Phase 3 Study of BK1310 in Healthy Infants

The purpose of this study is to:

• (cohort 1) evaluate safety and immunogenicity (Haemophilus influenzae type b, Hib) of BK1310.
• (cohort 2) evaluate efficacy and safety of BK1310 using ActHIB® and Tetrabik as a control in healthy infants.

Study Overview

• Status: Completed
• Conditions: Immunization; Infection
• Intervention / Treatment: Biological: DPT-IPV-Hib-High（Combined Vaccine）; Biological: DPT-IPV-Hib-Low（Combined Vaccine）; Biological: Hib vaccine; Biological: DPT-IPV

Detailed Description

<Cohort 1>

• Arm: BK1310-High. Intervention: DPT-IPV-Hib-High(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
• Arm: BK1310-Low. Intervention: DPT-IPV-Hib-Low(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.

<Cohort 2>

• Arm: BK1310-High or Low. Intervention: DPT-IPV-Hib-High(Combined Vaccine) or DPT-IPV-Hib-Low(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals.
• Arm: ActHIB® and Tetrabik. Intervention: Hib vaccine and DPT-IPV 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals.

• Study Type: Interventional
• Enrollment (Actual): 370
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Fukuoka
    • Fukuoka-shi, Fukuoka, Japan
    • Kasuga-shi, Fukuoka, Japan
  • Miyagi
    • Sendai-shi, Miyagi, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 months to 3 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Cohort 1: BK1310-High	Biological: DPT-IPV-Hib-High（Combined Vaccine）; Other Names: BK1310-High
EXPERIMENTAL: Cohort 1: BK1310-Low	Biological: DPT-IPV-Hib-Low（Combined Vaccine）; Other Names: BK1310-Low
EXPERIMENTAL: Cohort 2: BK1310-High or -Low; Either BK1310-High or -Low will be chosen based on the result of cohort 1	Biological: DPT-IPV-Hib-High（Combined Vaccine）; Other Names: BK1310-High; Biological: DPT-IPV-Hib-Low（Combined Vaccine）; Other Names: BK1310-Low
ACTIVE_COMPARATOR: Cohort 2: ActHIB® and Tetrabik	Biological: Hib vaccine; Other Names: ActHIB®; Biological: DPT-IPV; Other Names: Tetrabik

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anti-PRP antibody prevalence rate with 0.15 μg/mL or higher		4 weeks after the primary immunization (Visit 4)
Geometric mean antibody titer of anti-PRP antibody		4 weeks after the primary immunization (Visit 4)
Anti-PRP antibody prevalence rate with 1 μg/mL or higher		4 weeks after the booster dose (Visit 6)
Anti-PRP antibody prevalence rate with 0.15 μg/mL or higher		4 weeks after the booster dose (Visit 6)
Geometric mean antibody titer of anti-PRP antibody		4 weeks after the booster dose (Visit 6)
Geometric mean antibody titer against diphtheria toxin, pertussis, tetanus toxin, and polio virus		4 weeks after the primary immunization (Visit 4)
Antibody prevalence rate against diphtheria toxin, pertussis, tetanus toxin, and polio virus		4 weeks after the booster dose (Visit 6)
Geometric mean antibody titer against diphtheria toxin, pertussis, tetanus toxin, and polio virus		4 weeks after the booster dose (Visit 6)
Number of participants with adverse events and adverse reactions	Cohort 1	Through the first dose (Visit 1) to 4 weeks after the booster dose (Visit 6)
Number of participants with adverse events and adverse reactions	Cohort 2	Through the first dose (Visit 1) to 4 weeks after the primary immunization (Visit 4)

Collaborators and Investigators

• Sponsor: Mitsubishi Tanabe Pharma Corporation
• Collaborators: The Research Foundation for Microbial Diseases of Osaka University

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (ACTUAL): December 1, 2017
• Study Completion (ACTUAL): November 1, 2018

Study Registration Dates

• First Submitted: December 1, 2016
• First Submitted That Met QC Criteria: December 12, 2016
• First Posted (ESTIMATE): December 14, 2016

Study Record Updates

• Last Update Posted (ACTUAL): February 6, 2019
• Last Update Submitted That Met QC Criteria: February 4, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Hib; Haemophilus influenza type b; Adsorbed Diphteria-purified Pertussis-Tetanus-Inactivate poliovirus combined vaccine; DPT-IPV
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: BK1310-J01