Phase 3
N=1,124
Efficacy and Tolerability Study of V501 in Japanese Males (V501-122)
Anogenital Human Papilloma Virus Infection · Condyloma Acuminata
Bottom Line
View on ClinicalTrials.gov: NCT01862874 ↗Enrolled (actual)
1,124
Serious AEs
0.1%
Results posted
Aug 2018
Primary outcome: Primary: Combined Incidence of HPV Type 6, 11, 16, or 18-related Persistent Infection — 0.3; 1.9 Cases per 100 person-years of follow-up — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- V501 (Biological); Placebo (Biological)
- Age
- Pediatric, Adult · 16+ yrs
- Sex
- Male
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Aug 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Combined Incidence of HPV Type 6, 11, 16, or 18-related Persistent Infection |
0.3; 1.9 | <0.001 sig |
| PRIMARY Percentage of Participants With Maximum Temperature ≥37.5°C Reported on the Vaccination Report Card |
2.7; 3.9 | 0.256 |
| PRIMARY Percentage of Participants With an Injection-site Adverse Event Prompted on the Vaccination Report Card |
24.5; 21.6; 54.9; 48.5; 21.3; 14.5 | 0.251 |
| PRIMARY Percentage of Participants With a Systemic Adverse Event |
14.4; 15.4 | — |
| PRIMARY Percentage of Participants With a Vaccine-related Systemic Adverse Event |
3.4; 5.0 | — |
| SECONDARY Combined Incidence of HPV Type 6, 11, 16, or 18-related Persistent Infection or Disease |
0.3; 1.9 | <0.001 sig |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01862874). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.