NCT04053010

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

A Randomized, Controlled, Multicenter Vaccine Clinical Trial to Evaluate The Safety and Immunogenicity of Combined Immunization With sIPV and DTaP

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

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.

Detailed description

It is recommended by China Food and Drug Administration (CFDA) that studies on simultaneous immunization of Sabin-IPV and DTaP be carried out as soon as possible, and the immunogenicity and safety studies should also be conducted. Currently in China the vaccination schedules of sIPV and DTaP overlap at infants' 3rd and 4th months of age. In order to avoid the vaccination time conflict and explore the possibility of simultaneous vaccination, we design this clinical study of simultaneous vaccination of the two vaccines. To be specific, the subjects were divided into 3 groups. Group 1 : sIPV (1st, 2nd, and 3rd doses) and DTaP (1st, 2nd, and 3rd doses) were simultaneously inoculated at 3,4,5 months old ; Group 2 : received 1 dose of sIPV at 3,4,5 months old ; Group 3 : received 1 dose of DTaP at 3,4,5 months old . Blood sample would be collected both before vaccination and 28-40 days after the 3rd dose of vaccination. Neutralization antibody would also be detected to evaluate the seroprotection rates and antibody geometric mean concentrations. The safety of both immunization schedule will be monitored as well.

Conditions

• Vaccination

Interventions

Type	Name	Description
BIOLOGICAL	Sabin-IPV and DTaP	Sabin-IPV +DTaP at the age of 3/4/5 months old respectively
BIOLOGICAL	Sabin-IPV	Sabin-IPV only at the age of 3/4/5 months old respectively
BIOLOGICAL	DTaP	DTaP only at the age of 3/4/5 months old respectively

Timeline

• Start date: 2019-08-10
• Primary completion: 2019-12-31
• Completion: 2020-05-30
• First posted: 2019-08-12
• Last updated: 2019-08-12

Locations

1 site across 1 country: China