An Immunogenicity and Safety Study of GARDASIL™ in Chinese Female Subjects Aged 9 to 45 Years and Male Subjects Aged 9 to 15 Years

• Conditions: 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.; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-004581-16-Outside-EU/EEA
• Lead Sponsor: Merck Sharp & Dohme (China) Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04-02
• Last Update Posted: 7 April 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

Key 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

Key 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified