NCT02361866

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
376

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started May 2014

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2014

Completed
9 days until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 12, 2015

Completed
Last Updated

February 12, 2015

Status Verified

February 1, 2015

Enrollment Period

4 months

First QC Date

April 22, 2014

Last Update Submit

February 11, 2015

Conditions

Bacterial Infections

Outcome Measures

Primary Outcomes (1)

  • seroprotection rate of diphtheria and tetanus

    28days

Secondary Outcomes (6)

  • GMT (Geometric Mean Titer)

    28days

  • Boosting response of diphtheria and tetanus compared participants with before and after the injection

    28days

  • solicited adverse events

    7days

  • unsolicited adverse events

    28 days

  • Seroprotection rate according to the respective age group

    28days

  • +1 more secondary outcomes

Study Arms (2)

GC1107

EXPERIMENTAL

0.5ml, intramuscular, a single dosing

Biological: GC1107

Tetanus and Diphtheria(Td vaccine)

ACTIVE COMPARATOR

0.5ml, intramuscular, a single dosing

Biological: Tetanus and Diphtheria(Td vaccine)

Interventions

GC1107BIOLOGICAL

0.5 ml, Intramuscular, single dose(day0)

GC1107
Tetanus and Diphtheria(Td vaccine)BIOLOGICAL

0.5ml, Intramuscular, single dose(day0) only applicable step1

Tetanus and Diphtheria(Td vaccine)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Incheon St. Mary's Hospital Catholic Univ.

Incheon, Bupyeong 6-dong, Bupyeong-gu,, 1544-9004, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 30686952DERIVED

MeSH Terms

Conditions

Bacterial Infections

Interventions

Tetanus Toxoid

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

ToxoidsVaccinesBiological ProductsComplex Mixtures

Study Officials

  • JungHyeon Choi, MD

    Incheon St. Mary's Hospital Catholic University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2014

First Posted

February 12, 2015

Study Start

May 1, 2014

Primary Completion

September 1, 2014

Study Completion

October 1, 2014

Last Updated

February 12, 2015

Record last verified: 2015-02

Locations

KR(1)