Clinic Trial to Evaluate the Safety and Immunogenicity of Combined Immunization of sIPV and DTaP

Phase 4 Unknown 702 enrolled China National Biotec Group Company Limited Beijing Institute of Biological Products Co Ltd. · collab Hubei Provincial Center for Disease Control and Prevention · collab Shaanxi Provincial Center for Disease Control and Prevention · collab Wuhan Institute of Biological Products Co., Ltd · collab

RandomizedParallel-groupSingle-blindPrevention

Summary

Eligible,healthy infants will be recruited and divided into 3 groups:(1)combined immunization of sIPV and DTaP group, (2) sIPV group and (3) DTaP group. After completing the two basic vaccine EPI procedures, the immunogenicity and safety of the combined immunization group and the individual vaccination groups will be compared and analyzed.

Timeline

Start: 2019-08-10
Primary completion: 2019-12-31
Completion: 2020-05-30

Publications

Liu X, Han S, Chen X, Sun L, Wang R, Shi X, Guo Y, Wang H, Chen H, Chang S, Xu X, Zhang C, Wang Y, Zhang D, Hu W, Zhang S. Immunogenicity and safety of co-administration with the Sabin-strain-based inactivated poliovirus vaccine (vero cell) and the diphtheria-tetanus-acellular pertussis vaccine in eligible children in China: a randomized, controlled, multicenter, non-inferiority trial. Front Immunol. 2025 Sep 3;16:1633170. doi: 10.3389/fimmu.2025.1633170. eCollection 2025.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sabin-IPV	Vaccine	0.5 ml	—
Subject	diphtheria-tetanus-acellular pertussis vaccine	Vaccine	0.5 ml	—

Indications

No indication recorded.