Clinical trial · Interventional
Immunogenicity and Safety Study of NBP615 in Healthy Female
A Randomized, Double-Blinded, Active Controlled, Phase I/ II Clinical Trial to Assess the Immunogenicity, Safety, and Tolerability of NBP615 Vaccine in Healthy Female Participants Aged 19 to 26 Years and Adolescent Aged 9 to 13 Years
NCT04453241CI-TRIAL-00054229completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gardasil | Biological | — | UNRESOLVED |
| NBP615 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- NBP615
- description
- Adult : 3 doses of vaccination Adolescent :2 doses of vaccination
- interventionNames
- Biological: NBP615
- type
- ACTIVE_COMPARATOR
- label
- GARDASIL
- description
- Adult : 3 doses of vaccination Adolescent :2 doses of vaccination
- interventionNames
- Biological: Gardasil
Primary outcomes (4)
- measure
- Geometric mean titer measured by Enzyme-linked Immunosorbent Assay(ELISA)
- timeFrame
- 4 weeks after the vaccination
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 9 Years
- Maximum age
- 26 Years
Show eligibility criteria text
\[Inclusion Criteria\] * 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.
References
Publications (0)
Data not yet available
No reference posted for this study.