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

Tanabe Pharma Corporation

Status and phase

Completed

Phase 3

Conditions

Diphtheria

Pertussis

Tetanus

Treatments

Biological: Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid)

Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301)

Study type

Interventional

Funder types

Other

Industry

Identifiers

BKD1A

Details and patient eligibility

About

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

Enrollment

446 patients

Sex

All

Ages

11 to 12 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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