Overview

This trial is active, not recruiting.

Conditions diphtheria, tetanus, pertussis
Treatments diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (dtap vaccine, bk1301), adsorbed diphtheria-tetanus combined toxoid (dt toxoid)
Phase phase 3
Sponsor Mitsubishi Tanabe Pharma Corporation
Collaborator The Research Foundation for Microbial Diseases of Osaka University
Start date April 2014
End date October 2014
Trial size 430 participants
Trial identifier NCT02118961, BKD1A

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (dtap vaccine, bk1301) TRIBIK®
0.5 mL, subcutaneous injection
(Active Comparator)
adsorbed diphtheria-tetanus combined toxoid (dt toxoid) DTBIK®
0.1 mL, subcutaneous injection

Primary Outcomes

Measure
Percentage of participants with booster responses for anti-D and anti-T antibodies
time frame: pre-vaccination and 28-42 days after vaccination
Percentage of participants with booster responses for anti-PT and anti-FHA antibodies
time frame: pre-vaccination and 28-42 days after vaccination

Secondary Outcomes

Measure
Percentage of participants with anti-D and anti-T antibody titers above protocol defined cut-off values
time frame: 28-42 days after vaccination
Percentage of participants with anti-PT and anti-FHA antibody titers above protocol defined cut-off values
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
GMTs of anti-PT and anti-FHA antibodies
time frame: 28-42 days after vaccination
Increase in GMTs of anti-D and anti-T antibodies
time frame: pre-vaccination and 28-42 days after vaccination
Increase in GMTs of anti-PT and anti-FHA antibodies
time frame: pre-vaccination and 28-42 days after vaccination
Percentage of participants with Adverse Events
time frame: 28-42 days following vaccination

Eligibility Criteria

Male or female participants from 11 years up to 12 years old.

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

Additional Information

Official title Confirmatory Study to Evaluate the Immunogenicity of Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP Vaccine, BK1301) as a Booster in Adolescents
Trial information was received from ClinicalTrials.gov and was last updated in August 2014.
Information provided to ClinicalTrials.gov by Mitsubishi Tanabe Pharma Corporation.