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).

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 3

Conditions

Papillomavirus Infections

Treatments

Biological: V503

Study type

Interventional

Funder types

Industry

Identifiers

NCT01254643

V503-008

Details and patient eligibility

About

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 all human papillomavirus (HPV) strains contained in the vaccine. The success criterion for the primary analysis requires that point estimates for seroconversion rate be greater than 90% for all 9 HPV types.

Enrollment

100 patients

Sex

Female

Ages

9 to 15 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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 criteria

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