Confirmatory Study of BK1310 in Healthy Infants

Tanabe Pharma Corporation267 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

267

Conditions

Tetanus Diphtheria Pertussis Poliomyelitis Bacterial Meningitis

Interventions

DPT-IPV-HibBIOLOGICAL

0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.

Hib vaccineBIOLOGICAL

0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.

DPT-IPVBIOLOGICAL

0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.

Eligibility

Sex: ALLMin age: 2 MonthsMax age: 42 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Investigational Site

Fukuoka, Fukuoka, Japan

Outcomes

Primary Outcomes

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

Antibody prevalence rate is defined as the percentage of participants whose criteria of each antibody titer: Anti-diphtheria antibody concentrations: \>=0.1 IU/mL, Anti-PT antibody concentrations: \>=10.0 EU/mL, Anti-FHA antibody concentrations: \>=10.0 EU/mL, Anti-tetanus antibody concentrations: \>=0.01 IU/mL, Anti-poliovirus serotype 1,2 and 3 antibody titers (fold) \>=8

Time frame: 4 weeks after the primary immunization (Visit 4)

Secondary Outcomes

Anti-PRP Antibody Prevalence Rate With 0.15 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody

Time frame: 4weeks after the primary immunization (Visit 4)

Geometric Mean Antibody Titer of Anti-PRP Antibody

Time frame: 4weeks after the primary immunization (Visit 4)

Anti-PRP Antibody Prevalence Rate With 1 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody

Time frame: 4 weeks after the booster dose (Visit 6)

Anti-PRP Antibody Prevalence Rate With 0.15 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody

Time frame: 4 weeks after the booster dose (Visit 6)

Geometric Mean Antibody Titer of Anti-PRP Antibody

Time frame: 4 weeks after the booster dose (Visit 6)

Geometric Mean Antibody Titer Against Diphtheria Toxin

Time frame: 4 weeks after the primary immunization (Visit 4)

Data from ClinicalTrials.gov

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