Status:
COMPLETED
A Study of the Safety, Tolerability, and Immunogenicity of a 9-valent Human Papillomavirus Vaccine ([9vHPV]; V503) Administered to 9- to 15-Year-Old Japanese Girls (V503-008).
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Papillomavirus Infections
Eligibility:
FEMALE
9-15 years
Phase:
PHASE3
Brief Summary
This study will evaluate the safety, tolerability, and immunogenicity of V503 in Japanese girls between the ages of 9 and 15 and will determine whether V503 induces an acceptable immune response to al...
Eligibility Criteria
Inclusion
- Participant is in good physical health-
- Participant's parent/legal guardian is able to read, understand, and complete the vaccine report card
- Participant's parent/legal guardian agrees to provide a phone number for follow-up purposes
- Participant is not sexually active and does not plan to become sexually active during the time from Day 1 to Month 7 of the study
Exclusion
- Participant has a history of severe allergic reaction that required medical intervention
- Participant has thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection
- Participant is pregnant
- Participant intends to donate blood during the time from Day 1 to Month 7 of the study
- Participant is immunocompromised or has been diagnosed as having a congenital or acquired immunodeficiency, human immunodeficiency virus (HIV) infection, lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune condition.
- Participant has had a splenectomy
- Participant has received any of the following immunosuppressive therapies in the year prior to enrollment: radiation therapy, cyclophosphamide, azathioprine, methotrexate, any chemotherapy, cyclosporin, leflunomide (Arava), tumor necrosis factor alpha (TNF-α) antagonists, monoclonal antibody therapies, antilymphocyte sera, or other therapy known to interfere with the immune response.
- Participant has received any immune globulin product or blood-derived product in the three months prior to the Day 1 vaccination, or plans to receive any such product through Month 7 of the study
- Participant has received any inactivated vaccines within 14 days of the Day 1 vaccination or any live vaccines within 28 days of the Day 1 vaccination
- Participant has received a marketed HPV vaccine or has participated in an HPV vaccine clinical trial
- Participant has had a fever (oral temperature ≥37.8°C) within 24 hours of the Day 1 vaccination
- Participant has a history of a positive test for HPV or history of genital warts
Key Trial Info
Start Date :
January 12 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 10 2013
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01254643
Start Date
January 12 2011
End Date
August 10 2013
Last Update
November 28 2018
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