Immunogenicity and Safety Study of NBP615 in Healthy Female
- Conditions
- Cervical Cancer
- Interventions
- Biological: GardasilBiological: NBP615
- Registration Number
- NCT04453241
- Lead Sponsor
- SK Bioscience Co., Ltd.
- 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 (Gardasil). The safety of the test vaccine (NBP615) was confirmed by 2nd vaccination in adult subjects. After that, enrolment of 120 adolescent subjects proceeded. Eligible subjects who previously agreed to participate in the study were screened and only those subjects who met the inclusion/exclusion criteria were randomized in to 1:1 to receive two doses of test vaccine (NBP615) or comparator (Gardasil pre-filled syringe). 0.5 ml Intramuscular injection at were given at each vaccination and two blood sample, pre vaccine and post vaccine 4 weeks after completion of vaccine were collected to assess the immunogenicity of NBP615 and Gardasil, comparator vaccine. Solicited adverse events occurred up to 7 days after each dose of the investigational product were collected in the diary card. Unsolicited adverse events occurred up to 28 days after each dose of the investigational product were collated in the diary card. Serious adverse events were collected during the entire study period. In addition to this safety data was collected through the study period by active contact with the study participants by doing home visit or by telephone contact.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 200
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description GARDASIL Gardasil Adult : 3 doses of vaccination Adolescent :2 doses of vaccination NBP615 NBP615 Adult : 3 doses of vaccination Adolescent :2 doses of vaccination
- Primary Outcome Measures
Name Time Method Geometric mean titer measured by pseudovirion-based neutralization assay(PBNA) 4 weeks after the vaccination geometric mean titer against anti-HPV 6, 11, 16, and 18 for each treatment
Geometric mean titer measured by Enzyme-linked Immunosorbent Assay(ELISA) 4 weeks after the vaccination geometric mean titer against anti-HPV 6, 11, 16, and 18 for each treatment group
seroconversion rate measured by Enzyme-linked Immunosorbent Assay(ELISA) 4 weeks after the vaccination proportion of subjects who seroconverted from seronegative at baseline to seropositive at post vaccination for anti-HPV 6, 11, 16, and 18
Incidence rate of Solicited Adverse Event 7 days after the vaccination Solicited local/systemic adverse event after vaccination
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
SK Bioscience
🇰🇷Gyeonggi-do, Seongnam-si, Korea, Republic of