Status:
COMPLETED
Immunogenicity and Safety Study of NBP615 in Healthy Female
Lead Sponsor:
SK Bioscience Co., Ltd.
Conditions:
Cervical Cancer
Eligibility:
FEMALE
9-26 years
Phase:
PHASE1
PHASE2
Brief Summary
This was a randomized, double-blind, active-controlled, phase I/II clinical trial to enroll 200 healthy female including 80 healthy adult aged 19 to 26 years and 120 adolescents aged 9 to 13 years.
Detailed Description
In order to confirm the safety, 80 healthy adult were enrolled first. Eligible subjects were randomized into 1:1 ratio to receive three doses of either test vaccine (NPB615) or comparator vaccine (Gar...
Eligibility Criteria
Inclusion
- \[Inclusion Criteria\]
- Healthy adult(19 to 26 years)/adolescent(9 to 13 years) of age at the time of the 1st vaccination
- Participant fully understands study procedures, and voluntarily agrees to participate in the study and follow the study procedure by giving written informed consent
- \[Exclusion Criteria\]
- Received a marketed Human papillomavirus(HPV) vaccine, or had participated in an HPV vaccine clinical trial and had received either active agent or placebo.
- History of hypersensitivity to any component of the study vaccines.
- Currently immunocompromised or was diagnosed as having a congenital or acquired immunodeficiency, Human Immunodeficiency Virus(HIV) infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis (JRA), inflammatory bowel disease, other autoimmune condition, or other immune disorder which is decided to be medically significant by the investigator.
- Received immunoglobulins and/or blood product within 3 months preceding the first dose of study vaccine or planned administration during the study period.
- Receiving or had received chemotherapy, immunosuppressive therapies, or radiation therapy in the year prior to enrolment.
- Chronic administration (\>14 days) of immune-suppressants or immune modulating drugs within 3 months prior to the first vaccine dose or planned administration during the study period. Inhaled, nasal and topical steroids are allowed.
- Participant with severe thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections.
- Subject has active cervical disease or a significant history of cervical disease.
Exclusion
Key Trial Info
Start Date :
December 22 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2019
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04453241
Start Date
December 22 2018
End Date
December 30 2019
Last Update
October 1 2021
Active Locations (1)
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1
SK Bioscience
Gyeonggi-do, Seongnam-si, South Korea, 13494