Clinical trial NCT02118961: Study of BK1301 (DTaP Vaccine) as a Booster in Adolescents
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diphtheria
Tetanus
Pertussis
Keywords: Diphtheria
Tetanus
Pertussis
DTaP vaccine
Adolescents
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
Collaborators: name: The Research Foundation for Microbial Diseases of Osaka University
First posted: 2014-04-21
Enrollment: 446
Sex: ALL
Minimum age (years): 11
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


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

Primary outcomes:
measure: Percentage of Participants With Booster Responses for Anti-diphtheria Toxoid (Anti-D) and Anti-tetanus Toxoid (Anti-T) Antibodies
timeFrame: pre-vaccination and 28-42 days after vaccination
measure: Percentage of Participants With Booster Responses for Anti-pertussis Toxoid (Anti-PT) and Anti-Filamentous Hemagglutinin (Anti-FHA) Antibodies
timeFrame: pre-vaccination and 28-42 days after vaccination
Secondary outcomes:
measure: Percentage of Participants With Anti-D and Anti-T Antibody Titers Above Protocol Defined Cut-off Values
timeFrame: 28-42 days after vaccination
measure: Percentage of Participants With Anti-PT and Anti-FHA Antibody Titers Above Protocol Defined Cut-off Values
timeFrame: 28-42 days after vaccination
measure: Geometric Mean Titers (GMTs) of Anti-D and Anti-T Antibodies
timeFrame: 28-42 days after vaccination
measure: Geometric Mean Titers (GMTs) of Anti-PT and Anti-FHA Antibodies
timeFrame: 28-42 days after vaccination
measure: Geometric Mean Titer Ratios of Anti-D and Anti-T Antibodies
timeFrame: pre vaccination and 28-42 days after vaccination
measure: Geometric Mean Titer Ratios of Anti-PT and Anti-FHA Antibodies
timeFrame: pre vaccination and 28-42 days after vaccination
measure: Percentage of Participants With Adverse Events
timeFrame: 28-42 days following vaccination
Other outcomes:
Locations:
city: Fukuoka-shi
country: Japan
facility: Investigational site
state: Fukuoka
city: Itoshima-shi
country: Japan
facility: Investigational site
state: Fukuoka
city: Kasuga-shi
country: Japan
facility: Investigational site
state: Fukuoka
city: Hiroshima-shi
country: Japan
facility: Investigational site
state: Hiroshima
city: Kumagaya-shi
country: Japan
facility: Inverstigational site
state: Saitama
city: Shizuoka-shi
country: Japan
facility: Investigational site
state: Shizuoka
city: Shinjuku-ku
country: Japan
facility: Inverstigational site
state: Tokyo
Study officials:
affiliation: Osaka University
name: Shintaro Okada, M.D., Ph.D.
role: STUDY_DIRECTOR
References: