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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


Phase 3
9 Years
15 Years
Open (Enrolling)
Female
Papillomavirus Infections

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Number of participants who seroconvert for Human Papillomavirus (HPV) Type 6

Outcome Time Frame:

Month 7 (1 month postdose 3)

Safety Issue:

No

Authority:

Japan: Pharmaceuticals and Medical Devices Agency

Study ID:

V503-008

NCT ID:

NCT01254643

Start Date:

January 2011

Completion Date:

September 2013

Related Keywords:

  • Papillomavirus Infections
  • Papillomavirus vaccines
  • Uterine cervical cancer
  • Human Papilloma Virus infections
  • Papillomavirus Infections

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