NCT04054882

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

A Randomized, Controlled, Multicenter Phase 4 Clinic Trial to Evaluate the Safety and Immunogenicity of Simultaneously Administration of sIPV and DTaP

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 702 (actual)
• Sponsor: China National Biotec Group Company Limited · Industry
• Sex: All
• Age: 3 Months – 3 Months
• Healthy volunteers: Accepted

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.

Detailed description

It is recommended by China Food and Drug Administration (CFDA) that studies on simultaneous immunization of Sabin-IPV and DTaP be implemented soon and the immunogenicity and safety studies should be conducted. In China according to the current vaccination schedule, the arrangement of Sabin-IPV and DTaP falls on the same date -- at infants' 3rd and 4th months of age. In order to avoid the vaccination time conflict and explore the feasibility of simultaneous immunization, we design this phase 4 clinical trial of simultaneous vaccination of the two vaccines. To be specific, the subjects were divided into 3 groups. Group 1 : Sabin-IPV (1st, 2nd, and 3rd doses) and DTaP (1st, 2nd, and 3rd doses) are simultaneously administrated at 3,4,5 months old ; Group 2 : subjects receive 1 dose of sIPV only at 3,4,5 months old ; Group 3 : subjects receive 1 dose of DTaP only at 3,4,5 months old . Blood samples would be collected both before vaccination and 28-40 days after the 3rd dose of vaccination. Neutralization antibody will be detected to evaluate the seroprotection rates and antibody geometric mean concentrations. The safety of both immunization schedules will be monitored too.

Conditions

• Vaccination

Interventions

Type	Name	Description
BIOLOGICAL	Sabin-IPV and DTaP	simultaneously administration of Sabin-IPV and DTaP
BIOLOGICAL	Sabin-IPV	administration of Sabin-IPV only
BIOLOGICAL	DTaP	administration of DTaP only

Timeline

• Start date: 2019-08-16
• Primary completion: 2020-03-30
• Completion: 2021-09-09
• First posted: 2019-08-13
• Last updated: 2022-07-07

Locations

1 site across 1 country: China