A Study of the Safety, Tolerability, and Immunogenicity of V503 Administered to 9- to 15-Year-Old Japanese Girls (V503-008)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01254643
First received: December 3, 2010
Last updated: September 9, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Papillomavirus Infections
Biological: V503
Phase 3

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

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Number of participants who seroconvert for Human Papillomavirus (HPV) Type 6 [ Time Frame: Month 7 (1 month postdose 3) ] [ Designated as safety issue: No ]
  • Number of participants who seroconvert for HPV Type 11 [ Time Frame: Month 7 (1 month postdose 3) ] [ Designated as safety issue: No ]
  • Number of participants who seroconvert for HPV Type 16 [ Time Frame: Month 7 (1 month postdose 3) ] [ Designated as safety issue: No ]
  • Number of participants who seroconvert for HPV Type 18 [ Time Frame: Month 7 (1 month postdose 3) ] [ Designated as safety issue: No ]
  • Number of participants who seroconvert for HPV Type 31 [ Time Frame: Month 7 (1 month postdose 3) ] [ Designated as safety issue: No ]
  • Number of participants who seroconvert for HPV Type 33 [ Time Frame: Month 7 (1 month postdose 3) ] [ Designated as safety issue: No ]
  • Number of participants who seroconvert for HPV Type 45 [ Time Frame: Month 7 (1 month postdose 3) ] [ Designated as safety issue: No ]
  • Number of participants who seroconvert for HPV Type 52 [ Time Frame: Month 7 (1 month postdose 3) ] [ Designated as safety issue: No ]
  • Number of participants who seroconvert for HPV Type 58 [ Time Frame: Month 7 (1 month postdose 3) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Geometric mean titer (GMT) of HPV Type 6 antibody levels [ Time Frame: Month 7 (1 month postdose 3) ] [ Designated as safety issue: No ]
  • Geometric mean titer (GMT) of HPV Type 11 antibody levels [ Time Frame: Month 7 (1 month postdose 3) ] [ Designated as safety issue: No ]
  • Geometric mean titer (GMT) of HPV Type 16 antibody levels [ Time Frame: Month 7 (1 month postdose 3) ] [ Designated as safety issue: No ]
  • Geometric mean titer (GMT) of HPV Type 18 antibody levels [ Time Frame: Month 7 (1 month postdose 3) ] [ Designated as safety issue: No ]
  • Geometric mean titer (GMT) of HPV Type 31 antibody levels [ Time Frame: Month 7 (1 month postdose 3) ] [ Designated as safety issue: No ]
  • Geometric mean titer (GMT) of HPV Type 33 antibody levels [ Time Frame: Month 7 (1 month postdose 3) ] [ Designated as safety issue: No ]
  • Geometric mean titer (GMT) of HPV Type 45 antibody levels [ Time Frame: Month 7 (1 month postdose 3) ] [ Designated as safety issue: No ]
  • Geometric mean titer (GMT) of HPV Type 52 antibody levels [ Time Frame: Month 7 (1 month postdose 3) ] [ Designated as safety issue: No ]
  • Geometric mean titer (GMT) of HPV Type 58 antibody levels [ Time Frame: Month 7 (1 month postdose 3) ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: January 2011
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: V503
Study vaccine
Biological: V503
V503 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6

  Eligibility

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01254643     History of Changes
Other Study ID Numbers: V503-008
Study First Received: December 3, 2010
Last Updated: September 9, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Merck Sharp & Dohme Corp.:
Papillomavirus vaccines
Uterine cervical cancer
Human Papilloma Virus infections

Additional relevant MeSH terms:
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections

ClinicalTrials.gov processed this record on April 17, 2014