HPV InfectionsPhase 2NCT00411749

V501 Immunogenicity Study in Females Age 9 to 17 Years (V501-028)

A Phase 2 study testing Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (V501) in people with HPV 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.

Official record

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Trial summary

The study evaluates the immunogenicity, safety and tolerability of V501 in preadolescent females Read more about this study

Who is it for?: Ages 9 to 17 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 (V501)
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 107 participants
Where: No sites listed yet
Study dates: 11 Dec 2006to 18 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 9 to 17 years
Women only
Healthy volunteers accepted
Child

Who may be able to join

Virginal Female Subject Aged 9 To 17 Years

Who cannot join

Male Subject

About this study

Official title: V501 Phase II Immunogenicity Study in Females Aged 9 to 17 Years

The study evaluates the immunogenicity, safety and tolerability of V501 in preadolescent females

Conditions: HPV Infections
Being tested: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (V501), Comparator: Placebo (unspecified)
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 Vaccine (V501)Biological
Also called V501, Gardasil
V501; Gardasil, 0.5 ml injection in 3 dosing regimen
Comparator: Placebo (unspecified)Biological
Placebo 0.5 ml injection in 3 dosing regimen

Study groups in NCT00411749
Study group	Role	What they receive
V501	Experimental	V501 vaccination Quadrivalent HPV (Types 6, 11, 16, 18) L1 VLP Vaccine Injection cervix cancer exgenlesion Vaccination at Day 1, Month 2, and Month 6. Total 3 vaccinations. 0.5 mL intramuscular dose of V501 (HPV L1 Virus-Like Particle [VLP] Type 6, Type 11, Type 16, Type 18) or placebo at Day 1, Month 2 and Month 6. Receives: Biological: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (V501)
Placebo	Placebo comparator	Placebo vaccination, Placebo 0.5 ml injection in 3 dosing regimen Receives: Biological: Comparator: Placebo (unspecified)

What is being measured

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

Human Papilloma Virus (HPV) 6 Serum Antibody Titer at One Month After Completed Vaccination Series
Month 7 HPV Competitive Luminex immunoassay (cLIA) Geometric Mean Titers (GMT) 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)
Human Papilloma Virus (HPV) 11 Serum Antibody Titer at One Month After Completed Vaccination Series
Month 7 HPV Competitive Luminex immunoassay (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)
Human Papilloma Virus (HPV) 16 Serum Antibody Titer at One Month After Completed Vaccination Series
Month 7 HPV Competitive Luminex immunoassay (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)
Human Papilloma Virus (HPV) 18 Serum Antibody Titer at One Month After Completed Vaccination Series
Month 7 HPV Competitive Luminex immunoassay (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)

Secondary outcomes (1)

HPV 6, 11, 16 and 18 Serum Antibody Titer at 24 Month After Completed Vaccination Series
Month 30 HPV cLIA Geometric Mean Titers by vaccine group.
Measured: 24 month after completed vaccination series (Month 30)

Timeline

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

11 Dec 200618 Sep 2009

First posted15 Dec 2006 (estimated)
Study start11 Dec 2006
Primary completion18 Sep 2009
Study completion18 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 (1)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: 107 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00411749
Sponsor's protocol ID: V501-028
Other IDs: 2006_052
Status last verified: Mar 2017
First submitted: 14 Dec 2006
Last updated: 21 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

Murata 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

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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Active, not recruitingPhase 4
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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 HPV Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: V501 Phase II Immunogenicity Study in Females Aged 9 to 17 Years
ClinicalTrials.gov ID: NCT00411749
Acronym / sponsor ID: V501-028
Conditions: HPV Infections
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 107 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 11 Dec 2006 (actual)
Primary completion: 18 Sep 2009 (actual)
Study completion: 18 Sep 2009 (actual)
First posted: 15 Dec 2006 (estimated)
Results: Posted 18 Aug 2010

Clinical summary

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

The study evaluates the immunogenicity, safety and tolerability of V501 in preadolescent females

Study design

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

Arm	Type	Receives
V501	Experimental	Biological: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (V501)V501 vaccination Quadrivalent HPV (Types 6, 11, 16, 18) L1 VLP Vaccine Injection cervix cancer exgenlesion Vaccination at Day 1, Month 2, and Month 6. Total 3 vaccinations. 0.5 mL intramuscular dose of V501 (HPV L1 Virus-Like Particle [VLP] Type 6, Type 11, Type 16, Type 18) or placebo at Day 1, Month 2 and Month 6.
Placebo	Placebo comparator	Biological: Comparator: Placebo (unspecified)Placebo vaccination, Placebo 0.5 ml injection in 3 dosing regimen

Who may qualify

Ages: 9 to 17 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (1 listed)

Virginal Female Subject Aged 9 To 17 Years

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 Vaccine (V501)Also: V501, GardasilV501; Gardasil, 0.5 ml injection in 3 dosing regimen	Biological	V501
Comparator: Placebo (unspecified)Placebo 0.5 ml injection in 3 dosing regimen	Biological	Placebo

Primary outcome

Human Papilloma Virus (HPV) 6 Serum Antibody Titer at One Month After Completed Vaccination Series
Time frame: At one month after completed vaccination series (Month 7)
Month 7 HPV Competitive Luminex immunoassay (cLIA) Geometric Mean Titers (GMT) 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".
Human Papilloma Virus (HPV) 11 Serum Antibody Titer at One Month After Completed Vaccination Series
Time frame: At one month after completed vaccination series (Month 7)
Month 7 HPV Competitive Luminex immunoassay (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".
Human Papilloma Virus (HPV) 16 Serum Antibody Titer at One Month After Completed Vaccination Series
Time frame: At one month after completed vaccination series (Month 7)
Month 7 HPV Competitive Luminex immunoassay (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".
Human Papilloma Virus (HPV) 18 Serum Antibody Titer at One Month After Completed Vaccination Series
Time frame: At one month after completed vaccination series (Month 7)
Month 7 HPV Competitive Luminex immunoassay (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".

1 secondary outcome

HPV 6, 11, 16 and 18 Serum Antibody Titer at 24 Month After Completed Vaccination Series
Time frame: 24 month after completed vaccination series (Month 30)

Results and safety

Results posted to the registry on 18 Aug 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
V501	82	82
Placebo	25	25

Primary outcome: Human Papilloma Virus (HPV) 6 Serum Antibody Titer at One Month After Completed Vaccination Series

Time frame: At one month after completed vaccination series (Month 7). Geometric mean (95% Confidence Interval). Unit: Geometric Mean Titers (mMU/mL)

Measure	V501 n = 80	Placebo n = 25
Value	674.5 (528.6 to 860.8)	7.0 (7.0 to 8.4)

V501 vs Placebo: p <0.001, Wilcoxon (Mann-Whitney)

Population analysed: The per protocol immunogenicity population includes all subjects who were not general protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 for the relevant HPV type, and a Month 7 serum sample collected within an acceptable time range.

Primary outcome: Human Papilloma Virus (HPV) 11 Serum Antibody Titer at One Month After Completed Vaccination Series

Time frame: At one month after completed vaccination series (Month 7). Geometric mean (95% Confidence Interval). Unit: Geometric Mean Titers (mMU/mL)

Measure	V501 n = 80	Placebo n = 25
Value	944.5 (755.3 to 1181.0)	8.0 (8.0 to 8.5)

V501 vs Placebo: p <0.001, Wilcoxon (Mann-Whitney)

Primary outcome: Human Papilloma Virus (HPV) 16 Serum Antibody Titer at One Month After Completed Vaccination Series

Time frame: At one month after completed vaccination series (Month 7). Geometric mean (95% Confidence Interval). Unit: Geometric Mean Titers (mMU/mL)

Measure	V501 n = 82	Placebo n = 25
Value	4275.4 (3375.4 to 5415.4)	11.0 (11.0 to 13.5)

V501 vs Placebo: p <0.001, Wilcoxon (Mann-Whitney)

Primary outcome: Human Papilloma Virus (HPV) 18 Serum Antibody Titer at One Month After Completed Vaccination Series

Time frame: At one month after completed vaccination series (Month 7). Geometric mean (95% Confidence Interval). Unit: Geometric Mean Titers (mMU/mL)

Measure	V501 n = 82	Placebo n = 25
Value	829.2 (642.3 to 1070.5)	10.0 (10.0 to 10.1)

V501 vs Placebo: p <0.001, Wilcoxon (Mann-Whitney)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Serious Adverse Event (SAE) data were collected from the entire period of the study. Other non serious AE data were collected from Day 1 to Day 15 following vaccination.. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
V501	2 of 82 (2.4%)	77 of 82 (93.9%)	Not reported
Placebo	0 of 25 (0%)	23 of 25 (92%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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

Related trials for HPV 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 2 study testing Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (V501) 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 1 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 21 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 18 Aug 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?

Human Papilloma Virus (HPV) 6 Serum Antibody Titer at One Month After Completed Vaccination Series (time frame: At one month after completed vaccination series (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 NCT00411749, 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 21 Apr 2017.