HPV InfectionsPhase 3NCT00834106

Prevention of Human Papillomavirus (HPV) in 20 to 45 Year Old Chinese Women (V501-041)

A Phase 3 study testing Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine 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

A study to test the safety and effectiveness of Quadrivalent HPV (types 6, 11, 16, 18) L1 VLP vaccine against combined incidence of HPV 6/11/16/18-related persistent infection and vaccine type-specific genital disease among Chinese females between the ages of 20 and 45. Read more about this study

Who is it for?: Ages 20 to 45 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: 3,006 participants
Where: No sites listed yet
Study dates: 31 Dec 2008to 30 Sep 2016
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 20 to 45 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Healthy women between the ages of 20 and 45
Have used effective contraception for 2 weeks prior to starting in the study
Does not have a temperature within 24 hours before the first injection

Who cannot join

Prior history of genital warts
More than 4 lifetime sexual partners
Have undergone hysterectomy
Have active cervical disease or history of cervical disease

About this study

Official title: A Randomized, Placebo-Controlled, Double-Blind Study of Quadrivalent HPV (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine to Investigate the Safety, and Efficacy in Chinese 20 - to 45-Years-Old Women

Read the detailed description

The Base Study V501-041 duration was 30 months. The study was extended to further evaluate the efficacy of Quadrivalent HPV (Type 6, 11, 16, 18) L1 VLP (qHPV) vaccine against Cervical Intraepithelial Neoplasia Grade 2 (CIN 2), CIN 3, Adenocarcinoma In Situ (AIS), and/or cervical cancer. The efficacy was followed through the Month 78 visit, and the close-out visit was conducted at approximately Month 90 with only safety data collected

Conditions: HPV Infections
Being tested: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine, Comparator: placebo (unspecified)
Keywords: HPV 6/11/16/18 Infection
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 Gardasil ™, V501
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine injection at Day 1, Month 2, and Month 6.
Comparator: placebo (unspecified)Biological
Aluminum-containing Vaccine placebo injection at Day 1, Month 2, and Month 6.

Study groups in NCT00834106
Study group	Role	What they receive
qHPV	Experimental	Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine administered by intramuscular injection on Day 1, Month 2, and Month 6 Receives: Biological: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
Placebo	Placebo comparator	Placebo administered by intramuscular injection on Day 1, Month 2, and Month 6 Receives: Biological: Comparator: placebo (unspecified)

What is being measured

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

Base Study: Combined Incidence of 6-Month Persistent Infection, Cervical Intraepithelial Neoplasia (CIN+), and External Genital Lesions Related to Human Papillomavirus (HPV) Type 6, 11, 16, or 18 in 20 to 45 Year Old Participants (Test of Hypothesis)
The endpoint included pathology panel consensus diagnosis of 6-month persistent infection, CIN+ (including CIN grade 1, 2, or 3, cervical adenocarcinoma in situ (AIS), and cervical cancer), or external genital lesions related to HPV Types 6, 11, 16, or 18 detected by polymerase chain reaction (PCR) in an adjacent section from the same tissue block.
Measured: From Day 1 until >=25 cases accumulate, up to Month 30
Base Study: Combined Incidence of 6-Month Persistent Infection, CIN+, and External Genital Lesions Related to Human Papillomavirus (HPV) Type 6, 11, 16, or 18 in 20 to 26 Years Old Participants (Test of Hypothesis)
The endpoint included pathology panel consensus diagnosis of 6-month persistent infection, CIN+ (including CIN grade 1, 2, or 3, cervical adenocarcinoma in situ (AIS), and cervical cancer), or external genital lesions related to HPV Types 6, 11, 16, or 18 detected by PCR in an adjacent section from the same tissue block.
Measured: From Day 1 until >=17 cases accumulate, up to Month 30
Entire Study: Combined Incidence of CIN2+ Related to HPV Types 16 or 18 in 20 to 45 Year Old Participants (End of Study Test of Hypothesis)
The endpoint included pathology panel consensus diagnosis of CIN2+ (including CIN grade 2 or 3, AIS, and cervical cancer) related to HPV Types 16 or 18 detected by PCR in an adjacent section from the same tissue block.
Measured: Up to Month 78
Base Study: Percentage of Participants With One or More Solicited Injection-site Adverse Events
An adverse event (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 sponsor's product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the sponsor's product, is also an AE. Injection-site AEs were prompted on the Vaccination Report Card (VRC), which was completed by the participant for 15 days after each vaccination.
Measured: Up to 15 days after any vaccination
Base Study: Percentage of Participants With One or More Systemic Adverse Events
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 sponsor's product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the sponsor's product, is also an AE.
Measured: Up to 15 days after any vaccination
Base Study: Percentage of Participants Discontinued From Study Vaccination Due to an Adverse Event
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 sponsor's product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the sponsor's product, is also an AE.
Measured: Up to 6 months
Entire Study: Percentage of Participants With One or More Vaccine-related Serious Adverse Events
A serious adverse event (SAE) is an AE that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs a hospitalization, is a congenital anomaly or birth defect, is an overdose or, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention. Related SAEs were those deemed possibly, probably, or definitely related to study vaccine or a study procedure.
Measured: Up to approximately 90 months
Entire Study: Percentage of Participants Who Died
The percentage of participants who died on study due to any cause, whether or not related to the investigational product, were reported for each arm
Measured: Up to approximately 90 months

Secondary outcomes (2)

Entire Study: Combined Incidence of 12-Month Persistent Infection, CIN+, and External Genital Lesions Related to Human Papillomavirus (HPV) Type 6, 11, 16, or 18 in 20 to 45 Year Old Participants (End of Study Update)
The endpoint included pathology panel consensus diagnosis of 12-month persistent infection, CIN+ (including CIN grade 1, 2, or 3, cervical adenocarcinoma in situ (AIS), and cervical cancer), or external genital lesions related to HPV Types 6, 11, 16, or 18 detected by PCR in an adjacent section from the same tissue block.
Measured: Up to 78 months
Entire Study: Combined Incidence of 12-Month Persistent Infection, CIN+, and External Genital Lesions Related to Human Papillomavirus (HPV) Type 6, 11, 16, or 18 in 20 to 26 Year Old Participants (End of Study Update)
The endpoint included pathology panel consensus diagnosis of 12-month persistent infection, CIN+ (including CIN grade 1, 2, or 3, cervical adenocarcinoma in situ (AIS), and cervical cancer), or external genital lesions related to HPV Types 6, 11, 16, or 18 detected by PCR in an adjacent section from the same tissue block.
Measured: Up to 78 months

Timeline

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

31 Dec 200830 Sep 2016

First posted3 Feb 2009 (estimated)
Study start31 Dec 2008
Primary completion11 May 2012
Study completion30 Sep 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 (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 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 3,006 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00834106
Sponsor's protocol ID: V501-041
Other IDs: 2009_532
Status last verified: Jan 2019
First submitted: 30 Jan 2009
Last updated: 4 Feb 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Publications

Wei L, Xie X, Liu J, Zhao Y, Chen W, Zhao C, Wang S, Liao X, Shou Q, Qiu Y, Qiao Y, Saah AJ. Efficacy of quadrivalent human papillomavirus vaccine against persistent infection and genital disease in Chinese women: A randomized, placebo-controlled trial with 78-month follow-up. Vaccine. 2019 Jun 12;37(27):3617-3624. doi: 10.1016/j.vaccine.2018.08.009. Epub 2018 Aug 16.
PubMed 30122646
Chen W, Zhao Y, Xie X, Liu J, Li J, Zhao C, Wang S, Liao X, Shou Q, Zheng M, Saah AJ, Wei L, Qiao Y. Safety of a quadrivalent human papillomavirus vaccine in a Phase 3, randomized, double-blind, placebo-controlled clinical trial among Chinese women during 90 months of follow-up. Vaccine. 2019 Feb 4;37(6):889-897. doi: 10.1016/j.vaccine.2018.12.030. Epub 2019 Jan 9.
PubMed 30638797

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 HPV Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Placebo-Controlled, Double-Blind Study of Quadrivalent HPV (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine to Investigate the Safety, and Efficacy in Chinese 20 - to 45-Years-Old Women
ClinicalTrials.gov ID: NCT00834106
Acronym / sponsor ID: V501-041
Conditions: HPV Infections
Keywords: HPV 6/11/16/18 Infection
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 3,006 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 31 Dec 2008 (actual)
Primary completion: 11 May 2012 (actual)
Study completion: 30 Sep 2016 (actual)
First posted: 3 Feb 2009 (estimated)
Results: Posted 12 Oct 2017

Clinical summary

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

Detailed description

Study design

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

Arm	Type	Receives
qHPV	Experimental	Biological: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant VaccineQuadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine administered by intramuscular injection on Day 1, Month 2, and Month 6
Placebo	Placebo comparator	Biological: Comparator: placebo (unspecified)Placebo administered by intramuscular injection on Day 1, Month 2, and Month 6

Who may qualify

Ages: 20 to 45 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Healthy women between the ages of 20 and 45
Have used effective contraception for 2 weeks prior to starting in the study
Does not have a temperature within 24 hours before the first injection

Key exclusion criteria (4 listed)

Prior history of genital warts
More than 4 lifetime sexual partners
Have undergone hysterectomy
Have active cervical disease or history of cervical disease

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: Gardasil ™, V501Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine injection at Day 1, Month 2, and Month 6.	Biological	qHPV
Comparator: placebo (unspecified)Aluminum-containing Vaccine placebo injection at Day 1, Month 2, and Month 6.	Biological	Placebo

Primary outcome

Base Study: Combined Incidence of 6-Month Persistent Infection, Cervical Intraepithelial Neoplasia (CIN+), and External Genital Lesions Related to Human Papillomavirus (HPV) Type 6, 11, 16, or 18 in 20 to 45 Year Old Participants (Test of Hypothesis)
Time frame: From Day 1 until >=25 cases accumulate, up to Month 30
The endpoint included pathology panel consensus diagnosis of 6-month persistent infection, CIN+ (including CIN grade 1, 2, or 3, cervical adenocarcinoma in situ (AIS), and cervical cancer), or external genital lesions related to HPV Types 6, 11, 16, or 18 detected by polymerase chain reaction (PCR) in an adjacent section from the same tissue block.
Base Study: Combined Incidence of 6-Month Persistent Infection, CIN+, and External Genital Lesions Related to Human Papillomavirus (HPV) Type 6, 11, 16, or 18 in 20 to 26 Years Old Participants (Test of Hypothesis)
Time frame: From Day 1 until >=17 cases accumulate, up to Month 30
The endpoint included pathology panel consensus diagnosis of 6-month persistent infection, CIN+ (including CIN grade 1, 2, or 3, cervical adenocarcinoma in situ (AIS), and cervical cancer), or external genital lesions related to HPV Types 6, 11, 16, or 18 detected by PCR in an adjacent section from the same tissue block.
Entire Study: Combined Incidence of CIN2+ Related to HPV Types 16 or 18 in 20 to 45 Year Old Participants (End of Study Test of Hypothesis)
Time frame: Up to Month 78
The endpoint included pathology panel consensus diagnosis of CIN2+ (including CIN grade 2 or 3, AIS, and cervical cancer) related to HPV Types 16 or 18 detected by PCR in an adjacent section from the same tissue block.
Base Study: Percentage of Participants With One or More Solicited Injection-site Adverse Events
Time frame: Up to 15 days after any vaccination
An adverse event (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 sponsor's product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the sponsor's product, is also an AE. Injection-site AEs were prompted on the Vaccination Report Card (VRC), which was completed by the participant for 15 days after each vaccination.
Base Study: Percentage of Participants With One or More Systemic Adverse Events
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 sponsor's product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the sponsor's product, is also an AE.
Base Study: Percentage of Participants Discontinued From Study Vaccination Due to an Adverse Event
Time frame: Up to 6 months
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 sponsor's product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the sponsor's product, is also an AE.
Entire Study: Percentage of Participants With One or More Vaccine-related Serious Adverse Events
Time frame: Up to approximately 90 months
A serious adverse event (SAE) is an AE that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs a hospitalization, is a congenital anomaly or birth defect, is an overdose or, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention. Related SAEs were those deemed possibly, probably, or definitely related to study vaccine or a study procedure.
Entire Study: Percentage of Participants Who Died
Time frame: Up to approximately 90 months
The percentage of participants who died on study due to any cause, whether or not related to the investigational product, were reported for each arm

2 secondary outcomes

Entire Study: Combined Incidence of 12-Month Persistent Infection, CIN+, and External Genital Lesions Related to Human Papillomavirus (HPV) Type 6, 11, 16, or 18 in 20 to 45 Year Old Participants (End of Study Update)
Time frame: Up to 78 months
Entire Study: Combined Incidence of 12-Month Persistent Infection, CIN+, and External Genital Lesions Related to Human Papillomavirus (HPV) Type 6, 11, 16, or 18 in 20 to 26 Year Old Participants (End of Study Update)
Time frame: Up to 78 months

Results and safety

Results posted to the registry on 12 Oct 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
qHPV	1,503	1,401
Placebo	1,503	1,358

Primary outcome: Base Study: Combined Incidence of 6-Month Persistent Infection, Cervical Intraepithelial Neoplasia (CIN+), and External Genital Lesions Related to Human Papillomavirus (HPV) Type 6, 11, 16, or 18 in 20 to 45 Year Old Participants (Test of Hypothesis)

Time frame: From Day 1 until >=25 cases accumulate, up to Month 30. Number. Unit: Cases per 100 person-years of follow-up

Measure	qHPV n = 1281	Placebo n = 1249
Value	0.3	1.2

qHPV vs Placebo: Vaccine efficacy: 76.0 (95% CI 43.7 to 91.1)

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 HPV types 6, 11, 16, and 18.

Primary outcome: Base Study: Combined Incidence of 6-Month Persistent Infection, CIN+, and External Genital Lesions Related to Human Papillomavirus (HPV) Type 6, 11, 16, or 18 in 20 to 26 Years Old Participants (Test of Hypothesis)

Time frame: From Day 1 until >=17 cases accumulate, up to Month 30. Number. Unit: Cases per 100 person-years of follow-up

Measure	qHPV n = 760	Placebo n = 733
Value	0.2	1.2

qHPV vs Placebo: Vaccine efficacy: 82.3 (95% CI 38.3 to 96.7)

Population analysed: The population analyzed included participants 20 to 26 years old at Baseline 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 HPV types 6, 11, 16, and 18.

Primary outcome: Entire Study: Combined Incidence of CIN2+ Related to HPV Types 16 or 18 in 20 to 45 Year Old Participants (End of Study Test of Hypothesis)

Time frame: Up to Month 78. Number. Unit: Cases per 100 person-years of follow-up

Measure	qHPV n = 1265	Placebo n = 1237
Value	0.0	0.1

qHPV vs Placebo: Vaccine efficacy: 100 (95% CI 32.3 to 100), p = 0.0072, Exact test, 1-sided

Primary outcome: Base Study: Percentage of Participants With One or More Solicited Injection-site Adverse Events

Time frame: Up to 15 days after any vaccination. Number. Unit: Percentage of participants

Measure	qHPV n = 1499	Placebo n = 1498
Value	37.6	27.8

Population analysed: All vaccinated participants with safety follow-up

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to approximately 90 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
qHPV	38 of 1,499 (2.5%)	876 of 1,499 (58.4%)	Not reported
Placebo	43 of 1,498 (2.9%)	799 of 1,498 (53.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 30122646Wei L, Xie X, Liu J, Zhao Y, Chen W, Zhao C, Wang S, Liao X, Shou Q, Qiu Y, Qiao Y, Saah AJ. Efficacy of quadrivalent human papillomavirus vaccine against persistent infection and genital disease in Chinese women: A randomized, placebo-controlled trial with 78-month follow-up. Vaccine. 2019 Jun 12;37(27):3617-3624. doi: 10.1016/j.vaccine.2018.08.009. Epub 2018 Aug 16.
Derived from this study: PubMed 30638797Chen W, Zhao Y, Xie X, Liu J, Li J, Zhao C, Wang S, Liao X, Shou Q, Zheng M, Saah AJ, Wei L, Qiao Y. Safety of a quadrivalent human papillomavirus vaccine in a Phase 3, randomized, double-blind, placebo-controlled clinical trial among Chinese women during 90 months of follow-up. Vaccine. 2019 Feb 4;37(6):889-897. doi: 10.1016/j.vaccine.2018.12.030. Epub 2019 Jan 9.
Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

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
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Active, not recruitingPhase 4
Comparing Immune Response of 2 vs 3 HPV Doses (27-45 Years Old)
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RecruitingPhase 2
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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 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 3 inclusion and 4 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 2019. 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 12 Oct 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?

Base Study: Combined Incidence of 6-Month Persistent Infection, Cervical Intraepithelial Neoplasia (CIN+), and External Genital Lesions Related to Human Papillomavirus (HPV) Type 6, 11, 16, or 18 in 20 to 45 Year Old Participants (Test of Hypothesis) (time frame: From Day 1 until >=25 cases accumulate, up to Month 30). The study lists 8 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 NCT00834106, 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 2019.