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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).

ClinicalTrials.gov Identifier: NCT01254643 (view full study on clinicaltrials.gov)
Condition:  Papillomavirus infections
Status:  Completed


Official Title: A Phase III Open-label, Safety, Tolerability and Immunogenicity Study of a 9-Valent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine Administered to 9- to 15-Year-Old Japanese preadolescent and adolescent girls

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.

Study Type:
Interventional
Study Phase:
Phase 3
Enrollment:
100
Study Start Date:
January 2011
Study Completion Date:
August 2013
Primary Completion Date:
August 2013
Ages Eligible for Study:
9 years to 15 years
Genders Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes


CRITERIA

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

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Clinical Study Reports

Synopsis  V503-008


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