Prevention of HPV types 6, 11, 16 and 18 related cervical cancer, vulvar, vaginal pre-cancers, low-grade, pre-cancerous lesions, and genital warts in Chinese female subjects aged 9 to 45 years and male subjects aged 9 to 15 years.
Conditions
Interventions
Trade Name: GARDASIL
Product Name: GARDASIL
Product Code: V501
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Human Papillomavirus Type 6 L1 protein
Other descriptive name: Quadriv
Sponsors
Merck Sharp & Dohme (China) Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Key Inclusion criteria: Healthy Chinese female subjects aged 9-45 years old and male aged 9-15 years old upon receipt of the first study vaccination; not pregnant now for post-pubertal female subjects. Are the trial subjects under 18? yes Number of subjects for this age range: 230 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 370 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Key Exclusion criteria: subjects must have temperature <37.1 degrees C within 24 hours prior to the first injection; without a history of severe allergic reaction or allergic reaction to any vaccine component; no history of immune globulin or blood-derived products within 6 months prior to first injection or plan to receive any through the completion of the study; negative history of splenectomy, immune disorder or receiving immunosuppressives; no history of immunocompromised or HIV infection; no history of thrombocytopenia or any coagulation disorder; no history of abnormal Pap test or biopsy showing CIN or worse; = 4 lifetime sexual partners.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: (1) To evaluate the vaccine-induced serum anti-HPV 6, anti-HPV 11, anti-HPV 16, and anti-HPV 18 antibody titers following administration of a 3-dose regimen of GARDASIL™ compared with placebo. (2) To demonstrate that a 3-dose regimen of GARDASIL™ is generally well tolerated in subjects aged 9 to 45 years.;Secondary Objective: To evaluate the vaccine-induced seroconversion rate of anti-HPV 6, anti-HPV 11, anti-HPV 16, and anti-HPV 18 following administration of a 3-dose regimen of GARDASIL™ in subjects who are seronegative to respective HPV types prior to vaccination.;Primary end point(s): (1) The primary immunogenicity endpoint of interest are the GMTs for each HPV vaccine type, by 1 month Postdose 3. (2) The primary safety variables of key interest are serious adverse experiences, systemic adverse experiences prompted for on the vaccine report card (VRC) occurring within 14 days after each vaccination, and injection-site complaints prompted for on the VRC, such as temperature, redness, swelling, and pain/tenderness/soreness occurring Day 1 through Day 5 after each vaccination.;Timepoint(s) of evaluation of this end point: (1) 1 month Postdose 3; (2) adverse experiences occurring within 14 days after each vaccination. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints are the percentages of vaccine recipients who seroconvert to each of HPV 6, 11, 16, 18 by 1 month Postdose 3.;Timepoint(s) of evaluation of this end point: 1 month Postdose 3 | — |
Countries
China
Contacts
Public ContactGlobal Clinical Trials Operations
Merck Sharp & Dohme Corp.
Outcome results
None listed