drugset / Trial / NCT04941261
Clinical Trial to Evaluate the Recombinant Norovirus Bivalent (GI. 1 / GII. 4) Vaccine (Hansenula Polymorpha)
Phase 2
Unknown
1716 enrolled
National Vaccine and Serum Institute, China
Beijing Zhong Sheng Heng Yi Pharmaceutical Technology Co., Ltd. · collabLanzhou Institute of Biological Products Co., Ltd · collabZhengzhou University · collab
RandomizedParallel-groupDouble-blindPrevention
Summary
Phase II clinical study will explore dose and safety, immunogenicity in 4 age groups, including 18-59 years old group, 6-17 years old group, 3-5 years old group, 6-35 months old group, with a total of 1716 subjects.
Timeline
- Start
- 2021-06-30
- Primary completion
- 2024-02-28
- Completion
- 2024-03-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Norovirus Bivalent (GI.1 / GII.4) Vaccine | Vaccine | — | Intramuscular |