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

Tanabe Pharma Corporation446 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

446

Conditions

Diphtheria Tetanus Pertussis

Interventions

Eligibility

Sex: ALLMin age: 11 YearsMax age: 12 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (7)

Investigational site

Fukuoka, Fukuoka, Japan

Investigational site

Itoshima-shi, Fukuoka, Japan

Investigational site

Kasuga-shi, Fukuoka, Japan

Investigational site

Hiroshima, Hiroshima, Japan

Inverstigational site

Kumagaya-shi, Saitama, Japan

Investigational site

Shizuoka, Shizuoka, Japan

Inverstigational site

Shinjuku-ku, Tokyo, Japan

Outcomes

Primary Outcomes

Percentage of Participants With Booster Responses for Anti-diphtheria Toxoid (Anti-D) and Anti-tetanus Toxoid (Anti-T) Antibodies

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

Percentage of Participants With Booster Responses for Anti-pertussis Toxoid (Anti-PT) and Anti-Filamentous Hemagglutinin (Anti-FHA) Antibodies

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

Secondary Outcomes

Percentage of Participants With Anti-D and Anti-T Antibody Titers Above Protocol Defined Cut-off Values

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

Percentage of Participants With Anti-PT and Anti-FHA Antibody Titers Above Protocol Defined Cut-off Values

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

Time frame: 28-42 days after vaccination

Geometric Mean Titers (GMTs) of Anti-D and Anti-T Antibodies

Time frame: 28-42 days after vaccination

Geometric Mean Titers (GMTs) of Anti-PT and Anti-FHA Antibodies

Time frame: 28-42 days after vaccination

Geometric Mean Titer Ratios of Anti-D and Anti-T Antibodies

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

Time frame: pre vaccination and 28-42 days after vaccination

Geometric Mean Titer Ratios of Anti-PT and Anti-FHA Antibodies

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

Time frame: pre vaccination and 28-42 days after vaccination

Percentage of Participants With Adverse Events

Time frame: 28-42 days following vaccination