drugset / Trial / NCT04559204
Evaluation of Safety and Immunogenicity of Combined Immunization of PPV23 and IIV4
Phase 4
Completed
1224 enrolled
China National Biotec Group Company Limited
Center for Disease Control and Prevention, Fujian · collabChangchun Institute of Biological Products Co., Ltd. · collabChengdu Institute of Biological Products Co.,Ltd. · collabGuizhou Center for Disease Control and Prevention · collabHunan Provincial Center for Disease Control and Prevention · collabNational Institutes for Food and Drug Control, China · collabPeking University · collab
RandomizedParallel-groupSingle-blindPrevention
Summary
Subjects will be recruited and divided into 3 groups: 1. Experimental Group (408 subjects): combined immunization of PPV23 and IIV4; 2. Control Group A (408 subjects): IIV4 only; 3. Control Group B (408 subjects): PPV23 only; All blood samples will be collected before and one month after vaccinatioin. The immunogenicity and safety of both experimental and control groups will be compared and the data be analyzed.
Timeline
- Start
- 2020-09-11
- Primary completion
- 2020-11-26
- Completion
- 2021-10-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Influenza Virus Vaccine | Vaccine | 0.5 ml | — |
| Subject | Pneumovax 23 | Vaccine | 0.5 ml | — |