Confirmatory Study of BK1310 in Healthy Infants

Tetanus Clinical Trial

Official title:

Phase 3 Study of BK1310 Compared With ActHIB® and Tetrabik in Healthy Infants: A Randomized, Assessor-blind, Active-controlled

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03891758
• Other study ID #: BK1310-J03
• Status: Completed
• Phase: Phase 3
• Start date: April 1, 2019
• Est. completion date: August 10, 2020

Study information

• Verified date: November 2020
• Source: Mitsubishi Tanabe Pharma Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate immunogenicity of BK1310 for all antigens (anti-PRP, diphtheria toxin, pertussis, tetanus toxin, and polio virus), after 3 times of injection, when compared noninferiority with co-administration of ActHIB® and Tetrabik, as well as efficacy and safety, in healthy infants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 267
• Est. completion date: August 10, 2020
• Est. primary completion date: September 18, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Months to 42 Months

Eligibility

Inclusion Criteria:

• Healthy infants aged =2 and <43 months at the first vaccination of the study drug (recommended: =2 and <7 months)
• Written informed consent is obtained from a legal guardian (parent)

Exclusion Criteria:

• Possibility of anaphylaxis due to food or pharmaceuticals
• With experience of Hib infection, diphtheria, pertussis, tetanus or acute poliomyelitis
• With experience of Hib, diphteria, pertussis, tetanus or polio vaccination.
• Participated in other studies within 12 weeks before obtaining consent
• Considered to be not eligible by the principal investigators (sub-investigators) of the enrollment Additional screening criteria check may apply for qualification.

Related Conditions & MeSH terms

• Bacterial Meningitis
• Diphtheria
• Meningitis
• Meningitis, Bacterial
• Pertussis
• Poliomyelitis
• Tetanus
• Whooping Cough

Intervention

Biological:
• DPT-IPV-Hib
0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
• Hib vaccine
0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
• DPT-IPV
0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.

Locations

Country	Name	City	State
Japan	Investigational Site	Fukuoka-shi	Fukuoka

Sponsors (2)

Lead Sponsor	Collaborator
Mitsubishi Tanabe Pharma Corporation	The Research Foundation for Microbial Diseases of Osaka University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antibody prevalence rate against anti-PRP with 1 µg/mL or higher, diphtheria toxin, pertussis, tetanus toxin, and polio virus		4 weeks after the primary immunization (Visit 4)
Secondary	Anti-PRP antibody prevalence rate with 0.15 µg/mL or higher		4weeks after the primary immunization (Visit 4)
Secondary	Geometric mean antibody titer of anti-PRP antibody		4weeks after the primary immunization (Visit 4)
Secondary	Anti-PRP antibody prevalence rate with 1 µg/mL or higher		4weeks after the booster dose (Visit 6)
Secondary	Geometric mean antibody titer of anti-PRP antibody		4weeks after the booster dose (Visit 6)
Secondary	Geometric mean antibody titer against diphtheria toxin, pertussis, tetanus toxin, and polio virus		4weeks after the primary immunization (Visit 4)
Secondary	Antibody prevalence rate against diphtheria toxin, pertussis, tetanus toxin, and polio virus		4weeks after the booster dose (Visit 6)
Secondary	Geometric mean antibody titer against diphtheria toxin, pertussis, tetanus toxin, and polio virus		4weeks after the booster dose (Visit 6)
Secondary	Adverse events and adverse reactions		Through study completion, an average of 1 year