Clinical trial NCT02361866: To Evaluate the Effectiveness(Immunogeneicity) and Safety of 'GC1107' Administered Intramuscularly in Healthy Adults
Official title: Randomized, Double Blind, Multicenter, Phase III Study to Evaluate the Effectiveness(Immunogeneicity) and Safety of 'GC1107' Administered Intramuscularly in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bacterial Infections
Lead sponsor: GC Biopharma Corp
Sponsor class: INDUSTRY
First posted: 2015-02-12
Enrollment: 376
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Detailed description: Randomized, double blind, multicenter, phaseⅢ study

Eligibility criteria: 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.

Primary outcomes:
measure: seroprotection rate of diphtheria and tetanus
timeFrame: 28days
Secondary outcomes:
measure: GMT (Geometric Mean Titer)
timeFrame: 28days
measure: Boosting response of diphtheria and tetanus compared participants with before and after the injection
timeFrame: 28days
measure: solicited adverse events
timeFrame: 7days
measure: unsolicited adverse events
timeFrame: 28 days
measure: Seroprotection rate according to the respective age group
timeFrame: 28days
measure: GMT according to the respective age group
timeFrame: 28days
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Incheon St. Mary's Hospital Catholic Univ.
state: Bupyeong 6-dong, Bupyeong-gu,
Study officials:
affiliation: Incheon St. Mary's Hospital Catholic University
name: JungHyeon Choi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee J, Choi JH, Wie SH, Park SH, Choi SM, Lee MS, Kim TH, Lee HJ, Kang JH. A Phase III Study to Evaluate the Immunogenicity and Safety of GC1107 (Adult Tetanus Diphtheria Vaccine) in Healthy Adults. J Korean Med Sci. 2019 Jan 16;34(4):e31. doi: 10.3346/jkms.2019.34.e31. eCollection 2019 Jan 28.