Double Blind, Randomized Phase III Study to Evaluate the Immunogenicity and Safety of 'BR-TD-1001' Administered Intramuscularly in Healthy Children
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Diphtheria
- Sponsor
- Boryung Biopharma Co., Ltd.
- Enrollment
- 218
- Locations
- 9
- Primary Endpoint
- The seroprotection rate of anti-diphtheria toxoid (DT) and anti-tetanus toxoid (TT) at 28 days after vaccination with the investigational products
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
The purpose of this study is to evaluate immunogenicity by measuring the seroprotection rate against diphtheria and tetanus at 28 days after vaccination with BR-TD-1001 and Td-pur-inj.
Detailed Description
Primary objective: To evaluate immunogenicity by measuring the seroprotection rate against diphtheria and tetanus at 28 days after vaccination with BR-TD-1001 and Td-pur-inj. Secondary objectives: * To evaluate immunogenicity by measuring the geometric mean titer (of diphtheria and tetanus antitoxins at 28 days after vaccination with BR-TD-1001 and Td-pur-inj. * To evaluate a boosting response by comparing before and after the administration through measurement of diphtheria and tetanus antitoxin titers at 28 days after vaccination with BR-TD-1001 and Td-pur-inj. * To evaluate safety by observing solicited local and systemic adverse events that have occurred for 7 days after vaccination with BR-TD-1001 and Td-pur-inj. * To evaluate safety by observing unsolicited adverse events that have occurred for 28 days after vaccination with BR-TD-1001 and Td-pur-inj.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy boys and girls aged 10 to 12 years
- •Those who received primary immunization (5 doses of diphtheria and tetanus vaccination until the age of 6)
- •Voluntary written consent of the subject and the legally acceptable representative(LAR) to participate in this clinical study
Exclusion Criteria
- •2 weeks have not passed since recovery from an acute disease
- •Temporary thrombocytopenia or neurological complications due to diphtheria or tetanus vaccination
- •History of a severe allergy to any component of the investigational product
- •History of a severe adverse event due to administration of diphtheria, tetanus, or diphtheria tetanus combined vaccine
- •Administration of tetanus, diphtheria, or diphtheria tetanus combined vaccine within 5 years
- •Unable to verify diphtheria and tetanus vaccination completed until the age of 6
- •History of infection with diphtheria or tetanus (if clinically, serologically or microbiologically confirmed)
- •Current chronic disease that impedes implementation or completion of the clinical study
- •Scheduled surgery during the study period
- •Acute fever with a tympanic temperature exceeding 38.0ºC within 72 hours before administration of the investigational vaccine
Outcomes
Primary Outcomes
The seroprotection rate of anti-diphtheria toxoid (DT) and anti-tetanus toxoid (TT) at 28 days after vaccination with the investigational products
Time Frame: 28 days after vaccination
Seroprotection was defined as anti-DT and anti-TT antibody concentrations ≥ 0.1 IU/mL (ELISA)
Secondary Outcomes
- The geometric mean titer (GMT) of anti-DT and anti-TT at 28 days after vaccination with the investigational products(28 days after vaccination)
- The boosting response for antitoxins of diphtheria and tetanus at 28 days after vaccination with the investigational product(28 days after vaccination)