HPV InfectionsPhase 2NCT00378560
V501 Efficacy Study in Women Aged 18 to 26 (V501-027)
A Phase 2 study testing Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine in people with HPV Infections, run by Merck Sharp & Dohme LLC.
Trial summary
A study to evaluate the efficacy, immunogenicity, safety and tolerability of V501 in adult women Read more about this study
- Who is it for?
- Ages 18 to 26 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HPV Infections
- What is being tested?
- Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,021 participants
- Where
- No sites listed yet
- Study dates
- 12 Jun 2006to 16 Sep 2009
- Phase
- Phase 2
- 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 18 to 26 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female Subject Aged 18 To 26 Years
- With 1-4 Lifetime Sexual Partners
Who cannot join
- Male Subject
About this study
Official title: V501 Phase II Efficacy Study in Women Aged 18 to 26
A study to evaluate the efficacy, immunogenicity, safety and tolerability of V501 in adult women
- Conditions
- HPV Infections
- Being tested
- Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine, Comparator: Placebo
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant VaccineBiological
Also called V501, Gardasil
V501; Gardasil, 0.5 ml injection in 3 dosing regimen
Comparator: PlaceboBiological
Placebo 0.5 ml injection in 3 dosing regimen
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Placebo Receives: Biological: Comparator: Placebo |
| 2 | Experimental | Vaccine Receives: Biological: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined Incidence of Persistent Human Papillomavirus (HPV) 6, 11, 16 and 18 Infection or HPV 6, 11, 16 and 18 Related-Disease as Determined by Clinical/Pathologic Criteria and Positive Polymerase Chain Reaction (PCR) Assay for Virus Subtype
Participants with HPV 6, 11, 16 or 18 persistent infection, and genital disease (e.g., cervical, vaginal or vulval intraepithelial neoplasia, or cancer, adenocarcinoma in situ and genital warts) per 100 person-years of follow up.
Measured: Over 30 months
Secondary outcomes (4)
Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 6)
Month 7 HPV Competitive Luminex immunoassay (cLIA) Geometric Mean Titers (GMTs) by vaccine group.
The limit of detection of the assay was 7 mMU/ml. GMTs and confidence limits below the limit of detection are shown as "7.0".
Measured: At one month after completed vaccination series (Month 7)
Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 11)
Month 7 HPV cLIA Geometric Mean Titers by vaccine group.
The limit of detection of the assay was 8 mMU/ml. GMTs and confidence limits below the limit of detection are shown as "8.0".
Measured: At one month after completed vaccination series (Month 7)
Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 16)
Month 7 HPV cLIA Geometric Mean Titers by vaccine group.
The limit of detection of the assay was 11 mMU/ml. GMTs and confidence limits below the limit of detection are shown as "11.0".
Measured: At one month after completed vaccination series (Month 7)
Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 18)
Month 7 HPV cLIA Geometric Mean Titers by vaccine group.
The limit of detection of the assay was 10 mMU/ml. GMTs and confidence limits below the limit of detection are shown as "10.0".
Measured: At one month after completed vaccination series (Month 7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2006 (estimated)
- Study start12 Jun 2006
- Primary completion16 Sep 2009
- Study completion16 Sep 2009
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 HPV 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,021 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00378560
- Sponsor's protocol ID
- V501-027
- Other IDs
- 2006_032
- Status last verified
- Mar 2017
- First submitted
- 18 Sep 2006
- Last updated
- 17 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- Yes: http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf http://engagezone.msd.com/ds\_documentation.php
Publications
Yoshikawa H, Ebihara K, Tanaka Y, Noda K. Efficacy of quadrivalent human papillomavirus (types 6, 11, 16 and 18) vaccine (GARDASIL) in Japanese women aged 18-26 years. Cancer Sci. 2013 Apr;104(4):465-72. doi: 10.1111/cas.12106. Epub 2013 Mar 7.
PubMed 23331518Murata S, Shirakawa M, Sugawara Y, Shuto M, Sawata M, Tanaka Y. Post-hoc analysis of injection-site reactions following vaccination with quadrivalent human papillomavirus vaccine in Japanese female clinical trial participants. Papillomavirus Res. 2020 Dec;10:100205. doi: 10.1016/j.pvr.2020.100205. Epub 2020 Aug 19.
PubMed 32827835
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- V501 Phase II Efficacy Study in Women Aged 18 to 26
- ClinicalTrials.gov ID
- NCT00378560
- Acronym / sponsor ID
- V501-027
- Conditions
- HPV Infections
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,021 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 12 Jun 2006 (actual)
- Primary completion
- 16 Sep 2009 (actual)
- Study completion
- 16 Sep 2009 (actual)
- First posted
- 20 Sep 2006 (estimated)
- Results
- Posted 29 Jun 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study to evaluate the efficacy, immunogenicity, safety and tolerability of V501 in adult women
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Biological: Comparator: PlaceboPlacebo |
| 2 | Experimental | Biological: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant VaccineVaccine |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Female Subject Aged 18 To 26 Years
- With 1-4 Lifetime Sexual Partners
Key exclusion criteria (1 listed)
- Male Subject
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 |
|---|---|---|
| Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant VaccineAlso: V501, GardasilV501; Gardasil, 0.5 ml injection in 3 dosing regimen | Biological | 2 |
| Comparator: PlaceboPlacebo 0.5 ml injection in 3 dosing regimen | Biological | 1 |
Primary outcome
Combined Incidence of Persistent Human Papillomavirus (HPV) 6, 11, 16 and 18 Infection or HPV 6, 11, 16 and 18 Related-Disease as Determined by Clinical/Pathologic Criteria and Positive Polymerase Chain Reaction (PCR) Assay for Virus Subtype
Time frame: Over 30 months
Participants with HPV 6, 11, 16 or 18 persistent infection, and genital disease (e.g., cervical, vaginal or vulval intraepithelial neoplasia, or cancer, adenocarcinoma in situ and genital warts) per 100 person-years of follow up.
4 secondary outcomes
Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 6)
Time frame: At one month after completed vaccination series (Month 7)
Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 11)
Time frame: At one month after completed vaccination series (Month 7)
Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 16)
Time frame: At one month after completed vaccination series (Month 7)
Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 18)
Time frame: At one month after completed vaccination series (Month 7)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23331518Yoshikawa H, Ebihara K, Tanaka Y, Noda K. Efficacy of quadrivalent human papillomavirus (types 6, 11, 16 and 18) vaccine (GARDASIL) in Japanese women aged 18-26 years. Cancer Sci. 2013 Apr;104(4):465-72. doi: 10.1111/cas.12106. Epub 2013 Mar 7.
- Derived from this study: PubMed 32827835Murata S, Shirakawa M, Sugawara Y, Shuto M, Sawata M, Tanaka Y. Post-hoc analysis of injection-site reactions following vaccination with quadrivalent human papillomavirus vaccine in Japanese female clinical trial participants. Papillomavirus Res. 2020 Dec;10:100205. doi: 10.1016/j.pvr.2020.100205. Epub 2020 Aug 19.
- Individual participant dataSharing planned: Yes. http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php
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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 2 study testing Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine in people with HPV 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 1 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 17 Apr 2017. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 29 Jun 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?
Combined Incidence of Persistent Human Papillomavirus (HPV) 6, 11, 16 and 18 Infection or HPV 6, 11, 16 and 18 Related-Disease as Determined by Clinical/Pathologic Criteria and Positive Polymerase Chain Reaction (PCR) Assay for Virus Subtype (time frame: Over 30 months). 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 NCT00378560, 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 17 Apr 2017.