Phase 3
N=446
Study of BK1301 (DTaP Vaccine) as a Booster in Adolescents
Diphtheria · Tetanus · Pertussis
Bottom Line
View on ClinicalTrials.gov: NCT02118961 ↗Enrolled (actual)
446
Serious AEs
0.0%
Results posted
Nov 2016
Primary outcome: Primary: Percentage of Participants With Booster Responses for Anti-diphtheria Toxoid (Anti-D) and Anti-tetanus Toxoid (Anti-T) Antibodies — 100.0; 99.5; 98.7; 97.3 percentage of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301) (Biological); Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid) (Biological)
- Age
- Pediatric · 11+ yrs
- Sex
- All
- Sponsor
- Tanabe Pharma Corporation
- Primary completion
- Aug 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Booster Responses for Anti-diphtheria Toxoid (Anti-D) and Anti-tetanus Toxoid (Anti-T) Antibodies |
100.0; 99.5; 98.7; 97.3 | — |
| PRIMARY Percentage of Participants With Booster Responses for Anti-pertussis Toxoid (Anti-PT) and Anti-Filamentous Hemagglutinin (Anti-FHA) Antibodies |
91.0; 91.5 | — |
| SECONDARY Percentage of Participants With Anti-D and Anti-T Antibody Titers Above Protocol Defined Cut-off Values |
100.0; 100.0; 100.0; 100.0 | — |
| SECONDARY Percentage of Participants With Anti-PT and Anti-FHA Antibody Titers Above Protocol Defined Cut-off Values |
100.0; 100.0 | — |
| SECONDARY Geometric Mean Titers (GMTs) of Anti-D and Anti-T Antibodies |
20.856; 15.581; 13.378; 11.638 | — |
| SECONDARY Geometric Mean Titers (GMTs) of Anti-PT and Anti-FHA Antibodies |
241.15; 344.46 | — |
| SECONDARY Geometric Mean Titer Ratios of Anti-D and Anti-T Antibodies |
137.5; 106.3; 47.9; 44.3 | — |
| SECONDARY Geometric Mean Titer Ratios of Anti-PT and Anti-FHA Antibodies |
12.6; 8.5 | — |
| SECONDARY Percentage of Participants With Adverse Events |
90.1; 89.6 | — |
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
Data sourced from ClinicalTrials.gov (NCT02118961). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.