Clinical Trials List
2025-09-01 - 2029-12-31
Recruiting6
ICD-10B97.7
Papillomavirus as the cause of diseases classified elsewhere
ICD-9079.4
Human papilloma virus infections in conditions classified elsewhere and of unspecified site
A Phase 2, Randomized, Double-Blind, Comparator-Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of V540A in Healthy Females 16 to 26 Years of Age
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Trial Applicant
Merck Sharp & Dohme (I.A.) LLC
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2026/04/10
Investigators and Locations
Co-Principal Investigator
- 呂其融 Division of Infectious Disease
- 梁智瑋 Division of Infectious Disease
- Chun-Yu Lin Division of Infectious Disease
- Shang-Yi Lin Division of Infectious Disease
- Po-Liang Lu Division of Infectious Disease
- Chun-Yuan Lee Division of Infectious Disease
- Chung-Hao Huang Division of Infectious Disease
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Yhu-Chering Huang Division of Pediatrics
- Chi-Long Chen Division of Pediatrics
- MING-HAN TSAI Division of Pediatrics
- 郭貞孍 Division of Pediatrics
- 謝育嘉 Division of Pediatrics
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 黃建榮 Division of Urology
- CHIEN-CHIH WU Division of Urology
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 劉芝谷 Division of Obstetrics & Gynecology
- Chien-Hsing Lu Division of Obstetrics & Gynecology
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Human Papillomavirus 9-valent Vaccine, Recombinant
Dosage Form
270
Dosage
0.5 mL/vial
Endpoints
• Recorded fever from day 1 to day 5 after each vaccination
• Vaccine-related serious adverse events (SAEs) occurring from day 1 throughout the trial participation period
• Serum antibody titers against each common HPV vaccine type measured by cLIA on day 29 (7 months) after the third dose of vaccine
Inclution Criteria
The main inclusion criteria include but are not limited to the following:
Is in good health
Has a lifetime history of 0 to 4 sexual partners of any sex/gender
A participant assigned female sex at birth is eligible to participate if not breastfeeding during the study intervention period and for at least 30 days after the last dose of study intervention
Exclusion Criteria
The main exclusion criteria include but are not limited to the following:
Has a history of severe allergic reaction (e.g., swelling of the mouth and throat, difficulty breathing, hypotension, or shock) that required medical intervention
Has known or history of functional or anatomic asplenia
Is currently immunocompromised or has been diagnosed as having congenital or acquired immunodeficiency, human immunodeficiency virus infection, lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune condition
Has thrombocytopenia or other coagulation disorder
Has had a positive test for human papillomavirus (HPV)
Has a history of recurrent respiratory papillomatosis or HPV-related head and neck cancer, or HPV-related anal lesions or anal cancer
Has a history of an abnormal cervical biopsy result
Has a history of HPV-related external genital lesions or external genital cancer, HPV-related vaginal lesions or vaginal cancer
Has received a dose of any HPV vaccine before study entry
Has received within 12 months before the Day 1 vaccination, is receiving, or plans to receive during the study, immunosuppressive therapies or other therapy known to interfere with the immune response
Is currently receiving systemic steroid therapy or has received 2 or more courses of high-dose corticosteroids lasting at least 1 week in duration in the year prior to Day 1 vaccination
Has received within the 3 months before the Day 1 vaccination, is receiving, or plans to receive during the study any immune globulin product
The Estimated Number of Participants
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Taiwan
45 participants
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Global
525 participants
