Papillomavirus InfectionsPhase 3NCT00157950

Human Papillomavirus (HPV) Registration Study (Gardasil)(V501-023)(COMPLETED)

A Phase 3 study testing Gardasil™ 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 is an immunogenicity and safety study of Gardasil (V501) in females 9 to 23 years of age in Korea. Read more about this study

Who is it for?: Ages 9 to 23 years, women onlyHealthy volunteers can take part
Conditions the study is for: Papillomavirus Infections
What is being tested?: Gardasil™
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 176 participants
Where: No sites listed yet
Study dates: Oct 2005to Jun 2006
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 23 years
Women only
Healthy volunteers accepted
Child, Adult

Who may be able to join

Girls ages 9 to 15 years (must not yet have had coitarche)
Healthy females ages 16 to 23 years (individuals with a lifetime history of 0 to 3 male or female sexual partners)

Who cannot join

All Subjects:
History of known prior vaccination with an HPV vaccine.
Women Ages 16 to 23 Only:
Individuals with any prior history of genital warts or treatment for genital warts.
Individuals with > 3 lifetime male or female sexual partners.

About this study

Official title: An Immunogenicity and Safety Study of Gardasil (V501 (Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine)) in Females 9 to 23 Years of Age in Korea

This is an immunogenicity and safety study of Gardasil (V501) in females 9 to 23 years of age in Korea.

Conditions: Papillomavirus Infections
Being tested: Gardasil™, Placebo
Keywords: Human Papilloma Virus
Medical subject headings: Papillomavirus Infections

What participants receive

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

Gardasil™Biological
Also called V501
Gardasil™ 3 dose regimen (Day 1, Month 2 and Month 6)
PlaceboBiological
Gardasil™ matching placebo 3 dose regimen (Day 1, Month 2 and Month 6)

Study groups in NCT00157950
Study group	Role	What they receive
Gardasil™	Experimental	Gardasil™ 3 dose regimen Receives: Biological: Gardasil™
Placebo	Placebo comparator	Gardasil™ matching placebo 3 dose regimen Receives: Biological: Placebo

What is being measured

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

Number of Participants Who Seroconvert to HPV 6.
Vaccine-induced anti-HPV 6 seroconversion following administration of a 3-dose regimen of GARDASIL® in females 9 to 23 years of age in Korea. Seroconversion for HPV 6 was defined as achieving an anti-HPV cLIA (Competitive Luminex immunoassay) level of at least 20 mMU/mL.
Measured: Week 4 Postdose 3
Number of Participants Who Seroconvert to HPV 11.
Vaccine-induced anti-HPV 11 seroconversion following administration of a 3-dose regimen of GARDASIL® in females 9 to 23 years of age in Korea. Seroconversion for HPV 11 was defined as achieving an anti-HPV cLIA (Competitive Luminex immunoassay) level of at least 16 mMU/mL.
Measured: Week 4 Postdose 3
Number of Participants Who Seroconvert to HPV 16.
Vaccine-induced anti-HPV 16 seroconversion following administration of a 3-dose regimen of GARDASIL® in females 9 to 23 years of age in Korea. Seroconversion for HPV 16 was defined as achieving an anti-HPV cLIA (Competitive Luminex immunoassay) level of at least 20 mMU/mL.
Measured: Week 4 Postdose 3
Number of Participants Who Seroconvert to HPV 18.
Vaccine-induced anti-HPV 18 seroconversion following administration of a 3-dose regimen of GARDASIL® in females 9 to 23 years of age in Korea. Seroconversion for HPV 18 was defined as achieving an anti-HPV cLIA (Competitive Luminex immunoassay) level of at least 24 mMU/mL.
Measured: Week 4 Postdose 3

Secondary outcomes (1)

Number of Participants With Adverse Experiences
Number of participants who reported 1 or more adverse experience.
Measured: Overall study including 14 calendar days after the last vaccination visit.

Timeline

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

Oct 2005Jun 2006

First posted12 Sep 2005 (estimated)
Study startOct 2005
Primary completionJun 2006
Study completionJun 2006

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 (2)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: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 176 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00157950
Sponsor's protocol ID: V501-023
Other IDs: 2005_066
Status last verified: Jan 2016
First submitted: 7 Sep 2005
Last updated: 4 Feb 2016
Results posted: Yes, on ClinicalTrials.gov

Publications

Kang S, Kim KH, Kim YT, Kim YT, Kim JH, Song YS, Shin SH, Ryu HS, Han JW, Kang JH, Park SY. Safety and immunogenicity of a vaccine targeting human papillomavirus types 6, 11, 16 and 18: a randomized, placebo-controlled trial in 176 Korean subjects. Int J Gynecol Cancer. 2008 Sep-Oct;18(5):1013-9. doi: 10.1111/j.1525-1438.2007.01123.x. Epub 2007 Nov 6.
PubMed 17986242
Hurt L, Nsouli-Maktabi H, Rohrbeck P, Clark LL. Use of quadrivalent human papillomavirus vaccine and the prevalence of antibodies to vaccine-targeted strains among female service members before and after vaccination. MSMR. 2016 Feb;23(2):6-13.
PubMed 26930146

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 4 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Immunogenicity and Safety Study of Gardasil (V501 (Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine)) in Females 9 to 23 Years of Age in Korea
ClinicalTrials.gov ID: NCT00157950
Acronym / sponsor ID: V501-023
Conditions: Papillomavirus Infections
Keywords: Human Papilloma Virus
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 176 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Oct 2005
Primary completion: Jun 2006 (actual)
Study completion: Jun 2006 (actual)
First posted: 12 Sep 2005 (estimated)
Results: Posted 14 Sep 2010

Clinical summary

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

This is an immunogenicity and safety study of Gardasil (V501) in females 9 to 23 years of age in Korea.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Gardasil™	Experimental	Biological: Gardasil™Gardasil™ 3 dose regimen
Placebo	Placebo comparator	Biological: PlaceboGardasil™ matching placebo 3 dose regimen

Who may qualify

Ages: 9 to 23 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (2 listed)

Girls ages 9 to 15 years (must not yet have had coitarche)
Healthy females ages 16 to 23 years (individuals with a lifetime history of 0 to 3 male or female sexual partners)

Key exclusion criteria (5 listed)

History of known prior vaccination with an HPV vaccine.
Individuals with any prior history of genital warts or treatment for genital warts.
Individuals with > 3 lifetime male or female sexual partners.

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
Gardasil™Also: V501Gardasil™ 3 dose regimen (Day 1, Month 2 and Month 6)	Biological	Gardasil™
PlaceboGardasil™ matching placebo 3 dose regimen (Day 1, Month 2 and Month 6)	Biological	Placebo

Primary outcome

Number of Participants Who Seroconvert to HPV 6.
Time frame: Week 4 Postdose 3
Vaccine-induced anti-HPV 6 seroconversion following administration of a 3-dose regimen of GARDASIL® in females 9 to 23 years of age in Korea. Seroconversion for HPV 6 was defined as achieving an anti-HPV cLIA (Competitive Luminex immunoassay) level of at least 20 mMU/mL.
Number of Participants Who Seroconvert to HPV 11.
Time frame: Week 4 Postdose 3
Vaccine-induced anti-HPV 11 seroconversion following administration of a 3-dose regimen of GARDASIL® in females 9 to 23 years of age in Korea. Seroconversion for HPV 11 was defined as achieving an anti-HPV cLIA (Competitive Luminex immunoassay) level of at least 16 mMU/mL.
Number of Participants Who Seroconvert to HPV 16.
Time frame: Week 4 Postdose 3
Vaccine-induced anti-HPV 16 seroconversion following administration of a 3-dose regimen of GARDASIL® in females 9 to 23 years of age in Korea. Seroconversion for HPV 16 was defined as achieving an anti-HPV cLIA (Competitive Luminex immunoassay) level of at least 20 mMU/mL.
Number of Participants Who Seroconvert to HPV 18.
Time frame: Week 4 Postdose 3
Vaccine-induced anti-HPV 18 seroconversion following administration of a 3-dose regimen of GARDASIL® in females 9 to 23 years of age in Korea. Seroconversion for HPV 18 was defined as achieving an anti-HPV cLIA (Competitive Luminex immunoassay) level of at least 24 mMU/mL.

1 secondary outcome

Number of Participants With Adverse Experiences
Time frame: Overall study including 14 calendar days after the last vaccination visit.

Results and safety

Results posted to the registry on 14 Sep 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Gardasil™	117	116
Placebo	59	59

Primary outcome: Number of Participants Who Seroconvert to HPV 6.

Time frame: Week 4 Postdose 3. Number. Unit: Participants

Measure	Gardasil™ n = 111	Placebo n = 58
Value	109	0

Gardasil™: Proportion: 98.2 (95% CI 93.6 to 99.8)

Population analysed: Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.

Primary outcome: Number of Participants Who Seroconvert to HPV 11.

Time frame: Week 4 Postdose 3. Number. Unit: Participants

Measure	Gardasil™ n = 112	Placebo n = 58
Value	112	1

Gardasil™: Proportion: 100 (95% CI 96.8 to 100)

Population analysed: Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.

Primary outcome: Number of Participants Who Seroconvert to HPV 16.

Time frame: Week 4 Postdose 3. Number. Unit: Participants

Measure	Gardasil™ n = 113	Placebo n = 58
Value	112	0

Gardasil™: Proportion: 99.1 (95% CI 95.2 to 100)

Population analysed: Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.

Primary outcome: Number of Participants Who Seroconvert to HPV 18.

Time frame: Week 4 Postdose 3. Number. Unit: Participants

Measure	Gardasil™ n = 110	Placebo n = 58
Value	109	0

Gardasil™: Proportion: 99.1 (95% CI 95.0 to 100)

Population analysed: Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: During the double-blind period including 14 calendar days after the last vaccination visit.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Gardasil™	1 of 117 (0.9%)	88 of 117 (75.2%)	Not reported
Placebo	1 of 59 (1.7%)	41 of 59 (69.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 17986242Kang S, Kim KH, Kim YT, Kim YT, Kim JH, Song YS, Shin SH, Ryu HS, Han JW, Kang JH, Park SY. Safety and immunogenicity of a vaccine targeting human papillomavirus types 6, 11, 16 and 18: a randomized, placebo-controlled trial in 176 Korean subjects. Int J Gynecol Cancer. 2008 Sep-Oct;18(5):1013-9. doi: 10.1111/j.1525-1438.2007.01123.x. Epub 2007 Nov 6.
Derived from this study: PubMed 26930146Hurt L, Nsouli-Maktabi H, Rohrbeck P, Clark LL. Use of quadrivalent human papillomavirus vaccine and the prevalence of antibodies to vaccine-targeted strains among female service members before and after vaccination. MSMR. 2016 Feb;23(2):6-13.

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 Monitor study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Gardasil™ 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 2 inclusion and 5 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 4 Feb 2016. 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. Some participants in this study may receive a placebo. 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 14 Sep 2010). 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?

Number of Participants Who Seroconvert to HPV 6. (time frame: Week 4 Postdose 3). 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 NCT00157950, which also lists 2 linked publications.

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 4 Feb 2016.