drugset / Trial / NCT02710851
Immunogenicity Study of the Recombinant Human Papillomavirus Virus Type 6/11 Bivalent Vaccine
Phase 2
Unknown
640 enrolled
Jun Zhang
Beijing Wantai Biological Pharmacy Enterprise Co., Ltd. · collabXiamen Innovax Biotech Co., Ltd · collab
RandomizedParallel-groupQuadruple-blindPrevention
Summary
This phase Ⅱ clinical study was designed to evaluate the immunogenicity and safety of the novel recombinant HPV type 6/11 bivalent vaccine, manufactured by Xiamen Innovax Biotech CO., LTD., in healthy volunteers aged 18-55 years of age at enrollment. The study volunteers would be randomized to receive the 3 different formulations of the novel HPV vaccine or placebo vaccine (recombinant hepatitis E vaccine) administered intramuscularly according to a 0-1-6 month schedule. This is a double-blind study.
Timeline
- Start
- 2016-03-24
- Primary completion
- 2023-12-30
- Completion
- 2023-12-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gardasil | Vaccine | — | Intramuscular |