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

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:

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 ]

Estimated Enrollment:	100
Study Start Date:	January 2011
Estimated Study Completion Date:	September 2013
Estimated Primary Completion Date:	September 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:	Vice President, Late Stage Development Group Leader, 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:	May 17, 2011
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Merck:

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 May 21, 2013