Phase 3 Study of BK1310 Intramuscular Injection in Healthy Infants


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Verified June 2017 by Mitsubishi Tanabe Pharma Corporation

Sponsor:

Collaborator:

The Research Foundation for Microbial Diseases of Osaka University

Information provided by (Responsible Party):

Mitsubishi Tanabe Pharma Corporation

ClinicalTrials.gov Identifier:

NCT03188692

First received: June 13, 2017

Last updated: June 13, 2017

Last verified: June 2017

The purpose of this study is to evaluate the safety and efficacy of an intramuscular injection of BK1310 in healthy infants.

Immunization Biological: DPT-IPV-Hib (Combined Vaccine) Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Prevention
Official Title: Phase 3 Study of BK1310 Intramuscular Injection in Healthy Infants

Primary Outcome Measures:

  • 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:

  • Anti-PRP antibody prevalence rate with 0.15 μg/mL or higher [ Time Frame: 4 weeks after the primary immunization (Visit 4) ]
  • Geometric mean antibody titer of anti-PRP antibody [ Time Frame: 4 weeks after the primary immunization (Visit 4) ]
  • Anti-PRP antibody prevalence rate with 1 μg/mL or higher [ Time Frame: 4 weeks after the booster dose (Visit 6) ]
  • Anti-PRP antibody prevalence rate with 0.15 μg/mL or higher [ 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, pertussis, tetanus toxin, and polio virus [ Time Frame: 4 weeks after the primary immunization (Visit 4) ]
  • Antibody prevalence rate against diphtheria toxin, pertussis, tetanus toxin, and polio virus [ Time Frame: 4 weeks after the booster dose (Visit 6) ]
  • Geometric mean antibody titer against diphtheria toxin, pertussis, tetanus toxin, and polio virus [ Time Frame: 4 weeks after the booster dose (Visit 6) ]
  • Adverse events and adverse reactions [ Time Frame: Through the first dose (Visit 1) to 4 weeks after the booster dose (Visit 6) ]

Estimated Enrollment: 30
Anticipated Study Start Date: June 2017
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Experimental: BK1310 Biological: DPT-IPV-Hib (Combined Vaccine)

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

Other Name: BK1310

Ages Eligible for Study:   2 Months to 43 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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 diagnosis of thrombocytopenia and/or coagulopathy or currently under treatment of the antiplatelet agents and/or anticoagulant agents.
  • 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03188692

Investigational site 1
Chiba, Japan
Investigational site 2
Tokyo, Japan
Investigational site 3
Tokyo, Japan

Mitsubishi Tanabe Pharma Corporation

The Research Foundation for Microbial Diseases of Osaka University

Study Director: General Manager Mitsubishi Tanabe Pharma Corporation

Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT03188692     History of Changes
Other Study ID Numbers: BK1310-J02
Study First Received: June 13, 2017
Last Updated: June 13, 2017

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
Intramuscular

Additional relevant MeSH terms:

Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 15, 2017