Evaluation of the Safety and Immunogenicity of Simultaneously Administration of sIPV and DTaP

Phase 4 Completed 702 enrolled China National Biotec Group Company Limited Anhui Provincial Center for Disease Control and Prevention · collab Beijing Institute of Biological Products Co Ltd. · collab Chengdu Institute of Biological Products Co.,Ltd. · collab Jiangsu Province Centers for Disease Control and Prevention · collab National Institutes for Food and Drug Control, China · collab Peking University · collab Sichuan Center for Disease Control and Prevention · collab

RandomizedParallel-groupSingle-blindPrevention

Summary

Subjects will be recruited and divided into 3 groups:(1)combined immunization of Sabin-IPV and DTaP, (2) Sabin-IPV only and (3) DTaP only. After finishing the two basic vaccine EPI procedures, the immunogenicity and safety of both combined immunization group and individual vaccination groups will be compared and the data will be analyzed.

Timeline

Start: 2019-08-16
Primary completion: 2020-03-30
Completion: 2021-09-09

Publications

Sun X, Xu Y, Tang F, Xiao Y, Wang Z, Wang B, Zhu X, Yang X, Chen H. Immunogenicity and safety of concomitant administration of the chinese inactivated poliovirus vaccine with the diphtheria-tetanus-acellular pertussis (DTaP) vaccine in children: A multicenter, randomized, non-inferiority, controlled trial. Front Immunol. 2022 Jul 26;13:905634. doi: 10.3389/fimmu.2022.905634. eCollection 2022.

Drugs

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

Indications

No indication recorded.