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Completed

NCT Number: NCT02361866

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Incheon St. Mary's Hospital Catholic Univ.

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

About this study

Randomized, double blind, multicenter, phaseⅢ study

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GC1107

Biological

0.5 ml, Intramuscular, single dose(day0)

Tetanus and Diphtheria(Td vaccine)

Biological

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

Primary outcomes

  1. seroprotection rate of diphtheria and tetanus

    Time frame: 28days

Secondary outcomes

  1. GMT (Geometric Mean Titer)

    Time frame: 28days

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

    Time frame: 28days

    Boosting response is defined as more 4 times increase of the antibody titer after the injection

  3. solicited adverse events

    Time frame: 7days

  4. unsolicited adverse events

    Time frame: 28 days

  5. Seroprotection rate according to the respective age group

    Time frame: 28days

  6. GMT according to the respective age group

    Time frame: 28days

Sponsors and collaborators

Lead sponsor

Green Cross Corporation

Industry

Registry information

Official study title

Randomized, Double Blind, Multicenter, Phase III Study to Evaluate the Effectiveness(Immunogeneicity) and Safety of 'GC1107' Administered Intramuscularly in Healthy Adults

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Feb 12, 2015
Registry last updated
Feb 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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