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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Conditions: Cervical Cancer, Cervical Intraepithelial Neoplasia, Adenocarcinoma in Situ
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 groups in NCT01544478
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.

25 Nov 201127 Aug 2016

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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RecruitingPhase 2
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RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
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All Cervical Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01544478
Acronym / sponsor ID: V501-110
Conditions: Cervical Cancer, Cervical Intraepithelial Neoplasia, Adenocarcinoma in Situ
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,030 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 25 Nov 2011 (actual)
Primary completion: 27 Aug 2016 (actual)
Study completion: 27 Aug 2016 (actual)
First posted: 6 Mar 2012 (estimated)
Results: Posted 7 Jul 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
V501	Experimental	Biological: V501Participants received a 0.5-mL vaccination of V501 by intramuscular injection on Day 1, Month 2, and Month 6

Who may qualify

Ages: 16 to 26 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
V501Also: Gardasil™HPV types 6, 11, 16, and 18 vaccine 0.5 mL by intramuscular injection at Day 1, Month 2, and Month 6	Biological	V501

Primary outcome

Combined Incidence of Cervical Intraepithelial Neoplasia (CIN) 2/3 or Worse Related to Human Papillomavirus (HPV) Type 6, 11, 16, or 18
Time frame: Up to Month 48
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.

Results and safety

Results posted to the registry on 7 Jul 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
V501	1,030	912

Primary outcome: Combined Incidence of Cervical Intraepithelial Neoplasia (CIN) 2/3 or Worse Related to Human Papillomavirus (HPV) Type 6, 11, 16, or 18

Time frame: Up to Month 48. Number (95% Confidence Interval). Unit: Cases per 100 person-years at risk

Measure	V501 n = 967
Value	0.0 (0.0 to 0.1)

Population analysed: The population analyzed included participants who received the full vaccination series, had at least 1 visit after Month 7, had no general protocol violations, and were seronegative at Baseline and polymerase chain reaction-negative from Baseline through Month 7 for the relevant HPV type.

Adverse events

Time frame: Up to Month 48. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
V501	8 of 1,029 (0.8%)	169 of 1,029 (16.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30879979Sakamoto 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.
Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

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RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
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RecruitingPhase 2
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Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
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Head and Neck Cancer (H&N)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing V501 in people with Cervical Cancer and Cervical Intraepithelial Neoplasia, run by Merck Sharp & Dohme LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Combined Incidence of Cervical Intraepithelial Neoplasia (CIN) 2/3 or Worse Related to Human Papillomavirus (HPV) Type 6, 11, 16, or 18 (time frame: Up to Month 48). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01544478, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2018.