Trial Outcomes & Findings for Study of BK1301 (DTaP Vaccine) as a Booster in Adolescents (NCT NCT02118961)

NCT ID: NCT02118961

Last Updated: 2026-01-06

Results Overview

Booster response was defined as post titer ≥ 0.4 IU/mL and post/pre titer ≥ 4 increase.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 446 participants
• Primary outcome timeframe: pre-vaccination and 28-42 days after vaccination
• Results posted on: 2026-01-06

Participant Flow

Participant milestones

Measure	BK1301 Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection	DT Toxoid Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid): 0.1 mL, subcutaneous injection
Overall Study STARTED	224	222
Overall Study COMPLETED	223	222
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	BK1301 Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection	DT Toxoid Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid): 0.1 mL, subcutaneous injection
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	BK1301 n=224 Participants Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection	DT Toxoid n=222 Participants Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid): 0.1 mL, subcutaneous injection	Total n=446 Participants Total of all reporting groups
Age, Categorical <=18 years	224 Participants n=37 Participants	222 Participants n=56 Participants	446 Participants n=82 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=37 Participants	0 Participants n=56 Participants	0 Participants n=82 Participants
Age, Categorical >=65 years	0 Participants n=37 Participants	0 Participants n=56 Participants	0 Participants n=82 Participants
Sex: Female, Male Female	113 Participants n=37 Participants	104 Participants n=56 Participants	217 Participants n=82 Participants
Sex: Female, Male Male	111 Participants n=37 Participants	118 Participants n=56 Participants	229 Participants n=82 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	BK1301 n=223 Participants Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection	DT Toxoid n=222 Participants Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid): 0.1 mL, subcutaneous injection
Percentage of Participants With Booster Responses for Anti-diphtheria Toxoid (Anti-D) and Anti-tetanus Toxoid (Anti-T) Antibodies anti-D	100.0 percentage of Participants Interval 98.4 to 100.0	99.5 percentage of Participants Interval 97.5 to 100.0
Percentage of Participants With Booster Responses for Anti-diphtheria Toxoid (Anti-D) and Anti-tetanus Toxoid (Anti-T) Antibodies anti-T	98.7 percentage of Participants Interval 96.1 to 99.7	97.3 percentage of Participants Interval 94.2 to 99.0

PRIMARY outcome

Timeframe: pre-vaccination and 28-42 days after vaccination

Population: The Outcome Measure was only pre-specified for the BK1301 Arm/Group.

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.

Outcome measures

Measure	BK1301 n=223 Participants Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection	DT Toxoid Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid): 0.1 mL, subcutaneous injection
Percentage of Participants With Booster Responses for Anti-pertussis Toxoid (Anti-PT) and Anti-Filamentous Hemagglutinin (Anti-FHA) Antibodies anti-PT	91.0 percentage of Participants Interval 86.5 to 94.4	—
Percentage of Participants With Booster Responses for Anti-pertussis Toxoid (Anti-PT) and Anti-Filamentous Hemagglutinin (Anti-FHA) Antibodies anti-FHA	91.5 percentage of Participants Interval 87.0 to 94.8	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	BK1301 n=223 Participants Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection	DT Toxoid n=222 Participants Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid): 0.1 mL, subcutaneous injection
Percentage of Participants With Anti-D and Anti-T Antibody Titers Above Protocol Defined Cut-off Values anti-D	100.0 percentage of Participants Interval 98.4 to 100.0	100.0 percentage of Participants Interval 98.4 to 100.0
Percentage of Participants With Anti-D and Anti-T Antibody Titers Above Protocol Defined Cut-off Values anti-T	100.0 percentage of Participants Interval 98.4 to 100.0	100.0 percentage of Participants Interval 98.4 to 100.0

SECONDARY outcome

Timeframe: 28-42 days after vaccination

Population: The Outcome Measure was only pre-specified for the BK1301 Arm/Group.

Protocol defined cut-off values were 10 EU/mL.

Outcome measures

Measure	BK1301 n=223 Participants Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection	DT Toxoid Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid): 0.1 mL, subcutaneous injection
Percentage of Participants With Anti-PT and Anti-FHA Antibody Titers Above Protocol Defined Cut-off Values anti-PT	100.0 percentage of Participants Interval 98.4 to 100.0	—
Percentage of Participants With Anti-PT and Anti-FHA Antibody Titers Above Protocol Defined Cut-off Values anti-FHA	100.0 percentage of Participants Interval 98.4 to 100.0	—

SECONDARY outcome

Timeframe: 28-42 days after vaccination

Outcome measures

Measure	BK1301 n=223 Participants Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection	DT Toxoid n=222 Participants Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid): 0.1 mL, subcutaneous injection
Geometric Mean Titers (GMTs) of Anti-D and Anti-T Antibodies anti-D	20.856 IU/mL Interval 18.221 to 23.872	15.581 IU/mL Interval 13.748 to 17.658
Geometric Mean Titers (GMTs) of Anti-D and Anti-T Antibodies anti-T	13.378 IU/mL Interval 11.838 to 15.118	11.638 IU/mL Interval 10.348 to 13.09

SECONDARY outcome

Timeframe: 28-42 days after vaccination

Population: The Outcome Measure was only pre-specified for the BK1301 Arm/Group.

Outcome measures

Measure	BK1301 n=223 Participants Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection	DT Toxoid Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid): 0.1 mL, subcutaneous injection
Geometric Mean Titers (GMTs) of Anti-PT and Anti-FHA Antibodies anti-PT	241.15 EU/mL Interval 210.65 to 276.07	—
Geometric Mean Titers (GMTs) of Anti-PT and Anti-FHA Antibodies anti-FHA	344.46 EU/mL Interval 309.72 to 383.1	—

SECONDARY outcome

Timeframe: pre vaccination and 28-42 days after vaccination

Ratios were calculated as 28-42 days after vaccination titers over pre vaccination titers

Outcome measures

Measure	BK1301 n=223 Participants Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection	DT Toxoid n=222 Participants Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid): 0.1 mL, subcutaneous injection
Geometric Mean Titer Ratios of Anti-D and Anti-T Antibodies anti-D	137.5 titer ratio Interval 107.8 to 175.5	106.3 titer ratio Interval 83.9 to 134.7
Geometric Mean Titer Ratios of Anti-D and Anti-T Antibodies anti-T	47.9 titer ratio Interval 38.9 to 59.0	44.3 titer ratio Interval 36.4 to 53.9

SECONDARY outcome

Timeframe: pre vaccination and 28-42 days after vaccination

Population: The Outcome Measure was only pre-specified for the BK1301 Arm/Group.

Ratios were calculated as 28-42 days after vaccination titers over pre vaccination titers

Outcome measures

Measure	BK1301 n=223 Participants Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection	DT Toxoid Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid): 0.1 mL, subcutaneous injection
Geometric Mean Titer Ratios of Anti-PT and Anti-FHA Antibodies anti-PT	12.6 titer ratio Interval 10.5 to 15.2	—
Geometric Mean Titer Ratios of Anti-PT and Anti-FHA Antibodies anti-FHA	8.5 titer ratio Interval 7.2 to 10.0	—

SECONDARY outcome

Timeframe: 28-42 days following vaccination

Outcome measures

Measure	BK1301 n=223 Participants Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection	DT Toxoid n=222 Participants Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid): 0.1 mL, subcutaneous injection
Percentage of Participants With Adverse Events	90.1 percentage of participants	89.6 percentage of participants

Adverse Events

BK1301

Serious events: 0 serious events

Other events: 200 other events

Deaths: 0 deaths

DT Toxoid

Serious events: 0 serious events

Other events: 194 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	BK1301 n=223 participants at risk Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection	DT Toxoid n=222 participants at risk Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid): 0.1 mL, subcutaneous injection
General disorders Injection site erythema	74.9% 167/223	72.1% 160/222
General disorders Injection site induration	42.6% 95/223	37.8% 84/222
General disorders Injection site pain	56.1% 125/223	38.3% 85/222
General disorders Injection site pruritus	59.2% 132/223	50.9% 113/222
General disorders Injection site swelling	72.6% 162/223	66.7% 148/222
General disorders Injection site warmth	51.6% 115/223	39.2% 87/222
General disorders Pyrexia	6.7% 15/223	1.4% 3/222
Infections and infestations Nasopharyngitis	5.4% 12/223	6.8% 15/222
Nervous system disorders Headache	7.6% 17/223	5.9% 13/222

Additional Information

Clinical Trials, Information Desk / Clinical Development counter

Tanabe Pharma Corporation / The Research Foundation for Microbial Diseases of Osaka University

Email: cti-inq-ml.JP@ml.tanabe-pharma.com/clinicaldevelopment@mail.biken.or.jp

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER