TetanusPhase 2NCT04238975
A Study to Evaluate the Safety and Efficacy(Immunogenicity) of GC3111 in Healthy Adults
A Phase 2 study testing GC3111 vaccine and Boostrix® vaccine in people with Tetanus and Diphtheria, run by Green Cross Corporation at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate safety and efficacy (immunogenicity) of a single dose of GC3111 versus Boostrix® vaccine among healthy adults in 19-64 years of age. Read more about this study
- Who is it for?
- Ages 19 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Tetanus, Diphtheria, Whooping Cough
- What is being tested?
- GC3111 vaccine and Boostrix® vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 213 participants
- Where
- 1 siteSouth Korea
- Study dates
- 14 Oct 2019to May 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults aged above 19 and under 64 at the time of screening
- Subject without history of administrating vaccines including diphtheria, tetanus or whooping cough antigens within 2 years prior to administration of investigational drug
- Subject who provided informed consent and assent forms
Who cannot join
- Subject who received vaccine within 4 weeks prior to receiving study vaccine
- Subject who received Tdap vaccine prior to receiving study vaccine
- Subject with chronic cough history within 12 weeks before receiving study vaccine
- Subject who is pregnant, lactating, or of child bearing potential without using an effective method of contraception or not practicing abstinence
- Subject who participated in any other clinical study (investigational drug/equipment) within 6 months before receiving study vaccine
- Subject with any condition that, in the opinion of the Investigator, might interfere with the ability to comply with trial procedures
Trial locations and contacts
1 site in 1 country.
Sujin Lee contact
South Korea1 site, 1 recruiting
- Recruiting
The Catholic Univ. of Korea Eunpyeong St. Mary's Hospital
Seoul
About this study
Official title: Randomized, Double-blind, Active-controlled Phase II Clinical Trial to Evaluate the Safety and Immunogenicity of GC3111 in Healthy Adults
The purpose of this study is to evaluate safety and efficacy (immunogenicity) of a single dose of GC3111 versus Boostrix® vaccine among healthy adults in 19-64 years of age.
Read the detailed description
To evaluate immunogenicity of GC3111 as tetanus, diphtheria and acellular pertussis (Tdap) vaccine in healthy adults.
To evaluate safety of GC3111 in healthy adults.
- Conditions
- Tetanus, Diphtheria, Whooping Cough
- Being tested
- GC3111 vaccine, Boostrix® vaccine
- Medical subject headings
- Tetanus, Diphtheria, Whooping Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GC3111 vaccineBiological
Also called GC3111
0.5mL, Intramuscular
Boostrix® vaccineBiological
Also called Boostrix®
0.5mL, Intramuscular
| Study group | Role | What they receive |
|---|---|---|
| GC3111 Vaccine Group | Experimental | Participants randomized to receive a single dose of GC3111 vaccine (Biological: GC3111 vaccine). Receives: Biological: GC3111 vaccine |
| Boostrix® Vaccine Group | Active comparator | Participants randomized to receive a single dose of Boostrix® vaccine (Biological: Boostrix® vaccine). Receives: Biological: Boostrix® vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Solicited Adverse Events Following Vaccination with Either GC3111 or Boostrix® Vaccine
Measured: Day 0 (pre-vaccination) to Day 14 (post-vaccination)
Unsolicited Adverse Events Following Vaccination with Either GC3111 or Boostrix® Vaccine
Measured: Day 0 (pre-vaccination) to Day 28 (post-vaccination)
Serious Adverse Events Following Vaccination with Either GC3111 or Boostrix® Vaccine
Measured: Day 0 (pre-vaccination) to Day 180 (post-vaccination)
Vital Signs
Blood Pressure (systolic, diastolic) in mmHg
Measured: Day 0 (pre-vaccination), Day 28 (post-vaccination)
Vital Signs
Pulse Rate in pulses per minute
Measured: Day 0 (pre-vaccination), Day 28 (post-vaccination)
Vital Signs
Body Temperature in degrees Celcius
Measured: Day 0 (pre-vaccination), Day 28 (post-vaccination)
Laboratory Examinations
Blood Test (WBC with differential count (lymphocyte, monocyte etc.), RBC, hemoglobin, hematocrit, platelet count
Measured: Screening (pre-vaccination), Day 28 (post-vaccination)
Laboratory Examinations
Blood Chemistry Test (K, Na, Cl, P, ALT, AST etc.)
Measured: Screening (pre-vaccination), Day 28 (post-vaccination)
Laboratory Examinations
Urine Test (pH, specific gravity, bilirubin etc.)
Measured: Screening (pre-vaccination), Day 28 (post-vaccination)
Secondary outcomes (4)
Ratio of Participants with Antibody Responses (Seroprotection rate) to Tetanus and Diphtheria Components Following Vaccination With Either GC3111 or Boostrix® Vaccine
Measured: Day 0 (pre-vaccination) to Day 28 (post-vaccination)
Ratio of Participants With Antibody Responses (Boosting Response rate) to Tetanus and Diphtheria Components Following Vaccination With Either GC3111 or Boostrix® Vaccine
Measured: Day 0 (pre-vaccination) to Day 28 (post-vaccination)
Geometric Mean Concentrations (GMC) for Diphtheria, Tetanus and Acellular Pertussis Antigens
Measured: Day 28 (post-vaccination)
Geometric Mean Ratio (GMR) of Post-vaccination versus Pre-vaccination antibody concentrations for Diphtheria, Tetanus and Acellular Pertussis Antigens
Measured: Day 0 (pre-vaccination) to Day 28 (post-vaccination)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2020
- Study start14 Oct 2019
- Primary completionFeb 2021 (estimated)
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TetanusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 213 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Green Cross Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04238975
- Sponsor's protocol ID
- GC3111_P2
- Status last verified
- Jan 2020
- First submitted
- 8 Jan 2020
- Last updated
- 23 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Active-controlled Phase II Clinical Trial to Evaluate the Safety and Immunogenicity of GC3111 in Healthy Adults
- ClinicalTrials.gov ID
- NCT04238975
- Acronym / sponsor ID
- GC3111_P2
- Conditions
- Tetanus, Diphtheria, Whooping Cough
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 213 participants (estimated)
- Lead sponsor
- Green Cross CorporationIndustry (pharma, biotech, devices)
- Study start
- 14 Oct 2019 (actual)
- Primary completion
- Feb 2021 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 23 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate safety and efficacy (immunogenicity) of a single dose of GC3111 versus Boostrix® vaccine among healthy adults in 19-64 years of age.
Detailed description
To evaluate immunogenicity of GC3111 as tetanus, diphtheria and acellular pertussis (Tdap) vaccine in healthy adults.
To evaluate safety of GC3111 in healthy adults.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GC3111 Vaccine Group | Experimental | Biological: GC3111 vaccineParticipants randomized to receive a single dose of GC3111 vaccine (Biological: GC3111 vaccine). |
| Boostrix® Vaccine Group | Active comparator | Biological: Boostrix® vaccineParticipants randomized to receive a single dose of Boostrix® vaccine (Biological: Boostrix® vaccine). |
Who may qualify
- Ages
- 19 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy adults aged above 19 and under 64 at the time of screening
- Subject without history of administrating vaccines including diphtheria, tetanus or whooping cough antigens within 2 years prior to administration of investigational drug
- Subject who provided informed consent and assent forms
Key exclusion criteria (6 listed)
- Subject who received vaccine within 4 weeks prior to receiving study vaccine
- Subject who received Tdap vaccine prior to receiving study vaccine
- Subject with chronic cough history within 12 weeks before receiving study vaccine
- Subject who is pregnant, lactating, or of child bearing potential without using an effective method of contraception or not practicing abstinence
- Subject who participated in any other clinical study (investigational drug/equipment) within 6 months before receiving study vaccine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GC3111 vaccineAlso: GC31110.5mL, Intramuscular | Biological | GC3111 Vaccine Group |
| Boostrix® vaccineAlso: Boostrix®0.5mL, Intramuscular | Biological | Boostrix® Vaccine Group |
Primary outcome
Solicited Adverse Events Following Vaccination with Either GC3111 or Boostrix® Vaccine
Time frame: Day 0 (pre-vaccination) to Day 14 (post-vaccination)
Unsolicited Adverse Events Following Vaccination with Either GC3111 or Boostrix® Vaccine
Time frame: Day 0 (pre-vaccination) to Day 28 (post-vaccination)
Serious Adverse Events Following Vaccination with Either GC3111 or Boostrix® Vaccine
Time frame: Day 0 (pre-vaccination) to Day 180 (post-vaccination)
Vital Signs
Time frame: Day 0 (pre-vaccination), Day 28 (post-vaccination)
Blood Pressure (systolic, diastolic) in mmHg
Vital Signs
Time frame: Day 0 (pre-vaccination), Day 28 (post-vaccination)
Pulse Rate in pulses per minute
Vital Signs
Time frame: Day 0 (pre-vaccination), Day 28 (post-vaccination)
Body Temperature in degrees Celcius
Laboratory Examinations
Time frame: Screening (pre-vaccination), Day 28 (post-vaccination)
Blood Test (WBC with differential count (lymphocyte, monocyte etc.), RBC, hemoglobin, hematocrit, platelet count
Laboratory Examinations
Time frame: Screening (pre-vaccination), Day 28 (post-vaccination)
Blood Chemistry Test (K, Na, Cl, P, ALT, AST etc.)
Laboratory Examinations
Time frame: Screening (pre-vaccination), Day 28 (post-vaccination)
Urine Test (pH, specific gravity, bilirubin etc.)
4 secondary outcomes
Ratio of Participants with Antibody Responses (Seroprotection rate) to Tetanus and Diphtheria Components Following Vaccination With Either GC3111 or Boostrix® Vaccine
Time frame: Day 0 (pre-vaccination) to Day 28 (post-vaccination)
Ratio of Participants With Antibody Responses (Boosting Response rate) to Tetanus and Diphtheria Components Following Vaccination With Either GC3111 or Boostrix® Vaccine
Time frame: Day 0 (pre-vaccination) to Day 28 (post-vaccination)
Geometric Mean Concentrations (GMC) for Diphtheria, Tetanus and Acellular Pertussis Antigens
Time frame: Day 28 (post-vaccination)
Geometric Mean Ratio (GMR) of Post-vaccination versus Pre-vaccination antibody concentrations for Diphtheria, Tetanus and Acellular Pertussis Antigens
Time frame: Day 0 (pre-vaccination) to Day 28 (post-vaccination)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sujin Lee contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GC3111 vaccine and Boostrix® vaccine in people with Tetanus and Diphtheria, run by Green Cross Corporation at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dah Yoon Kim (+82-31-260-0976, kimdahyoon@greencross.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Solicited Adverse Events Following Vaccination with Either GC3111 or Boostrix® Vaccine (time frame: Day 0 (pre-vaccination) to Day 14 (post-vaccination)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2020; AzTrials last refreshed its copy on 30 Oct 2026.