Clinical trial NCT01254643: 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).
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Papillomavirus Infections
Keywords: Papillomavirus vaccines
Uterine cervical cancer
Human Papilloma Virus infections
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2010-12-06
Enrollment: 100
Sex: FEMALE
Minimum age (years): 9
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine
timeFrame: 4 weeks post-vaccination 3 (Month 7)
measure: Percentage of Participants With an Injection-site Adverse Event (AE)
timeFrame: up to 5 days after any vaccination
measure: Percentage of Participants With a Non-Injection Site (Systemic) AE
timeFrame: up to 15 days after any vaccination
measure: Percentage of Participants With a Vaccine-related AE
timeFrame: up to 15 days after any vaccination
Secondary outcomes:
measure: Geometric Mean Titers (GMTs) for Each of the HPV Types Contained in the Vaccine
timeFrame: 4 weeks post-vaccination 3 (Month 7)
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Iwata S, Murata S, Rong Han S, Wakana A, Sawata M, Tanaka Y. Safety and Immunogenicity of a 9-Valent Human Papillomavirus Vaccine Administered to 9- to 15-Year-Old Japanese Girls. Jpn J Infect Dis. 2017 Jul 24;70(4):368-373. doi: 10.7883/yoken.JJID.2016.299. Epub 2016 Dec 22.