NCT04618939

To Evaluate the Immunogenicity and Safety of 'BR-TD-1001' Administered Intramuscularly in Healthy Children

Double Blind, Randomized Phase III Study to Evaluate the Immunogenicity and Safety of 'BR-TD-1001' Administered Intramuscularly in Healthy Children

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 218 (actual)
• Sponsor: Boryung Biopharma Co., Ltd. · Industry
• Sex: All
• Age: 10 Years – 12 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate immunogenicity by measuring the seroprotection rate against diphtheria and tetanus at 28 days after vaccination with BR-TD-1001 and Td-pur-inj.

Detailed description

Primary objective: To evaluate immunogenicity by measuring the seroprotection rate against diphtheria and tetanus at 28 days after vaccination with BR-TD-1001 and Td-pur-inj. Secondary objectives: * To evaluate immunogenicity by measuring the geometric mean titer (of diphtheria and tetanus antitoxins at 28 days after vaccination with BR-TD-1001 and Td-pur-inj. * To evaluate a boosting response by comparing before and after the administration through measurement of diphtheria and tetanus antitoxin titers at 28 days after vaccination with BR-TD-1001 and Td-pur-inj. * To evaluate safety by observing solicited local and systemic adverse events that have occurred for 7 days after vaccination with BR-TD-1001 and Td-pur-inj. * To evaluate safety by observing unsolicited adverse events that have occurred for 28 days after vaccination with BR-TD-1001 and Td-pur-inj.

Conditions

• Diphtheria
• Tetanus

Interventions

Type	Name	Description
BIOLOGICAL	BR-TD-1001	0.5 mL, IM
BIOLOGICAL	Td-pur inj	0.5 mL, IM

Timeline

• Start date: 2016-10-20
• Primary completion: 2017-04-28
• Completion: 2017-04-28
• First posted: 2020-11-06
• Last updated: 2020-11-20

Locations

9 sites across 1 country: South Korea