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

Phase 3

Completed

• Conditions: Diphtheria; Tetanus; Pertussis
• Interventions: Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301); Biological: Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid)

• Registration Number: NCT02118961
• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-04-13
• Study First Submitted QC: 2014-04-18
• Study First Posted: 2014-04-21
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Results First Submitted: 2016-05-16
• Status Verified: 2016-09
• Results First Submitted QC: 2016-09-30
• Results First Posted: 2016-11-21
• Last Update Submitted: 2016-11-24
• Last Update Posted: 2017-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 446

Inclusion Criteria

• Age 11 or 12 years on the day of injection
• Received 3 or 4 doses of DTaP vaccine

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BK1301	Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301)	-
DT toxoid	Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid)	-

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Booster Responses for Anti-pertussis Toxoid (Anti-PT) and Anti-Filamentous Hemagglutinin (Anti-FHA) Antibodies	pre-vaccination and 28-42 days after vaccination	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.
Percentage of Participants With Booster Responses for Anti-diphtheria Toxoid (Anti-D) and Anti-tetanus Toxoid (Anti-T) Antibodies	pre-vaccination and 28-42 days after vaccination	Booster response was defined as post titer ≥ 0.4 IU/mL and post/pre titer ≥ 4 increase.

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Investigational site; 🇯🇵 Shizuoka-shi, Shizuoka, Japan

Inverstigational site; 🇯🇵 Shinjuku-ku, Tokyo, Japan