Safety and Efficacy of BK1310 Intramuscular Injection in Healthy Infants

Immunization Clinical Trial

Official title:

Phase 3 Study of BK1310 Intramuscular Injection in Healthy Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03188692
• Other study ID #: BK1310-J02
• Status: Completed
• Phase: Phase 3
• Start date: June 23, 2017
• Est. completion date: August 9, 2018

Study information

• Verified date: February 2019
• 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 the safety and efficacy of an intramuscular injection of BK1310 in healthy infants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: August 9, 2018
• Est. primary completion date: November 2, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Months to 43 Months

Eligibility

Inclusion Criteria:

• Healthy infants aged =2 and <43 months at the first vaccination of the study drug (recommended: =2 and <7 months). Those who are applicable of the following conditions must be carefully observed before the enrollment: infants with known underlying disease such as cardiovascular disease, renal disease, hepatic disease, blood dyscrasia, respiratory disease or developmental disorder. Infants who developed fever within 2 days after any previous vaccination. Infants with history of convulsions.

• Written informed consent is obtained from a legal guardian (parent)

Exclusion Criteria:

• With past diagnosis of immunodeficiency or currently under immunosuppressive treatment

• Have close relatives (the third degree of kinship) diagnosed with congenital immunodeficiency

• Possibility of anaphylaxis due to food or pharmaceuticals

• With diagnosis of thrombocytopenia and/or coagulopathy or currently under treatment of the antiplatelet agents and/or anticoagulant agents.

• With experience of Hib infection, diphtheria, pertussis, tetanus or acute poliomyelitis

• With experience of Hib, diphteria, pertussis, tetanus or polio vaccination.

• Administered a live vaccine within 27 days before the first vaccination of the study drug, or inactivated vaccine or toxoid within 6 days before vaccination

• Administered transfusion, immunosuppressant (excluding drugs for external use), or immunoglobulin formulation

• Administered corticosteroid 2 mg/kg per day or more as prednisolone (excluding drugs for external use)

• Participated in other studies within 12 weeks before obtaining consent

• With the gestational age <37 weeks or weighed less than 2500 grams at birth.

• Considered to be not eligible by the principal investigators (sub-investigators) of the enrollment.

Related Conditions & MeSH terms

• Immunization

Intervention

Biological:
• DPT-IPV-Hib (Combined Vaccine)
0.5mL, intramuscular injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.

Locations

Country	Name	City	State
Japan	Investigational site 1	Chiba
Japan	Investigational site 2	Tokyo
Japan	Investigational site 3	Tokyo

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		4 weeks after the primary immunization (Visit 4)
Secondary	Geometric mean antibody titer of anti-PRP antibody		4 weeks after the primary immunization (Visit 4)
Secondary	Anti-PRP antibody prevalence rate with 1 µg/mL or higher		4 weeks after the booster dose (Visit 6)
Secondary	Anti-PRP antibody prevalence rate with 0.15 µg/mL or higher		4 weeks after the booster dose (Visit 6)
Secondary	Geometric mean antibody titer of anti-PRP antibody		4 weeks after the booster dose (Visit 6)
Secondary	Geometric mean antibody titer against diphtheria toxin, pertussis, tetanus toxin, and polio virus		4 weeks after the primary immunization (Visit 4)
Secondary	Antibody prevalence rate against diphtheria toxin, pertussis, tetanus toxin, and polio virus		4 weeks after the booster dose (Visit 6)
Secondary	Geometric mean antibody titer against diphtheria toxin, pertussis, tetanus toxin, and polio virus		4 weeks after the booster dose (Visit 6)
Secondary	Adverse events and adverse reactions		Through the first dose (Visit 1) to 4 weeks after the booster dose (Visit 6)