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Completed

NCT Number: NCT03891758

Confirmatory Study of BK1310 in Healthy Infants

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.

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Key information

Conditions

Tetanus Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Bacterial Meningitis Bordetella Infections Central Nervous System Bacterial Infections Central Nervous System Diseases Central Nervous System Infections Clostridium Infections Corynebacterium Infections Diphtheria Enterovirus Infections Gram-Negative Bacterial Infections Gram-Positive Bacterial Infections Haemophilus Infections Infections Meningitis Meningitis, Bacterial Myelitis Nervous System Diseases Neuroinflammatory Diseases Neuromuscular Diseases Pasteurellaceae Infections Pertussis Picornaviridae Infections Poliomyelitis RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Spinal Cord Diseases Virus Diseases Whooping Cough

Age range

2 month–42 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Investigational Site

Fukuoka, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DPT-IPV-Hib

Biological

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

Other names: BK1310

Hib vaccine

Biological

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

Other names: ActHIB®

DPT-IPV

Biological

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

Other names: Tetrabik

Primary outcomes

  1. 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

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

    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

Secondary outcomes

  1. 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)

  2. Geometric Mean Antibody Titer of Anti-PRP Antibody

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

  3. 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)

  4. 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)

  5. Geometric Mean Antibody Titer of Anti-PRP Antibody

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

  6. Geometric Mean Antibody Titer Against Diphtheria Toxin

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

  7. Geometric Mean Antibody Titer Against Pertussis

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

  8. Geometric Mean Antibody Titer Against Tetanus Toxin

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

  9. Geometric Mean Antibody Titer Against Polio Virus

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

  10. 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

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

    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

  11. Geometric Mean Antibody Titer Against Diphtheria Toxin

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

  12. Geometric Mean Antibody Titer Against Pertussis

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

  13. Geometric Mean Antibody Titer Against Tetanus Toxin

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

  14. Fold Change in Geometric Mean Antibody Titer Against Polio Virus

    Time frame: Baseline and 4 weeks after the primary immunization (Visit 6)

Sponsors and collaborators

Lead sponsor

Tanabe Pharma Corporation

Industry

Collaborators

  • The Research Foundation for Microbial Diseases of Osaka University

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Mar 27, 2019
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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