Confirmatory Study of BK1310 in Healthy Infants

Study Overview
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Brief Summary
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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.

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

Conditions
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Tetanus, Diphtheria, Pertussis, Poliomyelitis, Bacterial Meningitis

Intervention / Treatment
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* Biological: DPT-IPV-Hib
* Biological: Hib vaccine
* Biological: DPT-IPV


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 2 Months
Maximum Age: 42 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BK1310<br> | Biological: DPT-IPV-Hib<br>* 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.<br>* Other names: BK1310;|
| Active Comparator: ActHIB® and Tetrabik<br> | Biological: Hib vaccine<br>* 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.<br>* Other names: ActHIB®;Biological: DPT-IPV<br>* 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.<br>* Other names: Tetrabik;|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Haemophilus influenza type b, Adsorbed Diphtheria-purified Pertussis-Tetanus- Inactivate poliovirus combined vaccine, Hib, DPT-IPV