Papillomavirus InfectionsPhase 3NCT01254643

A Study of the Safety, Tolerability, and Immunogenicity of a 9-valent Human Papillomavirus Vaccine ([9vHPV]; V503) Administered to 9- to 15-Year-Old Japanese Girls (V503-008).

A Phase 3 study testing V503 in people with Papillomavirus Infections, run by Merck Sharp & Dohme LLC.

Completed

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

Trial summary

This study will evaluate the safety, tolerability, and immunogenicity of V503 in Japanese girls between the ages of 9 and 15 and will determine whether V503 induces an acceptable immune response to all human papillomavirus (HPV) strains contained in the vaccine. Read more about this study

Who is it for?: Ages 9 to 15 years, women onlyHealthy volunteers can take part
Conditions the study is for: Papillomavirus Infections
What is being tested?: V503
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: No sites listed yet
Study dates: 12 Jan 2011to 10 Aug 2013
Phase: Phase 3
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 9 to 15 years
Women only
Healthy volunteers accepted
Child

Who may be able to join

Participant is in good physical health-
Participant's parent/legal guardian is able to read, understand, and complete the vaccine report card
Participant's parent/legal guardian agrees to provide a phone number for follow-up purposes
Participant is not sexually active and does not plan to become sexually active during the time from Day 1 to Month 7 of the study

Who cannot join

Participant has a history of severe allergic reaction that required medical intervention
Participant has thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection
Participant is pregnant
Participant intends to donate blood during the time from Day 1 to Month 7 of the study
Participant is immunocompromised or has been diagnosed as having a congenital or acquired immunodeficiency, human immunodeficiency virus (HIV) infection, lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune condition.
Participant has had a splenectomy

Show all 12Show fewer

Participant has received any of the following immunosuppressive therapies in the year prior to enrollment: radiation therapy, cyclophosphamide, azathioprine, methotrexate, any chemotherapy, cyclosporin, leflunomide (Arava), tumor necrosis factor alpha (TNF-α) antagonists, monoclonal antibody therapies, antilymphocyte sera, or other therapy known to interfere with the immune response.
Participant has received any immune globulin product or blood-derived product in the three months prior to the Day 1 vaccination, or plans to receive any such product through Month 7 of the study
Participant has received any inactivated vaccines within 14 days of the Day 1 vaccination or any live vaccines within 28 days of the Day 1 vaccination
Participant has received a marketed HPV vaccine or has participated in an HPV vaccine clinical trial
Participant has had a fever (oral temperature ≥37.8°C) within 24 hours of the Day 1 vaccination
Participant has a history of a positive test for HPV or history of genital warts

About this study

Official title: A Phase III Open-label, Safety, Tolerability and Immunogenicity Study of a 9-Valent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine Administered to 9- to 15-Year-Old Japanese Preadolescent and Adolescent Girls

Conditions: Papillomavirus Infections
Being tested: V503
Keywords: Papillomavirus vaccines, Uterine cervical cancer, Human Papilloma Virus infections
Medical subject headings: Papillomavirus Infections, Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

V503Biological
V503 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6

Study groups in NCT01254643
Study group	Role	What they receive
All Enrolled	Experimental	9-valent human papillomavirus (9vHPV) L1 VLP vaccine (V503), 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Receives: Biological: V503

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine
Serum antibody titers for HPV virus-like particles (VLPs), Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using competitive luminex immunoassay (cLIA). The serostatus cutoffs (milli Merck U/mL) for HPV types were as follows: HPV Type 6: ≥30, HPV Type 11: ≥16; HPV Type 16: ≥20, HPV Type 18: ≥24, HPV Type 31: ≥10, HPV Type 33: ≥8, HPV Type 45: ≥8, HPV Type 52: ≥8, and HPV Type 58: ≥8.
Measured: 4 weeks post-vaccination 3 (Month 7)
Percentage of Participants With an Injection-site Adverse Event (AE)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. AEs such as redness, swelling, and pain/tenderness/soreness at the injection site were recorded.
Measured: up to 5 days after any vaccination
Percentage of Participants With a Non-Injection Site (Systemic) AE
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Systemic AEs were those not categorized as injection-site AEs.
Measured: up to 15 days after any vaccination
Percentage of Participants With a Vaccine-related AE
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Adverse experience that is judged by the Investigator to be "definitely related," "probably related," or "possibly related" to the study drug is defined as a vaccine-related AE.
Measured: up to 15 days after any vaccination

Secondary outcomes (1)

Geometric Mean Titers (GMTs) for Each of the HPV Types Contained in the Vaccine
Serum antibody titers for HPV virus-like particles (VLPs), Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using cLIA. Titers are reported in milli Merck Units/mL.
Measured: 4 weeks post-vaccination 3 (Month 7)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Jan 201110 Aug 2013

First posted6 Dec 2010 (estimated)
Study start12 Jan 2011
Primary completion10 Aug 2013
Study completion10 Aug 2013

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 Papillomavirus InfectionsStudies 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 3
Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01254643
Sponsor's protocol ID: V503-008
Status last verified: Oct 2018
First submitted: 3 Dec 2010
Last updated: 28 Nov 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

Iwata S, Murata S, Rong Han S, Wakana A, Sawata M, Tanaka Y. Safety and Immunogenicity of a 9-Valent Human Papillomavirus Vaccine Administered to 9- to 15-Year-Old Japanese Girls. Jpn J Infect Dis. 2017 Jul 24;70(4):368-373. doi: 10.7883/yoken.JJID.2016.299. Epub 2016 Dec 22.
PubMed 28003597

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

Not yet recruitingPhase 1/2
Clinical Trial to Assess the Safety, Tolerability, Reactogenicity, and Immunogenicity of a 10 Valent Human Papillomavirus Virus (10vHPV) Vaccine
Human Papillomavirus Infection
Active, not recruitingPhase 4
Comparing Immune Response of 2 vs 3 HPV Doses (27-45 Years Old)
Immunization, HPV Infection
Not yet recruitingPhase 2
Combination Bevacizumab and PRGN-2012 in Adults With Recurrent Respiratory Papillomatosis (RRP)
Respiratory Recurrent Papillomatosis (RRP), Human Papillomavirus (HPV)
RecruitingPhase 2
A Study of the Preliminary Efficacy of DARE-HPV to Treat High-risk Persistent Human Papillomavirus (hrHPV)
Human Papilloma Virus (HPV), High-risk Human Papillomavirus Infection
RecruitingPhase 2
A Single Arm Phase II Trial in p16-positive Oropharynx Cancer of Selective Dose De-escalation of nodAl VolumEs at Minimal Risk and Primary Site Disease (SAVED)
Head and Neck Cancer, Head and Neck Squamous Cell Cancer

All Papillomavirus Infections 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 III Open-label, Safety, Tolerability and Immunogenicity Study of a 9-Valent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine Administered to 9- to 15-Year-Old Japanese Preadolescent and Adolescent Girls
ClinicalTrials.gov ID: NCT01254643
Acronym / sponsor ID: V503-008
Conditions: Papillomavirus Infections
Keywords: Papillomavirus vaccines, Uterine cervical cancer, Human Papilloma Virus infections
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 12 Jan 2011 (actual)
Primary completion: 10 Aug 2013 (actual)
Study completion: 10 Aug 2013 (actual)
First posted: 6 Dec 2010 (estimated)
Results: Posted 22 Dec 2014

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
All Enrolled	Experimental	Biological: V5039-valent human papillomavirus (9vHPV) L1 VLP vaccine (V503), 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6.

Who may qualify

Ages: 9 to 15 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (4 listed)

Participant is in good physical health-
Participant's parent/legal guardian is able to read, understand, and complete the vaccine report card
Participant's parent/legal guardian agrees to provide a phone number for follow-up purposes
Participant is not sexually active and does not plan to become sexually active during the time from Day 1 to Month 7 of the study

Key exclusion criteria (12 listed)

Participant has a history of severe allergic reaction that required medical intervention
Participant has thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection
Participant is pregnant
Participant intends to donate blood during the time from Day 1 to Month 7 of the study
Participant is immunocompromised or has been diagnosed as having a congenital or acquired immunodeficiency, human immunodeficiency virus (HIV) infection, lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune condition.

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
V503V503 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6	Biological	All Enrolled

Primary outcome

Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine
Time frame: 4 weeks post-vaccination 3 (Month 7)
Serum antibody titers for HPV virus-like particles (VLPs), Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using competitive luminex immunoassay (cLIA). The serostatus cutoffs (milli Merck U/mL) for HPV types were as follows: HPV Type 6: ≥30, HPV Type 11: ≥16; HPV Type 16: ≥20, HPV Type 18: ≥24, HPV Type 31: ≥10, HPV Type 33: ≥8, HPV Type 45: ≥8, HPV Type 52: ≥8, and HPV Type 58: ≥8.
Percentage of Participants With an Injection-site Adverse Event (AE)
Time frame: up to 5 days after any vaccination
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. AEs such as redness, swelling, and pain/tenderness/soreness at the injection site were recorded.
Percentage of Participants With a Non-Injection Site (Systemic) AE
Time frame: up to 15 days after any vaccination
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Systemic AEs were those not categorized as injection-site AEs.
Percentage of Participants With a Vaccine-related AE
Time frame: up to 15 days after any vaccination
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Adverse experience that is judged by the Investigator to be "definitely related," "probably related," or "possibly related" to the study drug is defined as a vaccine-related AE.

1 secondary outcome

Geometric Mean Titers (GMTs) for Each of the HPV Types Contained in the Vaccine
Time frame: 4 weeks post-vaccination 3 (Month 7)

Results and safety

Results posted to the registry on 22 Dec 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Enrolled	100	99

Primary outcome: Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine

Time frame: 4 weeks post-vaccination 3 (Month 7). Number (95% Confidence Interval). Unit: Percentage of Participants

Measure	All Enrolled n = 99
Anti-HPV 6 (n=97)	100 (96.3 to 100)
Anti-HPV 11 (n=97)	100 (96.3 to 100)
Anti-HPV 16 (n=99)	100 (96.3 to 100)
Anti-HPV 18 (n=98)	100 (96.3 to 100)
Anti-HPV 31 (n=97)	100 (96.3 to 100)
Anti-HPV 33 (n=98)	100 (96.3 to 100)
Anti-HPV 45 (n=99)	100 (96.3 to 100)
Anti-HPV 52 (n=99)	100 (96.3 to 100)

Population analysed: Participants who received all 3 vaccinations and met criteria for Per Protocol Immunogenicity (PPI) Population (not a general protocol violator, received all vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), and had a Month 7 serum sample collected within an acceptable day range) for at least 1 of the 9 HPV types.

Primary outcome: Percentage of Participants With an Injection-site Adverse Event (AE)

Time frame: up to 5 days after any vaccination. Number. Unit: Percentage of Participants

Measure	All Enrolled n = 100
Value	95.0

Population analysed: Safety Population, which consisted of all participants who received at least one vaccination and had available follow-up data.

Primary outcome: Percentage of Participants With a Non-Injection Site (Systemic) AE

Time frame: up to 15 days after any vaccination. Number. Unit: Percentage of Participants

Measure	All Enrolled n = 100
Value	35.0

Population analysed: Safety Population, which consisted of all participants who received at least one vaccination and had available follow-up data.

Primary outcome: Percentage of Participants With a Vaccine-related AE

Time frame: up to 15 days after any vaccination. Number. Unit: Percentage of Participants

Measure	All Enrolled n = 100
Value	96.0

Population analysed: Safety Population, which consists of all participants who received at least one vaccination and had available follow-up data.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Up to 5 days after any vaccination (Non-serious injection site AEs); up to 15 days after any vaccination (Serious AEs and Non-serious non-injection site AEs) and up to 30 months (Any death and serious drug-related AEs). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Enrolled	0 of 100 (0%)	96 of 100 (96%)	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.
Results publication: PubMed 28003597Iwata S, Murata S, Rong Han S, Wakana A, Sawata M, Tanaka Y. Safety and Immunogenicity of a 9-Valent Human Papillomavirus Vaccine Administered to 9- to 15-Year-Old Japanese Girls. Jpn J Infect Dis. 2017 Jul 24;70(4):368-373. doi: 10.7883/yoken.JJID.2016.299. Epub 2016 Dec 22.
Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Related trials for Papillomavirus Infections

Not yet recruitingPhase 1/2
Clinical Trial to Assess the Safety, Tolerability, Reactogenicity, and Immunogenicity of a 10 Valent Human Papillomavirus Virus (10vHPV) Vaccine
Human Papillomavirus Infection
Active, not recruitingPhase 4
Comparing Immune Response of 2 vs 3 HPV Doses (27-45 Years Old)
Immunization, HPV Infection
Not yet recruitingPhase 2
Combination Bevacizumab and PRGN-2012 in Adults With Recurrent Respiratory Papillomatosis (RRP)
Respiratory Recurrent Papillomatosis (RRP), Human Papillomavirus (HPV)
RecruitingPhase 2
A Study of the Preliminary Efficacy of DARE-HPV to Treat High-risk Persistent Human Papillomavirus (hrHPV)
Human Papilloma Virus (HPV), High-risk Human Papillomavirus Infection
RecruitingPhase 2
A Single Arm Phase II Trial in p16-positive Oropharynx Cancer of Selective Dose De-escalation of nodAl VolumEs at Minimal Risk and Primary Site Disease (SAVED)
Head and Neck Cancer, Head and Neck Squamous Cell Cancer

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 3 study testing V503 in people with Papillomavirus Infections, 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 12 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 22 Dec 2014). 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?

Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (time frame: 4 weeks post-vaccination 3 (Month 7)). The study lists 4 primary outcomes in all. 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 NCT01254643, 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.