Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
human papillomavirus recombinant vaccine · 1 trial · 1 indication
Participants with HPV 6/11/16/18-related external genital warts, penile/perianal/perineal intraepithelial neoplasia (PIN), penile, perianal or perineal cancer per 100 person-years of follow-up was assessed.
Incidence of HPV Type 6/11-related genital warts is expressed as events per 10,000 person-years of follow-up.
Incidence of HPV Type 6/11/16/18-related external genital warts, PIN, penile, perianal or perineal cancer is expressed as events per 10,000 person-years of follow-up.
Incidence of HPV Type 6/11/16/18-related AIN and anal cancer is expressed as events per 10,000 person-years of follow-up. MSM is men having sex with men.
An adverse event 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 adverse experience. A severe AE is incapacitating with inability to work or do usual activities.
A serious adverse event is an AE that 1) results in death, 2) is life threatening, 3) results in persistent or significant disability or incapacity, 4) results in or prolongs an existing hospitalization, 5) is a congenital anomaly or birth defect, 6) is a cancer, 7) is an overdose, or 8) based on appropriate medical judgment may jeopardize the participant and may require medical or surgical intervention. A vaccine-related AE is one deemed to be possibly, probably or definitely related to study vaccine by the investigator.
An SAE is an AE that 1) results in death, 2) is life threatening, 3) results in persistent or significant disability or incapacity, 4) results in or prolongs an existing hospitalization, 5) is a congenital anomaly or birth defect, 6) is a cancer, 7) is an overdose, or 8) based on appropriate medical judgment may jeopardize the participant and may require medical or surgical intervention. A vaccine-related AE is one deemed to be possibly, probably or definitely related to study vaccine by the investigator.
The number of participants who died was assessed.
| Arm | Type | Description |
|---|---|---|
| qHPV Vaccine | EXPERIMENTAL | The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6. Follow-up for the Base Study encompassed Month 7 through Month 36. |
| Placebo | PLACEBO_COMPARATOR | The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time participants received placebo at Day 1, Month 2 and Month 6. Follow-up for the Base Study encompassed Month 7 through Month 36. |
| Name | Type | Description |
|---|---|---|
| (Gardasil™) human papillomavirus (types 6, 11, 16, 18) recombinant vaccine | BIOLOGICAL | 0.5 mL intramuscular injection in the deltoid muscle at Day 1, Month 2, and Month 6 in the Base Study |
| Comparator: placebo (unspecified) | BIOLOGICAL | 0.5 mL intramuscular injection in the deltoid muscle at Day 1, Month 2, and Month 6 in the Base Study |
Inclusion Criteria: * Healthy heterosexual males between the ages of 16 years and 23 years and 364 days. Healthy men having sex with men (MSM) between the ages of 16 years and 26 years and 364 days. * No clinical evidence of genital lesions suggesting sexually-transmitted disease, and no history of...
The human papillomavirus recombinant vaccine is being studied for the prevention of Condylomata Acuminata, also known as anogenital warts, in young men. It is designed to reduce the incidence of this condition. The vaccine is a Phase 3 investigational product developed by Merck & Company, Inc.
The human papillomavirus recombinant vaccine is developed by Merck & Company, Inc., which trades under the ticker symbol MRK. Merck is responsible for the research and clinical development of this vaccine candidate.
The human papillomavirus recombinant vaccine is in Phase 3 clinical development. It is an investigational vaccine and has not been approved by the FDA for any indication. The Phase 3 trial has been completed.
The human papillomavirus recombinant vaccine has been evaluated in a Phase 3 clinical trial, NCT00090285, titled "An Investigational Study of Gardasil (qHPV Vaccine) in Reducing the Incidence of Anogenital Warts in Young Men (V501-020)." This completed trial enrolled 4,065 male participants aged 16 years and older.
Yes, the human papillomavirus recombinant vaccine is also known as Gardasil, specifically the human papillomavirus (types 6, 11, 16, 18) recombinant vaccine. Gardasil is the brand name used by Merck & Company, Inc. for this vaccine.