- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01862874
Efficacy and Tolerability Study of V501 in Japanese Males (V501-122)
March 25, 2019 updated by: Merck Sharp & Dohme LLC
A Phase III Placebo-controlled Clinical Trial to Study the Tolerability, Immunogenicity and Efficacy of V501 in 16- to 26-year-old Japanese Men
A study to evaluate the efficacy and tolerability of V501 (quadrivalent Human Papilloma Virus [HPV] [Type 6, 11, 16 and 18] L1 Virus-Like Particle vaccine, GARDASIL™) in healthy, 16- to 26-year old Japanese males.
The hypotheses tested are: 1) V501 reduces the combined incidence of HPV 6-, 11-, 16-, or 18-related persistent infection compared with placebo, and 2) V501 reduces the combined incidence of HPV 6-, 11-, 16-, or 18-related persistent infection, condyloma acuminata, penile/perianal/perineal intraepithelial neoplasia, or penile, perianal, or perineal cancer compared with placebo.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1124
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 26 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Japanese
- No clinical evidence of gross genital lesion suggesting sexually-transmitted disease and no clinically present external genital warts
- Other inclusion criteria will be discussed with the investigator during screening
Exclusion Criteria:
- History of known prior vaccination with an HPV vaccine or plans to receive one outside the study
- History of external genital warts
- History of severe allergic reaction that required medical intervention
- Received immune globulin or blood-derived products in the past 6 months or plan to receive any before Month 7 of the study
- History of splenectomy, is currently immunocompromised, or has been diagnosed with immunodeficiency, Human Immunodeficiency Virus (HIV), lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune condition
- Received immunosuppressive therapy in the past year, excluding inhaled, nasal, or topical corticosteroids and certain regimens of systemic corticosteroids
- Known thrombocytopenia or coagulation disorder that would contraindicate intramuscular injections
- Ongoing alcohol or drug abuse within the past 12 months
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: V501
Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Follow-up was up to Month 36.
|
Formulated with aluminum hydroxyphosphate sulfate (AAHS) adjuvant
Other Names:
|
Placebo Comparator: Placebo
Participants received placebo 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Follow-up was up to Month 36.
|
Formulated with AAHS adjuvant
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Combined Incidence of HPV Type 6, 11, 16, or 18-related Persistent Infection
Time Frame: Up to Month 36
|
Persistent infection was defined as 1) polymerase chain reaction (PCR) positive to HPV Type 6, 11, 16, or 18 in 2 consecutive anogenital or biopsy samples collected ≥4 months apart, or 2) Pathology Panel consensus diagnosis of condyloma acuminate, penile/perianal/perineal intraepithelial neoplasia (PIN), penile, perianal, or perineal cancer and PCR detection of HPV Type 6, 11, 16, or 18 in an adjacent section and PCR positive for the same HPV type at a separate adjacent visit.
The combined incidence of HPV Type 6, 11, 16, or 18 persistent infection detected in samples from ≥2 consecutive visits ≥6 months apart was assessed.
|
Up to Month 36
|
Percentage of Participants With Maximum Temperature ≥37.5°C Reported on the Vaccination Report Card
Time Frame: Up to 5 days after any vaccination
|
Body temperature (oral or oral equivalent) was recorded on the Vaccination Report Card (VRC).
The percentage of participants with a maximum temperature ≥37.5°C was summarized.
|
Up to 5 days after any vaccination
|
Percentage of Participants With an Injection-site Adverse Event Prompted on the Vaccination Report Card
Time Frame: Up to 5 days after any vaccination
|
An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study drug.
An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug or a protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure.
Any worsening of a preexisting condition that is temporally associated with the study drug or protocol-specified procedure is also an AE.
The percentage of participants with an injection-site AE prompted on the VRC (erythema, pain, and swelling) was summarized.
|
Up to 5 days after any vaccination
|
Percentage of Participants With a Systemic Adverse Event
Time Frame: Up to 15 days after any vaccination
|
An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study drug.
An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug or a protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure.
Any worsening of a preexisting condition that is temporally associated with the study drug or protocol-specified procedure is also an AE.
The percentage of participants with a systemic AE was summarized.
|
Up to 15 days after any vaccination
|
Percentage of Participants With a Vaccine-related Systemic Adverse Event
Time Frame: Up to 15 days after any vaccination
|
An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study drug.
An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug or a protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure.
Any worsening of a preexisting condition that is temporally associated with the study drug or protocol-specified procedure is also an AE.
Vaccine-related AEs are those that were deemed possibly, probably, or definitely related to vaccine administration by the investigator.
The percentage of participants with a vaccine-related systemic AE was summarized.
|
Up to 15 days after any vaccination
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Combined Incidence of HPV Type 6, 11, 16, or 18-related Persistent Infection or Disease
Time Frame: Up to Month 36
|
Persistent infection was defined as 1) polymerase chain reaction (PCR) positive to HPV Type 6, 11, 16, or 18 in 2 consecutive anogenital or biopsy samples collected ≥4 months apart, or 2) Pathology Panel consensus diagnosis of condyloma acuminate, penile/perianal/perineal intraepithelial neoplasia (PIN), penile, perianal, or perineal cancer and PCR detection of HPV Type 6, 11, 16, or 18 in an adjacent section and PCR positive for the same HPV type at a separate adjacent visit.
The incidence of persistent infection detected in samples from ≥2 consecutive visits ≥6 months apart was assessed.
Disease was defined as HPV Type 6, 11, 16, or 18-related condyloma acuminate, PIN, penile, perianal, or perineal cancer.
The combined incidence of HPV Type 6, 11, 16, or 18 persistent infection or disease was assessed.
|
Up to Month 36
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 27, 2013
Primary Completion (Actual)
August 30, 2017
Study Completion (Actual)
August 30, 2017
Study Registration Dates
First Submitted
May 22, 2013
First Submitted That Met QC Criteria
May 22, 2013
First Posted (Estimate)
May 27, 2013
Study Record Updates
Last Update Posted (Actual)
April 2, 2019
Last Update Submitted That Met QC Criteria
March 25, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- V501-122 (Other Identifier: Merck Protocol Number)
- 132237 (Registry Identifier: JAPIC-CTI)
- 2015-002931-16 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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