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

NCT04618939 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 218

Last updated 2020-11-20

No results posted yet for this study

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.

Conditions

  • Diphtheria
  • Tetanus

Interventions

BIOLOGICAL

BR-TD-1001

0.5 mL, IM

BIOLOGICAL

Td-pur inj

0.5 mL, IM

Sponsors & Collaborators

  • Boryung Biopharma Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Jong Hyun Kim · Saint Vincent's Hospital, Korea

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-10-20
Primary Completion
2017-04-28
Completion
2017-04-28

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04618939 on ClinicalTrials.gov