Clinical Trials List
Protocol NumberADITETA20171106
2018-01-01 - 2020-12-31
Phase III
Terminated1
ICD-10A35
Other tetanus
ICD-9037
Tetanus
An open label study to evaluate the immunogenicity and safety of a tetanus toxoid vaccine in volunteers, seven years of age and older
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Trial Applicant
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Sponsor
Adimmune corporation
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Trial scale
Taiwan Single Center
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Update
2025/08/20
Investigators and Locations
China Medical University Hospital-Taipei
Taiwan National PI
王任賢
Co-Principal Investigator
Audit
None
Principal Investigator
Co-Principal Investigator
- Po-Chang Lin 未分科
- Jen-Hsien Wang Division of Infectious Disease
- 林伯昌 Division of Infectious Disease
The Actual Total Number of Participants Enrolled
0 Completed
Audit
None
Condition/Disease
tetanus
Objectives
To evaluate the immunogenicity profiles including the seroprotection rate (SPR) and the booster
response of the tetanus toxoid vaccine
Test Drug
Tetana-Tetanus toxoid vaccine
Active Ingredient
Tetanus toxoid
Dosage Form
suspension for injection
Dosage
0.5ml
Endpoints
1.The primary endpoint will be the immunogenicity including seroprotection (SPR) and booster response.
2.Descriptive statistical analysis of proportion of subjects with reactogenicity events within 7 days after the administration of tetanus toxoid vaccine, including 30 min post-vaccination
record at the site. Local reactogenicity responses include pain at injection site or arm, swelling, redness. Systemic reactogenicity responses include fever (≧38.0°C), chills, malaise, headache,
nausea, vomiting, rash, itching, injection limb mobility decrease. Only local reactogenicity response is required to record within 30 min post-vaccination.
3. Changes in vital signs.
4. Adverse events (AE) incidences over the study period.
2.Descriptive statistical analysis of proportion of subjects with reactogenicity events within 7 days after the administration of tetanus toxoid vaccine, including 30 min post-vaccination
record at the site. Local reactogenicity responses include pain at injection site or arm, swelling, redness. Systemic reactogenicity responses include fever (≧38.0°C), chills, malaise, headache,
nausea, vomiting, rash, itching, injection limb mobility decrease. Only local reactogenicity response is required to record within 30 min post-vaccination.
3. Changes in vital signs.
4. Adverse events (AE) incidences over the study period.
Inclution Criteria
1 Male or female, age ≧7 years old.
2 Subjects’ medical history shows no contraindication or hypersensitivity to the test medication.
3 Subjects or the legal representative(s) must be able to maintain an accurate and complete diary for the solicited local and systemic symptoms during the dosing day (Day 0) and Day 1~7 in the
study and willing and able to adhere to visit schedules and all study requirements.
4 Subjects who understand and accept to enter the study by signing written informed consent forms. Subjects/subjects who are at the age < 20 should co-sign the informed consent forms with their legal representative(s).
2 Subjects’ medical history shows no contraindication or hypersensitivity to the test medication.
3 Subjects or the legal representative(s) must be able to maintain an accurate and complete diary for the solicited local and systemic symptoms during the dosing day (Day 0) and Day 1~7 in the
study and willing and able to adhere to visit schedules and all study requirements.
4 Subjects who understand and accept to enter the study by signing written informed consent forms. Subjects/subjects who are at the age < 20 should co-sign the informed consent forms with their legal representative(s).
Exclusion Criteria
1. Subjects received vaccination containing any tetanus toxoid within 10 years or tetanus
immunoglobulin within 30 days prior to the vaccination.
2. Subjects with the following disease background or condition should be excluded:
a. An acute febrile illness (≧38.0°C) or infection within 1 week prior to vaccination
b. Immunodeficiency
3. Subjects/subjects with the following medication or treatment should be excluded :
a. Systemic corticosteroids (≧20 mg/day of prednisone or equivalent for ≧14 days) within
30 days prior to the vaccination or are scheduled to do so 30 days after vaccination.
b. Any immunization vaccination within 7 days prior to the vaccination.
c. Immunosuppressive treatment within 30 days prior to the vaccination or are scheduled to do
so 30 days after vaccination.
4. Currently participating in another clinical trial or who participated in a previous clinical trial and
received any investigational product treatment within 30 days prior to the vaccination.
5. Subjects who are pregnant or breast feeding.
6. Underlying mental/physical/social condition in the investigators’ opinion may interfere with evaluation of the study vaccine.
immunoglobulin within 30 days prior to the vaccination.
2. Subjects with the following disease background or condition should be excluded:
a. An acute febrile illness (≧38.0°C) or infection within 1 week prior to vaccination
b. Immunodeficiency
3. Subjects/subjects with the following medication or treatment should be excluded :
a. Systemic corticosteroids (≧20 mg/day of prednisone or equivalent for ≧14 days) within
30 days prior to the vaccination or are scheduled to do so 30 days after vaccination.
b. Any immunization vaccination within 7 days prior to the vaccination.
c. Immunosuppressive treatment within 30 days prior to the vaccination or are scheduled to do
so 30 days after vaccination.
4. Currently participating in another clinical trial or who participated in a previous clinical trial and
received any investigational product treatment within 30 days prior to the vaccination.
5. Subjects who are pregnant or breast feeding.
6. Underlying mental/physical/social condition in the investigators’ opinion may interfere with evaluation of the study vaccine.
The Estimated Number of Participants
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Taiwan
188 participants
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Global
188 participants
