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Safety and Efficacy of BK1310 Intramuscular Injection 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: NCT03188692
Recruitment Status : Completed
First Posted : June 15, 2017
Last Update Posted : February 6, 2019
Sponsor:
Collaborator:
The Research Foundation for Microbial Diseases of Osaka University
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation

Tracking Information
First Submitted Date  ICMJE June 13, 2017
First Posted Date  ICMJE June 15, 2017
Last Update Posted Date February 6, 2019
Actual Study Start Date  ICMJE June 23, 2017
Actual Primary Completion Date November 2, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 13, 2017)
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) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03188692 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 13, 2017)
  • 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) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of BK1310 Intramuscular Injection in Healthy Infants
Official Title  ICMJE Phase 3 Study of BK1310 Intramuscular Injection in Healthy Infants
Brief Summary The purpose of this study is to evaluate the safety and efficacy of an intramuscular injection of BK1310 in healthy infants.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Immunization
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: BK1310
Intervention: Biological: DPT-IPV-Hib (Combined Vaccine)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 25, 2017)
33
Original Estimated Enrollment  ICMJE
 (submitted: June 13, 2017)
30
Actual Study Completion Date  ICMJE August 9, 2018
Actual Primary Completion Date November 2, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Months to 43 Months   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03188692
Other Study ID Numbers  ICMJE BK1310-J02
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mitsubishi Tanabe Pharma Corporation
Study Sponsor  ICMJE Mitsubishi Tanabe Pharma Corporation
Collaborators  ICMJE The Research Foundation for Microbial Diseases of Osaka University
Investigators  ICMJE
Study Director: General Manager Mitsubishi Tanabe Pharma Corporation
PRS Account Mitsubishi Tanabe Pharma Corporation
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP