Study of BK1301 (DTaP Vaccine) as a Booster in Adolescents

Study Overview
=================
Brief Summary
-----------------
This study is designed to assess the immunogenicity and safety of DTaP vaccine (BK1301) as a booster dose in adolescents. The purposes of this study are as follows: To confirm the non-inferiority of BK1301 to Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid) with respect to booster responses for anti-diphtheria toxoid (anti-D) and anti-tetanus toxoid (anti-T) antibodies To confirm that booster responses for anti-pertussis toxoid (anti-PT) and anti-Filamentous Hemagglutinin (anti-FHA) antibodies are more than 80% of participants received BK1301

Official Title
-----------------
Confirmatory Study to Evaluate the Immunogenicity of Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP Vaccine, BK1301) as a Booster in Adolescents

Conditions
-----------------
Diphtheria, Tetanus, Pertussis

Intervention / Treatment
-----------------
* Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301)
* Biological: Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 11 or 12 years on the day of injection Received 3 or 4 doses of DTaP vaccine Exclusion Criteria: History of pertussis, diphtheria, tetanus History of anaphylaxis to vaccine components Serious conditions or diseases of the heart, vein, blood, respiratory, hepar, kidney, digestive system, psychiatric or nervous system Transfused or received gamma globulin within 3 months, or received high-dose gamma globulin within 6 months before the day of injection

Ages Eligible for Study
-----------------
Minimum Age: 11 Years
Maximum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BK1301<br> | Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301)<br>* 0.5 mL, subcutaneous injection<br>* Other names: TRIBIK®;|
| Active Comparator: DT toxoid<br> | Biological: Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid)<br>* 0.1 mL, subcutaneous injection<br>* Other names: DTBIK®;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Booster Responses for Anti-diphtheria Toxoid (Anti-D) and Anti-tetanus Toxoid (Anti-T) Antibodies | Booster response was defined as post titer ≥ 0.4 IU/mL and post/pre titer ≥ 4 increase. | pre-vaccination and 28-42 days after vaccination | 
| Percentage of Participants With Booster Responses for Anti-pertussis Toxoid (Anti-PT) and Anti-Filamentous Hemagglutinin (Anti-FHA) Antibodies | Booster response was defined as post titer ≥ 20 EU/mL and post/pre titer ≥ 4 increase in a subject with pre titer < 20 EU/mL, or post/pre titer ≥ 2 increase in a subject with pre titer ≥ 20 EU/mL. | pre-vaccination and 28-42 days after vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Anti-D and Anti-T Antibody Titers Above Protocol Defined Cut-off Values | Protocol defined cut-off values were 0.1 IU/mL for anti-D and 0.01 IU/mL for anti-T. | 28-42 days after vaccination | 
| Percentage of Participants With Anti-PT and Anti-FHA Antibody Titers Above Protocol Defined Cut-off Values | Protocol defined cut-off values were 10 EU/mL. | 28-42 days after vaccination | 
| Geometric Mean Titers (GMTs) of Anti-D and Anti-T Antibodies |  | 28-42 days after vaccination | 
| Geometric Mean Titers (GMTs) of Anti-PT and Anti-FHA Antibodies |  | 28-42 days after vaccination | 
| Geometric Mean Titer Ratios of Anti-D and Anti-T Antibodies | Ratios were calculated as 28-42 days after vaccination titers over pre vaccination titers | pre vaccination and 28-42 days after vaccination | 
| Geometric Mean Titer Ratios of Anti-PT and Anti-FHA Antibodies | Ratios were calculated as 28-42 days after vaccination titers over pre vaccination titers | pre vaccination and 28-42 days after vaccination | 
| Percentage of Participants With Adverse Events |  | 28-42 days following vaccination | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diphtheria, Tetanus, Pertussis, DTaP vaccine, Adolescents