drugset / Trial / NCT02740777
Evaluating the 2-dose Immunization Schedule of Human Papillomavirus (HPV)-16/18 in Adolescent Females
Phase 2
Completed
900 enrolled
Shanghai Zerun Biotechnology Co.,Ltd
Guangxi Center for Disease Control and Prevention · collab
RandomizedParallel-groupOpen-labelPrevention
Summary
To evaluate the immune non-inferiority, as measured by antibody responses, of a 2-dose immunization schedule (0, 6 months) of recombinant human papillomavirus virus-like particle vaccine (type 16 and 18 L1 proteins, yeast) (hereinafter referred as HPV-2 vaccine) in adolescent females aged 9 to 14 years in comparison to 3-dose immunization schedule (0, 2, 6 months) in young females aged 18 to 26 years.
Timeline
- Start
- 2016-02
- Primary completion
- 2016-11
- Completion
- 2019-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | HPV 16/18 VLP AS04 | Vaccine | 20 ug | — |
| Subject | HPV 16/18 VLP AS04 | Vaccine | 40 ug | — |
| Subject | HPV 16/18 VLP AS04 | Vaccine | 225 ug | — |