Clinical Trial: Exploratory Clinical Study of MT-2301

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Exploratory Clinical Study of MT-2301 in Healthy Infants (Phase 2)

Brief Summary: The purpose of this study is to evaluate efficacy and safety of MT-2301 when co-administered with DPT-IPV using ActHIB® as a control in healthy infants.

Detailed Summary:
Sponsor: Mitsubishi Tanabe Pharma Corporation

Current Primary Outcome: Anti-PRP antibody prevalence rate with 1 μg/mL or higher [ Time Frame: 4 weeks after the primary immunization (Visit 4) ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 (GMT) 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 (GMT) of anti-PRP antibody [ Time Frame: 4 weeks after the booster dose (Visit 6) ]
  • Antibody prevalence rate and geometric mean antibody titer (GMT) against diphtheria toxin, pertussis, tetanus toxin, and less virulent strain of polio virus [ Time Frame: 4 weeks after the primary immunization (Visit 4) ]
  • Antibody prevalence rate and geometric mean antibody titer (GMT) against diphtheria toxin, pertussis, tetanus toxin, and less virulent strain of 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: Same as current

Information By: Mitsubishi Tanabe Pharma Corporation

Dates:
Date Received: May 14, 2014
Date Started: April 2014
Date Completion:
Last Updated: October 15, 2015
Last Verified: October 2015