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

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ClinicalTrials.gov Identifier: NCT02118961
Recruitment Status : Completed
First Posted : April 21, 2014
Results First Posted : November 21, 2016
Last Update Posted : January 13, 2017
Sponsor:
Collaborator:
The Research Foundation for Microbial Diseases of Osaka University
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
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)
Enrollment 446
Recruitment Details  
Pre-assignment Details  
Arm/Group Title BK1301 DT Toxoid
Hide Arm/Group Description Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid): 0.1 mL, subcutaneous injection
Period Title: Overall Study
Started 224 222
Completed 223 222
Not Completed 1 0
Reason Not Completed
Withdrawal by Subject             1             0
Arm/Group Title BK1301 DT Toxoid Total
Hide Arm/Group Description Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid): 0.1 mL, subcutaneous injection Total of all reporting groups
Overall Number of Baseline Participants 224 222 446
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 224 participants 222 participants 446 participants
<=18 years
224
 100.0%
222
 100.0%
446
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 224 participants 222 participants 446 participants
Female
113
  50.4%
104
  46.8%
217
  48.7%
Male
111
  49.6%
118
  53.2%
229
  51.3%
1.Primary Outcome
Title Percentage of Participants With Booster Responses for Anti-diphtheria Toxoid (Anti-D) and Anti-tetanus Toxoid (Anti-T) Antibodies
Hide Description Booster response was defined as post titer ≥ 0.4 IU/mL and post/pre titer ≥ 4 increase.
Time Frame pre-vaccination and 28-42 days after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title BK1301 DT Toxoid
Hide Arm/Group Description:
Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection
Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid): 0.1 mL, subcutaneous injection
Overall Number of Participants Analyzed 223 222
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of Participants
anti-D
100.0
(98.4 to 100.0)
99.5
(97.5 to 100.0)
anti-T
98.7
(96.1 to 99.7)
97.3
(94.2 to 99.0)
2.Primary Outcome
Title Percentage of Participants With Booster Responses for Anti-pertussis Toxoid (Anti-PT) and Anti-Filamentous Hemagglutinin (Anti-FHA) Antibodies
Hide Description 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.
Time Frame pre-vaccination and 28-42 days after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The Outcome Measure was only pre-specified for the BK1301 Arm/Group.
Arm/Group Title BK1301
Hide Arm/Group Description:
Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection
Overall Number of Participants Analyzed 223
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of Participants
anti-PT
91.0
(86.5 to 94.4)
anti-FHA
91.5
(87.0 to 94.8)
3.Secondary Outcome
Title Percentage of Participants With Anti-D and Anti-T Antibody Titers Above Protocol Defined Cut-off Values
Hide Description Protocol defined cut-off values were 0.1 IU/mL for anti-D and 0.01 IU/mL for anti-T.
Time Frame 28-42 days after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title BK1301 DT Toxoid
Hide Arm/Group Description:
Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection
Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid): 0.1 mL, subcutaneous injection
Overall Number of Participants Analyzed 223 222
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of Participants
anti-D
100.0
(98.4 to 100.0)
100.0
(98.4 to 100.0)
anti-T
100.0
(98.4 to 100.0)
100.0
(98.4 to 100.0)
4.Secondary Outcome
Title Percentage of Participants With Anti-PT and Anti-FHA Antibody Titers Above Protocol Defined Cut-off Values
Hide Description Protocol defined cut-off values were 10 EU/mL.
Time Frame 28-42 days after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The Outcome Measure was only pre-specified for the BK1301 Arm/Group.
Arm/Group Title BK1301
Hide Arm/Group Description:
Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection
Overall Number of Participants Analyzed 223
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of Participants
anti-PT
100.0
(98.4 to 100.0)
anti-FHA
100.0
(98.4 to 100.0)
5.Secondary Outcome
Title Geometric Mean Titers (GMTs) of Anti-D and Anti-T Antibodies
Hide Description [Not Specified]
Time Frame 28-42 days after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title BK1301 DT Toxoid
Hide Arm/Group Description:
Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection
Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid): 0.1 mL, subcutaneous injection
Overall Number of Participants Analyzed 223 222
Geometric Mean (95% Confidence Interval)
Unit of Measure: IU/mL
anti-D
20.856
(18.221 to 23.872)
15.581
(13.748 to 17.658)
anti-T
13.378
(11.838 to 15.118)
11.638
(10.348 to 13.090)
6.Secondary Outcome
Title Geometric Mean Titers (GMTs) of Anti-PT and Anti-FHA Antibodies
Hide Description [Not Specified]
Time Frame 28-42 days after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The Outcome Measure was only pre-specified for the BK1301 Arm/Group.
Arm/Group Title BK1301
Hide Arm/Group Description:
Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection
Overall Number of Participants Analyzed 223
Geometric Mean (95% Confidence Interval)
Unit of Measure: EU/mL
anti-PT
241.15
(210.65 to 276.07)
anti-FHA
344.46
(309.72 to 383.10)
7.Secondary Outcome
Title Geometric Mean Titer Ratios of Anti-D and Anti-T Antibodies
Hide Description Ratios were calculated as 28-42 days after vaccination titers over pre vaccination titers
Time Frame pre vaccination and 28-42 days after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title BK1301 DT Toxoid
Hide Arm/Group Description:
Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection
Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid): 0.1 mL, subcutaneous injection
Overall Number of Participants Analyzed 223 222
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer ratio
anti-D
137.5
(107.8 to 175.5)
106.3
(83.9 to 134.7)
anti-T
47.9
(38.9 to 59.0)
44.3
(36.4 to 53.9)
8.Secondary Outcome
Title Geometric Mean Titer Ratios of Anti-PT and Anti-FHA Antibodies
Hide Description Ratios were calculated as 28-42 days after vaccination titers over pre vaccination titers
Time Frame pre vaccination and 28-42 days after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The Outcome Measure was only pre-specified for the BK1301 Arm/Group.
Arm/Group Title BK1301
Hide Arm/Group Description:
Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection
Overall Number of Participants Analyzed 223
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer ratio
anti-PT
12.6
(10.5 to 15.2)
anti-FHA
8.5
(7.2 to 10.0)
9.Secondary Outcome
Title Percentage of Participants With Adverse Events
Hide Description [Not Specified]
Time Frame 28-42 days following vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title BK1301 DT Toxoid
Hide Arm/Group Description:
Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection
Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid): 0.1 mL, subcutaneous injection
Overall Number of Participants Analyzed 223 222
Measure Type: Number
Unit of Measure: percentage of participants
90.1 89.6
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title BK1301 DT Toxoid
Hide Arm/Group Description Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid): 0.1 mL, subcutaneous injection
All-Cause Mortality
BK1301 DT Toxoid
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
BK1301 DT Toxoid
Affected / at Risk (%) Affected / at Risk (%)
Total   0/223 (0.00%)   0/222 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
BK1301 DT Toxoid
Affected / at Risk (%) Affected / at Risk (%)
Total   200/223 (89.69%)   194/222 (87.39%) 
General disorders     
Injection site erythema  167/223 (74.89%)  160/222 (72.07%) 
Injection site induration  95/223 (42.60%)  84/222 (37.84%) 
Injection site pain  125/223 (56.05%)  85/222 (38.29%) 
Injection site pruritus  132/223 (59.19%)  113/222 (50.90%) 
Injection site swelling  162/223 (72.65%)  148/222 (66.67%) 
Injection site warmth  115/223 (51.57%)  87/222 (39.19%) 
Pyrexia  15/223 (6.73%)  3/222 (1.35%) 
Infections and infestations     
Nasopharyngitis  12/223 (5.38%)  15/222 (6.76%) 
Nervous system disorders     
Headache  17/223 (7.62%)  13/222 (5.86%) 
1
Term from vocabulary, MedDRA 17
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Trials, Information Desk / Clinical Development counter
Organization: Mitsubishi Tanabe Pharma Corporation / The Research Foundation for Microbial Diseases of Osaka University
EMail: cti-inq-ml@ml.mt-pharma.co.jp/clinicaldevelopment@mail.biken.or.jp
Layout table for additonal information
Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT02118961     History of Changes
Other Study ID Numbers: BKD1A
First Submitted: April 13, 2014
First Posted: April 21, 2014
Results First Submitted: May 16, 2016
Results First Posted: November 21, 2016
Last Update Posted: January 13, 2017