Clinical trial NCT02992925: Phase 3 Study of BK1310 in Healthy Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Immunization; Infection
Keywords: Haemophilus influenza type b
Adsorbed Diphteria-purified Pertussis-Tetanus-Inactivate poliovirus combined vaccine
Hib
DPT-IPV
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
Collaborators: name: The Research Foundation for Microbial Diseases of Osaka University
First posted: 2016-12-14
Enrollment: 370
Sex: ALL
Minimum age (years): 2
Maximum age (years): 43
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Anti-PRP
timeFrame: 4 weeks after the primary immunization (Visit 4)
Secondary outcomes:
measure: Anti-PRP Antibody Prevalence Rate With 0.15 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody
timeFrame: 4 weeks after the primary immunization (Visit 4)
measure: Geometric Mean Antibody Titer of Anti-PRP Antibody
timeFrame: 4 weeks after the primary immunization (Visit 4)
measure: Anti-PRP Antibody Prevalence Rate With 1 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody
timeFrame: 4 weeks after the booster dose (Visit 6)
measure: Anti-PRP Antibody Prevalence Rate With 0.15 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody
timeFrame: 4 weeks after the booster dose (Visit 6)
measure: Geometric Mean Antibody Titer of Anti-PRP Antibody
timeFrame: 4 weeks after the booster dose (Visit 6)
measure: Geometric Mean Antibody Titer Against Diphtheria Toxin
timeFrame: 4 weeks after the primary immunization (Visit 4)
measure: Geometric Mean Antibody Titer Against Pertussis （PT）
timeFrame: 4 weeks after the primary immunization (Visit 4)
measure: Geometric Mean Antibody Titer Against Pertussis （FHA）
timeFrame: 4 weeks after the primary immunization (Visit 4)
measure: Geometric Mean Antibody Titer Against Tetanus Toxin
timeFrame: 4 weeks after the primary immunization (Visit 4)
measure: Fold Change in Geometric Mean Antibody Titer Against Polio Virus
timeFrame: Baseline and 4 weeks after the primary immunization (Visit 4)
measure: Antibody Prevalence Rate Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus
timeFrame: 4 weeks after the booster dose (Visit 6)
measure: Geometric Mean Antibody Titer Against Diphtheria Toxin
timeFrame: 4 weeks after the booster dose (Visit 6)
measure: Geometric Mean Antibody Titer Against Pertussis （PT）
timeFrame: 4 weeks after the booster dose (Visit 6)
measure: Geometric Mean Antibody Titer Against Pertussis （FHA）
timeFrame: 4 weeks after the booster dose (Visit 6)
measure: Geometric Mean Antibody Titer Against Tetanus Toxin
timeFrame: 4 weeks after the booster dose (Visit 6)
measure: Fold Change in Geometric Mean Antibody Titer Against Polio Virus
timeFrame: Baseline and 4 weeks after the primary immunization (Visit 6)
Other outcomes:
Locations:
city: Fukuoka-shi
country: Japan
state: Fukuoka
city: Kasuga-shi
country: Japan
state: Fukuoka
city: Sendai-shi
country: Japan
state: Miyagi
Study officials:
affiliation: Mitsubishi Tanabe Pharma Corporation
name: General Manager
role: STUDY_DIRECTOR
References: