TetanusPhase 1/2NCT02813486
Safety and Immunogenicity Study of Tetanus, Diphtheria and Acellular Pertussis (Tdap) Vaccine
A Phase 1/2 study testing Biological: GC3111 vaccine and Biological: Boostrix® vaccine in people with Tetanus and Diphtheria, run by Green Cross Corporation at 5 sites in South Korea.
Trial summary
The purpose of this study is to evaluate safety of GC3111 and to describe immunogenicity of a single dose of GC3111 versus Boostrix® vaccine among healthy adults in 19 to <65 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?
- Biological: GC3111 vaccine and Biological: Boostrix® vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 5 sitesSouth Korea
- Study dates
- Jun 2016to Nov 2016
- Phase
- Phase 1/2
- 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 between 19 and 64 years at the time of vaccination
- Informed consent and assent forms have been signed and dated
Who cannot join
- Known or suspected receipt of any Tdap vaccine
- Subject is pregnant, or lactating, or of child bearing potential without using an effective method of contraception or not practicing abstinence
- Receipt of any vaccine within 30 days before receiving study vaccine
- Any condition that, in the opinion of the Investigator, might interfere with the ability to comply with trial procedures.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
South Korea5 sites
The Catholic Univ. of Korea Daejeon St.Mary's Hospital
Daejeon, Jung-Gu, 301-723
The Catholic Univ.of Korea Bucheon St.Mary's Hospital
Gyeonggi-do
The Catholic Univ.of Korea Uijeongbu St.Mary's Hospital
Gyeonggi-do
Incheon St. Mary's Hospital Catholic Univ.
Incheon, Bupyeong 6-dong, Bupyeong-gu,, 1544-9004
The Catholic Univ.of Korea Yeouido St.Mary's Hospital
Seoul
About this study
The purpose of this study is to evaluate safety of GC3111 and to describe immunogenicity of a single dose of GC3111 versus Boostrix® vaccine among healthy adults in 19 to <65 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 (solicited adverse events) of GC3111 in healthy adults.
- Conditions
- Tetanus, Diphtheria, Whooping Cough
- Being tested
- Biological: GC3111 vaccine, Biological: 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.
Biological: GC3111 vaccineBiological
Also called GC3111
0.5mL, Intramuscular
Biological: 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: Biological: GC3111 vaccine |
| Boostrix® Vaccine Group | Active comparator | Participants randomized to receive a single dose of Boostrix® vaccine (Biological: Boostrix® vaccine). Receives: Biological: Biological: Boostrix® vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants With Antibody Responses to Tetanus and Diphtheria Components Following Vaccination With Either GC3111 or Boostrix® Vaccine
Measured: Day 0 (pre-vaccination) to Day 28 (post-vaccination)
Percentage of Participants Achieving Predefined Antibody Level for Diphtheria, Tetanus, and Acellular Pertussis Antigens
Measured: 28 days after Vaccination
Geometric Mean Concentrations (GMC) for Diphtheria, Tetanus and Acellular Pertussis Antigens
Measured: 28 days after Vaccination
Geometric Mean Ratio (GMR) of post-vaccination versus pre-vaccination antibody concentrations against Diphtheria, Tetanus and Acellular Pertussis
Measured: Day 0 (pre-vaccination) to Day 28 (post-vaccination)
Secondary outcomes (1)
Participants Reporting Immediate Solicited Adverse Events Following Vaccination With Either GC3111 or Boostrix® Vaccine
Measured: Up to 30 minutes post-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionNov 2016 (estimated)
- Study completionNov 2016 (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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 220 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
- NCT02813486
- Sponsor's protocol ID
- GC3111_P1/2a
- Status last verified
- Nov 2016
- First submitted
- 20 Jun 2016
- Last updated
- 7 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immunogenicity Study of Tetanus, Diphtheria and Acellular Pertussis (Tdap) Vaccine
- ClinicalTrials.gov ID
- NCT02813486
- Acronym / sponsor ID
- GC3111_P1/2a
- Conditions
- Tetanus, Diphtheria, Whooping Cough
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Green Cross CorporationIndustry (pharma, biotech, devices)
- Study start
- Jun 2016
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Nov 2016 (estimated)
- First posted
- 27 Jun 2016 (estimated)
- 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 of GC3111 and to describe immunogenicity of a single dose of GC3111 versus Boostrix® vaccine among healthy adults in 19 to <65 years of age.
Detailed description
To evaluate immunogenicity of GC3111 as tetanus, diphtheria and acellular pertussis (Tdap) vaccine in healthy adults.
To evaluate safety (solicited adverse events) 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: Biological: GC3111 vaccineParticipants randomized to receive a single dose of GC3111 vaccine (Biological: GC3111 vaccine). |
| Boostrix® Vaccine Group | Active comparator | Biological: 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 (2 listed)
- Healthy adults aged between 19 and 64 years at the time of vaccination
- Informed consent and assent forms have been signed and dated
Key exclusion criteria (4 listed)
- Known or suspected receipt of any Tdap vaccine
- Subject is pregnant, or lactating, or of child bearing potential without using an effective method of contraception or not practicing abstinence
- Receipt of any vaccine within 30 days before receiving study vaccine
- Any condition that, in the opinion of the Investigator, might interfere with the ability to comply with trial procedures.
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 |
|---|---|---|
| Biological: GC3111 vaccineAlso: GC31110.5mL, Intramuscular | Biological | GC3111 Vaccine Group |
| Biological: Boostrix® vaccineAlso: Boostrix®0.5mL, Intramuscular | Biological | Boostrix® Vaccine Group |
Primary outcome
Participants With Antibody Responses to Tetanus and Diphtheria Components Following Vaccination With Either GC3111 or Boostrix® Vaccine
Time frame: Day 0 (pre-vaccination) to Day 28 (post-vaccination)
Percentage of Participants Achieving Predefined Antibody Level for Diphtheria, Tetanus, and Acellular Pertussis Antigens
Time frame: 28 days after Vaccination
Geometric Mean Concentrations (GMC) for Diphtheria, Tetanus and Acellular Pertussis Antigens
Time frame: 28 days after Vaccination
Geometric Mean Ratio (GMR) of post-vaccination versus pre-vaccination antibody concentrations against Diphtheria, Tetanus and Acellular Pertussis
Time frame: Day 0 (pre-vaccination) to Day 28 (post-vaccination)
1 secondary outcome
Participants Reporting Immediate Solicited Adverse Events Following Vaccination With Either GC3111 or Boostrix® Vaccine
Time frame: Up to 30 minutes post-vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2016.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Biological: GC3111 vaccine and Biological: Boostrix® vaccine in people with Tetanus and Diphtheria, run by Green Cross Corporation at 5 sites 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 2 inclusion and 4 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 7 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants With Antibody Responses to Tetanus and Diphtheria Components Following Vaccination With Either GC3111 or Boostrix® Vaccine (time frame: Day 0 (pre-vaccination) to Day 28 (post-vaccination)). The study lists 4 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 7 Nov 2016.