A Phase 3, Open-label Clinical Study to Evaluate the Immunogenicity and Safety of 9vHPV Vaccine, in Japanese Boys and Girls, 9 to 15 Years of Age.

Tanaka Yoshiyuki0 sites300 target enrollmentMay 11, 2021

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Not specified
Sponsor: Tanaka Yoshiyuki
Enrollment: 300
Status: Active, Not Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

May 11, 2021

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Tanaka Yoshiyuki

Eligibility Criteria

Inclusion Criteria

•Is Japanese male or female.
•\- Is aged at the time of providing the documented informed consent (inclusive): (3\-dose boy arm) male from 9 years to 15 years old, (2\-dose boy arm) male from 9 years to 14 years old, or (2\-dose girl arm) female from 9 years to 14 years old.
•\- Has a legally acceptable representative who can read, understand and complete the vaccination report card (VRC).
•\- Has not yet had coitarche and does not plan on becoming sexually active during the Day 1 through Month 7\.

Exclusion Criteria

•\- Has a fever (defined as oral temperature \=\>37\.5 degree celusius) within the 24\-hour period prior to the Day 1 visit.
•\- Has a history of severe allergic reaction that required medical intervention.
•\- Is allergic to any vaccine component, including aluminum, yeast, or Benzonase.
•\- Has known thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections.
•\- Is currently 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 auto immune condition.
•\- Has a history of splenectomy.
•\- Has a history of genital warts or positive test for human papillomavirus (HPV).
•\- Is, at the time of signing informed consent, a user of recreational or illicit drugs or has had a recent history (within 12 months) of drug or alcohol abuse or dependence at the discretion of the investigator.
•\- Has received within 12 months prior to enrollment, is receiving, or plans to receive during Day 1 through Month 7 of the study, any study\-prohibited concomitant immunosuppressive therapy.
•\- Has received within the 3 months prior to the Day 1 vaccination, is receiving, or plans to receive during Day 1 through Month 7 of the study, any immune globulin product or blood\-derived product other than intravenous gamma globulin (IVIG).