day 1, Month 2, and Month 6 Receives: Biological: V501 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined Incidence of Cervical Intraepithelial Neoplasia (CIN) 2/3 or Worse Related to Human Papillomavirus (HPV) Type 6, 11, 16, or 18
The endpoint included pathology panel consensus diagnosis of CIN 2 or 3, adenocarcinoma in situ, invasive squamous cervical carcinoma, or invasive adenocarcinoma of the cervix, and HPV type 6, 11, 16, or 18 detected in an adjacent section from the same tissue block. The point estimates and exact 95% confidence intervals for incidence rate were based on the Poisson distribution.
Measured: Up to Month 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2012 (estimated)
- Study start25 Nov 2011
- Primary completion27 Aug 2016
- Study completion27 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,030 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01544478
- Sponsor's protocol ID
- V501-110
- Other IDs
- 132247, 2015-002932-42, 2015
- Status last verified
- Nov 2018
- First submitted
- 29 Feb 2012
- Last updated
- 28 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
Publications
Sakamoto M, Miyagi E, Sumi Y, Aisaka K, Kuno N, Nagano H, Asahara S, Han SR, Wakana A, Murata S, Sawata M, Tanaka Y. Effectiveness on high-grade cervical abnormalities and long-term safety of the quadrivalent human papillomavirus vaccine in Japanese women. J Infect Chemother. 2019 Jul;25(7):520-525. doi: 10.1016/j.jiac.2019.02.012. Epub 2019 Mar 15.
PubMed 30879979