To Evaluate the Effectiveness(Immunogeneicity) and Safety of 'GC1107' Administered Intramuscularly in Healthy Adults

Green Cross Corporation

Status and phase

Completed

Phase 3

Conditions

Bacterial Infections

Treatments

Biological: Tetanus and Diphtheria(Td vaccine)

Biological: GC1107

Study type

Interventional

Funder types

Industry

Identifiers

GC1107_AD_P3

Details and patient eligibility

About

The purpose of this study is to evaluate the effectiveness(immunogeneicity) and safety of 'GC1107' administered intramuscularly in healthy Adults.

Full description

Randomized, double blind, multicenter, phaseⅢ study

Enrollment

376 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

healthy Korean adults (age: over 18 years)
who got the basic vaccination of DTP(Diphtheria, tetanus, pertussis) in the past
Subjects willing to provide written informed consent and able to comply with the requirements for the study

Exclusion criteria

subjects who have already got the additional vaccination of Td within 5 years
subjects with antitoxin of diphtheria and tetanus ≥1.0 IU/mL (ELISA)
- only applicable in step I
subjects who have not recovered from the acute disease within 2 weeks
subjects who have the medical history of allergic disease related to the components of investigational drug
who got the treatment of blood product and immunoglobulin product within 3 months
females who are pregnant
females who are breastfeeding
subjects who are infected from the diphtheria and tetanus
subjects who have experienced the severe adverse events for the diphtheria and tetanus vaccination
Subjects who are scheduled to participate in other clinical trial studies during the study
Subjects who have participated in any other clinical trials within 4 weeks of the administration of the study
Those who take the other medicine that affects this study or are vaccinated other vaccines
Subject who have received adrenocortical hormones or immunosuppressive drug within 4weeks of enrollment
Subjects with a history of chronic disease obstacles to the study.
Subjects who have episode of acute febrile (at least 37.4) after injection of vaccine during the study
Subject who have plan of operation during the study.
Individuals with other clinically significant medical or psychological condition who are considered by the investigator to be ineligible for the study.