drugset / Trial / NCT05079152
Evaluation of Immunogenicity and Safety of Combined Immunization of COVAX (Produced in Wuhan) and PPV23 / IIV4
Phase 4
Unknown
1404 enrolled
China National Biotec Group Company Limited
Changchun Institute of Biological Products Co., Ltd. · collabChengdu Institute of Biological Products Co.,Ltd. · collabGuangdong Center for Disease Prevention and Control · collabHenan Center for Disease Control and Prevention · collabHubei Provincial Center for Disease Control and Prevention · collabWuhan Institute of Biological Products Co., Ltd · collab
RandomizedParallel-groupSingle-blindPrevention
Summary
Subjects will be recruited and divided into 3 groups: Experimental Group (468 subjects): 1st dose : combined vaccination of COVAX+PPV23, 2nd dose: combined vaccination of COVAX+IIV4; Control Group A (468 subjects): 1st dose: COVAX only, 2nd dose: COVAX only; Control Group B (468 subjects): 1st dose: PPV23 only, 2nd dose: IIV4 only. Blood samples will be collected 3 times: before the 1st dose of vaccinatioin; before the 2nd dose of vaccination; 28 days after the 2nd dose of vaccination. The immunogenicity and safety of both experimental and control groups will be analyzed.
Timeline
- Start
- 2021-05-06
- Primary completion
- 2021-05-29
- Completion
- 2021-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | COVAX | Vaccine | — | — |
| Subject | Influenza Virus Vaccine | Vaccine | — | — |
| Subject | Pneumovax 23 | Vaccine | — | — |