NCT04618939CompletedPhase 3
Double Blind, Randomized Phase III Study to Evaluate the Immunogenicity and Safety of 'BR-TD-1001' Administered Intramuscularly in Healthy Children
Boryung Biopharma Co., Ltd.9 sites in 1 country218 target enrollmentStarted: October 20, 2016Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- 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
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Masking Description
double-blind
Eligibility Criteria
- Ages
- 10 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •Administration of other vaccines within 28 days before screening
- •Use of immunosuppressants or immune modifying drugs within 3 months before screening
- •Those who have received immunoglobulin therapies or blood derived products within 3 months before screening, or are expected to receive them during the study period
- •Use of antipyretics/analgesics/nonsteroidal anti inflammatory drugs within 4 hours before administration of the investigational vaccine
- •Participation in other clinical studies within 28 days before screening
- •Those who were determined by the investigator to be ineligible for other reasons
Arms & Interventions
Td-pur inj
Active Comparator
Randomized subjects were assigned to receive a single dose of Td-pur inj
Intervention: Td-pur inj (Biological)
BR-TD-1001
Experimental
Randomized subjects were assigned to receive a single dose of BR-TD-1001
Intervention: BR-TD-1001 (Biological)
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)
Investigators
Study Sites (9)
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