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Confirmatory Study of BK1310 in Healthy Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03891758
Recruitment Status : Completed
First Posted : March 27, 2019
Last Update Posted : November 13, 2020
Sponsor:
Collaborator:
The Research Foundation for Microbial Diseases of Osaka University
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Tetanus Diphtheria Pertussis Poliomyelitis Bacterial Meningitis Biological: DPT-IPV-Hib Biological: Hib vaccine Biological: DPT-IPV Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 267 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Phase 3 Study of BK1310 Compared With ActHIB® and Tetrabik in Healthy Infants: A Randomized, Assessor-blind, Active-controlled
Actual Study Start Date : April 1, 2019
Actual Primary Completion Date : September 18, 2019
Actual Study Completion Date : August 10, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diphtheria Tetanus

Arms and Interventions
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Arm Intervention/treatment
Experimental: BK1310 Biological: DPT-IPV-Hib
0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
Other Name: BK1310
Active Comparator: ActHIB® and Tetrabik Biological: Hib vaccine
0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
Other Name: ActHIB®

Biological: DPT-IPV
0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
Other Name: Tetrabik


Outcome Measures
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Primary Outcome Measures :
  1. Antibody prevalence rate against anti-PRP with 1 μg/mL or higher, diphtheria toxin, pertussis, tetanus toxin, and polio virus [ Time Frame: 4 weeks after the primary immunization (Visit 4) ]

Secondary Outcome Measures :
  1. Anti-PRP antibody prevalence rate with 0.15 μg/mL or higher [ 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 [ Time Frame: 4weeks after the booster dose (Visit 6) ]
  4. Geometric mean antibody titer of anti-PRP antibody [ Time Frame: 4weeks after the booster dose (Visit 6) ]
  5. Geometric mean antibody titer against diphtheria toxin, pertussis, tetanus toxin, and polio virus [ Time Frame: 4weeks after the primary immunization (Visit 4) ]
  6. Antibody prevalence rate against diphtheria toxin, pertussis, tetanus toxin, and polio virus [ Time Frame: 4weeks after the booster dose (Visit 6) ]
  7. Geometric mean antibody titer against diphtheria toxin, pertussis, tetanus toxin, and polio virus [ Time Frame: 4weeks after the booster dose (Visit 6) ]
  8. Adverse events and adverse reactions [ Time Frame: Through study completion, an average of 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   2 Months to 42 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03891758


Locations
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Japan
Investigational Site
Fukuoka-shi, Fukuoka, Japan
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
The Research Foundation for Microbial Diseases of Osaka University
Investigators
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Study Director: General Manager Mitsubishi Tanabe Pharma Corporation
More Information
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Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT03891758    
Other Study ID Numbers: BK1310-J03
First Posted: March 27, 2019    Key Record Dates
Last Update Posted: November 13, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mitsubishi Tanabe Pharma Corporation:
Haemophilus influenza type b
Adsorbed Diphtheria-purified Pertussis-Tetanus- Inactivate poliovirus combined vaccine
Hib
DPT-IPV
Additional relevant MeSH terms:
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Whooping Cough
Tetanus
Diphtheria
Poliomyelitis
Meningitis, Bacterial
Meningitis
Central Nervous System Diseases
Nervous System Diseases
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Infections
Respiratory Tract Infections
 Respiratory Tract Diseases
Clostridium Infections
Gram-Positive Bacterial Infections
Corynebacterium Infections
Actinomycetales Infections
Myelitis
Central Nervous System Infections
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Spinal Cord Diseases
Neuromuscular Diseases
Central Nervous System Bacterial Infections